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xtruss · 2 years ago

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Since gaining popularity online, the diabetes medication Ozempic (semaglutide) has been increasingly requested to manage weight. Now, there’s a shortage that’s affecting people who use the medication. Photograph By Imyskin, Getty Images

Ozempic is a Serious Drug with Serious Risks. Here’s What to Know.

The diabetes medication semaglutide has recently become a trendy weight loss treatment. But like every drug, there are downsides—and potentially serious side effects.

— By Allie Yang | August 1, 2023

Billionaire Elon Musk credited it for his dramatic weight loss. Celebrity sites allege that many more A-listers are using it to stay trim. And TikTok is full of influencers showing off their startling before-and-after shots showing off their weight loss after using it.

What is it? A medication called semaglutide, which is sold under different brand names, including Ozempic, approved in 2017 for treating type 2 diabetes, and Wegovy, approved just last year for weight loss.

The buzz about these drugs has created a shortage of both, according to the U.S. Food and Drug Administration, which is expected to last for several months—causing alarm among patients with diabetes who rely on Ozempic to help control their blood sugar. Experts caution that it’s important to understand these are not miracle drugs—and that there are risks to taking them outside of their intended use.

Here’s what you need to know about semaglutide, including how it works and the risks.

What’s The Science Behind The Drug?

Semaglutide helps lower blood sugar by mimicking a hormone that’s naturally secreted when food is consumed, says Ariana Chao, assistant professor at the University of Pennsylvania School of Nursing and medical director at the school’s Center for Weight and Eating Disorders. This medication, administered through injection, helps people feel full for longer, helps regulate appetite, and reduces hunger and cravings.

There is significant demand for the drug. In 2019, more than 11 percent of the population was diagnosed with diabetes, while more than four in ten adults classified as obese in 2020.

Patients with type 2 diabetes often have impairments in insulin, a hormone that helps break down food and convert it into fuel the body can use, Chao says. Semaglutide signals the pancreas to create more insulin and also lowers glucagon, which helps control blood sugar levels. This can result in weight loss but experts point out that Ozempic has not been approved for that purpose, though semaglutide at a higher dose (Wegovy) has been.

Wegovy is the first drug since 2014 to be approved for chronic weight management. The difference between the two drugs is that Wegovy is administered at a higher dose of semaglutide than Ozempic. Wegovy’s clinical trials showed more weight loss but only slightly greater improvements in glycemic control compared to Ozempic, Chao says.

The FDA sees Ozempic and Wegovy as two different medications for different uses. Chao says many insurance companies cover Ozempic for diabetes but don't cover Wegovy for obesity—a prime example of weight bias in health care. That's why some medical providers use the two doses somewhat interchangeably, as obesity and type 2 diabetes are inextricably linked–obesity is the leading risk factor for developing type 2 diabetes.

What Are The Risks?

Like every medication, there can be downsides.

The most common side effects are gastrointestinal issues, such as nausea, constipation, and diarrhea, Chao says—and more rarely, pancreatitis, gallbladder disease, and diabetic retinopathy.

Angela Godwin, nurse practitioner and clinical assistant professor at the NYU Rory Meyers College of Nursing, explains that recent reports of extreme vomiting and gastroparesis (delayed emptying of the stomach) are to be expected.

Gastroparesis “just means the food’s in your stomach longer, which then makes you feel fuller longer,” she explains.

Nausea is one of the biggest side effects of medications like Ozempic and Wegovy, and that can always lead to vomiting, Godwin says. In June, the American Society of Anesthesiologists recommended patients stop taking these medications before surgery to avoid aspiration and vomiting.

“Normally, in my experience, it's tolerable,” she says. “But then there are times when I ask [patients], ‘Well, what happened?’ And they [say] they ate too much and ate too quickly. And then yes, the body will vomit it up, because it just can't tolerate that much food anymore.”

These drugs have been extensively studied, but their relatively recent approval means researchers still don’t know what the effects of taking them long term might be.

Continuing research is helping us understand more about what happens when people stop taking these medications—which many may be forced to do amid current shortages. Research does suggest that stopping use of this medication could cause patients to regain weight, especially if they didn’t make any lifestyle changes.

“In almost all weight-loss studies, it really depends on your foundation,” says Stanford endocrinologist Sun Kim. “Your efforts at lifestyle will determine how much weight you lose. If you have your foundations like food, exercise, and sleep, you’re gonna do well.” If not, you might regain as much as 20 percent of the weight lost per year.

These medications can also be incredibly expensive, especially without insurance. Kim says an injection pen can run more than $1,000.

What Does It Mean To Use This Drug Off-label?

Using a drug off-label means using it in a way other than its intended and its FDA-approved purpose, which may not be safe or effective. Ozempic has been approved only for type 2 diabetics, and Wegovy has been approved only for patients with a BMI above 30, or 27 if they have a weight-related comorbidity like high blood pressure.

“There is no scientific evidence to show whether this medication will be effective or of benefit to those who do not fit the criteria from the FDA-approved label indications, such as people with a BMI lower than 27,” Chao says. “We also do not know the side effects or risks in these populations—there could be unknown drug reactions. These medications are not meant to be a quick fix.”

Even if you meet the criteria, experts warn against trying to obtain the medication without a prescription by traveling to countries that don't require them.

“When the medication’s not used under supervision of a health-care provider, then they can come into misuse,” Chao says. “There could be more serious adverse events that can happen.”

Godwin says recent reports of extreme vomiting and gastroparesis are a reminder that patients should schedule regular checkups with their doctor when taking these medications.

“I think it's so popular now that practitioners might be tempted to just prescribe more freely, and then maybe not monitor patients as frequently,” she says.

Patients should not increase their Ozempic dose without doctor approval—which is possible because there are multiple doses in one pen. “They could definitely have a lot of poor side effects, because they didn't titrate up to that level yet,” Godwin says. The same could be said for Wegovy, which comes in a pack of four one-dose pens.

Robert Gabbay, the American Diabetes Association’s chief scientific and medical officer, said the organization is “very much concerned” about the Ozempic shortage.

“The medication has been an important tool for people with diabetes,” he says. “Not only does it lower blood glucose and weight but it has been shown to decrease cardiovascular events—heart attacks—one of the leading causes of death for those living with diabetes.”

A Last Resort?

Still, Kim says that prescribing drugs like Ozempic and Wegovy to patients who are desperate for a new approach to weight loss can make her feel “like a superhero.” By the time patients come to her, they’ve often tried methods like Weight Watchers and following the advice of dieticians. In that case, she says, medications like Ozempic and Wegovy can be a great option.

“What I find is sometimes as they're becoming successful at losing weight, it really does feed into their lifestyle too, and then they're able to be more active,” Kim says. “It’s hard to lose weight. Seventy-five percent of the U.S. population is overweight or obese. I feel that we shouldn't be holding this back if this can help.”

Chao agrees that these medications are a good alternative for those who are unable to lose 5 percent of their body weight within about three months of making lifestyle changes. Still, she recommends trying those approaches before turning to medication.

Patients should “make sure that they're focusing on a healthy dietary pattern, reducing calories, as well as increasing physical activity,” she says. “It’s important they know that even if they are taking the medication, it's not an easy way out: They're still going to have to make lifestyle changes.”

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neighborlyhomecarepa · 2 years ago

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Why People Choose In Home Care as an Alternative to Residential Centers for Seniors

Today, families have options other than elderly nursing homes and similar full-time residential treatment centers. Neighborly Home Care is one professional provider of senior care that has found that many people in Delaware and Pennsylvania are choosing the more affordable and individualized in home care.

In Home Care Benefits for Seniors

In home care brings numerous benefits to seniors, particularly those who are still largely mobile and autonomous, but having difficulty in their day-to-day lives. Seniors can continue living in their own homes and maintain a level of independence. The caregiver is able to help with many tasks, such as light cleaning or cooking, while also being available to help monitor the senior’s well-being. Neighborly Home Care’s in home care providers will also accompany seniors to medical visits, offering safe transport as well as someone who can take notes and provide information to families.

In Home Care Benefits for Families

In home care also benefits families, as the responsibility on adult children or other relatives can be reduced. Those dedicated to providing care to their aging loved-ones will find that they need respite sometimes. Such care can easily cause significant physical, mental, or financial damage to those providing care – especially those untrained in best practices for helping the elderly. In home care is also less expensive than nursing facilities in nearly all cases, and can sometimes be covered under Medicaid and other public health options.

In home care combines the best in elderly care techniques: The elderly get as much freedom and autonomy as possible, while still receiving individualized care that fits their particular needs. Families gain assistance with their loved ones’ senior care: both physical relief and emotional relief, knowing that their loved ones are being cared for when they are unable to be present. Contact Neighborly Home Care directly for further information.

