The Journal of the American Medical Association, sheds light on the growth of clinics that are offering unproven stem cell therapies for profit.
More about profit
The article, titled ‘Unproven but Profitable: The Boom in US Stem Cell Clinics’ offers a clear look at the growing number of clinics selling unproven stem cell therapies. This makes hard for consumers to tell legitimate clinical trials from illegitimate ones.
We’ve blogged before about clinics offering unproven and unapproved treatments, charging patients thousands of dollars to reinject their own fat to treat a wide range of conditions.
The JAMA article explains that these clinics don’t just push unproven treatments. They also undermine researchers running scientifically sound clinical trials. A patient might wonder why would a patient join an FDA‑sanctioned trial where they might receive a placebo? Especially if they believe that a nearby clinic and buy what they’re told is a “real” treatment?
Science-back approaches
Another issue is that many people use http://www.clinicaltrials.gov to find clinical trials for their condition. The site lists all trials registered with the National Institutes of Health. But most people don’t realize that a listing does not guarantee a well‑designed study.
“Patients kind of see that as validation, that it’s done with government oversight,” said Sunir Garg, MD, a retina specialist at Philadelphia’s Wills Eye Hospital.
Garg, who is also a spokesman for the American Academy of Ophthalmology, said the clinical trials list isn’t vetted. “Even a lot of physicians don’t appreciate that nuance.”
Pamela Robey, PhD, chief of the skeleton biology section at the National Institute of Dental and Craniofacial Research, raised the same issue.
“Many of us have been begging the webmaster to post clearly that a listing on ClinicalTrials.gov does not mean NIH approval,” said Robey.
It also doesn’t mean the trial is IRB approval, or FDA approval, she said.
Tougher Enforcemebnt
The article highlights how widespread these clinics have become. They pose increasing risks to patients and to stem cell research as a whole. It cites several prominent researchers urging the FDA to take tougher action.
At CIRM, we work to educate people about the risks of unproven treatments. CIRM shows patients how to identify a well‑designed, scientifically sound clinical trial.
We also partner with our Alpha Stem Cell Clinic Network to offer patients trials that meet the highest standards. These trials only offer therapies approved to proceed by the FDA. They also never charge patients tens of thousands of dollars to participate.
The JAMA article is the latest high‑profile warning about these clinics. It’s encouraging that more doctors recognize that selling hope may be good business, but it is a terrible way to advance science.
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Clinical trials: separating the wheat from the chaff
the bogus clinics take advantage of lack of genuine treatment. If the legitimate clinical trials are expedited, it will help in preventing the quackery in the field