H

e made the emotional plea to his colleagues: Pass this bill.

“It might give somebody like my wife a chance to walk,” Texas Representative Drew Springer said through tears late Thursday at the state Capitol in Austin. “I’d trade every one of my bills I’ve passed, every single one of them, to get the chance to hear HB 810.”

HB 810 is one of three bills being considered in the Texas Legislature that would make it easier for sick people to try unproven therapies at their own risk, and cost. Springer’s bill would allow clinics offering unapproved stem cell treatments to treat patients in Texas. HB 661 would permit people with chronic illness to get therapies in early-stage clinical trials — not just terminally ill patients, as the state’s current “right-to-try” law does. And HB 3236 would allow companies to charge patients for unproven therapies.

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The debate in Texas echoes a national discussion over how much access patients should have to experimental drugs. For the lawmakers supporting the measures, the issue is about the ability to make one’s own decisions about health care and not let bureaucracy get in the way of that. But for stem cell researchers and many patient advocates, the bills are dangerous; they make it easier for people to be fleeced or potentially harmed by treatments with little evidence suggesting that they work, or are safe.

“When patients get desperate, they have a capacity to suspend disbelief,” said Sean Morrison, a stem cell biologist at the University of Texas Southwestern Medical Center in Dallas. “When offered the opportunity of a therapy they believe in, even without data and if the chances of benefit are low, they’ll fight for access to that therapy. The problem is there are fraudulent stem cell clinics that have sprung up to exploit that.”

The personal appeal from Springer, whose wife is paralyzed from the waist down, has worked, at least for now. HB 810 and the other two bills passed the House on Friday with no opposition. They have now moved to the Senate, which only has two weeks to take them up before the Legislature breaks on May 29 for two years. Governor Greg Abbott has indicated he supports HB 810.

Stem cells hold tremendous promise as therapies, but experts say they are still experimental and are not ready to be widely deployed outside regulated and limited trials. Yet clinics offering unproven, and sometimes dangerous, stem cell treatments to eager patients have proliferated around the country in recent years even without the state law, there are at least 71 clinics selling unapproved stem cell therapies in Texas alone. Stem cell scientists fear that the Texas bill would lend legitimacy to the field, provide false hope to patients, and even embolden hucksters touting stem cells as miracle cures for everything from diabetes to multiple sclerosis to spinal injuries.

“It may sound like an appealing idea to allow seriously ill patients accelerated access to experimental therapies,” Sally Temple, the president of the International Society for Stem Cell Research, wrote to Texas lawmakers this month. But “in the absence of full clinical testing, these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”

“When offered the opportunity of a therapy they believe in, even without data and if the chances of benefit are low, they’ll fight for access to that therapy.”

Sean Morrison, stem cell biologist at the University of Texas Southwestern Medical Center

In the letter, Temple also wrote that the bills “would cost more lives than they save” and “will undermine confidence in Texas’ medical system.” She cited the three women who were blinded after receiving stem cell procedures at a Florida clinic. At least one of the women thought she was participating in a clinical trial.

For the most part, stem cell clinics and their claims are unchecked. They have largely avoided regulatory scrutiny because they typically take a patient’s own stem cells and inject them back into the person, meaning the cells are considered “minimally manipulated,”  taken, perhaps, from belly fat, purified, and injected near the person’s knee. Plus, stem cell clinics typically do not publish data about their interventions and their patients’ results, so outside researchers have not been able to verify even their supposed successes.

“If these clinics really did have a cure for something, you think they would collect systematic data and publish it in a journal, so people would know,” Morrison said.

In a phone interview the morning after his speech, Springer, a Republican who represents a North Texas district, said he wanted to maintain some level of oversight for stem cell therapies and that the state attorney general’s office or health department could step in should problems arise. But he said he leaned toward letting people have treatments they think can help them, especially because the drug approval process takes so long.

Springer’s wife was injured in a diving accident when they were dating and has been in a wheelchair since. He said they stored cord blood from when one of their children was born 16 years ago in hopes that the stem cells from that could one day help his wife. For now, he wants the Texans who head to places like Panama and China for stem cell therapies to be able to get them in their home state, under state law.

