#for those who don’t know the history of thalidomide
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thalidomide came out in 1956
which means caryn very narrowly missed it considering 1956-1957 is about when the stan twins would have been born
(idk man it’s 1957 in our timeline)
#for those who don’t know the history of thalidomide#it was marketed as a drug that could reduce morning sickness and it did do that#it just also had severe negative effects on the. y’know. children#needless to say it’s not used to help pregnant folks anymore
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18 Reasons I Won’t Be Getting a Covid Vaccine.. Umm – I mean Jab
ON JUNE 14, 2021 BY GERI UNGUREAN
This article was sent to me by a Christian sister. Thank you, Michelle!
Much love to you in Jesus.
A few friends have asked my thoughts on the covid jab(s) so I thought it was time to write an article on the topic.
All my friends had not heard most of the details I shared, so I figured you might appreciate hearing some of what I told them.
Knowing how contentious this issue is, part of me would rather just write about something else, but I feel like the discussion/news is so one-sided that I should speak up.
As I always strive to do, I promise to do my best to be level-headed and non-hysterical.
I’m not here to pick a fight with anyone, just to walk you through some of what I’ve read, my lingering questions, and explain why I can’t make sense of these covid vaccines.
THREE GROUND RULES FOR DISCUSSION
If you care to engage on this topic with me, excellent.
Here are the rules…
I am more than happy to correspond with you if…
You are respectful and treat me the way you would want to be treated.
You ask genuinely thoughtful questions about what makes sense to you.
You make your points using sound logic and don’t hide behind links or the word “science.”
If you do respond, and you break any of those rules, your comments will be ignored/deleted.
With that out of the way, let me say this…
I don’t know everything, but so far no one has been able to answer the objections below.
So here are the reasons I’m opting out of the covid vaccine.
#1: VACCINE MAKERS ARE IMMUNE FROM LIABILITY
The only industry in the world that bears no liability for injuries or deaths resulting from their products, are vaccine makers.
First established in 1986 with the National Childhood Vaccine Injury Act, and reinforced by the PREP Act, vaccine makers cannot be sued, even if they are shown to be negligent.
The covid-vaccine makers are allowed to create a one-size-fits-all product, with no testing on sub-populations (i.e. people with specific health conditions), and yet they are unwilling to accept any responsibility for any adverse events or deaths their products cause.
If a company is not willing to stand behind their product as safe, especially one they rushed to market and skipped animal trials on, I am not willing to take a chance on their product.
No liability. No trust.
Here’s why…
#2: THE CHECKERED PAST OF THE VACCINE COMPANIES
The four major companies who are making these covid vaccines are/have either:
Never brought a vaccine to market before covid (Moderna and Johnson & Johnson).
Are serial felons (Pfizer, and Astra Zeneca).
Are both (Johnson & Johnson).
Moderna had been trying to “Modernize our RNA” (thus the company name)–for years, but had never successfully brought ANY product to market–how nice for them to get a major cash infusion from the government to keep trying.
In fact, all major vaccine makers (save Moderna) have paid out tens of billions of dollars in damages for other products they brought to market when they knew those products would cause injuries and death–see Vioxx, Bextra, Celebrex, Thalidomide, and Opioids as a few examples.
If drug companies willfully choose to put harmful products in the market, when they can be sued, why would we trust any product where they have NO liability?
In case it hasn’t sunk in, let me reiterate…3 of the 4 covid vaccine makers have been sued for products they brought to market even though they knew injuries and deaths would result.
Johnson & Johnson has lost major lawsuits in 1995, 1996, 2001, 2010, 2011, 2016, 2019 (For what it’s worth, J&J’s vaccine also contains tissues from aborted fetal cells, perhaps a topic for another discussion)
Pfizer has the distinction of the biggest criminal payout in history. They have lost so many lawsuits it’s hard to count. You can check out their rap sheet here. Maybe that’s why they are demanding that countries where they don’t have liability protection put up collateral to cover vaccine-injury lawsuits.
Astra Zeneca has similarly lost so many lawsuits it’s hard to count. Here’s one. Here’s another…you get the point. And in case you missed it, the company had their covid vaccine suspended in at least 18 countries over concerns of blood clots, and they completely botched their meeting with the FDA with numbers from their study that didn’t match.
Oh, and apparently J&J (whose vaccine is approved for “Emergency Use” in the US) and Astrazenca (whose vaccine is not approved for “Emergency Use” in the US), had a little mix up in their ingredients…in 15 million doses. Oops.
Let me reiterate this point:
Given the free pass from liability, and the checkered past of these companies, why would we assume that all their vaccines are safe and made completely above board?
Where else in life would we trust someone with that kind of reputation?
To me that makes as much sense as expecting a remorseless, abusive, unfaithful lover to become a different person because a judge said deep down they are a good person.
No. I don’t trust them.
No liability. No trust.
Here’s another reason why I don’t trust them.
#3: THE UGLY HISTORY OF ATTEMPTS TO MAKE CORONAVIRUS VACCINES
There have been many attempts to make viral vaccines in the past that ended in utter failure, which is why we did not have a coronavirus vaccine in 2020.
In the 1960’s, scientists attempted to make an RSV (Respiratory Syncytial Virus) vaccine for infants.
In that study, they skipped animal trials because they weren’t necessary back then.
In the end, the vaccinated infants got much sicker than the unvaccinated infants when exposed to the virus in nature, with 80% of the vaccinated infants requiring hospitalization, and two of them died.
After 2000, scientists made many attempts to create coronavirus vaccines.
For the past 20 years, all ended in failure because the animals in the clinical trials got very sick and many died, just like the children in the 1960’s.
You can read a summary of this history/science here.
Or if you want to read the individual studies you can check out these links:
In 2004 attempted vaccine produced hepatitis in ferrets
In 2005 mice and civets became sick and more susceptible to coronaviruses after being vaccinated
In 2012 the ferrets became sick and died. And in this study mice and ferrets developed lung disease.
In 2016 this study also produce lung disease in mice.
The typical pattern in the studies mentioned above is that the children and the animals produced beautiful antibody responses after being vaccinated.
The manufacturers thought they hit the jackpot.
The problem came when the children and animals were exposed to the wild version of the virus.
When that happened, an unexplained phenomenon called Antibody Dependent Enhancement (ADE) also known as Vaccine Enhanced Disease (VED) occurred where the immune system produced a “cytokine storm” (i.e. overwhelmingly attacked the body), and the children/animals died.
Here’s the lingering issue…
The vaccine makers have no data to suggest their rushed vaccines have overcome that problem.
In other words, never before has any attempt to make a coronavirus vaccine been successful, nor has the gene-therapy technology that is mRNA “vaccines” been safely brought to market, but hey, since they had billions of dollars in government funding, I’m sure they figured that out.
Except they don’t know if they have…
#4: THE “DATA GAPS” SUBMITTED TO THE FDA BY THE VACCINE MAKERS
When vaccine makers submitted their papers to the FDA for the Emergency Use Authorization (Note: An EUA is not the same as a full FDA approval), among the many “Data Gaps” they reported was that they have nothing in their trials to suggest they overcame that pesky problem of Vaccine Enhanced Disease.
They simply don’t know–i.e. they have no idea if the vaccines they’ve made will also produce the same cytokine storm (and deaths) as previous attempts at such products.
As Joseph Mercola points out…
“Previous attempts to develop an mRNA-based drug using lipid nanoparticles failed and had to be abandoned because when the dose was too low, the drug had no effect, and when dosed too high, the drug became too toxic. An obvious question is: What has changed that now makes this technology safe enough for mass use?”
If that’s not alarming enough, here are other gaps in the data–i.e. there is no data to suggest safety or efficacy regarding:
Anyone younger than age 18 or older than age 55
Pregnant or lactating mothers
Auto-immune conditions
Immunocompromised individuals
No data on transmission of covid
No data on preventing mortality from covid
No data on duration of protection from covid
Hard to believe right?
In case you think I’m making this up, or want to see the actual documents sent to the FDA by Pfizer and Moderna for their Emergency Use Authorization, you can check out this, or this respectively. The data gaps can be found starting with page 46 and 48 respectively.
For now let’s turn our eyes to the raw data the vaccine makers used to submit for emergency use authorization.
#5: NO ACCESS TO THE RAW DATA FROM THE TRIALS
Would you like to see the raw data that produced the ���90% and 95% effective” claims touted in the news?
Me too…
But they won’t let us see that data.
As pointed out in the BMJ, something about the Pfizer and Moderna efficacy claims smells really funny.
There were “3,410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1,594 occurred in the vaccine group vs. 1,816 in the placebo group.”
Wait…what?
Did they fail to do science in their scientific study by not verifying a major variable?
Could they not test those “suspected but unconfirmed” cases to find out if they had covid?
Apparently not.
Why not test all 3,410 participants for the sake of accuracy?
Can we only guess they didn’t test because it would mess up their “90-95% effective” claims?
Where’s the FDA?
Would it not be prudent for the FDA, to expect (demand) that the vaccine makers test people who have “covid-like symptoms,” and release their raw data so outside, third-parties could examine how the manufacturers justified the numbers?
I mean it’s only every citizen of the world we’re trying to get to take these experimental products…
Why did the FDA not require that? Isn’t that the entire purpose of the FDA anyway?
Good question.
Foxes guarding the hen house?
Seems like it.
No liability. No trust.
#6: NO LONG-TERM SAFETY TESTING
Obviously, with products that have only been on the market a few months, we have no long-term safety data.
In other words, we have no idea what this product will do in the body months or years from now–for ANY population.
Given all the risks above (risks that ALL pharmaceutical products have), would it not be prudent to wait to see if the worst-case scenarios have indeed been avoided?
Would it not make sense to want to fill those pesky “data gaps” before we try to give this to every man, woman, and child on the planet?
Well…that would make sense, but to have that data, they need to test it on people, which leads me to my next point…
#7: NO INFORMED CONSENT
What most who are taking the vaccine don’t know is that because these products are still in clinical trials, anyone who gets the shot is now part of the clinical trial.
They are part of the experiment.
Those (like me) who do not take it, are part of the control group.
Time will tell how this experiment works out.
But, you may be asking, if the vaccines are causing harm, wouldn’t we be seeing that all over the news?
Surely the FDA would step in and pause the distribution?
Well, if the adverse events reporting system was working, maybe things would be different.
#8: UNDER-REPORTING OF ADVERSE REACTIONS AND DEATH
According to a study done by Harvard (at the commission of our own government), less than 1% of all adverse reactions to vaccines are actually submitted to the National Vaccine Adverse Events Reports System (VAERS) – read page 6 at the link above.
While the problems with VAERS have not been fixed (as you can read about in this letter to the CDC), at the time of this writing VAERS reports over 2,200 deaths from the current covid vaccines, as well as close to 60,000 adverse reactions.
“VAERS data released today showed 50,861 reports of adverse events following COVID vaccines, including 2,249 deaths and 7,726 serious injuries between Dec. 14, 2020 and March 26, 2021.”
And those numbers don’t include (what is currently) 578 cases of Bell’s Palsy.
If those numbers are still only 1% of the total adverse reactions (or .8 to 2% of what this study published recently in the JAMA found), you can do the math, but that equates to somewhere around 110,00 to 220,000 deaths from the vaccines to date, and a ridiculous number of adverse reactions.
Bet you didn’t see that on the news.
That death number would currently still be lower than the 424,000 deaths from medical errors that happen every year (which you probably also don’t hear about), but we are not even six months into the rollout of these vaccines yet.
If you want a deeper dive into the problems with the VAERS reporting system, you can check this out, or check this out.
But then there’s my next point, which could be argued makes these covid vaccines seem pointless…
#9: THE VACCINES DO NOT STOP TRANSMISSION OR INFECTION
Wait, what?
Aren’t these vaccines supposed to be what we’ve been waiting for to “go back to normal”?
Nope.
Why do you think we’re getting all these conflicting messages about needing to practice social distancing and wear masks AFTER we get a vaccine?
The reason is because these vaccines were never designed to stop transmission OR infection.
If you don’t believe me, I refer you again to the papers submitted to the FDA I linked to above.
The primary endpoint (what the vaccines are meant to accomplish) is to lower your symptoms.
Sounds like just about every other drug on the market right?
That’s it…lowering your symptoms is the big payoff we’ve been waiting for.
Does that seem completely pointless to anyone but me?
It can’t stop us from spreading the virus.
It can’t stop the virus from infecting us once we have it.
To get the vaccine is to accept all the risk of these experimental products and the best it might do is lower symptoms?
Heck, there are plenty of other things I can do to lower my symptoms that don’t involve taking what appears to be a really risky product.
Now for the next logical question:
If we’re worried about asymptomatic spreaders, would the vaccine not make it more likely that we are creating asymptomatic spread?
If it indeed reduces symptoms, anyone who gets it might not even know they are sick and thus they are more likely to spread the virus, right?
For what it’s worth, I’ve heard many people say the side effects of the vaccine (especially the second dose) are worse than catching covid.
I can’t make sense of that either.
Take the risk.
Get no protection.
Suffer through the vaccine side-effects.
Keep wearing your mask and social distancing…
And continue to be able to spread the virus.
What?
It gets worse.
#10: PEOPLE ARE CATCHING COVID AFTER BEING FULLY VACCINATED
Talk about a bummer.
You get vaccinated and you still catch covid.
It’s happening in Washington State
It’s happening in New York
It’s happening in Michigan
It’s happening in Hawaii
It’s happening in several other states too.
It happened to 80% of 35 nuns who got the vaccine in Kentucky. Two of them died by the way.
In reality, this phenomenon is probably happening everywhere, but those are the ones making the news now.
Given the reasons above (and what’s below), maybe this doesn’t surprise you, but bummer if you thought the vaccine was a shield to keep you safe.
It’s not.
That was never the point.
If 66% of healthcare workers in L.A. are going to delay or skip the vaccine…maybe they aren’t wowed by the rushed science either.
Maybe they are watching the shady way deaths and cases are being reported…
#11: THE OVERALL DEATH RATE FROM COVID
According to the CDC’s own numbers, covid has a 99.74% survival rate.
Why would I take a risk on a product, that doesn’t stop infection or transmission, to help me overcome a cold that has a .26% chance of killing me–actually in my age range is has about a .1% chance of killing me (and .01% chance of killing my kids), but let’s not split hairs here.
With a bar (death rate) that low, we will be in lockdown every year…i.e. forever.
But wait, what about the 500,000 plus deaths, that’s alarming right?
I’m glad you asked.
#12: THE BLOATED COVID DEATH NUMBERS
Something smells really funny about this one.
Never before in the history of death certificates has our own government changed how deaths are reported.
Why now, are we reporting everyone who dies with covid in their body, as having died ofcovid, rather than the co-morbidities that actually took their life?
Until covid, all coronaviruses (common colds) were never listed as the primary cause of death when someone died of heart disease, cancer, diabetes, auto-immune conditions, or any other major co-morbidity.
The disease was listed as the cause of death, and a confounding factor like flu or pneumonia was listed on a separate line.
To bloat the number even more, both the W.H.O. and the C.D.C. changed their guidelines such that those who are suspected or probable (but were never confirmed) of having died of covid, are also included in the death numbers.
Seriously?
If we are going to do that then should we not go back and change the numbers of all past cold and flu seasons so we can compare apples to apples when it comes to death rates?
According to the CDCs own numbers, (scroll down to the section “Comorbidities and other conditions”) only 6% of the deaths being attributed to covid are instances where covid seems to be the only issue at hand.
In other words, reduce the death numbers you see on the news by 94% and you have what is likely the real numbers of deaths from just covid.
Even if the former CDC director is correct and covid-19 was a lab-enhanced virus (see Reason #14 below), a .26% death rate is still in line with the viral death rate that circles the planet ever year.
Then there’s this Fauci guy.
I’d really love to trust him, but besides the fact that he hasn’t treated one covid patient…you should probably know…
#13: FAUCI AND SIX OTHERS AT NIAID OWN PATENTS IN THE MODERNA VACCINE
Thanks to the Bayh-Dole Act, government workers are allowed to file patents on any research they do using tax payer funding.
Tony Fauci owns over 1,000 patents (see this video for more details), including patents being used on the Moderna vaccine…which he approved government funding for.
In fact, the NIH (which NIAID is part of) claims joint ownership of Moderna’s vaccine.
Does anyone else see this as a MAJOR conflict of interest, or criminal even?
I say criminal because there’s also this pesky problem that makes me even more distrustful of Fauci, NIAD, and the NIH in general.
#14: FAUCI IS ON THE HOT SEAT FOR ILLEGAL GAIN-OF-FUNCTION RESEARCH
What is “Gain-of-Function” research?
It’s where scientists attempt to make viruses gain functions–i.e. make them more transmissible and deadlier.
Sounds at least a touch unethical, right?
How could that possibly be helpful?
Our government agreed, and banned the practice.
So what did the Fauci-led NIAID do?
They pivoted and outsourced the gain-of-function research (in coronaviruses no less) to China–to the tune of a $600K grant.
You can see more details, including the important timeline of these events in this fantastically well-researched documentary.
Mr. Fauci, you have some explaining to do…and I hope the cameras are recording when you have to defend your actions.
For now, let’s turn our attention back to the virus…
#15: THE VIRUS CONTINUES TO MUTATE
Not only does the virus (like all viruses) continue to mutate, but according to world-renowned vaccine developer Geert Vanden Bossche (who you’ll meet below if you don’t know him) it’s mutating about every 10 hours.
How in the world are we going to keep creating vaccines to keep up with that level of mutation?
We’re not.
Might that also explain why fully vaccinated people are continuing to catch covid?
Why, given that natural immunity has never ultimately failed humanity, do we suddenly not trust it?
Why, if I ask questions like the above, or post links like what you find above, will my thoughts be deleted from all major social media platforms?
That brings me to the next troubling problem I have with these vaccines.
#16: CENSORSHIP…AND THE COMPLETE ABSENCE OF SCIENTIFIC DEBATE
I can’t help but get snarky here, so humor me.
How did you enjoy all those nationally and globally-televised, robust debates put on by public health officials, and broadcast simultaneously on every major news station?
Wasn’t it great hearing from the best minds in medicine, virology, epidemiology, economics, and vaccinology from all over the world as they vigorously and respectfully debated things like:
Lockdowns
Mask wearing
Social-distancing
Vaccine efficacy and safety trials
How to screen for susceptibility to vaccine injury
Therapeutics, (i.e. non-vaccine treatment options)
Wasn’t it great seeing public health officials (who never treated anyone with covid) have their “science” questioned.
Wasn’t it great seeing the FDA panel publicly grill the vaccine makers in prime time as they stood in the hot-seat of tough questions about products of which they have no liability?
Oh, wait…you didn’t see those debates?
No, you didn’t…because they never happened.
What happened instead was heavy-handed censorship of all but one narrative.
Ironically, Mark Zuckerberg can question vaccine safety, but I can’t?
Hypocrite?
When did the first amendment become a suggestion?
It’s the FIRST amendment Mark–the one our founders thought was most important.
With so much at stake, why are we fed only one narrative…shouldn’t many perspectives be heard and professionally debated?
WHAT HAS HAPPENED TO SCIENCE?
What has happened to the scientific method of always challenging our assumptions?
What happened to lively debate in this country, or at least in Western society?
Why did anyone who disagrees with the WHO, or the CDC get censored so heavily?
Is the science of public health a religion now, or is science supposed to be about debate?
If someone says “the science is settled” that’s how I know I’m dealing with someone who is closed minded.
By definition science (especially biological science) is never settled.
If it was, it would be dogma, not science.
OK, before I get too worked up, let me say this…
I WANT TO BE A GOOD CITIZEN
I really do.
If lockdowns work, I want to do my part and stay home.
If masks work, I want to wear them.
If social distancing is effective, I want to comply.
But, if there is evidence they don’t (masks for example), I want to hear that evidence too.
If highly-credentialed scientists have different opinions, I want to know what they think.
I want a chance to hear their arguments and make up my own mind.
I don’t think I’m the smartest person in the world, but I think I can think.
Maybe I’m weird, but if someone is censored, then I REALLY want to hear what they think.
Don’t you?
To all my friends who don’t have a problem with censorship, will you have the same opinion when what you think is censored?
Is censorship not the technique of dictators, tyrants, and greedy, power-hungry people?
Is it not a sign that those who are doing the censoring know it’s the only way they can win?
What if a man who spent his entire life developing vaccines was willing to put his entire reputation on the line and call on all global leaders to immediately stop the covid vaccines because of problems with the science?
What if he pleaded for an open-scientific debate on a global stage?
Would you want to hear what he has to say?
Would you want to see the debate he’s asking for?
#17: THE WORLD’S LEADING VACCINOLOGIST IS SOUNDING THE ALARM…
Here is what may be the biggest reason this covid vaccine doesn’t make sense to me.
When someone who is very pro-vaccine, who has spent his entire professional career overseeing the development of vaccines, is shouting from the mountaintops that we have a major problem, I think the man should be heard.
In case you missed it, and in case you care to watch it, here is Geert Vanden Bossche, explaining:
Why the covid vaccine may be putting so much pressure on the virus that we are accelerating it’s ability to mutate and become more deadly.
Why the covid vaccines may be creating vaccine-resistant viruses (similar to anti-biotic resistant bacteria).
Why, because of previous problems with Antibody Dependent Enhancement, we may be looking at a mass casualty event in the next few months/years.
If you want to see/read about a second, and longer, interview with Vanden Bossche, where he was asked some tough questions, you can check this out.
If half of what he says comes true, these vaccines could be the worst invention of all time.
If you don’t like his science, take it up with him.
I’m just the messenger.
But I can also speak to covid personally.
#18: I ALREADY HAD COVID
I didn’t enjoy it.
It was a nasty cold for two days:
Unrelenting butt/low-back aches
Very low energy.
Low-grade fever.
It was weird not being able to smell anything for a couple days.
A week later, coffee still tasted a little “off.”
But I survived.
Now it appears (as it always has) that I have beautiful, natural, life-long immunity…
…not something likely to wear off in a few months if I get the vaccine.
In my body, and my household, covid is over.
In fact, now that I’ve had it, there is evidence the covid vaccine might actually be more dangerous for me.
That is not a risk I’m willing to take.
IN SUMMARY
The above are just my reasons for not wanting the vaccine.
Maybe my reasons make sense to you, maybe they don’t.
Whatever does makes sense to you, hopefully we can still be friends.
I for one think there’s a lot more that we have in common than what separates us.
We all want to live in a world of freedom.
We all want to do our part to help others and to live well.
We all want the right to express our opinions without fearing we’ll be censored or viciously attacked.
We all deserve to have the access to the facts so we can make informed decisions.
Agree or disagree with me; I’ll treat you no differently.
You’re a human just as worthy of love and respect as anyone else.
For that I salute you, and I truly wish you all the best.
I hope you found this helpful.
If so, feel free to share.
If not, feel free to (kindly) let me know what didn’t make sense to you and I’d be happy to hear your thoughts too.
Stay curious and stay humble.
PS. If you think I studied this topic well, think about how much thought I would put into helping you with your health. Helping people with their health is what I do all day, every day.
PPS. Health can’t be injected, but it can be earned.
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I really want to know if Japan’s population decline and lack of immigration had any effect on how many people got quirks and how many didn’t. Also did the first generation consist of select people of all ages getting quirks before passing it down to the 2nd generation who started manifesting around 4 years old? If so why was the first generation the only one where people older than 4 got their quirks? Does everyone have a quirk factor gene and some people activate it while others don’t? I like the idea that more quirks occurred each generation but how did it happen?
I too am pretty curious about it! To address the second question first, it 100% is the case that there were people in the early years manifesting quirks well past the age of four. That seems plausible even in what we see of the broad-strokes history provided by the first chapter, but it becomes unequivocally the case as of the OFA dream. In it, we see a man who was the sole caretaker of his elderly parents come to AFO because he’d manifested a quirk that gave him spikes all over his body and his parents rejected him; he was desperate to have it removed so he could go back to caring for them. There’s no way that story works if the guy has had spikes since he was four.
And heck, we don’t even know if that scene is in the first generation. I mean, everyone kind of assumes so—assumes AFO is from the first generation—but nowhere does the story actually say that explicitly. Indeed, if the origin of quirks is a widespread but naturally occuring genetic mutation, some sort of sudden evolutionary leap, I’d still expect it would take many years for it to become widespread enough for the world to slide into the kind of chaos we’re told about/shown in the dream flashback.
Surely, after all, there would have been a lot of skepticism! People would be much more apt to believe that it was some kind of hoax, a weird isolated government experiment, all sorts of things that people could tell themselves before quirks became so widespread that everyone—from the person on the street corner to heads of state—had to accept that this was an issue all of humanity, every country in the world, would have to face.
(Let's continue this past the jump, shall we?)
There’s also the possibility that quirks were artificially induced in those early years, via some power we’ve yet to glimpse, and that’s why the manifestation was different for the early generation(s). An artificial source would certainly be a better explanation for the periodic incidences we have of animals manifesting quirks: if they were purely the result of some kind of widespread, concurrent genetic mutation in humans, and passed down solely in that fashion, what could the explanation be for beings like Nedzu or the bakeneko in Vigilantes?(1)
Yet another possibility is that quirks were some sort of latent trait that began to manifest as a result of exposure to some new technology or medicine—or, like Overhaul thought, began as some sort of disease. This is a terrible example, for which I apologize, but the first thing that came to my mind was something like thalidomide in the 50s, marketed in many countries as an over-the-counter medication for morning sickness, only for it to get rapidly pulled within a decade as it became clear that it was the common element in a subsequent surge in congenital anomalies. An unexpected biological reaction to a new environmental factor might explain, depending on the details, the rare occurrence of quirk-bearing animals; it falters somewhat in that if there were such a clear-cut common element, you’d think it would have been isolated a long time ago.
Whatever the case, it’s explicit canon that there was at least one generation of people who manifested quirks well into adulthood before quirks became widespread and consistently began appearing earlier.
As to why the early generation(s) could/did manifest later, and assuming that quirks are naturally occurring, not the result of some hidden plan, my handwave would be that it’s tied to Ujiko’s theory about quirks becoming stronger over time. If it was always the case that, as Aizawa says early on, quirks are like a muscle that you can exercise to strengthen, I could see them taking longer to manifest in generations where the quirks themselves are weaker. Maybe back then, children just weren’t typically strong enough to manifest quirks at all, and it took the body stabilizing and strengthening with maturity to bring them out. Now, however, quirks have gotten so strong that even gradeschoolers can be a credible menace with them!
As to the first part of your question, anon, while I’m interested in the question from a worldbuilding perspective, I wouldn’t venture to take any guesses about how the spread of quirks looked in Japan without having any clue which of the above explanations is correct.
To raise a further consideration, though: are we actually going to find out? And to that, I think the answer is this: The origin of quirks we get, if any, will depend on the endgame we get for quirks. Specifically, my bet is that it’s riding on what the story’s going to make of the Quirk Singularity Theory.
See, if the origin of quirks were just a handwave for why superpowers are A Thing in Horikoshi’s setting, that’d make it an interesting but ultimately peripheral aspect of the story. If that’s all he needed it for, though, I feel like he probably wouldn’t have introduced a concept like Quirk Singularity, and he definitely wouldn’t have brought it up repeatedly. The fact that Quirk Singularity keeps coming up suggests it’s a real issue, and if the story resolves without dealing with it, it’s going to feel like that “terrible collapse in the far future” is still looming, an ominous shadow that heroes have chosen to close their eyes and ignore.
On the other hand, the only people who do bring it up are villains or gullible; we keep hearing about it being a fringe theory, a weird thing that only cults believe. So maybe the intent is that it isn’t a real thing, and believing that it is is nothing but a paltry justification for AFO and Ujiko’s ghastly mad science.
After all, grappling with the biological destiny of humanity feels wildly outside the scope of the story, which is generally more concerned with the inequality and instability brought about superpowers. It’s about how society adjusts to superpowers, the “correct” way to use them, and how to deal with people who misuse them. It’s definitely about how to address the snowball effect that happens when your predecessors’ shortsighted decisions result in a society that seems “peaceful” (at least compared to the previous era of chaos), but is actually terminally unbalanced by the way it segregates autonomy and responsibility to a chosen few and makes victims/villains of everyone else. That all adds up to a perfectly valid story to tell, one that a bunch of random teenagers learning to be heroes can actually meaningfully affect.
But what exactly is Midoriya Izuku, crime-fighting high schooler, supposed to do about an inevitable calamity in human evolution that he will be middle-aged, old-aged, or even dead by the time comes to fruition?
And that takes us back to the origin of quirks. If, again, there’s nothing to the Quirk Singularity Doomsday Theory, then the origin of quirks doesn’t really matter. If there is something to it, and humanity has only a few more generations to figure out a solution, then the origin becomes much more relevant. In turn, assuming that society isn’t going to do a 180 and embrace Overhaul or Ujiko’s solutions, whatever that origin is needs to reflect something Midoriya can actually affect.
It’s awfully late in the game to be introducing some ominous other power that’s behind this whole thing, something older and even more foundational to superpowered society than AFO.(2) AFO’s power, meanwhile, is at least the seed of something that could be used to strip humanity of quirks, though that’s certainly not something it’s capable of at its current levels. Star & Stripe’s New Order would certainly have brought it closer, but that was removed from the table as quickly as it was put there.
Moreover, given the series’ framing of quirks as connected to a person’s inherent nature, as frequently having a profound impact on foundational aspects of one’s personality, is taking that all away really the most likely outcome of the series? And is a character who only got a superpower because Horikoshi’s first editor said, “Wouldn’t it be cooler if he had a power, though?” really going to be cleared by the last editor to take away everyones’ powers forever?
I really have no idea. I’ve long been fascinated with the Quirk Singularity issue both because it’s just about the only thing that even gets us in the ballpark of “excusing Ujiko,”(3) and because it just seems so incredibly out of Midoriya’s league.
…Which, given the way the writing is trending lately, probably means that we’re going to find out that there was never anything to it except Ujiko’s paranoid delusions after all. RIP.
Thanks for the interesting question, anon!
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1: Maybe the Queen Bee, too, but its association with Ujiko significantly ups the odds that it’s the result of some experimentation on his part, rather than an animal that manifested a quirk naturally.
2: No one needs another one of those, “It was aliens all along,” curveballs that made Platinum End such a universal laughingstock.
3: Averting species-wide evolutionary doomsday, and all it costs is a few measly decades of corpse desecration! Then they’ll see! They’ll all see!
#bnha#bnha endgame#on the origin of quirks#ujiko daruma#quirk singularity theory#bnha worldbuilding#stillness answers
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Gloucester History Festival : Call the Midwife, Q&A with Heidi Thomas and Stephen McGann. September 21st 2019. Blackfriars Priory.
Disclaimer: These are purely my thoughts and impressions as an audience member at this event (sat at the back). I didn’t make an audio recording or scribble any written notes. I haven’t got the greatest short-term memory in the world and I am human, so have a tendency to add my own interpretations to what I hear. Also there was a lot of content in almost an hour-and-half.
There aren’t any mind blowing revelations contained in my write up and I understand most fans will have knowledge of the subjects discussed in this talk. So I have to admit, I have therefore probably over shared my impressions of the event rather than the search for revelations . I have tried to provide an insight for fans who have not had the opportunity and privilege to listen to or meet either Heidi, Stephen or any of the CtM crew. It is incredibly difficult to do justice to the passion and enthusiasm of Stephen or reflect the clarity and intelligence of Heidi, but I have done my inadequate best.
I have failed to find out the name of the host, but what I do know is, he was excellent. He asked the right questions at the right times, without unnecessary interruption or pursuing his own agenda.
Just to get it out of the way, nothing new was revealed about series 9 apart from the political landscape that affected London in 1965. The CS was touched on, but only what we know regarding the Hebridean location, although there will also be a Poplar story involving Reggie. I was very relieved that Stephen, who as we know doesn’t interfere with Heidi’s writing, is dropping lots of World Cup hints for series 10. (For those who don’t know England held it and won it in 1966, we are talking football)
So to what was discussed:
Thalidomide was spoken about at some length, including the involvement of the Thalidomide community in reference to the story thread. I think a significant thing I picked up from listening to both of them talk concerning this and other topics, is how much the storylines affect the team. Obviously some have a personal edge, the Mrs Jenkins CS12 storyline was mentioned, touching on Stephen’s mam’s own story of the lost twin brothers told in Flesh and Blood. But I got the impression that every story is meticulously researched and also “lived” by Heidi in writing and the cast in trying to depict the human side to the historical facts.
What I was unaware of was how every person affected by Thalidomide developed completely unique combinations of deformities. So in the same way, Susan isn’t based on any particular person, her range of disabilities is unique to her, like it would be in reality. They didn’t say if there would be more Susan and the Mullucks’ in the future.
I hadn’t seen Heidi and Stephen interviewed together before and it is obvious how close they are. Stephen is well, I can’t think of a more appropriate word than besotted and uses every opportunity to compliment his wife. I felt Heidi is used to it, but by nature is very modest and would rather talk about other people’s input or Call the Midwife in general than her own achievements.
She is definitely a people person and is very happy to talk about Jennifer Worth and the original order that became the fictional Order of Raymond Nonnatus all day long. Both these relationships seem to have left a huge impression on her. It left me wondering what influence Jennifer would have now on CtM if she was still with us. Heidi did say that Jennifer, who in her own memoirs merged facts together to tell a good story, understood how drama works.
Which leads me on to another subject that was touched on, the shows authenticity. I found this particularly interesting because I love my history and I love research, archives, stats and all stuff nerdy. To try and sum up various strands of conversation; the impression I got is audiences can be very selective when it comes to authenticity.
They explained that sometimes it isn’t always possible physically, financially and legally (health and safety etc) to replicate everything perfectly, although they do go to ridiculously great lengths to do so. They used the example of a pram that was completely in keeping with the year it was featured, apart from the lining and this was picked up by viewers!!! But as Heidi explained the prams were reused frequently and often relined, so it’s very hard to find one today with the original lining.
This led to a discussion on what I call “selective desire for authenticity”, people want it to be realistic, but have difficulty accepting smoking Drs and nurses, drugs being prescribed to “cure” homosexuality etc. The audience having to accept that it is a mid-20th century show reflecting mid-20th century values and attitudes and that can make CtM a hard watch at times. (I must reiterate my words)
Heidi explained how since they moved on from Jennifer’s memoirs she starts each series by meticulously reviewing the medical statistics and reports for each particular year and that is where her inspiration comes from. She then has to translate this into drama and inject the human story. This struck me, as much as they aim for CtM to be as accurate as possible, sometimes dry facts just don’t tell a good tale and it’s the essence of the story that appears to be the priority, the human angle and truth behind the facts is what they are aiming to get right.
There was time for some excellent questions at the end, (someone mentioned something about alpacas but they were removed swiftly and appropriately by security). One lady explained her mother had been a Queen's Nurse in that era and I loved how she explained what an inspiration her mother had been to her. She touched on the fact that her mother and the nurses and midwives CtM are depicting were revolutionary, they were changing lives for women, pioneering independence, including continuing working after marriage and during motherhood, forging careers not just making ends meet. Something I have always thought needs highlighting and celebrating more. (My words here again, I need to clarify)
A lady asked if CtM will explore legal abortion as it has illegal. Heidi just explained those events are inline with series 10 and she hasn’t considered how she will tackle this, but as always she will try and highlight the main medical stories of each particular year as appropriate.
The final question from Di, asked what would Dr T think of today’s NHS? Heidi actually offered a lot of thoughts on this and explained that the NHS has never been perfect. Again, I can’t remember the exact words, but she implied it has always been over stretched because it’s always trying to reach forward and there has never been enough resources to fulfill its aims and ideals. “The goal posts are always moving” as I would say. She did say Dr T wouldn’t be happy.
Stephen talked about the dilemma we have now created for ourselves by the overuse of antibiotics (Heidi pointed out Dr T was part of the generation who created that problem). He also highlighted the anti-vaccine culture and how Dr T wouldn’t understand today’s thinking because he had seen those diseases up close and personal in his lifetime and wouldn’t be able to comprehend a generation who wouldn’t embrace a solution. (I emphasise these are my words from the impressions I got listening to their responses)
On a personal note; What a day I had! Gloucester was a mystery to me before yesterday and I have totally fallen in love with this stunning historic city and its cheery friendly folk. The venue Blackfriars Priory was perfect. Closing thoughts; Heidi and Stephen are genuinely lovely people who care very much about what they do and the people who appreciate what they do.
#call the midwife live#Heidi Thomas#Stephen McGann#Gloucester history festival 2019#al’s thoughts#do I get travel expenses
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Hey, as someone with severe schizophrenia who spent two whole years of my life thinking I was being tortured by the Illuminati, Satan, and so on, I have to tell you that what you're experiencing is an illness. I avoided meds because I didn't think I was sick until I was in so much pain I asked my own mom to shoot me. You don't have to live in constant fear and pain. Please seek help - Invega saved my life.
