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The year in review and some predictions about next year/ Part One: Stem Cells

The year in review and some predictions about next year/ Part One: Stem Cells

It’s time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells.

We started 2017 awaiting the FDA’s final guidance documents on HCT/P’s (“stem cells”). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/P’s were in violation of the FDA trifecta (unapproved new drug, misbranding and adulteration), and that their facilities were not in compliance with applicable good tissue and manufacturing practices.
Here is my post about it:

Within two months of the warning letters, the FDA published the final guidance documents. They were at least as bad (from the perspective of these clinics and the patients which seek out non-FDA approved stem cell treatments) as the draft guidance documents.

See my prior post analyzing the final guidance document:

On the other hand, two states passed stem cell legislation. California passed a meaningless law aimed at providing informed consent to patients.

See my post at:

Texas passed a stem cell law which could allow patients to use both autologous and allogenic stems cells therapeutically (or in FDA parlance, “non-homologously”).

The law won’t open-up the floodgates because of the relatively high barriers to entry (i.e., the cost of an ambulatory surgical center, and the big-time IRB requirements), but as I’ve said, as long as the Texas Medical Board doesn’t mess it up, Texas could become the Mecca for the therapeutic use of stem cells.

here is my post about it:

And yes, Congress did pass some legislation involving stem cells, but it just deals with supposedly faster approval. It won’t cause a single patient to receive stem cell treatments in 2018, or so is my prediction. The bill was just a tactic to get stem cell advocates off of Congress folks’ back.

Finally, last week, a civil lawsuit was filed against the Florida clinic which has become the poster child of the “greedy and evil” for-profit, heretofore unregulated stem cell industry. These are the folks that had a nurse practitioner inject HCT P’s in the eyeballs of patients and allegedly caused blindness or reduced vision. That’s bad news for them and all of the stem cell clinics in the intermediate term. It’s going to take a while for the case to reach any meaningful result. But the institutional stem cell Mafioso will surely keep banging the drums about this case to keep the pressure on the FDA to do more.

What’s going to happen in 2018 in the stem cell field?

For sure, the FDA will try to pick-off a few more clinics by starting the process of inspections, issuing 486 field reports, and then following-up with warning letters. I expect to see one or more of the recipients of these warning letters to be involved in litigation with the FDA. However I don’t expect any court rulings until at least mid to late 2018. As I said before, if the first case decided involves the Florida clinic involved in eyeball injections, the stem cell field won’t like the result.

Are private stem cell clinics going to disappear from the US in 2018?

Absolutely not! If anything I think 2018 will bring more options to patients in terms of use of their own stem cells and even umbilical cord stem cells and other HCT/P’s.

You might ask how I can possibly think this in light of the final guidance documents and the FDA’s recent warning letters?

I think the delivery of these new therapies is going underground. My read is that more and more physicians are quietly using HCT/P’s in their practice. Therefore, I think that in 2018 and beyond, more people will have access to these treatments, but not necessarily through the large, high profile stem cell only clinics, because some of them will be mired in legal battles with the FDA.

Won’t the FDA shut all of these stem cell docs down?

I don’t think so because the FDA doesn’t have the resources or infrastructure to eliminate the clinical use of stem cells.

More in the weeds: more doctors are using stem cells in their clinical practice. The FDA isn’t equipped to go after all of these practitioners, because its structure, resources and operations are geared towards drugs, not the practice of medicine. (And the practice of medicine just happens to be the best defense these docs have, albeit, not recognized by the one case in which it was raised, but more about that another time).

Equally important, patient demand is too great, and more and more physicians are seeing the dramatic benefits of these treatments.

I predict that many more docs will start using stem cells because of these two factors, and FDA be dammed. Ultimately, I predict that the popularity and the anecdotal evidence of success will prevail over the FDA and the stem cell Mafioso. So while the FDA may pick-off a few of the large, high profile or infamous clinics, I think there will be as good, if not better access to these innovative treatments in 2018. That is my prediction and hope.

Richard Jaffe, Esq.

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Texas stem cell legislative battle goes down to the wire, but alas, it’s less the meets the eye

Under current law, it is illegal for patients to have their own stems cells removed, cultured/expanded and reinjected. That’s too bad because there are plenty of instances where this treatment seems to be helping patients with incurable chronic diseases such as MS. Patients who want this type of treatment have to go abroad, usually either Mexico or Panama. That’s quite burdensome for some, given their medical problems.

