Drug Regulators Are Trying to Quash Study, Senator Says

THE NEW YORK TIMES
February 12, 2005
Drug Regulators Are Trying to Quash Study, Senator Says
By GARDINER HARRIS

WASHINGTON, Feb. 11 – The tension and intrigue surrounding a crucial federal drug advisory committee meeting next week, already high, reached a boil on Friday when Senator Charles E. Grassley charged that top federal drug regulators intended to suppress an important study.

The panel has been convened to discuss whether Celebrex and Bextra, heavily selling arthritis pills from Pfizer, hurt the heart and are worth their potential risks. But top officials of the Food and Drug Administration have forbidden Dr. David Graham, a drug-safety officer at the agency, to discuss before the panel a large study of that very question, said Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham’s co-author.

“We have significant new information that will alter the thinking about these drugs,” Dr. Singh said. “I don’t understand why they won’t let us present this information.”

Mr. Grassley, an Iowa Republican, wrote a letter Friday to the agency’s acting commissioner, Dr. Lester Crawford, demanding to know by Monday the reason for the agency’s decision.

Dr. Graham expressed frustration that F.D.A. officials had instructed him not to discuss the new study in a presentation he is scheduled to give to the committee on Thursday.

“This study bears directly on the whole reason why this advisory meeting is being held in the first place,” Dr. Graham said.

Agency officials told him the study had not yet been properly vetted, he said.

A spokesman for the agency denied that Dr. Graham had been barred from presenting the new findings. He said that agency officials had simply expressed a preference “that he rely on published literature in his talk, but that it was his call if he wanted to offer data from his new study.”

The latest charge suggests that the panel will render judgment not only on the safety of Celebrex and Bextra but also on how well the F.D.A. is doing its job.

A series of controversies have called into question whether the agency has the tools or the will to protect patients’ health.

Some in Congress, including Mr. Grassley, are calling for fundamental changes at the agency. Drug-safety advocates claim that top agency officials are far too cozy with drug makers. Agency officials say they are doing a good job.

Both sides point to the story of Vioxx, a pain pill similar to Celebrex and Bextra that Merck withdrew from the market in September, an action that will also be discussed at the hearing.

“There seems to be this view that we did something wrong with Vioxx,” Dr. Robert Temple, director of the agency’s office of medical affairs, said in an interview. “What exactly is the thing that we did wrong? Approving it? Making them do a 6,000-patient study to get a claim? What?”

Mr. Grassley had a quick answer. “The Vioxx disaster and its aftermath have shaken the public’s confidence in the Food and Drug Administration,” he said, in part because, instead of listening to its best scientists, the agency is “sitting down to negotiate with drug companies.”

Vera Sharav, president of the Alliance for Human Research Protection, said that the Vioxx story demonstrated that “the F.D.A. has abandoned its public responsibility to protect us from unsafe drugs and is standing by as drug companies market lethal drugs.”

A Merck spokeswoman said that the company had acted appropriately in its research, marketing and eventual withdrawal of Vioxx.

Pfizer representatives say that studies show that Celebrex and Bextra are safe.

There is a sense of déjà vu to Dr. Singh’s latest charge. The agency convened an advisory panel a year ago to discuss whether antidepressants cause children and teenagers to become suicidal. Dr. Andrew Mosholder, another drug-safety officer for the agency, had concluded that the drugs did increase the risks of suicide. Top officials were skeptical of his findings and would not let him testify about his data before the panel.

A second study eventually confirmed Dr. Mosholder’s conclusions, but the agency’s refusal to let Dr. Mosholder testify caused a firestorm of criticism and prompted Mr. Grassley to begin an investigation of the agency.

The advisory panel will meet for three days beginning on Wednesday. It already has a mountain of data to sort through.

At the end of the hearings, the committee will be asked whether Celebrex and Bextra should be withdrawn or whether warnings on their labels should simply be strengthened.

The committee may debate whether the withdrawal of Vioxx was appropriate. And the committee will also discuss what, if any, studies of the drugs should be undertaken, according to F.D.A. documents.

Copyright 2005 The New York Times Company