October 21, 2020

The Niche

Knoepfler lab stem cell blog

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.

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