Two years ago, a list of stem cell clinics, (along with their associated practitioners) offering “unproven”, “unapproved” cell-based therapies was published, provoking a broad and enduring drumbeat of concern and controversy and spawning countless cautionary articles, op-eds, and related research studies in both popular and academic press. The backlash hit swiftly, augmented by tragic stories of malpractice, and prompting a reaction typical of our species when it is faced with ambiguities we need to identify before we understand. The application of a descriptive label, for the clinics, as the “Wild West”.
The onslaught brought a chill to public opinion and regulatory interpretation of policy, and has resulted in persistent calls from some critics for FDA to “crack down” indiscriminately on the clinics offering stem cell treatments which we all know we don’t know enough about.
After 2 years as an incidental insider to the regenerative medicine space, I have concluded that I don’t believe a broad FDA crack down against most clinics will ever come, because it simply won’t have to.
I can’t help but feel that if I were the FDA, I’d rather have daily root canals than endure the almost certain disdain that would come my way if I got heavy handed in enforcement against stem cell clinics. I’d find every way possible to save resources, time, and headaches in order to focus on the work of spurring innovation in the brave new world of regenerative medicine.
I’d simply allow negative exposure to play out, and let clinics and their natural enemies go after each other. I’d let the exposure do the enforcement.
Monitoring, after all, is often a best and most effective intervention. In this case, the effect of “exposure enforcement” on the stem cell clinic space since the 2015 list was published has been both formidable and impressive to watch. I think we’re in for more of it soon, and at a higher caliber than we’ve seen it play out thus far, and I predict that in the coming year, anti stem cell clinic momentum will gain even further influence when critics apply more savvy, advanced data mining and artificial intelligence algorithms to expand their evidence base, not just against stem cell clinics, but also against the medical practitioners associated with them.
Why should this be concerning to cell therapy providers who are silently concerned their practice, and in some cases a major source of satisfaction, may be vulnerable, despite FDA’s current detente of elective enforcement?
The answer is becoming clearer to me with each passing week: Because decentralized influences outside our centralized regulatory systems, like strategically-positioned public and academic exposure of provider misbehavior, are at least as potent and capable of forcing a slowdown in proliferation of stem cell clinics, as may be the FDA. The FDA doesn't have to be the only sheriff in our Wild West town. It has willing deputies from multiple walks of life and disciplinary perspectives, willing to step up their tactics of exposure enforcement, and planning to do so.
A cell therapy provider may not necessarily be thinking in these terms. Theres is a busy existence, beholden to a culture that expects relative anonymity within such public exposure, and with well-guarded legal and professional castles. S/he may be enjoy what is actually a false sense of relative security reflecting the sanctity of the profession, and neatly deflecting any threat of disclosure of their “warts”. But this is a false consciousness that may reflect an unfortunate lack of awareness about just how proficient modern data technology has become in digging deep into our behavior patterns, public image, opinions and preferences, affiliations, moving and driving habits, insurance and banking practices, and more.
(Cell therapy providers aren't the only experts in the field vulnerable to such a blind spot to the power of metadata and intelligent data technology. Even the publishers of the clinic list were caught off guard when they discovered an ad for a stem cell clinic posted right next to their Twitter announcement of journal publication!)
The takeaway here is that even professional records may not be as immune from this kind of metadata discovery, decoding, and reassembly as one might think. While they are, in a sense, considered protected and “classified”, the metadata surrounding may not be.
By combining public-facing and/or “statistical” or “de-identified” data from professional associations, medical board statistics, insurance providers, social media data mining, and other specialized sources, with an artificial intelligence algorithm that excels at interpreting that type of information, any skilled technician can identify possible flags potentially linked to a given provider already associated with a published list of clinics. The result would be a treasure trove of data yielding enough information to catalyze a correlation to possible secrets s/he is keeping, or past events long thought irrelevant. Then that can be leveraged against that provider's professional reputation, and that of the stem cell clinic industry as well.
Note that this exposure need not be complete, just strong enough to exert influence from outside the formal systems charged with oversight. I predict that even such a broad-brush strategy of correlative intelligence is likely to be plenty personal, and very very effective.
Crackdown is NOT necessary. Clinics on the list, as well as those identified after the initial controversy erupted, may no longer be the juiciest targets. Providers will be.
What are your thoughts?