Industry, Political Players Drive Proposed Rules on Adult Stem Cell Therapy

When the Texas Medical Board called a stakeholder meeting in July to discuss the state’s burgeoning adult stem cell industry, it was at the behest of Gov. Rick Perry, the soon-to-be presidential hopeful who had just received an injection of his own stem cells, and of Stanley Jones, the orthopedist and biotech entrepreneur who performed Perry’s experimental procedure.

They hoped the board would establish rules that would foster the fledgling adult stem cell therapy — which is not FDA-approved and has so far had mixed evidence of success — not hinder it.

The board took another approach. In draft rules floated in August and again in November, the board suggested the treatment could only be offered if it was likely to have a favorable outcome. And it proposed patient consent forms listing the risks and benefits of the treatment, describing the science behind how it works and detailing the expected outcome for the patient.

But by last month, those elements had been stripped from the proposed rules, which come up for debate again on Friday. What happened in between, records obtained from the medical board show, was an aggressive campaign by key industry leaders, an interested lawmaker and university researchers to curb requirements they saw as duplicative and unnecessary.  

Perry, who has repeatedly and vocally opposed research into embryonic stem cells on moral and religious grounds, has no such qualms with adult stem cells — particularly when they could mean big business for Texas. During his 2009 State of the State address, he called on Texas leaders to invest in adult stem cell companies. His Emerging Technology Fund has awarded millions of dollars in grants to a stem cell business and a Texas A&M research center.

And David Eller, a major Perry donor and former chairman of the Texas A&M University System Board of Regents, has partnered with Jones and a South Korean company best known for cloning dogs to found Celltex Therapeutics, a Houston-based biotech firm that banks and grows adult stem cells.

In the last legislative session, right before Jones removed some of Perry’s stem cells and reinjected them into the governor’s spine during back surgery, Perry directed his staff to work with state Rep. Rick Hardcastle, R-Vernon, to push through legislation establishing guidelines for adult stem cell banks in Texas. The legislation, originally drafted by Jones and touched up by the governor’s office, could mean big business for Celltex and other such companies. Perry’s support of the adult stem cell industry “just goes along with the whole prospect of regenerative medicine he’s a big advocate of,” Eller said in an interview this week.

In July, two days before the medical board convened the stakeholder group to start discussing new stem cell rules, Perry sent a letter to its chairman, asking him to “recognize the revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life and economy,” and suggesting that Texas must foster an “environment that encourages technological advancement.”

But after the first draft of the rules came out in August, concerns mounted. 

In an Aug. 18 email to Dr. Linda Gage-White, the board’s medical director, Jones wrote that there were doctors across Texas waiting to use stem cell therapies on their patients. “Please do not make this difficult,” Jones wrote, “as Governor Perry has really gone all out personally to make stem cells available to people in need of them in Texas.”

Hardcastle, who has multiple sclerosis and has also received stem cell treatments from Jones, fired off another email, suggesting the medical board had taken the rule-making process too far. “It was not, and is not, my intent to create onerous and unnecessary regulations to impede the practice and research of physicians,” he wrote. Board members "should focus their attention on the protection of patients from unethical doctors using unproven treatments.”

By mid-fall, Jones and Eller had weighed in together, sending a letter on Celltex letterhead saying they did not believe the proposed rules “would achieve what is truly needed to enable innovation in stem cell therapies.”

“We’re just concerned the proposed rules might be too restrictive for Texas doctors,” Eller said in an interview this week. “Hopefully the board won’t deny Texas patients from having this type of treatment.”

The state’s major hospital systems joined in, too. Dr. Stacey Berg, Baylor College of Medicine’s associate dean for research assurances, wrote that the proposed rules “could have major unintended consequences that would severely impede the conduct of clinical research in Texas.” Dr. Kenneth Shine, the University of Texas System’s executive vice chancellor for health affairs, wrote that the rules would “create an additional regulatory burden” and “produce confusion for physicians who lead clinical trials.”

Not everyone agreed. Bettie Sue Masters, a biochemistry researcher at the University of Texas Health Science Center at San Antonio, wrote, “I feel the extremes of regulatory burden every day, but I also feel that we must protect patients from risky treatments advanced by overzealous, even greedy, entrepreneurs.”

In his own notes, Texas A&M University System Vice Chancellor Brett Giroir tried to reach a middle ground. He suggested deleting language in the rules about the risks and benefits of the stem cell treatment and the probability of its effectiveness, saying the medical board was “over-reaching” and “starting to sound like” a review board for clinical trials. But he added that “much of the evidence suggesting clinical benefit [from adult stem cells] remains empirical, uncontrolled, and highly subject to bias.”

“There is urgent need to prove (or disprove) the safety and efficacy of adult stem cells,” he wrote, “so they can be approved for widespread use, or else sent back to the research laboratory.”

Officials with the medical board, who are set to discuss a less-stringent version of the rules at Friday’s meeting, declined to comment for this story. Hardcastle said there seemed to be some understanding that the first version of the stem cell rules “basically prohibited doing anything.”

“I don’t want them to hamstring the state moving forward, or any company,” he said. “At the same time, I want to protect the people.”  

In response to a media request, Perry’s office released a prepared statement saying that the governor expects the medical board “to review all the facts” on Friday and make the right call “regarding the use of this promising technology in Texas.”