About Neighborly Home Care

Neighborly Home Care is a Pennsylvania-based provider of in home health care and life-assistance services for the elderly and infirm. Neighborly Home Care prides themselves on maintaining the highest possible levels of expertise, compassion, and professionalism among their care staff, while offering a wide range of assistance services. Within home care in Delaware County, whether it entails 24/7 around-the-clock care, periodic check-ins, or transport for seniors lacking mobility, Neighborly Home Care seeks to allow seniors the most autonomy while still caring for their needs. For more information, please visit https://www.neighborlyhomecare.com or contact 610-658-5822.

Blog is originally published at: https://www.neighborlyhomecare.com/neighborly-home-care-discusses-people-choosing-home-care-analternative-residential-centers-seniors-delaware-county/

It is republished with the permission from the author.

#in home care #in-home care #elder care services #senior care #senior care services #elderly care #in home health care

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mystlnewsonline · 2 years ago

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Complete Physician Services to Pay $1.5 Million

Complete Physician Services, Kenneth Wiseman, DO, and Steven Schmidt, DO to Pay $1.5 Million to Resolve False Claims Act Liability for Submitting Unsupported Diagnosis to The Medicare Advantage Program PHILADELPHIA, PA (STL.News) United States Attorney Jacqueline C. Romero announced that Complete Physician Services, Kenneth Wiseman, DO, and Steven Schmidt, DO (collectively, “CPS”), have agreed to pay a total of $1,500,000 plus interest to resolve False Claims Act allegations that they caused the submission of false claims by misrepresenting the severity of illness and services rendered to increase reimbursement from the Medicare Part C (Medicare Advantage) and Part B programs. CPS, a primary care physician practice located in Philadelphia, treated patients under the Medicare Advantage program and the Medicare Part B (Medical Insurance) program. The government alleges that CPS caused the submission of false claims for payment to Part C from January 1, 2015, to December 31, 2018, arising from CPS submitting unsupported diagnosis codes, resulting in increased reimbursement to Part C health insurance companies. Specifically, CPS submitted morbid obesity diagnosis codes to Part C, where the diagnoses lacked medical support in that patients had a body mass index under 35. The government contends that the diagnosis of morbid obesity in this situation is inappropriate. Further, the government alleges that CPS’s submission of chronic obstructive pulmonary disease (“COPD”) diagnoses was not medically supported or supported by appropriate medical documentation in many instances. As a result of these unsupported diagnoses, CPS substantially increased Part C reimbursement from the Centers for Medicare & Medicaid Services (“CMS”). The government also alleges that CPS caused the submission of inappropriate claims to the Medicare Part B program that were not supported by medical documentation from January 1, 2015, to December 31, 2018, in order to maximize its reimbursement. Specifically, the government contends that CPS improperly billed Evaluation and Management visits using Current Procedural Terminology Code 99214 without the requisite level and complex medical decision-making that this code requires. Further, CPS inappropriately billed physician assistant services “incident to” the professional services of a physician, including occasions when the physician was out of the country. Finally, CPS also submitted unsupported billing to CMS for smoking cessation counseling, pulmonary function tests, and unsupported claims for vaccine administration. “Almost half of Medicare beneficiaries are now enrolled in Medicare Advantage plans. As a result, investigation of credible allegations of fraud impacting it is more important than ever,” said U.S. Attorney Romero. “The Medicare Advantage Program relies on accurate information about its enrollees’ health status, such as whether they really have morbid obesity or COPD. It is imperative that enrollees receive appropriate treatment and that participating providers and health plans receive proper compensation for the services they actually provide. We will hold accountable those who report unsupported diagnoses to inflate Medicare Advantage payment.” “Today’s settlement shows our attention to and commitment to investigating all potential allegations of fraud against the Medicare Part C Programs, no matter the size of the physician practice or the complexity of the scheme,” said Maureen R. Dixon, Special Agent in Charge for the U.S. Department of Health and Human Services, Office of the Inspector General. “We will continue to partner with the United States Attorney’s Office to evaluate allegations brought under the False Claims Act to ensure the integrity of Medicare programs.” This settlement resolved a lawsuit filed under the False Claims Act in the U.S. District Court for the Eastern District of Pennsylvania by former CPS employees captioned United States ex rel. Michael Helzner, D.O., et al. v. Complete Physician Services, LTD, at al., No. 16-cv-5401 (E.D. Pa.). Under the qui tam or whistleblower provisions of the False Claims Act, lawsuits like this one may be brought on behalf of the United States, and the relators share in any recovery by the government. The relators were represented in this case by John M. Hanamirian of the Hanamirian Law Firm. “We thank the relators and the relators’ counsel for their contributions. Detecting fraud is much easier when we have the cooperation of whistleblowers like the ones in this case,” said Romero. This matter was investigated by the U.S. Attorney’s Office for the Eastern District of Pennsylvania in conjunction with the U.S. Department of Health and Human Services Office of Inspector General. The investigation and settlement were handled by Assistant U.S. Attorney Deborah W. Frey, Civil Division Chief Gregory B. David, and Auditor George Niedzwicki. The claims resolved by this settlement are allegations only, and there has been no determination of liability. SOURCE: U.S. Department of Justice Read the full article

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verycleverboy · 4 years ago

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Welcome to October 7th.

(cough cough)

Where we are today:

After spending the weekend at Walter Reed Medical Center for treatment of his COVID-19 infection, President Donald Trump returned to the White House yesterday afternoon, where he is expected to continue treatment under quarantine.

The slim hopes there were that Trump would calm down and take his current situation seriously--and yeah, I know, but some people are just born suckers--were exploded yesterday when Trump's first full day out of the hospital was highlighted by an almost incoherent tweet storm, followed by a declaration out of nowhere that long-stalled talks over a second stimulus package were dead until after the election, and everyone had been instructed to dedicate their undivided attention to the Supreme Court nomination. The response was instantaneous: one spur-of-the-moment tweet shaved 600 points off the stock market before closing.

He walked back the stance slightly later on, saying he'd be willing to sign off on just the personal stimulus checks, part of a piecemeal approach that Democrats have repeatedly said was a nonstarter. For those who were depending on extended unemployment relief or waiting for a federal lifeline for their small businesses (or even larger ones, in the case of the airlines), the message from Trump and his party, with 27 days until the election, is what it's been all summer: Help isn't on the way. You're on your own. Please suffer quietly while we play confirmation games in the Senate.

The above would appear to demonstrate that the President’s emotional state is even more unhinged than usual, and the speculation (not to mention a certain style of headline) has been zeroing in on the manic episodes that are a known side-effect of the steroid treatment Trump has been taking. The impression is that there’s still a lot that’s being kept from us, and the main thing the West Wing has been open about since the President’s diagnosis is that they have no intention of being open about anything related to the current state of affairs.

Physician to the President Dr. Sean Conley maintains that Trump’s recovery is continuing in a positive direction, but the memorandum begins with the one line that has been casting a long shadow over any hope of honesty:

“I release the following information with the permission of President Donald J. Trump.”

In 2015, Trump’s personal physician Dr. Harold Bornstein released a hyperbole-laden assessment of the then-candidate’s health status: “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency." Like Conley’s status report, there we no real negatives. The main difference was that Borstein’s letter sounded a lot like a Trump-penned press release.

Borstein later revealed there was a reason that letter sounded so Trumpian. "He dictated that whole letter. I didn't write that letter."

Folks, this could be some hard-earned paranoia talking, since there’s no major reason to assume that a Borstein level of hijacking is happening with Conley, apart from his Walter Reed declaration that he was intentionally skewing towards optimism over the weekend while dodging (and sometimes backtracking on) a lot of key questions. But if some of us feel like we smell a rat in a sunshine-and-rainbows status report, it’s because that rat was caught in this particular corn crib once before.

HIPAA rules entitle every American citizen to a certain expectation of privacy when it comes to medical records. If you want to allow even another member of your family to be able to talk about your condition with your doctors, you have to sign off specific names. That means the onus of allowing transparency in the case of Donald J. Trump, a man whose health (for better or for worse) has international implications, falls on the full consent of Donald J. Trump himself. But since Borstein’s revelation came days after members of the Trump Organization seized his Trump-related medical records in what he characterized as a “raid” on his office, it’s safe to assume that’s not going to happen....not until it’s too late, anyway.

Meanwhile...

The Trump/Pence team continues to openly mock the medically-recommended safety measures that, had they been applied consistently, would've kept the President out of the hospital. Trump is still making the claim that COVID-19 is no worse than the flu, which by any metric is demonstrably false and highly dangerous, while Pence and his team made a last-minute attempt yesterday to flex on the previously agreed-to plexiglas guards in front of the podiums. His debate with Kamala Harris is scheduled for tonight.

Since Trump loves Citizen Kane, while not necessarily understanding that Kane isn't the hero of the movie, let's end this wall of words with a quote that he probably hasn't figured out yet either.

