Texas leans into unproven stem cell treatments, to the dismay of … – STAT
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. Id trade every one of my bills Ive 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. Springers bill would allow clinics offering unapproved stem cell treatments to treat patientsin Texas. HB 661 would permit people with chronic illness to get therapies in early-stage clinical trials not just terminally ill patients, as the states 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 experimentaldrugs. For the lawmakers supporting the measures, the issue is about the ability to make ones 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, orare safe.
With patients demanding experimental drugs, right to try is becoming the law of the land
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, theyll 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 billspassed 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 areat 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, theyll 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. Theyhave largely avoided regulatory scrutiny because they typically take a patients 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 persons 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 generals 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.
Stem cell clinics hawking unproven therapies sprout up across US
Springers 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 theyre 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 hasnt 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 wouldnt 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.
Perrys story and Springers 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 were the devil, which pisses me off because were 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.
Baless 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 ofteneven pay participants for their effort.
We dont 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.
Andrew Joseph can be reached at andrew.joseph@statnews.com Follow Andrew on Twitter @DrewQJoseph
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Texas leans into unproven stem cell treatments, to the dismay of ... - STAT