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Vol. LXII, No. 19
September 17, 2010
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Ruling Under Appeal, Temporary Stay Granted
NIH Ordered to Halt Intramural hESC Research

On the front page...

NIH intramural scientists were ordered to shut down research using human embryonic stem cells (hESC), effective Aug. 27. HHS issued the order, which was communicated to scientists via a memo from NIH deputy director for intramural research Dr. Michael Gottesman. The halt followed an injunction by a federal judge who ruled that human embryonic stem cell research conducted or funded by the federal government violates the Dickey-Wicker provision.

After hESC work—and funding for it—stopped for about 12 days, an appeals court granted a temporary stay of the injuction on Sept. 9.

“We are pleased with the court’s interim ruling, which will allow promising stem cell research to continue while we present further arguments to the court in the weeks to come,” NIH said in a statement Sept. 10, as the Record went to press. “With the temporary stay in place, NIH has resumed intramural research and will continue its consideration of grants that were frozen by the preliminary injunction on [Aug. 23]. The suspension of all grants, contracts and applications that involve the use of human embryonic stem cells has been temporarily lifted.”

Continued...


NIH will continue to update the status of the case on the agency’s stem cell web page at http://stemcells.nih.gov/index.asp.

Note to Intramural Scientists

Prior to the Sept. 9 stay, Gottesman sent a note to intramural scientists: “HHS has determined that the recent preliminary injunction ordered by the United States District Court for the District of Columbia in the matter of Sherley v. Sebelius is applicable to the use of human embryonic stem cells in intramural research projects. In light of this determination, effective today Aug. 27, 2010, all intramural scientists who use hESC lines should initiate procedures to terminate these projects. Procedures that will conserve and protect the research resources should be followed.”

The note continued, “All intramural principal investigators using hESCs should succinctly describe what research will be terminated, provide the parent annual report number (if the project is associated with one from FY 2009 or before) and describe any alternate use of funds that will become available as a result of this action. This information should be sent to the [institute/center scientific director] and a copy should be sent to [Gottesman].”

Director Responds

The judge’s Aug. 23 injunction came as a sudden and unwelcome surprise to NIH director Dr. Francis Collins.

“Human embryonic stem cell research holds great promise for the development of treatments for people threatened by potentially curable diseases,” he said Aug. 26 in a written statement. “The recent court ruling that halted the federal funding of human embryonic stem cell research could cause irreparable damage and delay potential breakthroughs to improve care for people living with serious diseases and conditions such as spinal cord injury, diabetes or Parkinson’s disease. The injunction threatens to stop progress in one of the most encouraging areas of biomedical research, just as scientists are gaining momentum—and squander the investment we have already made.

“The possibility of using these cells to replace those that have been damaged by disease or injury is one of the most breathtaking advances we can envision,” the statement continued. “Human embryonic stem cells also represent a powerful new approach to the early stages of screening for new drugs and may hold the secrets to creating entirely new, targeted clinical therapies. We must move forward—without delay—to sustain this field of research that provides so much hope for thousands of patients and their families.”

By Aug. 27, HHS had analyzed the ruling and determined that work in progress—no matter what stage the project was in—must stop in accordance with the injunction.

Dickey-Wicker, also called an amendment or “rider,” was first enacted in 1995 as an addition to an appropriations bill. The rider, attached and passed by Congress on every funding bill since then, prohibits federal government agencies to pay for scientific research that involves the destruction of human embryos.

Before Aug. 27, federal agencies including NIH conducted and funded research using hESCs derived by private organizations who then supplied them to the agencies. The new ruling makes no distinction between federal agencies themselves deriving the hESCs and federal agencies funding or conducting research on hESCs provided from sources outside the federal government.

NIH Appeals, Asks for Stay

Within days, HHS and NIH filed an appeal through the Department of Justice, which is also handling all official public responses on the matter. NIH posted copies of the appeal documents on its web site.

“The preliminary injunction issued in this case will have extraordinary adverse effects not only on the prospects of delivering new therapies to patients suffering from numerous diseases and disorders but also on scientific progress from the wider biomedical research community,” said Collins in a 12-page declaration Aug. 31 requesting a stay of the injunction. “It will result in immeasurable loss of valuable and one-of-a-kind research resources. Unique modifications and applications of hESC, under way in laboratories with federal funded research as far back as 2002, could be lost irretrievably or could take years to recreate…Government resources already expended on hESC research to date, including over $546 million of public funds, will have been wasted and the mission and operations of NIH will be severely hampered as a result of this court’s order.”

Eight intramural hESC research projects were under way at the time of the stay. An estimated 45 scientists and other workers were staffing the research, which had a combined budget of about $9.5 million, according to FY 2009 figures. NIHRecord Icon


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