3 Dangerous Texas Bills Would Boost Stem Cell Clinics

Texit stem cells

The Calexit and Texit state secession campaigns for California and Texas to leave the union, which are linked to Russian President Putin, are never going to be successful. However, if some Texas lawmakers and stem cell clinics there have their way, Texas would take a big step away from the rest of us on the stem cell front, endangering patients. Such a development would strongly contrast to all the great, cutting edge stem cell research going on in labs across that state. Somehow this major development has not been covered yet by national or even Texas media.

What’s the scoop?

Three bills are pending at the Texas Capitol that if passed and signed into law would pave the way for unproven, risky stem cell therapies to be sold much more readily to patients by clinics. The Texas stem cell bills include HB 661 and HB 810 by Rep. Tan Parker, and HB 3236 by Kyle Kacal. You can learn more about the bills by following direct links to each bill here, here, and here.

HB 661 seems to be a very loose kind of right to try effort that concerningly would extend it from restricted just to patients with terminal illnesses to also those with chronic conditions that could be just about anything. In a sense, a stem cell clinic’s own doctor perhaps could decide whether their patient/customer has a chronic disease that is eligible. How often would the clinic doctor say “no” since that would mean the patient would not get the treatment and so would not pay them big bucks?

Stem cell cartoon

HB 810 is a stem cell-specific kind of right to try bill that would greatly lower oversight standards and put patients at greater risks. The third bill, HB 3236, is what I call “Right to Profit” for the clinics because if that bill passes then the clinics would have free rein to make millions in profits from vulnerable patients. How would that be a good thing for most Texans? It wouldn’t. In fact, I see it as a consumer ripoff bill.

Other than stem cell clinics, it’s hard imagine many fans of these bills. Most people I have talked to strongly oppose them including top stem cell scientists in Texas. The organization Texans for Cures, which has been very balanced, sensible and supportive of stem cell-based regenerative medicine for many years, strongly opposes these bills too. Here’s a statement from its Chairman David Bales:

“After careful examination of HB 661, HB 810 by Rep. Parker and HB 3236 by Texans for Cures Medical Advisory Committee, which includes leaders like Dr. Doris Taylor and Dr. William Decker, we decided to vigorously oppose all three bills because they jeopardize patient safety and responsible research in the State of Texas”.

There’s broader opposition too. For instance, the largest global stem cell research organization, ISSCR, is opposed to these stem cell bills. You can read more about ISSCR’s viewpoints in a letter from its President Sally Temple to Texas lawmaker Todd Hunter. Here’s a big picture quote from the ISSCR letter:

“…these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”

What businesses exactly would stand to benefit mostly at the expense of patients?

In our survey last year, Leigh Turner and I found 71 stem cell businesses in Texas that did not appear to have FDA approval for selling stem cells to consumers so these kinds of companies would likely stand to profit from the trio of stem cell bills under consideration. When I think of stem cell clinics in Texas, one called Celltex specifically comes to mind. It is most famous for having transplanted experimental stem cells by the billions into then governor Rick Perry. I was fortunate to have the chance to have met in a small group with Perry some years ago here in California. It was clear he genuinely felt that the infused Celltex stem cells had made a positive difference for him, but collecting and impartially analyzing data from a large group of patients including experimental controls is the only way to be sure about this kind of still unproven clinical science.

What’s the back story on Celltex? Celltex was one of the first high-profile stem cell clinics in the U.S. Despite its friendly relationship with Perry, it ran afoul of the FDA some years back. After that it headed south for the border to do its clinical transplants in Mexico even as it remained HQ’d in Texas. I’ve covered Celltex on this blog in the past and you can see archived posts here. Over the years of blogging occasionally about Celltex I’ve been verbally attacked and even threatened by some of their supporters so there are clearly strong feelings out there.

