#Medicines and Healthcare

[swapnamakro]

AI's Role in Medical Device Certification: Challenges Ahead

As AI continues to revolutionize healthcare, its impact on medical device certification is profound. While AI can streamline processes and improve accuracy, regulatory challenges persist. Certifying AI-driven devices requires navigating complex standards, ensuring safety, and addressing transparency concerns. Overcoming these hurdles is key to unlocking AI's full potential in medical technology.

For more info: https://www.vistaar.ai/blog/the-impact-of-ai-on-medical-device-technology-and-certification/

[mysharona1987]

Gee, I thought these people were the ones who were like “If you don’t like it, you can just move to a blue state.”

And now they’re mad the guy is doing just that?

You can’t oppress and discriminate against someone then be mad when they take their highly useful skill elsewhere.

[reasonsforhope]

A new treatment combining ReCET and semaglutide could eliminate the need for insulin in type 2 diabetes, with 86% of participants in a study no longer requiring insulin therapy. The treatment was safe and well-tolerated, and further trials are planned to confirm these results.

Groundbreaking research presented at UEG Week 2024 introduces a promising new treatment approach for type 2 diabetes (T2D) that has the potential to greatly reduce or even eliminate the need for insulin therapy.

This innovative approach, which combines a novel procedure known as ReCET (Re-Cellularization via Electroporation Therapy) with semaglutide, resulted in the elimination of insulin therapy for 86% of patients.

Globally, T2D affects 422 million people... While insulin therapy is commonly used to manage blood sugar levels in T2D patients, it can result in side effects... and further complicate diabetes management. [Note: Also very importantly it's fucking bankrupting people who need it!!] A need therefore exists for alternative treatment strategies.

Study Design and Outcomes

The first-in-human study included 14 participants aged 28 to 75 years, with body mass indices ranging from 24 to 40 kg/m². Each participant underwent the ReCET procedure under deep sedation, a treatment intended to improve the body’s sensitivity to its own insulin. Following the procedure, participants adhered to a two-week isocaloric liquid diet, after which semaglutide was gradually titrated up to 1mg/week.

Remarkably, at the 6- and 12-month follow-up, 86% of participants (12 out of 14) no longer required insulin therapy, and this success continued through the 24-month follow-up. In these cases, all patients maintained glycaemic control, with HbA1c levels remaining below 7.5%.

Tolerability and Safety

The maximum dose of semaglutide was well-tolerated by 93% of participants, one individual could not increase to the maximum dose due to nausea. All patients successfully completed the ReCET procedure, and no serious adverse effects were reported.

Dr Celine Busch, lead author of the study, commented, “These findings are very encouraging, suggesting that ReCET is a safe and feasible procedure that, when combined with semaglutide, can effectively eliminate the need for insulin therapy.”

“Unlike drug therapy, which requires daily medication adherence, ReCET is compliance-free [meaning: you don't have to take it every day], addressing the critical issue of ongoing patient adherence in the management of T2D. In addition, the treatment is disease-modifying: it improves the patient’s sensitivity to their own (endogenous) insulin, tackling the root cause of the disease, as opposed to currently available drug therapies, that are at best disease-controlling.”

Looking ahead, the researchers plan to conduct larger randomized controlled trials to further validate these findings. Dr. Busch added, “We are currently conducting the EMINENT-2 trial with the same inclusion and exclusion criteria and administration of semaglutide, but with either a sham procedure or ReCET. This study will also include mechanistic assessments to evaluate the underlying mechanism of ReCET.”

-via SciTechDaily, October 17, 2024

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Note: If it works even half as well as suggested, this could free so many people from the burden of the ongoing ridiculous cost of insulin. Pharma companies that make insulin can go choke (hopefully).

[starlightshadowsworld]

In healthcare, you'll find that a lot of words and phrases that are most commonly used become acronyms.

Such as CPR and PRN.

In Gaza they have one called WCNSF.

It stands for, wounded child no surviving family.

For that to be made into an acronym... It's telling of how many times that phrase is said and documented.

Israel is inacting a genocide on the Palestinian people, on a population that is 50% children.

Children who are losing everything.

[floral-ashes]

🚨 Important new article on gender self-determination as a medical right in CMAJ! I argue that people have a right to gender-affirming care and that many common barriers aren’t justified by evidence. Trans health needs to centre human rights more! 🏳️‍⚧️

(Audio version.)

[taibhsearachd]

Very cool that in the US I have a problem with my ankle that's been ongoing for a year... on real bad days I can feel something in my foot grinding or clicking over something... and I gotta clear this with my insurance before I can get a test that will diagnose this problem I've been having for a year. Extra cool that I have to wait for the time of year when you're allowed to switch insurance providers, bc I want to negotiate with the new insurance providers vs the old ones about whether they should X-Ray my ankle that doesn't work.