“You're the greatest fool I've ever known, Kane. If it was anybody else, I'd say what's going to happen to you would be a lesson to you. Only you're going to need more than one lesson. And you're going to get more than one lesson.”

Will Trump's next lesson come from the disease or the electorate? Either way, we're in for a long, dark October. Stay warm, everybody.

First Lady Melania Trump, who did not join her husband at Walter Reed, continues to rest at the White House during her recovery.

Other confirmed positives for COVID-19:

(This is not intended to be a complete list, and is based on news reports concerning those who are known to have been in contact with other infected individuals in connection with recent events. Status changes and additions since yesterday’s megapost will be listed in bold. Updated throughout the day as new information becomes available from the CNN, NBC News, and CBS News live update pages, supplemented by other sources.)

White House

Hope Hicks: Began showing symptoms on Wednesday, tested positive on Thursday morning. Was not in attendance at Judge Amy Coney Barrett’s nomination event on September 26th.

Nicholas Luna, personal assistant to the President: Luna is a “body man”, whose duties require him to be in close proximity to the President at all times.

Kayleigh McEnany, White House press secretary: She was not aware of the Hicks diagnosis when she addressed the press on Thursday.

Stephen Miller, Senior Advisor to the President: Was already working remotely and self-isolating, announced positive test on Monday. His wife, Katie Miller, is Vice President Pence’s director of communications, had coronavirus several months ago.

Chad Gilmartin and Karoline Leavitt, members of Kayleigh McEnany’s staff.

Assistant White House press secretary Jalen Drummond: Another McEnany staffer who tested positive Monday morning

Unidentified staffer: Military personnel directly assigned to support the President in the Oval Office and residence, diagnosed over the weekend per CNN.

Three initially unidentified members of the White House press corps and an unidentified staffer who works with the media. Per the White House Correspondents’ Association president Zeke Miller: Individual #1 attended a Sunday briefing and tested positive on Friday after exhibiting symptoms on Thursday. Individual #2 (later confirmed to be Michael Shear of the New York Times) was part of the press pool which traveled to last Saturday’s Pennsylvania rally; also exhibited symptoms on Thursday and tested positive on Friday. Individual #3 was in the press pool for the Barrett Rose Garden event and also travelled with the press pool on Sunday. #3 exhibited symptoms on Wednesday and tested positive Friday afternoon. The press at the Barret event were confined in a crowded “penlike enclosure” behind the invited guests (per Washington Post).

Campaign personnel

Chris Christie: Attended the Barrett nomination event and was part of Trump debate prep. Christie, whose asthma puts him in a higher risk group, checked himself into Morristown Medical Center as a precautionary measure.

Kellyanne Conway: Attended the Barrett nomination event and was part of Trump debate prep. The initial news came in the form of a string of snarky Tiktok posts on Friday from her daughter Claudia, followed much later by a confirmation from Kellyanne herself.

RNC Chairwoman Ronna McDaniel: Isolating at home since September 26th, tested last Wednesday.

Bill Stepien, current Trump 2020 campaign manager: In the White House on Monday, in Cleveland for Tuesday’s presidential debate, traveled with Trump and Hicks aboard Air Force One afterwards.

US Congress

Sen. Ron Johnson (R-WI): Per CNN: “Johnson was not at the Amy Coney Barrett ceremony because he was quarantining from a prior exposure, during which he twice tested negative for the virus, according to the spokesperson.” He was exposed “shortly after” returning to Washington.

Sen. Mike Lee, (R-UT): Attended the Barrett nomination event.

Sen. Thom Tillis (R-NC): Attended the Barrett nomination event.

Military

Admiral Charles Ray, Vice Commandant of the US Coast Guard: Recently attended several meetings with the Joint Chiefs of Staff. Nearly all the Joint Chiefs of Staff, including chairman General Mark Milley, are in precautionary quarantine.

Gen. Gary L. Thomas, assistant commandant of the US Marine Corps

Others

University of Notre Dame President Rev. John I. Jenkins, CSC: Attended the Barrett nomination event. Jenkins was told that he didn’t need to wear a mask to the event after he and other guests tested negative at the White House.

Thirteen employees at Murray’s restaurant in Minneapolis: Catered a party attended by President Trump on September 30th, although none of them were in close proximity to the President.

Confirmed negatives:

(Because of the nature of COVID-19, this list is subject to change.)

Mike and Karen Pence: The Pences have been testing daily since the announcement of the Trumps’ diagnosis.

Secretary of State Mike Pompeo

Treasury Secretary Steve Mnuchin

Ivanka Trump and Jared Kushner: Recently traveled with Hope Hicks

Barron Trump

Eric Trump: At debate.

Lara Trump: At debate.

Donald Trump Jr.: Flew on Air Force One to Cleveland debate, did not fly back.

Mark Meadows, White House chief of staff

Pat Cipollone, White House counsel

Dan Scavino, Deputy Chief of Staff for Communications and Director of Social Media

HHS Secretary Alex Azar

Attorney General Bill Barr

Defense Secretary Mark Esper

WH Press Secretary Kayleigh McEnany

Justin Clark, deputy campaign manager

Rudy Giuliani: Was in Trump debate prep.

Jason Miller: Was in Trump debate prep.

Alice Marie Johnson: Flew on Air Force One to Cleveland debate.

Judge Amy Coney Barrett: Barrett and her husband had coronavirus earlier this year and recovered, per AP News.

House Speaker Nancy Pelosi, (D-CA): Tested out of "an abundance of caution” because of Steve Mnuchin meeting earlier this week.

Rep. Jim Jordan (R-OH): Few on Air Force One to Cleveland debate, did not fly back.

DNC Chairman Tom Perez: In front row for Tuesday’s debate.

Sen. Josh Hawley (R-MO): Attended the Barrett nomination event, was seen there without a face covering.

Sen. Ted Cruz (R-TX): Precautionary quarantine because of close contact with COVID-19-positive individuals.

Sen. Ben Sasse (R-NE): Precautionary quarantine because of close contact with COVID-19-positive individuals.

Sen. James Lankford (R-OK): Precautionary quarantine because of close contact with COVID-19-positive individuals.

All of the Democrats on the Senate Judiciary Committee.

Status unknown as of Tuesday midday:

Kimberly Guilfoyle (at debate)

Alyssa Farah, White House Director of Strategic Communications

Robert O’Brien, national security adviser (tested positive for coronavirus in July)

Tiffany Trump (at debate)

Derek Lyons, Counselor to the President

Sen. Chuck Grassley, (R-IA), Senate pro tem: Declined to be tested, claiming physician’s advice as his reason; attended a meeting Thursday with Sen. Mike Lee.

30-50 donors who were in close contact with President Trump during an in-person event held at Trump’s Bedminster golf club on Thursday night. According to the official story, the event was held hours before President Trump’s positive test came back, but Hicks’s positive came back immediately before he left (although for a variety of reasons, the validity of that timeline is up in the air).

And because they’re stuck in this story, too:

Joe and Jill Biden: negative, committed to regular testing on all campaign event days.

Kamala Harris and her husband Doug Emhoff: negative

Previous megaposts, in case you’re a masochist: October 2 3 4 5 6

#Donald Trump #megapost #coronavirus #COVID-19

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uicscience · 4 years ago

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Top: Dr. Damiano Rondelli; above, sickle cells under a microscope.

CRISPR technology to cure sickle cell disease at UIC

University of Illinois Chicago is one of the U.S. sites participating in clinical trials to cure severe red blood congenital diseases such as sickle cell anemia or Thalassemia by safely modifying the DNA of patients’ blood cells.

The first cases treated with this approach were recently published in an article co-authored by Dr. Damiano Rondelli, the Michael Reese Professor of Hematology at the UIC College of Medicine. The article reports two patients have been cured of beta thalassemia and sickle cell disease after their own genes were edited with CRISPR-Cas9 technology. The two researchers who invented this technology received the Nobel Prize in Chemistry in 2020.

In the paper published in the New England Journal of Medicine, CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β-Thalassemia, researchers reported gene editing modified the DNA of stem cells by deleting the gene BCL11A, the gene responsible for suppressing fetal hemoglobin production. By doing so, stem cells start producing fetal hemoglobin so that patients with congenital hemoglobin defects (beta thalassemia or sickle cell disease) make enough fetal hemoglobin to overcome the effect of the defective hemoglobin that causes their disease.

The advantage of this approach is that it uses the patient’s cells with no need for a donor. Also, the gene manipulation does not use a viral vector as with other gene therapy studies but is done with electroporation (quick production of pores into the cells with high voltage) which is known to have low risk of off-target gene activation, according to Rondelli.

