Consensus Document on Amniotic and Umbilical Cord Scams
There’s an old adage that if you get 10 doctors in a room, you get 10 different opinions. And like all old sayings, there’s a kernel of truth there. Which is why I was surprised that a group of high-powered physicians that I pulled together on the amniotic and umbilical cord scams were all able to quickly agree on a consensus statement. Is it the beginning of the end for the scammers?
What Is a Consensus Document in Medicine?
Getting to consensus means all agreeing on something. Since agreement between physicians is what drives most of our medical care system and the standard of care, universities and organizations will often convene consensus panels of doctors. There are many methods described for how these documents get created.Request a Regenexx Appointment
What’s the Problem Here?
We have many chiropractors and some physicians who are scamming patients by claiming that amniotic and umbilical cord products contain millions of live stem cells. We also have the companies that manufacture these products that are making the same inaccurate claims. Since what’s really being sold is all dead tissue, this is a classic consumer bait-and-switch fraud. In addition, the scammers often claim that these are safe and effective treatments for just about everything from arthritis to erectile dysfunction.
What Does This New Document Say?
The new consensus document says that there are two studies that have been conducted on amniotic and umbilical cord products that both agree that they are dead cell products that are growth-factor poor. Meaning that they have no live and functional stem cells. It also says that there is no evidence that these products are safe and effective treatments for arthritis or other incurable diseases. This is, of course, the opposite of what’s preached all over the country at hundreds of seminars a day where elderly patients are scammed.
Who Signed the Document?
The document represents a “who’s who” of physicians, scientists, and regulatory experts in the field of regenerative medicine. On the physician side, we have numerous doctors who lecture frequently at major regenerative medicine conferences and have published peer-reviewed studies in this area. As for researchers, we have Cornell, Mayo, Stanford, Emory, and CSU represented. We also have several regulatory experts who also lecture frequently on the topic of orthobiologics.
Why Does This Matter?
For the scammers, this document is not a good thing. Why? There are several fraud cases brewing against chiropractors around the country, and this document will likely be used as exhibit A in that criminal case. It will also be used in countless malpractice cases against the fraudsters when complications happen. Hopefully, it will also be used by state medical and chiropractic boards to discipline the physicians and chiropractors involved in these scams. Finally, I’m hoping it prompts both the FDA and FTC to act both against the medical providers and the companies manufacturing these products and making these claims.
What’s Next for This Document?
That’s up to the signatories. The goal here was to have a small panel that could agree on a statement and then begin to ask other physicians to sign on. Then I would like to see this document circulated to major professional organizations for their buy-in. Finally, perhaps it can serve as a nucleus to be expanded to get to consensus on other issues facing the orthobiologics community.
The upshot? I was impressed by this group at how quickly they were all able to turn this around. This bodes well for the community of doctors working hard to use orthobiologics the right way.