February 4, 2024: Wegovy shortages; CPAP device discontinued; Adulhelm no more; polarizing topic of gender affirming meds; psychiatry drugs prediction; pharma exposé book; more
Wegovy Weight Loss Drug Shortage
Four out of five dose strengths of GLP-1 weight loss drug Wegovy remain in shortage in the United States, but Novo Nordisk plans to more than double supplies of the lower dose strengths of the drug in the United States in the next few months.
https://news.yahoo.com/novo-nordisk-more-double-u-074637194.html
FDA Drug Shortage Database listing for semaglutide injection
ASHP (American Society of Health Systems Pharmacists) Drug Shortage Database
Global shortages of Glp-1 diabetes and weight loss drugs have led to an increase in counterfeit products. Reports of hypoglycemia have been linked to the fake drugs.
https://www.reuters.com/business/healthcare-pharmaceuticals/rise-reports-fake-weight-loss-drugs-linked-shortage-real-thing-who-says-2024-01-29/
Read Wegovy reviews at Ask a Patient
Drug & Device Discontinuations
Amidst a safety recall of millions of sleep apnea (or CPAP) devices that began in 2021, Philips has announced that as part of a tentative consent decree with the FDA, it will stop selling CPAP devices in the U.S.
https://www.usatoday.com/story/news/health/2024/01/29/philips-sleep-apnea-recall/72400759007/
Biogen is discontinuing its controversial Alzheimer's disease drug Aduhelm (aducanumab) and will focus on promoting its other Alzheimer's drug Leqembi, which it co-sponsors with Eisai. Both drugs aim to reduce the amount of amaloid plaque in the brain, which is thought to contribute to development of the disease. Leqembi performed better in clinical trials than Aduhelm. An FDA advisory committee had advised against Aduhelm's approval, but the FDA approved it anyway. So far, 800 patients in the U.S. have received doses of Leqembi.
https://www.forbes.com/sites/joshuacohen/2024/02/01/alzheimers-drug-aduhelm-went-from-being-hailed-a-game-changer-to-becoming-a-dud/
More on Leqembi from AskaPatient Health News:
https://askapatientnews.substack.com/p/july-9-2023-alzheimers-leqembi-lecanemab
Human-Brain Trial by Neuralink Begins
Elon Musk announced that the first person has been implanted with the Neuralink brain chip as part of its clinical trial and is "recovering well." Although the trial was approved by the FDA in May 2023, it is not registered in the Clinical Trials database, so we know very little about it. (Read about other brain-computer interface experiments for speech and movement in our newsletter.)
https://www.popsci.com/technology/neuralink-first-human-trial/
FTC to Crack Down on Patent Holders
The Federal Trade Commission is now aggressively trying to rein in the pharmaceutical industry by scrutinizing patents reporting. The first effort challenges listings of more than 100 patents held by manufacturers of asthma and other inhalers, epinephrine autoinjectors, and Restasis MultiDose bottles. The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.
https://kffhealthnews.org/news/article/federal-trade-commission-fda-orange-book-drug-patents-epipen/
New Drug Features from MedShadow Foundation
Have you considered taking a pill for hair loss? Check out MedShadow's explanation of finasteride side effects (Propecia brand name), approved for males to treat hair loss.
https://medshadow.org/the-price-of-propecia-side-effects-of-the-hair-loss-drug/
Check out patient ratings of Propecia (finasteride) on Ask a Patient
Overwhelmed by all the positive and negative news about new semaglutide weight loss/diabetes drugs? Visit MedShadow's side effect tracker page to keep track of all of the studies. They will be updating the article regularly as more information comes out about benefits and side effects.
https://medshadow.org/weight-loss-drugs-a-side-effect-tracker/
Puberty blockers and Cross-Sex Hormones
Independent health journalist Joshua Cohen investigated the topic of access to gender-affirming care for minors in the U.S. and Europe. So far, twenty-two states have passed bans on the use of cross-sex hormones (such as off-label use of estradiol or testosterone), puberty blockers (such as off-label use of Lupron) and sex-change surgery in minors. He writes "In the U.S., the discussion on trans care for youth is polarized, with dueling diametrically opposed viewpoints. It’s either provide access to a full set of services (hormone blockers, cross-sex hormones, and surgery) without reservation and cite existing evidence as if it’s settled science, or prohibit those services entirely." Cohen says that in Europe, the debate is much more fact-based, with an increasing number of countries adopting a more cautious approach and demanding systematic reviews of evidence to determine the benefits and risks of puberty blockers and cross-sex hormones.