Sickle cell disease is an inherited defect of the hemoglobin that causes the red blood cells to become crescent-shaped. These cells can lyse and obstruct small blood vessels, depriving the body’s tissues of oxygen. The disease can cause extreme pain and damage the lungs, heart, kidneys and liver. Beta thalassemia is a blood disorder that reduces the production of hemoglobin — the iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body.

The first two patients to receive the treatment have had successful results and continue to be monitored. Rondelli is on the steering committee for an international clinical trial, with UIC being the only site in Chicago. Although the trial is at an early stage and the first patients will be followed for some time before expanding the numbers worldwide, UIC will be among the few sites ready for this treatment.

“It is a great privilege for UIC to be part of this international study and I hope that in the future we will have our own patients undergo this procedure,” Rondelli said.

“UIC and UI Health is an ideal place for any cellular therapy in sickle cell disease because of our experience and success in stem cell transplantation in these patients. In fact, over 75% of sickle cell patients can be cured with a transplant, and we have already done over 50 cases,” he said.

While a full-match donor is still the first line of treatment, finding a compatible stem cell donor is challenging. For this reason, many centers including UI health have developed strategies to successfully utilize donors who are only 50% compatible, called haploidentical donors. However, according to Rondelli, in about 30% to 50% of the patients, there are still multiple barriers that can limit the possibility of a donor-derived transplant, such as a family donor availability, or the presence of antibodies in the patient caused by many prior red cell transfusions, that would reject the donor stem cells.

“This gene-editing procedure has the potential to overcome all of these. Cells of the same patient can be manipulated and can be transplanted without the risk of rejection or to cause immune reactions from the donor (graft-versus-host disease),” said Rondelli. “For the almost 900 patients with SC coming to our hospital, this should be great news.”

Patients who in the future will participate in the trial will have cells sent to the CRISPR manufacturing site where the cells undergo genetic editing. Patients then receive chemotherapy prior to the edited stem cells being re-inserted into their bloodstream.

Researchers hope this treatment can be a game-changer for world health. Sickle cell disease and beta thalassemia and other congenital blood disorders are major diseases in the world. Rondelli said 5 million people only in Nigeria suffer from sickle cell disease, and many others in Africa. Also, currently, 30% of transplants being performed in India, which has 1.3 billion people, are to treat severe beta thalassemia, he added.

“The hope is that this treatment will be accessible and affordable in many low-middle-income countries the Middle East, Africa, and India, and have an important impact in the lives of many people in these areas,” said Rondelli.

The CRISPR-Cas9 Gene Editing for Sickle Cell Disease and β-Thalassemia research paper was authored by Haydar Frangoul and Jennifer Domm of the Sarah Cannon Center for Blood Cancer at the Children’s Hospital at TriStar Centennial, Nashville; Akshay Sharma of St. Jude Children’s Research Hospital, Memphis; David Altshuler, Brenda K Eustace, Julie Lekstrom-Himes and Angela Yen of Vertex Pharmaceuticals; Martin Steinberg of Boston University School of Medicine; Yi-Shan Chen, Tony Ho, Andrew Kernytsky and Sandeep Soni of CRISPR Therapeutics, Cambridge, Massachusetts; M. Domenica Cappellini of University of Milan; Franco Locatelli of Ospedale Pediatrico Bambino Gesù Rome, Sapienza, University of Rome; Juergen Foell and Selim Corbacioglu of University of Regensburg, Regensburg, Germany; Rupert Handgretinge of Children’s University Hospital, University of Tübingen, Tübingen, Germany; Josu de la Fuente of Imperial College Healthcare NHS Trust, St. Mary’s Hospital, London; Stephan Grup of Children’s Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia; Antonis Kattamis of University of Athens, Athens; Amanda Li of BC Children’s Hospital, University of British Columbia, Vancouver; Donna Wall of Hospital for Sick Children-University of Toronto; Markus Mapara of Columbia University, New York; Sujit Sheth of Joan and Sanford I. Weill Medical College of Cornell University, New York; Mariane de Montalembert of Necker-Enfants Malades Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris; and Damiano Rondelli, University of Illinois Chicago.

Funded by CRISPR Therapeutics and Vertex Pharmaceuticals; ClinicalTrials.gov numbers, NCT03655678 for CLIMB THAL-111 and NCT03745287 for CLIMB SCD-121.

#CRISPR #sickle cell disease #gene editing #beta-thalassemia

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newstfionline · 4 years ago

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Saturday, December 19, 2020

Tax cuts for the wealthy aren’t trickling down (CBS News) Do tax cuts for the wealthy really help the overall economy and “trickle down” to everyone else? It’s not a trickle question. David Hope of the London School of Economics and Julian Limberg of King’s College London examined 18 developed countries and did the math. “Per capita gross domestic product and unemployment rates were nearly identical after five years in countries that slashed taxes on the rich and in those that didn’t, the study found. But the analysis discovered one major change: The incomes of the rich grew much faster in countries where tax rates were lowered. Instead of trickling down to the middle class, tax cuts for the rich may not accomplish much more than help the rich keep more of their riches and exacerbate income inequality.” 50 years of tax cuts for the rich failed to trickle down.

Suspected Russian Cyberattack Strikes at Heart of U.S. Government (Foreign Policy) As more details are revealed about Russia’s alleged hack of the U.S. government, it’s becoming clear that the breach is much worse than previously thought. On Thursday, the U.S. Cybersecurity and Infrastructure Security Agency warned that is “poses a grave risk” to federal, state, and local governments as well as private companies and organizations. There is a growing list of reported victims: the Centers for Disease Control, the Defense Department, State Department, Commerce Department, Department of Homeland Security, Treasury Department, the U.S. Postal Service, the National Institutes of Health, and the Department of Energy were all affected. “This is, I think, appears to be at this point the most serious cyberattack this country has ever endured,” Sen. Angus King, I-Maine said on NPR. Microsoft, which is helping to respond to the hack, noted that “the attack unfortunately represents a broad and successful espionage-based assault on both the confidential information of the U.S. Government and the tech tools used by firms to protect them … ongoing investigations reveal an attack that is remarkable for its scope, sophistication and impact.”

California hospitals buckle as virus cases surge (AP) Hospitals across California have all but run out of intensive care beds for COVID-19 patients, ambulances are backing up outside emergency rooms, and tents for triaging the sick are going up as the nation’s most populous state emerges as the latest epicenter of the U.S. outbreak. On Thursday, California reported a staggering 52,000 new cases in a single day—equal to what the entire U.S. was averaging in mid-October—and a one-day record of 379 deaths. More than 16,000 people are in the hospital with the coronavirus across the state, more than triple the number a month ago. Patients are being cared for at several overflow locations, including a former NBA arena in Sacramento, a former prison and a college gymnasium.

‘Unbelievable’ snowfall blankets parts of the Northeast (AP) The Northeast’s first whopper snowstorm of the season buried parts of upstate New York under more than 3 feet (1 meter) of snow, broke records in cities and towns across the region, and left plow drivers struggling to clear the roads as snow piled up at more than 4 inches (10 centimeters) per hour. “It was a very difficult, fast storm and it dropped an unbelievable amount of snow,” Tom Coppola, highway superintendent in charge of maintaining 100 miles (160 kilometers) of roads in the Albany suburb of Glenville, said Thursday. “It’s to the point where we’re having trouble pushing it with our plows.” The storm dropped 30 inches (76 centimeters) on Glenville between 1 a.m. and 6 a.m. Thursday, leaving a silent scene of snow-clad trees, buried cars and laden roofs when the sun finally peeked through at noon. Much of Pennsylvania saw accumulations in the double digits. Boston had more than 9 inches (23 centimeters) of snow early Thursday morning.

1 in 5 prisoners in the US has had COVID-19, 1,700 have died (AP) One in every five state and federal prisoners in the United States has tested positive for the coronavirus, a rate more than four times as high as the general population. In some states, more than half of prisoners have been infected, according to data collected by The Associated Press and The Marshall Project. As the pandemic enters its 10th month—and as the first Americans begin to receive a long-awaited COVID-19 vaccine—at least 275,000 prisoners have been infected, more than 1,700 have died and the spread of the virus behind bars shows no sign of slowing. New cases in prisons this week reached their highest level since testing began in the spring, far outstripping previous peaks in April and August. As the virus spreads largely unchecked behind bars, prisoners can’t social distance and are dependent on the state for their safety and well-being.

