The Statesman story ran on Friday. Here are the first two paragraphs:
The Texas Medical Board voted Friday to delay until next year final approval of new stem cell therapy rules that could restrict or even block procedures such as the one Gov. Rick Perry recently underwent on his aching back.
Its 19 members, including a dozen physicians, voiced support for greater oversight but opted to tweak the proposed rules and take them up again at their next meeting in February. If the reworked rules prove satisfactory, formal approval could come as soon as April.
Perry had a spinal fusion in July. The Statesman described the procedure: “He had stem cells taken from fat in his own body, which were then grown in a lab. They were injected into his back and his bloodstream during an operation in July to fuse part of his spine.”
Three things are troubling about this situation:
1. Perry is a candidate for president of the United States. He is free to make decisions about his own health, and what therapies he chooses. However, if he is resorting to nonstandard, nonapproved treatments that do not have the approval of the Food & Drug Administration, isn’t this something the American people should know?
2. Perry has tried to influence the medical board to approve the procedure for general use in Texas. On July 25, he wrote the board’s chairman:
As the Texas Medical Board considers new rules regarding adult stem cells research and treatments, I would ask you and your colleagues to recognize the revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life, and economy. Adult stem cells have proven medical benefits and many uses yet to be found.
I appreciate the board’s responsibility to protect patients. As you meet with stakeholders, I urge you to recognize the sound science and good work that is already being done, and will continue to be done in the future, in this field. We need to ensure that physicians in this state can continue to pursue new technologies and treatments that will benefit all Texans.
3. What credentials does Rick Perry have to state that the procedure under discussion is “sound science?” The answer is, “none,” because it is not sound science–or so says the federal Food and Drug Administration, which has taken legal action against a Colorado company that grows cultured stem cells. The FDA says, “[the company’s] … product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.”
The Statesman article brings the situation up to date:
The proposed rule — to be published in the Texas Register for comments that the board will consider before acting — would forbid such experimentation without oversight by a review panel. The rule also says stem cell transplants fall under the province of medical practice and can only be done by physicians. The doctors would have to follow all state and federal laws, under the proposed rule, in addition to having an accredited, hospital-based or academic institutional review board approve the doctor’s plans for using the stem cells.
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In addition to the Statesman’s story, the Associated Press also wrote on the subject of the Medical Board’s proposed action. This has become a major story; the AP’s version appeared on the Web site of a Wisconsin television station. Both stories are very well done.
The current status of the proposed rule is that the Board plans to “tweak” it at its February meeting. If it is approved, it could become final in April.
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