Tag: fda
Kennedy's Promotion Of Unproven Peptides Undermines Science And Public Safety

Kennedy's Promotion Of Unproven Peptides Undermines Science And Public Safety

Journalists are often accused of using the following aphorism to determine the newsworthiness of a story: “Once an accident. Twice a coincidence. Three times? A trend. Go for it!”

Using that habit of mind to drive journalism is a bad idea. People will be misinformed. Using it to drive the practice medicine is worse because people will get hurt.

This past weekend, I read a recent story in The New Yorker about “the seductive world of unapproved peptides,” written by Dhruv Khullar, an outstanding medical journalist. The physician-writer visited several clinics run by board-certified physicians pushing these protein snippets on gullible people looking to heal ailing muscles, improve memory and live longer lives, among other alleged benefits.

The testimonials offered by physicians promoting various peptides defied every standard of medical evidence developed since Founding Father Benjamin Rush gave up bloodletting. Charleston, South Carolina’s Craig Koniver, trained in family medicine, called one peptide used for tissue healing (BPC-157) “supersafe” and said “almost everyone I could think of” will benefit from it. A few paragraphs later, he says, “I’m not a big vaccine guy. A lot of them don’t have the data.”

What’s the data behind BPC-157? There are exactly two clinical trials for that peptide in the federal government’s clinical trials database. One is an early-stage safety trial of unknown scope and status that is taking place in Tijuana. The second is an efficacy study based in Shenzhen, China, which is still recruiting patients. Vaccines, on the other hand, have undergone extensive testing and they’ve gained FDA approval, which means there are reams of data documenting both their safety and efficacy.

Koniver goes on to say “anecdotal data means a lot to me. Two days after a vaccine, someone has a stroke. Two days later they’re dead. … You see enough of that, it makes an impression.”

There’s no shortage among his 1,000 patients, who pay $15,000 a year for the services of his concierge medical practice (it doesn’t take insurance), willing to attest to peptides’ benefits. After all, wait long enough and most tissue tears eventually heal. Koniver (is a Charles Dickens doppelganger now the resident fact-checker at The New Yorker?) has 6,000 people on his waiting list.

Many of the people lining up to spend their hard-earned money on peptides may have heard the siren call of the ultimate peptide guru, Robert F. Kennedy, Jr., who sits atop the Health and Human Services Department. He frequently claims he benefited from injecting peptides to cure injuries sustained during body-building exercises.

He appeared earlier this year on the Joe Rogan podcast (the world’s most popular with 11 million listeners). Rogan frequently touts peptides on his show. The field also received an unexpected boost from the FDA’s approval of semaglutide (Ozempic, Wegovy, Zepbound), a peptide for diabetes and weight loss. If that one works, won’t they all?

Semaglutide is the exception, not the rule when it comes to data on peptides. There is almost no evidence beyond individual anecdotes that most of the peptides now in circulation, mostly produced by compounding pharmacies, actually benefit patients or are safe.

Earlier this year, Kennedy removed the limited regulation of unapproved peptides that had been put in place during the Biden administration because their manufacturers failed to submit data to the FDA proving they could be safety injected in patients. The Kennedy reversal hurled peptides back into the regulatory vacuum enjoyed by dietary supplements, where the only rules that apply involve purity (does it contain what it claims to contain) and a ban on making medical claims (which is routinely violated by industry advertising).

For a dispassionate dissection of Kennedy’s views on peptides as expressed on the Joe Rogan podcast, watch this YouTube video by Matt Kaeberlein, a professor pathology at the University of Wisconsin Medicine and co-founder of UW’s Health Aging and Longevity Research Institute. “There are numerous cases out there where people have been harmed by peptides … Nobody has come forward with any good data on the safety of these peptides.," says Kaeberlein.

Good data on peptides, whether for efficacy or safety, requires someone conducting randomized clinical trials that test whether the products are better than a placebo or the current standard of care. The tests need to be in a sufficiently large population to show statistical significance in any outcomes differences between the two groups. Absent clinical proof of efficacy in such trials, there will only be the risk of harm or unpleasant side effects.

The Biden administration upheld evidence-based medicine when it required most peptides undergo such tests. The Trump administration via Kennedy opted instead for allowing money-hungry physicians and compounding pharmacies to conduct what amounts to an uncontrolled science experiment on gullible Americans, where no one takes a measure of the outcomes except the individuals and families who will be harmed both physically and financially.

The peptide craze is following the same trajectory of the anti-vaccination movement (also championed by Kennedy); the evisceration of National Institutes of Health research into the many social causes of disease; and the degradation of the Centers of Disease Control and Prevention’s ability to promote population health. It is anti-science, pitch perfect for a society addicted to addictions, promoted by someone who admits he once snorted cocaine off a toilet seat, who now jabs needles in his body in the evidence-free pursuit of faster healing and better health.

