RFK Jr. wants to allow more experimental therapies, acknowledging health risks and threat of ‘charlatans'

Boston Globe

2 days ago

'And of course you're going to get a lot of charlatans, and you're going to get people who have bad results,' he added. 'And ultimately, you can't prevent that either way. Leaving the whole thing in the hands of pharma is not working for us.'
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Kennedy cited his own experience at a clinic in Antigua, where he said he received a stem cell treatment that 'enormously' eased his neurological condition, spasmodic dysphonia, which affects his voice and has few treatment options.
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If Kennedy does permit broader use of unauthorized or experimental therapies, he would be reversing long-standing efforts by the FDA to monitor and sometimes police the emerging field. Experts, including some who support alternative medicine, worry that without safeguards, an expansion of such treatments could undermine legitimate development of new therapies.
The FDA now narrowly permits stem cell therapies to treat blood and immune disorders.
Nearly a decade ago, the field was so loosely regulated that the agency pursued court actions to shut down rogue clinics using unauthorized treatments for a wide array of ailments. Some providers in the United States and in other countries continue to offer experimental stem cell therapies for everything from autism to Alzheimer's to erectile dysfunction.
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The latest move reflects an expansion of Kennedy's drive to dismantle federal health policy to reflect his long-held views, which had so far focused mainly on vaccines, chronic diseases, food dyes and fluoride. A push to open up the field of unregulated stem cell infusions meshes with his oft-stated contention that the FDA is a 'sock puppet' for major drug companies and faces a crisis of distrust. Wellness industry products, he has claimed, are unfairly sidelined.
A spokesperson for the Department of Health and Human Services did not respond to requests for comment.
Kennedy's statements alarmed experts on the field of sometimes dangerous stem cell infusions -- who noted that many of Kennedy's allies endorse wellness products ranging from red-light therapy to magnetism.
'It's a complete abdication of protection of the public, letting these grifters go forward,' said Timothy Caulfield, a research chair in health law and policy at the University of Alberta in Canada. 'For him to say, 'There are problems with Big Pharma, so we want our opportunity to be bad actors too,' it doesn't make any sense.'
One leading expert group, the International Society for Stem Cell Research, reviewed Kennedy's podcast statements and condemned the approach as potentially allowing products that are 'sometimes contaminated with pathogens and are often marketed with scientifically implausible claims.'
'It is critical that the FDA maintain its regulatory authority to protect Americans from these potentially harmful and deceptive products,' the society said in a statement.
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On Thursday, a panelist appearing at an FDA meeting on cell and gene therapies raised a concern about 'snake oil' treatments.
Dr. Vinay Prasad, the agency's director of the center for biologics evaluation research, responded, 'We have to regulate the bad actors. We can't let that taint what we do here at the FDA.'
Kennedy, who also attended the event, voiced full support for the researchers and biotech executives working on gene therapies for rare diseases, including those who made history by creating a custom gene therapy for an infant named KJ.
'We're going to do everything in our power to sweep away the barriers from you getting those solutions to market and getting them funded, and do everything that we can to support you all,' Kennedy said.
On Brecka's podcast in May, Kennedy cited other products that he'd like to see more of, including chelation treatment, which was discussed in a 2015 book edited by him that focused on widely debunked theories about mercury in vaccines and autism and cites 'evidence of chelation's benefits' from a few small studies. One 5-year-old Pennsylvania boy died in 2005 from cardiac arrest after a doctor tried to treat his autism with chelation.
Neither Kennedy nor the FDA has released a formal plan to change agency standards for stem cell treatments, which have typically been reviewed by the agency as individual therapies to treat a specific disease.
Widening overall access could also happen informally if the agency decided to relax enforcement, an approach the FDA used in the past to indicate that it wouldn't crack down on unauthorized products. During the pandemic, for example, the agency allowed providers to retrofit infusion pumps and ventilators to treat hordes of sick patients.