Since federal law trumps state law it’s unclear what would happen if these bills pass. However, with Donald Trump and Rick Perry, who is now DOE Secretary, both in power at the federal level, and uncertainty about the views of future FDA leadership on stem cells, maybe the feds would back down on stem cells if Texas passed these laws? That’s probably what the folks backing these bills are daydreaming about as they imagine the future. Their wish is likely that Trump & Perry will lean heavily on the FDA to back off. Such political pressure on the FDA is possible and in theory could work, but it would be a really bad thing for both patients and the FDA itself in terms of its reputation if it backed down.

“Now, hold on, Paul,” you might say, “these laws are only about making promising stem cell therapies available to needy patients!” As much as that sounds good, I believe that’s not true. No one is more bullish on stem cells than me, but despite their great longer-term potential both for healing patients and boosting the economy, mostly they are not ready.

The stem cell field has good momentum now and I believe new game-changing therapies are coming via several types of stem cells including adult stem cells, but unfortunately it takes time so if you take shortcuts you can royally mess things up and harm many people. Today most of what is offered for sale on the stem cell front directly marketed to patients by clinics is more hype than hope. These Texas bills would end up just helping the clinics and risk harming patients with new health risks and big hits to their wallets. The US stem cell field, including physicians and scientists working hard every day especially in Texas labs, but also all across America, also stands to be harmed by these bills.

If you are a Texan and find this situation concerning please call your representatives and tell them to oppose these bills. There is a reasonable chance that these bills will never become laws, with them particularly likely facing opposition in the Texas Senate, but you never know. Make a difference by helping to make sure this ends right.

11 thoughts on “3 Dangerous Texas Bills Would Boost Stem Cell Clinics”

  1. Dear Admin:

    Announcing and providing the three new bills for off-protocol treatments with investigational stem cell medicine therapies is a good public service that you provide to your readership. But you should also read the proposed legislation. It is modeled very closely after off-protocol and compassionate care exceptions that have existed for decades for unproven investigational pharmaceuticals. Your charlatan exploitation narrative is not only opinion, in this case it is irrelevant opinion, bordering on obtuse logic. Of course, you are joined by many other alarmist scientists in this erroneous vilification of the bills and their intent. So, your stated motivation – to protect patients – is simply not credible.

    These bills legislate specifically regarding INVESTIGATIONAL stem cell treatments that are already in FDA-approved clinical trials. The bills simply give extremely ill and suffering patients, in consultations with their physicians (who may or may not be trial sponsors), the opportunity to try investigational therapies that have not yet demonstrated safety and efficacy profiles required to become an FDA-approved treatment. In many cases, these therapies will in fact have already been evaluated for safety; and in all cases they will have undergone sufficient scientific inquiry to obtain an approved IND. Moreover, the outcomes of off-protocol treatments are often still available to clinical trial developers for factoring into trial evaluations and future trial design. Alarmist scientists should not conflate these important considerations for patients’ medical autonomy, in dire medical situations at the edge of existing scientific and medical knowledge, with “non-investigational” stem cell therapies in private stem cell clinics. Even the latter types of stem cell treatments are likely to have much more value for patients and stem cell medical science than the ignorance and arrogance of alarmists permits them to recognize.

    James at Asymmetrex

    James L. Sherley, M.D., Ph.D.
    Asymmetrex, LLC

    1. James,
      Your comment reminds of the expression, “putting lipstick on a pig” in terms of how you portray this legislation. It’s not been so simple or so pro-patient as you indicated. For instance, what about the forcing patient payments part for being experiment upon?

      The legislation on the whole in my view was not going to benefit patients or science. Over time because of the hard work of advocates such as Texans for Cures the legislation has evolved to be relatively much better and contain important protections for patients.
      We’ll see in the end what becomes law. It’s a moving target.

      Finally, your saying things like, “ignorance and arrogance of alarmists” isn’t helpful for constructive dialogue, and future comments with that kind of tone just won’t be posted at all.

  2. Daniel, you mention,” cleared trials” by Celltex. Please let us know how you define,” cleared” and by whom? We would like to know this information. Thank you.