Hahaha... first allow me say, I hope you are doing well. If so I am glad for you. Secondly; your unfortunate mental illness does NOT in any way define the experiences of others. So, according to your ill mind’s perceptions my being shot twice in my left leg and as I was attempting to exfiltrate from the area and being run-over by an F-350. Which resulted in my being hospitalized for almost a week and spending 30 days in a recovery facility till I could walk without the need of a walker. All that is just a fabrication of my mind. Hmmmmm, seems you are a gifted psychic as well, my schizophrenic friend. I have been shot, stabbed, in explosions, on fire, burnt by chemicals and acids, beaten almost to death, run-over several times, drugged and subject to the protocols of the New Phoenix Program just to name a few things I have experienced and been subjected to by various groups or elements, many associated to or with the Shadow Government. Yeah, I know you will want to say that that statement in and of itself is demonstrative of your point. If so, I suppose you would have said the same to all the victims the Government tested LSD on back in the day, or the Tuskegee Syphilis Experiment victims, or the those children - now adults who were tortured under MK Ultra, or the thousands many still have not been informed of the Radiation Experiment done on them, or the Thalidomide Children that were murdered in experiments during the Cold War even unto the present, this list of victims is near endless. What would you and your schizophrenic mind tell all these Very Real Historical Victims, cause guess what; many were locked in institutions and drugged out of their minds for decades. Till the Truth came out, and the Government says, “Oooops Sorry”! Wholly inadequate, and criminal beyond belief. So I guess, someone like yourself, who obviously is mentally ill and subject to delusions and hallucinations can explain all that away because of you sickness. I have no desire to be rude or cruel to the handicapped or mentally deficient. However, I do NOT suffer fools lightly either. Why don’t you read some of my other posts, and do the research to find out the facts of the matter to each. I include all the ancillary information to help those that may doubt what I say. Not that being right in one area makes me correct and Truthful in another, because believe me I am very well aware of how “crazy” most everything I discuss sounds; and I haven’t even gotten to the really fantastic and surreal stuff. Made all the more so since I am discussing very obscure and much of it still classified material and events; nonetheless I am giving a True and Factual account. Like why did Nixon go to China, a historical event that even Kissinger in his recent book admits the actual purpose is still classified. And NOT that it is any of your business; but I have undergone several psychological evaluations and have PASSED each and everyone of them. A consequence of the “Barney Fifes” in the world doing what they have been told to do. The FACT that you have a mental illness; Does NOT change my histories and realities. Unlike you, who still lives at Mommy’s, I have Lived a very full Life. I am use to small minds judging me and calling me a lair for telling the Truth. I wish you well, and hope you have had a Merry Christmas and that your New Year is prosperous. Please keep taking your medication, though if you think you KNOW anything about me or the TRUTH of the matter. I think you need to adjust your dosing, or add some additional psychotropics to your cocktail. Hahahaha... cause I sincerely wish you the best.
I encourage anyone and everyone who reads any of my essays/posts to correspond or ask questions. Even you, all I ask is that instead of trying to waste mine and your time with trying to impugn my mental state or assassinate my character, try to focus on the facts or elements within the content I post. The reason I have invested the effort to answer your sad statement is so that should others in similar fashion presume to do so in the future I can reference my response to your’s. Not that anyone bothers to read anymore, LMFAO.
P.S. For my part I don’t Live in Fear, just so we are clear on that point. Since your Mommy did NOT teach you; a brave man dies only once. A coward dies a thousand times a day. Any concern I have is for others especially the innocent and weakest members of our society. And the Pain, mostly physical is from actual encounters as the one I mentioned above. Please don’t project your issues of Fear and Pain onto me.
Donn
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Side Effects
Cycle 7, Day 10
So, today, I’m going to whinge about chemotherapy. I know that’s hardly a change, but, what will be a change is which drug I’m whinging about.
I started this blog/writing project referring to the drug Marizomib as “the Captain Ameica supersoldier serum,” (and variations on that), because it’s cooler and less scary-sounding than “potentially lethal desperate gamble.” The good news is, it’s now passed Phase 2 safety testing, and gone on to Phase 3 (so, it’s probably safe-ish). And there’s some studies using it to treat various other neurological cancers and diseases. So, like Temodar, if you do plan on getting a central nervous system malignancy (and I know that’s one of the first places breast and lung cancers metastasize to) and require chemo, there’s a chance you’ll get dosed with Marizomib sooner or later (this isn’t some sort of secret knowledge either, it’s just being able to navigate PubMed and/or the FDA clinical trials/testing website).
First off, even though this is good news for glioblastoma patients, it’s still extremely targeted. I used to think that implied a degree of precision with much less collateral damage; I’m pretty sure now it means it’ll only directly effect cells with certain biochemical markers, and still do a fair amount of damage to the surrounding cells. The brain is both anatomically and molecularly walled off from the body, so any substance that can make it to that sacred ground is potentially dangerous. A known toxic substance (again, all chemotherapeutic agents are toxic) that’s injected and designed with the hope of getting to the brain, is an act of desperation (and possibly a weird long-form suicide, but those are the only choices available). Anyway, I have no doubt that if this proves effective at treating gliomas, it’ll be tested on all sorts of various other, seemingly-unrelated cancers, because that’s how the biotech/pharmaceutical industry works (again, Temodar was developed for skin cancer and breast cancer)(and thalidomide was originally developed as a sedative for children - I’m not making that up)(also, thalidomide is making a comeback as an anticancer drug as an antiangiogenic, but that’s not usually anyone’s first-choice drug group for chemo). So, first, the boring, technical med/tech stuff. If memory serves, early studies indicated Marizomib only worked on cancers with a p53 mutation (this is a near-universal mutation in solid tumors) when treated with radiation. In other words, you’re gonna need a brain tumor with both the p53 mutation, in an anatomical location they can get at it with radiotherapy, which isn’t all of the brain (google “pontine gliomas” or “Wernicke’s area” for fun). In my case, i believe they were testing it on IDH1 tumors (that’s indicative of a secondary glioma)(in my case, there’s two previous brain tumors that could be the hive queen, although a good mental flossing, nuking, and 20+ rounds of chemo seem to have soothed the situation). There were a half-dozen-ish mutations that made me a candidate in this trial, and I had them all on a post-it note that I seem to have misplaced. Ask your doctor if it’s right for you! Also, as someone who knows a little about how the safety data is valued and analyzed, if I were a cynic and in charge of such things, I’d look for candidates who were likely to do well on regular treatment (ATRX and MGMT come to mind, along with patient’s age, prior history, etc.) and then just pump them full of the experimental drug.
Now for the fun and/or gruesome part’ what to expect when you’re on Marizomib. I’ll admit, this is extraordinarily unscientific, and based on my own experience, combined with what the Warlocks and their research staff have told me; also, part of Phase 2 testing is establishing the safe, recommended dose, and, although I’m not dead (yet) or displaying any severe long-term side-effects, knock on wood; there’s always a good chance the Warlocks slightly overdosed me (and if that’s the case, I’d tell them they were doing their job well; seriously, I’ve had this damned disease for 16 years, I’m ready for some sort of closure); so, your side effects and mileage may vary. First of all, chemo doses build up (in me, anyway). The fifth day of Temodar is worse than the first, I just didn’t previously notice it with Marizomib because I only get three doses a month, and they’re a week apart, so I can heal a little between episodes. So, day 15 is much worse than Day 1 (in terms of marizomib; Day1 of each cycle is combined Marizomib and temodar which is awesome).
The main things I’ve noticed with Marizomib are the sort of extreme, severe nausea we used to associate with old-school leukemia and lymphoma chemo agents, so keep zofran on you at all times i still haven’t puked*. I also get severe muscle pain usually in my arm and upper body, but it’s not too bad if the nurses can put an IV into one of my ulnar or radial veins in the wrist. This pain has varied from “Aw, I pulled a muscle” to “wild animal gnawing a limb off to get out of the leghold trap.” I also keep Tylenol on me, and, at a nurse’s suggestion, started using it like the zofran - one big dose to start with, and smaller doses every 2-6 hours, which, like the zofran, makes it tolerable, but I still spend most infusion evenings trapped in a Johnny Cash lyric. The interest effects are that Marizomib is linked to hallucinations, which I have had. In my case, these are all pretty low-key (in my case) and brief, and usually concern weird little tricks of the light, or inanimate objecs moving or swaying. One of the researchers told me one guy quit the trial after hallucinating that his furniture attacked him (personally, I think that would be a siginificant improvement on the couch, but I digress). Because I try to go to bed early on infusion nights, before the dancing furniture shows up, I only rarely experience it. I do, however, get hyper-realistic, amazingly vivid dreams (usually on Marizomib-only days), which are kind of cool and psychedelic. However, they are so convincingly real that it usually takes me a minute after waking to figure out who and where I am. That’s all the first 12-ish hours post-infusion, though (for me), and there’s a solid 6-8 hour gap between infusion and side-effects that you might want to use to grab a meal, or do whatever you had planned for the day (still, keep the zofran and pain-killers nearby), The day after, I usually wake up with the hangover from hell (assuming I find my way back to my own dimension and body)(I’m serious, these dreams are something else)(the Warlocks have made a note of it and said it sounds like there may be some sort of weird, quasi-hallucinatory sleep stuff happening). I’m also dioriented (in the physical sense - my left side’s wonky) the day after. as bad as it might sound, it’s usually done in 36 hours, Nowadays, there’s fatigue. This one’s big; it wasn’t so bad in the initial treatment, but now that I’m up to maintenance doses (the Temodar is over four times what it initially was, I shudder to think at the Marizomib), it might not hit until day 3, but it’s nasty. I’m still just trying to power through it, but it does catch up with you (my personal definition of fatigue is when it it’s almost physically painful to be awake). Still, all things considered, it beats the alternatives I’ve been presented with. And if I’ve presented it as physically miserable and mentally unpleasant, that’s an understatement. I’ve been able to “cheat” a bit by keeping mega-high levels of hydration (fun fact: according to a sports health study, beer counts as a hydrating source if you’re using it as well as water rather than “instead of water”)(I wish I’d known that one in the initial treatment), and maintaining a near-psychotic level of physical activity (that’ll increase your metabolism, so you don’t keep them in your body a minute longer than they have to be.
*Your sense of achievement gets a little twisted throughout the process.
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308: How to Use Your Hormones to Your Advantage With FloLiving
New Post has been published on https://healingawerness.com/news/308-how-to-use-your-hormones-to-your-advantage-with-floliving/
308: How to Use Your Hormones to Your Advantage With FloLiving
Child: Welcome to my Mommy’s podcast.
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Katie: Hello and welcome to “The Wellness Mama Podcast.” I’m Katie from wellnessmama.com. And this episode is all about hormones, specifically for women, and how we can use our hormones and monthly fluctuations in hormones to our advantage. I’m here with Alisa Vitti, who is a women’s hormone and functional nutrition expert and a pioneer in female biohacking. She is the best-selling author of a book called “WomanCode,” the creator of “Cycle Syncing,” which is a female-centric diet and lifestyle program that leverages our hormonal patterns for optimal health, fitness, and productivity. As the founder of floliving.com, she has built the world’s first menstrual health care platform that helps women around the world put their period issues to rest using her natural protocols. She’s also the creator of an app I use all the time called MyFLO, which is a period tracking app. But it’s the first and only one that gives functional medicine period tracking advice, and it’s designed to help users eliminate symptoms and schedule our lives according to our cycles. It’s consistently ranked one of the top 10 paid apps in health and fitness. And in this episode, we are going to go deep on all things related to female hormonal health, and how you can use your hormones to your advantage. Alisa, Welcome, Thanks for being here
Alisa: I’m so happy to be here, Katie. Thanks for having me.
Katie: I’m so excited to chat with you, mainly because you’re so fun to talk to anyway. And also because you have so much important information to share This topic is increasingly important. I know you’ve just written a new book “In the Flo” and a term that stood out to me and I think we need to establish as a starting point is the idea of infradian biological rhythm. So, if you don’t mind, let start there. Explain what that is.
Alisa: Yes. Yes. Yes. I mean, for me, so the infradian biological rhythm is the special biological rhythm that women have in their reproductive years. So, from puberty to menopause, you have this activated infradian rhythm. And, you experienced that, you know, across the month in your monthly cycle. However, it isn’t just something that affects your reproductive health. It affects five other systems of the body and really, you know, dictates the quality of your overall health. And it’s something that is a term that comes from, you know, chronobiology, but it’s not a term that we’ve heard about before.
We’ve heard all about the circadian rhythm. We know how important that is. We know we should be taking care of it with our blue-light-blocking glasses and with, you know, getting to bed when it’s dark, and waking up with the sunrise, and not messing with that. And there have been numerous studies, for example, the nurses study back…it’s been a multi-decade study confirming that if you disrupt that circadian pattern, you will develop big disease of inflammation. And what I was really so excited to share in this new book is just how critical, health critical it is for women to be caring for their infradian rhythm while it is active as really the foundation, the cornerstone of absolutely everything they do because it affects so many systems of their body while it’s active.
Katie: Yea, that makes a perfect sense and that’s actually probably a new term for a lot people. It was definitely a new term for me. And I’d love to hear, I’ve read some of the research and I hear from a lot of people daily about women who are struggling with health and especially with hormone related health issues. But I know, in your research, explain some of the stats. How big of a problem this is that we are facing now.
Alisa: Oh, my goodness. I mean, you know, 47%, and I think that’s a conservative number, of women are dealing with a hormonal health issue. You know, 90% of moms feel like they’re chronically stressed and exhausted. You know, almost all research, medical, fitness, nutrition research is being done on men, but then those suggestions and recommendations are being shared to women as things that are going to help them, and then they end up feeling worse because their infradian rhythm’s disrupted. And I think it’s just so important that we recognize that if we’re not specifically supporting and working with our infradian rhythm, we are actually disrupting it and making ourselves unnecessarily sick, stressed, fat, tired, you know, you name it, and, of course, hormonal. But nature really with this infradian rhythm has designed you to be super optimized, and it’s really the ultimate biohack, in my opinion.
Katie: Yea, I love that. I think understanding that gives us more tools in our toolkit to address these things. But to circle back, you mentioned that all these studies are done on men. Explain that. Explain why, because you’re right, a lot of studies I read even on Pubmed, are on male. Is there a reason this is the case?
Alisa: Yeah. So, I mean, there’s a long history of women being excluded from medical research. I mean, some of it is just some good old fashioned research bias in terms of whoever has been historically conducting research. You know, you have to keep in mind, women have only been allowed to practice medicine recently in recent history, so you had a lot of male researchers just coming from their point of view. But then there was also sort of a big, terrible crisis that happened with a drug trial for thalidomide in the ’60s that caused a huge amount of birth defects, and so women were then actively, during their reproductive years, excluded from drug trials.
However, in 1996, the National Institute of Health put out a special committee to request that medical research actively go out of their way to include young females in their studies, young being women, you know, over the age of 21 and not postmenopausal. And then, in 2016, VWC Women’s Health Collective published kind of a progress report following that mandate, and, you know, the unfortunate update was that progress has been basically slim to painfully slow. And, you know, we’re just nowhere being included. And that’s important from a medical point of view because, of course, you know, medications and all these things are not being developed or dosed, you know, within a female ecosystem, but then it also has transmitted this sort of gender bias into nutrition and fitness research.
So, again, here, all nutrition and fitness research is really mainly done on men and postmenopausal women because they find it to be, I guess, too difficult to try to figure out how to create experiments for women in these different stages of their infradian rhythm. But what then happens, of course, is that you’ll get, you know, some sort of new discovery like intermittent fasting is probably my favorite one to talk about because it’s so…you know, the promise of intermittent fasting is absolutely fantastic, right? It’s going to help with insulin sensitivity, it’s going to help with cellular health and anti-aging, and it seems to be this universally wonderful tool to help you stay healthy.
But the truth is that those studies are done on men and postmenopausal women for whom intermittent fasting is a fantastic health tool. But for women in their reproductive years, the few studies that have been done, which I sort of detail in the new book, they actually show that it has the opposite and adverse reaction in women in their reproductive years. Meaning if you do intermittent fasting while you have your infradian rhythm active, you will make your insulin sensitivity worse, right? So instead of improving it, which is what all the intermittent fasting research shows for men and postmenopausal women, for women in their reproductive years, you’ll have worse insulin sensitivity. You can gain weight. You can increase your cortisol levels dramatically. You can shrink your ovaries, stop ovulation, disrupt sleep, and dysregulate your mood. So it’s not like a little bad for you. It’s completely bad for you.
And I think that’s really important because we need, just like medicine is moving to more bio-individual forms of treatment for cancer, for example, for all sorts of diseases, we really need to look at making the nutrition information that we’re being given specific to the biological rhythms that are affecting that individual. And that sometimes can be gender-based.
So I love the idea of women sort of understanding that not everything is something that they should try. And it really should be much more detailed about, you know, “This study was done for men, or for postmenopausal women.” But if you’re in your reproductive years, I’d love to see that kind of coverage being shared in mainstream articles that, you know… You know, for example, and I know Mark Sisson has done this in some of his blogs when he shares about the ketogenic diet, and how that has…the few studies that have been done show that actually can disrupt women’s thyroid hormones and not have them have all the weight loss. It can disrupt fertility.
So to make sure that that is being presented to women when they’re reading about these health trends, I think, is so important. And it’s important because we have been sort of, you know, living in an environment, culturally as women, that basically has told us one story, which is, you know, “Your hormones are crazy and not to be trusted. Your metabolism is slower than men’s, and therefore, you have to compensate for that by just generally finding new and better ways to have some sort of restrictive diet and to work out more. And that’s how you’re going to ‘have the body or control your body in the way that you want.’
And that is just not accurate at all. In fact, in the book, I kind of go into how your metabolism actually is affected by the infradian rhythm and how you can eat to, you know, maximize your metabolism. It’s completely different than what we’ve been taught.
Katie: That’s so fascinating. And I get in the research sense why it’s easier to work on men because their hormones are more stable. But, like you said, it’s a disadvantage to women and I think a lot of women have turned to figure out what works for them individually because of that. Because there’s not a lot of knowledge of this in the medical system. I’m curious, you mentioned you can eat in rhythm with your infradian rhythm and that can be really beneficial. Is that also true for time restricted eating or for any type of fasting. Because like you said, the research is really amazing on what fasting can do in the body and I know a lot of women want to try it. Is there a time in the cycle that is less problematic?
Alisa: Yeah, you can do intermittent fasting much more safely in the first half of the cycle when your metabolism is naturally slower and you need less calories. But for women in their reproductive years, the only amount of time that is safe to do intermittent fasting is the 12-hour kind of like between dinner and breakfast fast. So, you wouldn’t want to…as soon as you push past the 12-hour mark, then you start to have all the adverse reactions that the studies sort of outline. So you don’t want to do like a two-day fast or, you know, a 13…even the 13-hour fast is too much. Again, once you’ve completed your…you know, once you’re postmenopausal, you can go to town and do as much intermittent fasting as feels good to you. But while you’re in your reproductive years, you know, let’s say you’re done with dinner at 7:00, just don’t eat breakfast till 7:00 the next morning, and that will be every-single-day intermittent fast that is hugely health beneficial and will give you all those great benefits without harming you. And that will be much easier to do in the first half of your cycle because of your metabolic changes.
Katie: That makes sense and I think that’s another important distinction. We all “intermittent fast” while we’re sleeping, no one is eating while they are asleep. I know there is good data, even for women, about not eating too late at night. Because that digestive system interrupt and how you want your digestion to be pretty calm so your body can do other things.I think that’s an easy, like you said, even when you’re pregnant, you can choose to not eat after 7pm and just eat a good breakfast.
It’s not like you have to eat every three hours while you’re sleeping, but it means you don’t have to do a super long fast either. I also think, I wonder if there’s an alternative side to this. Which is yes, women are harder to research because our hormones change, but because of this, we get so much more data if we pay attention to our hormones than men do. And I know you have an app that I use regularly, the myflo app, and seeing those hormonal changes and getting input on what you’re supposed to eat that time of the month, it makes a huge difference. And so I try to think of it, on the positive side, I think we also have this amazing benefit if we learn to pay attention to it of how our hormones change. So, walk us through some of those things that those monthly fluctuations and hormones tell us.
Alisa: Well, I mean, first of all, the fact that we think that our hormones are not stable, or that, you know, it’s harder to research, it’s just not medically accurate, you know, which I go into great detail in the book. You know, the truth is, the men’s hormones fluctuate, they just fluctuate in a pattern that mimics the circadian pattern, meaning…and I like to kind of contrast this to just…and I’ll go right in into how your hormones fluctuate in the infradian rhythm.
But for example, men, they make all their testosterone while they’re sleeping. They wake up with the full dose of testosterone that is concurrent with their big surge in cortisol that everyone gets in the circadian biological rhythm. So they wake up with all of this. And then they get, you know, two, three more pulses of that in decreasing concentration throughout the day. So you’ll get a big dose at 5:00 or 6:00 in the morning, then there’ll be another pulse at like noon, another one around 3:00, and then that starts to really taper off so that they can wind down for the evening and go to sleep.
But this is exactly why that it’s easier for them to, let’s say, do research on men because they’re just tracking the sort of one or two, you know, cortisol and testosterone, but they’re tracking it throughout the day. So they are factoring in time differences and hormone differences. So, for example, Olympic coaches who train Olympic athletes will have men do any sort of training that will help them gain muscle in the early morning when testosterone and cortisol is at a maximum. It’s going to make that happen more easily, and it’s going to help them be able to do that with less risk for injury versus, let’s say, having them train later in the afternoon. And they’re doing this based on all this research that goes deep into the fluctuating levels of hormones for men. It just happens in a shorter timeframe in a day, 24 hours, versus women happening over 30 days.
But the technology or the technique to create studies that factor in these changes already exists because they’re using them for men. So I think the medical community realizes they need to figure this out. They actually have created a menstrual cycle in a petri dish, you know, hooked up to a computer, and they’re starting to do some testing of medications throughout the cycle, which I think is a huge step forward. There’s a long way to go. But I think the more that women like you who are tracking where you are in your cycle, and I’m so thrilled you’re using the MyFLO app, you know, that we can actually participate in studies with the full knowledge of where we are in our cycle. And so people can do studies for women who are just in the follicular phase, or just in the ovulatory phase, or just in the luteal phase, or in the menstrual phase.
And these four phases have their own distinct hormonal signature, a ratio of hormonal combination that create a certain response in these six systems of the body, which include the brain, the metabolism, the immune system, the microbiome, the stress response system, and the reproductive system. So, you know, any sort of testing or research could be done on any of these systems of the body to see how they fluctuate. In fact, in 1996, Catherine Woolley from Northwestern University published a really important paper, you know, in psychoneuroendocrinology about her research looking at the fluctuating levels of estrogen throughout the infradian rhythm and how the brain actually changes 25% across the cycle. And just knowing that is really important because, you know, knowing that your brain is going to change throughout the cycle can help you set yourself up for, you know, better productivity, better workflow with less stress throughout the month, for example.
And, of course, this can be applied to your workouts, to your eating. And it’s just amazing once you understand these fluctuating patterns, just how easy it is to just work with that, to go with the flow, to get in your flow, and to start making everything just less of a push, less of a force, and more of this state of flow, which I just think is so important.
And I don’t know about you, Katie, but, you know, I’ve done all the fun, personal growth and development things. Like I’ve attended one of my favorite Tony Robbins, you know, the weekend, where you walk across the firewalk and, you know, listening to people and experts talk about these peak flow states and biohackers talk about these peak flow states. And I always found…I felt a sense of disconnection from achieving that because it was all predicated on this concept that you have to do the same thing day in and day out to achieve that peak flow state, to put you in a peak flow state, right, to optimize for that. And that really makes sense, you know, to have a morning routine, for example, that’s the same day in and day out if you have the male hormonal pattern that closely mimics the circadian biological rhythm. Because it does make sense for them to get up in the morning, to do a big workout, to do some of their big deep work first thing in the morning when their cognitive focus is really turned on. But it doesn’t make sense for women. In fact, I find it…it kind of feels like this…for me, that somehow I have to feel like I’m a failure already even though I haven’t started my day, right, because I don’t always feel like depending on where I am in my infradian rhythm, jumping out of bed in the morning and doing a workout. And the pushing and forcing myself to do that actually is infradian rhythm disruptive. And so what I want to say to women is you can achieve a peak flow state, but it’s going to look very different from that of men. And it means that instead of trying to force yourself to be the same every day, to do the same routine at the same time, to eat the same food day in and day out, week over week, month over month, that actually is disruptive to you and forces your body to perform sub-optimally. The way you’re going to achieve your peak flow state is to really work with your infradian rhythm and to optimize for that week over week. So, your state of flow is going to look very different from that of men.
And I also think it’s really interesting that biohacking is such a popular concept among men. And that also makes sense because there is a real energy cliff that happens for them around 3:00 in the afternoon when testosterone and cortisol really start to move toward their lower serum concentration levels in the body, so they’re less able to focus on deep project work, they have less energy and stamina for workouts. And, you know, using nootropics or upgraded coffee or things like that really do help in that timeframe to help with that natural energy cliff. But as women, we don’t have these energy cliffs. You know, because we’re the ones that carry babies when we’re pregnant, natures made our bodies extremely good at conserving nutrients and energy. And so if you support your infradian rhythm, what you’re going to find is that you don’t ever fall off the energy cliff.
And Katie, you might be saying now to yourself, “Well, what about PMS and all the things that happened to women around their period where they do feel so bad?” I’ve been taking care of women with their hormones and their periods for close to 20 years now. And myself, having suffered from a major, you know, bout of PCOS in my 20s, in my teens and 20s, and having recovered from that, what I can tell you is, the reason, the deepest reason why so many women are struggling with their hormones is because everything we’re doing, the way we’re eating, the way we’re working out, the way we’re organizing how we work during the day is disrupting our infradian rhythm. And when you disrupt your infradian rhythm, you disrupt all those six systems of the body, and you just can’t feel your best. You can’t be your healthiest. You can’t have the energy you want. It’s not in your head. And it’s not that you’re a failure and you have no willpower and you just can’t stick to these days, you’re just using the wrong system to support your biological rhythm.
Katie: That makes so much sense. And a couple of follow-up questions to that, a short one to begin with. So I do regular blood tests just to keep track of all my metrics, and I also track, like through my Oura Ring, for instance, and, like, kind of line that up with my cycle so I can see what’s going on. Is there a time of the month for women that’s the best to get blood test if you’re going to do regular blood testing, or is it more about getting it at the same time in your cycle?
Alisa: It really depends on what you’re trying to test. So if you’re trying to test progesterone levels, right, you would want to test those in the luteal phase, you know, because that’s when your progesterone levels are active. You know, if you’re doing fertility testing, some people will recommend that you do that on day three of your cycle. So it just depends on what you’re looking for. If you’re trying to test for cortisol levels, you can do that, you know, sort of in a 24-hour saliva testing situation. I really just think it’s about what you’re trying to test. And, of course, that’s for static blood tests where it’s a standard blood draw. I think there’s a lot more sophisticated things now that you can be using like Dutch testing and for urine analysis and saliva testing that gives you a spectrum of hormonal levels over time. That’s always the best way to see things, is, you know, how do your hormone levels rise and fall over the whole course of the infradian rhythm? And the first place to really start doing that, you know, every single day is just with some basic basal body temperature tracking to just see. Even though many people use that for fertility, it also will sort of indicate, you know, how your infradian rhythm is performing over the course of a month. Katie: Got it. Okay, that’s really helpful. So then you’ve mentioned several times, like, different ways we can start to support our infradian rhythm, through different lifestyle factors, through diet. I’d love to go a little bit deep on some of these, maybe starting with diet. I love and totally resonate with that idea that if you are having trouble sticking to a diet, it’s probably not really that you’re doing it wrong, it’s that you’re on the wrong type of system for your body right now. So let’s start with food. How can we support our infradian rhythm using food?
Alisa: So first, we have to understand how the infradian rhythm affects our metabolism. So in the 30-day period where the infradian rhythm makes ts like one rotation, right, as opposed to in one day, you will have a pretty dramatic fluctuation in your metabolism. So in the first half of your cycle, meaning the follicular phase and the ovulatory phase, your metabolism is naturally slower. So you can actually get away with fewer calories and, you know, lighter meals, in general, and I’ll go into specifics of what you should be eating.
In the second half of your cycle, the luteal phase and the bleeding phase, your calorie requirements are higher, in fact, up to anywhere between 16% and 20% more caloric levels are required during this time and your metabolism speeds up because there’s an epic amount of structural changes happening inside the body during this phase of the cycle from a reproductive standpoint. You know, the lining of the uterus is being built and maintained, the corpus luteum is growing, and, you know, all of this is happening, and it takes nutrients to make it happen. Plus, you have to build, manufacture bigger levels of estrogen and progesterone to have a healthy cycle.
So, again, the nutrient requirements are much greater in the second half of the cycle, and your metabolism speeds up. It’s important to know that for, let’s say, metabolic maintenance, or another way to say this, like weight maintenance or blood sugar stability, that when your metabolism is slower, right, you can eat lighter. So I always suggest in this phase of the cycle, you know, and I break it down by each of the four phases. But for today’s purposes, we’ll kind of just talk in sort of broader swathes here, that in the first half of the cycle, you can eat more, let’s say, raw foods, salads, smoothies, kind of like what you would associate your typical diet, healthy light eating, right?
You know, steamed veggies, and poached fish, and things that are going to be easier on the digestion because your metabolism is slower. It’s going to seek to conserve those nutrients. You don’t need to snack as frequently because, again, slower metabolism, you’re going to conserve these nutrients for longer. And you can just get away with a lighter, less fat in the diet, in the food preparation during this time.
Then when you switch to the luteal phase and the menstrual phase, this is when… I’m trying to think of like a dietary type that you could easily grab on to. This is kind of like the luteal phase, which is 10 to 12 days. I always say this is kind of like your macrobiotic phase where you really want to be eating proactively slow-burning carbohydrates, and whichever ones work for you. If they’re legumes, great. If it’s some grains, great. If you can’t do grains, you can do root vegetables, whatever your digestion and food sensitivities can handle, but making sure that you’re proactively eating more of them because your metabolism is so much faster and your caloric needs are higher, you have to put that in proactively. We all know what happens when we don’t, right, when you try to stick to this stereotypical lighter eating, the salad life, you know, in your luteal phase, what happens when you do that all day, right? You have your smoothie in the morning, you have a salad at lunch. And you get home from work, and you just start eating, and you don’t stop, and you don’t know what happened like four hours later. You’ve eaten chips, and crackers, and pasta, and cheese, and cookies, and your body is like trying to make up for its caloric requirement, but you’re now binge eating because you haven’t proactively been eating slow-burning carbohydrates throughout the day.
So we have specific meal plans and recipes to help you really understand what to eat when so that this is not confusing for you at all because I know this can be an adjustment because we’ve been told just to eat the same way every day, and that’s completely wrong for your infradian rhythm. And then in your menstrual phase, you don’t need as many complex carbohydrates, but you do need more fats and proteins. And so this would be more of like, let’s say your paleo or keto week, if you will.
So to help you kind of break it down into these diets that you are familiar with, that would be the way to think about it. And doing this stabilizes blood sugar throughout the infradian rhythm, optimizes your metabolism, works with the metabolic changes that are happening, and keeps your energy and your mood, like, supercharged, right? So instead of falling off the energy cliff around the luteal phase because you’re not nourishing your body the way it needs, and you’re now tired, PMSing, fatigued, stressed, moody, instead you’d feel the opposite. You feel good, you feel energized, you feel clear-headed and happy, and you don’t have PMS symptoms that, you know, certainly will balance that out because you’re also eating foods that are going to help you make more hormones and break them down more efficiently.
So some of us struggle with, let’s say, estrogen dominance. The foods that you’re going to be eating, the foods that are in the food chart in the book are going to help you, you know, both manufacture and metabolize hormones really efficiently as well. So that really helps stabilize any symptoms that you’re having throughout the cycle.
Katie: Yeah, when I learned of this concept from you, it was kind of like a paradigm shift for me because I started just paying attention to what was already happening but that I had never really paid attention to because I didn’t know to pay attention to, and I definitely noticed that shift. Like, in the first half of my cycle, I really wasn’t that hungry. I could do like soups, and salads, and light stuff and like generally not think about food. I’ve been on a pretty big, like, weight loss journey the last year as I’m finally now not pregnant or nursing a baby. And I’ve noticed that first half of my cycle, it’s easy to lose weight, and then that’ll, like, stabilize. I won’t gain weight in the second half, but it’ll just kind of like rest there for a while, and then the next first half of a cycle I’ll lose more weight. And I also noticed, like, when we start paying attention to our hormones, it’s like my cravings now are telling me what I actually need. So in the second week of my cycle, I’m craving like salmon, and sweet potatoes, and tons of olive oil, and like all the green things I can possibly eat for the micronutrients. Like I’ll make a pesto out of, like, so much parsley, and cilantro, and all these things.
Alisa: Oh, my gosh. I’m so proud of you.
Katie: But it’s just amazing when you have that lens to look through. I just, like, start seeing those patterns, and then it’s, like, I don’t have to stress about it. I can be like, “Oh, first half of cycle, I don’t have to really worry about getting enough calories. I’ll just eat when I’m hungry. It’s totally fine.” And then second half, I pre-plan, so I know I’m not going to hit that afternoon like, “Oh my gosh, I’m starving.” I have sweet potatoes pre-made or whatever it may be, and like just having that prep makes it so much easier. I’m also curious, are there different nutrient needs at different times as well? Like, are there supplements that can be beneficial at certain times, and is it also that we shouldn’t take the same supplements every single day?
Alisa: So that’s interesting because there are micronutrients that are, you know, pretty universally required by the endocrine system to function. So, you know, I think the endocrine system, we want to be supporting that too. So, I would say that yes, nutrient needs do change throughout the cycle, but certain baseline nutrients like B vitamins which are water-soluble, and you need to put that in every day. Magnesium, which is lost daily, again, water-soluble. So some of these very transient micronutrients that we tend to be very deficient in or easily depleted with due to stress, or caffeine intake, or chemical exposure, it is really helpful to keep putting those in on a daily basis, especially if you’re someone who’s dealing with a health issue. Giving yourself that extra boost of certain micronutrients, which I outline in the book can be really, really helpful. But from the food point of view, and taking micronutrients is one thing. Macronutrients, which are these food changes that you make, you know, we’re really talking about, for example, in the ovulatory phase as you know, Katie, because I know you’re a cycle syncer, is that, you know, you’re eating foods that are high in glutathione and in the most bioavailable form. And this is because estrogen is at its peak concentration, that it will be, throughout the cycle, that its most serum concentration that you’ll ever have. And so depending on how your body is functioning, right, if your liver is optimized, for example, for elimination, or if you’re having great bowel movements, or if you’re having constipation, you may be more sensitive to that estrogen, right?
So if you’re breaking out during ovulation, that’s a sign that you’re not metabolizing that estrogen efficiently. But by eating the foods in the ovulatory phase that I’m outlining for you in the book, you’re going to break down that estrogen as quickly as possible because you’re supercharging the liver with glutathione. So that’s a great example of these types of macronutrient and micronutrient intersections that happen throughout the cycle. And I think the more we leverage that like you’re describing in your own experience, you lose weight more easily. You know, you maintain your energy.
And I think this weight loss thing, this is like a personal thing for me because, you know, you know me. I used to be 60 pounds heavier, and I gained quite a bit of weight when I had my pregnancy. And I’ve lost all that without dieting, right. And I love saying that to people because that just doesn’t make any sense given the current cultural narrative about how you’re supposed to lose weight as a woman. You know, actually, it’s not really gender specified, though it should be.
So how men lose weight is just by restricting calories and working out more, but how women lose weight is not by restricting calories. So you actually have to nourish yourself in order for your metabolism to work optimally. And I love that you’ve already seen for your own weight loss journey that you are able to take advantage of that slower metabolic phase, right, the first half of the cycle, the follicular and ovulatory phases to slower metabolism, which, if we listen to the current rhetoric, would mean that you wouldn’t be able to lose weight during that time. But by eating the right way during that time, you do lose weight.
And then instead of eating the same way during the luteal phase, which would if you continue to eat the lower-calorie, let’s say, format in the luteal and menstrual phases, you jack up your cortisol levels, okay, because that creates internal stress on the body to be calorically deprived when you have new caloric requirements. And that cortisol increase signals to your fat cells to stay put, right? So now you’re gaining weight, or at least not losing any weight, and that’s why women feel so frustrated like they can’t lose weight. They’re like, “I don’t get it. I’m depriving myself. I’m counting my calories. I’m doing the same thing each and every day.” But if you do do it each and every day, you’re actually, again, disrupting your hormones, disrupting the infradian rhythm, and you’ll end up either, at best, not losing any weight or, at worst, gaining weight. And this also has big implications when we start talking about fitness as well.
Katie: That makes sense. And I want to…let’s jump into fitness in just a second. But to reiterate what you said as well, that was the other really staggering thing for me. I think there’s, especially for women, that we often underestimate how much the emotional and mental side really is important for stress, and for weight loss, and for everything. And I know that’s an area I fought for a lot of years. And when I finally addressed that, it was like my relationship with food entirely changed. And I was able to lose weight without dieting, without really changing my diet or exercise at all.