Shut down by corona, Berlin restaurant opens for homeless (AP) The coronavirus pandemic hasn’t made life on the streets of Berlin any easier for Kaspars Breidaks. For three months, the 43-year-old Latvian has faced homeless shelters operating at reduced capacity so that people can be kept at a safe distance from one another. And with fewer Berliners going outdoors, it’s much harder to raise money by panhandling or collecting bottles to sell for recycling. But on a chilly winter morning this week Breidaks found himself with a free hot meal and a place to warm up, after the German capital’s biggest restaurant, the Hofbraeu Berlin—itself closed down due to coronavirus lockdown restrictions—shifted gears to help the homeless. It was a clear win-win proposition, said Hofbraeu manager Bjoern Schwarz. As well as helping out the homeless during tough times the city-funded project also gives needed work to employees—and provides the restaurant with welcome income. In cooperation with the city and two welfare organizations, the restaurant quickly developed a concept to take in up to 150 homeless people in two shifts every day until the end of the winter, and started serving meals on Tuesday.

Japan: Snow traps 1,000 drivers in frozen traffic jam (BBC) Rescuers are trying to free more than 1,000 vehicles which have been stranded on a highway for two days after a heavy snow storm struck Japan. Authorities have distributed food, fuel and blankets to the drivers on the Kanetsu expressway, which connects the capital Tokyo to Niigata, in the north. The snow, which began on Wednesday evening, has caused multiple traffic jams along the road. Officials have been using a combination of heavy machinery and physical labour to dig out the vehicles one by one, but around 1,000 cars were still stranded on the road as of Friday noon.

‘Nightmare’ Australia Housing Lockdown Called Breach of Human Rights (NYT) The sudden lockdown this summer of nine public housing towers in Melbourne that left 3,000 people without adequate food and medication and access to fresh air during the city’s second coronavirus wave breached human rights laws, an investigation found. The report, released on Thursday by the ombudsman in the state of Victoria, of which Melbourne is the capital, said that the residents had been effectively placed under house arrest for 14 days in July without warning. It deprived them of essential supports, as well as access to activities like outdoor exercise, the report said. The lockdown was not “compatible with residents’ human rights, including their right to humane treatment when deprived of liberty,” Deborah Glass, the Victorian ombudsman, wrote. The report recommended the state government apologize publicly to tower residents, as well as improve relationships and procedures at similarly high-risk accommodations in the city so that they might be better prepared for future outbreaks. Though Australia has won global praise for successfully slowing the spread of the coronavirus in the country, the report was a scathing rebuke of state officials’ decision to apply stringent measures to the public housing residents, who said they felt trapped and traumatized and suspected discrimination. Several described it as a “nightmare.”

Fiji says two dead as powerful cyclone tears across Pacific nation (Reuters) A powerful cyclone pounded Fiji, killing two people and leaving a trail of destruction across the Pacific Island nation, authorities said on Friday. Cyclone Yasa, a top category five storm, made landfall over Bua province on the northern island of Vanua Levu on Thursday evening, bringing torrential rain, widespread flooding and winds of up to 285 km per hour (177 miles) across the archipelago. Scores of houses were destroyed, while power was cut to some areas and roads blocked by fallen trees and flash flooding, authorities said. Officials with the Red Cross said authorities were scrambling to help affected communities. Adverse weather has hampered efforts by aid groups to dispatch assistance, with waves of more than 3 metres (10 ft) preventing ships leaving Suva.

Radio stations may be the real “e-learning” revolution (Rest of World) The impact of a student’s socioeconomic status on their access to education during the pandemic is playing out globally, exposing just how closely tied internet access is to educational opportunity. In Sub-Saharan Africa, over 85% of households lack access to the internet at home and 89% of students do not have access to a computer outside of school. On the African continent, expensive and unreliable internet reaches only 40% of the population. Many governments, companies, and NGOs think that throwing millions of dollars behind providing tablets is the best way to improve the quality of education, but this impulse overlooks infrastructural issues like access to the internet, teacher training, and the cost of upkeep that students need to use the tablets in the first place. “Even if we did have a device for every student, they would have nowhere to charge them,” Reshma Patel, the executive director of Impact Network, a nonprofit that provides education for over 6,000 kids in rural Zambia through community schools, told Rest of World. Impact-run schools adapted radio lessons, since a majority of their students live in homes without electricity. Faced with the shutdown of the 43 schools she supervises, Patel relied on the “forgotten stepchild of tech interventions” to reach students: radio. On the continent, radio has long been a window to the external world. Shoeshoe Qhu works as the station manager at Voice of Wits 88.1 FM, a university radio station in Johannesburg, South Africa. She grew up in a mountainous village of 100 homesteads without electricity or running water. While there wasn’t television, there was radio. As long as her family had access to batteries and a receiver, it was free. “If you wanted to hear what was happening everywhere else, you could only get it through the radio,” Qhu said. “I grew up with radio, and it gave me access to the world,” she added. “It meant everything.”

Watch those passwords (NYT) Dutch hacker Victor Gevers claims to have logged in to President Trump’s Twitter account six years ago by guessing the password: “yourefired.” Then he did it again. On Oct. 16, Gevers, 44, made an accurate guess, “maga2020!,” on his fifth try, according to Dutch prosecutors. Hacking is a crime in the Netherlands. But on Wednesday, Dutch officials said they would not press charges because Gevers had met the bar for “responsible disclosure,” demonstrating how easy it could be to gain access to the U.S. president’s handle: @realdonaldtrump.

#headlines #news

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clearbrookmassachusetts · 2 years ago

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Pennsylvania Addiction Treatment: All You Need to Know About Clearbrook Treatment Centers

Pennsylvania Drug Rehab Centers Help Those Struggling With Addiction

Clearbrook Treatment Centers aims to help people struggling with addiction break the cycle and work on their recovery. For those who live in Pennsylvania, these drug rehab centers offer guidance and assistance to those working to regain control of their lives. The goal of the clinicians at these addiction treatment centers is to provide individuals with the skills they need for personal growth, sobriety, and long term recovery. The team uses Dialectical Behavioral Therapy, which is an evidence-based approach to helping people develop skills to cope with and manage their emotions effectively. It is designed to help individuals gain mindfulness, regulate emotions, and improve inter-personal relationships. Other therapies offered at the centers include Cognitive Behavioral Therapy, dual diagnosis treatment, and family therapy. The article lays out the following benefits that the center provides:

Assistance in developing a better understanding and awareness of addiction

Help in finding new ways to build healthy coping skills

Guidance on how to establish and maintain a healthy lifestyle

The addiction treatment centers provide a structured environment, which includes detoxification, medication management, and evidence-based therapeutic interventions. In addition, the centers provide individualized care to best suit the needs of each patient. The staff works around the clock in order to monitor patient progress and ensure that treatment practices are in line with their goals. In order to make sure patients receive the supportive atmosphere necessary in order to make sustainable progress in their recovery, the staff also manages recreational activities and outings. This helps to make sure that individuals are staying engaged in treatment and pursuing activities that help reinforce sobriety. The Pennsylvania drug rehab centers offer a safe and supportive environment for those looking to break free from the cycle of addiction. With the right combination of medication management, therapies, and recreational activities, patients will be able to make real progress in their recovery. If you or someone you know is struggling with addiction, Clearbrook Treatment Center is a great option to explore for drug rehabilitation. The dedicated staff is knowledgeable and experienced in managing addiction, and committed to helping patients succeed in their recovery.

#Drug Detox #Substance Abuse Treatment #Drug Rehab #Alcohol Rehab #Opiate Addiction

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theliberaltony · 5 years ago

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via Politics – FiveThirtyEight

The first time Bob Duffy entered the world of epidemiology, he was an amateur scientist. It was 2003. He had retired from the New York City Fire Department and taken a sabbatical from his normal life in suburban Long Island to help his daughter Meghan earn her Ph.D. in Michigan. She was studying the ecology and evolution of infectious diseases, using tiny lake crustaceans as a model organism.

Together, Meghan and Bob would go out in a truck, towing a little, flat-bottomed rowboat. They were studying how epidemics begin and spread under a variety of conditions. They’d unhitch at one lake, and then another, working their way across the countryside as they collected and counted diseased crustaceans and the fish that preyed on them. “Over the course of a few months, you can go through a whole epidemic,” Meghan Duffy told me. Her father was her paid research assistant, and one of his jobs was to catch the fish. After 30 years of running into burning buildings, he couldn’t believe his luck, she said.

The last time Bob Duffy entered the world of epidemiology, he was a statistic.

Bob Duffy was a father, grandfather, retired firefighter, and longtime volunteer in his Long Island community. He died on March 29.

COURTESY OF MEGHAN DUFFY

He died, at home, on March 29, 2020. Officially, the cause of death was chronic lung disease. But there was more going on than just that. A sudden illness had left him too fatigued to leave the house, and he had had contact with multiple people who later tested positive for COVID-19. Yet Bob’s death certificate doesn’t list that disease as a cause or even a probable cause of his death. He never got tested — he didn’t want to enter a hospital and be separated from Fran, his wife of 48 years.

Instead, because he didn’t die at a hospital and because this was at the beginning of the pandemic, when guidelines were rapidly changing and testing was hard to come by, Bob Duffy became one of the people who fell through the statistical cracks. As of this writing,1 22,843 New Yorkers have officially died from COVID-19. Bob Duffy is not counted among them.

