The FDA’s “untitled letter” to R3 Stem Cell (R3), based in Scottsdale Arizona, cautioned R3 that the product they are marketing is considered a drug. It must, therefore, be cleared by the FDA and approved for safety, purity, and potency.
According to a recent report in ProPublica, R3 has been selling its product to people with life-threatening disorders such as Parkinson’s, Lyme disease, rheumatoid arthritis, and kidney disease to name a few.
David Greene, M.D., R3’s CEO, claims that these products, which are composed of birth tissue, are a “cure-all”. Yet he does not give any scientific evidence to back up his claims. R3 markets these products through over 50 clinics throughout the nation. Dr. Greene did not respond to inquiries from news organizations concerning the FDA’s warning.
About Dr. Greene
As reported in ProPublica, in 2009 Dr. Greene had his medical license revoked as a result of botched surgeries, resulting in the death of several patients plus permanent injuries to other patients.
Yet Dr. Greene boasts of the “great outcomes” he has had with the surgeries he performed. He claims that other doctors with similar records have not been sanctioned.
After losing his license to practice medicine, Dr. Greene returned to his studies and earned an MBA. Then, as a distributor, he began to promote stem cell products to the public while supplying his products to various clinics.
ProPublica attended a seminar hosted by Dr. Greene. He explained to the audience that his product, amniotic stem cells, originates from placentas and umbilical cords. He claimed that it can treat a wide range of disorders. His most outstanding claim was that eighty-five percent of patients may benefit from this treatment.
After the seminar, Dr. Greene explained to ProPublica that his claim about the benefits that he espoused at the seminar was the result of case studies and many success stories in lieu of clinical trials.
Dr. Green then later told ProPublica that he doesn’t really claim anything. He said he does not even claim his product to be a treatment or that it is a cure. He said he only discusses that possibly some people can see some improvement from stem cell care.
A Cause For Concern
The FDA has been increasingly concerned that companies such as R3 are marketing stem cell therapy under the guise of being a “cure-all” to people with life-threatening diseases.
People with rare diseases are especially vulnerable and fall prey to this type of “cure-all” marketing. They may see it as a last resort but it not only represents false hope, it endangers their lives.
An Alarming Increase in Clinics
Recently, over seven hundred clinics in the U.S. have been found to advertise these unproven treatments which are generally not covered by insurance. Therefore the patient is paying a minimum of $5000 for these injections or at least $10,000 for intravenous infusions.
With respect to these unregulated products, the substance is purportedly taken from the amniotic fluid that surrounds the fetus. The stem cells are injected or infused into the patient’s joints or into their spine. It was reported that in 2018, twelve patients had bacterial infections and were hospitalized due to stem cells from a contaminated batch.
The FDA Was Lenient
For a while, the FDA rules were somewhat relaxed. During that time manufacturers were able to make their own decision about whether their product is a drug and needs FDA approval.
In order to avoid the expense of clinical trials, many developers took the easy route and decided that their products were not drugs. Without being tested in clinical studies, there was scant evidence of the safety or efficacy of their products.
The FDA Changes Course
Everything has changed over the past two years. The FDA has begun to notify many more companies that their therapies must be reclassified and listed as drugs.
The FDA’s warning letters are a step above R3’s “untitled letter” which gives recipients a chance to voluntarily correct the situation.
The warning letters alert these companies to the possibility of enforcement action. In the past two years, the FDA has sent out approximately forty-six warning letters to the health care community and to manufacturers.
The FDA’s New Priority
Acting Commissioner Dr. Ned Sharpless said the FDA’s priority is to take appropriate action against anyone who jeopardizes a person’s health through the promotion of unapproved products.
Have you had experience with stem cell promotions?