I think there was such a shift in my stress response, and so I think that’s another issue. I always say to women, like that’s really worth looking at, whether it’s therapy, whatever your process is going to be. That was hugely pivotal for me. And I want to talk about fitness too because I’m really curious now. So you said men have this 24-hour cycle, and they’re better to train in the morning. For women, are there times of the month that we should maybe look at different types of training that can really line up with our biology?
Alisa: You bet. In fact, not only is this like…And, by the way, this is like not just a nice idea or like, “Oh, this would be fun to try.” This is a must-do. Like just as much as we now know disrupting the circadian rhythm causes disease, disrupting your infradian rhythm really messes with your health. And so much so that the U.S. women’s soccer team is cycle syncing and training their athletes based on this methodology because they understand that there are metabolic changes and, you know, fitness requirements of the body that really affect performance as it goes throughout the cycle.
So what that means is in the first half of your cycle, let’s say you want to put on some lean muscle and lose some body fat, like who doesn’t want to do that right? And that’s just good for all-around well being. The way you want to accomplish that in the first half of your cycle is with cardio-based exercise, and then high-intensity interval training. However, if you were to continue to do the cardio and the high-intensity interval training, which, by the way, is kind of what we’re told to do every day, right? Like, I mean, think of any workout slogan like Nike, like “Just do it.” Push yourself. Don’t quit. Just commit. No pain, no gain, right, all of this like… Just even if you don’t want to, you should keep trying to do the same thing every day. That’s really good for guys, really bad for you. Because if you do cardio and high-intensity interval training in the luteal and menstrual phases, you turn on fat storage and turn on muscle wasting.
So, here you are. And I discovered this years ago in my practice because I routinely be like, 15 years ago, there was this trend for people to get fit by training for a triathlon, even if they weren’t like athletes. They just used it as an excuse to get in shape. And I had many, many clients coming in to see me say, you know, “Gee, I don’t understand what’s happening. I’m running five miles every day, I’m swimming, you know, four times a week,” and whatever else they were doing, “and I’m eating what I’m supposed to be eating according to my trainer.” And they’ve put on 20 or 25 pounds at the end of three months. And I, you know, looked into that, and, of course, the answer was very clear, “Because your metabolism changes. And if you do the same physical activity at the same intensity day over day throughout the infradian rhythm, you disrupt it, you increase cortisol, you mess with estrogen levels, and you end up gaining weight. And that’s the fact.”
So if you are somebody who’s been, you know…you know, New Year’s resolutions or you sign up for some online fitness program, and it’s the similar kind of workouts every day, high-intensity interval training, you should expect, at best, not to gain any weight, or sorry, not to lose any weight. But at worst, you’re going to gain some weight. And that’s what’s so frustrating because we’re told the wrong information. We’re told information that’s meant for men or postmenopausal women. And if you’re in your reproductive years, you need the right information. And that’s why I’m so excited about having written this book because it’s finally just clearing this up once and for all.
There is an infradian rhythm, you have to work out differently. First half of the cycle, you’ll do your cardio, you’ll do your high-intensity interval training. Second half of the cycle, you’ll do body resistance or slow strength training with no cardio component. So that could be lifting a heavy set at the gym or in your home gym, that could be just doing push-ups and, you know, squats up against the wall, or that could be doing pilates, or doing, you know, strenuous yoga.
And then in the menstrual phase, it could be walking, it could be just like a yin yoga stretching class, or it could be napping. And I say that, and I know that that might make some you laugh, like, “Oh yeah, I’d love to take a nap during my period.” But actually, depending on your hormonal status quo, meaning if you have hormonal issues, if you’re dealing with elevated levels of cortisol due to, you know, emotional or lifestyle stresses, taking a nap can be hugely restorative and actually boost your metabolism during the menstrual phase. So that is one of the exercises that’s listed in the exercise chart in the book during that phase because it is so beneficial. And it’s so important that I point that out because the truth of the matter is when you work out with your infradian rhythm, you can work out less and get more fit. And you can work out less at the right times, including napping during the menstrual phase and still, at the end of the month, either maintain the weight that you hope to maintain or lose weight if that’s what you’re trying to do.
And, again, having done this myself two times with big numbers, you know, 60 pounds the first time and 40 to 50 pounds the second time with my pregnancy again using this methodology, it’s just so effortless. It’s just so easy. It’s not a push, it’s not forcing. You don’t have to just do it. You don’t have to push yourself. There’s no pain and all the gain that you want. And I think that’s just such a comforting thought because I don’t know about you, but I’m just tired of this idea that you have to work so hard to achieve small results because we’ve been working for these little crumbs with the systems that were designed for men when if we simply use a system that was designed for us, we could really get the gold.
Katie: Yeah, I couldn’t agree more. And I think that’s been a really big shift for me as well, the effortless part of this. My whole adult life, it feels like I fought my body trying to get it to do what I wanted. And then when I finally learned to love and support it, it just naturally started doing those things I had hoped to do all along. It reminds me there’s a beautiful quote online, I’ll have to look up who said it, but it’s basically the idea that, like, “I said to my body, ‘I want to be your friend.’ And it took a deep breath and said, ‘I’ve been waiting my whole life for this.’” And I think that’s what you teach. It’s so beautiful. And you’ve kind of explained the concept of cycle syncing. But for anyone who’s new to this, can you just kind of give us like the really technical definition and what that looks like?
Alisa: Yeah, so I created this term, gosh, many, many years ago now, but it was this idea that once I really understood the infradian rhythm, I wanted to create a term that would help women understand the active part of what it means to connect with that, to support it. And so cycle syncing, syncing your activities, your food, your fitness, your sex drive, your relationships, your career, your parenting styles, all of that can be synchronized with your cyclical changes with these fluctuating hormones, with these four phases of the infradian rhythm. And when you do that, things just get in the flow.
Katie: Makes so much sense.
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Katie: I know it’s not, or I’d love to talk about a little bit like the emotional and stress response side of the cycle as well, and if there are things we can do, A, to optimize those, and, B, like how we can use that to our advantage in relationships.
Alisa: So, you know, you are more sensitive to cortisol in the second half of the cycle, which is why it’s so important to do the right eating to stabilize blood sugar so you’re not, you know, adding the cortisol demand in the second half of the cycle and that, again, you’re doing the right workouts. Doing those two things will decrease your stress levels dramatically in the second half of the cycle. And, by the way, if any of you are struggling with, you know, luteal phase anxiety, or depression, or mood swings, or irritability, again, just doing these first two components of the cycle syncing method with the food and the fitness, you will see enormous impact in a positive way on your mood and your energy levels. And, again, it just it’s remarkable what happens when you start taking care of this biological rhythm.
So I think we have to look at stress as external stress, right, things that are like, I don’t know, the kids are driving you crazy, you’re having friction in your relationship, something is going on that’s stressful at work. And that these are things that involve other people that are outside of your control, and that’s just life, and we all have to learn how to balance our emotional reactivity in those situations, to not take things personally, and to really rise above and figure out how to navigate that with a lot of emotional intelligence. But then there are these types of stressors that can be managed by understanding the infradian rhythm.
So, for example, we just talked about how you can create unnecessary amounts of stress cortisol level in the body by eating and exercising incorrectly during the luteal phase, for example. But you can also have stress created at any point in the cycle by, let’s say, you know, not feeling…and let’s pick career or work, right? So I obviously cycle sync absolutely every area of my life, which I outline in great detail in the book and give you every chart that I created for myself. But in work, for example, because we know the brain changes by 25% over the course of the month, there are certain times that you’re more naturally inclined to do certain activities. You can do anything you want anytime you want, of course, but when you’re in the mood to bake cookies, right, that’s like more fun. But then when you have to make cookies for the class, you know, fundraiser and it’s late at night, you don’t feel like doing it. It’s stressful, right? So that’s a great example of doing things when you’re in the mood to do something. They feel effortless and pleasurable versus pushing yourself to do it when you, you know, don’t really feel like doing it.
Wouldn’t it be amazing if you could set up your workflow to just kind of always pick the things that you’re naturally in the mood for so everything feels like that joyful, like, “Oh yeah, I’m so happy to be baking these cookies right now, you know? I’m so happy to be working on this marketing copy, or I’m so happy to be doing this report for my boss, or I’m so happy to be doing this customer call because just really my verbal social center is being stimulated right now by my estrogen in my ovulatory phase. This is working for me I’m feeling really good.” It’s so fun since these changes are predictable, and they repeat, you know, every month. You can map out your calendar to optimize your work around this. And, in fact, I put in my own daily planner into the book because…this is another fun funny personal aside.
But years ago, I mean, I was always an eager student, you know, even at a young age, I remember I convinced an employer of mine. I had an internship in high school, I said, “I believe that the key to success is figuring out how to manage your time successfully.” So I convinced them to send me to a time management class, Franklin Covey. And specifically, you know, that’s that whole rhetoric of like, “You gotta sharpen the saw every day and do the same activities and big rocks and the whole thing,” right?
And I had the planner in the analog days, so, you know, it was a big notebook, spiral notebook. And I remember being so excited. I literally was holding this, like, “This is going to, like, change my life.” I filled it out, and, you know, I was, like, really diligent for a week or two and then something changed. I didn’t know what then because I was only in high school, I hadn’t yet done all this work that I now do, and I just felt like I couldn’t do the things that I had mapped out in my calendar. They felt like a burden, and I felt so bad. I felt so self-critical. I said, “Oh my God, I’m so lazy. I’m so undisciplined.” That inner critical voice just started raging, like, “What’s wrong with you?” And I kept trying for several months to just like really stick with whatever it was that I was… Like, every month would start off the same. Like, I’d be, like, “Okay, great. I’m in the zone. I’m doing what I said I was going to do each day,” and then something would change.
I didn’t realize then it was my hormonal brain chemistry was changing. Then I couldn’t follow those same plans in the schedule, and I felt so bad. I literally, after a few months, was so upset about the whole thing. I stopped using that planner. I broke up with time. I stopped wearing a watch. I was like, “That’s it. I’m just never going to be a success because I can’t manage my time.”
Then fast forward years later when I discovered the infradian rhythm, and I create the cycle syncing method, and I start, like, planning all of my work around my biochemical advantages throughout the month for each week. The amount that I could get done in a month astonished me. I mean, I just couldn’t believe it. Because I was enjoying what I was doing. Everything was flowing in terms of my work, and my productivity, and my creativity, and I wasn’t draining my energy, right? We cannot make more time, but we can make more energy. And by working and doing the things that are my natural proclivities based on my infradian rhythm at any given week, I never put myself in the energy hole, right.
Like, you know, when you bake these cookies at 8:00 at night, you don’t really want to do it. You feel exhausted afterwards, and you feel sort of energy hungover the next day. Because we’re not planning our productivity and our creativity around our infradian rhythm, we’re in an energy hangover, in fact, an energy crisis all of the time. And I did say earlier, 90% of moms feel exhausted and to the point where just last year, the World Health Organization made burnout an official medical diagnosis. We’re all working in a way that’s not supporting our infradian rhythm, and that’s really to our detriment.
Katie: It makes so much sense. And I’m so glad that there are people like you out there really breaking this down for women and giving us practical tools, even if the research hasn’t quite caught up to our hormones yet. I think that’s been the lesson for a lot of us. I know it’s part of my story and part of yours as well is that, at the end of the day, we do have to take our health into our own hands. And doctors can be amazing partners, and hopefully, we find some incredible ones to work with. But at the end of the day, we’re the ones responsible for those changes and having tools like this make it so much easier.
And that point we’ve mentioned several times in this interview of just not having to fight your body, that alone is just a complete paradigm shift for women. And so I love that you are spreading the word about this, and I highly recommend your new book. Of course, it will be linked in the show notes at wellnessmama.fm, but any starting advice for women who are listening to this going, “Oh my gosh, yes. I need to do this.” Obviously, get the book but what else? Where can we start?
Alisa: I mean, I think you’ve got to know where you are in your cycle. So like yourself, Katie, if you haven’t downloaded the MyFLO app, that’s a great place to start because it’s going to tell you…it’s the world’s first and only cycle syncing app, of course. I had to build one. So, you know, you’ll know which phase of the cycle you’re in, and it will start to teach you what you need to know about that phase when you go into the cycle syncing section. And it will remind you and send you reminders about, “Okay, you’ve just moved into this phase, you know, you want to think about eating these types of foods, etc.” And we also have content that, you know, you can get more recipes and meal plans, and workout videos, and all of that as well with the cycle syncing membership. So that’s a place where you can get more support. But I would say start with just being aware of where you are in your cycle.
Of course, we didn’t get a chance to talk about, “Well, what if you have hormone problems, or what if you’re on the pill?” And I’ll just quickly say that if you have hormone struggles, you know, I would say, you know, if you have a diagnosed condition like PCOS, or fibroids, or endometriosis, or you have irregular cycles, you do need to do kind of the cleanup work that I describe in my first book, “WomanCode,” to help your body, your endocrine system, let’s say, recalibrate or get back to homeostasis so you can get yourself to a regular cycle so your hormones are giving you the opportunity to have a healthy infradian rhythm.
If you’re on a hormone suppressive birth control, whether that be a pill, or a device, or an insert, unfortunately, then you will not be able to…it kind of really messes with the infradian rhythm, and so you’re not going to have the cycle happening over the 30 days. You’re kind of in this like phaseless no cycle zone, and so you won’t experience these changes. And, of course, I go into detail about what you can do in the book to kind of understand what you need to know about that.
So first things first is just to understand where you are in the cycle, and then pick a lane, right? So there are five different areas in the book that you can start with. You could start with food. You could start with fitness. You could start with the new daily planner, the time and, like, your work, your monthly project list. You could take this into looking at your sex life and relationships, romantic relationship, and you can look at motherhood.
So there are these five charts in the book, then you can just pick one of them and decide that you’re going to just do an experiment for that month. You’re going to just change your food for one month and see how that makes you feel, or you’re just going to do the workouts for a month and see how that makes you feel, and then you start to slowly add, right, because this is really about a system that allows you to really optimize every area of your health and life. So, you can’t expect to make all the changes at once, but you want to build on them over time. And using the charts in the book are really going to help with that. In fact, we also have a great, like a starter, you know, in the flow quick start guide that people are getting when they order the book that’s on the book website. So before the book arrives, you can start to figure out, you know, which life area you want to address, health, work, or relationships, and start to make these changes for that week that you’re waiting for the book to arrive to see how you can apply this in each of these four phases. It’s much easier than you realize once…like, Katie, you’ve been saying, you just start to have that awareness, and then it goes from there.
Katie: I love it. And we might have to do another round one day to address those specific hormone-related, like if you have PCOS, but I love that we covered this for now. And lastly, is there a book or number of books that have really dramatically impacted your life besides obviously your own?
Alisa: Oh, well, yes. There are… I mean, my books are my, like, prized possessions, I would say, and I was really thinking about this. So I think, for me, the very first book that woke me up to the idea that our bodies are special and sacred were “Daughters of the Earth,” which is a book about Native American menstrual rights that I came across as a junior high schooler in my local library, and just something about that was really like a call home in some way. And then Natalie Angier’s book, “Vagina,” hugely eye-opening, and Clarissa Pinkola Estés, “Women who Run with the Wolves.” Also a very game-changing book for me.
Katie: I love it. Those are all great recommendations. I’ll make sure they’re in the show notes as well. But Alisa, thank you so much for your time and being here. I love the education and the work that you do. And I’ll, of course, make sure everything we talked about and a link to our website are in the show notes so you guys can find those if you are walking, or running, or driving while you’re listening to this. But thank you so much for being here.
Alisa: Thanks for having me. It’s always a joy to have a conversation with you about cutting-edge health information.
Katie: I love it. And thanks as always to all of you for listening, for sharing your valuable resource, your time, with both of us. We’re so grateful that you did, and I hope that you will join me again on the next episode of “The Wellness Mama Podcast.”
If you’re enjoying these interviews, would you please take two minutes to leave a rating or review on iTunes for me? Doing this helps more people to find the podcast, which means even more moms and families could benefit from the information. I really appreciate your time, and thanks as always for listening.
Source: https://wellnessmama.com/podcast/floliving/
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Call the Midwife: I am Obsessed
I have fallen head-long in love with Call the Midwife. In fact, I’m not even in love, I’m obsessed. I’m so obsessed that I watched the series available on Netflix and then bought series 6 on Amazon because it’s not on Netflix. Sometime after that I realized that the episodes were cut from their original length (I guess by PBS?) so I went to the library and checked out the two available series they had (series 1 and 4). After seeing how much was left out I purchased series 2, 3, 5, and 6. I have watched all of those and am starting another re-watch. I AM OBSESSED. I love how female-centric the show is. I love the bonds of mothers/friends/sisters. I even love the narration.
But I have no one to talk to about it!! So I am sending out a Tumblr SOS hoping it’ll be seen. Help a poor gal out. I need people to discuss my many, many feelings with!!!! Below you will find my thoughts on the show/characters, many exclamation marks, and unnecessary capitalizations.
Favorite characters and stories:
I actually like every single character on CtM, with the exception of Sister Ursula, but she was meant to be disliked. I do wonder if she might come back at some point, just to see if she has grown any. Here’s my master list of characters:
Shelagh Turner: I LOVE HER. Her story, her style, her romance/marriage, her children, her entire life. I just want to read a book about what she does every minute of every day. My love for her reminds me of my days in X-Files fandom (I’m an old fangirl) back in the late 90’s. She’s my new Scully. Smart, capable, amazing, great hair—what more can I ask for???
Patrick Turner: I love him almost as much as I love his wife. He’s got amazing hair, and I love the way he looks in a vest or with his sleeves turned up. He’s so compassionate and I love how he’s so dedicated to Poplar and the women he treats. I love his relationship with his children and his romance/marriage—MY HEART.
In fandom I see that they’re called Turnadette. I LOVE THEM. My gosh, season 2 is so full of longing and stares and me sitting on the edge of my computer seat wanting them to be together forever and have babies and save Poplar, one birth or vaccine at a time. That foggy road scene? OH MY GOD. What I love so much about them is how in love they are and how we get to SEE it. I hate romance stories that end with people getting together. I want to know what happens AFTER they get together.
Timothy/Angela/Teddy: I LOVE THEM ALL. Tim is the cutest boy ever and I love how he’s grown into a teenager that Patrick and Shelagh can laugh at. That bassoon!! Hahaha! Angela is adorable. Her little nurse outfit?? And the baby. THE BABY. That reminds me of the singing during labor where I felt my heart just burst out of my chest with the emotion. My God.
But! I love more than just the Turners. I love them all!!
Nuns:
SISTER MONICA JOAN I love her. I adore her. I want to sit and watch television and eat cake with her. I love her and all of her rambling thoughts.
Sister Evangelina: I adored her. She was amazing. She reminds me of a friend of mine, actually. I love how she was ready for any battle. Her death made me weep.
Sister Julienne: The best there ever was. I love her compassion and strength.
Sister Mary Cynthia: The sweetest voice. I hated that she was so brutalized. I hope Northfield helps her to the right track like it did Dr. Turner.
Sister Winnifred: I want to know more about her! I loved her dancing in South Africa. The actress and I have the exact same hair!!!
Nurses:
Chummy: I love Chummy!!! She was my original favorite until the Turners bowled me over. I love her romance and Peter and their baby. I wish she’d come back!!
Trixie: She’s such a sweetheart. So smart and bold. I love her manner with patients.
Patsy: I adore her. She’s so capable and smart, and with nerves of steel. I loved her romance with Delia and am sorry they won’t be back! I was hoping they would get their little apartment together again.
Barbara: I love her introduction with Sister Monica Joan and the superfluous bananas. She’s sweet and kind, and I think she and Tom work well together as a couple.
Nurse Crane: Love her to bits, with that rolodex.
Jenny Lee: I have checked the memoir out from the library to read. I know it’s different from the show, but think it’ll be fascinating. I loved the character and miss her. The actress was just gorgeous.
Nurse Dyer: I am excited to learn more about her. I liked the scene with Sister Monica Joan about Valerie’s birth, which showed the bonds of Nonnatus House.
Others:
Fred: I find him very funny and I like him and Violet.
Jane: I miss her!! She was so sweet. I liked how her goldfish was named. LOL
Favorite characters/stories of the week:
Thalidomide. I really like the character of Rhoda and the story is heart-breaking but also has hope. I would like to check-in with this family more often in future series. I think they handled the real-life story well by treating it with respect and nuance.
Hyperemesis Gravidarum: This sort of kicked off Thalidomide, but since we never saw that mother again I assume she started taking it post 9 weeks and had no troubles. As I suffered HG in my pregnancy I liked seeing it on screen. I am always reminded how much worse I could have had things if my pregnancy had been at any other point in history.
Christmas Specials: I really like all of them so far. I love how Christmas feels familiar in some of the songs they play, but also set in another time. Timothy’s polio and Shelagh and Patrick’s wedding being a particular favorite.
Irish Travelers: I just really liked the dynamic of women, who sort of mirrored our nuns.
I am enamored with this show. I want to write fanfic, but fear I need a Britpicker. If anyone would like to send me a message to chat—please do!! I need someone to talk with!! Back in the day I would have found a message board to talk with fellow fans. Now I don’t know how to find friends in a new fandom. I am in deep!!
#call the midwife#shelagh turner#patrick turner#shelagh and patrick#turnadette#nonnatus house#sister monica joan#sister evangelina#sister julienne#sister winifred#sister mary cynthia#trixie franklin#patsy mount#delia busby#valerie dyer#barbara gilbert#phyllis crane#new fandom#obssessed#seriously obsessed#chummy
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A Tale of 2 FDAs
By ANISH KOKA
Frances Oldham Kelsey by all accounts was not mean to have a consequential life. She was born in Canada in 1914, at a time women were meant to be seen and not heard. Nonetheless, an affinity for science eventually lead to a masters in pharmacology from the prestigious McGill University. Her first real break came after she was accepted for PhD level work in the pharmacology lab of a professor at the University of Chicago. An esteemed professor was starting a pharmacology lab and needed assistants, and the man from Canada seemed to have a perfect resume to fit. That’s right, I said man. Frances was thought to be a man’s name, and the acceptance letter accepted Mr. Frances Oldham. Given the times, her Canadian mentor advised the young Frances she not write to inform the Chicago professor of the mistake but to simply sign the acceptance letter as Miss Oldham. The rest, as they say, is history. Ms. Frances Oldham arrived in Chicago in 1936, and just two years later was asked to work on figuring out what caused one of the worst poisonings in American history by the nascent US Food and Drug Administration (FDA).
The FDA at the time was a small organization within the federal government that had come into being a few decades earlier after the passage of one of many progressive laws passed to protect consumers from rapacious pharmaceutical companies of the day. At the time there was no standard for claims that could be made to an unsuspecting public and no requirement that drug companies specify what ingredients were being consumed by the public. The companies of the day would take alcohol, water and coloring mixed together – give the formulation a name, get a US patent, and make millions by heavily marketing testimonials of cures to all that ails directly to the consumer. At one point, it was estimated that there was more alcohol being sold via ‘patent medicines’ than at liquor stores.
Sadly, it was not medical professionals that put a stop to this, but muckraking journalists like Samuel Hopkins Adams who exposed the seamy underside in a series of articles for Collier’s Weekly entitled The Great American Fraud. Popular outrage followed publication of this series in 1905 and in response, the first draft of the FDA came into being by order of Congress in 1906.
The initial purpose of the FDA was a small, but important one – ensure the correct labeling of drugs being sold to the public. The 1906 act – fought tooth and nail by industry – mandated that ingredients such as alcohol, cocaine, heroin, morphine and cannabis be accurately labeled with contents and dosage. To understand the scope of the problem at the turn of the century, understand that Coca-Cola (Coke) was sold initially as a ‘patent medicine’ that was marketed as a cure for headaches, impotence, morphine addiction as well as a number of other ills. The main ingredients? Cocaine and Caffeine. Current drinkers of Coke will be happy to know that cocaine was eliminated from the formula in 1903.
The FDA as we know it now is a result of the passage of the Federal, Food, Drug and Cosmetic Act (FFDCA) of 1938 that came as a reaction to national tragedy in 1937 that once again drove home the point that the public needed protection from private corporations. The matter was a simple one that involved an ingredient that actually worked – sulfanilamide. Sulfanilamide was an antibiotic that killed bacteria by preventing the synthesis of Folic Acid. Humans are relatively primitive and don’t make Folic acid – so it isn’t toxic to humans. That is, unless you’re the chief chemist of S. E. Massengill Company, and you create a preparation of sulfinilamide that is dissolved in di-ethylene glycol (DEG). DEG is toxic to humans – the first case reports of toxicity had been reported six years earlier. Unfortunately the chemist, Harold Watkins, who worked for the company was unaware as this was not widely known at the time. Watkins simply added some raspberry flavor to the sulfa dissolved in DEG, and the company founded by a Tennessee medical student who saw more opportunity in selling drugs to doctors than practicing medicine started distributing the drug widely. No animal studies or any type of premarket testing was required at the time, and so the drug went straight from the lab to the consumer. More than a hundred people died.
Figuring out what was happening fell to the FDA, and it was investigative work by Kelsey working in her Chicago lab that ultimately lead to the identification of DEG as the culprit. Months later, the FFDCA act passed, effectively changing the scope of the FDA from ensuring proper labeling, to safeguarding the public from known and unknown formulations of drugs.
The nation found itself engulphed in World War 2 shortly after, and all the resources of the nation were diverted to the war effort. Pharmacists like Kelsey worked to solve the problem of the day – create a synthetic anti-malarial for troops fighting in mosquito infested lands. There was no synthetic anti-malarial that came of the effort, but in working with a pregnant rabbit model Kelsey learned drugs could affect mothers very differently from their fetuses.
The experience with sulfilinimide and the work with antimalarials would soon be brought to bear after Kelsey was hired in 1960 by the FDA to help oversee the approval of new drugs. A few months after starting, an application from the William S Morrel company in Cincinnati lay on Kelsey’s desk. There was a new German drug – thalidomide – that the Morell company sought to sell in the United States. The drug was meant as a mild sedative for pregnant women with morning sickness. It was already approved in multiple other countries and being prescribed by doctors widely. This was a chip shot. A stamp was all that was needed. But, the three-person team was not happy with the animal studies presented or the clinical studies which essentially amounted to testimonials from doctors. While Kelsey delayed the application asking for more data, the company grew more and more irate, pressing approval of the drug for what they felt was going to be a profitable Christmas season. The bureaucrats won the day. Slowly a trickle , and then like a flood came stories from pediatricians of babies born deformed with tiny limbs. The final toll was gruesome – 10,000 affected in 46 countries. There were only 17 reported cases in the United States. And so it came to pass that a bureaucratic delay saved thousands of lives.
The story was reportedly leaked to the Washington Post by politicians attempting to pass legislation to further expand the FDA’s scope and ran under the headline “Heroine of the FDA keeps bad drug off market”. Shortly after, the Kefauver-Harris drug amendment was signed into law by John F Kennedy, creating the FDA we would recognize now. Drug companies had to prove efficacy in addition to safety, and it was going to take a lot more than physician/patient testimonials to prove it. The law also put the FDA in charge of advertising, as well as manufacturing quality.
It is a beautiful story. But there are other stories.
Diane
Diane came to the emergency room with unbearable chest pain. She was 52, had struggled with controlling her blood pressure, but was otherwise well, until she suddenly wasn’t. It was like there was something ripping and tearing in her chest. The main pipe that serves as the conduit from heart to the rest of the body is called the aorta. The walls of the aorta are made of multiple layers to withstand the pressure wave generated by each heartbeat. Making it to 70 years of age means the aorta will withstand over 30 million pulsations. It is a remarkable thing that we don’t all die from exploding aortas once we hit the 10 million mark. Some aren’t as lucky as others – the higher the stress on the aorta the greater the chance a microscopic tear forms in the innermost layer with one of those pulsations. The whole wonderful system begins to fail with that small tear. Each pulsation now makes the tear bigger. Eventually blood forces it’s way into the tear, and the innermost layer starts to be torn away. It’s like your insides are being ripped apart. This was Diane’s problem. Mortality for the patients lucky enough to make it to the hospital is measured in hours- the oft-quoted number is 2%/hour. The technical term is an ascending aortic dissection. There is little in medicine that is more acute. Something needs to be done to stabilize the aorta and usually this means rapid transport to an operating room where a cardiothoracic surgeon can saw through the sternum, arrest the heart, and replace the defective portion of the aorta. That patients like this survive is one of the miracles of modern medicine.
Diane was in the operating room an hour after coming to the Emergency Department. Minutes from starting, a problem emerged. Diane was on a blood thinner to treat a specific arrhythmia called atrial fibrillation. The anticoagulant was called apixaban, and it is commonly used by cardiologists to prevent the strokes normally associated with atrial fibrillation. There are three anticoagulants in wide use – 2 belong to the class of medications called Factor Xa inhibitors, one is a direct thrombin inhibitor. The problem here is that the direct thrombin inhibitor has an FDA approved antidote, the factor Xa inhibitors do not. Apixaban is a Factor Xa inhibitor. There is no FDA approved antidote, no effective reversal agent. All one can do is wait for the drug to be metabolized. The instructions are to wait 24 hours for minor surgery, 48 hours for major surgery. Diane didn’t have 48 hours, and only had a flip of a coins chance of making it 24 hours. But cutting through the aorta when any cut made has little hope of clotting is a daunting proposition in its own right.
The team elected to wait. Diane was moved to intensive care. Analgesics brought some relief from the chest pain. Medicines were started to help reduce the shear stress from every heartbeat on the aorta to buy time. The next day came and went. 36 hours later she began to have more chest pain. Suddenly and abnormal heart rhythm developed. Minutes later she became unresponsive and lost her pulse. Half an hour later Diane was pronounced dead.
The proximate cause of death was paralysis on the part of the surgical team worried about uncontrollable bleeding. The surgical team pointed to the class of blood thinners Diane was on. Factor Xa inhibitors are a class of medications started somewhat gleefully every day by cardiologists. The underlying reason is typically an arrhythmia of the heart called atrial fibrillation that predisposes patients afflicted to strokes. It is believed small blood clots form in the heart of patients with atrial fibrillation, and are ultimately pumped into the brain, where occlusion of a vessel results in a stroke. The treatment shown to reduce the risk of this for years now has been the blood thinner known as coumadin – an inhibitor of Vitamin K dependent factors the body needs to clot blood. Coumadin is also known as rat poison – take too much, make the blood too thin, and death from internal hemorrhage results. Coumadin is a bear for patients and their physicians to deal with. Blood tests are sometimes needed weekly, and eating a varying amount of vitamin K in your diet causes dangerous fluctuations in blood thinning. The only upside of bleeding while on coumadin is that the rapid reversal of this effect is provided by transfusion of factors.
The difficulties of coumadin meant there was a market for alternative anticoagulants that were hopefully safer and easier to use. After decades of failure, three such agents hit the market just within the last 10 years. Pradaxa (dabigatran) inhibited the procoagulant thrombin, while Eliquis (Apixaban), and Xarelto (Rivaroxaban) bound and inhibited the procoagulant Factor X (ten). In each of the three randomized controlled trials patients given assigned to the new class of medications did just as well (Xarelto) or better (Pradaxa,Apixaban) than Coumadin at preventing clots being thrown from the heart. Remarkably, they did this despite being on a fixed dose of medication that didn’t require weekly/monthly blood tests to check the level of blood thinning. They also importantly reduced the feared complication of bleeds into the brain by half relative to Coumadin. The small problem, though, was that none of the new agents had an effective antidote. The drugs were approved knowing patients would bleed on them or need emergent surgery for some other reason with no effective way of reversing the effects of the drug. You couldn’t just give plasma or Factor concentrates as you did with Coumadin because the administered thrombin / Factor X would be inactivated by the circulating drug. The only thing to do was stop the drug and wait the 48 hours it typically took for the drug to lose effectiveness.
This did not stop cardiologists just like me from prescribing the drugs. After all, the drugs are equally as effective and reduced the rate of bleeding into the brain. Bleeds into the brain are very bad, and that even a reversal agent was no assurance of a good outcome. The best thing is to prevent a bleed, not deal with it after the fact. It also seemed highly likely that a reversal agent was around the corner.
Dancing with the FDA
Even with accelerated approval, the current FDA process takes years, not months. The first antidote developed was for the first class of novel anticoagulant that had hit the market, the direct thrombin inhibitor Pradaxa. Idarucizumab was a humanized monoclonal antibody fragment that bound Pradaxa and it’s active metabolites. The FDA approved the drug based on pharmacokinetic studies in healthy volunteers as well as a case series of patients on Pradaxa with life-threatening bleeding. Idarucizumab completely reversed the effect of Pradaxa on clotting times and was not associated with any major adverse events. The next antidote waiting in the wings for the only other class of anticoagulants – the Factor Xa inhibitors – appeared in the published literature months later. The new drug was called Andexanet and was ingeniously designed as a mimic to the body’s own Factor Xa, with some important mutations at critical sites that would prevent triggering of the normal coagulation cascade. Circulating Factor Xa inhibitors would bind the Factor Xa copy instead of the real thing and thus abolish the anticoagulant effect.
The first in man trials of Andexanet took place with healthy volunteers who were given either Apixaban or Rivaroxaban. After steady state of drugs was achieved, volunteers were infused andexanet or placebo, and anti-Factor Xa levels were measured serially for 12 hours.
The results were remarkable – anti-Factor Xa levels fell immediately after infusion of Andexanet. A two hour infusion of antidote to follow the initial bolus kept anti-Factor Xa level suppressed for the duration of the infusion. No serious or severe adverse events or thrombosis was noted. Anti-Factor Xa is of course a surrogate marker for bleeding. Though there are strong links between bleeding control and anti-Factor Xa activity in animal studies, and the correction of Factor levels in Hemophiliacs is a well accepted marker for abolishing coagulopathies, patients and their doctors care about bleeding stopping, not what the anti-Factor Xa level is. Outcome studies in this space are challenging in part because not every patient may necessarily benefit from andexanet. Bleeding may stop spontaneously in many cases for many reasons with the conventional approach of just waiting. After all, the placebo graph shows Anti Factor Xa levels fall 50% in 12 hours doing nothing. When bleeding into the closed compartment of the brain, the hope is that the amount of brain tissue necrosis that results from the consequent disastrous rise in pressure in the cranium may be ameliorated by decreasing the amount of bleeding. Unfortunately, we don’t have a great way of quantifying brain cell death. The Intracranial Hemmorhage (ICH) score is a commonly used system to help predict mortality in patients presenting with bleeding in the brain. It is a six point scale that incorporates volume of bleeding, age, neurologic dysfunction at presentation, and location of bleeding to predict mortality.
Other than pointing out the information lost when a continuous variable is made categorical, what stands out is the nonlinearity of outcomes relative to ICH score. An ICH score of 3 is not a little worse than a score of 2, it is a lot worse. Mortality jumps from 26 to 72%. Harm increases in a non linear fashion. While the volume of blood gets only one measly point, it is the central problem – an obtunded patient with 5 ml of blood is probably not in that state because of the blood. The problem in relating just the volume of blood to outcome is that everyone’s intracranial compartment is different. 80 year olds have more space to accomodate a certain volume of blood than a 40 year old because the brain atrophies with age. Certain parts of the brain are more critical than others – a small volume of blood in the brain stem may be worse than a larger volume of blood in the frontal lobe. So a combination of volume of blood, location of blood, and the clinical effect of bleeding determine prognosis.
With these difficulties in mind, the next adenxanet study tested the antidote in 67 patients with severe life-threatening bleeding within 18 hours of administration of a Factor Xa inhibitor. The coprimary endpoints were anti-factor Xa activity and the rate of good or excellent ‘hemostatic efficacy’. With regards to head bleeds, a reduction in volume of blood relative to baseline <20% was termed excellent, <35% was termed good. Of the 47 patients in the efficacy population, 37 patients were adjudicated as having good or excellent hemostasis. Anti-Xa activity levels decreased significantly after bolus and infusion of andexanet as well.
With regards to safety the concern with any antidote to a drug that causes bleeding is too much clotting. Recall that Adenxanet is engineered without critical sites that normally catalyze thrombosis, and that in healthy volunteers, no thrombotic events were reported. The population of patients presenting to ERs with life-threatening bleeding however, are a whole separate ball of wax. The published article helpfully lists everyone who had either a death or complication.
This group of elderly patients arriving at the hospital with any acute illness, let alone life threatening bleeding have a significant background rate of morbidity and mortality with standard of care. It is, of course, hard to say with certainty without an appropriately matched control group whether the rate of thrombosis is higher after andexanet. The study was also not designed to assess actual outcome differences. We don’t know if patients are any less disabled because we were able to reduce their level of anti-Factor Xa activity.
