Victory for stem-cell research: Court backs Obama's guidelines

A federal judge on Wednesday upheld the Obama administration’s position in a long-running battle over the scope of federal funding for human embryonic stem-cell research.

Chief US District Judge Royce Lamberth ruled against two scientists who had challenged the legality of new research guidelines issued by the National Institutes of Health in 2009.

The new NIH guidelines invalidated restrictions imposed by former President George W. Bush and significantly expanded federal funding options for a wider range of stem-cell research projects, as favored by President Obama.

Stephanie Cutter, an assistant to Mr. Obama, called the judge’s ruling “another step in the right direction.”

“We know that stem-cell research offers hope to millions of Americans across the country,” Ms. Cutter wrote on a White House blog.

“We are elated at Judge Lamberth’s ruling,” said Lisa Hughes, president of the Coalition for the Advancement of Medical Research.

“This ensures the science will continue to move forward without the impediment of ideologically based challenges,” she said in a statement.

Lawyers for the two scientists said they are weighing their options for an appeal.

“Americans should not be forced to pay for experiments that destroy human life, have produced no real-world treatments, and violate federal law,” said Steven Aden, senior counsel with the Alliance Defense Fund.

“In these tough economic times, it makes no sense for the federal government to use taxpayer money for this illegal and unethical purpose,” Mr. Aden said in a statement.

Research that uses human embryonic stem cells is controversial and has split US public opinion. Supporters say it could open the way for major medical breakthroughs. Opponents see it as a form of abortion, as an embryo (typically four to 32 cells) is destroyed in the creation of a stem-cell line.

At the center of the debate is the question: to what extent can federal funds support research that is linked to the destruction of human embryos?

In 1996, Congress adopted a restriction – the Dickey-Wicker Amendment – that prohibits the NIH from funding “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.”

Under President Clinton, the NIH pursued a policy that permitted continued stem-cell research despite the congressional restriction.

In contrast, Mr. Bush sharply limited stem-cell research by allowing federal funds to go only to research that used 21 lines of cells that had already been developed from embryos. Under Bush, no federal money could be used for research using any lines of cells created after the enactment of his 2001 policy.

After his election, Obama lifted the Bush restrictions and ordered the NIH to adopt a policy that would permit the use of taxpayer dollars to fund research involving new lines of cells – lines developed from embryos destroyed after 2001 or any time in the future.

That policy change prompted two scientists to file suit, alleging that the new Obama policy violated the Dickey-Wicker Amendment.

Chief Judge Lamberth ruled last year that the new guidelines violated the congressional restrictions. In April, a federal appeals court panel voted 2-1 to reverse his decision.

Wednesday’s ruling by Lamberth upholding the new guidelines is a result of that appeals court reversal.

At the center of the dispute was how the courts would define the word “research” in the congressional restriction. The Obama administration and the NIH said the term “research” was limited to the particular study at hand, not to the broader process used to obtain the stem cells.

The two scientists argued that the term “research” must include any and all upstream processes used to obtain the stem cells.

“This court initially agreed with plaintiffs’ understanding of the Dickey-Wicker Amendment, finding that the term ‘research’ in the statute bore only the broader meaning…” Judge Lamberth wrote. “On appeal, however, the D.C. Circuit rejected this court’s view, concluding that the text of the Dickey-Wicker Amendment is ambiguous.”

The judge added: “Absent a compelling reason to depart from that holding, the court is constrained to adopt it.”

Judge Lamberth ruled that since the congressional restriction was itself ambiguous, the courts must defer to the NIH’s own interpretation of the restriction.

Guided by the appeals court’s earlier decision, Lamberth found that the NIH reasonably interpreted the Dickey-Wicker Amendment, and thus federal funds can be used to support a broader range of stem-cell research.