Washington Editor

WASHINGTON - The House is expected to vote today on a pair of stem cell research bills, both of which were promoted during press conferences here Monday.

The most contentious of them, legislation co-sponsored by Reps. Mike Castle (R-Del.) and Diana DeGette (D-Colo.), would lift restrictions on federal funding for embryonic stem cell research that were established almost four years ago by President Bush. And its chief architects said enough votes are in place to ensure passage on the House floor.

"The bill is maddeningly reasonable," DeGette said, "which is why we think it will pass the House [today] with strong bipartisan support."

Late last week, the bill was said to have the support of about 200 other House members. Called the Stem Cell Research Enhancement Act, it needs 218 to pass. Castle added that companion legislation introduced in the Senate also has enough support in that chamber. (See BioWorld Today, May 20, 2005.)

"If we had the engine of the National Institutes of Health supervising and promoting embryonic stem cell research," DeGette said, "then the state of the research would move along so much faster, and we would institute important ethical controls."

Opponents of the measure expect a veto from the executive office, and Bush on Friday said he would indeed reject the bill, essentially basing his opposition on a pro-life foundation. The bill, labeled H.R. 810, would allow federal money for research resulting from excess embryos produced at in vitro fertilization clinics.

Supporting the president are groups such as the U.S. Conference of Catholic Bishops, which last week released results from a poll that showed that 52 percent of respondents oppose federal funding of embryonic stem cell research compared to 36 percent in favor of it. Castle countered that various polls show public support ranging between 60 percent and 70 percent, adding that the bill fits the White House administration guidelines.

"We feel it's really an extension of the Aug. 9, 2001, policy that the president adopted," he said. "We think it would give the researchers the opportunity that they need to do the work that is so important in this country."

Concurrent with action on the Castle-DeGette bill will be a vote on legislation designed to support other stem cell research, from umbilical cord blood. Its proponents stressed the promise that such research holds for nearly 70 diseases.

"One of the best-kept secrets in America today," said Christopher Smith (R-N.J.), "is that umbilical cord blood stem cells and adult stem cells are curing people of a myriad of terrible conditions and diseases."

His bill, called the Stem Cell Therapeutic and Research Act of 2005, would provide $79 million in federal funds over five years to increase the number of cord blood units available to match and treat patients.

"Because this legislation promotes cord blood research," Smith said, "we can expect new and expanded uses of these versatile stem cells."

Many opposed to the Castle-DeGette legislation, including the House Republican leadership, have instead lent their support to the cord blood bill, which is labeled H.R. 2520. Smith himself labeled cord blood research a more "ethical way of deriving stem cells," adding that he does not support "federal funding to kill embryos."

But Castle, DeGette and other allies noted that the two measures are complementary rather than contrary. They said they would vote for both.

The cord blood bill is expected to be voted on first, though DeGette said she did not expect it to siphon away any votes from the embryonic stem cell bill.

"Perhaps before it's all said and done," Castle said, "we'll end up with a policy that could benefit many people in this country."

New Questions Surround FDA Decisions

Allegations recently surfaced that the FDA rejected an advisory panel's recommendation to approve over-the-counter use of the Plan B contraceptive, based on a dissenting opinion written by a conservative doctor on the panel. In contrast, the panel had voted 23-4 to recommend that the agency sanction over-the-counter sales of the emergency contraceptive. Despite the rejection, the generic company seeking the license, Barr Laboratories Inc. in Woodcliff Lake, N.J., reapplied last year for approval. But the FDA's inaction to date on that second application has drawn the ire of Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.), who sit on the Senate Health, Education, Labor and Pensions Committee that is scheduled to vote on Lester Crawford's nomination to become FDA commissioner.

Separately, the Senate Committee on Finance is looking into an FDA decision to issue an approvable letter to examine the agency's handling of an application for Cyberonics Inc.'s vagus nerve stimulation therapy for treatment-resistant depression in adults. The Houston company acknowledged the query, but added that the committee has alleged no wrongdoing on its part. Prior to the approvable letter, which was issued in February, an FDA advisory panel had recommended approval a year ago. Cyberonics' application is seeking a supplemental approval for the implantable device, which already is authorized as an epilepsy treatment.

Aredia Label Amended With Warning

A bone cancer drug once marketed by Chiron Corp., Aredia (pamidronate disodium), has had its label revised to reflect a new safety risk.

The FDA and Novartis AG, the drug's maker, issued the notice describing the occurence of osteonecrosis of the jaw observed in cancer patients receiving treatment with Aredia, an intravenous bisphosphonate drug, and another such drug, Zometa (zoledronic acid).

The updated prescribing information recommends that cancer patients receive a dental examination prior to therapy with either product, and avoid invasive dental procedures while receiving them. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery could exacerbate the condition.

Novartis, of Basel, Switzerland, owned 42.4 percent of the outstanding common stock of Chiron, of Emeryville, Calif., as of Jan. 31. Their alliance dates back a decade.