But the data seemed more than good enough, and Portola Pharmeceuticals, bay area biotech firm that makes Andexanet first submitted a New Drug Application (NDA) in 2015. The FDA responded in Auguest of 2016 with a surprise rejection in the form of a Complete Response Letter (CRL). These communications are private, but the company at the time noted that the FDA was primarily concerned about the quality of manufacturing facilities for the drug. One year after the rejection, Portola reapplied in August 2017 expecting to hear from the FDA in February 2018. February came and went as regulators pushed their expected response to May 4th, and the CEO of Portola hinted at even further delays on an earnings call. Casually mentioned on the same earnings call was a net loss for 2017 of $286million , just slightly more than the $269million loss posted in 2016. Hemorrhaging money, stock price declining, much hung on the May 4th decision by the FDA.
The drug was approved.
Little details are public about what the company did to gain approval. The FDA did make approval conditional on performance of post-marketing RCT of usual care vs Andexanet. The drug will be available in limited fashion to 40-50 hospitals in late June of this year, with wider distribution and availability expected later in the year.
Unfortunately, all of this was too late for Diane. The eventual review of the case in a conference of cardiologists amounted to a giant shrug of collective shoulders. A small case series of patients who were operated on anticoagulation was presented suggesting high mortality of bleeding, and the collective conclusion appeared to be that there were mortalities that just couldn’t be helped. No one expressed any frustration that 3 years had passed after publication of the positive trials, and still, no antidote was clinically available.
We have come a very long way from cocaine laced Coke being sold to patients to cure morphine addiction. One wonders if we have traveled too far. An approval process for an antidote to life threatening bleeding now takes hundreds of millions of dollars and years of regulatory approval. There are clearly patients dying as a result. Is anyone counting?
Even with approval, a post marketing RCT will require clinicians to choose patients with life threatening bleeding to not administer andexanet to. Will it be a patient like Diane? I imagine the argument for another trial, and slow approval relates to concerns a Perhaps some will raise the uncertain safety profile because of the lack of a comparison group in the only trial in a real world setting. That would be unfortunate because this is a poor way to navigate the real world. Any clinician taking care of Diane would have taken their chances with what is known about Andexanet now. There is an intuitive understanding about the potential upsides and downsides that doesn’t require a strong mathematical foundation in game theory, and certainly does not require knowing anything about p-values.
Nassim Taleb, the mathematician/philosopher/flaneur conceptualizes what should be clear to physicians uninfected by the average treatment effect virus as decision making under non-linear conditions.
There are large outsize gains here to operating to repair the aorta in a timely fashion with the blood thinner neutralized that vastly outweigh risks. The best thing about the graph is that it incorporates uncertainty – it does not require one to know exactly which direction from the starting point any given patient may travel. Because traveling to the right results in outsize gains, one doesn’t have to ‘win’ much to come out ahead. To be clear, it helps, of course that the gain here is the chance of life with surgery vs. certain death without surgery, and that the probability of pain/harm as suggested by biology and demonstrated in the trials to date suggest harm related to Andexanet is low.
In the parlance of Taleb –
Regulators should worry more about efficacy than harms in the face of convexity.
(The threshold for approval of an antidote for life threatening bleeding should have a low threshold for rapid approval if the drug has a high probability of being effective and a low probability of harm)
Physicians who have never heard of Taleb do this intuitively. Every day in some emergency room a trauma surgeon is working to find and stop the bleeding in a patient shot in the chest. Many of these patients will not survive – does this mean surgeons should cease their efforts to find and stop bleeding as soon as possible? Is there no point to innovating quicker ways to stop bleeding in service men and women in the field because most folks stepping on IEDs won’t make it?
None of this takes into account the significant costs that must be recouped for this type of an approval process. Portola plans to sell the drug for $27,000 per dose. It is estimated there are 100,000 admissions and 2000 deaths for bleeding related complications in patients taking Factor Xa inhibitors. The figure makes me groan because I know the drug will be reached for over and over again in EDs across the country, and it is entirely possible that a large proportion will not derive a significant benefit. The idea is significantly more palatable if the drug cost $2000. But given that Portola lost $500million dollars in the last 2 years alone, can we grouse for lower prices given the regulatory hurdles erected?
If we really are interested in helping patients , we will need to pay heed to impulses on all sides – that of profit seeking corporations to cut corners, and that of regulatory excess to overwhelm, stifle innovation, and raise cost.
Anish Koka is a Cardiologist in practice in Philadelphia. Troll him on twitter @anish_koka
Article source:The Health Care Blog
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Bad Medicine, Part 2: (Drug) Trials and Tribulations (Rebroadcast)
Birth defects resulting from thalidomide led medical researchers to exclude women of child-bearing age from clinical trials. (Photo: AP/flickr)
Our latest Freakonomics Radio episode is called “Bad Medicine, Part 2: Drug Trials and Tribulations (Rebroadcast)” (You can subscribe to the podcast at iTunes or elsewhere, get the RSS feed, or listen via the media player above.)
How do so many ineffective and even dangerous drugs make it to market? One reason is that clinical trials are often run on “dream patients” who aren’t representative of a larger population. On the other hand, sometimes the only thing worse than being excluded from a drug trial is being included.
Below is a transcript of the episode, modified for your reading pleasure. For more information on the people and ideas in the episode, see the links at the bottom of this post. And you’ll find credits for the music in the episode noted within the transcript.
* * *
Last week, we brought you Part 1 of the rebroadcast of our Bad Medicine series. Today, Part 2. It’s called “Drug Trials and Tribulations,” and it starts right now …
In the mid-20th century, an exciting new drug hit the market.
Teresa WOODRUFF: It’s a small molecule that was produced in West Germany in the late ‘50s and early ‘60s.
It was a sedative, but not a barbiturate. So it wasn’t addictive, it didn’t clash with alcohol or other drugs and, according to its manufacturer, was entirely safe. They based this claim on the fact that no matter how much of it they fed the lab rats, the rats did not die. Once this new sleeping pill was made available, doctors discovered it did more than help people sleep.
WOODRUFF: It would combat for pregnant women morning sickness.
And so pregnant women all over the world were given the drug. It was called thalidomide.
WOODRUFF: The problem was the thalidomide would actually cross the placenta and impact the baby. It would cause a whole series of malformations and probably a lot of fetal death.
Fetal deaths were thought to number at least 10,000. Among the babies who survived, there were serious birth defects:
WOODRUFF: Children that survived were deaf and blind, had a number of disabilities; they had shortened or lacked limbs.
Babies born with horribly malformed limbs, with missing or malfunctioning organs. Because of the putatively super-safe drug their mothers took to prevent morning sickness. Thalidomide was on the market for roughly five years before it was banned. Its German manufacturer, Chemie Grunenthal, first denied the disastrous side effects before ultimately accepting blame. The history of medicine is full of tragic missteps. But thalidomide, coming as it did during a boom in global mass media, made more noise than most:
NEWS CLIP: The problem of tighter controls to prevent the distribution of dangerous drugs such as thalidomide is a matter of concern to the president at his news conference …
NEWS CLIP: Concern over the tragic effects of the new sedative thalidomide prompts President Kennedy …
NEWS CLIP: Already more than 7000 children have been born with some or all of their arms and legs missing …
John F. KENNEDY: Every doctor, every hospital, every nurse has been notified …
Although a few million thalidomide tablets had been distributed to doctors in the U.S. for trial use, it was never approved for sale here. That was thanks to a doctor at the Food and Drug Administration named Frances Oldham Kelsey. She didn’t believe the application from the American distributor offered complete and compelling evidence of the drug’s safety. President Kennedy later hailed Dr. Kelsey as a hero:
KENNEDY: The alert work of our Food and Drug Administration, in particular Francis Kelsey, prevented this particular drug from being distributed commercially in this country.
Even though the U.S. was an outlier in blocking thalidomide, the disaster had a number of lasting effects on American drug regulation. For one, the FDA established much more stringent rules for drug approval. It also rewrote the rules on what kind of people should be included in clinical trials.
WOODRUFF: Because of the effects on young women and on the fetus, it suggested that women shouldn’t be included in clinical trials because of the potential adverse events to the fetus.
Meaning: women were summarily excluded from early clinical trials for new drugs. On one level, this might make sense; it’s a protective impulse. But this impulse had a downside.
WOODRUFF: The study of women in general became part of the collateral damage of that pregnancy conversation. There certainly are young women who are not pregnant who could be included in clinical trials. Women in general could be included in clinical trials, to really understand some of the effects of drugs on their own health. They were labeled as broadly vulnerable because of the potential to become pregnant. That was part of a very rapid response to a very visible tragedy.
We see this all the time. Something terrible happens and we rush to introduce laws or regulations or just mores that respond to the terrible thing but, often, wind up overcorrecting. Think about the Three Mile Island nuclear-reactor accident in 1979. No one was killed, and the lasting health and environmental effects were negligible. But it was so frightening that it essentially killed off the nuclear-power expansion in the U.S. Even as other countries embraced nuclear as a relatively clean and safe way to make electricity — often using American technology, by the way — the U.S. retreated.
What’d we do instead? We burned more and more coal to make electricity. From an environmental and health perspective, coal is almost indisputably worse than nuclear. But that’s where the correction took us; that’s where the fear took us. And the fear of another thalidomide took us to exclude most women from early-stage drug trials, and also to underrepresent women for a time in Phase 2 and 3 trials, even if the drug’s market included women. And, as you’ll hear today on Freakonomics Radio, that had some severe unintended consequences:
WOODRUFF: It’s just heartbreaking to know that so many women had to wake up in the morning and drive into the side of a mailbox because we didn’t have sex as one of the variables that we would study.
Also: when the only thing worse than being excluded from a medical trial was being included:
Evelynn HAMMONDS: The use of vulnerable populations of African-Americans, people in prison, children in orphanages, vulnerable populations like these had been used for medical experimentation a fairly long time.
And: what happens when a new class of drugs comes to market with great clinical-trial results …
Ben GOLDACRE: But none of them have got evidence showing that they reduce your risk of heart attack or renal failure or any of the actual, real stuff that patients actually care about.
* * *
This is the second episode in a three-part series we’re calling “Bad Medicine.” It’s about the many ways in which the medical establishment — for all the obvious good they’ve done in the world — has also failed us. Last episode, we talked about how much we still don’t know, from a medical perspective, about the human body:
Anupam JENA: I would say maybe 30, 40 percent that we don’t know.
We talked about the fact that medicine hasn’t always been — and, often, still isn’t — as empirical as you might think.
Vinay PRASAD: Medical practice was based on bits and scraps of evidence, anecdotes, bias, preconceived notions, and probably a lot psychological traps.
We went over some of medicine’s greatest hits and its worst failures.
Jeremy GREENE: You take a sick person, slice open a vein, take a few pints of blood out of them …
On any list of medical failures, thalidomide is near the top. Although we should point out that long after it was found to have disastrous side effects on pregnant women, it’s had a productive renaissance. Thalidomide and its derivatives have been used to successfully treat leprosy, AIDS, and multiple myeloma. That said, its effect on pregnant women, as we heard, contributed to women being excluded from many drug trials. Thalidomide and another good-seeming drug that went bad, called DES.
WOODRUFF: Diethylstilbestrol, or DES, was manufactured in the early part of 1900s.
That’s Teresa Woodruff, who’s been telling us the thalidomide story.
WOODRUFF: I am the Watkins professor of obstetrics and gynecology at Northwestern University.
Woodruff also founded, and directs, the Women’s Health Research Institute at Northwestern. And she’s an advocate for something called oncofertility.
WOODRUFF: It’s a word that was coined only about 10 years ago. What we did was to bring together both oncologists and fertility specialists. Many young people are surviving that initial diagnosis of cancer that we’ve really converted it over the last 20 years from a death sentence to a critical illness. Many of the young people will actually survive that initial diagnosis and live long lives. When they returned from that cancer experience many of them were sterilized by those same life-preserving treatments. We want to provide fertility options to both males and females. So we developed — not only kind of the corridors of communication between oncology and fertility — but we also created new technologies that could provide new options for young women and for pediatric males and females.
So for Teresa Woodruff, as for many in the medical community, the future holds great promise. But so many decisions are informed by mistakes of the past. Like thalidomide and DES, which first became available in the 1930s.
WOODRUFF: DES is an estrogenic compound, was being prescribed to pregnant women to prevent miscarriage. Miscarriage was thought at the time, medically, to be caused at some level by low estrogen. Supplying this estrogenic-like factor was thought to correct a really difficult problem.
Stephen J. DUBNER: Makes perfect sense. Was miscarriage in fact caused by an estrogen shortage?
WOODRUFF: It’s probably not. It’s multifactorial. There may be some cases where low estrogen would have modest effect, but in general that’s not the case.
DES, as it turned out, wasn’t very effective in preventing miscarriage.Worse yet, it sometimes produced side effects that would become manifest only years later — in the offspring of women who’d taken DES. If affected boys and, especially, girls.
WOODRUFF: Physicians just started reviewing the medical records of these young women who were now coming up with this very rare vaginal cancer. The onset of that disease is clearly estrogen-dependent and probably a very narrow window during pregnancy when estrogen would have that effect.DES and thalidomide are both tragedies, but it wasn’t that the physicians were going out trying to create an adverse problem for women who are pregnant. But as you look back across medicine, across science, we’re always learning.
In 1977, because of the tragic consequences of DES and thalidomide, the F.D.A. made a big change. It recommended excluding from early clinical trials all “premenopausal females capable of becoming pregnant” unless they had life-threatening diseases. Which meant that many of the drugs that later came to market had been tested only on male subjects. Which could cause some real trouble for women.
WOODRUFF: A great example of this is the drug Ambien, which was just the latest of the large number of drugs that had adverse events in females.
Ambien is a sleeping pill whose main ingredient is a drug called zolpidem. Americans love their sleeping pills — about 60 million prescriptions are written each year for roughly 9 million people. Some two-thirds of these medications contain zolpidem, which was approved by the F.D.A. in 2007. But as it turned out, men and women metabolize the drug differently.
WOODRUFF: The drug maker actually have in the F.D.A. filing the metabolism of this drug in males and females and, in fact, knew that it cleared the circulation of males faster than it did females. But they only studied the efficacy on males, had no females in that efficacy study.
DUBNER: When you say the clearance, it means how quickly the body is metabolizing, yes?
WOODRUFF: That’s right. How long that drug is available in the body.
DUBNER: Can you just explain that a little bit? Let’s say it’s a 150-pound male and a 150-pound female. I assume those will be different clearance rates. Can you explain why that is?
WOODRUFF: Right. It’s going to depend on individuals and so some drugs will go into the fat and will be available for longer, so how much fat exists and what kind of fat can take up some of the drugs. But probably the most important part of drug metabolism is the liver. Males and females have different enzymes and different P450s that are on the liver. That can alter the way drugs get cleared. For example, women wake faster from sedation, with anesthetics, so they recover much more slowly and have more reported pain events in hospital.
DUBNER: Talk for a few moments about the differences between females and males in medicine and/or medical science.
WOODRUFF: Well, one is hormones and that’s what we often think about. Males have testosterone, and females have estrogen and progesterone. And so those hormones influence a lot of the biology of males and females in a very distinct and different way. But the fundamental way males and females differ is that every cell in a male’s body is XY and every female cell is XX. The sex chromosomes actually also inform — just like the other chromosomes within the cell — the overall function of that particular cell.
Understanding how chromosomal sex informs the biology of kidney cells or of eye cells or of muscle cells is really important. In addition, there are anatomical differences between males and females. Heart size might differ, and that’s relevant to cardiovascular disease. Then the environment, the microbiome. We now know from a variety of studies that there is a sex to the gut microbiome that inhabits all of us.
DUBNER: Therefore, if I want to be a doctor or medical researcher, or running the F.D.A., or anywhere up and down the ladder, I would like to think that for the past 100 if not for the past 1,000 years I’ve been very careful to consider any treatment and how different people would accept it differently based on their biology.
WOODRUFF: Right, that’s the surprise to everyone. That, in fact, sex has not been a fundamental part of the way we look at biological systems. At some level this is just the way biology has always been done, and then science keeps building on what was done in the past. That’s the really critical question, “Are there real adverse events that occur when you only use one sex?” The answer is, of course, “Yes.” Something like eight out of the last ten drugs pulled from market by the F.D.A. were because of this profound sex difference.
In the case of Ambien, the F.D.A. was getting complaints for years from users who were sleepwalking, even sleep driving.
WOODRUFF: It’s just heartbreaking to know that so many women had to wake up in the morning — and they still got up — but they went out and drove into the side of a mailbox, because we didn’t have this sex as part of one of the variables that we would study.
Eight hours after taking an Ambien, 10 to 15 percent of women still had enough zolpidem in their system to impair daily function, compared to 3 percent of men. The FDA’s ultimate recommendation: women should take a smaller dose than men. The federal government had acknowledged for years the problem of excluding women from medical trials. In 1993, Congress required that women be included in all late-stage clinical trials funded by the National Institutes of Health unless it was a drug taken only by men. But what that didn’t do …
WOODRUFF: … what that didn’t do was include males and females in the animal studies and the cell studies that are the engine to all of medicine.
Meaning: drugs that might be useful for women, but not for men, might not even get to the earliest stages of testing.
WOODRUFF: It wasn’t that they were thinking, “Let’s make it hard on women to have this drug down the line.” They were trying to do the most clean study they could imagine and the study group that they imagined were the simplest were the males.
Males were considered “simple” because they don’t have menstrual cycles that change hormone levels; they don’t get pregnant; they don’t go through menopause. As one researcher puts it, studying only men “reduces variability, and makes it easier to detect the effect that you’re studying.” But ultimately, the exclusion of women was deemed inappropriate. In 2014, the N.I.H. spent $10 million to include more women in studies, and in 2016, they decreed that all studies had to include sex as part of the equation:
WOODRUFF: And that date January 25, 2016 — to me there is a before and there is an after. And before that time, sex wasn’t a variable in the way time or temperature or dose has always been. And I think we’re going to see an enormous number of new discoveries simply because science now has an entirely new toolbox to work with.
So that’s progress. But, as we’ll hear later, drug companies still like to use very narrow populations for their drug trials — the better to prove efficacy, of course. So exclusion still exists. On the other hand, it wasn’t so long ago that exclusion from a certain kind of medical trial would have been a blessing.
HAMMONDS: African-Americans, people in prison, children in orphanages — vulnerable populations like these had been used for medical experimentation a fairly long time.
That’s Evelynn Hammonds, a professor of the history of science and African-American studies at Harvard. And this is Keith Wailoo, an historian at Princeton.
Keith WAILOO: You see it in the era when the birth control pill is being tested in Puerto Rico in the 1950s. You see it in things like the Tuskegee syphilis study, which extended from the ‘30s into the 1970s.
“The Tuskegee Study of Untreated Syphilis in the Negro Male,” as it was called, is one of the most infamous cases in U.S. medical history. Its goal was …
WAILOO: … trying to understand the long-term effects of venereal disease as it developed through its various stages. The study was being conducted on a group of really poor African-American men.
HAMMONDS: White government doctors working for the U.S. public-health service found approximately 400 African-American men presumed to all have syphilis.
WAILOO: The problems emerge after penicillin is discovered and more widely used. The question that should’ve been asked is, “Now that we have a series of effective treatments for venereal disease, ought we to continue a study of untreated syphilis or ought we to provide treatment?”
So even though a syphilis treatment became available, it was withheld from the men in the study. Put aside for a moment the short-term elements of this maneuver — the cruelty, the ethical failure. Consider the long-term implications: what happens when one segment of the population is so willfully exploited by the mainstream medical establishment? Well, that part of the population might develop a deep mistrust of said establishment. A recent study by two economists found that the Tuskegee revelation seriously diminished African-Americans’ participation in the healthcare system. They were simply less willing to go to a doctor or a hospital. The result? A decrease in male African-American life expectancy of about 1.4 years. Which, at the time, accounted for roughly one-third of the life-expectancy gap between blacks and whites. Coming up on Freakonomics Radio: with such a fraught history of inclusion and exclusion in medical studies, who does end up in clinical trials?
GOLDACRE: When you look at the evidence, what you often find is that trials are often conducted in absolutely perfect dream patients.
Also: how good are the new drugs that typically make it to market?
PRASAD: If we’re honest with ourselves, we have to admit that the majority of new cancer drugs offer sort of very small gains at tremendous prices.
And: what happens if you write about conflicts of interest among oncology researchers, and then you go to an oncology conference?
PRASAD: I always wear a bulletproof vest.
* * *
This is the second of a three-part series we’re calling “Bad Medicine.” We don’t mean to be ungrateful for the many marvels that medicine has bestowed upon us; nor do we mean to pile on, or to point out the avalanche of obvious flaws and perverse incentives — but, well, it’s just so easy.
PRASAD: Doctors do something for decades and it’s widely done, it’s widely believed to be beneficial and then one day, a very seminal study contradicts that practice.
That’s Vinay Prasad. He’s an oncologist and an assistant professor of medicine at Oregon Health & Science University. He also co-authored a book about what are called medical reversals — when an established treatment is overturned. Which happens how often?
PRASAD: It’s widespread, and it’s resoundingly contradicted. It isn’t just that it had side effects we didn’t think about. It was that the benefits that we had postulated, turned out to be not true or not present.
How can it be that so many smart, motivated people — physicians and medical researchers — come up with so many treatments that go all the way through the approval process and then turn out to be ineffective, or even harmful? A lot of it simply comes down to the incentives.
PRASAD: Much of the research agenda, even the randomized-trial research agenda, is driven by the biopharmaceutical industry. That’s not necessarily a bad thing. There’s many good things about that, that really drives many trials. It drives a lot of good products. It also drives a lot of marginal products, or products that don’t work. The people who designed those trials are very clever. You can tilt the playing field a little bit to favor your drug.
The incentive to do so is often tremendous — billions of dollars hinge on one of these pivotal trials. To some degree that’s because it’s a human pursuit. But to some degree we could have policy changes that could more align the medical research agenda with what really matters to patients and doctors.
DUBNER: Let me ask you: in your own field, in oncology and in the particular cancers that you treat, how much more effective generally would you say the new cancer drugs are than the ones that they are replacing or augmenting?
PRASAD: Let me say that there are a few cancer drugs that have come out in the last two decades that are really wonderful drugs, great drugs. One drug came out of work here, in the Oregon Health & Science University, by Dr. Druker — Gleevec. That’s a drug that transformed a condition where maybe 50 or 60 percent of people are alive at three years, to one where people more or less have a normal life expectancy. That’s a really wonderful drug.
But if we’re honest with ourselves, we’ll have to admit that the majority of new cancer drugs are marginal, that they offer very small gains at tremendous prices. To give you an example of that: among 71 drugs approved for the solid cancers, the median improvement in overall survival or how long people lived was just 2.1 months. Those drugs routinely cost over $100,000 per year of treatment or course of treatment.
DUBNER: But that points to one of the tricks that works so well — which is if it’s 2.1 months extra, and if the expected lifespan was, just let’s pretend for a moment, six months, then on a percentage basis that’s a massive improvement. As the patient or as the pharma representative, I’m not talking about that length of time — which might be lived under physical duress and financial duress — but rather I’m thinking about, “Goodness gracious, 33 percent life expectancy extension!”
PRASAD: Right, “A new drug improves lifespan 33 percent longer!”
DUBNER: And who doesn’t want that, especially when you’re sitting there with your loved one in a horrible situation, facing the end?
PRASAD: The other thing that I’d point out is those 2.1 months, these clinical trials that are often conducted by the biopharmaceutical industry, they really choose the healthiest patient, the people who are the fittest of the patients. On average, the age is almost 10 years younger in pivotal trials for the F.D.A. drug approval than in the real world. Then when you start to extrapolate drugs that have real side effects and small benefits in carefully selected populations to the average patient that walks into my clinic, who is older, who has other problems, who is taking heart medicine.
There was a paper that came out about one of those costly expensive drugs for liver cancer, and in the pivotal trial it had the benefit of about two, three months, something like that. But in the real world, in the Medicare data set, it had no improvement in survival over just giving somebody good nursing care and good supportive care. That’s the reality for many of these marginal drugs, when you actually use them in the real world, they start to not work so well and maybe not work at all.
DUBNER: You’ve written and spoken about cronyism and conflicts of interest between drug makers and the doctors who prescribe drugs. I’m curious what happens when you go to an oncology conference. Are you an unpopular person there?
PRASAD: Stephen, I always wear a bulletproof vest when I go. No, but this has really been the way medicine has operated for, for many years. To some degree, practicing doctors in the community having ties to the drug makers — that’s one thing — but increasingly, we see that the leaders in the field, the ones who design the clinical trials, who write up the manuscripts, who write the review articles, who sort of guide everyone in how to practice in those fields, they have heavy financial ties to drug makers.
There’s a large body of evidence suggesting that biases the literature of towards finding benefits,where benefits may not exist, towards more favorable cost-effective analyses when drugs are really not cost-effective. It’s a bias.
BERO: Yes, well, we have a great deal of empirical data showing that funding sources and author financial conflicts of interest are associated with over-optimistic data.
That’s Lisa Bero. She’s a professor of medicine. She’s also co-chair of the Cochrane Collaboration, a global consortium of medical professionals and statisticians. Cochrane promotes evidence-based medicine by performing systematic reviews of medical research.
BERO: In fact, we have a Cochrane review on this very question. This finding shows that if a drug study is funded by a pharmaceutical company whose drug is being examined, they’re much more likely to find that the drug is effective or safe.
How much more likely?
BERO: It’s about thirty percent.
Did you catch that? An industry-funded study is thirty percent more likely to find the drug is effective and safe than a study with non-industry funding.
BERO: They’re likely to find this even if they control for other biases in the study. It could be a really well-done study, it could be randomized, it could be blinded, but if it’s industry-funded it’s still more likely to find that the drug works.
But if a study is well-done, how can the results be so skewed?
BERO: It’s everything from the question they’re actually asking, to how they frame the question, the comparators they use, how they design the study, how it’s conducted behind the scenes …
GOLDACRE: Trials are very often flawed by design in such a way that they are no longer the gold standard, no longer a fair test of which treatment is best.
That’s Ben Goldacre.
GOLDACRE: I’m an academic in Oxford working in evidence-based medicine and I also write books about how people misuse statistics.
He’s also a doctor.
GOLDACRE: Yeah, that’s right. I qualified in medicine in 2000, and I’ve been seeing patients on and off in the N.H.S. for the past 15 years now.
One of Goldacre’s books is called Bad Pharma. He echoes what Vinay Prasad was telling us about the people who are chosen for clinical trials.
GOLDACRE: When you look at the evidence, what you’ll often find is that trials are often conducted in absolutely perfect dream patients. People who are, by definition, much more likely to get better quickly. Now that’s very useful for a company that are trying to make their treatment look like it’s effective. But actually for my real-world treatment decisions, that kind of evidence can be really very uninformative.
Imagine you’re a doctor who’s treating a patient with asthma. Not hard at all to imagine:
GOLDACRE: Now asthma is obviously a very common condition, it’s [found in] about one in 12 adults.
With such strong demand for asthma treatment, there’s been a bountiful supply from drug makers, with dozens of clinical trials. A 2007 review of these studies looked at the characteristics of real-world asthma patients and how they compared to the people who’d been included in the trials.
GOLDACRE: They said, “Let’s have a look and see, on average, what proportion of those real-world asthma patients would have been eligible to participate in the randomized trials that are used to create the treatment guidelines which are then in turn used to make treatment decisions for those asthma patients. The answer was, overall, on average, six percent. 94 percent of everyday real-world patients with asthma would have been completely ineligible to participate in the trials used to make decisions about those very patients.
Of course it isn’t only with asthma patients where this happens.
GOLDACRE: It’s very common for randomized trials of antidepressants, for example, to reject people if they drink alcohol. Now that sounds superficially sensible. But actually I can tell you as somebody who has prescribed antidepressants to patients in everyday clinical practice, it’s almost unheard of to have somebody who is depressed and warrants antidepressants who doesn’t also drink alcohol. You need trials to be done in people who are like people who you actually treat.
If you look at the overall efficacy rate of most antidepressants, you’ll find it to be very, very low, if there’s any efficacy at all. And of course there’s the opportunity cost to consider:
GOLDACRE: Because you tend to prescribe one antidepressant at a time.
Which means while a patient is on one drug that may not be working, they can’t try another that might. Plus which, there are the side effects to consider. So a lot of drugs that look great on paper don’t do very well in the real world. Why? Part of it is what Ben Goldacre and Vinay Prasad were talking about — cherry-picking subjects for clinical trials. But Goldacre says there are plenty of other ways to manipulate trial numbers in the drug maker’s favor. What do you do, for instance, when research subjects quit a trial because of the treatment’s side effects?
GOLDACRE: What you see is people inappropriately using a statistical technique like Last-Observation-Carried-Forward to account for missing data from patients who dropped out of a study because of side effects.
“Last-Observation-Carried-Forward” is a statistical extrapolation — pretty much what it sounds like, and worth looking up if you’re interested in that kind of thing. You can see how an inappropriate use of such a technique would tilt things in the drug maker’s favor. There’s also the widespread use of what are called surrogate outcomes, as opposed to real-world outcomes. Consider the recent drugs approved by the F.D.A. to treat diabetes.
GOLDACRE: All of those drugs have been approved onto the market with only evidence showing that they improve your blood sugar.
But, Goldacre says, none of those drugs showed evidence they reduced the risk of heart attack, renal failure, or eye problems — the actual consequences of having diabetes. There are a couple new drugs on the market that seem promising. But it’s hard to test for these outcomes in a clinical trial — and by “hard,” what I really mean is time-consuming and expensive. So, instead, the researchers go for the simple surrogate outcome of whether their pill lowers blood sugar.
GOLDACRE: But actually it’s not correlated as well as you might hope. And the history of medicine is absolutely littered with examples of where we have been given false reassurance by a treatment having a good impact on a surrogate outcome, a laboratory measure, and then discovering that actually it had completely the opposite effect on real-world outcomes.
As in the case of the infamous CAST trial that we covered in Part 1 of this series, in which the drug that suppressed aberrant heart rhythms actually worsened survival outcomes. Now, we should point out that Ben Goldacre — and everyone we’ve been speaking with for our “Bad Medicine” episodes — fully appreciates that medicine is science and that failure is part of science. The human body is an extremely complex organism, with lots to go wrong. Diagnosing and treating even a simple problem can be very difficult.
It’s easy to take potshots from the sideline at good ideas that went bad; it’s even easier to criticize pharmaceutical companies who seem much more intent on making money than on making good medicines. But, as Goldacre points out, those companies are simply responding to the incentives that are placed before them. Incentives that don’t necessarily encourage them to do the right thing. Goldacre points to a massive eight-year study, called the ALLHAT trial, in which academic researchers compared various drugs, from a number of drug makers, that were intended to lower blood pressure and cholesterol.
Two of these drugs were made by the American pharmaceutical company Pfizer.
GOLDACRE: Pfizer came along and they said, “Look, we’ve got this fantastic new blood-pressure-lowering drug, and we’ve got various grounds for believing it’s going to be better than old-fashioned blood-pressure-lowering drugs. But at the moment all we can tell you is that it’s roughly as good at lowering blood pressure.”
So Pfizer asked the ALLHAT researchers to test whether their drug actually reduced the real-world outcomes that really matter: heart attack, stroke, and death.
GOLDACRE: The researchers said what all academic researchers have said to drug companies since the dawn of time, which was, “Thank you very much, that sounds like a fabulous idea. That will be about $175 million please.”
Actually, Goldacre misspoke — it was only $125 million, and Pfizer’s share was just $40 million but still — $40 million!
GOLDACRE: It was so expensive simply because measuring real-world outcomes like that, especially before the era of electronic health records, was extraordinarily expensive.
So Pfizer pays in, and the trial begins.
GOLDACRE: It was timetabled to run for a very long time — many, many, many years. But it was stopped early because the Pfizer treatment, which was just as good at lowering blood pressure, was so much worse at preventing heart attack, stroke, and death that it was regarded as unethical to continue to exposing patients to it.
The Pfizer drug we’re talking about was called Cardura. So where does Pfizer come out in all this?
GOLDACRE: It’s really important to recognize that Pfizer did nothing wrong here. Pfizer did exactly what we hope all companies should do. They didn’t just say, “That’s fine, we’ve got some surrogate end-point data. We’ve got laboratory data showing it lowers blood pressure and that’s all we need.” Instead, they went down and they did the right thing. They exposed themselves to a fair test. They said, “We want to see if this treatment improves real-world outcomes that matter to patients” — heart attack, stroke and death.
They were unlucky. It flopped.
The real problem, Goldacre says, is when drugs aren’t subjected to the real-world test.
GOLDACRE: The real bad guys here are the people who continue to accept weak surrogate end-point data. Like, for example, on the new diabetes drugs. It may well be that they lower the laboratory measurement on a blood test but that doesn’t necessarily mean that they reduce your chance of heart attack, stroke, and death. To find that out, we need to do proper randomized trials, which are admittedly longer and more expensive.
But there’s yet another problem. What happens if a proper randomized trial doesn’t show the efficacy a drug-maker was hoping to show? Well, there’s a good chance the world will never know about it, because of…
CHALMERS: Publication bias.
Iain Chalmers, a co-founder of the Cochrane Collaboration, is a major player in the evidence-based medicine movement.
CHALMERS: About half of the clinical trials that are done never see the light of day. They don’t get published. Isn’t that outrageous?
Which trials do get published?
CHALMERS: Trials that show results that are so-called “statistically significant” are more than twice as likely to get published as those that don’t have those results.
Now, you might think: Well yes, it makes sense to publish trials where a medicine seems to work; and if it doesn’t seem to work, why is that important to publish? Ben Goldacre again:
GOLDACRE: If you cherry-pick the results, if you only publish or promote the results of trials which show your favored treatments in a good light, then you can exaggerate the apparent benefits of that treatment.
As Chalmers tells us, there are all kinds of reasons why the results of an unsuccessful trial might not get published.
CHALMERS: It may threaten a commercial enterprise’s interests to publish a trial which is disappointing. It may be something which someone who has had a favorite hypothesis and been known for writing and speaking about it for years finds out that the first really good study to test the hypothesis doesn’t find any support for it. There’s laziness.
GOLDACRE: That’s the real scandal here, that you are allowed to legally withhold the results of these trials, and so people do. The results of trials are routinely and legally withheld from doctors, researchers, and patients — the people who need this information the most. That is a systematic, structural failure.
The structure, that is, imposed by government regulators, by funding sources, by the markets themselves. All of which can be very hard to change. So: how does Ben Goldacre see the situation improving?
GOLDACRE: We’ve set up something called the AllTrials Campaign a couple years ago. The AllTrials Campaign is a global campaign to try and stop this problem from happening, asking companies, research institutes, academic and medical professional bodies, patient groups, and all of the rest to sign up and to say all trials should be registered. You publicly post on a publicly accessible register the fact that you’ve started a trial because that means we know which trials are actually happening, so at least we can see if some of them aren’t being published.
The AllTrials Campaign also urges the publication of what’s called a clinical study report:
GOLDACRE: A clinical study report is a very long, detailed document — hundreds, sometimes thousands of pages long, that describes in great detail the design of the study and the results of the study. That’s really important because often a trial can be flawed by design in a way that is sufficiently technical that it is glossed over in the brief report that you get in an academic journal article about a trial. Those flaws can only be seen in a full-length clinical study report.
There’s also a growing momentum to curb conflicts of interest in medical research.
BERO: We’ve already had great improvements in transparency and what’s really pushed the disclosure of funding sources has been the journals.
That’s Lisa Bero again, from the Cochrane Collaboration.
BERO: If you publish something, you are required to disclose the funding source. This is still not 100 percent enforced but it’s getting pretty close.
On the other hand, Bero says, a given researcher or investigator may have undisclosed biases or conflicts of interest.
BERO: One reason, one loophole, is that the investigator themselves have to decide if something is relevant to the particular study. They may say, “I just don’t think it’s relevant.”
There’s another quirk in the medical industry that probably doesn’t serve the public good:
BERO: Drug companies evaluate their own products, whereas in software you usually get somebody external to check the quality of your project. Engineers get people to do the earthquake checks for them, who are independent from the people who built the bridge. It’s a very odd system that we have, where the companies with an interest or stand to gain financially from testing the product are testing it themselves. We need to change that.
And finally, there are the doctors themselves — the endpoint in this complicated, conflicted infrastructure that’s meant to deliver better medicine. Ben Goldacre — the gadfly physician who knows so much about bad pharma and bad medicine — acknowledges the entire system is due for reform.
GOLDACRE: It’s a structural failure that persists because of inaction by regulators, by policy makers, by doctors and researchers, as much as because of industry, and none of us can let ourselves off the hook.
So next time on Freakonomics Radio, in our third and final episode of “Bad Medicine” — what’s a doctor to do?
WAILOO: I see the opioid story as part of the recurring sense of hope and despair associated with these drugs that are supposed to solve problems, but they end up being problems in themselves.
What to do about the troubling finding that more experienced doctors have worse outcomes than young doctors:
DUBNER: I would think that you are a downright danger to your patients. How is it that you’re not?
JENA: [laughs] No comment.
And finally — yes, finally — lots of reasons to be optimistic, at least cautiously so, about the future of medicine:
WOODRUFF: Where science and medicine is going in the future is to more and more precision medicine, so that we can get closer to an autonomous and individualized diagnosis.