More than a month later, the question of who counts as a COVID-19 fatality has become political. In Florida, the Medical Examiners Commission accused state officials of suppressing their state death count. Pennsylvania’s death tally bounced up and down, enough to prompt the state senate to discuss giving coroners a bigger role in investigating COVID-19 deaths. And President Trump has questioned the official national death count of 90,340 as of May 19,2 reportedly wondering whether it was exaggerated.

The experts who are involved in counting novel coronavirus deaths at all levels — from local hospitals to the Centers for Disease Control and Prevention — disagree with the president. If anything, they say, these deaths are undercounted. And with a death like Bob Duffy’s, you can begin to see why.

Bob was a person, beloved by his family and his community. Ever since he died, Bob has also become a number — data entered into a spreadsheet, just like the tiny shellfish he and his daughter once pulled from cold Michigan lakes. His death might never end up being attributed to SARS-CoV-2, but his death matters to the way we understand it.

There was never a cough. Instead, the first sign of illness Fran Duffy remembers was when she and Bob tried to go for a walk and he couldn’t make it to the end of the block. “We got three houses down, and he said, ‘I can’t walk today. I’m too tired.’ I thought maybe he’s getting a bug. Maybe he’s just tired. So we came back. That was Wednesday,” she said.

He died four days later.

It was a very fast decline. But in other ways, Bob’s final illness was just part of a long string of sicknesses. Over the two decades since his retirement, he had had a stroke. He also had had cancer in his mouth, colon and liver. There was scarring — fibrosis — that had damaged his lungs and forced him onto supplemental oxygen. The radiation treatments that had cured his cancers years ago had also left him with nerve damage in his legs and a slowly eroding jawbone. Bob was not the picture of health. We are, after all, talking about a guy who worked for the NYFD during a time when firefighters did not routinely wear the ventilators and masks they had been issued. It was a macho thing, Fran said. You couldn’t be the one guy who put on the mask if nobody else did.

So when Bob got sick in late March this year, whatever it was was not the only thing he was sick with. He was also so sick of being sick that he wasn’t interested in going to the hospital. Even as his temperature soared to 103 degrees, Bob chose to do a video chat with his family doctor, Ihor Magun, rather than leave the house. Fran remembers the doctor suggesting they treat Bob as if he was positive for COVID-19, in terms of isolation from friends and family. He could have gotten a test — but the nearest testing center at Jones Beach was 30 minutes away, and then there were the long lines besides. Fran thought about driving him out there, but he was already sick enough that that option seemed worse for him than not knowing what it was that he had contracted.

All those small decisions, made in the moment because of what was best for Bob, ended up determining how his death was recorded.

The way deaths are counted, like so much else in the U.S., differs among (and even within) states. There’s a lot of variation in this process, even on a good day — a fact that stretches all the way back to the beginning of mortality records in this country. While the census began counting living people nationwide in 1790, recording deaths was left up to state and local governments. The first state to fully document its deaths was Massachusetts, in 1842. It wasn’t until 1933 that all states were turning in death counts to federal authorities.

Even today, now that the death certificate itself is fairly standardized, who first records your death and decides what you died of varies by where you live and where you die. And that variation is only likely to increase when people begin dying of a new disease that we still don’t understand. In Milwaukee County, Wisconsin, for example, medical examiners — medical doctors who investigate deaths and perform autopsies — must provide official certification for every COVID-19 or COVID-19-related death in the county, said Dr. Sally Aiken, president of the National Association of Medical Examiners. But that’s not true everywhere. In New York State, medical examiners get involved only in cases that seem strange or suspicious, like when an otherwise healthy young person dies with no prior warning, said Richard Sullivan, president of the New York State Funeral Directors Association. Otherwise, the decision is left up to health care workers.

Bob’s death certificate was filled out by his family doctor and did not mention COVID-19. The county medical examiner called Fran but asked only about Bob’s preexisting conditions. He had had enough of them that there was no reason to suspect foul play, and that was all the medical examiner needed to know.

If Bob had died in a nearby hospital, such as one of the ones in Nassau County owned by Northwell Health, he would have been tested for COVID-19, either before or after his death. Whether he’d been there for five minutes or a month, hospital staff would have been in charge of filling out the part of his electronic death record that pertains to cause of death, a representative from Northwell told me. This process can look deceptively simple — just write a cause of death on the line — but there’s more to it than you’d think.

A standard certificate of death provided by the National Center for Health Statistics leaves room for the chain of events that led to someone’s death.

The New York electronic death records form provides three lines for cause of death, which are supposed to be filled out in a way that tells a story. The idea is that nobody ever really dies of just one thing, Aiken told me. Even if you die in a traffic accident, the death record might read something like “Blunt force trauma … as a consequence of a car crash.” This is the information that helps people further up the data chain classify a death accurately. Leaving any part of the story out means a gap in the data later.

Not everyone fills out these records completely, though. And early on during the COVID-19 pandemic, there was a lot of confusion happening, said Shawna Webster, executive director of the National Association for Public Health Statistics and Information Systems, which represents vital registrars nationwide. “It might just say ‘coronavirus,’ which I’m sure you know is not as descriptive as it needs to be,” she said. There are, after all, multiple ways COVID-19 might kill a person. On the other end of the spectrum are people who fill out the forms completely wrong. “Please do not put ‘COVID-19 test negative,'” Webster said. “Do not do that. There were several.”

In the days after his first symptoms, Bob’s condition worsened. He’d become so tired he couldn’t leave the house — then so tired that walking anywhere by himself was impossible. He had a massively high fever. But even Saturday, the night before he died, he was still talking, Fran said, and so she asked him what he wanted for dinner. She expected something light. Bob said, “Corned beef hash.”

“I said, ‘Bob, corned beef hash?'” But he was sure. So Fran put it together for him, the man she loved. She had to move him to a wheelchair and bring him to the kitchen to eat. He could no longer walk without falling. “I bring him to the kitchen and I’m just turning to the sink to wash my hands and I hear plop,” she said. He had fallen asleep at the table. “His head went right down in the plate. And I just said, ‘Bob. What about the corned beef hash!’ So it just … he thought about it and he wanted it, but he just couldn’t get it, you know?”

Doctors say this kind of oxygen depletion and exhaustion — coupled with an ability to still communicate — is a common feature of COVID-19. Even after he collapsed at the table, Bob was lucid enough to talk to the priest who gave him his last rites later that night. He died the next day.

Over the next few weeks, it would become clear that Bob had been in contact with a number of potential sources of COVID-19 — or maybe he’d been a source that passed it to them. It’s impossible to know. His son-in-law was later diagnosed with the disease, and his wife — one of Bob’s three daughters — tested positive for COVID-19 antibodies. One day Fran would open the newspaper to find that the woman who had cut her and Bob’s hair for three decades — and who had come to their house just before Bob got sick — had died of COVID-19.

But Bob’s death certificate makes no mention of the novel coronavirus. Bob’s doctor did not return requests for an interview, so we don’t know why he made the choices he did when completing the certificate. But Bob’s immediate cause of death is listed as “cardiopulmonary arrest” — his heart stopped — as a consequence of “chronic obstructive lung disease,” as a consequence of “fibrosis.”

Bob is a prime example of why doctors and other experts think that COVID-19 deaths are probably being undercounted — not overcounted, as some COVID-19 skeptics have alleged. In fact, if Bob had died today, there’s a decent chance that he’d have been labeled a “probable” COVID death, based on current CDC guidelines, which, among other things, advise doctors to include “probable COVID-19” on death certificates when a patient has had symptoms of the disease and been in contact with people who tested positive. Originally, only people who themselves had tested positive for the virus were being counted. Like Bob, a lot of people were probably left out. But even as the guidelines were revised and the national death count — which includes probable as well as confirmed cases — shot upward, experts said that undercounting was still more likely than overcounting.

COVID-19’s death toll has been so overwhelming that officials have had to resort to makeshift morgues in trailers.

TAYFUN COSKUN / ANADOLU AGENCY VIA GETTY IMAGES

Some of this reasoning is based on logic. We know that we had a widespread shortage of tests when people were already dying of COVID-19, so it makes sense that these two problems would overlap at times.

Other reasoning is based on data. In a lot of states the number of pneumonia deaths in March was higher than what you’d expect for that time of year, or for the level of influenza active during that time — an important detail, given that pneumonia can often be a complication of that disease as well. These increases were particularly noticeable in New Jersey, Georgia, Illinois, Washington and New York, according to research led by Dan Weinberger, a professor of epidemiology at Yale School of Medicine. But pneumonia isn’t the only way COVID-19 kills. All deaths in the state of New York went up in March, and these excess deaths — deaths above the usual rate for that place and time of year — outstrip diagnosed COVID-19 cases statewide by nearly three times. Data collected by The New York Times suggests that the high number of “excess” deaths in New York continued through April.

