Pfizer Releases Results of Celebrex Study:

Calls to Overhaul Federal Drug Saftey Regulation

Pfizer Inc.'s revelation Friday that its popular Celebrex arthritis pain reliever might increase heart disease risks is bolstering calls to overhaul federal drug safety regulation.

Drug giant Pfizer's announcement came less than three months after another drug giant, Merck, pulled its big-selling Vioxx arthritis drug off the market after tests showed increased risks of heart attack and stroke.

Both drugs have been heavily marketed directly to consumers, a practice that's been criticized as leading to unnecessary prescriptions.

And now both drugs have critics of the federal Food and Drug Administration basically saying, "I told you so."

"The FDA is broken and needs to be fixed," said Catherine DeAngelis, editor of the Chicago-based Journal of the American Medical Association. "We're certainly not alone in believing it."

The FDA isn't adequately monitoring safety after a drug has been approved for commercial sale, DeAngelis said, so after-the-fact announcements like the ones involving Celebrex and Vioxx will increasingly occur.

Pfizer made its announcement after the National Cancer Institute suspended use of Celebrex in a study.

On Friday, the FDA said patients in a cancer prevention trial who took two 400 milligram doses of Celebrex a day had 3.4 times the risk of cardiovascular events than those who took a placebo.

For patients in the trial taking 200 mg of Celebrex twice a day, the risk was 2.5 times greater, the agency said.

The average duration of treatment in the trial was 33 months, the FDA said.

"A similar ongoing study comparing Celebrex 400 mg once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk," the FDA said.

Pfizer called the results unexpected, but said it has no plans to take Celebrex off the market. Vioxx, a drug based on a similar chemical structure, was pulled off the market after it doubled patients' risks of heart attacks and strokes.

In the aftermath of the Vioxx fiasco, a high-ranking FDA official told a U.S. Senate committee that his agency had immense problems in ensuring drug safety.

The country was "virtually defenseless" against unsafe drugs finding their way into people's homes, David Graham, an associate director in the FDA's Office of Drug Safety, told senators.

"I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx," Graham said.

Graham was disparaged by his supervisors and "vilified" for taking his stand, DeAngelis said. And it has taken a toll on him, said DeAngelis, who said she recently talked with Graham.

He looks "gaunt," and said he had lost about 15 pounds, DeAngelis said