That’s next time, on Freakonomics Radio.
Freakonomics Radio is produced by WNYC Studios and Dubner Productions. This episode was produced by Stephanie Tam. Our staff also includes Alison Hockenberry, Merritt Jacob, Greg Rosalsky, Eliza Lambert, Emma Morgenstern, Harry Huggins, and Brian Gutierrez. You can subscribe to Freakonomics Radio on Apple Podcasts, Stitcher, or wherever you get your podcasts. You can also find us on Twitter, Facebook, or via e-mail at [email protected].
Here’s where you can learn more about the people and ideas in this episode:
SOURCES
Teresa Woodruff, professor of obstetrics and gynecology and director of Women’s Health Research Institute at Northwestern University
Evelynn Hammonds, professor of the history of science and African-American studies at Harvard University
Keith Wailoo, health policy historian at Princeton University
Vinay Prasad, assistant professor of medicine at Oregon Health & Science University
Ben Goldacre, physician and senior clinical research fellow at University of Oxford
Lisa Bero, pharmacologist and co-chair of the Cochrane Collaboration
Sir Iain Chalmers, co-founder of the Cochrane Collaboration
RESOURCES
Commissioner, Office of the. “Women’s Health Research – Regulations, Guidance, and Reports Related to Women’s Health.” WebContent.
ORWH. “Sex as a Biological Variable | ORWH Director’s Corner.” https://orwh.od.nih.gov/about/director/messages/sex-biological-variable/
“Tuskegee Study – Timeline – CDC – NCHHSTP.”
Alsan, Marcella, and Marianne Wanamaker. “Tuskegee and the Health of Black Men.” Working Paper. National Bureau of Economic Research, June 2016.
Ending Medical Reversal, Vinay Prasad, 2015, Johns Hopkins University Press
Sanoff, Hanna K., YunKyung Chang, Jennifer L. Lund, Bert H. O’Neil, and Stacie B. Dusetzina. “Sorafenib Effectiveness in Advanced Hepatocellular Carcinoma.” The Oncologist, May 16, 2016, theoncologist.2015-0478. doi:10.1634/theoncologist.2015-0478
Lundh, Andreas, Sergio Sismondo, Joel Lexchin, Octavian A Busuioc, and Lisa Bero. “Industry Sponsorship and Research Outcome.” In Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, 2012.
Goldacre, Ben. Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. Reprint edition. New York: Farrar, Straus and Giroux, 2013.
Travers, Justin, Suzanne Marsh, Mathew Williams, Mark Weatherall, Brent Caldwell, Philippa Shirtcliffe, Sarah Aldington, and Richard Beasley. “External Validity of Randomised Controlled Trials in Asthma: To Whom Do the Results of the Trials Apply?” Thorax 62, no. 3 (March 2007): 219–23. doi:10.1136/thx.2006.066837.
Turner, Erick H., Annette M. Matthews, Eftihia Linardatos, Robert A. Tell, and Robert Rosenthal. “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy.” New England Journal of Medicine 358, no. 3 (January 17, 2008): 252–60. doi:10.1056/NEJMsa065779.
Yu, Tsung, Yea-Jen Hsu, Kevin M. Fain, Cynthia M. Boyd, Janet T. Holbrook, and Milo A. Puhan. “Use of Surrogate Outcomes in US FDA Drug Approvals, 2003–2012: A Survey.” BMJ Open 5, no. 11 (November 1, 2015): e007960. doi:10.1136/bmjopen-2015-007960.
Research Group, The ALLHAT Officers and Coordinators for the ALLHAT Collaborative. “Major Cardiovascular Events in Hypertensive Patients Randomized to Doxazosin vs Chlorthalidone: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).” JAMA 283, no. 15 (April 19, 2000): 1967–75. doi:10.1001/jama.283.15.1967.
Dolgin, Elie. “Publication Bias Continues despite Clinical-Trial Registration.” Nature News, September 11, 2009. doi:10.1038/news.2009.902.
Hopewell, Sally, Kirsty Loudon, Mike J Clarke, Andrew D Oxman, and Kay Dickersin. “Publication Bias in Clinical Trials due to Statistical Significance or Direction of Trial Results.” In Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd, 2009.
ETC.
The Cochrane Collaboration
AllTrials Campaign
Retro Report. “The Shadow of Thalidomide.” The New York Times, September 23, 2013.
MUSIC CREDITS
Rudy Pusateri, “Hot Springy Bass”
Jack Miele, “Otis Theme” (from Jack Miele)
Little Invisibles, “Headrush”
Blindfold, “Ambiharmina” (from Blindfold)
Jetty Rae, “Take Me To The Mountain” (from Jetty Rae)
Mike Barresi, “It’s All Good” (from All of Me)
Kero One, “When the Sunshine Comes” (from When the Sunshine Comes)
Jetty Rae, “Still Gotta Fight It” (from Jetty Rae)
Debbie Miller, “It’s Been a Day” (from Measures and Weights)
Beckah Shae, “Me First” (from Champions)
The post Bad Medicine, Part 2: (Drug) Trials and Tribulations (Rebroadcast) appeared first on Freakonomics.
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Prisons must Become ADDITIONAL CARE ENVIRONMENTS. These Locations will be OPPORTUNITIES to receive ADDITIONAL Medical, Educational, Spiritual, and Employment Attention for the Residents. There will be 3 SEPARATE Levels : a. First-time Offenders b. Multiple Time Offenders c. Habitual Offenders These A.C.E.s will also be places where Teaching, Medical and Psychiatrist GRADUATES acquire their GRADUATE TRAINING. ALSO, the prison residents can do Supervised SERVICE for the community, Not just sit on their A€£ES All day. 15. In addition to Prison Residents performing Supervised Service to the community, WELFARE & DOLE recipients will perform SERVICE work in the community as well. 16. Additional SALES TAX 💸 added to: ALCOHOL & CIGARETTES & JUNK FOOD & SUGAR & SALT & MEAT & GLUTEN & DAIRY to COVER: a. TV Warning ADs. b. EDUCATION for Primary School Children c. GUARANTEED RESULTING ADDITIONAL GOVERNMENT FUNDED HEALTH CARE 17. PROVIDE "THAT SUGAR FILM" & Book, by Australian Damon Gameau, to EVERY Classroom. "Sugar is the NEW Nicotine." Artificial Sweeteners are ALSO a Health Risk. 18. EVERY FOOD & DRINK, MEDICATION, BUILDING MATERIAL and WMD - Weapon of Mass Destruction, must be EVALUATED for CHEMICAL CONTENT. PHARMACEUTICALS & CHEMICALS are the Cause of So much ILLNESS and DEATH. Remember Thalidomide? Apparently "BIG PHARMA" has been given a seat in the USA FDA. Is this Wise? The CANCER, AUTISM and DEMENTIA Rates in the 1st World are SKY-HIGH. WHY is that? Because of PHARMACEUTICALS 💊💉, GMOs and Agricultural Practices. EVERY Doctor KNOWS that Pharmaceuticals are LARGELY the cause of the 3 previously mentioned Illnesses, so WHY do they continue to prescribe them? One Word. 💰 MONEY💰. DOCTORS get KICKBACKS 💸💸 from the PHARMACEUTICAL COMPANIES every time they for Prescribe their medications. That explains why 70% of Americans are on Pills💊, and in 20 years, 40% of U.S. children will have AUTISM. Those Post WW11 Pharmaceutical companies try to say those diseases are "Genetic". Were they Genetic 70 Years ago, BEFORE WW11? 19. RWN - READING - WRITING - NOW, is a Program that would be USEFUL for some Aborigines who are too ashamed to admit that they cannot read or write. This way the problem is Solved in Private : 1 800 018 802 20. Physical and Sexual Assault are a CRIME. VERBAL Assault - BULLYING, should ALSO become a CRIME. The effects of these 3 types of Assault, Especially in the First 7 years, is LIFE-LONG. 21. The Life Expectancy is increasing. In 20 years, women are expected to live to 92 years. Medical Care is Improving. The RETIREMENT AGE can be Increased from 65 to 70 years, thus INCREASING the TAX BASE 💸. 22. The TAX FREE STATUS of Churches should be RECONSIDERED. In the USA, in the 1970's a KCIA FRONT GROUP & BIG BUSINESS 💸 Organization "PRETENDED to be a religious institution" in order to escape paying it's rightful share of TAXES on it's Very PROFITABLE 💸💸 Enterprises. 23. INCREASE the FOCUS on PRIMARY SCHOOL Teachers & Students. There Must be : a. MORE MALE teachers to be Positive Examples / Role models to the children, ESPECIALLY in Under-privileged Areas. b. SPECIALIZED TRAINING for Primary School teachers c. PAY RISES 💸 for PRIMARY School Teachers The FIRST 7 YEARS and to a lesser extent, the NEXT 7 years, are ESSENTIAL to an individual's Future lifestyle choices. School MUST be seen as a FUN 🎉 and JOYFUL 🙋 experience, ESPECIALLY for Underprivileged children. Schools can be a POSITIVE Influence for ALL children, giving them confidence to Participate fully in Society. "CHILDHOOD should be a JOY" - Dalai Lama Change from Primary Schools to Learning CENTRES Or CLUBS, as this terminology is more attractive for children. 24. POLICE Officers must become CARE Officers 25. GOVERNMENTS go from Force & Law to CARE & RESPECT 26. SENIOR CITIZENS are a RAPIDLY Growing population, with greatly improved health and lifespan. There's alot of issues to be addressed with these citizens. A Huge opportunity is now present for retired individuals to OFFER SERVICE and WORK Together with others. LEARN from EXPERIENCE You're Not Getting OLDER, You're getting BETTER 27. Have EVERY child read "A LITTLE HISTORY of the WORLD" by E.H. Gombrich. This International bestseller 📚 is written in very easy to understand English, for ALL CHILDREN to understand the HISTORY of the WORLD🌍 28. EVERY Individual Deserves at Least 14 years of Love, Care and Protection from at least 1 PRIMARY Care-giver. The First 7-14 years is where MOST of a person's character development occurs. The Majority of a person's attitudes and thinking come from their FIRST 14 YEARS, that's why psychiatrists always ask about your Childhood. 29. The Original and First Australians - Aborigines, are very similar to the African-American population. Their "Rite of Passage" is to spend time in "Lock-up" - Prison. It used to be that the White man considered them both to have 75% of the brain capacity of the White man. Why are Aborigines and African-Americans so "mis-behaved? Because one was seen as property, and the other was seen as animals who happened to inhabit one of the places that the British EMPIRE wanted to Utilize #2. 😀 INDIGENOUS PEOPLE 1. EVERY primary school child must be taught the : a. Song 🙌 b. Dance💃 c. History 📚 d. Culture 🌋 of it's INDIGENOUS Citizens. 40,000 years versus 240 years??..... The Australian and American ORIGINAL citizens need to be APPRECIATED, PROMOTED and VALUED, in order to address their issues, and to make Every other child appreciate and value them. #3. 😀 9 CAUSES 😀 Am I telling you to NOT get SCAMMED by a Predatory CULT, the MEDICAL/NURSING HOME GAME, FALSE PHARMACEUTICALS💊,GUNS🔫 or the WAR BUSINESS 💣 ? NO ! It's a FREE Country, last I checked, as Long as you know the TRUTH, the Whole TRUTH, NOTHING but the TRUTH, so help me GOD. 😇 THEN U can't BLAME anyone but your OWN SELF for YOUR Choices. I've got 9 CAUSES that are Listed below. Here they are. 😀 SCAMS : 1. PREDATORY Cults 2. DEATH RESORTS - Nursing Homes 3. PHARMACEUTICALS - BIG PHARMA 💊 4. The WAR BUSINESS 💰💰 CAUSES : 5. 3rd WORLD WOMEN 6. HEALTHY LIVING 7. GUN CONTROL 🔫 8. TRUE ISLAM 9. INDIGENOUS PEOPLE 1. PREDATORY CULTS - I have a friend who was in a Predatory Cult. They're ALL the Same. Their REAL motivation is Money 💸 & Power (and usually weird Sex). EXAMPLES are People's Temple & Children of God & Scientology & Moonies/FFWPU/Unification Church & Oneida Community & Jehovah's Witnesses Regarding "The TRUE Family of Mankind" - MOONIES - The Family of SELF-PROCLAIMED Lord of the Second Advent Sun Myung Moon - KNOW THEM BY THEIR FRUITS���� The APPLE DOESN'T FALL FAR FROM THE TREE 🍎 ACTIONS SPEAK LOUDER THAN WORDS 💪 DO AS I SAY, NOT AS I DO The THINGS People do for MONEY 💸💸💸💸 are the ROOT of ALL EVIL 🙉LEARN FROM YOUR PARENTS🙈 👏PRACTICE WHAT YOU PREACH👎 1. They're Usually led by a MALE, who is CONVINCED that he is a UNIQUE Voice of GOD. 2. Their MARKET is Disenfranchised, "SEARCHING" People. 3. The members are Always told that they're BETTER than others via being part of "The Master Race, God's Lineage, Chosen Skin Color, Religion, Nationality etc." 4. They get those people to do STRANGE actions such as ALL NIGHT Prayers, FASTING, Working for FREE - raising MONEY 💸💸 & Bringing in New members via the Threat "If you don't do this you WON'T Go to Heaven / be Saved OR WILL Go to Hell" 5. They're Always told to MARRY WITHIN the Cult. 6. The Cults Always say the members' REAL natural FAMILIES are "EVIL / FALLEN" in order to create SOLE "Loyalty" to the Cult 7. The Cults are ALWAYS EXPOSED /Destroyed in the END. 8. The Offspring ALWAYS Leave in DISGUST. 😉 GOOD GROUPS : 1. UCSA 2. FREEDOM OF MIND 2. DEATH RESORTS / NURSING HOMES - They are a BOOMING Business💸 now that the Baby Boomers are hitting their 70s and people are living LONGER and medical care is IMPROVING. In some nations, the Aged Care Business Participants "Are ALL in BED TOGETHER 💸💸" ALMOST Every Doctor, Psychiatrist, Nursing Home, Pharmaceutical Coy., and EVEN the COMPLAINTS Organizations 😨"Share Information together for a NON Caring Purpose" 😉 💸💸 I have a friend who TEMPORARILY spent some time in a Nursing Home due to an Injury. After a Medically Educated Individual REMOVED the Incorrect Medication that she was on, she wrote EVERYTHING Down. There was SO MUCH Verbal & Physical Abuse going on, towards Mostly 70 - 85 year old residents, with the Staff Hoping that the Residents are SO DRUGGED UP, that They wouldn't be BELIEVED by others, regarding what was REALLY Going on. After weeks of writing EVERYTHING Down, the Manager KICKED my friend out via calling / lying to the POLICE. It is ALL a SCAM YOU'RE as YOUNG AS YOU FEEL 🙌 70 is the NEW 30 🙌 LEARN from EXPERIENCE You're NOT Getting OLDER, You're getting BETTER GOOD INDIVIDUALS & GROUPS : 1. LET'S TALK 2. LYNDA SALTARELLI 3. DAVID STEWART - IRVING 3. 💊 PHARMACEUTICALS 💊 From Everything that I've read, ALL CANCER, DEMENTIA and AUTISM comes from PHARMACEUTICALS & GMOs. But the DRUG Companies try to Cover their A€£ES via LIES such as "Cancer is Genetic". Currently, 70% of Americans are on PILLS. In 20 years, 40% of USA CHILDREN will be AUTISTIC. WHY is this Happening NOW? PHARMACEUTICALS 💊 : 1. RARELY WORK 2. CAUSE GREATER PROBLEMS 3. SOMETIMES CAUSE DEATH Also, did you know that EVERY Doctor KNOWS that the Pharmaceuticals they're Prescribing cause these 3 Sometimes FATAL Illnesses? So WHY is your OWN Family Doctor doing This? One Word. 💸 MONEY 💸 EVERY DOCTOR gets PAID 💸 KICKBACKS 💸 from the PHARMACEUTICAL COMPANIES when they Prescribe their Drugs💊. The THINGS People do for MONEY 💸💸 are the ROOT of ALL EVIL 😈 Remember THALIDOMIDE? That was a Post WW11 Drug for "Pregnancy Pains". 1 FDA Doctor Repeatedly said that it was Already causing HUGE Problems in Europe and to STOP It Immediately. You know what that Drug Companies said? "Oooh those Bossy Bureaucrats" And the Result? DEFORMED BABIES Left and Right 👹 I am NOT a Hippie Chick who wants an Organic Lifestyle, I'm an Accountant 💸Sales Queen 💸 and I feel that IF a person makes the CHOICE to be involved with a Predatory Cult, Nursing Home, Take Pharmaceuticals, FIGHT / DIE in a War, have an UNhealthy Lifestyle, live as a 3rd World Female, participate in UNREVISED Islam, Buy MURDER WEAPONS, then FINE ! AS LONG AS YOU KNOW : "The TRUTH, the WHOLE TRUTH, NOTHING but the TRUTH, so help me GOD" 😇 Then FREELY & INTELLIGENTLY make your OWN CHOICE. GOOD INDIVIDUALS : 1. DR. BRAD McKAY 2. ROGER BEZANIS 4. The WAR BUSINESS 💸💸 - The USA is a VERY SAD Example of this one. For EVERY WAR Check : a. WHO'S at the TOP ? b. WHERE'S the MONEY 💸💸? In EVERY WAR : 1. Men (usually) RAPE 💸💸 a Country of it's Natural RESOURCES & the INDIGENOUS People get ANGRY & FIGHT BACK 😠 2. The ARMS Companies make Even MORE BIG, BIG Money 💸💸 SELLING BOMBS & GUNS to those Invading Men who want to defend themselves because of their OWN invasion, and SOMETIMES to those ANGRY INDIGENOUS People TOO!! 😂😈😂 WHENEVER there's a Inexplicable SCREW-UP in the World, ALWAYS : 💸 💸 "SHOW ME THE MONEY" 💸💸 GOOD GROUPS : 1. CODE PINK 5. 3rd WORLD WOMEN - 80% of the WORLD (3rd World) sees Females as ONLY : 1. BREEDING Animals 2. Sex TOYS 3. PROPERTY The Time is Coming when the COMMON KNOWLEDGE that Females & Males are Totally EQUAL INTELLECTUALLY will be ACCEPTED WORLDWIDE. ALSO ! IF you wish to Procreate, WHO Ya gonna Call?? 😉 WOMEN are SUPERIOR, BUT! We Don't wanna Remind you... WHY? Cuz WE MADE YOU ! 😂😂😂 GOOD GROUPS : 1. IWDA 2. 50 MILLION MISSING 3. AHA FOUNDATION 4. MALALA FOUNDATION 6. HEALTHY LIVING - People need to be AWARE of the PROPER FOODS to put in their Bodies & how to beneficially MAINTAIN their Body via EXERCISE and CARE. A MAJOR problem in the 1st World is OBESITY. People Must REVISE their food intake and EXERCISE on a DAILY BASIS. 😀 ADD ADDITIONAL Sales TAX 💸💸 to ALCOHOL🍾, CIGARETTES, SUGAR🍩, SALT, MEAT, GLUTEN and DAIRY in order to Cover the GUARANTEED RESULTING ADDITIONAL HEALTHCARE & TV Ads & PRIMARY School EDUCATION COSTS 💸 GOOD GROUPS : 1. NUTRITION FORCE 2. AUTHORITY NUTRITION 7. GUN CONTROL 🔫 - It's pretty OBVIOUS WHY the USA is the ONLY 1st World Nation that STILL Allows PERSONAL OWNERSHIP of 🔫 MURDER WEAPONS 🔫. One WORD = MONEY 💸💸💸💸. GUN MASSACRES have gone from BI-weekly to WEEKLY to DAILY. The NRA has REFUSED to NOT Sell Guns to "JIHADISTS", WHAT DOES THAT SAY? The NRA Also "Strongly SUGGESTS" to EVERY GUN Company CEO to give them a BIG DONATION 💸💸💸💸 😱 EL CAPITALISTA AMERICANA 💸💸💸💸 MONEY 💸💸💸💸 vs. HUMAN LIFE 😇 8. ISLAM 🌹 - EVERY Single one of my EXCELLENT MUSLIM friends does NOT practice : a. FGM - Female Genital Mutilation - SEXUAL ASSAULT b. CHILD BRIDES & Baci Baazi - PEDOPHILIA c. FORCED MARRIAGE - DEPRIVATION of Liberty/BREEDING d. HONOR KILLINGS - MURDER e. HIJAB/BURKHA - MISOGYNY f. GANG RAPES / ACID ATTACKS - ASSAULT ALL of these "Practices" have NOTHING to do with ISLAM - Qur'an, and EVERYTHING to do with Feudal, ARCHAIC, MIDDLE AGES, PRIMITIVE 3rd WORLD Behaviour. BTW - FGM - Female Genital Mutilation is practiced by BOTH CHRISTIANS and MUSLIMS in NORTH AFRICA, HONOR KILLINGS are performed in BOTH LATIN AMERICA and MUSLIM countries, FORCED Marriage / CHILD BRIDES are performed in 80% of the WORLD - 3rd World. GOOD GROUPS : 1. MUSLIM REFORM MOVEMENT 2. FAITHFREEDOM 3. FAITH 4 FREEDOM 9. INDIGENOUS PEOPLE - 20,000 YEARS vs. 239 Years..... Hmmmm......... EVERY NATION MUST Teach About /Appreciate / Value it's FIRST PEOPLE. EVERY School Child MUST be Taught the History, Culture, Song & Dance of it's INDIGENOUS People NOT Just the WHITE Culture. GOOD INDIVIDUALS & GROUPS : 1. SUNNY REDCLOUD 2. "I'M NOT RACIST, BUT" 3. "1 MILLION INDIGENOUS" #4. 😀 DAILY HEALTH REGIME 😀 1. EAT : a. RAW Fruit & Vegetables b. STARCH - Cereal, Potatoes, Rice, NO REFINED Flour or Cereal c. PROTEIN - (Cheese, Milk, Yogurt, Eggs- but Dairy MAY be a problem - research VEGANISM) Peas, Nuts & Beans (and Fish) 2. 😠 NO 😠 CHEMICALS, NICOTINE, MEAT, ALCOHOL, SUGAR, DAIRY, GLUTEN and MINIMAL Salt 3. Minimum of 1 HOUR DAILY EXERCISE - try an Exercise Machine or a Walk or a Gym #5. 😀 SUGAR & CHEMICALS 😀 🍁 Finally 🍁 everyone knows the Damage that SUGAR can cause to your Body, but ARTIFICIAL SWEETENERS are ALSO a very Big DANGER. Coca-Cola's BEST $$ International Market $$ is an Australian Aboriginal community, and in the U.S.A., some Hill-billies put it in their baby's bottles as well. As suggested before, an ADDITIONAL SALES TAX $ must be Added to JUNK FOOD, ALCOHOL, CIGARETTES and Also SUGARY & DIET SOFT DRINKS in order to Cover the GUARANTEED EXTRA COST $ of the ADDITIONAL Government Supplied MEDICAL Care + TV WARNING ADS and PRIMARY SCHOOL EDUCATION that are Necessary for these DANGEROUS substances🍁 https://youtu.be/yRhq-yO1KN8 1. FORBID and REMOVE ALL WMDs , Guns, Swords and Knives from Public Usage. INFORM the Weapons Manufacturers🔫 and Gun Shops 🔫 that the CEOs & Shop Owners will be Tried and Prosecuted for "Providing & Profitting 💸 from Accessories to Murder" if they choose to continue. 2. LIFE RIGHTS - a. 90 Years of LIFE - to be INCREASED with advanced medical care b. 14 Years of Love ❤ Care and Protection from at least 1 Primary Care-giver. A person's Childhood determines the MAJORITY of their Personality and Character Traits, because That's when their Character is Developed c. 4 Years of World SERVICE 18-21 yrs. - M / F 3. NO Physical - Audio - Visual EXPOSURE to SEXUAL Organs / Intercourse BEFORE "The Age of Consent". Such Exposure classifies as ASSAULT resulting in Lifelong Damage - Anger. 4. EVERY school child will receive Courses on : a. FAMILY b. CONFLICT RESOLUTION 5. NO Abortion, Guns / Swords / Knives / WMDs, Suicide, Starvation OR Death Penalty. 6. ALL Religions 7. SAME MONETARY Rate 💸 8. SAME TAX RATE 💸 9. SAME PAY RATE 💸 10. 1 WORLD GOVERNMENT - Democratic Socialist - Not Flawless, but the best choice. 11. REMOVE ALL National BOUNDARIES 12. ENGLISH Language for WORLD Communication - Beneficial for Education and Business. INDIGENOUS Languages at Home 13. EVERY ORIGINAL NATIVE Culture in the World must be APPRECIATED💃 / PROMOTED👳 / TAUGHT / VALUED 👲 within it's Own area, NOT just the WHITE Culture eg. African, Indian, Asian and Middle-Eastern. EACH Nation must teach EVERY one of it's PRIMARY Schoolchildren the Song, Dance, Stories and Culture of it's FIRST People. The ORIGINAL inhabitants DESERVE to feel VALUED, RECOGNIZED and RESPECTED. An Example would be Australia, Canada and the USA 1st People's CULTURE, DANCE, SONGS, HISTORY must be Taught, Promoted and Appreciated and Valued in ALL the PRIMARY Schools to EVERY child of EVERY COLOR. 14. Prisons must Become ADDITIONALCARE ENVIRONMENTS. These Locations will be OPPORTUNITIES to receive ADDITIONAL Medical, Educational, Spiritual, and Employment Attention for the Residents. There will be 3 SEPARATE Levels : a. First-time Offenders b. Multiple Time Offenders c. Habitual Offenders These A.C.E.s will also be places where Teaching, Medical and Psychiatrist GRADUATES acquire their GRADUATE TRAINING. ALSO, the prison residents can do Supervised SERVICE for the community, Not just sit on their A€£ES All day. 15. In addition to Prison Residents performing Supervised Service to the community, WELFARE & DOLE recipients will perform SERVICE work in the community as well. 16. Additional SALES TAX 💸 added to: ALCOHOL & CIGARETTES & JUNK FOOD & SUGAR & SALT & MEAT & GLUTEN & DAIRY to COVER: a. TV Warning ADs. b. EDUCATION for Primary School Children c. GUARANTEED RESULTING ADDITIONAL GOVERNMENT FUNDED HEALTH CARE 17. PROVIDE "THAT SUGAR FILM" & Book, by Australian Damon Gameau, to EVERY Classroom. "Sugar is the NEW Nicotine." Artificial Sweeteners are ALSO a Health Risk. 18. EVERY FOOD & DRINK, MEDICATION, BUILDING MATERIAL and WMD - Weapon of Mass Destruction, must be EVALUATED for CHEMICALCONTENT. PHARMACEUTICALS & CHEMICALS are the Cause of So much ILLNESS and DEATH. Remember Thalidomide? Apparently "BIG PHARMA" has been given a seat in the USA FDA. Is this Wise? The CANCER, AUTISM and DEMENTIA Rates in the 1st World are SKY-HIGH. WHY is that? Because of PHARMACEUTICALS 💊💉, GMOs and Agricultural Practices. EVERY Doctor KNOWS that Pharmaceuticals are LARGELY the cause of the 3 previously mentioned Illnesses, so WHY do they continue to prescribe them? One Word. 💰 MONEY💰. DOCTORS get KICKBACKS 💸💸 from the PHARMACEUTICAL COMPANIES every time they for Prescribe their medications. That explains why 70% of Americans are on Pills💊, and in 20 years, 40% of U.S. children will have AUTISM. Those Post WW11 Pharmaceutical companies try to say those diseases are "Genetic". Were they Genetic 70 Years ago, BEFORE WW11? 19. RWN - READING - WRITING - NOW, is a Program that would be USEFUL for some Aborigines who are too ashamed to admit that they cannot read or write. This way the problem is Solved in Private : 1 800 018 802 20. Physical and Sexual Assault are a CRIME. VERBAL Assault - BULLYING, should ALSO become a CRIME. The effects of these 3 types of Assault, Especially in the First 7 years, is LIFE-LONG. 21. The Life Expectancy is increasing. In 20 years, women are expected to live to 92 years. Medical Care is Improving. The RETIREMENT AGE can be Increased from 65 to 70 years, thus INCREASING the TAX BASE 💸. 22. The TAX FREE STATUS of Churches should be RECONSIDERED. In the USA, in the 1970's a KCIA FRONT GROUP & BIG BUSINESS 💸 Organization "PRETENDED to be a religious institution" in order to escape paying it's rightful share of TAXES on it's Very PROFITABLE 💸💸 Enterprises. 23. INCREASE the FOCUS on PRIMARY SCHOOL Teachers & Students. There Must be : a. MORE MALE teachers to be Positive Examples / Role models to the children, ESPECIALLY in Under-privileged Areas. b. SPECIALIZED TRAINING for Primary School teachers c. PAY RISES 💸 for PRIMARY School Teachers The FIRST 7 YEARS and to a lesser extent, the NEXT 7 years, are ESSENTIAL to an individual's Future lifestyle choices. School MUST be seen as a FUN 🎉 and JOYFUL 🙋 experience, ESPECIALLY for Underprivileged children. Schools can be a POSITIVE Influence for ALL children, giving them confidence to Participate fully in Society. "CHILDHOOD should be a JOY" - Dalai Lama Change from Primary Schools to Learning CENTRES Or CLUBS, as this terminology is more attractive for children. 24. POLICE Officers must become CARE Officers 25. GOVERNMENTS go from Force & Law to CARE & RESPECT 26. SENIOR CITIZENS are a RAPIDLY Growing population, with greatly improved health and lifespan. There's alot of issues to be addressed with these citizens. A Huge opportunity is now present for retired individuals to OFFER SERVICE and WORK Together with others. LEARN from EXPERIENCE You're Not Getting OLDER, You're getting BETTER 27. Have EVERY child read "A LITTLE HISTORY of the WORLD" by E.H. Gombrich. This International bestseller 📚 is written in very easy to understand English, for ALL CHILDREN to understand the HISTORY of the WORLD🌍 28. EVERY Individual Deserves at Least 14 years of Love, Care and Protection from at least 1 PRIMARY Care-giver. The First 7-14 years is where MOST of a person's character development occurs. The Majority of a person's attitudes and thinking come from their FIRST 14 YEARS, that's why psychiatrists always ask about your Childhood. 29. The Original and First Australians - Aborigines, are very similar to the African-American population. Their "Rite of Passage" is to spend time in "Lock-up" - Prison. It used to be that the White man considered them both to have 75% of the brain capacity of the White man. Why are Aborigines and African-Americans so "mis-behaved? Because one was seen as property, and the other was seen as animals who happened to inhabit one of the places that the British EMPIRE wanted to Utilize #2. 😀 INDIGENOUS PEOPLE 1. EVERY primary school child must be taught the : a. Song 🙌 b. Dance💃 c. History 📚 d. Culture 🌋 of it's INDIGENOUS Citizens. 40,000 years versus 240 years??..... The Australian and American ORIGINAL citizens need to be APPRECIATED, PROMOTED and VALUED, in order to address their issues, and to make Every other child appreciate and value them. #3. 😀 9 CAUSES 😀 Am I telling you to NOT get SCAMMED by a Predatory CULT, the MEDICAL/NURSING HOME GAME, FALSE PHARMACEUTICALS💊,GUNS🔫 or the WAR BUSINESS 💣 ? NO ! It's a FREE Country, last I checked, as Long as you know the TRUTH, the Whole TRUTH, NOTHING but the TRUTH, so help me GOD. 😇 THEN U can't BLAME anyone but your OWN SELF for YOUR Choices. I've got 9 CAUSES that are Listed below. Here they are. 😀 SCAMS : 1. PREDATORY Cults 2. DEATH RESORTS - Nursing Homes 3. PHARMACEUTICALS - BIG PHARMA 💊 4. The WAR BUSINESS 💰💰 CAUSES : 5. 3rd WORLD WOMEN 6. HEALTHY LIVING 7. GUN CONTROL 🔫 8. TRUE ISLAM 9. INDIGENOUS PEOPLE 1. PREDATORY CULTS - I have a friend who was in a Predatory Cult. They're ALL the Same. Their REAL motivation is Money 💸 & Power (and usually weird Sex). EXAMPLES are People's Temple & Children of God & Scientology & Moonies/FFWPU/Unification Church & Oneida Community & Jehovah's Witnesses Regarding "The TRUE Family of Mankind" - MOONIES - The Family of SELF-PROCLAIMED Lord of the Second Advent Sun Myung Moon - KNOW THEM BY THEIR FRUITS🍇 The APPLE DOESN'T FALL FAR FROM THE TREE 🍎 ACTIONS SPEAK LOUDER THAN WORDS 💪 DO AS I SAY, NOT AS I DO The THINGS People do for MONEY 💸💸💸💸 are the ROOT of ALL EVIL 🙉LEARN FROM YOUR PARENTS🙈 👏PRACTICE WHAT YOU PREACH👎 1. They're Usually led by a MALE, who is CONVINCED that he is a UNIQUE Voice of GOD. 2. Their MARKET is Disenfranchised, "SEARCHING" People. 3. The members are Always told that they're BETTER than others via being part of "The Master Race, God's Lineage, Chosen Skin Color, Religion, Nationality etc." 4. They get those people to do STRANGE actions such as ALL NIGHT Prayers, FASTING, Working for FREE - raising MONEY 💸💸 & Bringing in New members via the Threat "If you don't do this you WON'T Go to Heaven / be Saved OR WILL Go to Hell" 5. They're Always told to MARRY WITHIN the Cult. 6. The Cults Always say the members' REAL natural FAMILIES are "EVIL / FALLEN" in order to create SOLE "Loyalty" to the Cult 7. The Cults are ALWAYS EXPOSED /Destroyed in the END. 8. The Offspring ALWAYS Leave in DISGUST. 😉 GOOD GROUPS : 1. UCSA 2. FREEDOM OF MIND 2. DEATH RESORTS / NURSING HOMES - They are a BOOMING Business💸 now that the Baby Boomers are hitting their 70s and people are living LONGER and medical care is IMPROVING. In some nations, the Aged Care Business Participants "Are ALL in BED TOGETHER 💸💸" ALMOST Every Doctor, Psychiatrist, Nursing Home, Pharmaceutical Coy., and EVEN the COMPLAINTS Organizations 😨"Share Information together for a NON Caring Purpose" 😉 💸💸 I have a friend who TEMPORARILY spent some time in a Nursing Home due to an Injury. After a Medically Educated Individual REMOVED the Incorrect Medication that she was on, she wrote EVERYTHING Down. There was SO MUCH Verbal & Physical Abuse going on, towards Mostly 70 - 85 year old residents, with the Staff Hoping that the Residents are SODRUGGED UP, that They wouldn't be BELIEVED by others, regarding what was REALLY Going on. After weeks of writing EVERYTHING Down, the Manager KICKED my friend out via calling / lying to the POLICE. It is ALL a SCAM YOU'RE as YOUNG AS YOU FEEL 🙌 70 is the NEW 30 🙌 LEARN from EXPERIENCE You're NOT Getting OLDER, You're getting BETTER GOOD INDIVIDUALS & GROUPS : 1. LET'S TALK 2. LYNDA SALTARELLI 3. DAVID STEWART - IRVING 3. 💊 PHARMACEUTICALS 💊 From Everything that I've read, ALL CANCER, DEMENTIA and AUTISM comes from PHARMACEUTICALS & GMOs. But the DRUG Companies try to Cover their A€£ES via LIES such as "Cancer is Genetic". Currently, 70% of Americans are on PILLS. In 20 years, 40% of USA CHILDREN will be AUTISTIC. WHY is this Happening NOW? PHARMACEUTICALS 💊 : 1. RARELY WORK 2. CAUSE GREATER PROBLEMS 3. SOMETIMES CAUSE DEATH Also, did you know that EVERY Doctor KNOWS that the Pharmaceuticals they're Prescribing cause these 3 Sometimes FATAL Illnesses? So WHY is your OWN Family Doctor doing This? One Word. 💸 MONEY 💸 EVERY DOCTOR gets PAID 💸 KICKBACKS 💸 from the PHARMACEUTICALCOMPANIES when they Prescribe their Drugs💊. The THINGS People do for MONEY 💸💸 are the ROOT of ALL EVIL 😈 Remember THALIDOMIDE? That was a Post WW11 Drug for "Pregnancy Pains". 1 FDA Doctor Repeatedly said that it was Already causing HUGE Problems in Europe and to STOP It Immediately. You know what that Drug Companies said? "Oooh those Bossy Bureaucrats" And the Result? DEFORMED BABIES Left and Right 👹 I am NOT a Hippie Chick who wants an Organic Lifestyle, I'm an Accountant 💸Sales Queen 💸 and I feel that IF a person makes the CHOICE to be involved with a Predatory Cult, Nursing Home, Take Pharmaceuticals, FIGHT / DIE in a War, have an UNhealthy Lifestyle, live as a 3rd World Female, participate in UNREVISED Islam, Buy MURDER WEAPONS, then FINE ! AS LONG AS YOU KNOW : "The TRUTH, the WHOLE TRUTH, NOTHING but the TRUTH, so help me GOD" 😇 Then FREELY & INTELLIGENTLY make your OWN CHOICE. GOOD INDIVIDUALS : 1. DR. BRAD McKAY 2. ROGER BEZANIS 4. The WAR BUSINESS 💸💸 - The USA is a VERY SAD Example of this one. For EVERY WAR Check : a. WHO'S at the TOP ? b. WHERE'S the MONEY 💸💸? In EVERY WAR : 1. Men (usually) RAPE 💸💸 a Country of it's Natural RESOURCES & the INDIGENOUS People get ANGRY & FIGHT BACK 😠 2. The ARMS Companies make Even MORE BIG, BIG Money 💸💸 SELLING BOMBS & GUNS to those Invading Men who want to defend themselves because of their OWN invasion, and SOMETIMES to those ANGRY INDIGENOUS People TOO!! 😂😈😂 WHENEVER there's a Inexplicable SCREW-UP in the World, ALWAYS : 💸 💸 "SHOW ME THE MONEY" 💸💸 GOOD GROUPS : 1. CODE PINK 5. 3rd WORLD WOMEN - 80% of the WORLD (3rd World) sees Females as ONLY : 1. BREEDING Animals 2. Sex TOYS 3. PROPERTY The Time is Coming when the COMMON KNOWLEDGE that Females & Males are Totally EQUAL INTELLECTUALLY will be ACCEPTED WORLDWIDE. ALSO ! IF you wish to Procreate, WHO Ya gonna Call?? 😉 WOMEN are SUPERIOR, BUT! We Don't wanna Remind you... WHY? Cuz WE MADE YOU ! 😂😂😂 GOOD GROUPS : 1. IWDA 2. 50 MILLION MISSING 3. AHA FOUNDATION 4. MALALA FOUNDATION 6. HEALTHY LIVING - People need to be AWARE of the PROPER FOODS to put in their Bodies & how to beneficially MAINTAIN their Body via EXERCISE and CARE. A MAJOR problem in the 1st World is OBESITY. People Must REVISE their food intake and EXERCISE on a DAILY BASIS. 😀 ADD ADDITIONAL Sales TAX 💸💸 to ALCOHOL🍾, CIGARETTES, SUGAR🍩, SALT, MEAT, GLUTEN and DAIRY in order to Cover the GUARANTEEDRESULTING ADDITIONAL HEALTHCARE & TV Ads & PRIMARY School EDUCATION COSTS 💸 GOOD GROUPS : 1. NUTRITION FORCE 2. AUTHORITY NUTRITION 7. GUN CONTROL 🔫 - It's pretty OBVIOUS WHY the USA is the ONLY 1st World Nation that STILL Allows PERSONAL OWNERSHIP of 🔫 MURDER WEAPONS 🔫. One WORD = MONEY 💸💸💸💸. GUN MASSACRES have gone from BI-weekly to WEEKLY to DAILY. The NRA has REFUSED to NOT Sell Guns to "JIHADISTS", WHAT DOES THAT SAY? The NRA Also "Strongly SUGGESTS" to EVERY GUN Company CEO to give them a BIG DONATION 💸💸💸💸 😱 EL CAPITALISTA AMERICANA 💸💸💸💸 MONEY 💸💸💸💸 vs. HUMAN LIFE 😇 8. ISLAM 🌹 - EVERY Single one of my EXCELLENT MUSLIM friends does NOT practice : a. FGM - Female Genital Mutilation - SEXUAL ASSAULT b. CHILD BRIDES & Baci Baazi - PEDOPHILIA c. FORCED MARRIAGE - DEPRIVATION of Liberty/BREEDING d. HONOR KILLINGS - MURDER e. HIJAB/BURKHA - MISOGYNY f. GANG RAPES / ACID ATTACKS - ASSAULT ALL of these "Practices" have NOTHING to do with ISLAM - Qur'an, and EVERYTHING to do with Feudal, ARCHAIC, MIDDLE AGES, PRIMITIVE 3rd WORLD Behaviour. BTW - FGM - Female Genital Mutilation is practiced by BOTH CHRISTIANS and MUSLIMS in NORTH AFRICA, HONOR KILLINGS are performed in BOTH LATIN AMERICA and MUSLIM countries, FORCED Marriage / CHILD BRIDES are performed in 80% of the WORLD - 3rd World. GOOD GROUPS : 1. MUSLIM REFORM MOVEMENT 2. FAITHFREEDOM 3. FAITH 4 FREEDOM 9. INDIGENOUS PEOPLE - 20,000 YEARS vs. 239 Years..... Hmmmm......... EVERY NATION MUST Teach About /Appreciate / Value it's FIRST PEOPLE. EVERY School Child MUST be Taught the History, Culture, Song & Dance of it's INDIGENOUS People NOT Just the WHITE Culture. GOOD INDIVIDUALS & GROUPS : 1. SUNNY REDCLOUD 2. "I'M NOT RACIST, BUT" 3. "1 MILLION INDIGENOUS" #4. 😀 DAILY HEALTH REGIME 😀 1. EAT : a. RAW Fruit & Vegetables b. STARCH - Cereal, Potatoes, Rice, NOREFINED Flour or Cereal c. PROTEIN - (Cheese, Milk, Yogurt, Eggs- but Dairy MAY be a problem - research VEGANISM) Peas, Nuts & Beans (and Fish) 2. 😠 NO 😠 CHEMICALS, NICOTINE, MEAT, ALCOHOL, SUGAR, DAIRY, GLUTEN and MINIMAL Salt 3. Minimum of 1 HOUR DAILY EXERCISE - try an Exercise Machine or a Walk or a Gym #5. 😀 SUGAR & CHEMICALS 😀 🍁 Finally 🍁 everyone knows the Damage that SUGAR can cause to your Body, but ARTIFICIALSWEETENERS are ALSO a very Big DANGER. Coca-Cola's BEST $$ International Market $$ is an Australian Aboriginal community, and in the U.S.A., some Hill-billies put it in their baby's bottles as well. As suggested before, an ADDITIONAL SALES TAX $ must be Added to JUNK FOOD, ALCOHOL, CIGARETTES and Also SUGARY & DIET SOFT DRINKS in order to Cover the GUARANTEED EXTRA COST $ of the ADDITIONAL Government Supplied MEDICAL Care + TV WARNING ADS and PRIMARY SCHOOL EDUCATION that are Necessary for these DANGEROUS substances🍁
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What Is Autism? Causes, Symptoms, And Diet + Natural Methods To Manage The Symptoms
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What Is Autism? Causes, Symptoms, And Diet + Natural Methods To Manage The Symptoms
Shaheen Naser March 6, 2019
If you have just found out that your little one has autism, know that you’re not alone. According to the Centers For Disease Control and Prevention, autism spectrum disorder affects 1 in every 59 children (1).