[ayaahh00]

The world of medicine is deeply patriarchal, with so many biases against women both as patients and healthcare providers. Statistics reveal that women are 32% more likely to die during surgery when a male surgeon is performing, and they often face dismissal in emergency rooms compared to male patients. While having 15% higher chances of survival if a female surgeon performed the surgery. Also, some medical schools in the US allow male students to perform pelvic exams on unconscious women without consent, with male doctors claiming they don’t want to risk a “no.” This reduces women to mere subjects for study, stripping away our autonomy and dignity, a pure violation of our bodies.

Female doctors also face a lot of systemic barriers. For instance, my colleague’s mom, a leading cardiologist in Ontario, faced attacks after reporting a male physician for sexual misconduct. Instead of support, she was punished by losing her ability to perform CCTA, medicine men protect one another at the expense of women’s careers. While 90% of new gynecology graduates are women, there are still men who feel entitled to this field. It’s crucial to remember medicine’s long history of bias and misogyny including the dismissal of women’s health issues as “female hysteria.” As women continue to prove their capabilities as doctors, it’s time for the medical system to reflect that truth and prioritize women’s health and leadership first.

[taviamoth]

Fundraiser for fashion designer Leena Sobieh's nephew to leave Gaza and continue his medical studies in Egypt. Please share and donate if you can.

[feminist-space]

"Physicians have a history of antagonism to the idea that they themselves might present a health risk to their patients. Famously, when Hungarian physician Ignaz Semmelweis originally proposed handwashing as a measure to reduce purpureal fever, he was met with ridicule and ostracized from the profession.

Physicians were also historically reluctant to adopt new practices to protect not only patients but also physicians themselves against infection in the midst of the AIDS epidemic. In 1985, the CDC presented its guidance on workplace transmission, instructing physicians to provide care, “regardless of whether HCWs [health care workers] or patients are known to be infected with HTLV-III/LAV [human T-lymphotropic virus type III/lymphadenopathy-associated virus] or HBV [hepatitis B virus].”

These CDC guidelines offered universal precautions, common-sense, nonstigmatizing, standardized methods to reduce infection. Yet, some physicians bristled at the idea that they need to take simple, universal public health steps to prevent transmission, even in cases in which infectivity is unknown, and instead advocated for a medicalized approach: testing or masking only in cases when a patient is known to be infected. Such an individualized medicalized approach fails to meet the public health needs of the moment."

[macgyvermedical]

Harm Reduction Ideas for Substance Use Disorder

Recently I have been listening to a podcast called The Curbsiders Addiction Medicine. If you are a clinician that works even sometimes with people who use substances (every clinician ever), it is a fantastic look at all the harm reduction practices you can use to make these individuals safer. Plus, you get free CME.

I’m hardly going to do the podcast itself justice with this post, but I wanted to share some things I learned from it:

If the dangers of using substances (social and legal consequences, time commitment, health problems, money problems, etc…) was a deterrent, people wouldn’t be doing it. But it’s not. Because uncontrolled substance use is a chronic disease that generally does not get better without treatment. When people are treated, not only do they generally use less, but they have a much lower chance of death and a much higher chance of a happy, productive life- whatever that means for the patient.

Previously (even a few years ago) we hung such treatment on the requirement that people be abstinent from substances in order to receive help. This works for some people, but far from everyone.

The evidence shows that best thing we can do for many individuals is to make their use safer and less of a burden on their life and health. This is called harm reduction, and it WORKS.

Here are some evidence-based ideas for how to help your patients:

Create a space where you are working together with your patient and following your patient’s lead. Do they want to become abstinent? Great! Do they want to use less or use in a more controlled way? Also great! Do they want to continue use in a safer way? You guessed it, also great! Support them in whatever their goal is

Provide or prescribe safe, clean tools of use. Things like clean needles, Pyrex pipes, and straws. This decreases rates of infection and abscesses

Prescribe medications that reduce cravings or reduce/eliminate withdrawal (methadone, buprenorphine, topiramate, bupropion, naltrexone) without requiring abstinence

Teach people safer use practices and safer routes, such as rectal (booty bumping) or oral (parachuting) instead of injection drug use

Prescribe PrEP if people are at risk of HIV without requiring abstinence

Test for and treat the consequences of substance use (such as HIV and Hep C) without requiring abstinence

Provide fentanyl and xylazine test strips so people know what is in the substances they are using and can adjust doses/use pattern accordingly

Recommend Never Use Alone hotlines to prevent overdose death or better yet, take turns using with a buddy

Prescribe naloxone to anyone who uses any substance- nearly all street drugs are contaminated with synthetic opioids and naloxone is an effective way to prevent deaths

People use substances for a reason, especially early in their journey- pain, coping with depression/other mental illness, ADHD, and social issues like being unhoused. Treat the problem if you can find it, and you can help people significantly decrease use or use in a more controlled way

Be aware that return to use (or return to uncontrolled use) is a thing you can plan for with the patient and manage before it even happens

It’s hard sometimes to change the idea of addiction/substance use disorder as something that can only be treated as a reward for staying sober. But thats why so few people seek treatment for it. The evidence does not equivocate. Harm reduction WORKS.

