An apology.  This was supposed to be another piece in my stem cell update series.  But, somehow, it got moved weeks ahead in the queue.  (We discussed the technology on 13 June, 12 June, and  11 June.) And, now, again, today.)

So, we’ve seen how these stem cell clinics make their money.  Finding desperate patients, sometime using the same sales tactics that time-share operators use (on-the-spot discounts, emotional videos, etc) are their bailiwick.

But, these clinics do more.  They have even manipulated the NIH (the National Institutes of Health) system to publish unapproved, paid procedures as “clinical trials” at http://www.clinicaltrials.gov.  That affords their fly-by-night techniques with an aura of respectability.  (The problem is that NIH never independently verifies the information that will be published on the site- nor whether any trial involved the Food and Drug Administration (FDA) oversight or informed consent and control groups.  The NIH ‘leaves that” to the funders, regulators, and ethical review boards.  Boy, does that system fail the public!)

By the way, these charlatans aren’t simply operating within the USA.  Especially since rich patrons have begun using “medical tourism”, shopping for venues that have exclusive clinics, posh facilities, and lax oversight- not to mention lower costs than those that obtain in the USA or Europe.  So, these clinics are now found in Russia, China, South Korea, and India. Among other locations.

And, it’s growing by the minute.  Folks like Drs. Berman and Lander not only operate clinics willy nilly, they train others to do exactly the same sort of procedures.  (Some of these folks franchise the “Cell Surgical Network” system, the company that controls the clinics Berman and Lander operate.  Others just purchase a “proprietary centrifuge” they call the “Time Machine”, along with the lesson from Berman and Lander how to operate the clinics.  Cheap at $ 30K!)

Now, the FDA (back in November 2017) issued its proposed regulation of the industry.  Normally, that would start a 90 comment period, with final regulations to be issues shortly thereafter.  Except it’s the end of June and nothing has been issued.

The only real action the FDA has taken has been against two of the larger operators of stem cell clinics- US Stem Cell Clinic in Florida and the Cell Surgical Network in California.

But, last month, Congress passed the “Right to Try” bill (when this was written, S 204 and HR 878 have passed were reconciled, the president signed the bill recently) now provides permission for patients with life-threatening treatments a chance to use untested (or not-fully tested) drugs, devices, or even these stem cell clinics.  The only requirement is that the patients have “exhausted all other options”  and the choice is currently involved in clinical trials.

Given the sham “clinical trials” that the stem cell clinic operators have been “conducting”, you can see how any new regulation of the “business” will be circumvented.

This is not going to end well.

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