Peptide proponents claim it is their right to try unapproved substances based on claims made by family, friends,or their concierge physician. It’s my body. I willingly take the risk. Whom else does it harm?

Actually, everyone. Who pays when you end up in the hospital and wrack up huge treatment bills? Two people fell desperately ill during a Las Vegas “anti-aging” event after injecting peptides and had to be intubated. Widespread allergic reactions to the shots, some of which were life-threatening, forced regulators in Australia to issue a safety alert. Health Canada has issued a warning that unauthorized peptides can cause blood clots and liver and kidney damage.

The U.S. used to have a regulatory agency that the rest of the world awarded a gold medal for how to manage the entry of medical products into the marketplace. Today, under this government, it isn’t even in the race.

Merrill Goozner, the former editor of Modern Healthcare, writes about health care and politics at GoozNews.substack.com, where this column first appeared. Please consider subscribing to support his work.

Reprinted with permission from Gooz News

U.S. Senator Jon Ossoff (D-GA).

Senators Roast Trump's FDA Chief Over Fired Scientists

The Commissioner of the Food and Drug Administration, Marty Makary, came under strong criticism for his inconsistent remarks before a Senate Appropriations subcommittee after the accuracy of his claims related to terminated scientists and others was called into question by Sen. Jon Ossoff (D-GA).

"You were asked on April 17th whether any of the personnel reductions had included personnel responsible for food safety or infant formula safety," Ossoff told Makary. "You said, quote, 'There were no cuts to scientists or reviewers or inspectors—absolutely none'. You were asked on April 23rd on CNN, and said, quote, 'Again, there were no cuts to scientists or inspectors'."

"But then just two days later, an HHS spokesperson confirmed that in fact, scientists had been fired, and that you were scrambling to rehire them," Ossoff continued. "Did you, in fact, say on April 23d, there were no cuts to scientists or inspectors? Just before we get into the details, is that an accurate quote?"

"No scientific reviewer was cut as part of the reduction in force," replied Makary.

"You said there were no cuts to scientists or inspectors. Didn't you say that?" Ossoff pressed.

"My understanding," Makary replied, "was that there were no cuts to the scientific staff, but specifically the scientific reviewers is what I was referring to."

"But you said there were," Ossoff responded.

A similar back and forth continued for several minutes, then Ossoff asked, "Had, in fact, scientists who study outbreaks of food related illnesses and the safety of infant formula been fired?"

"The reason it's not accurate, Senator, is that people were not fired, they were scheduled for the reduction in force, and when that was before I got there. When I got there, we did an assessment, and so some of those individuals out of the 19,000 were restored," Makary replied.

"Have all scientists responsible for food safety and infant formula safety, been rehired or reinstated?" Ossoff asked.

"Look, we have not reduced in force the scientific review staff. I know where you're going with this," Makary replied.

"You said there were no cuts to scientists, and then the HHS spokesperson said, actually, there were cuts to scientists, and now we're trying to rehire them. I mean, so it gives the impression you're not sure about the personnel actions ongoing in your own agency," said Ossoff.

After more back-and-forth, Ossoff wrapped it up: "You were very specific. You said there were no cuts to scientists. And then five days later, there were cuts to scientists. Those are your direct quotes. There were no cuts to scientists, but there were cuts to scientists."

Again, more back-and-forth and then Makary appeared to grow frustrated.

"I mean, this is the problem in government. Somebody has a fancy sounding name like, 'Infant Formula Safety,' and no one can ever touch them, even if they're not doing their job."

During his testimony, Makary also declared to another Senator, "By the way, America doesn't want COVID boosters."

And a third chastised him, saying: "You're prepared for a question that I didn't ask ... I'm asking you what are you doing about bird flu! Just answer that. Please. Don't give me a runaround about other stuff."

Watch the video below or at this link.

Reprinted with permission from Alternet.

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

Why Trump's Latest FDA Appointee May Imperil Agency's Vital Work

By appointing Dr. Vinay Prasad to run the Center for Biologics Evaluation and Research, the Trump regime has installed another prominent opponent of Covid-era public health policies to a key position at the Food and Drug Administration.

CBER is responsible for ensuring the safety and efficacy of vaccines, biologic drugs, gene therapies and the blood supply. When FDA Commissioner Martin Makary announced Prasad’s appointment yesterday, he noted the 42-year-old oncologist-epidemiologist has published hundreds of articles in the medical literature. I read their titles this morning. Only a few shed light on how he views the arenas he will soon oversee.

On the other hand, his recent writings on X (formerly Twitter), the substack Sensible Medicine, and his own substack Observations and Thoughts have plenty to say about school closures (“the great domestic policy failure of the last 25 years”); kids wearing masks outdoors (“whoever made the policy is an idiot”); and the annual Covid booster shot (“a public health disaster the likes of which we’ve never seen before”).

