GEN | Magazine Articles: Stem Cell Breakthroughs Renew …

Cloning Fears Resurface

The stem cell advances have reawakened fears they will be used toward human reproductive cloning. In 1998, FDA declared jurisdiction over clinical trials intended to study the practice, citing authority over INDs.

But as Bernard Siegel, J.D., executive director of the Genetics Policy Institute, correctly noted to GEN, the agency didnt use its notice-and-comment rulemaking or official guidance processes. Instead, FDAs then-acting commissioner Michael A. Friedman, M.D., simply said so in a radio interview.

The FDA needs to take the matter seriously and reiterate its authority. The agency should make sure its authority will not be undermined for its casualness in establishing its original claims of jurisdiction, Siegel said. Last year, Siegel and Arnold I. Friede, J.D., whose eponymous law firm specializes in FDA matters, co-authored a Stem Cells and Development article urging FDA to formally establish jurisdiction over cloning, with input from all stakeholders.

The Center for Genetics and Society wants Washington to go further, urging Congress to join some U.S. states and 60 countries in banning reproductive cloning. Marcy Darnovsky, Ph.D., the centers executive director, cited efforts by several scientists a decade ago to clone humans, and the cost of creating stem cell lines.

The vision of SCNT-enabled medicine presumes that each patient would have a stem cell line created for him or herwhich would be enormously expensive, and thus likely not widely accessible, Dr. Darnovsky told GEN. This is an argument about how to think about the promise of regenerative medicine, one consideration for funding agencies and others who are prioritizing the allocation of public moneys.

Dazzling new cell therapies are more possible than ever based on the recent studies. Researchers must express that publicly to officials and the publicboth skeptical audiencesby promoting beneficial cloning toward treatments while joining with others to ban reproductive cloning, which nearly all professionals insist they oppose.

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GEN | Magazine Articles: Stem Cell Breakthroughs Renew ...