This behavioral disorder may cause repetitive and stereotypical behavior in the affected lot. While such behaviors may be difficult to observe initially, you may figure it out eventually when your child doesn’t behave as expected at that age.
To know more about this behavioral disorder and its treatment options, read on!
Table Of contents
What Is Autism?
Autism is a neurobehavioral condition that is characterized by a range of symptoms. The symptoms usually include impairments in social interaction and developmental and communication skills. These symptoms are usually rigid and repetitive.
Due to the range of symptoms associated with autism, this condition is now termed as autism spectrum disorder (ASD). This covers a large array of symptoms, skills, and levels of impairment.
Children who have autism usually have trouble communicating and understanding what other people think or feel. This makes it extremely hard for them to express their emotions through words, gestures, touch, and facial expressions.
ASD is four times more common in boys than in girls. This disorder is reported across all racial, ethnic, and socioeconomic groups (1).
ASD is categorized into five subtypes according to the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders.
Types Of Autism
The five subtypes of ASD are:
With or without intellectual impairment
With or without language impairment
Associated with a genetic or medical condition or an environmental factor
Associated with a mental, behavioral, or neurodevelopmental disorder
Associated with catatonia, which is a behavioral syndrome characterized by the inability to move
An individual can be diagnosed with one or more subtypes or specifiers.
Before being categorized under the DSM subtypes, the individuals in question are likely to be diagnosed with any of the following disorders. They are:
Childhood disintegrative disorder
Pervasive development disorder-not otherwise specified (PDD-NOS)
Autistic disorder
Asperger’s syndrome
Most symptoms associated with autism usually emerge during early childhood, i.e., between 12 and 24 months. These symptoms may also occur earlier or later.
Signs And Symptoms Of Autism
One of the earliest symptoms of autism is a marked delay in language or social development.
The symptoms of autism are further divided into two categories according to the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders. They are:
1. Problems with communication and social interaction
Issues with communication like sharing emotions or interests or maintaining a conversation
Issues with non-verbal communication, such as trouble maintaining eye contact
Difficulties in maintaining relationships
2. Restricted or repetitive patterns of behavior or activities
Repetitive motions, movements, or speech patterns
Fixated interests
Rigid adherence to specific behavioral patterns
An increase or decrease in one’s sensitivity to certain sensory information, like a negative reaction to sound
While an individual is being diagnosed with autism, they are evaluated within each of these categories, and the severity of their symptoms are noted. To be diagnosed with ASD, the patient must display all the symptoms discussed in the first category of symptoms along with at least two symptoms in the second category.
The exact cause of autism is yet to be determined. Most scientific researches state that there is no single cause of ASD.
Causes And Risk Factors For Autism
A few factors known to cause or increase one’s risk of developing autism are:
An immediate family member who has autism
Genetic mutations
Genetic disorders like fragile X syndrome
Delayed pregnancy
Low weight at birth
Exposure to environmental toxins
Imbalances in metabolism
A history of viral infection
Exposure of the fetus to medications like valproic acid (Depakene) or thalidomide (Thalomid)
Once the child is diagnosed with autism or ASD, immediate treatment and intervention should be availed to help manage the symptoms.
While there is no cure for this condition, the following are some medical treatments that can help in managing ASD.
Medical Treatment
The most commonly availed treatment approaches for autism usually include therapies such as:
Play therapy
Behavioral therapy
Speech therapy
Occupational therapy
Physical therapy
The affected individuals may also benefit from massages, weighted blankets/clothing, and meditation.
There are also some natural ways, like the ones listed below, that can help in managing the symptoms of autism.
Natural Ways To Manage The Symptoms Of Autism
1. Epsom Salt Bath
shutterstock
You Will Need
1 cup of Epsom salt
Water
What You Have To Do
Add a cup of Epsom salt to a tub filled with water.
Mix well and get the child/individual to soak in the water for 15-20 minutes.
How Often You Should Do This
Do this once daily.
Why This Works
People with autism are often deficient in magnesium. An Epsom salt bath can help the skin absorb magnesium and also manage other symptoms of autism (2).
2. Omega-3 Fatty Acids
shutterstock
You Will Need
Omega-3 supplements
What You Have To Do
Give the affected individual omega-3 supplements daily.
Also, include foods rich in omega-3s like salmon, mackerel, soybean and walnut in the diet.
Note: Go for additional supplements after consulting a doctor.
How Often You Should Do This
Do this once daily.
Why This Works
Omega-3 deficiencies are often linked to autism spectrum disorder (ASD). Restoring this deficiency was found to improve symptoms like lethargy, hyperactivity, and stereotypy in the affected individuals as concluded by a study published in the journal Neuropsychiatric Disease and Treatment (3).
3. Essential Oils
a. Lavender Oil
shutterstock
You Will Need
2-3 drops of lavender oil
A diffuser
Water
What You Have To Do
Add two to three drops of lavender oil to a diffuser filled with water.
The affected individual should inhale the diffused aroma.
How Often You Should Do This
You may do this 1-2 times daily.
Why This Works
The soothing aroma of lavender oil may help alleviate symptoms of anxiety and enhance cognitive ability in ASD individuals (4).
b. Orange Oil
shutterstock
You Will Need
2-3 drops of orange oil
A diffuser
Water
What You Have To Do
Add two to three drops of orange oil to a diffuser that is already filled with water.
Inhale the aroma of orange oil.
How Often You Should Do This
You may do this 1-2 times daily.
Why This Works
The odor of orange oil was also noted to improve anxiety and mood (4). Hence, it may help in managing similar symptoms exhibited by patients with autism.
4. Probiotics
shutterstock
You Will Need
Probiotic foods and supplements
What You Have To Do
The child must have a probiotic supplement daily.
You can also increase their intake of probiotic-rich foods like yogurt and kefir.
Note: Consult a doctor before going for any additional supplements.
How Often You Should Do This
You can do this once daily.
Why This Works
Gastrointestinal symptoms are quite common in children with autism. Probiotics can positively impact the gut microbes and help alleviate gastrointestinal symptoms (5).
While there is no specific diet designed for those with ASD, diet does play an important role in improving their overall quality of life.
Autism Diet
An autism diet should pay more attention to whole foods like:
Lean poultry
Fresh fruits and vegetables
Fish
Unsaturated fats
Water
Magnesium-rich foods like green leafy vegetables, seafood, and nuts may have a positive impact on those who have autism (6). Seafood is also rich in omega-3 fatty acids that can help with the symptoms of ASD (3). Probiotic yogurt is also a great addition to the diet of an autistic individual (5).
Certain foods can increase inflammation within the body, thereby aggravating existing symptoms in autistic children. Avoid the following:
Preservatives
Food coloring
Sweeteners and sugar
The following are some tips that can help in parenting a child with autism.
Tips For Parenting A Child On The Autism Spectrum
Focus on the positive aspects of your child. Shower them with praises for every well-behaved moment.
Adhere to a schedule as children on the spectrum like routines.
Indulge in activities that are fun-filled and don’t come across as educational or therapeutic.
Take your time to find the best possible combination of treatment approaches to help your child.
Involve your child in everyday activities like grocery shopping.
Don’t hesitate to seek support from other families or professionals who deal with similar challenges.
Autism is a disorder that needs to be dealt with utmost care and patience. It is very important that parents provide immense support to the affected children to deal with this disorder and help them lead as close-to-normal lives as possible.
Hope this post helped address all your doubts revolving around autism. If you have any more doubts or inputs to deal with this condition better, feel free to post them in the comments box below.
Expert’s Answers For Readers’ Questions
Can individuals with high-functioning autism live a normal life?
Individuals with high-functioning autism are often found to be quite bright. Compared to those at the lower spectrum, people with high functioning autism may lead a life that is as close to normal as possible. However, they too find it equally challenging to deal with the disorder.
Is CBD oil good for autism?
The therapeutic effects of CBD oil may help alleviate behavioral symptoms of anxiety and seizures associated with autism.
How to test for autism in adults?
There is no standard diagnostic procedure for adults suspected to have ASD. Primarily, clinicians diagnose ASD in adults through a range of in-person interactions and observations.
How does autism affect the brain?
Autism is believed to affect the entire brain of the affected child. Such children have increased number of synapses between the brain cells.
When to visit a doctor for autism?
If you notice any autistic or unusual behavioral symptoms in your child, visit a doctor to confirm the diagnosis for the behavioral disorder.
References
“Autism Spectrum Disorder” Centers For Disease Control and Prevention.
“Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder-A Randomized, Controlled 12-Month Trial.” Nutrients, US National Library Of Medicine.
“Supplementation of omega 3 fatty acids may improve hyperactivity, lethargy, and stereotypy in children with autism spectrum disorders: a meta-analysis of randomized controlled trials” Neuropsychiatric Disease and Treatment, US National Library Of Medicine.
“Ambient odors of orange and lavender reduce anxiety and improve mood in a dental office” Physiology & Behavior, ScienceDirect.
“Can probiotics benefit children with autism spectrum disorders?” World Journal Of Gastroenterology, US National Library Of Medicine.
“Magnesium profile in autism.” Biological Trace Element Research, US National Library Of Medicine.
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Bad Medicine, Part 1: The Story of 98.6 (Rebroadcast)
We think modern medicine is pretty advanced, but what if we’re wrong about something as simple as the average body temperature? (stevepb / Pixabay)
Our latest Freakonomics Radio episode is called “Bad Medicine, Part 1: The Story of 98.6 (Rebroadcast).” (You can subscribe to the podcast at Apple Podcasts or elsewhere, get the RSS feed, or listen via the media player above.)
We tend to think of medicine as a science, but for most of human history it has been scientific-ish at best. In the first episode of a three-part series, we look at the grotesque mistakes produced by centuries of trial-and-error, and ask whether the new era of evidence-based medicine is the solution.
Below is a transcript of the episode, modified for your reading pleasure. For more information on the people and ideas in the episode, see the links at the bottom of this post. And you’ll find credits for the music in the episode noted within the transcript.
* * *
We’re taking advantage of August to replay you a special three-part series we did last year, called “Bad Medicine.” Today, Part 1: “The Story of 98.6,” and it starts right now …
We begin with the story of 98.6. You know the number, right? It’s one of the most famous numbers there is. Because the body temperature of a healthy human being is 98.6 degrees Fahrenheit. Isn’t it?
Anupam JENA: So I’m going to take your temperature, if you don’t mind. Just open your mouth and I’ll insert the thermometer.
Jackson BRAIDER: Ah!
JENA: Perfect.
The story of 98.6 …
Philip MACKOWIAK: … dates back to a physician by the name of Carl Wunderlich.
This was in the mid-1800s. Wunderlich was medical director of the hospital at Leipzig University. In that capacity, he …
MACKOWIAK: Oversaw the care and the taking the vital signs on some 25,000 patients.
Pretty big data set, yes? Twenty-five thousand patients! And what did Wunderlich determine?
MACKOWIAK: He determined that the average temperature of the normal human being was 98.6 degrees Fahrenheit or 37 degrees centigrade.
This is Philip Mackowiak, a professor of medicine and a medical historian at the University of Maryland.
MACKOWIAK: I’m an internist by trade and an infectious-disease specialist by subspecialty. So my bread and butter is fever.
There’s one more thing Mackowiak is …
MACKOWIAK: I am by nature a skeptic. It occurred to me very early in my career that this idea that 98.6 was normal — and then if you didn’t have a temperature of 98.6 you were somehow abnormal — just didn’t sit right.
Philip Mackowiak, you have to understand, cares a lot about what is called clinical thermometry. And if you care a lot about clinical thermometry, you care a lot about the thermometer that Carl Wunderlich used to establish 98.6.
Wunderlich was using this thermometer to measure axillary temperatures, not temperatures in the mouth or the rectum. (Photo: The College of Physicians of Philadelphia)
MACKOWIAK: His thermometer is an amazing key to this story of 98.6.
So you can imagine how excited Mackowiak was when, on a tour of the weird and wonderful Mutter Museum in Philadelphia, the curator told him they had one of Wunderlich’s original thermometers.
MACKOWIAK: I said: “Good heavens, may I see it?” And she said: “Would you like to borrow it?” And I said: “Of course!” I was able to take this thermometer back to Baltimore and do a number of experiments.
The Wunderlich thermometer, Mackowiak realized, was not at all a typical thermometer.
MACKOWIAK: First of all, it was about a foot long, fairly thick stem. It registered almost two degrees Centigrade higher than current thermometers or thermometers of that era.
Two degrees higher — centigrade? Uh oh!
MACKOWIAK: In addition to that, it is a non-registering thermometer, which means that it has to be read while it’s in place. So it would have been awkward to use.
Mackowiak noticed something else about the original Wunderlich research.
MACKOWIAK: Investigating further it became apparent that he was not measuring temperatures either in the mouth or the rectum. He was measuring axillary or armpit temperatures and so that in many ways his results are not applicable to temperatures that are taken using current thermometers and current techniques.
As it turns out, the esteemed Dr. Carl Wunderlich …
MACKOWIAK: … was not the most careful investigator ever to come on the scene.
The more Mackowiak looked into the Wunderlich data, and how the story of 98.6 came to be, the more he wondered about its accuracy. So he set up his own body-temperature study. He recruited healthy volunteers, male and female, and took their temperature one to four times a day, around the clock, for about two days, using a well-calibrated digital thermometer in the patients’ mouths. What did he find?
MACKOWIAK: Of the total number of temperatures that were taken, only 8 percent were actually 98.6. If you believe that 98.6 is the normal temperature, than 92 percent of the time, the temperature was abnormal. Obviously that’s not even reasonable.
In his study, Mackowiak found the actual “normal” temperature to be 98.2 degrees. Not a huge difference — and yet, the whole notion of a “normal” body temperature was looking more and more suspect. Why? A lot of reasons. Temperature varies from person to person, sometimes so much that one person’s normal would nearly register as nearly feverish for another person.
MACKOWIAK: It’s almost like a fingerprint.
Temperature varies throughout the day — it’s roughly one degree higher at night than in the morning, sometimes even more. And an elevated temperature isn’t necessarily a sign of illness:
MACKOWIAK: In women it goes up with ovulation, during the menstrual cycle. The temperature goes up during vigorous exercise and this is not a fever.
And so, Mackowiak concluded …
MACKOWIAK: Looking at a rise in temperature as a reliable sign of infection or disease is inappropriately simplistic thinking.
Inappropriately simplistic thinking. It makes you wonder: if the medical establishment believed for so long in an inappropriately simplistic story about something as basic as normal body temperature — what else have they fallen for? What other mistakes have they made? I hope you’ve got some time; it’s a long list:
Jeremy GREENE: You take a sick person, slice open a vein, take a few pints of blood out of them …
JENA: Drilling holes into people’s skulls.
Vinay PRASAD: It was literally taking someone to hell and back.
Teresa WOODRUFF: It would cause a whole series of malformations and probably a lot of fetal death.
JENA: Lobotomies.
Keith WAILOO: The overuse of a mercury compound.
Evelynn HAMMONDS: The Tuskegee case.
WAILOO: Losing your teeth and having your gums bleed.
WOODRUFF: DES and thalidomide.
PRASAD: We use a cement.
WOODRUFF: Hormone replacement therapy.
WAILOO: The oxycontin and opioid problem.
MACKOWIAK: As a medical historian, it is patently obvious to me that future generations will look at what we’re doing today and ask themselves “What was Grandpa thinking of when he did that and believed that?” They’ll have to learn all over again that science is imperfect and to maintain a healthy skepticism about everything we believe and do in life in general, but in the medical profession in particular.
On today’s show: Part 1 of a special three-part series of Freakonomics Radio. We’ll be talking about the new era of personalized medicine; the growing reliance on evidence-based medicine; and especially — pay attention now, I’m going to use a technical term — we’ll be talking about bad medicine.
* * *
We have a lot of ground to cover in these three episodes: medicine’s greatest hits, the biggest failures, where we are now and where we’re headed. In the interest of not turning a three-part series about bad medicine into a twenty-part series, we’re not even going to touch adjacent fields like nutrition and psychiatry. Maybe another time. Let’s start, very briefly, at the beginning. Nearly 2,500 years ago, you had the Greek physician Hippocrates, who’s still called the “father of modern medicine.” You’ve heard, of course, of the Hippocratic Oath, the creed recited by new doctors.
And you know the Oath’s famous phrase — “First, do no harm.” Even though, as it turns out, that phrase isn’t actually included in the Oath. It came from something else Hippocrates wrote. Nor do many contemporary doctors recite the original Hippocratic Oath; there’s a modern version, written in 1964, by the prominent pharmacologist Louis Lasagna. The pledge begins: “I swear to fulfill, to the best of my ability and judgment, this covenant.” It’s a fascinating, inspiring document — and I think before we go too far, it’s worth hearing some of it …
Louis Lasagna adaptation of the Hippocratic Oath: “I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow. I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug. I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
Above all, I must not play at God. I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person’s family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick. I will prevent disease whenever I can, for prevention is preferable to cure. May I long experience the joy of healing those who seek my help.”
It’s comforting to think about the thoughtfulness, the nuance — the massive responsibility — that doctors pledge before they attempt to diagnose or heal us. How well has that pledge been upheld throughout medical history? We’ll talk to a variety of people about that today, starting with this gentleman.
JENA: My name is Anupam Jena. I’m a healthcare economist and physician at Harvard Medical School.
So Jena, as both a practitioner and an analytic researcher, is especially useful for our purposes. Because one of the themes we’ll hit today, several times, is that medicine, even though it’s scientific, or at least scientific-ish, hasn’t always been as empirical as you might think — and sometimes, not very empirical at all.
DUBNER: Here is an easy question: can you tell me please the history of medicine, or at least Western medicine in three or four minutes?
JENA: Let me first answer the meaning of life.
DUBNER: Is that going to be easier?
JENA: That’ll take about five to six minutes. How about three words: trial and error. If you think about medicine and how it has evolved — let’s just say in the last 100 to 200 years — the practices that at some point in history people thought were actually medically legitimate included drilling holes into people’s skulls, lobotomies. Even as late as in the 1940s – 1950s, lobotomies were thought to actually have a treatment effect in patients with mental illness, be it schizophrenia or depression.
The practice of bloodletting, which is basically trying to remove the “bad humors” from the body was thought to be therapeutic in patients. Things like mercury, which we know is downright toxic, were used as treatments in the past. That was in a time and place when it was very difficult to get evidence. Not only that, there was probably a perception of the field that didn’t allow for the ability to question itself.
In the last 50+ years, probably 50 to 75 years, we’ve seen tremendous strides in the ability of the profession to constantly question itself.
DUBNER: It’s easy to get indignant over the idea of these treatments that turned out to be so wrong. But understanding wellness and illness is hard, obviously. When you look back at the history of medicine, do those interventions strike you as shameful — you can’t believe you’re in the profession that tried things like that — or is that just part of the trial-and-error process that you accept?
JENA: I certainly wouldn’t call it shameful. The only thing that’s shameful is when someone doesn’t believe that they have the potential for being wrong and they don’t have that desire to inquire further about whether something actually works or doesn’t work. But the idea of trying things, particularly trying things that have a really strong plausible pathophysiologic basis, there is nothing wrong with that. In fact, that’s what spurred scientific discovery and many of the treatments that we have now.
DUBNER: I have a broad question for you: the human body is and extraordinarily complex organism. Over history, doctors and others have learned a great deal about it. But if we consider the entire human body — from the medical perspective only, let’s leave out metaphysics and theology and what have you — how would you assess the share of the body and its functions that we truly understand and the share that we don’t really yet understand?
JENA: That’s a tough one. We’ve made a lot of headway, but to put a number on it … I would say maybe 30 percent, 40 percent that we don’t know.
GREENE: That’s a tough question for me to quantify.
I asked the same question of someone else.
GREENE: My name is Jeremy Greene. I’m a physician and a historian of medicine at Johns Hopkins.
So what’s Greene’s answer?
GREENE: There is a Rumsfeldian answer of the known knowns, known unknowns and unknown unknowns. A different way of answering that question would have to do with what the idea of relevant science of medicine is.
For example?
GREENE: For example, the moment in Renaissance, the Vesalian moment: the opening of cadavers, and [describing] and rendering precise three-dimensional chiaroscuro engravings of the human body was an exciting area for research that actually this humanist process of opening up cadavers, showing that the innards were not exactly what the ancient Greeks had described. As a historian, rather than giving you a fixed percent of where we are, I can give you a Zeno’s paradox that we keep on getting close to that finite moment and then reinvent a new broader room for us to inhabit.
And that’s because there’s been a lot of progress in how we’re able to explore the human body.
JENA: There is the gross anatomy of the body, which you can see with your own eyes.
Anupam Jena again:
JENA: Then go a layer further and we’re now at the microscopic anatomy of the body. What do the cells of the body look like when they are diseased under a microscope?
And now …
JENA: Now go a layer further where you are now trying to understand things about the body that you can’t even see with the microscope. That’s at, let’s say, the level of the proteins in the cell, or even further down, the level of the DNA that encodes that protein.
GREENE: By the end of the 20th century, there’s a very strong genetic imaginary, which really helps to then fuel the excitement behind The Human Genome Project. It’s thought once we know the totality of the human genome, we’ll know all we need to know about bodies and health and disease.
Of course we already know a great deal. And, to be fair, for all the mistakes and oversights in medicine, there’s been extraordinary progress. What are some of medicine’s greatest hits?
HAMMONDS: I’m sure every historian of science medicine would give you a different set of hits.
That’s Evelynn Hammonds. She’s a professor of the history of science and African-American studies at Harvard.
HAMMONDS: The ones that I typically think about are the introduction of more efficacious therapeutics and medicines.
WAILOO: I would put something like the discovery of insulin right up there near the top.
That’s Keith Wailoo. He’s a Princeton historian who focuses on health policy.
WAILOO: It transformed diabetes from an acute disease into a disease that you live with. To me, that is much more the story of what medicine has been able to do in the 20th century.
JENA: The medicine that comes to my mind is statins. They’ve been shown to have benefit in preventing heart attacks and prolongation of life among people who have had heart attacks and the same thing for stroke and other forms of cardiovascular disease. But there are many, many drugs that are like that.
These are, truly, awesome interventions, for which we should all be thankful. One of the most remarkable developments over the past century and a half is the unbelievable gain in life expectancy: in the U.S., and elsewhere, it nearly doubled! It might be natural to ascribe that gain primarily to breakthrough medicines. But in fact a lot of it had to do with something else.
WAILOO: A lot of the advances in mortality and morbidity have come from, really, changes in the nature of social life. Infectious disease as the source of high mortality in the early 20th century began to drop long before penicillin and the antibacterials came along in the mid-century because of improvements in housing, sanitation, diet, and [the] tackling [of] urban problems that really created congestion and produced the circumstances that made things like tuberculosis the leading cause of mortality.
HAMMONDS: For example, if you think about the reversal of the Chicago River — it used to flow into Lake Michigan, in the 19th-century. People were dumping their waste into it, and every summer, there would be hundreds of deaths of babies and children from infant diarrhea because the water was so contaminated. They reversed the flow of the river so it flowed downriver towards the Mississippi. That significantly improved the health of the people who lived there.
So we’ve got public-health improvements to thank. And yes, better therapeutics and medicines. Also: new and better ways of finding evidence.
PRASAD: The technology that really revolutionized how we think is the use of controlled experiments.
That’s Vinay Prasad. He’s an assistant professor of medicine at Oregon Health & Science University. Prasad treats cancer patients. But also:
PRASAD: The rest of my time I devote to research on health policy, on the decisions doctors make, on how doctors adopt new technologies, and when those things are rational and when they’re not rational.
Which means that Prasad is part of a relatively new, relatively small movement to make medical science a lot more scientific:
PRASAD: For thousands of years what was medicine but something that somebody of esteemed authority had done for many years, and told others that, “It worked for me so you better do it.”
Even though medical science seemed to be based on evidence, Prasad says …
PRASAD: The reality was that what we were practicing was something called eminence-based medicine. It was where the preponderance of medical practice was driven by really charismatic and thoughtful leaders in medicine. Medical practice was based on bits and scraps of evidence, anecdotes, bias, preconceived notions, and probably a lot psychological traps that we fall into. Largely from the time of Hippocrates and the Romans until maybe even the late Renaissance, medicine was unchanged.
It was the same for 1,000 years. Then something remarkable happened which was the first use of controlled clinical trials in medicine.
Coming up on Freakonomics Radio: how clinical trials began to change the game.
PRASAD: It really doesn’t matter that the smartest people believe something works. The only thing that really counts is what is the evidence you have that it works.
How some people didn’t have much of an appetite for actual evidence:
CHALMERS: There was a great deal of hostility to it from the medical establishment
And, in a strange twist, how better science is pushing medicine not always forward, but sometimes backwards:
JENA: It is quite common to see practices that end up getting reversed. The best estimates are that [it] happens about 15 percent of the time.
* * *
JENA: All right, take a deep breath through your mouth, in and out. Good, okay. One more.
Anupam Jena is an M.D. and a healthcare economist.
JENA: I’m going to lift up your shirt and listen to your heart.
In most developed countries, we tend to think of medicine as a rigorous science, and of our doctors as, if not infallible, at least reliable.
JENA: The typical patient probably does look to their doctor for answers and they value very highly what that opinion is.
But as we’ve been hearing, the history of medical science was often “eminence-based” rather than “evidence-based.” When did evidence really start to take over?
JENA: Evidence-based medicine has become hugely important in the last 25 to 30 years.
The movement is a result, Jena says, of at least two factors: Number one:
JENA: We’re doing more randomized controlled trials and that tells us more information about what works and doesn’t work.
And, number two:
JENA: Improvements in computer technology have now allowed us to study data in a way that we couldn’t have done 30 years ago.
There’s also been a movement to collect and synthesize all that research and all those data:
Lisa BERO: Our vision is to produce systematic reviews that summarize the best available research evidence to inform decisions about health.
That’s Lisa Bero, a pharmacologist by training, who studies the integrity of clinical and research evidence.
BERO: I’m also a co-chair of the Cochrane Collaboration.
The Cochrane Collaboration was founded in Britain but is now a global network. The “systematic reviews” they produce …
BERO: … are really the evidence base for evidence-based medicine. We’ve been a leader in so many ways in developing systematic reviews. We were the first to regularly update these reviews. We were one of the first to have post-publication peer review and a very strong conflict-of-interest policy. Actually, we were one of the first journals that was published only online.
Which means that whatever realm of medical science you’re working on, you can access nearly all the evidence on all the research ever conducted in that realm — constantly updated, available on the spot. Compare that to how things used to work — looking up some 5- or 10-year-old medical journal to find one relevant article that may well have been funded by the pharmaceutical company whose drug it happened to celebrate. How is Cochrane funded?
BERO: We are primarily funded by governments and nonprofits.
What about industry money?
BERO: We don’t take any money from industry to support any official Cochrane groups.
Which means, in theory at least, that the evidence assembled by the Cochrane Collaboration is pretty reliable evidence. As opposed to …
Iain CHALMERS: … a whole variety of things. Opinion. What the doctor had been taught 30 years previously in medical school. Tradition. What they had been told to do by, or advised to do, by a drug-company representative that had visited them a week previously.
That is Sir Iain Chalmers, who co-founded the Cochrane Collaboration. He’s a former clinician who specialized in pregnancy, childbirth, and early infancy. He was a medical student in the early 1960s. When Chalmers observed his elders in practice, he was struck by how much variance there was from doctor to doctor.
CHALMERS: Some doctors — if a woman had a baby presenting by the breach — would do a Caesarean section, without any questions asked. Or they may take different views about the way the baby should be monitored during labor. Or the extent to which drugs should be used during pregnancy for one thing or another. Lots and lots of differences in practices. It’s as long as your arm. It’s madness isn’t it?
When he became a doctor himself, Chalmers worked at a refugee camp in Gaza. And, as he discovered …
CHALMERS: … some of the things that I had learned at medical school were lethally wrong.
Like how you were supposed to treat a child with measles.
CHALMERS: I had been taught at medical school never to give antibiotics to a child with a viral infection, which measles is, because you might induce resistance, antibiotic resistance. But these children died really quite fast after getting pneumonia from bacterial infection, which comes on top of the viral infection of the measles. What was most frustrating was that it wasn’t until some years later that I found that there had been six controlled trials comparing antibiotic prophylaxis given preventatively with nothing done by the time I arrived in Gaza.
And those studies suggested that children with measles should be given antibiotics. But Chalmers had never seen those studies.
CHALMERS: I feel very sad that in retrospect I let my patients down.
This led Chalmers to embark on a years-long effort to systematically create a centralized body of research to help attack the incomplete, random, subjective way that too much medicine had been practiced for too long. He was joined by a number of people from around the world — many of whom, by the way, were more versed in statistics than in medicine.
CHALMERS: We embarked on these systematic reviews, about 100 of us. That resulted, at the end of the 1980s, in a massive, two-volume, one-and-a-half-thousand-page book. At the same time, we started to publish electronically.
And so the Cochrane Collaboration became the first organization to really systematize, compile, and evaluate the best evidence for given medical questions. You’d think this would have been met with universal praise. But, as with any guild whose inveterate wisdom is challenged, as unwise as that wisdom may be, the medical community wasn’t thrilled.
CHALMERS: There was a great deal of hostility to it from the medical establishment. In fact, I remember a colleague of mine was going off to speak to a local meeting of the British Medical Association, who had basically summoned him to give an account of evidence-based medicine. “What the hell did people who were statisticians and other non-doctors think they were doing messing around in territory which they shouldn’t be messing around in?” He asked me before he drove off, “What should I tell them?”
I said, “When patients start complaining about the objectives of evidence-based medicine, then one should take the criticism seriously. Up until then, assume that it’s basically vested interests playing their way out.”
It took a long while, but the Cochrane model of evidence-based medicine did become the new standard.
CHALMERS: I would say it wasn’t actually until this century. One way you can look at it is where there is death, there is hope. As a cohort of doctors who rubbished it moved into retirement and then death, the opposition disappeared.
PRASAD: That’s been the slower evolution.
That, again, is Vinay Prasad, from Oregon Health and Science University.
PRASAD: The very first studies with randomization concerned tuberculosis.
This was in the late 1940s.
PRASAD: From then the end of the 1980s, we did use randomized trials but they weren’t mandatory. They were optional.