Texas MS Patients to the Rescue, (maybe)

During the current Texas legislative session, a group of deeply committed Texas stem cell patients have been leading the charge to change the law in Texas, to allow patients access to their own cultured/expanded cells and even allogeneic stem cells.

The bill they have championed, HB 810, passed the Texas House easily and just a few days ago passed the Senate, and Governor Abbott has promised to sign it. So all good right? Well, actually no.

There’s a hitch and it’s a big one.

In Texas it’s easy to kill a bill, and very hard to pass a bill if there is any opposition whatsoever. And there is a lot of opposition to this bill, some visible and some, I believe, behind the scenes.

How to cut the heart out of a bill

One of the nastiest ways to kill a bill is to gut it with an amendment; by making it meaningless via a seemingly innocuous and reasonable addition. That’s exactly what the Senate did to HB 810. My guess is that there were one or two Senators who were told by the powers-that-be,(and that would probably be the Texas Medical Association and the Texas Medical Board) to kill the bill, and this Senator or two, convinced the other Senators to go along with the changes, with the other Senators not realizing that they were actually killing the bill.

HB 810

HB 810 gives people the right to use their own cultured stem cells and even other adult stem cells (meaning from umbilical cords and from humans, but not fetal stem cells) as long as the use was part of a “clinical trial.” However, HB 810 did not say that it had to be an FDA approved clinical trial, and that is important. So HB 810 would allow doctors to do their own non-FDA approved clinical trials. That’s critical because getting the FDA to approve a clinical trial, via filing an IND (Investigational New Drug application) is a very, very expensive and time consuming process and well beyond the abilities and financial wherewithal of doctors and clinics.

Under the bill, a physician had to agree and certify that the treatment was necessary, and of course there had to be informed consent. But that’s basically it. HB 810 would have dramatically opened the doors for patients with all kinds of diseases to receive their own expanded cells and someone else’s stem cells in Texas.

HB 810 is good news for patients, but bad news for the establishment types

That would be very good news for patients with chronic, incurable diseases who are willing to accept the risk of undergoing treatments which haven’t been approved by the FDA. But it would be very bad news for the stem cell research Mafioso, the guardians of the Holy Grail who are trying to corral everyone they can into FDA approved clinical trials. It would be worse news for the medical establishment types who have the heartfelt belief that patients need to be protected from their own foolishness, and the false hope that their own stem cells might be able to help cure or mitigate their condition, or that these foolish people have the right to try this kind of treatment in the U.S. These folks have decided that they decide when patients can use their own body parts.

I surmise that some of these establishment types had some quiet conversations with one or two state senators and were told to kill HB 810.

Here’s what they did, and regrettably, it’s good.

The HB 810 Bill-Killer’s Amendments

1. The Senate bill added a provision that the use of stem cells sanctioned by HB 810 has to be in accordance with 21 CFR 1271, which is the section of the federal code of regulation which states that autologous, expanded stem cells (your own stem cells which are cultured) and someone else’s stem cells are drugs and cannot be used until they are approved for marketing by the FDA (or under an FDA approved clinical trial). This completely eviscerates HB 810. The whole point of the bill was to allow patients to get stem cell treatment which did not comply with 21 CFR 1271. It’s already legal to use stem cells which are 1271 compliant, so… well you get the idea.

2. Another Senate amendment requires that the stem cells can only be administered in a hospital or ambulatory surgical center. That’s a very expensive proposition and basically puts stem cell treatment beyond the reach of most physicians. By the way, this was the same tactic used in the Texas abortion law to effectively outlaw abortion clinics, (which provision was, I believe, struck down.)

3. Finally, the Senate amendment proposed that stem cells can only be given if their use is approved by a university or big hospital IRB (Institutional Review Board). I can tell you that no university is going to approve non-FDA approved stem cell treatment unless the clinical trial is approved by the FDA, via the full IND process. Further, stand-alone big hospitals don’t have a full IRB, and those which do research and have IRB’s are not going to jeopardize their on-going research by using or allowing their IRB’s to sanction non-FDA approved drugs to be administered outside of FDA approved clinical trials. For these folks, there is no such thing as a non-FDA approved clinical trial of a non-FDA approved drug. Practically speaking, this makes it very difficult to impossible for a physician to deliver these unapproved stem cell treatments under this Seanate amendment.

There are only a couple days left in the current legislative session. While there is still time to negotiate, my guess is that the Senator(s) who introduced these amendments, who did so to kill HB 810 is (are) not going to back down, barring some almost miraculous level of public pressure put on him (them).

Here’s hoping……

Rick Jaffe, Esq.