Gov. Rick Perry
Gage Skidmore
Tomorrow the medical Council of Texas decide whether to sign what is said to be the first political-level state to impose control over the medical use of experimental treatments using adult stem cells. The hotly debated plan has attracted mixed views from the scientific community about whether it is a good way to raise standards and generated confusion in the media.
Some experts say that the rule will allow unscrupulous doctors to evade review by the Food and Drug Administration (FDA) because it can identify methods that are not rigorously examined. But others say the rule, while not perfect, is a good faith effort to bring oversight to these treatments, unproven controversial, that clinical around the world supply of diseases ranging from arthritis to multiple sclerosis. Currently, the rules of society require physicians who provide stem cell therapies in Texas only comply with general standards for the practice of medicine. The International Society for Stem cells (ISSCR) today issued a statement that, contrary to press reports this week, he took no position on the proposed rule Texas.
Texas has become a flash point for concerns about stem cell clinics thanks in part to Governor Rick Perry, who has taken steps to promote stem cell industry in the state and last summer, as a treatment for a back injury, received an injection of his own stem cells from the fat of a Houston doctor. Meanwhile, Sugar Land, Texas, a company called CellTex Therapeutics Perry who prepared the cells has recently been under fire for charging patients for stem cell therapies that have not been validated in trials clinics.
Last summer after Perry requested a review, the Medical Council of Texas began drafting a rule that would impose new oversight on the use of experimental agents, including stem cell doctors. The latest project, published in the Register of Texas in March, would among other things require that stem cell treatments, or be part of a National Institutes of Health or protocol or study (all of the subject ethics review) approved by the FDA, or have approval from an ethical review of research of the local council known as an Institutional review Board (IRB).
Critics say the proposed rule would allow doctors to avoid rigorous monitoring. "It opens a lot of opportunities for abuse or fairly lax regulation," says the expert science policy Douglas Sipp of the RIKEN Center for Developmental Biology in Kobe, Japan. Commenting views similar to the card ( see p. 9), University of Minnesota, Twin Cities, bioethicist Leigh Turner warns that the proposed rule would review RIR, private for-profit. Turner opposes because it maintains that the RIR may be under financial pressure approve the protocols. And stem cell researcher Irving Weissman of Stanford University in Palo Alto, California, told Houston Chronicle that the proposed rule is "a clever way around appropriate role FDA to oversee clinical trials "and violates ISSCR guidelines.
But unlike the Chronicle "the suggestion that Weissman spoke for the ISSCR, the company said in its statement that it" has not approved a position on the draft language. "the company is concerned about how the untested stem cell treatments are marketed it even created a website to inform patients and supports rigorous testing. "We've generally heard positive things about the intention" of Texas proposed rule says Director Heather Rooke ISSCR science.
Sean Morrison, ISSCR member at the University of Texas Southwestern Medical Center at Dallas, said that even if it wanted to, the board could not require the supervision of the FDA because the agency does not regulate not all experimental treatments: numerous clinical trials legitimate US, including stem cell trials, test treatments that do not meet the definition of an FDA regulated product. But the proposed rule would not stop the FDA to walk, he said, because "federal laws trump the state."
Morrison expressed their concerns that the requirements of the proposed rule for the review of the IRB are "weak" because, for example, the IRB would not have to be affiliated with a hospital or Texas the school. The regulations "are not perfect," said Morrison. But he said the medical commission "should be commended for trying to prevent the proliferation of unproven therapies of stem cells." Texas, he said, "has done more to remedy this problem that most other states "
CellTex dislikes is the rule. It argues in comments to the Commission (see page 3.) that its stem cells should be exempt because" they are "not more than" slightly modified "or in combination with another drug and it does not meet (and therefore the board) definition of an investigational agent by the FDA. (the premise of CellTex can be carried doubt, however: the US government has pursued a similar company in Colorado, arguing that stem cells offer it qualify as a regulated product)
the medical commission will be deciding to move the project. policy, pull down for more tweaking, or scrap it completely, said the spokeswoman Leigh Hopper board.
UPDATE April 13: Today, the Medical Council of Texas adopted the proposed rule by a vote from October to April after "many debate, "said the spokeswoman Leigh Hopper board. Some members were concerned the rule would open the door to abuse (physicians manage patients for large sums of money for unproven treatments), said Hopper. Others noted that some doctors treat patients and already felt that, in the absence of clear guidance from the FDA, the rule was imperfect reasonable start. She said the board has awarded a subcommittee to refine the rule with the participation of Leigh Turner and others.
Turner, University of Minnesota, Twin Cities, bioethicist who spoke at the meeting, said Science Insider email from the Austin airport that he continues to feel the policy "has many flaws" and that what is needed are "more robust and consistent guidelines. "
0 Komentar