Posted on behalf of David Cyranoski.
The Texas Medical Board on Friday approved regulations (see Chapter 198) that are claimed to ensure safe clinical use of stem cells and other “investigational agents”. The regulations, however, have been criticized as too permissive and opening the door for the sale of dubious treatments.
There has been debate and confusion, even among stem-cell scientists, who usually criticize attempts to use stem cells in the clinic without clinical evidence, as to whether the regulations are aiming to rein in rogue clinicians or to open the door for expanded use.
The support for the new regulations from those already receiving or selling stem cells shows that they are on the permissive side. They were initiated by Governor Rick Perry, who had a stem-cell treatment for back pain last summer, and approved by a board of Perry appointees. And the Centeno-Schultz Clinic in Broomfield, Colorado, which is in a legal tussle with the US Food and Drug Administration (FDA) over its use of unapproved stem cells in orthopaedic surgery, applauded the new regulations as support for “a time honored traditional [sic] of medical innovation that’s responsible for many of the medical advances we take for granted”.
The regulations require those who wish to provide stem cells to patients to get approval either from the FDA — which considers most stem-cell treatments to be under its jurisdiction and requires that they be clinically verified — or an institutional review board (IRB). This latter hurdle is likely to be lower.
IRBs, say the regulations, “can be affiliated with an academic setting or a Texas licensed hospital, be accredited by the Association for the Accreditation of Human Research Protections Programs, Inc. (AAHRPP), be register by the US Departments of Health and Human Services Office for Human Research Protection… or have received national accreditation by an organization acceptable to the TMB”.
As Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis points out in an 8 April letter to the Texas Medical Board, this broad and ill-defined characterization could include for-profit boards, produce financial conflicts of interest and result in researchers rejected by one IRB “searching for an IRB until they find one that approves whatever studies they wish to conduct”.
CellTex Therapeutics, a company based outside of Houston, Texas, that has been paying doctors to inject stem cells into patients while denying conducting any such stem-cell procedures, pushed for the regulations to be made even more lax. In a 6 April letter to the Texas Medical Board, CellTex asked for the regulations to be made still more permissive and asked the board to recognize that cells that are not more than “minimally modified” to be exempt even from the need to pass an IRB.
The letter claims that the company’s cells are not more than minimally modified “as defined by federal law”. Present and former FDA officials, however, seem to think that CellTex’s cells are more than minimally modified.
The letter also says that even if the changes are not made, CellTex “will invest the time, finances and other resources necessary to make these therapies available to physicians in Texas”. That’s a strange comment, considering that CellTex has already started supplying physicians without waiting for the regulations to be drafted, much less approved or implemented. The Texas Medical Board’s first chore might be to see how many doctors are already violating the regulations.