    1. @David According to the quote in this article, your organization “vigorously opposes” these bills. I don’t know about the other two, but I watched your testimony on HB 810 before the house. During that testimony, you stated the your organization was “neutral”. Why the disparity?

      1. Hi Bill, we were still in discussions with both Rep. Parker and Rep. Kacal and had given them language we believed protected patients and responsible research by clearly defining clinical trials, and putting a cap on what patients could pay for an investigational drug. Ultimately, neither member accepted our language, so now we oppose them both. Feel free to contact me any time with any questions. Thank you.

  3. Jeanne A. Pawitan

    Dear Paul,
    In my opinion, to prevent desperate patients becoming prey is to educate them how to sue when bad things happen, and be careful when they are signing the informed consent.

    Be careful, not to sign that they will not sue. Be aware, what is their right, what are the promises, and what if the promises are not fulfilled.

    I think that it will be very valuable if you can make a blog about this, to educate the patients to be.

    I do not think that there were clinics that wanted to be sued. This will make them to take more care about the safety and efficacy.

    1. Paul, thanks for your blog and thank you for everything you do for stem cell science.

      These bills, HB661, HB810 and HB3236 do not allow anyone providing these unproven products to be sued by granting immunity from lawsuits. Also, the bills do not clarify the definition of a clinical trial and allow insurance companies to not cover these therapies. In addition, patients open themselves up to lawsuits. Seems like patients are giving up their rights.

      The bills could be vastly improved by adding language that would help protect patients and ensure that the collection of important data and information would not be lost.

      Patient should have a right to try the best medicines possible.

      1. Jeanne Adiwinata

        If the bills were accepted, the condition would be very bad for the patients.

        There should be efforts to make amendments to those bills

  4. Patients are doing stem cell therapy anyway and having to fly overseas just to get their cells introveniously back in them. I’ve not heard of any negative experiences from the patients themselves about CellTex. We the patients should have the right to try. If it’s left up to the FDA and big pharma, there’s no hope for us until they decide to develop a drug that they can sell which is just not starting for regenerative therapy.
    After reading several of your articles, it’s clear to me that you actually have no clue what you’re reporting on especially when it comes to these house bills. It seems your goal is to place fear in patients and steer them clear of the future of stem cell and the potential that it has for patients today. You just make subtle remarks making jabs at clinics that are actually doing cleared trials such as CellTex. With that being said, your reporting only angers me to the point of feeling the absolute need to comment, which I rarely ever do and so far, have done twice on your fake news reports. So, this is the last report of yours I will ever read and hope people actually research some of these clinics for themselves before drawing a conclusion based on your fake reports.

    1. @Daniel,

      As I write this blog, I have to call it like I see it (on opinions I write) and I’m careful about researching what I write about on the more factual/news side.
      When it comes to this “news” element of any particular piece, I aim to be completely factual in a way that is independently verifiable. If you have questions about the factual nature of specific things that I write about, let me know. Of course I can be mistaken at times.
      By instead saying inflammatory things like “you have no clue” and “your fake news”, what does that achieve?
      As to opinions, I don’t think we are going to see eye-to-eye and I understand that you disagree with my views.

      1. I respectfully disagree. I’ve followed this blog for many years. I have found the same “witch hunt” mentality with each passing article. Especially with articals aimed at CellTex and StemGenex. When there are SO many other snake oil sellers as you put it, makes me wonder now whose pocket you and Mr Turner are in? Far too many people have undergone treatment now with positive response and as Daniel mentioned, many having to go overseas all while the American people wait on the FDA and big pharma to come up with a means of them making big money off these treatments. It is a disgusting state of affairs. There are, in my opinion, far more complications and side effects to be had by taking pharmaceuticals for which have clearly been fast tracked due to the $$$ backing them than in undergoing stem cell treatment with ones own cells. For myself, I’ll take that risk as I have already done the many years of all these “miracle drug” remedies with no improvement and multiple side effects. I have, however, in fact, had many positive improvements having undergone adult adipose stem cell treatment.

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