Monday, August 30, 2010

Why it’s Time for Congress to Write New Stem Cell Legislation

We need policy that allows the research to proceed, with federal dollars and with appropriate oversight.

By Margaret Anderson
Executive Director, FasterCures

On August 23, a federal judge blocked NIH from funding human embryonic stem cell research, ruling that the support violates the rider (the Dickey Wicker amendment) of the Health and Human Services appropriations bill written by Congress in 1996. The rider prohibits the use of taxpayer money for research “in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.”

In 1999, the Department of Health and Human Services General Counsel determined that this law does not prevent NIH from supporting research that uses embryonic stem cells derived—using private funds—from embryos destined to be destroyed by those no longer needing them for infertility treatment. That ruling was expectedly controversial but it set the wheels in motion for U.S. scientists to explore how these most versatile of human cells could be used to safely test new drugs, restore worn and torn tissue, and replace diseased cells with healthy cells.

In 2001, President Bush halted research on all but a few embryonic stem cell lines. Last year, President Obama lifted some restrictions, but only after a clear and publicly vetted set of guidelines was in place for proceeding with scientific work.

Although the private sector is always free to conduct this type of research, most agree that we need the rigor, stature, and transparency of federal funding for the field to move forward.

At the bench, there are many ways to read the intent of Congress. Judge Lamberth read the intent of Congress in a way that would prohibit federal funding for such research.

If you visit the NIH’s Stem Cell information page today you will read that:
“Pursuant to a court order issued August 23, 2010, NIH is not accepting submissions of information about human embryonic stem cell lines for NIH review. All review of human embryonic stem cell lines under the NIH Guidelines is suspended. The February 23, 2010, proposal to revise the Guidelines is also suspended.”

The impact of this decision cannot be understated. Millions of research dollars and the grant review process have been frozen. Policymakers on both sides of the aisle have spoken out in support of this area of research, given that specific safeguards are in place.

The public opinion on pursuing this research is clear. The scientific need to pursue these avenues is clear. If, as the judge in this case asserts, the 1996 amendment is in the way, then it needs to be reexamined.

A June 2008 Time magazine poll conducted by the SBRI research group found that 73 percent of Americans support embryonic stem cell research using cells derived from embryos about to be discarded by couples after infertility treatment. A majority of Americans support embryonic stem cell research as long as there are strict guidelines and systems of oversight in place, which there are.

In addition to extensive ethics review at NIH, every institution receiving federal funding for this research—that could mean the academic medical center down the street from you—has several committees in place to review this area of research to ensure it is conducted ethically and with only the highest scientific justification. Citizens sit on these committees, as well as scientists, physicians, lawyers, and ethicists.

The solution now is for Congress to craft a new policy that allows the research to proceed, with federal dollars and with appropriate oversight. In the absence of a legislative change, the lawyers will continue to battle, which will take valuable time, while patients and their families sit by helplessly, waiting for a political miracle.

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