On the day after Trump’s election last November, he gave failing grades to the FDA and National Institutes of Health. He called for the elimination of 10,000 jobs at the Centers for Disease Control and Prevention, which he rated as an “abject failure.”

The rhetoric sounds more Trump/Muskian than even-handed or scientific. It is typical of his recent writings, which have taken on an increasingly strident tone since the pandemic. He has repeatedly attacked officials like Anthony Fauci and those at the CDC for ignoring alternative strategies and censoring proponents of herd immunity like Jay Bhattacharya, who now runs NIH.

One of Prasad’s recent posts called for large-scale, randomized clinical trials for the annual booster shots for COVID vaccines. That was in line with Makary’s order late last month that Novavax conduct a new clinical trial to test the annual update of its traditional Covid vaccine, which is the only alternative to the mRNA vaccines sold by Pfizer and Moderna. This new requirement may also be applied to the annual flu vaccines, which will cost the vaccine makers money (who cares?), but more importantly, will take much more time (something we should all care about).

“The FDA is a failure,” Prasad wrote last fall. “It rubber stamps too many useless products. It needs to either remove itself from the picture, or demand randomized trials measuring appropriate endpoints.”

Right turn

This rightward turn in Prasad’s public posture is a relatively recent phenomenon. He began his academic career by studying conflicts of interest in medicine (my own field when working at the Center for Science in the Public Interest). In 2017, he published a study in JAMA Internal Medicine that challenged the ridiculously high sum big drug companies claimed it cost to develop a new drug. (Full disclosure: I was invited to write the accompanying editorial, which was headlined “A Much-Needed Corrective on Drug Development Costs”).

To this day, the insidious role money plays in medicine remains central to how he views the relationship between the drug industry and government. “This is the core rot in American regulation. The revolving door politics. I find this behavior abhorrent, and it should be criminal,” he has written.

He has called for ending all conflicts of interest on FDA advisory committees and wants to set up a “new Phase IV safety detection system” for monitoring adverse vaccine events. “I think vaccine makers should face litigation, as drug makers do,” he has written. He’s also skeptical of using surrogate endpoints and accelerated approvals, which led the FDA to “rubber stamp dozens of drugs with no evidence they help Americans.”

So here we are again. A top Trump regime appointee is championing many positions held by left wing and progressive critics of weak government oversight. Indeed, Prasad has written he once considered himself a progressive Democrat. No wonder biotech stocks temporarily tanked on news of Prasad’s appointment to run CBER.

However, as I’ve said many times in writing about these appointments, let’s watch what they do, not what they say, past or present. Will the Makary/Prasad team slow or even stop vaccine approvals to please their boss, Robert F. Kennedy Jr., the secretary of Health and Human Services? Will Trump order the new team to back off from policies and decisions that tank the stock market (vaccines on their own could never do that; they’re too small a revenue item)?

If I were a gambling man, I’d bet the answer will be ‘yes’ to both those questions.

Reprinted with permission from Gooz News.

Robert F. Kennedy Jr.

Kennedy's Latest Cuts To Food Safety Could Make America Very Sick

Health and Human Services Secretary Robert F. Kennedy Jr. is continuing his life’s work of making public health more precarious as the Food and Drug Administration, which he oversees, is suspending its quality-control testing of raw fluid milk and other dairy products due to budget cuts, according to Reuters.

The suspension of testing begins this week and includes Grade “A” raw milk and other finished dairy products. Grade “A” is the nation’s highest sanitary standard for milk, making sure it does not contain harmful pathogens.

According to a spokesperson, the FDA's Moffett Center Proficiency Testing Laboratory, which conducts such food safety testing, has been “decommissioned.” That, along with massive Trump administration budget cuts, has left the FDA "no longer able to provide laboratory support for proficiency testing and data analysis,” according to an internal email obtained by Reuters.

This news follows the suspension of programs focused on bird flu outbreaks, which included studies showing how pasteurized milk can kill the virus, after Kennedy fired senior veterinarians designing them.

In his quest to fund tax for the wealthy, President Donald Trump’s administration demanded that the HHS, which includes the FDA, cut $40 billion from its budget. Since January, HHS has lost an estimated 20,000 positions in its workforce.

Kennedy has long been a proponent of raw milk, claiming it is superior to pasteurized dairy products, though the FDA has thoroughly documented raw milk’s dangers.

It remains unclear whether Kennedy will be able to slap together a replacement testing program, like the one at the now-closed Moffett Center Proficiency Testing Laboratory. Like many of the government agencies decimated by Trump and Elon Musk’s so-called Department of Government Efficiency, the scramble to rehire essential employees seems to have become a weekly crisis.

As Trump continues to pretend that he has conquered soaring egg prices, which are still largely driven by one of the worst outbreaks of avian flu in U.S. history, his budget cuts and the decision to have Kennedy run public health leave no clear end in sight.

Reprinted with permission from Daily Kos.

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