Yet another reason why experts say we’re not overcounting COVID-19 deaths is that we’re now counting them in much the same way as we have always counted deaths from infectious disease. The methodology is longstanding and is used for all sorts of diseases — and there’s never been cause to think that the methodology made us overcount the deaths from those other diseases.

In the bureaucracy of death everything happens fast, fast, fast, and then, after a while, things just grind on.

If you look at the CDC’s annual report of flu deaths, for example, you’ll see that it’s “estimated,” modeled on official flu deaths reported, deaths from flu-like causes reported, and what we know about flu epidemiology. The calculation is done this way precisely because public health officials know that a straight count of formally diagnosed flu deaths would be an undercount of actual flu deaths.

While flu tests aren’t in short supply and essentially anyone who wants to be tested for the flu can be, not everyone who catches it gets tested. Plenty of people get sick with the flu and never go to a doctor, said Alberto Marino, a research officer at the London School of Economics who has studied disease case and death counts for both LSE and the Organization for Economic Cooperation and Development. If they die — especially if they are also old or have some underlying condition — the role the flu played in their deaths can easily go unnoticed and unrecorded. We don’t record “probable” flu deaths (again, the tests aren’t rationed), but we do record deaths due to “flu-like illnesses” — and plenty of people who die from the flu don’t have that listed as the cause on their death certificates.

Likewise, when a doctor lists COVID-19 as a condition that led to someone’s death — even if it was just the last in a series of illnesses — they’re not doing anything different from what’s been done with the flu for years, Aiken told me.

Basically, if you think COVID-19 deaths are being inflated, then you shouldn’t trust annual flu death counts, either. Or a whole host of other death counts. The only reason to really think that COVID-19 death counts are less trustworthy at this point is that the flu is politically neutral while the new coronavirus is not.

If there’s any major difference between the way we count flu deaths and the way we count COVID-19 deaths, it’s that nobody is trying to publish flu deaths daily, in real time. And that’s where death counting for COVID-19 gets complicated.

When Bob Duffy died, his community responded immediately. Fran found her mailbox filled with cards; flowers and baked goods piled up on the porch. At one point, there were so many tulips, hydrangeas and pansies that the Amazon delivery guy started to make comments, so Fran decided to plant the flowers around the yard. “There’s not one card that doesn’t have a separate letter in it,” she said. And many were from people she didn’t even know.

Besides being a firefighter and Ph.D. assistant, Bob spent many years working with the local Catholic parish’s social ministry. Essentially, he was a volunteer social worker. He made sure people who were hungry found meals. He helped strangers pay their utility bills, and he coordinated a Long Island-wide food bank. “Most people volunteer one day a week. Bob officially volunteered five days a week,” Fran told me. “He ended up with the keys to the parish. He was up there seven days a week, and he couldn’t be stopped.”

So when he did stop, people cared. And they cared for his widow.

Bob Duffy’s family will never know for sure whether he died of COVID-19.

COURTESY OF MEGHAN DUFFY

Death happens suddenly, abruptly. At first, family, friends and, sometimes, if we’re lucky, strangers burst into action like Roman candles, sending out showers of casseroles and condolences like sparks. For a short period of time, there is a lot to do, decisions to be made, love to be accepted. But then there is quiet. And then there is the rest of your life. The absence that death leaves behind lasts far longer than the initial flurry of condolences.

The bureaucracy of death has a similar dynamic — first, everything happens fast, fast, fast, and then, after a while, things just grind on.

In New York, in the heady first day or two after a person dies, the doctor or hospital enters the cause of death on an electronic death record, the funeral home fills out demographic data on the same form, and the state registrar of vital statistics logs the data. But from there things slow down considerably.

Usually, that’s fine — death statistics aren’t so volatile that we need them to be updated as quickly as, say, election returns or live sports scores. But the pandemic has changed our relationship with these stats. Now they’re how we know whether we’re stopping the spread of COVID-19, and just how big that spread is. The problem is that the system isn’t designed to do that work.

Normally, if a death is uncomplicated and requires no investigation or autopsy or debate, death records are transferred to the National Center for Health Statistics, an arm of the CDC that organizes and analyzes the data of life and death in this country. It’s here that a death is categorized and tabulated. And this process is happening now, with COVID-19 deaths as well.

It takes time to investigate some of the deaths and get them to NCHS — the frequency of investigations varies widely, but state-level emergency operations teams work with medical personnel and state epidemiology surveillance to review COVID-19 deaths and possible COVID-19 deaths, Webster said. So the records can be in the state databases for a while before they’re solid enough that they go to NCHS. Then, someone at the NCHS is reading each of these death records to make sure that, say, a car crash victim who happened to have a COVID-19 diagnosis is logged in a database differently from a COVID-19-positive patient who died on a ventilator. The result of all this is that, even though public counts include confirmed COVID-19 deaths and probable ones, the deaths aren’t just being recorded willy-nilly. And it will be possible, in the future, to go back and look at the records and see which cases were confirmed by testing and which weren’t.

But these are slow stats. And they’re slowed down even further by the confusion caused by a novel virus pandemic. Currently, the count of COVID-19 deaths produced this way is at least two weeks behind, said Robert Anderson, chief of the mortality statistics branch of the NCHS. The counts in some states, including New York, might be lagging even more. This system is the gold standard, Webster said, but it’s designed to produce accurate statistics — not monitor a pandemic in real time.

Death is hard — hard to count, hard to experience.

And so the CDC also has fast stats on COVID-19 deaths. Besides going to the NCHS, the data from the New York State vital records office is also gathered directly from that agency’s database and into one maintained by USAFacts, a nonpartisan nonprofit organization charged with collecting daily death reports from the state and county registrars that first record them. The CDC’s COVID Data Tracker comes directly from the USAFacts count.

That means there are two distinct death counts being published by the CDC — one slow, one fast. (That’s in addition to counts being kept by Johns Hopkins University, The New York Times, and other entities.) As of May 19, the CDC’s slow count was 67,008, and its fast count was 90,340. You’ll find both counts in various sections of the CDC’s website, and when you look at those pages, it’s not always clear what these separate counts do and don’t represent. It’s easy to get confused and assume that the death count you’ve just seen in the newspaper has suddenly been cut in half. On May 2, conservative firebrand Dinesh D’Souza falsely claimed exactly that, linking his followers to the CDC’s slow count.

The smaller, slow count is more accurate, but it doesn’t reflect how many people have died as of today. It’s weeks behind. The fast count does a better job of portraying the real-time situation, but the exact number will shift as state and local counts fluctuate. Some of that change is due to confusion between state and local entities. New York City, for example, has its own vital records office — almost as though it’s an independent state — and the fast-count numbers it produces for itself don’t usually match the fast-count numbers produced for it by the State of New York, said Tanveer Ali, a data visualization analyst for USAFacts.

And while Bob Duffy will not be counted in either the slow or the fast counts happening now, he will likely end up included in the data — if only by algorithmic proxy. Eventually, experts said, the CDC will come back and do an estimated burden of death counts for COVID-19, just as it does for the flu every year.

All of this is why we won’t know the exact number of people who died of COVID-19 for years, Aiken said. Again, that’s nothing new. Final estimates for the number of people who died in the 2009 H1N1 pandemic weren’t published until 2011. Getting the slow count right, sorting through differences between disparate and nonstandardized state reporting systems, correcting errors and categorizing probable cases, finding ways to understand how many Bob Duffys we’re missing — it all takes time. This is, experts emphasized again and again, something nobody has ever done before. But the precedent that does exist suggests we shouldn’t expect to get a “right” answer soon. “If you look at opioid mortality, they’re two and a half years behind on compiling that,” Aiken said.

Death is hard — hard to count, hard to experience. The personal and the statistical both reside in a space where the question of “what happened” can be answered as an absolute — as certain as we can ever be about a thing — while simultaneously remaining painfully inexact and mysterious.

We will almost certainly never know exactly how many Americans died of COVID-19. But any count we get by leaving out deaths probably related to the virus — and, ultimately, leaving out Bob and a lot of people like him — will be less accurate than a count that includes them.

“We like to have answers. We like to have a yes, a no, a definite answer,” Fran said. Bob had been dead for about a month when Fran spoke to me from her kitchen. Just that day, someone she didn’t know had sympathetically left a loaf of banana bread in her mailbox. He was still so close. He was so far away. “But we certainly don’t always get what we like,” she said. “That’s really the truth, you know?”

Additional reporting by Kaleigh Rogers.