[swapnamakro]

MHRA Guidelines on AI/ML Medical Device Transparency

The MHRA has released new guidelines addressing transparency and performance standards for AI/ML-based medical devices. These updates aim to enhance patient safety, ensure device reliability, and provide clear regulatory pathways for developers. Understanding these changes is critical for aligning with compliance and improving device performance in real-world settings.

For more info: https://www.vistaar.ai/blog/mhra-issues-transparency-for-machine-learning-and-medical-devices/

[mostly-funnytwittertweets]

[reasonsforhope]

THANK FUCKING GOD

"The Supreme Court on Thursday [June 13, 2024] unanimously preserved access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion decision since conservative justices overturned Roe v. Wade two years ago.

The nine justices ruled that abortion opponents lacked the legal right to sue over the federal Food and Drug Administration’s approval of the medication, mifepristone, and the FDA’s subsequent actions to ease access to it. The case had threatened to restrict access to mifepristone across the country, including in states where abortion remains legal.

Abortion is banned at all stages of pregnancy in 14 states, and after about six weeks of pregnancy in three others, often before women realize they’re pregnant.

Justice Brett Kavanaugh, who was part of the majority to overturn Roe, wrote for the court on Thursday that “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”

The opinion underscored the stakes of the 2024 election and the possibility that an FDA commissioner appointed by Republican Donald Trump, if he wins the White House, could consider tightening access to mifepristone, including prohibiting sending it through the mail...

Kavanaugh’s opinion managed to unite a court deeply divided over abortion and many other divisive social issues by employing a minimalist approach that focused solely on the technical legal issue of standing and reached no judgment about the FDA’s actions...

While praising the decision, President Joe Biden signaled Democrats will continue to campaign heavily on abortion ahead of the November elections. “It does not change the fact that the right for a woman to get the treatment she needs is imperiled if not impossible in many states,” Biden said in a statement...

About two-thirds of U.S. adults oppose banning the use of mifepristone, or medication abortion, nationwide, according to a KFF poll conducted in February. About one-third would support a nationwide ban...

More than 6 million people [in the U.S.] have used mifepristone since 2000. Mifepristone blocks the hormone progesterone and primes the uterus to respond to the contraction-causing effect of a second drug, misoprostol. The two-drug regimen has been used to end a pregnancy through 10 weeks gestation...

Biden’s administration and drug manufacturers had warned that siding with abortion opponents in this case could [have] undermined the FDA’s drug approval process beyond the abortion context by inviting judges to second-guess the agency’s scientific judgments. The Democratic administration and New York-based Danco Laboratories, which makes mifepristone, argued that the drug is among the safest the FDA has ever approved."

-via AP, June 13, 2024

--

Note: A massive relief and a genuine victory - this will preserve access to the medication used in 2/3rds of abortions last year, for at least another 2 years. (Probably minimum time it will take Republicans to get their next attempt before the Supreme Court.)

Still, with this, a sword that has been hanging over our heads for the last two years is gone. There will be a new one soon, but we just bought ourselves probably at least 2 years. The fight isn't over, but this is absolutely worth celebrating.

[atavist]

An ob-gyn in Virginia performed unnecessary surgeries on patients for decades. He took their reproductive organs, gave them false cancer diagnoses, and did other terrible harm. When his victims learned the truth, they fought back. Issue no. 146, DAMAGES, is now available: 

[Debra] requested her medical records and was stunned to find discrepancies with what Perwaiz had said to her during appointments. Most glaringly, she didn’t see any mention of precancerous cells on her cervix; the tests Perwaiz performed on her had come back normal. “If I was normal,” Debra said, “why did I have a surgery?”

There were other inconsistencies. One form from an appointment described Debra complaining of back and pelvic pain, which she told me she never did. Another document dated the day before her surgery stated that she “insisted on having those ovaries removed through the abdominal wall incision and not vaginally,” and that the “consent obtained after entirely counseling the patient [was] for abdominal hysterectomy.” In fact, she had requested the opposite surgical approach, and she recalled no such conversation with Perwaiz; the only time she’d spoken with him in the lead-up to her procedure was in passing in the hospital hallway.

Debra was sure she had a malpractice case. She went to several lawyers, but none of them would take her on as a client. “So many men—man after man saying, ‘You had a decent amount of care, and that’s all you’re afforded,’ ” she said. Frustrated, she came up with a new plan: “I said, ‘Alright, I’m going to learn how to sue this bastard myself.’ ”

[memories-of-ancients]

Roman surgical kit, 1st-2nd century AD

from The John Hopkins University Archaeological Museum

[floral-ashes]

Our paper on randomized-controlled trials in trans healthcare was just assigned an issue. Read to learn more about levels of evidence and why RCTs aren’t actually good quality evidence for gender-affirming care!

Read here: https://www.tandfonline.com/doi/full/10.1080/26895269.2023.2218357