https://www.forbes.com/sites/joshuacohen/2023/12/02/europe-and-us-diverge-on-treatment-of-gender-incongruence-in-minors/
Cohen also reports that the Food and Drug Administration may consider approval of the cross-sex hormone estradiol for gender-affirming care for adults and minors based only on an observational study.
https://www.forbes.com/sites/joshuacohen/2023/12/02/without-rct-fda-may-consider-approval-of-a-cross-sex-hormone-for-gender-affirming-care/
Recommended Reading: "Big Food, Big Pharma, Big Lies"
An exposé by investigative health reporter Martha Rosenberg, originally written in 2012 and updated as a second edition late in 2023, provides history and insight into the dangerous marketing practices within the pharmaceutical ("Big Pharma) and agriculture ("Big Food") industries.
Chapter one provides a brief history of drug advertising, beginning with print ads in medical journals in the 1950s through the 1970s. Rosenberg presents samples of vintage ads (some hilarious) that appeared in JAMA and Psychosomatic Medicine (see example below of Serpasil ad). In 1997, the first direct-to-consumer commercial made its debut on U.S. television: an ad for allergy drug Claritin appeared during an episode of “Touched By an Angel.” From there, a new era of marketing drugs was born, and by 2006, the pharmaceutical industry was spending $5.5 billion a year on direct-to-consumer advertising.
Other chapters in Section One focus on the marketing of psychiatric drugs, hormonal therapy, and bone drugs. Veteran suicides linked to antipsychotic drugs and bone injuries caused by bisphosphonates are examined.
The other half of the book focuses on food, including health consequences of using antibiotics and growth hormones in meat and dairy animals. A chapter called, "The Drugstore in Your Meat" reveals that hormones used routinely in the U.S. meat supply are banned in Europe.
One reviewer on Amazon/GoodReads says: “Those who wish to know the real lowdown on how companies treat humans and animals in less than ethical ways will not be disappointed. It comes across akin to a Frontline PBS episode!”
Available from many book retailers, including Amazon. Big Food, Big Pharma, Big Lies: Exposing the Dangers Within the Pharmaceutical and Agriculture Industries (Published by Prometheus Books, 2nd edition 2023, originally published in 2012.)
https://www.amazon.com/Big-Food-Pharma-Lies
Example of vintage advertisement included in the book:
Perspectives on Psychiatric Medicine
Psychiatrist Martin Greenwald, M.D., writer of Socratic Psychiatrist, responded to a reader asking, "any hot pharmacological takes?” Here are his (off the top of his head) takes:
(1) Ketamine is overhyped and won't be the great treatment for depression (and whatever else) we’re hoping for.
(2) Some substantial part of the controversy surrounding SSRI efficacy for depression is that we call way too many things “depression”. There are plenty of ways to be sad, unhappy, unmotivated, and feel that life sucks, all while not being depressed, and in my experience SSRIs tend not to help with that kind of misery very much.
(3) The amount of amphetamines we’re currently prescribing is unsustainable and at some point we’re going to figure out how to get millions of people off this stuff. We will also have to realize that not having the attention, concentration, and energy that you want isn’t “having ADHD”; it is to some significant extent a function of living in a world we were not evolved to live in.
What’s Old is New Again: Low Dose Aspirin
People's Pharmacy reports on some recent studies that are bad news for those using daily doses of low dose aspirin to prevent heart disease. They also present a roundup of studies that could be good news for cancer patients (lung, breast, head and neck, and others) who take a low dose aspirin while undergoing treatment. https://www.peoplespharmacy.com/articles/the-resurrection-of-aspirin-as-an-anticancer-and-pregnancy-drug
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