We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials.
See my prior post at: http://wp.me/p7pwQD-bB
So what’s going on so far in 2018?
Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more than a rumor. I can also say that the FDA is looking hard at cGMP and GTP compliance issues, and my informed guess is that not many of the private stem cell clinics are so compliant. I think the FDA’s reaction to these non-compliance issues as these entities go through the administrative process will vary and depend on some key factors. But we’ll have to wait and see how this shakes out.
The new Texas Stem Cell Law: Are we there yet?
The short answer is no because the law isn’t fully implemented yet.
For the details of the Texas law, see my post at: http://wp.me/p7pwQD-ab
The Texas law (HB 810) called on the Texas Medical Board (TMB) to issue a rule flushing out the law. Presumably, it’s not going to be legal to treat patients under HB 810 until the board creates an implementing rule.
Does that mean that stem cell treatments are not available in Texas now? Of course not. There are many docs and clinics administering stem cells right now in Texas. But they are operating very arguably in violation of federal FDA law. HB 810 creates, in effect, a Texas safe harbor for stem cell clinics to operate, but not until the TMB passes a rule about it. (The TMB already has a rule on investigational treatments, but that rule excludes stem cells.)
There was an initial stakeholder meeting in December about the rule, and there is a second meeting set for next week. The stakeholder group is composed of approximately 25 various interest groups, legislators, and state agencies. No doubt the key players are the stem cell clinics which plan to open up under the new law and some of the patient groups, which groups did the heavy lifting for the passage of the new law. They are a formidable group of people.
The Medical Board has already set up an ad-hoc committee to consider the rules once they are drafted. Expect the draft rule to be published in the Texas Register.
But that’s not the end of the process. Even if the TMB passes a rule, the statute requires that Health and Human Services Commission (HHSC) define terminal illness and severe chronic disease which are the statutory requirement to be eligible for treatment with stem cells. HHSC has delegated those duties to the Department of State Health Services, which has not yet started its rulemaking process.
The bottom line for patients: Don’t expect to get the treatment from these statutory clinics in the near future.
And for potential clinics: same, but further: It’s not a slam dunk that these statutorily approved clinics will ever see the light of day in Texas. After all, the Texas stem cell law bumps-up hard against federal law. Texas is a very conservative state, medically speaking. I have been dealing with the TMB and the AG’s office for 30 years, and I can tell you they are deeply committed to protecting the public against what they feel are unsafe or questionable medical practices. I think the HB 810 conflict with federal law is likely to cause some serious reflection on their part, and I think they will be very, very cautious in light of all the negative PR about the private stem cell clinics. But we’ll see.
And speaking of the drone of negative information about private stem cell clinics:
Of course there continues to be the hand-wringing and fear mongering about the private medical clinics and how the FDA is not doing enough to regulate them (read, put them all out of business). Expect the drum beat to continue, with citation to the same three eyeball injection/blindness cases brought to you by those idiots in Florida, along with the dangers of the deadly viruses used by the California stem cell physician group, that is, until there is a new stem cell horror/ fear inspiring story.
But there’s also a new PR tactic: mock those who say there is a conspiracy between Pharma, government, the stem cell academic institutions and stem cell trade groups to pressure the FDA to shut down the private stem cell clinics. I don’t know about Pharma’s role, but I suppose my constant use of the phrase “Stem Cell Mafioso” makes me a member of the conspiracy mongers. I’ve been called worse.
I’m going to be an adjunct professor! (for two hours anyway)
I’ve been asked to speak about stem cell regulation at a major university health law center graduate seminar on healthcare controversies. I was flattered to be asked, especially when I heard that the other speaker (pro-regulation) was Professor Leigh Turner, who is half of the Knoepfler-Turner team which published the seminal article about the 500 plus unregulated, wild west stem cell clinics, which article has been one of the key justifications of the aforementioned Stem Cell Mafioso’s efforts.
For sure, we’ll talk about the recent California and Texas stem cell laws, but I hope to broaden the discussion out to the role of medical innovation and restrictions on innovation. I think I’m also going to talk about the myth and limitations of evidence based medicine. I haven’t stepped foot in a law school lecture hall since law school, and that was when most of the original Saturday Night Live cast was still on the show. Yikes!
Any ideas of what I should talk about or what I should ask Professor Turner?
Should be interesting for a guy who lives in the trenches to have a brief visit to lofty academia.
Rick Jaffe, Esq.