The Journal of the American Medical Association, better known as JAMA, is a prestigious peer-reviewed journal that is not for the faint of heart. Its articles are dense scientific studies with equally dense titles – such as ‘Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy’. But a recent article was a very powerful exception.
The article was titled ‘Unproven but Profitable: The Boom in US Stem Cell Clinics’ and was a great look at the growing number of stem cell clinics offering unproven therapies and how difficult it is for ordinary consumers to tell what is a legitimate clinical trial and what is not.
We have blogged in the past (here and here) about clinics offering unproven and unapproved therapies to patients, charging them thousands of dollars to have their own fat reinjected in them to treat any number of conditions.
The JAMA article points out that these clinics are not just peddling unproven treatments, they are harming the ability of researchers who are running scientifically sound clinical trials. After all why would a patient take part in a clinical trial sanctioned by the Food and Drug Administraton (FDA) where they might get a placebo (which contains no active substance), when they can just go down the street and get what they are told is a “real” treatment for their condition.
Another issue raised is that many people turn to the www.clinicaltrials.gov website for help in identifying a clinical trial for their problem. This is a site that lists all the clinical trials registered with the National Institutes of Health. However, most people don’t appreciate that being registered and listed on the site doesn’t mean it’s a well-designed study.
“Patients kind of see that [a listing on ClinicalTrials.gov] as validation, that it’s done with government oversight,” said Sunir Garg, MD, a retina specialist at Philadelphia’s Wills Eye Hospital and a spokesman for the American Academy of Ophthalmology. But, Garg noted, trials posted on ClinicalTrials.gov don’t go through a vetting process. “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, which, like ClinicalTrials.gov, is part of the NIH, said, “There are many of us who have been begging the webmaster to post very clearly that listing in ClinialTrials.gov does not mean NIH (National Institutes of Health) approval, IRB (institutional review board) approval, or FDA approval.”
What’s important about the article is that it shows how pervasive these clinics have become and how they are being perceived as a growing problem to patients and to stem cell research in general. The article cites several prominent researchers (many of them funded by CIRM) calling for tougher action by the FDA to crack down on the clinics offering these therapies.
At CIRM we are doing all we can to both educate people about the risks of these unproven therapies and what they need to do to find a well-designed and scientifically sound clinical trial.
We are also working with our Alpha Stem Cell Clinic Network to offer patients clinical trials that meet the highest standards of care and research. These trials only offer therapies that have been given the go-ahead by the FDA and they don’t charge patients tens of thousands of dollars to be part of them.
The JAMA article is the latest high-profile piece raising the alarm about these clinics. It’s an encouraging sign that more and more doctors are recognizing that peddling hope may be a good business strategy, but a terrible way to promote good science and improve the health of patients.