#IFTTT #Politics – FiveThirtyEight #politics #538 #Maggie Koerth

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floramyecbd-blog · 5 years ago

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Does CBD Help

The CBD industry is flourishing, conservatively projected to strike $16 billion in the United States by 2025. Already, the plant extract is being added to cheeseburgers, toothpicks and breath sprays. More than 60 percent of CBD users have taken it for anxiety, according to a study of 5,000 individuals, conducted by the Brightfield Group, a cannabis marketing research firm. Persistent discomfort, sleeping disorders and depression follow behind. Kim Kardashian West, for instance, relied on the product when "going crazy" over the birth of her 4th baby. The professional golfer Bubba Watson drifts off to sleep with it. And Martha Stewart's French bulldog engages, too.

What is CBD? Cannabidiol, or CBD, is the lesser-known child of the cannabis sativa plant; its more famous brother or sister, tetrahydrocannabinol, or THC, is the active ingredient in pot that catapults users' "high." With roots in Central Asia, the plant is believed to have actually been initially utilized medicinally-- or for routines-- around 750 B.C., though there are other quotes too.

Cannabidiol and THC are simply 2 of the plant's more than 100 cannabinoids. THC is psychoactive, and CBD Elixir may or might not be, which refers argument. THC can increase anxiety; it is unclear what effect CBD is having, if any, in lowering it. THC can result in dependency and cravings; CBD is being studied to assist those in healing. Marijuana including 0.3 percent or less of THC is hemp. Although in 2015's Farm Costs legalized hemp under federal law, it also preserved the Fda's oversight of products originated from cannabis.

What are the claims? CBD is marketed as providing relief for stress and anxiety, anxiety and trauma. It is likewise marketed to promote sleep. Part of CBD's popularity is that it professes to be "nonpsychoactive," which consumers can reap health gain from the plant without the high (or the midnight pizza munchies).

Just as hemp seedlings are growing up throughout the United States, so is the marketing. From oils and nasal sprays to lollipops and suppositories, it seems no location is too sacred for CBD. "It's the monster that has actually taken over the space," Dr. Brad Ingram, an associate teacher of pediatrics at the University of Mississippi Medical Center, stated about all the wild usages for CBD now. He is leading a scientific trial into administering CBD to kids and teens with drug-resistant epilepsy.

Does CBD work? " It's appealing in a lot of various restorative opportunities due to the fact that it's fairly safe," said James MacKillop, co-director of McMaster University's Michael G. DeGroote Center for Medicinal Cannabis Research Study in Hamilton, Ontario.

Last year, the F.D.A. authorized Epidiolex, a purified CBD Elixir extract, to treat unusual seizure disorders in clients 2 years or older after three randomized, double-blind and placebo-controlled medical trials with 516 clients that showed the drug, brought with other medications, assisted to decrease seizures. These kinds of studies are the gold requirement in medication, in which individuals are divided by possibility, and neither the subject nor the detective understands which group is taking the placebo or the medication.

While there is hope for treating other conditions with the plant extract, Epidiolex remains the only CBD-derived drug approved by the F.D.A. Most of the research study on cannabidiol has been in animals, and its current popularity has outpaced science. "We do not have the 101 course on CBD quite determined yet," said Ryan Vandrey, an associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine.

Does CBD help anxiety and PTSD? For students with generalized social stress and anxiety, a four-minute talk, with very little time to prepare, can be disabling. Yet a small experiment in the journal Neuropsychopharmacology found that CBD appeared to minimize uneasiness and cognitive disability in clients with social anxiety in a simulated public speaking job.

Nevertheless, a double-blind study discovered healthy volunteers administered CBD had little to no change in their emotional reaction to unpleasant images or words, compared to the placebo group. "If it's a soothing drug, it ought to alter their reactions to the stimuli," stated Harriet de Wit, co-author of the research study and a teacher in the University of Chicago's department of psychiatry and behavioral neuroscience. "However it didn't.".

Numerous soldiers return house haunted by war and PTSD and typically prevent certain activities, places or people associated with their distressing events. The Department of Veterans Affairs is moneying its first research study on CBD, pairing it with psychiatric therapy.

" Our top therapies attempt to break the association in between tips of the injury and the worry reaction," stated Mallory Loflin, an assistant adjunct teacher at the University of California, San Diego and the research study's primary private investigator. "We think that CBD, at least in animal designs, can assist that procedure occur a lot much faster." While large clinical trials are underway, psychologists say there isn't compelling evidence yet as to whether this is a feasible treatment.

Does CBD help sleep and anxiety? Up in the wee hours of the night, stuck seeing videos of puppies? CBD may be appealing as a sleep help; one of the negative effects of the Epidiolex trials for epilepsy was sleepiness, according to Mr. MacKillop, a co-author of an evaluation on cannabinoids and sleep. "If you are trying to find brand-new treatments for sleep, that might be a hint," he said. But he cautions that the side effects could have been because of an interaction with other medications the children were requiring to manage the seizures. So far, there hasn't been a randomized, placebo-controlled, double-blind trial (the gold standard) on sleep disorders and CBD.

[Stressed-out moms and dads are offering it a shot.] A current chart evaluation of 72 psychiatric patients treated with CBD discovered that stress and anxiety improved, but not sleep. "Over all, we did not find that it worked out as a beneficial treatment for sleep," stated Dr. Scott Shannon, assistant scientific teacher of psychiatry at the University of Colorado, Denver and the lead author of the evaluation in The Permanente Journal.

Sleep can be interrupted for numerous reasons, including depression. Rodents appeared to adapt better to demanding conditions and displayed less depressive-like behavior after taking CBD, according to a review in Journal of Chemical Neuroanatomy. "Remarkably, CBD seems to act faster than conventional antidepressants," wrote one of the authors of a new evaluation, Sâmia Joca, a fellow at the Aarhus Institute of Advanced Studies in Denmark and an associate professor at the University of São Paulo in Brazil, in an e-mail interview. Obviously, it's tough to spot anxiety in animals, but the studies that Ms. Joca and her coworkers reviewed suggested that in models of persistent stress direct exposure, the mice and rats treated with CBD were more durable.

However without clinical trials in people, psychologists state CBD's result on anxiety is still a hypothesis and not an evidence-based treatment.

Is CBD harmful? " If you take pure CBD, it's pretty safe," stated Marcel Bonn-Miller, an adjunct assistant teacher at the University of Pennsylvania's Perelman School of Medication. Negative effects in the Epidiolex trial consisted of diarrhea, drowsiness, tiredness, weak point, rash, reduced appetite and raised liver enzymes. Likewise, the safe total up to consume in a day, or at all throughout pregnancy, is still not understood. Recently, the F.D.A. sent a caution letter to Curaleaf Inc. about its "unsubstantiated claims" that the plant extract deals with a variety of conditions from family pet anxiety and anxiety to cancer and opioid withdrawal. (In a statement, the company stated that some of the items in question had actually been discontinued and that it was working with the F.D.A.).

Dr. Smita Das, chair of the American Psychiatric Association's Council on Dependency Psychiatry's cannabis work group, does not recommend CBD for stress and anxiety, PTSD, sleep or anxiety. With clients turning to these to unproven items, she is fretted that they may postpone looking for suitable psychological healthcare: "I'm dually worried about how exposure to CBD products can lead somebody into continuing to marijuana products.".

Some CBD products might include undesirable surprises. Forensic toxicologists at Virginia Commonwealth University analyzed nine e-liquids marketed as being one hundred percent natural CBD extracts. They discovered one with dextromethorphan, or DXM, used in over-the counter cough medications and thought about addictive when abused; and 4 with a synthetic cannabinoid, often called Spice, that can trigger stress and anxiety, psychosis, tachycardia and death, according to a research study in 2015 in Forensic Science International.

Earlier research study found fewer than a 3rd of 84 items studied included the amount of CBD on their labels. Some users of CBD have actually likewise failed drug tests when the product included more THC than suggested.

This year, 1,090 people have actually gotten in touch with poison control focuses about CBD, according to the American Association of Toxin Control Centers. Over a third are approximated to have gotten medical attention, and 46 were admitted into an important care system, possibly because of exposure to other items, or drug interactions. In addition, issue over 318 animals poured into the American Society for the Avoidance of Cruelty to Animals' Animal Poison Control Center.

Is CBD a fraud or not? A few drops of CBD oil in a mocha or healthy smoothie are not likely to do anything, researchers contend. Physicians say another force may also be at play in individuals feeling good: the placebo result. That's when somebody believes a drug is working and symptoms appear to improve.

" CBD is not a fraud," stated Yasmin Hurd, director of the Addiction Institute of Mount Sinai in New York City who led a double-blind study of 42 recovering heroin addicts and found that CBD reduced both yearnings and cue-based stress and anxiety, both of which can cycle individuals back into utilizing. "It has a possible medicinal value, however when we are putting it into mascara and putting it into tampons, for God's sake, to me, that's a fraud.".

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