Browsed by
Tag: 21 CFR 1271

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.

rickjaffeesquire@gmail.com