“We do have a responsibility not to let every snake oil salesman come in,” Springer said, “but when we do have these rays of hope, we have to make sure they’re available.”

Springer is only an author of HB 810, not the other two measures. The lead authors of the other two measures, Republican Representative Tan Parker for HB 661, and Republican Representative Kyle Kacal for HB 3236, did not respond to requests for comment.

HB 810 would give some legal recognition to the stem cell clinics that are already operating in Texas, an indication that troubles some researchers. Paul Knoepfler, a stem cell scientist at the University of California, Davis, co-led a nationwide survey that found Texas has more stem cell clinics than many other states, but that the businesses were part of a national pattern. But he said he hasn’t seen other states consider the types of policies Texas is weighing now.

The “kind of murky status quo” that exists now for regulating stem cell clinics “is quite different than there being laws on the books that explicitly say that what the clinics are doing is legal at the state level,” Knoepfler wrote in an email.

A few years ago, in one famous case, a Houston company, Celltex Therapeutics, moved its treatment operations to Mexico after a warning from the Food and Drug Administration. But experts wonder if the FDA would take such an action again if the bills became law in Texas, even though the agency would still maintain its authority to do so under federal law. That concern also stems from the feeling that the regulation-averse Trump administration wouldn’t endorse such actions, especially because Vice President Mike Pence is a proponent of right-to-try measures and Energy Secretary Rick Perry, the former Texas governor, credits a stem cell treatment from Celltex for helping relieve his back problems.

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Perry’s story and Springer’s emotional testimony highlight the uphill battle scientists have faced in recent years as right-to-try laws have been passed around the country. Powerful personal stories of patients cured by unapproved drugs or who die before they can get access to an experimental drug have swayed many lawmakers from both parties.

“They look at us like we’re the devil, which pisses me off because we’re doing it the right way,” said David Bales, the chairman of Texans for Cures, a stem cell research advocacy group that opposes the three bills as written.

Bales’s group wants to fund legitimate clinical trials involving stem cell treatments to help determine in what ways the cells can help patients. But for now, its top target is stopping HB 3236, which would open the door to patients paying for experimental therapies. Virtually all reputable clinical trials provide experimental treatments to patients at no cost and often even pay participants for their effort.

“We don’t think that patients in the most vulnerable positions should pay for an unproven drug,” Bales said.

Springer, the state representative, said he had not spoken to the governor about HB 810. But Abbott, who has been paralyzed from the waist down since a 1984 accident, when a tree branch fell on him while he was out for a run, tweeted a message of support to Springer early last Friday.

“I look forward to signing HB 810,” the tweet said.

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  • I was diagnosed with early onset parkinsons 19 tears ago. I was 38. I started a brand new drug and went through hell from side effects that I had. (Only 3% were shown to get them), gained 78 lbs in less than 4 months, spent almost 500k gambling and shopping, just took a complete 180 from the person I was.My personality became ugly and unkind. Almost lost my family, home, good friends. But thanks to the love of those closest to me, they knew it wasn’t “me.” Changed meds and was a different person after about 6 months. Had to be weaned off slowly. I have had 4 brain surgeries since then. A few weeks ago I saw a stem cell ad on the internet and requested more info. What I got were endless rude sales calls trying to hard sell me this treatment even after I told her I couldn not afford it now. There were a few videos posted on the site also, but there were no stats or true evidence it would work. These people made it sound so easy. If I would not have already gone through my own struggles I probably would have been convinced, but even though I do understand the science behind it, I will wait until there is unequivocal evidence that I will get at least some positives from it. I cannot deal with any more negatives. Oh, the drug that caused my problems was very new on the market and I believe if had it tested on humans longer, the percentage would have been way more than 3%. I would have stayed on it had I not had my problems because it worked better than any other meds since. My advice is don’t jump the gun. If you waited this long a little while longer won’t matter. They are on to something obviously, but just have not perfected it yet. Your remaining health is not worth doing something you may regret later. If and when this procedure is perfected, don’t you think it will be celebrated as the breakthrough of the century? Wait for the celebration.

