I agree with Kennedy that people with diseases or conditions that cannot be cured by mainstream medicine have the right try experimental therapies, and should be allowed what some are calling “health freedom.” For those who want certification of safety, private labels would emerge if the government exited from its role of allowing or banning. In the unregulated supplement business, multiple such organizations exist, e.g., the United States Pharmacopeial Convention (USP).
If the public decides the Kennedy/Diamond position is too radical, a step in the right direction would be for the government to provide informational certification of therapies or providers, but not to mandate that patients use only those therapies and providers.
(p. A1) Health Secretary Robert F. Kennedy Jr. recently declared that he wanted to expand access to experimental therapies but conceded that they could be risky or fraudulent.
In a podcast with Gary Brecka, who describes himself as a longevity expert, Mr. Kennedy vowed to end what he called the Food and Drug Administration’s war with alternative medicine. He said that would include stem cells, vitamins, peptides and chelation therapy, which involves removing heavy metals from the blood.
“If you want to take an experimental drug — you can do that, you ought to be able to do that,” Mr. Kennedy said.
“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.”
Mr. 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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(p. A11) Neither Mr. Kennedy nor the F.D.A. 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 F.D.A. 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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Dr. Moreno and his colleagues found that the trials with funding from the red meat industry were nearly four times as likely to report favorable or neutral cardiovascular results after eating unprocessed red meat when compared with the studies with no such links.
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“We don’t want to have the Wild West,” Mr. 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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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.
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Some providers sidestep the costly, yearslong process of careful work that can lead to an F.D.A. approval. Among them is Dr. Chadwick Prodromos, a Chicago doctor who offers stem cell treatments in Antigua. Mr. Kennedy welcomed him warmly at the March meeting, Dr. Raizman recalled. Reached for comment, Dr. Prodromos’s office said that he was in Antigua doing treatments and was not available.
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A website for Dr. Prodromos’s 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 F.D.A.-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. Dr. 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.
For the full story see:
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(Note: the online version of the story has the date June 5, 2025, and has the title “Kennedy Says ‘Charlatans’ Are No Reason to Block Unproven Stem Cell Treatments.”)