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During the first Trump administration, the agency's commissioner, Dr. Scott Gottlieb, escalated enforcement against stem cell providers whom he described in 2017 as 'unscrupulous actors who have seized on the clinical promise of regenerative medicine.'
The FDA followed through with lawsuits seeking to stop some stem cell providers, including one case that the government won on appeal in the fall. In that case, the agency alleged that one provider, the California Stem Cell Treatment Center, was offering a drug without FDA approval by taking stem cells from a person's fat, manipulating them and infusing them as a remedy for Alzheimer's disease, cancer and arthritis.
The agency classifies stem cell treatments as a 'biologic' and approves them much like a drug after careful studies of safety and effectiveness. But the FDA does make exceptions: It does not regulate some treatments if providers say they are extracting and then reinserting a person's cells with minimal manipulation.
In March, Kennedy convened a meeting with leaders in the stem cell field. Two people who attended said the gathering was a fact-finding effort to explore a safe way to increase access.
To Dr. Noah Raizman, who attended the meeting on behalf of the American Academy of Orthopaedic Surgeons, Kennedy's new pronouncement 'sounds a little more casual and a little bit more emboldened.'
In the podcast, Kennedy said that consumers should be able to navigate the industry's claims.
'We don't want to have the Wild West,' Kennedy said. 'We want to make sure that information is out there. But we also want to respect the intelligence of the American people -- the capacity of people who explore the outcomes that are going to benefit them the most.'
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In recent years, stem cell treatments have caused harm in the United States and abroad. Experts at the Pew Research Center tallied more than 350 cases of side effects including life-threatening blood infections, heart attacks and tumors. One Boston neurosurgeon discovered a huge mass of bloody tissue in the lower spine of a man who had received unproven stem cell treatments in Mexico, China and Argentina. Three patients were blinded after stem cell treatments at a Florida clinic. The FDA prevailed in getting a court order to stop the clinic from operating.
The field of stem cell treatments is so complex that the Harvard Medical School created a free course to help doctors navigate patient questions, said Insoo Hyun, the director of life sciences at the Museum of Science in Boston.
More than 110 stem cell clinical studies are advancing under regulatory oversight. In one, scientists at the National Institutes of Health are using retinal cells developed from patients' blood to try to treat vision loss in older adults -- and follow them for 15 years.
In another study aimed at helping patients with Parkinson's disease, researchers at a biotech company in California are exploring the safety of infusing dopamine-producing neurons in a region of the brain that controls the body's movements. A Chinese company is studying a treatment for heart failure that involves transplanting cardiac muscle cells into the heart.
Some providers sidestep the costly, yearslong process of careful work that can lead to an FDA approval. Among them is Dr. Chadwick Prodromos, a Chicago doctor who offers stem cell treatments in Antigua. Kennedy welcomed him warmly at the March meeting, Raizman recalled. Reached for comment, Prodromos' office said that he was in Antigua doing treatments and was not available.
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In an April interview on YouTube, Prodromos said that he was still in touch with the FDA about stem cell treatments that could help people 'without allowing scams and things that aren't valid. And you know, it's a tricky proposition.'
A website for Prodromos' clinic says that he and colleagues offer injections in Antigua into the joints, back, neck, scalp, penis and pelvic floor for an array of conditions including autism, thinning hair and lupus. He uses AlloRX cells, which are derived from the umbilical cord, in a manner that in the United States would require an FDA-cleared clinical trial.
People can seek out unregulated treatments using their own cells that are processed, purified and amplified in different ways. They can also find treatments using others' cells that vary widely in quality and sterility.
Some low-quality clinics process cells in a back room, which is the opposite of a clinical-grade cell processing site. Hyun said he recently toured one in the Netherlands that used specialized air filtering, layers of gowns and a ban on bacteria-laden cellphones in their sterile area. 'It's kind of like you're entering a space station,' he said.
Ultimately, Caulfield said, many unauthorized stem cell providers adopt the language of biotech and regenerative medicine, post glowing patient testimonials and exploit patients who are desperate for a cure.
This article originally appeared in
.