Warning of a "devastating impact" on ongoing research, government lawyers this afternoon asked a federal court to stay a preliminary injunction that last week forced the National Institutes of Health (NIH) to suspend future grant payments to study human embryonic stem cells (hESC) and shut down its in-house research on hESCs.
The Department of Justice (DOJ) filed a 23-page memorandum in support of an emergency motion to stay the injunction pending an appeal with the United States District Court for the District of Columbia, whose chief judge, Royce Lamberth, issued the stunning 23 August ruling. DOJ argues that the injunction should be stayed "to avoid terminating research projects midstream, invalidating results in process, and impeding or negating years of scientific progress toward finding new treatments" for diseases such as diabetes and spinal cord injuries.
The motion calls the judge’s order to stop funds "sweeping," noting it covers research that began in 2002 during the Bush Administration. DOJ says this is "causing irrevocable harm" to millions of patients who could benefit from hESC research, NIH, hundreds of scientists, and taxpayers who have spent hundreds of millions of dollars on hESC research. It is already having "disastrous consequences" for $9.5 million in NIH intramural research on hESCs, which the agency began shutting down yesterday, DOJ states.
The brief discusses DOJ's disagreement with Judge Lamberth's view that NIH's 2009 guidelines allowing work on hESCs violates the Dickey-Wicker amendment, a 14-year-old law barring the use of federal funds on research that involves the destruction of embryos. The brief also take issue with the arguments of the two plaintiffs—researchers James Sherley and Theresa Deisher. They claim that they are harmed by the NIH policy because allowing research on hESCs has decreased their chances of winning funding to study adult stem cells. The DOJ brief notes that applications using hESCs and adult cells "are not in direct competition," that Sherley received funding from NIH after the guidelines came out, and that Deisher apparently has never even applied for NIH funding.
NIH Director Francis Collins wrote a 12-page affidavit in support of the DOJ motion. It describes four specific projects that will run out of funds in September—including work at Children's Hospital in Boston comparing hESCs to induced pluripotent stem cells. Since 2001, the affidavit says, NIH has spent more than $546 million on hESC research. The injunction "will have extraordinary adverse effects" on the development of new therapies and work on hESCs "could be lost irretrievably or could take years to recreate," Collins attests.
Legal experts have told ScienceInsider that they expect Lamberth to deny the request for a stay. The DOJ brief says that if the District Court hasn't ruled by next Tuesday, 7 September, the government will take its request to the U.S. Court of Appeals the next day. Another document notifies the District Court that DOJ plans to appeal the preliminary injunction to the Appeals Court.
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