Risky Pro-Stem Cell Clinic Bills Still Alive in Texas Legislature

The Texas Legislature is considering three risky bills that would give free rein to stem cell clinics to profit big time off of patients by selling unproven and unapproved “stem cell treatments” that have little if any science behind them. I call one of these bills “Right to Profit” for clinics, which if these became law could get millions from vulnerable patients and potentially block patient rights.Texas Representative Drew Springer

Some of these bills including HB 810 reportedly got a boost from emotional, teary-eyed testimony from Texas Representative Drew Springer (photo from Texas State Directory), who talked about his wife being paralyzed and how stem cells via these bills would help her. From the Dallas News:

“Maybe my wife will walk,” said Springer, whose wife is Lydia paralyzed from the waist down from a diving accident. The next bill on the calendar would affect experimental stem-cell treatments.

“I’ll be damned if we don’t have a chance tonight that would open the doors to science,” he said.

In large numbers, Republicans flanked Springer at the front of the chamber. The GOP rebels relented, letting the stem-cell bill win tentative approval.”

I wish all the best to Springer and his wife. Unfortunately, these bills have little to do with actual stem cell science.

The bills aren’t fully passed by the Texas House yet as they at least must get through another vote and then even if they survive there, they have to get through the Texas Senate, but unfortunately this is a move forward for the bills.

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? Continue reading

SCOTS, Selling Stem Cells, & More Patient Claims of Blindness

Have more patients been blinded by stem cell clinics?

The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning of information beginning to flow on negative outcomes for patients who are customers of stem cell clinics selling non-FDA approved offerings. The NEJM authors linked the loss of vision to interventions received by patients from the publicly-traded company US Stem Cell, Inc., but different patients also in Florida have been alleging that they were blinded by a different entity, the “SCOTS trial”.

Steven Levy Jeffrey Weiss

Drs. Steven Levy & Jeffrey Weiss, leaders of the SCOTS trial.

I’ve blogged about SCOTS several times before including the patient allegations of being blinded and various other concerns. Now there’s a new BBC investigation on these allegations reported in a striking radio broadcast.

Two physicians are central to the SCOTS trial, Drs. Steven Levy and Jeffrey Weiss. A number of patients have alleged negative experiences including patient George Gibson, who is one focus of the BBC report. But by contrast another patient named Doug Oliver has said that he had very good results from SCOTS. How do we in the broader stem cell community try to understand the SCOTS situation? It’s difficult right now, but can we learn anything from the BBC investigation? Continue reading

Top 10 reasons for optimism on Stem Cell Awareness Day 2016

Happy Stem Cell Day!

It is a tumultuous time for the stem cell and regenerative medicine fields, but despite this there are concrete reasons for optimism on this Stem Cell Awareness Day. I’ve listed my top 10 below. What else gives you a sense of optimism? You can also check out CIRM’s nifty stem cell awareness day page too, from which I borrowed the below image.stem-cell-awareness-day-2016

  1. More trials = road to progress. There are more real, robust clinical trials than ever and they are progressing past the early phases in some cases. The trials are piling up and while not all will succeed, some will. Keep an eye open for the for-profit, non-FDA-approved ones and steer people away from those.
  2. We are seeing a flow of clinical trial data too pointing to encouraging outcomes, but also to challenges to overcome (witness the preclinical study on IPSC for heart attacks that found efficacy but also arrhythmias). With that kind of awareness such hurdles can be overcome in many cases as the work progresses.
  3. The FDA held public meetings on stem cells. We can grouch about certain things about these meetings and we can ding the FDA for various issues, but it never before has engaged with the community like this on stem cells so it’s a good thing.
  4. Stem cells firing on all cylinders: adult and pluripotent. Adult stem cell trials are building, but so now are pluripotent ones. The best way to help the most people in the long run is with all the tools (types of cells) we can utilize. The notion of “adult versus embryonic”, for instance, as some sort of cosmic battle seems out of date. We need both and also IPSC as well as other types as yet to come.
  5. The stem cell clinic problem out in the open. Never before has there been this much information and awareness out there on the problem of stem cell clinics taking advantage of vulnerable people. For instance, see my recent article with Leigh Turner and the one from John Rasko’s group. I believe awareness will translate into action for the positive.
  6. Putting the fun back in funding? NIH funding trends are looking at least slightly better overall which will help with stem cell research. CIRM is continuing its life extension and will fund many more projects in years to come. Other states are funding stem cell research too. It’s still a bad time for funding but the trend lines are at least moving the right way.
  7. Much more educational outreach on stem cells. When I started blogging about stem cells in early 2010 it was very quiet out there on the Internet in terms of those of us trying to educate a wider community in a positive manner. That’s really changed now with quite a few blogs that at least touch on stem cells and a number entirely dedicated to stem cells and regenerative medicine. This is a positive change and it means the public has more resources than ever to learn about stem cells.
  8. IPSC clinically-relevant work is looking up. It was a decade ago that IPSC cells were “born” and there were great expectations. Now 10 years later there are tangible signs that these cells will have lasting, huge impact including both from disease modeling and more recently via potential future clinical use.
  9. Stem cells meet CRISPR and…boom! Okay so everyone is nuts about CRISPR no matter what kind of cells they study including me, but CRISPR-Cas9 gene editing combined with stem cells in particular equals great potential both for new insights such as into human development and also potentially clinically through designer stem cells.
  10. Stem cell biotechs & stocks hanging in there. It has always been tough going for stem cell biotechs and that is likely to continue quite a while longer, but many are hanging in there and could surprise you down the road. Others have been acquired by pharma companies or inked collaborative deals in the last year or so. In the long run some of these companies are going to change medicine.

Report on day 2 of FDA stem cell meeting: patients, researchers, & more

The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on average about 350 people were watching the webcast of the meeting both days.

fda-stem-cell-meeting-day-2

Screen shot from FDA stem cell meeting webcast

The patients gave powerful, often emotional testimonials today on their experiences at various stem cell clinics including Celltex and most prominently Stemgenex. I think there were 7 of its patients who spoke. I have no doubt of the patients’ sincerity in their belief that they’ve been helped.

Various stem cell clinic doctors also testified.

As with yesterday, a common statement was that there are “no side effects” of stem cell treatments, which is concerning as all medical therapies have some risk of side effects.

Continue reading