In the opening months of last year’s Republican pre-primary, Gov. Rick Perry pandered a wild-West vision of the Lone Star State’s regulatory environment:
There's still a land of freedom in America, freedom from over-taxation, freedom from over-litigation and freedom from over-regulation, and it's called Texas.
While Perry may have faded from the presidential limelight, his dream of a regulation-free Texas appears to be making its way into the medical context.
Case in point: adult stem cells. Last week, the Texas Medical Board approved a set of regulations (see Chapter 198) purportedly designed to ensure the safe clinical use of stem cells and other “investigational agents.”
That the drafting of the new regulations was initiated by Gov. Perry, an adult stem cell advocate since his own treatment for back pain last summer, might by itself be reason for wariness. And rightly so. The new rules in fact amount to a functional deregulation of stem cells in Texas, opening the door for the sale of dubious and dangerous “treatments.”
Most stem cell interventions require submitting an Investigational New Drug Application to the FDA and having study protocols approved by Institutional Review Boards. However, the new Texas policy places an “or” where the “and” should be.
In short, the regulations provide a mechanism that allows Texas stem cell companies to circumvent FDA guidelines by opting for approval by an Institutional Review Board (IRB) instead. Although the FDA regulations aren’t perfect, an IRB review process presents much graver problems. As a recent Government Accountability Office report notes:
The IRB system is vulnerable to unethical manipulation, which elevates the risk that experimental products are approved for human subject tests without full and appropriate review.
The general problems with IRBs become even more pronounced given the lax guidelines for what constitutes an “IRB” in the Texas policy. In a compelling letter to the Texas Medical Board, University of Minnesota bioethicist Leigh Turner argues that the vague characterization could permit companies to use for-profit IRBs, which may produce financial conflicts of interest. Turner envisions a situation wherein corporate researchers rejected by one board go “searching for an IRB until they find one that approves whatever studies they wish to conduct.”
This may be a real danger in Texas, which has already seen its fair share of stem cell controversy this year. A slew of bioethicists and scientists have raised concerns about CellTex Therapeutics, which has already been paying doctors to inject non-FDA improved stem cells into patients for some time (you can read more about that controversy here, here, and here).
Amidst this controversy, industry advocates have unsurprisingly continued to argue that the therapies are safe, the risks are minimal, and the potential benefits are extreme. Unfortunately, such unsubstantiated claims obscure the real risks associated with stem cell procedures.
Even some of the most vocal proponents of stem cell treatments acknowledge the risks. Paul Knoepfler, a Professor at the UC Davis School of Medicine who researches stem cells, puts this point bluntly:
The complex, unfortunate reality is that any cell when given as a transplant has a potential risk to form a tumor and an additional risk to cause other side effects. Period. The risk is not zero.
There are serious safety concerns afoot in Texas, and the Lone Star State may already be in violation of FDA rules, as David Cyranoski noted in Nature.
Given these risks, the stance taken by Dr. William Smythe, a Texas Medical Board member who voted against the rules seems to be on point:
“If Texas wants to be a leader in this area, there are other ways to do this,” Dr. Smythe said. “You want to add a layer of protection? Put a moratorium on the use of these agents until they’re proven.”
Previously on Biopolitical Times:
Posted in Bioethics, Biopolitics, Parties & Pundits, Stem Cell Research, The States
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