One big benefit of a randomized trial is that you can plainly measure, in the data, the cause and effect of whatever treatment you’re looking at. This may sound obvious but it is remarkable how many medical treatments of the past were conducted without that evidence. Anupam Jena again:
JENA: Some of the biggest mistakes in the last century, let’s say from 1900 to 1950 — things like lobotomy used to treat mentally illness, either depression or schizophrenia — those strike me as being some of the most horrific things that could be done to man without any really solid evidence base at all.
This is one of the trickiest things about practicing medicine day-to-day. Let’s say you’re a doctor, and a patient comes to see you with a persistent headache. You make a diagnosis, and you write a prescription. What happens next? In many cases, you have no idea. The feedback loop in medicine is often very, very sloppy. Did the patient get better? Maybe. They never came back. But maybe they went to a different doctor. Or maybe they died? If they did get better, was it because of the medicine you prescribed? Maybe.
Or maybe they didn’t even fill the scrip. Or maybe they did fill the scrip but stopped taking it because they got an upset stomach. Or maybe they did take the medicine and they did get better but … maybe they would have gotten better without the medicine? Like I said, you have no idea. But with a well-constructed randomized controlled trial, you can get an idea. Vinay Prasad again:
PRASAD: The moment that set us on different course was a study called CAST.
CAST stands for Cardiac Arrhythmia Suppression Trial. It was conducted in the late 1980s.
PRASAD: One of the things doctors were doing a lot for people after they had a heart attack was prescribing them an antiarrhythmic drug, that was supposed to keep those aberrant rhythms, those bad heart rhythms, at bay. That drug actually, in a carefully done randomized trial, turned out not to improve survival as we all had thought, but to worsen survival. That was a watershed moment where people realized that randomized trials can contradict even the best of what you believe.
It really doesn’t matter in medicine that the smartest people believe something works. The only thing that really counts at the end of the day, is what is the evidence you have that it works.
The rise of randomized controlled trials led to a rise in what are called medical reversals. Vinay Prasad wrote the book on medical reversals, literally. It’s called Ending Medical Reversal.
PRASAD: What is a medical reversal? Doctors do something for decades, it’s widely believed to be beneficial, and then one day, a very seminal study — often better-designed, better-powered, better-controlled than the entirety of the pre-existing body of evidence — contradicts that practice. It isn’t just that it had side effects we didn’t think about. It was that the benefits that we had postulated, turned out to be not true or not present.
For instance …
PRASAD: In the 1990s we would recommend to postmenopausal women to start taking estrogen supplements, because we knew that women before they had menopause had lower rates of heart disease, and we thought that was because of a favorable effect of estrogen. And then in 2002, a carefully done randomized control trial, found that actually, it doesn’t decrease heart attacks and strokes; in fact, if anything it increases them.
I asked Prasad what first got him interested in studying medical reversal.
PRASAD: I started to get interested in this even when I was a student, and I saw that there [were] some practices that had been contradicted just in the recent past but were still being done day in and day out in the hospital. The example that comes to mind is the stenting for stable coronary angina. A stent is a little foldable metal tube that goes in a blocked coronary artery and the doctors spring it open, and it opens up the blockage.
Stents are incredibly valuable for certain things. If you have a heart attack and there’s a blockage that just happened a few minutes ago, and the doctor goes in and opens that blockage up, we’re talking about a tremendous improvement in mortality, one of the best things we do in medicine. But stenting, like every other medical procedure, has something called indication drift where it works great for a severe condition, but does it work just as good for a very mild condition?
Over the years, doctors has used stenting for something called stable angina. Stable angina is just slow, incremental, narrowing of the arteries that happens to sadly all of us as we get older. But the bulk of stenting was this indication drift. We thought it worked and made perfect sense. Then in 2007, a well-done study showed that it didn’t improve survival, and didn’t decrease heart attacks, which were, even to this day studies show that most patients who undergo this procedure believe it will do those things.
In fact, it’s been disproven for eight years.
And yet: while stenting for stable angina did decline, it didn’t disappear. The rate of inappropriate stenting, Prasad says, is still way too high. This obviously starts getting into doctors’ incentives — financial and otherwise — and we’ll get into more in Parts 2 and 3 of this series. As Prasad makes clear, there’s a long, long list of medical treatments that simply don’t stand up to empirical scrutiny. Some common knee surgeries, for instance, where orthopedic surgeons take a tiny camera …
PRASAD: … take a tiny camera, make a tiny incision, and go in there, and actually debride and remove those scuffed and scraped knees. In fact, people felt a lot better. They had improved range of motion. There’s no argument there. But you’ve studied against just taking ibuprofen, or maybe just doing some physical therapy … What if you studied it against making the patient believe that you were doing the surgery, but you don’t actually do it?
In fact, they’ve done those studies. Those are called “sham” studies. We give the appearance that we’re going to do this procedure. The only thing we omit is actually the debridement of the menisci and the cartilage. In fact, when you do it that way, you find that the entire procedure is a placebo effect. There’s another example where we use a cement that we inject into a broken vertebral bone. That, again, was found to be no better than injecting a saline solution in a sham procedure.
The cement itself cost $6,000, and I said, “At a minimum you can save yourself $6,000, and you don’t need to use the cement.”
DUBNER: What would be the incentives for me to do the study that might result in a reversal? Because we know how publishing works — whether it’s in your field, in any academic field, or in the media as well — it’s the juicy, sexy, new findings that get a lot of heat. It’s the maintenance articles, or the reversal articles, that nobody wants to hear about. I would gather there are fairly weak incentives to doing the studies that would result in reversals — which also makes me wonder if there is a woeful undersupply of such studies, which means there probably would be even more reversals then there are.
PRASAD: Yeah. That’s a fantastic question. One of the things that we did in the course of our research was we took a decade worth of articles, [from] probably one of the most prestigious medical journals, The New England Journal of Medicine. There was about 1,300 articles that concern things that doctors do. About 1,000 of those articles were something new that’s coming down the pipeline, the newest anticoagulant, the newest mechanical heart valve.
If you tested something new — exactly as you’d expect, 77 percent of those published manuscripts concluded that what’s newer is better. But we also discovered about 360 articles tested something doctors were already doing. If you tested something doctors were already doing, 40 percent of the time, we found that it was contradicted or, a reversal.
DUBNER: I’d love for you to talk about the various consequences of reversals, including perhaps a loss of faith in the medical system generally.
PRASAD: If you find out something you were doing for decades is wrong you harmed a lot of people, you subjected many people to something ineffective, potentially harmful, certainly costly, and it didn’t work. The second harm we say is this lag-time harm. Doctors, we’re like a battleship. We don’t turn on a dime. We continue to do it for a few years after the reversal. The third is loss of trust in the medical system. We’ve seen it in the last decade, particularly with our shifting recommendations for mammography and for prostate cancer screening.
People come to the doctor and they say, “You guys can’t get your story straight. What’s going on?” It’s a tremendous problem. I’m afraid that we are making people feel like that there’s nothing that the doctor does that’s really trustworthy. I’m afraid that that’s the deepest problem that we’re faced, this loss of trust.
DUBNER: Okay, so how do you not throw out the baby with the bathwater? What are some solutions to a practice of medicine and medical research that results in fewer reversals?
PRASAD: That is a million-dollar question. One is medical education. We have a medical education where for two years, students are trained in the basic science of the body. Only in the latter years, the third and fourth year of medical school, are students trained in the epidemiology of medical science, evidence-based medicine, in thinking not just how does something work, but what’s the data that it does work? I’ve argued that needs to be flipped on its head. That the root, the basic science of medical school is evidence-based medicine.
It’s approaching a clinical question knowing what data to seek, and how to answer that in a very honest way. That’s one. The next category is regulation. This is where you get into, “What is the FDA’s role, and what does the FDA do?” Many people in the community hope that products that are approved by the FDA are both safe and efficacious for what they do. But we were faced with a problem in the ‘80s and ‘90s that we had never faced before, which was the HIV/AIDs epidemic. Advocates rightly said that we need a way to get drugs to patients faster, maybe even accepting a little bit more uncertainty.
I think that was right and that’s still right for many conditions that are very dire, for which few other treatment options exist, and, which sometimes have very low incidence, so it’s very hard to do those studies because very few people have it. But what’s happened is that mechanism has been extrapolated to conditions that are not dire, that have very good survival, that don’t have few options, have many options, and that many people do have. We’ve had, again, a slippery slope for what qualifies for this accelerated approval.
There [are] ways in which regulation can be adjusted. Then, the last thing is the ethic of practicing physicians. We have to have an ethic where when we offer something to someone, and there’s uncertainty, we should be very clear about communicating uncertainty. It’s a tragedy today that no matter what you think of stenting for stable coronary artery disease, that so many people who are having it done believe something that is clearly not true, that it lowers the rate of heart attacks and death.
That’s just factually not true, and the fact that many people believe that speaks to the fact that, as doctors, we allow them to believe it.
DUBNER: Let me ask you one last question: I have a pretty good sense, of having spoken to you for a bit, of what has prevented in the past medicine from being more scientific or more evidence-based, but what do you believe are the major barriers still that are still preventing it from becoming as evidence-based as you want it to be?
PRASAD: We should be honest about what medicine is. In the United States, medicine is something that now takes, nearly or over 20 percent of G.D.P. It’s a colossus in our economy. We spend more on medicine than any other Western nation. We probably don’t get as much from what we’re spending. Because it’s such a large sector of the economy, the entrenched interest for the companies and the people who really profit from the current system are tremendously reluctant to change things.
We see that with, just for one instance, the pharmaceutical drug-pricing problem we’re having right now. No one will doubt that the pharmaceutical industry has made some great drugs. They’ve also made some less-than-great drugs. But does every drug, great or worthless, have to cost $100,000 per year? I [didn’t] invent that number. That’s actually the cost per annum of the average cancer drug being approved in the United States in the last year — well over $100,000 per year of treatment.
There’s got to be a breaking point and people are recognizing that.
Next week on Freakonomics Radio, Part 2 of “Bad Medicine,” how do those great drugs, and the less-than-great ones too, get made, and then how do they get to market? We’ll look into the economics of new-drug trials and how carefully the research subjects are chosen:
Ben GOLDACRE: Now that’s very useful for a company that are trying to make their treatment look like it’s effective, but does the population of people in this randomized trial really reflect the real-world people out there?
We look at who’s been left out of most clinical trials:
WOODRUFF: It suggested that women shouldn’t be included in clinical trials because of the potential adverse events to the fetus.
And how sometimes, the only thing worse than being excluded from a medical trial was being included:
HAMMONDS: The use of vulnerable populations of African- Americans, people in prison, children in orphanages — vulnerable populations like these had been used for medical experimentation for a fairly long time.
That’s next time, on Freakonomics Radio.
Freakonomics Radio is produced by WNYC Studios and Dubner Productions. This episode was produced by Stephanie Tam. Our staff also includes Alison Hockenberry, Merritt Jacob, Greg Rosalsky, Eliza Lambert, Emma Morgenstern, Harry Huggins and Brian Gutierrez. You can subscribe to Freakonomics Radio on Apple Podcasts, Stitcher, or wherever you get your podcasts. You can also find us on Twitter, Facebook, or via e-mail at [email protected].
Here’s where you can learn more about the people and ideas in this episode:
SOURCES
Anupam Jena, health care economist and physician at Harvard Medical School
Philip Mackowiak, professor or medicine and medical historian at the University of Maryland
Jeremy Greene, physician and historian of medicine at Johns Hopkins University
Evelynn Hammonds, professor of the history of science and African-American studies at Harvard University
Keith Wailoo, health policy historian at Princeton University
Vinay Prasad, assistant professor of medicine at Oregon Health & Science University
Lisa Bero, pharmacologist and co-chair of the Cochrane Collaboration
Sir Iain Chalmers, co-founder of the Cochrane Collaboration
RESOURCES
Ending Medical Reversal, Vinay Prasad, 2015, Johns Hopkins University Press
The Cochrane Collaboration
“A Critical Appraisal of 98.6F, the Upper Limit of the Normal Body Temperature, and Other Legacies of Carl Reinhold August Wunderlich,” Philip Mackowiak, Steven Wasserman and Myron Levine, 1992, University of Maryland
Effective Care in Pregnancy and Childbirth, Sir Iain Chalmers, Murray Enkin and Marc Keirse, 1989, Oxford University Press
“A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices,” Vinay Prasad, et al., 2013, Mayo Clinic
“Mortality and Morbidity in Patients Receiving Encainide, Flecainide, or Placebo: The Cardiac Arrhythmia Suppression Trial,” Debra Echt, et al., 1991, New England Journal of Medicine
“Optimal Medical Therapy with or without PCI for Stable Coronary Disease,” William Boden, et al., 2007, New England Journal of Medicine
MUSIC CREDITS
Paul Avgerinos, “Times a Tickin”
Jack Miele, “Otis Theme” (from Jack Miele)
Christopher Norman, “Emerald” (from Strange Games)
Paul Avgerinos, “Ladies Day”
Nicholas Pesci, “Feeling Quirky” (from All The Feelings)
Baba Brinkman, “Seed Pod” (from The Rap Guide)
Morella and the Wheels of It, “Vincent” (from Shipwrecked)
Lerin Herzer and Andrew Joslyn, “Roots” (from The Girl and the Ghost)
Judson Lee Music, “Snoopin’”
Mike Barresi, “It’s All Good” (from Mike Barresi)
Additional Scoring by Jay Cowit
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😀 😀 1 WORLD FAMILY 😀 😀 Watch "John Lennon - Imagine (official video)" on YouTube https://youtu.be/yRhq-yO1KN8 1. FORBID and REMOVE ALL WMDs , Guns, Swords and Knives from Public Usage. INFORM the Weapons Manufacturers🔫 and Gun Shops 🔫 that the CEOs & Shop Owners will be Tried and Prosecuted for "Providing & Profitting 💸 from Accessories to Murder" if they choose to continue. 2. LIFE RIGHTS - a. 90 Years of LIFE - to be INCREASED with advanced medical care b. 14 Years of Love ❤ Care and Protection from at least 1 Primary Care-giver. A person's Childhood determines the MAJORITY of their Personality and Character Traits, because That's when their Character is Developed c. 4 Years of World SERVICE 18-21 yrs. - M / F 3. NO Physical - Audio - Visual EXPOSURE to SEXUAL Organs / Intercourse BEFORE "The Age of Consent". Such Exposure classifies as ASSAULT resulting in Lifelong Damage - Anger. 4. EVERY school child will receive Courses on : a. FAMILY b. CONFLICT RESOLUTION 5. NO Abortion, Guns / Swords / Knives / WMDs, Suicide, Starvation OR Death Penalty. 6. ALL Religions 7. SAME MONETARY Rate 💸 8. SAME TAX RATE 💸 9. SAME PAY RATE 💸 10. 1 WORLD GOVERNMENT - Democratic Socialist - Not Flawless, but the best choice. 11. REMOVE ALL National BOUNDARIES 12. ENGLISH Language for WORLD Communication - Beneficial for Education and Business. INDIGENOUS Languages at Home 13. EVERY ORIGINAL NATIVE Culture in the World must be APPRECIATED💃 / PROMOTED👳 / TAUGHT / VALUED 👲 within it's Own area, NOT just the WHITE Culture eg. African, Indian, Asian and Middle-Eastern. EACH Nation must teach EVERY one of it's PRIMARY Schoolchildren the Song, Dance, Stories and Culture of it's FIRST People. The ORIGINAL inhabitants DESERVE to feel VALUED, RECOGNIZED and RESPECTED. An Example would be Australia, Canada and the USA 1st People's CULTURE, DANCE, SONGS, HISTORY must be Taught, Promoted and Appreciated and Valued in ALL the PRIMARY Schools to EVERY child of EVERY COLOR. 14. Prisons must Become ADDITIONAL CARE ENVIRONMENTS. These Locations will be OPPORTUNITIES to receive ADDITIONAL Medical, Educational, Spiritual, and Employment Attention for the Residents. There will be 3 SEPARATE Levels : a. First-time Offenders b. Multiple Time Offenders c. Habitual Offenders These A.C.E.s will also be places where Teaching, Medical and Psychiatrist GRADUATES acquire their GRADUATE TRAINING. ALSO, the prison residents can do Supervised SERVICE for the community, Not just sit on their A€£ES All day. 15. In addition to Prison Residents performing Supervised Service to the community, WELFARE & DOLE recipients will perform SERVICE work in the community as well. 16. Additional SALES TAX 💸 added to: ALCOHOL & CIGARETTES & JUNK FOOD & SUGAR & SALT & MEAT & GLUTEN & DAIRY to COVER: a. TV Warning ADs. b. EDUCATION for Primary School Children c. GUARANTEED RESULTING ADDITIONAL GOVERNMENT FUNDED HEALTH CARE 17. PROVIDE "THAT SUGAR FILM" & Book, by Australian Damon Gameau, to EVERY Classroom. "Sugar is the NEW Nicotine." Artificial Sweeteners are ALSO a Health Risk. 18. EVERY FOOD & DRINK, MEDICATION, BUILDING MATERIAL and WMD - Weapon of Mass Destruction, must be EVALUATED for CHEMICAL CONTENT. PHARMACEUTICALS & CHEMICALS are the Cause of So much ILLNESS and DEATH. Remember Thalidomide? Apparently "BIG PHARMA" has been given a seat in the USA FDA. Is this Wise? The CANCER, AUTISM and DEMENTIA Rates in the 1st World are SKY-HIGH. WHY is that? Because of PHARMACEUTICALS 💊💉, GMOs and Agricultural Practices. EVERY Doctor KNOWS that Pharmaceuticals are LARGELY the cause of the 3 previously mentioned Illnesses, so WHY do they continue to prescribe them? One Word. 💰 MONEY💰. DOCTORS get KICKBACKS 💸💸 from the PHARMACEUTICAL COMPANIES every time they for Prescribe their medications. That explains why 70% of Americans are on Pills💊, and in 20 years, 40% of U.S. children will have AUTISM. Those Post WW11 Pharmaceutical companies try to say those diseases are "Genetic". Were they Genetic 70 Years ago, BEFORE WW11? 19. RWN - READING - WRITING - NOW, is a Program that would be USEFUL for some Aborigines who are too ashamed to admit that they cannot read or write. This way the problem is Solved in Private : 1 800 018 802 20. Physical and Sexual Assault are a CRIME. VERBAL Assault - BULLYING, should ALSO become a CRIME. The effects of these 3 types of Assault, Especially in the First 7 years, is LIFE-LONG. 21. The Life Expectancy is increasing. In 20 years, women are expected to live to 92 years. Medical Care is Improving. The RETIREMENT AGE can be Increased from 65 to 70 years, thus INCREASING the TAX BASE 💸. 22. The TAX FREE STATUS of Churches should be RECONSIDERED. In the USA, in the 1970's a KCIA FRONT GROUP & BIG BUSINESS 💸 Organization "PRETENDED to be a religious institution" in order to escape paying it's rightful share of TAXES on it's Very PROFITABLE 💸💸 Enterprises. 23. INCREASE the FOCUS on PRIMARY SCHOOL Teachers & Students. There Must be : a. MORE MALE teachers to be Positive Examples / Role models to the children, ESPECIALLY in Under-privileged Areas. b. SPECIALIZED TRAINING for Primary School teachers c. PAY RISES 💸 for PRIMARY School Teachers The FIRST 7 YEARS and to a lesser extent, the NEXT 7 years, are ESSENTIAL to an individual's Future lifestyle choices. School MUST be seen as a FUN 🎉 and JOYFUL 🙋 experience, ESPECIALLY for Underprivileged children. Schools can be a POSITIVE Influence for ALL children, giving them confidence to Participate fully in Society. "CHILDHOOD should be a JOY" - Dalai Lama Change from Primary Schools to Learning CENTRES Or CLUBS, as this terminology is more attractive for children. 24. POLICE Officers must become CARE Officers 25. GOVERNMENTS go from Force & Law to CARE & RESPECT 26. SENIOR CITIZENS are a RAPIDLY Growing population, with greatly improved health and lifespan. There's alot of issues to be addressed with these citizens. A Huge opportunity is now present for retired individuals to OFFER SERVICE and WORK Together with others. LEARN from EXPERIENCE You're Not Getting OLDER, You're getting BETTER 27. Have EVERY child read "A LITTLE HISTORY of the WORLD" by E.H. Gombrich. This International bestseller 📚 is written in very easy to understand English, for ALL CHILDREN to understand the HISTORY of the WORLD🌍 28. EVERY Individual Deserves at Least 14 years of Love, Care and Protection from at least 1 PRIMARY Care-giver. The First 7-14 years is where MOST of a person's character development occurs. The Majority of a person's attitudes and thinking come from their FIRST 14 YEARS, that's why psychiatrists always ask about your Childhood. 29. The Original and First Australians - Aborigines, are very similar to the African-American population. Their "Rite of Passage" is to spend time in "Lock-up" - Prison. It used to be that the White man considered them both to have 75% of the brain capacity of the White man. Why are Aborigines and African-Americans so "mis-behaved? Because one was seen as property, and the other was seen as animals who happened to inhabit one of the places that the British EMPIRE wanted to Utilize #2. 😀 INDIGENOUS PEOPLE 1. EVERY primary school child must be taught the : a. Song 🙌 b. Dance💃 c. History 📚 d. Culture 🌋 of it's INDIGENOUS Citizens. 40,000 years versus 240 years??..... The Australian and American ORIGINAL citizens need to be APPRECIATED, PROMOTED and VALUED, in order to address their issues, and to make Every other child appreciate and value them. #3. 😀 9 CAUSES 😀 Am I telling you to NOT get SCAMMED by a Predatory CULT, the MEDICAL/NURSING HOME GAME, FALSE PHARMACEUTICALS💊,GUNS🔫 or the WAR BUSINESS 💣 ? NO ! It's a FREE Country, last I checked, as Long as you know the TRUTH, the Whole TRUTH, NOTHING but the TRUTH, so help me GOD. 😇 THEN U can't BLAME anyone but your OWN SELF for YOUR Choices. I've got 9 CAUSES that are Listed below. Here they are. 😀 SCAMS : 1. PREDATORY Cults 2. DEATH RESORTS - Nursing Homes 3. PHARMACEUTICALS - BIG PHARMA 💊 4. The WAR BUSINESS 💰💰 CAUSES : 5. 3rd WORLD WOMEN 6. HEALTHY LIVING 7. GUN CONTROL 🔫 8. TRUE ISLAM 9. INDIGENOUS PEOPLE 1. PREDATORY CULTS - I have a friend who was in a Predatory Cult. They're ALL the Same. Their REAL motivation is Money 💸 & Power (and usually weird Sex). EXAMPLES are People's Temple & Children of God & Scientology & Moonies/FFWPU/Unification Church & Oneida Community & Jehovah's Witnesses Regarding "The TRUE Family of Mankind" - MOONIES - The Family of SELF-PROCLAIMED Lord of the Second Advent Sun Myung Moon - KNOW THEM BY THEIR FRUITS🍇 The APPLE DOESN'T FALL FAR FROM THE TREE 🍎 ACTIONS SPEAK LOUDER THAN WORDS 💪 DO AS I SAY, NOT AS I DO The THINGS People do for MONEY 💸💸💸💸 are the ROOT of ALL EVIL 🙉LEARN FROM YOUR PARENTS🙈 👏PRACTICE WHAT YOU PREACH👎 1. They're Usually led by a MALE, who is CONVINCED that he is a UNIQUE Voice of GOD. 2. Their MARKET is Disenfranchised, "SEARCHING" People. 3. The members are Always told that they're BETTER than others via being part of "The Master Race, God's Lineage, Chosen Skin Color, Religion, Nationality etc." 4. They get those people to do STRANGE actions such as ALL NIGHT Prayers, FASTING, Working for FREE - raising MONEY 💸💸 & Bringing in New members via the Threat "If you don't do this you WON'T Go to Heaven / be Saved OR WILL Go to Hell" 5. They're Always told to MARRY WITHIN the Cult. 6. The Cults Always say the members' REAL natural FAMILIES are "EVIL / FALLEN" in order to create SOLE "Loyalty" to the Cult 7. The Cults are ALWAYS EXPOSED /Destroyed in the END. 8. The Offspring ALWAYS Leave in DISGUST. 😉 GOOD GROUPS : 1. UCSA 2. FREEDOM OF MIND 2. DEATH RESORTS / NURSING HOMES - They are a BOOMING Business💸 now that the Baby Boomers are hitting their 70s and people are living LONGER and medical care is IMPROVING. In some nations, the Aged Care Business Participants "Are ALL in BED TOGETHER 💸💸" ALMOST Every Doctor, Psychiatrist, Nursing Home, Pharmaceutical Coy., and EVEN the COMPLAINTS Organizations 😨"Share Information together for a NON Caring Purpose" 😉 💸💸 I have a friend who TEMPORARILY spent some time in a Nursing Home due to an Injury. After a Medically Educated Individual REMOVED the Incorrect Medication that she was on, she wrote EVERYTHING Down. There was SO MUCH Verbal & Physical Abuse going on, towards Mostly 70 - 85 year old residents, with the Staff Hoping that the Residents are SO DRUGGED UP, that They wouldn't be BELIEVED by others, regarding what was REALLY Going on. After weeks of writing EVERYTHING Down, the Manager KICKED my friend out via calling / lying to the POLICE. It is ALL a SCAM YOU'RE as YOUNG AS YOU FEEL 🙌 70 is the NEW 30 🙌 LEARN from EXPERIENCE You're NOT Getting OLDER, You're getting BETTER GOOD INDIVIDUALS & GROUPS : 1. LET'S TALK 2. LYNDA SALTARELLI 3. DAVID STEWART - IRVING 3. 💊 PHARMACEUTICALS 💊 From Everything that I've read, ALL CANCER, DEMENTIA and AUTISM comes from PHARMACEUTICALS & GMOs. But the DRUG Companies try to Cover their A€£ES via LIES such as "Cancer is Genetic". Currently, 70% of Americans are on PILLS. In 20 years, 40% of USA CHILDREN will be AUTISTIC. WHY is this Happening NOW? PHARMACEUTICALS 💊 : 1. RARELY WORK 2. CAUSE GREATER PROBLEMS 3. SOMETIMES CAUSE DEATH Also, did you know that EVERY Doctor KNOWS that the Pharmaceuticals they're Prescribing cause these 3 Sometimes FATAL Illnesses? So WHY is your OWN Family Doctor doing This? One Word. 💸 MONEY 💸 EVERY DOCTOR gets PAID 💸 KICKBACKS 💸 from the PHARMACEUTICAL COMPANIES when they Prescribe their Drugs💊. The THINGS People do for MONEY 💸💸 are the ROOT of ALL EVIL 😈 Remember THALIDOMIDE? That was a Post WW11 Drug for "Pregnancy Pains". 1 FDA Doctor Repeatedly said that it was Already causing HUGE Problems in Europe and to STOP It Immediately. You know what that Drug Companies said? "Oooh those Bossy Bureaucrats" And the Result? DEFORMED BABIES Left and Right 👹 I am NOT a Hippie Chick who wants an Organic Lifestyle, I'm an Accountant 💸Sales Queen 💸 and I feel that IF a person makes the CHOICE to be involved with a Predatory Cult, Nursing Home, Take Pharmaceuticals, FIGHT / DIE in a War, have an UNhealthy Lifestyle, live as a 3rd World Female, participate in UNREVISED Islam, Buy MURDER WEAPONS, then FINE ! AS LONG AS YOU KNOW : "The TRUTH, the WHOLE TRUTH, NOTHING but the TRUTH, so help me GOD" 😇 Then FREELY & INTELLIGENTLY make your OWN CHOICE. GOOD INDIVIDUALS : 1. DR. BRAD McKAY 2. ROGER BEZANIS 4. The WAR BUSINESS 💸💸 - The USA is a VERY SAD Example of this one. For EVERY WAR Check : a. WHO'S at the TOP ? b. WHERE'S the MONEY 💸💸? In EVERY WAR : 1. Men (usually) RAPE 💸💸 a Country of it's Natural RESOURCES & the INDIGENOUS People get ANGRY & FIGHT BACK 😠 2. The ARMS Companies make Even MORE BIG, BIG Money 💸💸 SELLING BOMBS & GUNS to those Invading Men who want to defend themselves because of their OWN invasion, and SOMETIMES to those ANGRY INDIGENOUS People TOO!! 😂😈😂 WHENEVER there's a Inexplicable SCREW-UP in the World, ALWAYS : 💸 💸 "SHOW ME THE MONEY" 💸💸 GOOD GROUPS : 1. CODE PINK 5. 3rd WORLD WOMEN - 80% of the WORLD (3rd World) sees Females as ONLY : 1. BREEDING Animals 2. Sex TOYS 3. PROPERTY The Time is Coming when the COMMON KNOWLEDGE that Females & Males are Totally EQUAL INTELLECTUALLY will be ACCEPTED WORLDWIDE. ALSO ! IF you wish to Procreate, WHO Ya gonna Call?? 😉 WOMEN are SUPERIOR, BUT! We Don't wanna Remind you... WHY? Cuz WE MADE YOU ! 😂😂😂 GOOD GROUPS : 1. IWDA 2. 50 MILLION MISSING 3. AHA FOUNDATION 4. MALALA FOUNDATION 6. HEALTHY LIVING - People need to be AWARE of the PROPER FOODS to put in their Bodies & how to beneficially MAINTAIN their Body via EXERCISE and CARE. A MAJOR problem in the 1st World is OBESITY. People Must REVISE their food intake and EXERCISE on a DAILY BASIS. 😀 ADD ADDITIONAL Sales TAX 💸💸 to ALCOHOL🍾, CIGARETTES, SUGAR🍩, SALT, MEAT, GLUTEN and DAIRY in order to Cover the GUARANTEED RESULTING ADDITIONAL HEALTHCARE & TV Ads & PRIMARY School EDUCATION COSTS �� GOOD GROUPS : 1. NUTRITION FORCE 2. AUTHORITY NUTRITION 7. GUN CONTROL 🔫 - It's pretty OBVIOUS WHY the USA is the ONLY 1st World Nation that STILL Allows PERSONAL OWNERSHIP of 🔫 MURDER WEAPONS 🔫. One WORD = MONEY 💸💸💸💸. GUN MASSACRES have gone from BI-weekly to WEEKLY to DAILY. The NRA has REFUSED to NOT Sell Guns to "JIHADISTS", WHAT DOES THAT SAY? The NRA Also "Strongly SUGGESTS" to EVERY GUN Company CEO to give them a BIG DONATION 💸💸💸💸 😱 EL CAPITALISTA AMERICANA 💸💸💸💸 MONEY 💸💸💸💸 vs. HUMAN LIFE 😇 8. ISLAM 🌹 - EVERY Single one of my EXCELLENT MUSLIM friends does NOT practice : a. FGM - Female Genital Mutilation - SEXUAL ASSAULT b. CHILD BRIDES & Baci Baazi - PEDOPHILIA c. FORCED MARRIAGE - DEPRIVATION of Liberty/BREEDING d. HONOR KILLINGS - MURDER e. HIJAB/BURKHA - MISOGYNY f. GANG RAPES / ACID ATTACKS - ASSAULT ALL of these "Practices" have NOTHING to do with ISLAM - Qur'an, and EVERYTHING to do with Feudal, ARCHAIC, MIDDLE AGES, PRIMITIVE 3rd WORLD Behaviour. BTW - FGM - Female Genital Mutilation is practiced by BOTH CHRISTIANS and MUSLIMS in NORTH AFRICA, HONOR KILLINGS are performed in BOTH LATIN AMERICA and MUSLIM countries, FORCED Marriage / CHILD BRIDES are performed in 80% of the WORLD - 3rd World. GOOD GROUPS : 1. MUSLIM REFORM MOVEMENT 2. FAITHFREEDOM 3. FAITH 4 FREEDOM 9. INDIGENOUS PEOPLE - 20,000 YEARS vs. 239 Years..... Hmmmm......... EVERY NATION MUST Teach About /Appreciate / Value it's FIRST PEOPLE. EVERY School Child MUST be Taught the History, Culture, Song & Dance of it's INDIGENOUS People NOT Just the WHITE Culture. GOOD INDIVIDUALS & GROUPS : 1. SUNNY REDCLOUD 2. "I'M NOT RACIST, BUT" 3. "1 MILLION INDIGENOUS" #4. 😀 DAILY HEALTH REGIME 😀 1. EAT : a. RAW Fruit & Vegetables b. STARCH - Cereal, Potatoes, Rice, NO REFINED Flour or Cereal c. PROTEIN - (Cheese, Milk, Yogurt, Eggs- but Dairy MAY be a problem - research VEGANISM) Peas, Nuts & Beans (and Fish) 2. 😠 NO 😠 CHEMICALS, NICOTINE, MEAT, ALCOHOL, SUGAR, DAIRY, GLUTEN and MINIMAL Salt 3. Minimum of 1 HOUR DAILY EXERCISE - try an Exercise Machine or a Walk or a Gym #5. 😀 SUGAR & CHEMICALS 😀 🍁 Finally 🍁 everyone knows the Damage that SUGAR can cause to your Body, but ARTIFICIAL SWEETENERS are ALSO a very Big DANGER. Coca-Cola's BEST $$ International Market $$ is an Australian Aboriginal community, and in the U.S.A., some Hill-billies put it in their baby's bottles as well. As suggested before, an ADDITIONAL SALES TAX $ must be Added to JUNK FOOD, ALCOHOL, CIGARETTES and Also SUGARY & DIET SOFT DRINKS in order to Cover the GUARANTEED EXTRA COST $ of the ADDITIONAL Government Supplied MEDICAL Care + TV WARNING ADS and PRIMARY SCHOOL EDUCATION that are Necessary for these DANGEROUS substances🍁 https://youtu.be/yRhq-yO1KN8 1. FORBID and REMOVE ALL WMDs , Guns, Swords and Knives from Public Usage. INFORM the Weapons Manufacturers🔫 and Gun Shops 🔫 that the CEOs & Shop Owners will be Tried and Prosecuted for "Providing & Profitting 💸 from Accessories to Murder" if they choose to continue. 