  • I have had MS for 34 years. I have been to Panama, the results are unbelievable. I would be the first in line if Texas passes this bill. Were do I find out who’s will be doing this if passed. Thanks so much Roger Schuerbaum

  • This is so good to have the chance to get Stem Cell therapy in Texas because flying to Panama is so difficult when you cannot walk. I live in Grapevine Tx and understand a Dr. in Nearby South Lake is one of the Doctors who has been responsible for the stem cell therapy in Panama and I have met 2 people with MS that now can walk again. There ate several people who are able to walk again. It is expensive but to have to make a long flight also when it can be done here in our state is the right choice and I thank all who voted for it!

  • I don’t understand your point. I am not against research with stem cells I just don’t believe that people with the problems should be subjected to taking medication that is unproven in terms of recovering anything and unproven in terms of safety

  • Typical Texas. The hell with science, treat medicine like any other business, get the suckers to pay. Government shouldn’t regulate anything.

  • Mr. Bales doesn’t get it. The only reason patients are in this “fight” to begin with is that we are mostly LAST RESORT patients. Try thinking about us, instead of yourself!! The FDA drugs caused me physical and mental distress and damage that might be beyond repair. When you feel relief for this first time in years, using adult stem cells, you can bet your boots, I’m going to fight for others to have access to this.
    So, Mr. Bales, sorry to piss you off, but the feeling is quite mutual.

  • Scientists are overstepping their bounds when they wade into treatments that are medical procedures. There’s big money at stake here; that’s the reality behind all the fear mongering. Endless grants, not to mention the patents many scientists have make for a huge conflict of interest. Big Pharma can’t profit from simple medical procedures done by doctors. The dream is off the shelf products that can be mass produced. As for Bales, his group enjoys magnificent fundraising events, but just where are all those clinical trials. Too many years have gone by with little to show from such efforts. Patients grow weary of healthy academic elites and advocates who ignore the science that is already there along with thousands of published studies showing that adult stem cell therapy is safe. Patient testimonials are ignored as they attempt to throttle those who dare say that treatment helped them gain a better quality of life. Thankfully Texas is trying to do the right thing for patients. I’ve had treatment which completely changed my life for the better. You can now kill yourself legally in many states and that seems to be okay, but try to better your life and a barrage of conflicted scientists and other groups want to take that freedom away. It makes little sense unless you follow the money trail. Who are these people to tell patients how to spend their money or what to do with their own body parts? It’s as despicable as anything I’ve ever been through in my life. It needs to stop. The media needs to start doing its homework too. Vet sources for conflicts of interest, find out how many patients have actually been harmed by stem cell treatment rather than just using sources that don’t want anyone to know that the number is ridiculously low.

  • Problem with those advocating that unproven clinics are dangerous are simply dealing with demagoguery, because the statistics show differently. Taking the ball out of their court and moving into the medical procedure courts takes their control over it and not to mention the millions in research grant they get. The supervision of state medical boards should suffice as thousands of previous medical procedures have proven to be successful in the past and continue to do so.

    • Patients are going to be much safer if they are able to avoid going abroad for stem cell therapy, and get treated in the U.S. instead.

  • The real danger that Texans do not get is that as the 71 snake-oil clinics multiply, and patients get worse, the public might well become doubtful of “proven” stem cell interventions leading to a chaotic hit-or-miss search for cures among the public. This law is like Texas’ concealed carry law – short-sighted.

    • So your argument is patients should wait because otherwise it might mess up the market for an eventual patent stem cell? THAT is exactly the problem.

      We aren’t lab rats, or “markets” for the taking by the medico-research-acadamia complex. We are people and we have a God given right to self determination including to buy stem cells for ourselves if we would like to try it.
      If it doesn’t work the same patients will gladly cheer on your better effort when it is available and sign themselves up.

      Problem is your “better effort” may not be here for a decade. I know it doesn’t matter to YOU if I don’t make it, but it matters to me.

  • thank you for this article. the proposed texas legislation is a step in the right direction. it properly balances the desire of prospective patients to take advantage of a safe and effective therapy, while preserving the regulatory oversight of the state. i have personally benefited from adult stem cell therapy. i traveled to nanjing, china for mine. hopefully, future recipients can receive theirs here in the u.s. other states should follow texas’ lead, making adult stem cell therapy accessible and affordable to those who, in consultation with a qualified physician. are eligible.

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