The Texas Medical Board will vote today on controversial guidelines for the state's fledgling — and likely lucrative — adult stem cell industry, rules some fear will lead to Texans being treated with unsafe or unproven therapies.
It's the latest step in a months-long process sparked by Gov. Rick Perry — who was injected with his own stem cells last summer in the lead-up to his failed presidential bid — and by his doctor, Stanley Jones, one of the founders of a Texas-based adult stem cell company.
Some medical experts say the board is moving ahead of science, allowing for the use of adult stem cell procedures that have not yet been shown to work in clinical trials.
“You have to do a proper, blinded, controlled trial in order to really judge whether a novel therapy is going to work or not,” said Arnold Kriegstein, director of the stem cell research center at the University of California at San Francisco. “The problem is none of these so-called treatments have been subjected to that standard of evaluation.”
The rules’ supporters say the board is giving patients access to potentially life-changing procedures and point out that the guidelines include protections for patients.
Koben Puckett of Canyon, who was treated with his own stem cells after being paralyzed from the neck down in a bull-riding accident, sees the use of the therapy as his right. “It’s my genetic makeup, it’s my stem cells, it’s already in me,” said Puckett, who had to fly to Cyprus for this stem cell transplant because the procedure isn't allowed in the U.S. under current FDA regulations. “It’s definitely my right to use this.”
The rules under consideration by the Medical Board do not address the use of embryonic stem cells — a far more controversial procedure that has drawn moral and religious objections.
Blood-forming stem cell transplants, commonly known as bone marrow transplants, have been used as treatments for decades, but other adult stem cell procedures remain “highly experimental,” said George Daley, director of Harvard Medical School’s Stem Cell Transplantation Program.
Ted Sand, vice president of Cellular Therapies at Celling Technologies, an Austin-based company that prepares adult stem cells, said overpromising physicians and companies are the problem, not the use of stem cells. “The concern about efficacy is generally related to claims or unscrupulous operators that say they can cure multiple sclerosis or Parkinson’s,” Sand said. He said he knows of no study that shows adult stem cells working with either disease, but that “does not mean doctors can’t help therapeutic outcomes” with other illnesses.
“We don’t make huge claims,” he said. “No therapy will benefit every patient.”
The Texas Medical Board’s proposed rules do put in place safeguards for patients, such as informed consent forms that reveal what treatments patients will receive and institutional review boards (IRBs) that can deny approval of physicians’ proposed use of stem cells.
Some researchers are taking issue with the wording of the proposed rules, which they say do not distinguish between research and treatment. The proposed rules refer to the use of stem cells as both a “clinical research study” and a “treatment” that “constitutes the practice of medicine.”
“The use of the word ‘treatment’ itself suggests a level of confidence regarding safety and efficacy that is not justified at the experimental stage,” said Douglas Sipp, a stem cell policy and ethics expert at the RIKEN Center for Developmental Biology in Japan.
Meanwhile, the IRBs have also been a target for critics, who say the state is skirting the Food and Drug Administration by granting oversight to private, for-profit review boards. The proposed rules say physicians can use stem cells either according to FDA protocol or by getting IRB approval. This means physicians could provide treatments that have not undergone FDA scrutiny.
Irvin Zeitler, Jr., president of the Texas Medical Board, said through a spokeswoman that the board has no intention of circumventing federal law. “The board simply wants to ensure that the use of an investigational agent [stem cells] is safe for the patient," he said. "The rules are written with the understanding that they may become moot under new federal regulation. But for now, the rules provide a framework for protecting the patients of Texas.”
And supporters of the Texas Medical Board’s move say research involving clinical trials — which are placebo-controlled — demands too much time and money. Charging patients who are given placebos gives rise to ethical concerns; avoiding doing so by providing placebos and stem cell procedures for free is expensive.
“This is probably a less expensive way to do the research, with these private IRBs,” said Mario Salinas, director of Texans for Stem Cell Research. “The research has to move forward and TMB is attempting to hasten that.”
The FDA declined to comment on Texas' proposed regulations. Irving Weissman, director of Stanford University’s Institute for Stem Cell Biology and Regenerative Medicine and a member of the International Society for Stem Cell Research, said there's no guarantee that IRBs bring the same "scientific rigor" that the FDA does.
Wrote Leigh Turner, a professor at the University of Minnesota's Center for Bioethics, in comments to the Texas Medical Board: “If the guidelines are not substantially revised before the Texas Medical Board approves them, then it is possible that Texas could become a magnet for unscrupulous individuals who perceive a lax regulatory environment as an opportunity to profit from ill, vulnerable and in some cases desperate individuals."
For Puckett, the bull rider whose surgery involved pulling stem cells out of his hip bone and injecting them into the bruised area of his spinal cord, opening up this therapy at home in Texas can't come soon enough. Puckett said he has noticed improvements in his body since the surgery, such as stability in his spine and overall muscle gain.
“Young people are in [wheelchairs] and don’t want to wait because what have you got to lose?” said his mother, Vana Puckett. “Recovery is possible, and to wait until there’s enough data while their life is passing them by doesn’t make sense.”