Judge temporarily blocks Obama administration stem cell regulations

Obama stem cell regulations temporarily blocked

WASHINGTON — The Obama administration’s expansion of stem cell research has suffered a significant setback with a judge’s ruling that blocks important work on treating life-threatening conditions, say private groups pushing for scientific breakthroughs in medicine.

Monday’s decision by U.S. District Judge Royce Lamberth will “drive the best scientific minds into work less likely to yield treatments,” says Sean Tipton of the American Society for Reproductive Medicine.

“It will be incredibly disruptive,” Tipton added.

Stem cell research holds the potential to address some of the most difficult areas in the medical field — from spinal cord injury to diabetes to Parkinson’s, which all have resisted traditional treatment.

Two doctors who do research with adult stem cells, James Sherley of the Boston Biomedical Research Institute and Theresa Deisher of AVM Biotechnology, argue that the guidelines will result in increased competition for limited federal funding and will injure their ability to compete successfully for National Institutes of Health stem cell research money.

Scientists say they need to do research with embryonic stem cells as well as so-called adult ones because the former are more flexible, and the National Institutes of Health is funding both types.

In his decision, Lamberth concluded that the two researchers have demonstrated a strong likelihood of success in their argument that the Obama administration’s government guidelines violate the intent of the law about federal funding of embryo destruction.

“As demonstrated by the plain language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of federal funds on ‘research in which a human embryo or embryos are destroyed,’” the judge wrote.

Having concluded that the law is unambiguous, “the question before the court is whether ESC research is research in which a human embryo is destroyed. The court concludes that it is,” Lamberth added.

Federal law explicitly forbids use of taxpayer dollars to destroy a human embryo — and culling stem cells from an embryo does destroy the embryo. However, once created, these batches of stem cells, or lines, can reproduce indefinitely in lab dishes.

The Obama administration expanded the number of stem cell lines created with private money that federally funded scientists could research, up from the 21 that President George W. Bush had allowed to 75 so far. To qualify, the NIH insisted on evidence that the woman or couple who donated the original embryo did so voluntarily and were told of other options, such as donating to another infertile woman.

The federal judge’s decision is “a deplorable brake on all stem cell research,” Alan Trounson, the president of California’s stem cell agency, said in a statement.

The agency — the California Institute for Regenerative Medicine — said it will continue providing a stable source of funds for researchers who have committed their labs to pursuing new therapies based on work with human embryonic stem cells.

The judge’s ruling drew praise from the Alliance Defense Fund, a group of Christian attorneys and co-counsel in the suit.

“The American people should not be forced to pay for experiments — prohibited by federal law — that destroy human life. The court is simply enforcing an existing law passed by Congress that prevents Americans from paying another penny for needless research on human embryos,” Steven H. Aden, ADF’s senior legal counsel, said.

Lamberth’s opinion “allows a vocal minority to hold science hostage to a narrow political agenda,” said Susan L. Solomon, CEO of The New York Stem Cell Foundation.

Lisa Hughes, president, the Coalition for the Advancement of Medical Research, called it “a blow to the hopes of millions of patients and their families suffering from fatal and chronic diseases and disorders.”

Tony Perkins, president of the Family Research Council, a conservative public policy foundation, called the decision “a stinging rebuke to the Obama administration and its attempt to circumvent sound science and federal law.”

The NIH declined to comment, referring calls to the Justice Department, where department spokeswoman Tracy Schmaler said the ruling was under review.

In his ruling, Lamberth said the injury of increased competition that Sherley and Deisher would face because of the guidelines “is not speculative. It is actual and imminent. Indeed, the guidelines threaten the very livelihood of plaintiffs Sherley and Deisher.”

AP Medical Writer Lauran Neergaard contributed to this report.