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Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Over the Memorial Day weekend, the Texas Legislature passed amended HB 810, which allows access to autologous (yours) and allogenic (not your) stem cells. It is landmark legislation in that it is the first state law allowing access to stem cell treatments which are not FDA approved, and which do not fit within the narrow types of autologous stem cell treatments permissible under federal law.

Here is the amended bill awaiting the Governor’s signature. (The Governor has previously tweeted that he’s going to sign it)
ftp://ftp.legis.state.tx.us/bills/85R/billtext/html/house_bills/HB00800_HB00899/HB00810F.htm\

Bluntly speaking, the passage of HB 810 means that treatments which are illegal under federal law will be permitted, if given in Texas, at least under Texas state law.

That makes the Texas stem cell law analogous to the medical and recreational marijuana state laws, in that those state laws are in direct conflict with federal law. Another example of state laws in conflict with federal FDA law are the “right to try” laws which allow access to post phase 1 clinical trial drugs outside of FDA approved clinical trials, which is illegal under federal law.

Will the feds try to stop people from getting stem cells in Texas under the Texas law?

My guess is no for a variety of reasons. I don’t think the bill will open-up the floodgates to the kind of single doc small clinics based on the very severe limitations which the amended bill places of facilities and physicians seeking to do these treatments. For reasons which I’ll explain, you’re going to have to be big, well financed and well-connected to open-up a stem cell clinic in Texas which takes full advantage of the Texas law, meaning using cultured/expanded stem cells or umbilical or other allogenic (other people’s) stem cells.

The easy part of complying with the bill

To be eligible to receive stem cells under the bill, you’re going to need a certification from a physician that you have a terminal or chronic, incurable disease. That’s easy, since there are, regrettably, an overabundance of these types of conditions, anything from cancer, to MS, ALS and dozens more incurable diseases.

The patient is going to have to receive “informed consent” and maybe the Texas Medical Board will have a say in that, but that’s easy too. It’s experimental treatment, meaning that it hasn’t been proven by controlled clinical trials to be safe and effective. But these treatments are only going to be available for people with no other hope of cure, so informed consent won’t be much of an issue.

The Hard Part

The amended bill which came from the senate contained three onerous conditions. The first, which basically killed the whole bill, required that the treatments be in compliance with federal law. The whole point of the bill is to allow stem cell treatments not currently permissible under federal law, namely cultured/expanded autologous stems cells and umbilical cord and other types of allogenic stem cells. Fortunately, based on negotiations between the House and Senate, this provision was dropped, and that made the bill at least meaningful and possibly helpful to patients.

However, the House had to accept the other two Senate requirements to get the job done, and these limitations will mean that these type of stem cell treatments will probably only be available at a handful of places in Texas, at least for the foreseeable future. Here are the limitations on access to these treatments under the passed legislation:

1. Where you can get treated

The treatment will only be available at a hospital, medical school or ambulatory surgical center (“ASC”). In other words, you can’t get it at a regular physician’s office. Further, you can forget about getting these treatments at any medical school hospital because none of them (all of which do FDA approved research) are going allow the administration of non FDA approved drugs without FDA approval via the IND approval process (Investigational New Drug application). They get mega bucks from Pharma to do FDA clinical trials, and they’re not going to jeopardize that on so-called “unregulated human experimentation.”

The ASC (ambulatory surgical center) requirement was previously used by the Texas Legislature to eliminate or severely restrict abortions because individual physicians couldn’t afford to turn their offices into ASC level facilities. That might not be as much of a financial barrier in the stem cell arena since stem cell treatments are orders of magnitude more lucrative than abortions (hundreds of dollars versus 20k a pop for stem cells). Still, if a doc wants to provide these services, he/she will have to shell-out a few large, (as in millions) for up-front costs to create an ASC. That won’t be a problem for some of the popular off-shore stem cell clinics which had years to amass war chests awaiting their entry/reentry into the US market. Because of all the money in the field, ultimately, there will be players who will be able to either create ASC’s or partner-up with cash needy hospitals.

2. University or Big Hospital IRB Approval, Oversight and Paperwork Submission

The biggest impediment to unfettered access to unapproved stem cell treatments is that all stem cells under this bill must be given with IRB (Institutional Review Board) approval and oversight from a university/teaching hospital or large hospital IRB. As indicated, I don’t see any University IRBs granting IRB approval for the administration of non FDA approved drugs outside of clinical trials. But per previous, the lure of huge amounts of cash (and all these non FDA approved stem cell treatments are cash treatments) will induce at least some large but cash poor hospitals to try to set up an IRB and partner with or start their own HB 810 stem cell clinics.

The IRB requirement will stop every Tom, Doc and Harry from opening-up strip mall, doc-in-a-box facilities, and that’s probably not a bad thing. But it probably won’t stop the big off-shore or U.S, stem cell players.

Treatment will be expensive because the IRBs are going to have to maintain information about all patients treated and make annual submissions to the Texas Medical Board which takes time and money. The stem cell providers are going to have to give the hospitals and their IRBs their cut, while maintaining their substantial profit margins.

3. Texas Medical Board Approval of IRBs?

The bill allows the Texas Medical Board (TMB) to regulate the IRBs overseeing HB 810 stem cell clinics. I have a crystal ball and I’m getting a very clear picture that the TMB will decide to do so. Wait… I’m also seeing some language. Yes, I see the actual text of the TMB’s regulations of these IRBs. Here is what the TMB’s IRB regulations will look like:
In addition to being affiliated with a university or hospital per the bill, the IRB will also have to be accredited by the Association for the Accreditation Of Human Research Protection Programs, Inc. (AAHRPP) and be registered and qualified under the federal IRB statute (21 CFR part 56) dealing with human experimentation, or some other national accreditation organization recognized by the TMB.

Ok, my crystal ball isn’t that accurate, but I do know how to read the TMB’s current rules. The TMB already regulates IRBs overseeing the use of investigational agents, (Board Rule 198). What I’ve related above is what the TMB currently requires for IRBs supervising investigational agents. There is no reason to think that the Board will do anything other than apply this already existing board rule to stem cells.

4. Physician Compliance with Board Rules
The bill also states that a physician administering stem cell treatments must comply with all applicable medical board rules. That’s alittle vague for my taste. As an experienced Texas Board lawyer, it opens up all kinds of stumbling blocks and pitfalls. But we’ll leave that discussion for another day.

So here it is: Texas is poised to become the first state to allow the use of cultured/expanded stem cells, as well as umbilical and other allogenic tissue products outside of FDA approved clinical trials.

That is very good news for patients with terminal and incurable chronic diseases who chose to assume the risk of “unproven” treatment, (and I personally think this is a basic but heretofore unrecognized right). It’s bad news for the stem cell institutional Mafioso who wants to limit access to these treatment to FDA approved clinical trials.

The patient advocates (and the legislators) deserve a great deal of credit. They did an amazing and almost unbelievable job which will benefit many patients.

But my message to them is that it’s not over yet, even when the Governor signs the bill. The ball will go to the TMB’s court and there are many ways in which this can all go sideways.

So continued vigilance is the watchword.

Still, congrats on a job well done. Patients with incurable diseases owe you big-time.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

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