Washington Editor

GAITHERSBURG, Md. - A year later, FDA officials said the agency has no reason to alter its decision to slap black box warnings on nonsteroidal anti-inflammatory drugs (NSAIDs).

That message was delivered Friday to the FDA’s Drug Safety and Risk Management Advisory Committee, which met for two days to receive updates on that matter and others. The black box warnings, which apply to both COX-2 selective and non-selective NSAIDs, note that use of such products increase the risk of serious cardiovascular thrombotic events and gastrointestinal side effects, and also contraindicate their usage in the setting of coronary artery bypass surgery.

Based on its latest retrospective studies, the FDA was unable to "add to current knowledge" on the drugs, said Sharon Hertz, although "the reporting of cardiovascular events was low" in the agency’s recent evaluation of industry-supplied study data. In the past year, the FDA pooled findings from a range of studies carried out by drug companies over the past couple of decades to detect cardiovascular side-effect trends.

Admitting that the resulting data failed to indicate "the presence or absence" of cardiovascular side effects, Hertz nonetheless noted that the old studies were not designed with such an outcome in mind. She suggested that more light could be shed on the subject from a proposed study of Celebrex (celecoxib), although the agency and New York-based Pfizer Inc. have yet to reach agreement on trial design.

In a separate matter discussed during the meeting, committee members criticized the agency’s safety oversight efforts for not providing more disclosure.

"I think this process of oversight has to be more transparent," said Peter Gross, the committee’s chairman. He and others also argued that the FDA’s Drug Safety Oversight Board’s name is misleading, given its lack of public representation and strict adherence to government-only membership.

But the FDA’s Susan Cummins countered that the board has to meet in closed-door sessions because of matters discussed, namely the patent-protected nature of products in question. She added that the board’s government-only membership includes representatives outside the FDA’s Center for Drug Evaluation and Research (CDER), the division in which it is housed. Other board members come from the Center for Biologics Evaluation and Research (CBER) and Center for Device and Radiological Health (CDRH), as well as the National Institutes of Health and the Veterans Administration.

Calling drug safety a "top priority for CDER," which collectively spends half its total work on pre- and post-market safety surveillance, Cummins conceded that the "mix of science judgment and policy" leads to honest disagreements. She recommended that complaints be forwarded to the Institute of Medicine, which is due to release findings in July from a multiyear study on the FDA’s safety oversight abilities.

Separately, the Office of Drug Safety was praised for its efforts to mine deeper into safety issues through database sharing with private organizations such as health insurance companies. Since September, epidemiologists at the FDA and four outside organizations have been able "to work collaboratively on their data sets," said Gerald Dal Pan, who heads the Office of Drug Safety, adding that "these data sources are complementary to each other."

The safety committee also met Thursday to review issues related to drugs for attention deficit hyperactivity disorder, concluding that the drugs should receive black box warnings related to their alleged cardiovascular and psychiatric adverse events. The matter also has surfaced recently on Capitol Hill, with Sen. Chuck Grassley (R-Iowa) sending a letter to Acting FDA Commissioner Andrew von Eschenbach to express concern that the agency has been slow to address such issues. Grassley, who chairs the Committee on Finance, frequently criticizes the FDA.

NIH Spearheading New Genome Efforts

The National Institutes of Health in Bethesda, Md., last week unveiled two initiatives to speed up research on a range of common diseases.

Using a multi-institute effort, the first initiative aims to identify the genetic and environmental underpinnings of common illnesses. The second is a public-private partnership to accelerate genome association studies to find the genetic roots of widespread sicknesses.

The latter includes the NIH and companies such as Affymetrix Inc., of Santa Clara, Calif., and Pfizer Inc.’s Global Research & Development division in New London, Conn. Called the Genetic Association Information Network (GAIN), it is being launched with a $5 million donation from Pfizer to set up the management structure and $15 million worth of laboratory studies to determine the genetic contributions to five common diseases. Affymetrix will contribute lab resources to study two additional common diseases. The genotyping work will be performed by either commercial or government laboratories, with the initial Pfizer-supported research to be carried out by Perlegen Sciences Inc., of Mountain View, Calif. A similar arrangement will be worked out with Affymetrix.

The other NIH-led work, the Genes and Environment Initiative, is to be supported by a $68 million allocation included in President Bush’s budget proposal for the new fiscal year. Designed to combine a type of genetic analysis and environmental technology development to understand the causes of common diseases, it will be managed by an NIH coordinating committee under usual government rules, subject to competition between research facilities.

CMS Sees Drug Benefit Improvements

Mark McClellan, the administrator of the Centers for Medicare & Medicaid Services, testified before the Senate Committee on Finance that CMS has gotten a better handle on early Part D drug benefit problems, issues related largely to people enrolled in both Medicare and Medicaid that have prompted some to call for reworking the bill.

But McClellan stressed that things are running more smoothly, pointing out that enrollment totaled almost 24 million people by the middle of last month. He also said costs are dropping - beneficiary premiums now are expected to average $25 a month, down from $37 per month projected last summer. In addition, the government now is expected to spend about 20 percent less per person this year, and payments over the next five years are projected to be more than 10 percent lower than first estimated.

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