2. LIFE RIGHTS - a. 90 Years of LIFE - to be INCREASED with advanced medical care b. 14 Years of Love ❤ Care and Protection from at least 1 Primary Care-giver. A person's Childhood determines the MAJORITY of their Personality and Character Traits, because That's when their Character is Developed c. 4 Years of World SERVICE 18-21 yrs. - M / F 3. NO Physical - Audio - Visual EXPOSURE to SEXUAL Organs / Intercourse BEFORE "The Age of Consent". Such Exposure classifies as ASSAULT resulting in Lifelong Damage - Anger. 4. EVERY school child will receive Courses on : a. FAMILY b. CONFLICT RESOLUTION 5. NO Abortion, Guns / Swords / Knives / WMDs, Suicide, Starvation OR Death Penalty. 6. ALL Religions 7. SAME MONETARY Rate 💸 8. SAME TAX RATE 💸 9. SAME PAY RATE 💸 10. 1 WORLD GOVERNMENT - Democratic Socialist - Not Flawless, but the best choice. 11. REMOVE ALL National BOUNDARIES 12. ENGLISH Language for WORLD Communication - Beneficial for Education and Business. INDIGENOUS Languages at Home 13. EVERY ORIGINAL NATIVE Culture in the World must be APPRECIATED💃 / PROMOTED👳 / TAUGHT / VALUED 👲 within it's Own area, NOT just the WHITE Culture eg. African, Indian, Asian and Middle-Eastern. EACH Nation must teach EVERY one of it's PRIMARY Schoolchildren the Song, Dance, Stories and Culture of it's FIRST People. The ORIGINAL inhabitants DESERVE to feel VALUED, RECOGNIZED and RESPECTED. An Example would be Australia, Canada and the USA 1st People's CULTURE, DANCE, SONGS, HISTORY must be Taught, Promoted and Appreciated and Valued in ALL the PRIMARY Schools to EVERY child of EVERY COLOR. 14. Prisons must Become ADDITIONALCARE ENVIRONMENTS. These Locations will be OPPORTUNITIES to receive ADDITIONAL Medical, Educational, Spiritual, and Employment Attention for the Residents. There will be 3 SEPARATE Levels : a. First-time Offenders b. Multiple Time Offenders c. Habitual Offenders These A.C.E.s will also be places where Teaching, Medical and Psychiatrist GRADUATES acquire their GRADUATE TRAINING. ALSO, the prison residents can do Supervised SERVICE for the community, Not just sit on their A€£ES All day. 15. In addition to Prison Residents performing Supervised Service to the community, WELFARE & DOLE recipients will perform SERVICE work in the community as well. 16. Additional SALES TAX 💸 added to: ALCOHOL & CIGARETTES & JUNK FOOD & SUGAR & SALT & MEAT & GLUTEN & DAIRY to COVER: a. TV Warning ADs. b. EDUCATION for Primary School Children c. GUARANTEED RESULTING ADDITIONAL GOVERNMENT FUNDED HEALTH CARE 17. PROVIDE "THAT SUGAR FILM" & Book, by Australian Damon Gameau, to EVERY Classroom. "Sugar is the NEW Nicotine." Artificial Sweeteners are ALSO a Health Risk. 18. EVERY FOOD & DRINK, MEDICATION, BUILDING MATERIAL and WMD - Weapon of Mass Destruction, must be EVALUATED for CHEMICALCONTENT. PHARMACEUTICALS & CHEMICALS are the Cause of So much ILLNESS and DEATH. Remember Thalidomide? Apparently "BIG PHARMA" has been given a seat in the USA FDA. Is this Wise? The CANCER, AUTISM and DEMENTIA Rates in the 1st World are SKY-HIGH. WHY is that? Because of PHARMACEUTICALS 💊💉, GMOs and Agricultural Practices. EVERY Doctor KNOWS that Pharmaceuticals are LARGELY the cause of the 3 previously mentioned Illnesses, so WHY do they continue to prescribe them? One Word. 💰 MONEY💰. DOCTORS get KICKBACKS 💸💸 from the PHARMACEUTICAL COMPANIES every time they for Prescribe their medications. That explains why 70% of Americans are on Pills💊, and in 20 years, 40% of U.S. children will have AUTISM. Those Post WW11 Pharmaceutical companies try to say those diseases are "Genetic". Were they Genetic 70 Years ago, BEFORE WW11? 19. RWN - READING - WRITING - NOW, is a Program that would be USEFUL for some Aborigines who are too ashamed to admit that they cannot read or write. This way the problem is Solved in Private : 1 800 018 802 20. Physical and Sexual Assault are a CRIME. VERBAL Assault - BULLYING, should ALSO become a CRIME. The effects of these 3 types of Assault, Especially in the First 7 years, is LIFE-LONG. 21. The Life Expectancy is increasing. In 20 years, women are expected to live to 92 years. Medical Care is Improving. The RETIREMENT AGE can be Increased from 65 to 70 years, thus INCREASING the TAX BASE 💸. 22. The TAX FREE STATUS of Churches should be RECONSIDERED. In the USA, in the 1970's a KCIA FRONT GROUP & BIG BUSINESS 💸 Organization "PRETENDED to be a religious institution" in order to escape paying it's rightful share of TAXES on it's Very PROFITABLE 💸💸 Enterprises. 23. INCREASE the FOCUS on PRIMARY SCHOOL Teachers & Students. There Must be : a. MORE MALE teachers to be Positive Examples / Role models to the children, ESPECIALLY in Under-privileged Areas. b. SPECIALIZED TRAINING for Primary School teachers c. PAY RISES 💸 for PRIMARY School Teachers The FIRST 7 YEARS and to a lesser extent, the NEXT 7 years, are ESSENTIAL to an individual's Future lifestyle choices. School MUST be seen as a FUN 🎉 and JOYFUL 🙋 experience, ESPECIALLY for Underprivileged children. Schools can be a POSITIVE Influence for ALL children, giving them confidence to Participate fully in Society. "CHILDHOOD should be a JOY" - Dalai Lama Change from Primary Schools to Learning CENTRES Or CLUBS, as this terminology is more attractive for children. 24. POLICE Officers must become CARE Officers 25. GOVERNMENTS go from Force & Law to CARE & RESPECT 26. SENIOR CITIZENS are a RAPIDLY Growing population, with greatly improved health and lifespan. There's alot of issues to be addressed with these citizens. A Huge opportunity is now present for retired individuals to OFFER SERVICE and WORK Together with others. LEARN from EXPERIENCE You're Not Getting OLDER, You're getting BETTER 27. Have EVERY child read "A LITTLE HISTORY of the WORLD" by E.H. Gombrich. This International bestseller 📚 is written in very easy to understand English, for ALL CHILDREN to understand the HISTORY of the WORLD🌍 28. EVERY Individual Deserves at Least 14 years of Love, Care and Protection from at least 1 PRIMARY Care-giver. The First 7-14 years is where MOST of a person's character development occurs. The Majority of a person's attitudes and thinking come from their FIRST 14 YEARS, that's why psychiatrists always ask about your Childhood. 29. The Original and First Australians - Aborigines, are very similar to the African-American population. Their "Rite of Passage" is to spend time in "Lock-up" - Prison. It used to be that the White man considered them both to have 75% of the brain capacity of the White man. Why are Aborigines and African-Americans so "mis-behaved? Because one was seen as property, and the other was seen as animals who happened to inhabit one of the places that the British EMPIRE wanted to Utilize #2. 😀 INDIGENOUS PEOPLE 1. EVERY primary school child must be taught the : a. Song 🙌 b. Dance💃 c. History 📚 d. Culture 🌋 of it's INDIGENOUS Citizens. 40,000 years versus 240 years??..... The Australian and American ORIGINAL citizens need to be APPRECIATED, PROMOTED and VALUED, in order to address their issues, and to make Every other child appreciate and value them. #3. 😀 9 CAUSES 😀 Am I telling you to NOT get SCAMMED by a Predatory CULT, the MEDICAL/NURSING HOME GAME, FALSE PHARMACEUTICALS💊,GUNS🔫 or the WAR BUSINESS 💣 ? NO ! It's a FREE Country, last I checked, as Long as you know the TRUTH, the Whole TRUTH, NOTHING but the TRUTH, so help me GOD. 😇 THEN U can't BLAME anyone but your OWN SELF for YOUR Choices. I've got 9 CAUSES that are Listed below. Here they are. 😀 SCAMS : 1. PREDATORY Cults 2. DEATH RESORTS - Nursing Homes 3. PHARMACEUTICALS - BIG PHARMA 💊 4. The WAR BUSINESS 💰💰 CAUSES : 5. 3rd WORLD WOMEN 6. HEALTHY LIVING 7. GUN CONTROL 🔫 8. TRUE ISLAM 9. INDIGENOUS PEOPLE 1. PREDATORY CULTS - I have a friend who was in a Predatory Cult. They're ALL the Same. Their REAL motivation is Money 💸 & Power (and usually weird Sex). EXAMPLES are People's Temple & Children of God & Scientology & Moonies/FFWPU/Unification Church & Oneida Community & Jehovah's Witnesses Regarding "The TRUE Family of Mankind" - MOONIES - The Family of SELF-PROCLAIMED Lord of the Second Advent Sun Myung Moon - KNOW THEM BY THEIR FRUITS🍇 The APPLE DOESN'T FALL FAR FROM THE TREE 🍎 ACTIONS SPEAK LOUDER THAN WORDS 💪 DO AS I SAY, NOT AS I DO The THINGS People do for MONEY 💸💸💸💸 are the ROOT of ALL EVIL 🙉LEARN FROM YOUR PARENTS🙈 👏PRACTICE WHAT YOU PREACH👎 1. They're Usually led by a MALE, who is CONVINCED that he is a UNIQUE Voice of GOD. 2. Their MARKET is Disenfranchised, "SEARCHING" People. 3. The members are Always told that they're BETTER than others via being part of "The Master Race, God's Lineage, Chosen Skin Color, Religion, Nationality etc." 4. They get those people to do STRANGE actions such as ALL NIGHT Prayers, FASTING, Working for FREE - raising MONEY 💸💸 & Bringing in New members via the Threat "If you don't do this you WON'T Go to Heaven / be Saved OR WILL Go to Hell" 5. They're Always told to MARRY WITHIN the Cult. 6. The Cults Always say the members' REAL natural FAMILIES are "EVIL / FALLEN" in order to create SOLE "Loyalty" to the Cult 7. The Cults are ALWAYS EXPOSED /Destroyed in the END. 8. The Offspring ALWAYS Leave in DISGUST. 😉 GOOD GROUPS : 1. UCSA 2. FREEDOM OF MIND 2. DEATH RESORTS / NURSING HOMES - They are a BOOMING Business💸 now that the Baby Boomers are hitting their 70s and people are living LONGER and medical care is IMPROVING. In some nations, the Aged Care Business Participants "Are ALL in BED TOGETHER 💸💸" ALMOST Every Doctor, Psychiatrist, Nursing Home, Pharmaceutical Coy., and EVEN the COMPLAINTS Organizations 😨"Share Information together for a NON Caring Purpose" 😉 💸💸 I have a friend who TEMPORARILY spent some time in a Nursing Home due to an Injury. After a Medically Educated Individual REMOVED the Incorrect Medication that she was on, she wrote EVERYTHING Down. There was SO MUCH Verbal & Physical Abuse going on, towards Mostly 70 - 85 year old residents, with the Staff Hoping that the Residents are SODRUGGED UP, that They wouldn't be BELIEVED by others, regarding what was REALLY Going on. After weeks of writing EVERYTHING Down, the Manager KICKED my friend out via calling / lying to the POLICE. It is ALL a SCAM YOU'RE as YOUNG AS YOU FEEL 🙌 70 is the NEW 30 🙌 LEARN from EXPERIENCE You're NOT Getting OLDER, You're getting BETTER GOOD INDIVIDUALS & GROUPS : 1. LET'S TALK 2. LYNDA SALTARELLI 3. DAVID STEWART - IRVING 3. 💊 PHARMACEUTICALS 💊 From Everything that I've read, ALL CANCER, DEMENTIA and AUTISM comes from PHARMACEUTICALS & GMOs. But the DRUG Companies try to Cover their A€£ES via LIES such as "Cancer is Genetic". Currently, 70% of Americans are on PILLS. In 20 years, 40% of USA CHILDREN will be AUTISTIC. WHY is this Happening NOW? PHARMACEUTICALS 💊 : 1. RARELY WORK 2. CAUSE GREATER PROBLEMS 3. SOMETIMES CAUSE DEATH Also, did you know that EVERY Doctor KNOWS that the Pharmaceuticals they're Prescribing cause these 3 Sometimes FATAL Illnesses? So WHY is your OWN Family Doctor doing This? One Word. 💸 MONEY 💸 EVERY DOCTOR gets PAID 💸 KICKBACKS 💸 from the PHARMACEUTICALCOMPANIES when they Prescribe their Drugs💊. The THINGS People do for MONEY 💸💸 are the ROOT of ALL EVIL 😈 Remember THALIDOMIDE? That was a Post WW11 Drug for "Pregnancy Pains". 1 FDA Doctor Repeatedly said that it was Already causing HUGE Problems in Europe and to STOP It Immediately. You know what that Drug Companies said? "Oooh those Bossy Bureaucrats" And the Result? DEFORMED BABIES Left and Right 👹 I am NOT a Hippie Chick who wants an Organic Lifestyle, I'm an Accountant 💸Sales Queen 💸 and I feel that IF a person makes the CHOICE to be involved with a Predatory Cult, Nursing Home, Take Pharmaceuticals, FIGHT / DIE in a War, have an UNhealthy Lifestyle, live as a 3rd World Female, participate in UNREVISED Islam, Buy MURDER WEAPONS, then FINE ! AS LONG AS YOU KNOW : "The TRUTH, the WHOLE TRUTH, NOTHING but the TRUTH, so help me GOD" 😇 Then FREELY & INTELLIGENTLY make your OWN CHOICE. GOOD INDIVIDUALS : 1. DR. BRAD McKAY 2. ROGER BEZANIS 4. The WAR BUSINESS 💸💸 - The USA is a VERY SAD Example of this one. For EVERY WAR Check : a. WHO'S at the TOP ? b. WHERE'S the MONEY 💸💸? In EVERY WAR : 1. Men (usually) RAPE 💸💸 a Country of it's Natural RESOURCES & the INDIGENOUS People get ANGRY & FIGHT BACK 😠 2. The ARMS Companies make Even MORE BIG, BIG Money 💸💸 SELLING BOMBS & GUNS to those Invading Men who want to defend themselves because of their OWN invasion, and SOMETIMES to those ANGRY INDIGENOUS People TOO!! 😂😈😂 WHENEVER there's a Inexplicable SCREW-UP in the World, ALWAYS : 💸 💸 "SHOW ME THE MONEY" 💸💸 GOOD GROUPS : 1. CODE PINK 5. 3rd WORLD WOMEN - 80% of the WORLD (3rd World) sees Females as ONLY : 1. BREEDING Animals 2. Sex TOYS 3. PROPERTY The Time is Coming when the COMMON KNOWLEDGE that Females & Males are Totally EQUAL INTELLECTUALLY will be ACCEPTED WORLDWIDE. ALSO ! IF you wish to Procreate, WHO Ya gonna Call?? 😉 WOMEN are SUPERIOR, BUT! We Don't wanna Remind you... WHY? Cuz WE MADE YOU ! 😂😂😂 GOOD GROUPS : 1. IWDA 2. 50 MILLION MISSING 3. AHA FOUNDATION 4. MALALA FOUNDATION 6. HEALTHY LIVING - People need to be AWARE of the PROPER FOODS to put in their Bodies & how to beneficially MAINTAIN their Body via EXERCISE and CARE. A MAJOR problem in the 1st World is OBESITY. People Must REVISE their food intake and EXERCISE on a DAILY BASIS. 😀 ADD ADDITIONAL Sales TAX 💸💸 to ALCOHOL🍾, CIGARETTES, SUGAR🍩, SALT, MEAT, GLUTEN and DAIRY in order to Cover the GUARANTEEDRESULTING ADDITIONAL HEALTHCARE & TV Ads & PRIMARY School EDUCATION COSTS 💸 GOOD GROUPS : 1. NUTRITION FORCE 2. AUTHORITY NUTRITION 7. GUN CONTROL 🔫 - It's pretty OBVIOUS WHY the USA is the ONLY 1st World Nation that STILL Allows PERSONAL OWNERSHIP of 🔫 MURDER WEAPONS 🔫. One WORD = MONEY 💸💸💸💸. GUN MASSACRES have gone from BI-weekly to WEEKLY to DAILY. The NRA has REFUSED to NOT Sell Guns to "JIHADISTS", WHAT DOES THAT SAY? The NRA Also "Strongly SUGGESTS" to EVERY GUN Company CEO to give them a BIG DONATION 💸💸💸💸 😱 EL CAPITALISTA AMERICANA 💸💸💸💸 MONEY 💸💸💸💸 vs. HUMAN LIFE 😇 8. ISLAM 🌹 - EVERY Single one of my EXCELLENT MUSLIM friends does NOT practice : a. FGM - Female Genital Mutilation - SEXUAL ASSAULT b. CHILD BRIDES & Baci Baazi - PEDOPHILIA c. FORCED MARRIAGE - DEPRIVATION of Liberty/BREEDING d. HONOR KILLINGS - MURDER e. HIJAB/BURKHA - MISOGYNY f. GANG RAPES / ACID ATTACKS - ASSAULT ALL of these "Practices" have NOTHING to do with ISLAM - Qur'an, and EVERYTHING to do with Feudal, ARCHAIC, MIDDLE AGES, PRIMITIVE 3rd WORLD Behaviour. BTW - FGM - Female Genital Mutilation is practiced by BOTH CHRISTIANS and MUSLIMS in NORTH AFRICA, HONOR KILLINGS are performed in BOTH LATIN AMERICA and MUSLIM countries, FORCED Marriage / CHILD BRIDES are performed in 80% of the WORLD - 3rd World. GOOD GROUPS : 1. MUSLIM REFORM MOVEMENT 2. FAITHFREEDOM 3. FAITH 4 FREEDOM 9. INDIGENOUS PEOPLE - 20,000 YEARS vs. 239 Years..... Hmmmm......... EVERY NATION MUST Teach About /Appreciate / Value it's FIRST PEOPLE. EVERY School Child MUST be Taught the History, Culture, Song & Dance of it's INDIGENOUS People NOT Just the WHITE Culture. GOOD INDIVIDUALS & GROUPS : 1. SUNNY REDCLOUD 2. "I'M NOT RACIST, BUT" 3. "1 MILLION INDIGENOUS" #4. 😀 DAILY HEALTH REGIME 😀 1. EAT : a. RAW Fruit & Vegetables b. STARCH - Cereal, Potatoes, Rice, NOREFINED Flour or Cereal c. PROTEIN - (Cheese, Milk, Yogurt, Eggs- but Dairy MAY be a problem - research VEGANISM) Peas, Nuts & Beans (and Fish) 2. 😠 NO 😠 CHEMICALS, NICOTINE, MEAT, ALCOHOL, SUGAR, DAIRY, GLUTEN and MINIMAL Salt 3. Minimum of 1 HOUR DAILY EXERCISE - try an Exercise Machine or a Walk or a Gym #5. 😀 SUGAR & CHEMICALS 😀 🍁 Finally 🍁 everyone knows the Damage that SUGAR can cause to your Body, but ARTIFICIALSWEETENERS are ALSO a very Big DANGER. Coca-Cola's BEST $$ International Market $$ is an Australian Aboriginal community, and in the U.S.A., some Hill-billies put it in their baby's bottles as well. As suggested before, an ADDITIONAL SALES TAX $ must be Added to JUNK FOOD, ALCOHOL, CIGARETTES and Also SUGARY & DIET SOFT DRINKS in order to Cover the GUARANTEED EXTRA COST $ of the ADDITIONAL Government Supplied MEDICAL Care + TV WARNING ADS and PRIMARY SCHOOL EDUCATION that are Necessary for these DANGEROUS substances🍁
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😀 1 WORLD FAMILY PLAN 😀
😀 😀 1 WORLD FAMILY 😀 😀 Watch "John Lennon - Imagine (official video)" on YouTube https://youtu.be/yRhq-yO1KN8 1. FORBID and REMOVE ALL WMDs , Guns, Swords and Knives from Public Usage. INFORM the Weapons Manufacturers🔫 and Gun Shops 🔫 that the CEOs & Shop Owners will be Tried and Prosecuted for "Providing & Profitting 💸 from Accessories to Murder" if they choose to continue. 2. LIFE RIGHTS - a. 90 Years of LIFE - to be INCREASED with advanced medical care b. 14 Years of Love ❤, Care and Protection from at least 1 Primary Care-giver c. 4 Years of World SERVICE 18-21 yrs. - M / F 3. NO Physical - Audio - Visual EXPOSURE to SEXUAL Organs / Intercourse BEFORE "The Age of Consent". Such Exposure classifies as ASSAULT resulting in Lifelong Damage - Anger. 4. EVERY school child will receive Courses on : a. FAMILY b. CONFLICT RESOLUTION 5. NO Abortion, Guns / Swords / Knives / WMDs, Suicide, Starvation OR Death Penalty. 6. ALL Religions 7. SAME MONETARY Rate 💸 8. SAME TAX RATE 💸 9. SAME PAY RATE 💸 10. 1 WORLD GOVERNMENT - Democratic Socialist - Not Flawless, but the best choice. 11. REMOVE ALL National BOUNDARIES 12. ENGLISH Language for WORLD Communication - Beneficial for Education and Business. INDIGENOUS Languages at Home 13. EVERY ORIGINAL NATIVE Culture in the World must be APPRECIATED💃 / PROMOTED👳 / TAUGHT / VALUED👲 within it's Own area, NOT just the WHITE Culture eg. African, Indian, Asian and Middle-Eastern. EACH Nation must teach EVERY one of it's PRIMARY Schoolchildren the Song, Dance, Stories and Culture of it's FIRST People. The ORIGINAL inhabitants DESERVE to feel VALUED, RECOGNIZED and RESPECTED. An Example would be Australia, Canada and the USA 1st People's CULTURE, DANCE, SONGS, HISTORY must be Taught, Promoted and Appreciated and Valued in ALL the PRIMARY Schools to EVERY child of EVERY COLOR. 14. Prisons must Become ADDITIONAL CARE ENVIRONMENTS. These Locations will be OPPORTUNITIES to receive ADDITIONAL Medical, Educational, Spiritual, and Employment Attention for the Residents. There will be 3 SEPARATE Levels : a. First-time Offenders b. Multiple Time Offenders c. Habitual Offenders These A.C.E.s will also be places where Teaching, Medical and Psychiatrist GRADUATES acquire their GRADUATE TRAINING. ALSO, the prison residents can do Supervised SERVICE for the community, Not just sit on their A€£ES All day. 15. In addition to Prison Residents performing Supervised Service to the community, WELFARE & DOLE recipients can perform SERVICE work in the community as well. 16. Additional SALES TAX 💸 added to: ALCOHOL & CIGARETTES & JUNK FOOD & SUGAR & SALT & MEAT & GLUTEN & DAIRY to COVER: a. TV Warning ADs. b. EDUCATION for Primary School Children c. GUARANTEED RESULTING ADDITIONAL GOVERNMENT FUNDED BY GOVERNMENT HEALTH CARE 17. PROVIDE "That Sugar Film" & Book, by Australian Damon Gameau, to EVERY Classroom. "Sugar is the NEW Nicotine." Artificial Sweeteners are ALSO a Health Risk. 18. EVERY Food & Drink, Medication, Building Material and WMD - Weapon of Mass Destruction, must be EVALUATED for CHEMICAL CONTENT. PHARMACEUTICALS & CHEMICALS are the Cause of So much ILLNESS and DEATH. Remember Thalidomide? Apparently "BIG PHARMA" has been given a seat in the USA FDA. Is this Wise? The CANCER, AUTISM and DEMENTIA Rates in the 1st World are SKY-HIGH. WHY is that? Because of PHARMACEUTICALS 💊💉, GMOs and Agricultural Practices. EVERY Doctor KNOWS that Pharmaceuticals are Largely the cause of the 3 previously mentioned Illnesses, so WHY do they continue to prescribe them? One Word. 💰 MONEY💰. Doctors get KICKBACKS 💸💸 from the PHARMACEUTICAL companies every time they for Prescribe their medications. That explains why 70% of Americans are on Pills💊, and in 20 years, 40% of U.S. children will have Autism. Those Post WW11 Pharmaceutical companies try to say those diseases are "Genetic". Were they Genetic 70 Years ago, BEFORE WW11? 19. RWN - READING - WRITING - NOW, is a Program that would be USEFUL for some Aborigines who are too ashamed to admit that they cannot read or write. This way the problem is Solved in Private : 1 800 018 802 20. Physical and Sexual Assault are a CRIME. VERBAL Assault - BULLYING, should ALSO become a Crime. The effects of these 3 types of Assault, Especially in the First 7 years, is LIFE-LONG. 21. The Life Expectancy is increasing. In 20 years, women are expected to live to 92 years. Medical Care is Improving. The RETIREMENT AGE can be Increased from 65 to 70 years, thus INCREASING the TAX BASE 💸. 22. The TAX FREE STATUS of Churches should be RECONSIDERED. In the USA, in the 1970's a KCIA Front Group & Big Business 💸 Organization "PRETENDED to be a religious institution" in order to escape paying it's rightful share of TAXES on it's Very PROFITABLE 💸💸 Enterprises. 23. INCREASE the FOCUS on PRIMARY School Teachers & Students. There Must be : a. MORE MALE teachers to be Positive Examples / Role models to the children, Especially in Under-privileged Areas. b. SPECIALIZED TRAINING for Primary School teachers c. PAY RISES 💸 The FIRST 7 years and to a lesser extent, the next 7 years, are ESSENTIAL to an individual's Future lifestyle choices. School MUST be seen as a FUN 🎉 and JOYFUL 🙋 experience, ESPECIALLY for Underprivileged children. Schools can be a POSITIVE Influence for All children, giving them confidence to Participate fully in Society. "Childhood should be a JOY" - Dalai Lama Change from Primary Schools to Learning CENTRES Or CLUBS, as this terminology is more attractive for children. 24. POLICE Officers must become CARE Officers 25. GOVERNMENTS go from Force & Law to CARE & RESPECT 26. SENIOR Citizens are a RAPIDLY Growing population, with greatly improved health and lifespan. There's alot of issues to be addressed with these citizens. A Huge opportunity is now present for retired individuals to OFFER SERVICE and WORK Together with others. Learn from Experience You're Not Getting OLDER, You're getting BETTER 27. Have Every child read "A LITTLE HISTORY of the WORLD" by E.H. Gombrich. This International bestseller 📚 is written in very easy to understand English, for ALL children to understand the HISTORY of the WORLD 🌍 28. EVERY Individual Deserves at Least 14 years of Love, Care and Protection from at least 1 Primary Care-giver. The First 7-14 years is where MOST of a person's character development occurs. The Majority of a person's attitudes and thinking come from their FIRST 14 YEARS, that's why psychiatrists always ask about your Childhood. 29. The Original and First Australians - Aborigines, are very similar to the African-American population. Their "Rite of Passage" is to spend time in "Lock-up" - Prison. It used to be that the White man considered them both to have 75% of the brain capacity of the White man. Why are Aborigines and African-Americans so "mis-behaved? Because one was seen as property, and the other was seen as animals who happened to inhabit one of the places that the British EMPIRE wanted to Utilize #2. 😀 RAISE THE RETIREMENT AGE TO 70 😀 1. Due to Improved Medical Care, citizens are living longer and healthier lives. 2. Raising Retirement age will increase the Tax Base💲. 3. Raising Retirement age will Also cover the Increasing Centrelink Costs for the Aged & Disability Pensions for an Aging Population. #3. 😀 INDIGENOUS PEOPLE 1. Every primary school child must be taught the : a. Song 🙌 b. Dance💃 c. History 📚 d. Culture 🌋 of it's Indigenous Citizens. 40,000 years versus 240 years??..... The Australian and American Original citizens need to be APPRECIATED, PROMOTED and VALUED, in order to address their issues, and to make Every other child appreciate and value them. #4. 😀 9 CAUSES 😀 Am I telling you to NOT get SCAMMED by a Predatory CULT, the MEDICAL/NURSING HOME GAME, FALSE PHARMACEUTICALS💊, GUNS🔫, or the WAR BUSINESS 💣 ? NO ! It's a FREE Country, last I checked, as Long as you know the TRUTH, the Whole TRUTH, NOTHING but the TRUTH, so help me GOD. 😇 THEN U can't BLAME anyone but your OWN SELF for YOUR Choices. I've got 9 CAUSES that are Listed below. Here they are. 😀 SCAMS : 1. PREDATORY Cults 2. DEATH RESORTS - Nursing Homes 3. PHARMACEUTICALS - BIG PHARMA 💊 4. The War BUSINESS CAUSES : 5. 3rd WORLD WOMEN 6. HEALTHY LIVING 7. GUN CONTROL 🔫 8. TRUE ISLAM 9. INDIGENOUS PEOPLE 1. PREDATORY CULTS - I have a friend who was in a Predatory Cult. They're ALL the Same. Their REAL motivation is Money 💸 & Power (and sometimes weird Sex). EXAMPLES are People's Temple & Children of God & Scientology & Moonies/FFWPU/Unification Church & Oneida Community & Jehovah's Witnesses Regarding "The TRUE Family of Mankind" - MOONIES - The Family of SELF-PROCLAIMED Lord of the Second Advent Sun Myung Moon - KNOW THEM BY THEIR FRUITS🍇 The APPLE DOESN'T FALL FAR FROM THE TREE 🍎 ACTIONS SPEAK LOUDER THAN WORDS 💪 DO AS I SAY, NOT AS I DO The THINGS People do for MONEY 💸💸💸💸 are the ROOT of ALL EVIL 🙉LEARN FROM YOUR PARENTS🙈 👏PRACTICE WHAT YOU PREACH👎 1. They're Usually led by a MALE, who is CONVINCED that he is a UNIQUE Voice of GOD. 2. Their MARKET is Disenfranchised, "SEARCHING" People. 3. The members are Always told that they're BETTER than others via being part of "The Master Race, God's Lineage, Chosen Skin Color, Religion, Nationality etc." 4. They get those people to do STRANGE actions such as ALL NIGHT Prayers, FASTING, Working for FREE - raising MONEY 💸💸 & Bringing in New members via the Threat "If you don't do this you WON'T Go to Heaven / be Saved OR WILL Go to Hell" 5. They're Always told to MARRY WITHIN the Cult. 6. The Cults Always say the members' REAL natural FAMILIES are "EVIL / FALLEN" in order to create SOLE "Loyalty" to the Cult 7. The Cults are ALWAYS EXPOSED /Destroyed in the END. 8. The Offspring ALWAYS Leave in DISGUST. 😉 GOOD GROUPS : 1. UCSA 2. FREEDOM OF MIND 2. DEATH RESORTS / NURSING HOMES - They are a BOOMING Business💸 now that the Baby Boomers are hitting their 70s and people are living LONGER and medical care is IMPROVING. In some nations, the Aged Care Business Participants "Are ALL in BED TOGETHER 💸💸" ALMOST Every Doctor, Psychiatrist, Nursing Home, Pharmaceutical Coy., and EVEN the COMPLAINTS Organizations 😨"Share Information together for a NON Caring Purpose" 😉 💸💸 I have a friend who TEMPORARILY spent some time in a Nursing Home due to an Injury. After a Medically Educated Individual REMOVED the Incorrect Medication that she was on, she wrote EVERYTHING Down. There was SO MUCH Verbal & Physical Abuse going on, towards Mostly 70 - 85 year old residents, with the Staff Hoping that the Residents are SO DRUGGED up, that They wouldn't be BELIEVED by others, regarding what was REALLY Going on. After weeks of writing EVERYTHING Down, the Manager KICKED my friend out via calling / lying to the POLICE. It is ALL a SCAM YOU'RE as YOUNG AS YOU FEEL 🙌 70 is the NEW 30 🙌 LEARN from EXPERIENCE You're NOT Getting OLDER, You're getting BETTER GOOD INDIVIDUALS & GROUPS : 1. LET'S TALK 2. LYNDA SALTARELLI 3. DAVID STEWART - IRVING 3. BIG PHARMA-PHARMACEUTICALS💊 From Everything that I've read, ALL CANCER, DEMENTIA and AUTISM comes from PHARMACEUTICALS & GMOs. But the DRUG Companies try to Cover their A€£ES via LIES such as "Cancer is Genetic". Currently, 70% of Americans are on PILLS. In 20 years, 40% of USA CHILDREN will be Autistic. WHY is this Happening NOW? PHARMACEUTICALS 💊 : 1. RARELY WORK 2. CAUSE GREATER PROBLEMS 3. SOMETIMES CAUSE DEATH Also, did you know that EVERY Doctor KNOWS that the Pharmaceuticals they're Prescribing cause these 3 Sometimes FATAL Illnesses? So WHY is your OWN Family Doctor doing This? One Word. 💸 MONEY 💸 EVERY DOCTOR gets PAID 💸KICKBACKS💸 from the PHARMACEUTICAL COMPANIES when they Prescribe their Drugs💊. The THINGS People do for MONEY 💸💸 are the ROOT of ALL EVIL 😈 Remember THALIDOMIDE? That was a Post WW11 Drug for "Pregnancy Pains". 1 FDA Doctor Repeatedly said that it was Already causing HUGE Problems in Europe and to STOP It Immediately. You know what that Drug Companies said? "Oooh those Bossy Bureaucrats" And the Result? DEFORMED BABIES Left and Right 👹 I am NOT a Hippie Chick who wants an Organic Lifestyle, I'm an Accountant 💸Sales Queen 💸 and I feel that IF a person makes the CHOICE to be involved with a Predatory Cult, Nursing Home, Take Pharmaceuticals, FIGHT / DIE in a War, have an UNhealthy Lifestyle, live as a 3rd World Female, participate in UNREVISED Islam, Buy MURDER WEAPONS, then FINE ! BUT as Long you KNOW : "The TRUTH, the WHOLE TRUTH, NOTHING but the TRUTH, so help me GOD" 😇 Then FREELY & INTELLIGENTLY make your OWN CHOICE. GOOD INDIVIDUALS : 1. DR. BRAD McKAY 2. ROGER BEZANIS 4. The WAR BUSINESS 💸💸 - The USA is a VERY SAD Example of this one. For EVERY WAR Check : a. WHO'S at the TOP ? b. WHERE'S the MONEY 💸💸? In EVERY WAR : 1. Men (usually) RAPE 💸💸 a Country of it's Natural RESOURCES & the INDIGENOUS People get ANGRY & FIGHT BACK 😠 2. The ARMS Companies make Even MORE BIG, BIG Money 💸💸 Selling BOMBS & GUNS to those Invading Men who want to defend themselves because of their OWN invasion, and SOMETIMES to those ANGRY INDIGENOUS People TOO!! 😂😈😂 WHENEVER there's a Inexplicable SCREW-UP in the World, ALWAYS : 💸 💸"SHOW ME THE MONEY"💸💸 GOOD GROUPS : 1. CODE PINK 5. 3rd WORLD WOMEN - 80% of the WORLD (3rd World) sees Females as ONLY : 1. BREEDING Animals 2. Sex TOYS 3. PROPERTY The Time is Coming when the COMMON KNOWLEDGE that Females & Males are Totally EQUAL INTELLECTUALLY will be ACCEPTED WORLDWIDE. ALSO ! IF you wish to Procreate, WHO Ya gonna Call?? 😉 WOMEN are SUPERIOR, BUT! We Don't wanna Remind you... WHY? Cuz WE MADE YOU ! 😂😂😂 GOOD GROUPS : 1. IWDA 2. 50 MILLION MISSING 3. AHA FOUNDATION 4. MALALA FOUNDATION 6. HEALTHY LIVING - People need to be AWARE of the Proper FOODS to put in their Bodies & how to beneficially MAINTAIN their Body via EXERCISE and CARE. A MAJOR problem in the 1st World is OBESITY. People Must REVISE their food intake and EXERCISE on a DAILY Basis. 😀 ADD ADDITIONAL Sales TAX 💸💸 to ALCOHOL🍾, CIGARETTES, SUGAR🍩, SALT, MEAT, GLUTEN and DAIRY in order to Cover the GUARANTEED RESULTING ADDITIONAL HEALTHCARE & TV Ads & PRIMARY School EDUCATION COSTS 💸 GOOD GROUPS : 1. NUTRITION FORCE 2. AUTHORITY NUTRITION 7. GUN CONTROL 🔫 - It's pretty OBVIOUS WHY the USA is the ONLY 1st World Nation that STILL Allows PERSONAL ownership of MURDER WEAPONS🔫. One WORD = MONEY 💸💸💸💸. GUN MASSACRES have gone from BI-weekly to WEEKLY to DAILY. The NRA has REFUSED to NOT Sell Guns to "JIHADISTS", WHAT DOES THAT SAY? The NRA Also "Strongly SUGGESTS" to EVERY GUN Company CEO to give them a BIG DONATION 💸💸💸💸 😱 EL CAPITALISTA AMERICANA 💸💸💸💸 MONEY 💸💸💸💸 vs. HUMAN LIFE 😇 8. ISLAM 🌹 - EVERY Single one of my EXCELLENT MUSLIM friends does NOT practice : a. FGM - Female Genital Mutilation - SEXUAL ASSAULT b. Child Brides & Baci Baazi - PEDOPHILIA c. Forced Marriage - DEPRIVATION of Liberty/BREEDING d. Honor Killings - MURDER e. Hijab/Burkha - MISOGYNY f. Gang Rapes / Acid Attacks - ASSAULT ALL of these "Practices" have NOTHING to do with ISLAM - Qur'an, and EVERYTHING to do with Feudal, Archaic, MIDDLE AGES, Primitive 3rd WORLD Behaviour. BTW - FGM - Female Genital Mutilation is practiced by BOTH CHRISTIANS and MUSLIMS in NORTH AFRICA, HONOR KILLINGS are performed in BOTH LATIN AMERICA and MUSLIM countries, FORCED Marriage / CHILD BRIDES are performed in 80% of the WORLD - 3rd World. GOOD GROUPS : 1. MUSLIM REFORM MOVEMENT 2. FAITHFREEDOM 3. FAITH 4 FREEDOM 9. INDIGENOUS PEOPLE - 20,000 YEARS vs. 239 Years..... Hmmmm......... EVERY NATION MUST Teach About /Appreciate / Value it's FIRST PEOPLE. EVERY School Child MUST be Taught the History, Culture, Song & Dance of it's INDIGENOUS People NOT Just the WHITE Culture. GOOD INDIVIDUALS & GROUPS : 1. SUNNY REDCLOUD 2. "I'M NOT RACIST, BUT" 3. "1 MILLION INDIGENOUS" #5. 😀 DAILY HEALTH REGIME 😀 1. EAT : a. RAW Fruit & Vegetables b. STARCH - Cereal, Potatoes, Rice, NO REFINED Flour or Cereal c. PROTEIN - (Cheese, Milk, Yogurt, Eggs- but Dairy MAY be a problem - research Veganism) Peas, Nuts & Beans and Fish 2. NO CHEMICALS, NICOTINE, MEAT, ALCOHOL, SUGAR, DAIRY, GLUTEN and MINIMAL Salt 3. Minimum of 1 HOUR DAILY EXERCISE - try an Exercise Machine or a Walk or a Gym #6. 😀 SUGAR & CHEMICALS 😀 🍁 Finally 🍁 everyone knows the Damage that SUGAR can cause to your Body, but ARTIFICIAL SWEETENERS are ALSO a very Big DANGER. Coca-Cola's BEST International Market $$ is an Australian Aboriginal community, and in the U.S.A., some Hill-billies put it in their baby's bottles as well. As suggested before, an ADDITIONAL SALES TAX $ must be Added to JUNK FOOD, ALCOHOL, CIGARETTES and Also SUGARY & DIET SOFT DRINKS in order to Cover the GUARANTEED EXTRA COST $ of the Additional Government Supplied Medical Care + TV Warning Ads and Primary School education that are Necessary for these obviously dangerous substances.🍁
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