I’ve written in Second Opinion before about the growing number of clinics across the United States, including in Minnesota, that are marketing unproven and unapproved stem cell therapies for a long list of conditions, including aging skin, sports injuries, sexual dysfunction, autism, dementia and multiple sclerosis.
It’s become a highly profitable industry, which explains the proliferation of these dubious clinics. Two years ago, Leigh Turner, a bioethicist at the University of Minnesota, identified 351 companies and 570 individual clinics that were marketing questionable and potentially dangerous stem cell therapies directly to consumers.
The Food and Drug Administration (FDA) has belatedly begun to crack down — sort of — on the industry. Just last week, for example, the agency sent a California-based stem cell company a warning letter regarding “significant deviations” in how the company manufactures and sells unapproved stem cell products derived from human umbilical cords.
In addition to that warning letter, the FDA sent 20 other letters to stem cell manufacturers and health care providers that offer unapproved treatments, reminding them that they must make sure they are in compliance with government regulations.
“We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients that have not been appropriately evaluated for safety or efficacy,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement issued with the letters.
On Wednesday, the FDA also released a one-minute video that warns consumers to “watch out” for unapproved stem cell therapies.
“The FDA has only approved a stem cell product for treating certain blood disorders,” the video’s narrator points out.
“Beware,” she adds. “Unapproved stem cell therapies and products have led to serious infections, blindness and death.”
There are, of course, safe and legitimate medical uses for stem cells, as Dr. Deepak Srivastava, president of the International Society for Stem Cell Research (ISSCR), explains in an article posted earlier this week on Scientific American’s website.
“Stem cell science is moving forward rapidly, with potential therapies to treat intractable human diseases on the horizon,” Srivastava writes. “Clinical trials are now underway to test the safety and effectiveness of stem cell-based treatments for blindness, spinal cord injury, heart disease, Parkinson’s disease, and more, some with early positive results. A sense of urgency drives the scientific community, and there is tremendous hope to finally cure diseases that, to date, have had no treatment.”
“But don’t believe everything you hear about stem cells,” he stresses.
To identify exploitive and dishonest stem cell clinics, Srivastava recommends that consumers look for the following telltale signs:
- Claims that stem cell treatments can treat a wide range of diseases using a singular stem cell type. This is unlikely to be true.
- Claims that stem cells taken from one area of the body can be used to treat another, unrelated area of the body. This is also unlikely to be true.
- Patient testimonials used to validate a particular treatment, with no scientific evidence. This is a red flag.
- Claims that evidence doesn’t yet exist because the clinic is running a patient-funded trial. This is a red flag; clinical trials rarely require payment for experimental treatment.
- Claims that the trial is listed on ClinicalTrials.gov and is therefore NIH-approved. This may not be true. The Web site is simply a listing; not all are legitimate trials.
- The bottom line: Does the treatment sound too good to be true? If so, it probably is. Look for concrete evidence that the treatment works and is safe.
“Advertisements and pseudo news articles promote stem cell treatments for everything from Alzheimer’s disease, autism and ALS, to cerebral palsy and other diseases,” writes Srivasta. “The claims simply aren’t true — they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public.”
“Patients and their families can be misled by deceptive marketing from unqualified physicians who often don’t have appropriate medical credentials and offer no scientific evidence of their claims,” he adds. “In many cases, the cells being utilized are not even true stem cells.”
In other words, don’t believe the hype.