Pfizer To Halt Celebrex Ads

Drug-maker Pfizer said Sunday it would immediately stop advertising its best-selling arthritis pain reliever Celebrex to consumers after a study showed high doses of it were associated with an increased heart attack risk.

Pfizer said it plans to keep Celebrex on the market and will continue marketing the drug to doctors.

Pfizer says the Food and Drug Administration, which said Friday it was considering warning labels for Celebrex or withdrawing the drug from the U.S. market, agreed with the decision to halt advertising.

In the face of questions about FDA oversight of drug safety, the White House chief of staff said Sunday that the federal drug safety agency is doing a "spectacular job" of protecting the public.

The assessment drew an immediate outcry from a Senate critic who charged that government oversight under the Bush administration has proved "a catastrophic failure."

Chief of staff Andrew Card said, "I support the FDA. They do a spectacular job. When you think about all of the new technologies and the new drugs that are coming into the marketplace, and they have to review them all to make sure that when they come into the marketplace, they live up to the expectation of improving health care."

That the public is learning about drugs on the markets that "may not live up to those expectations is a testament to the FDA in how they do their job," Card said in a broadcast interview.

But the top Democrat on the Senate Health, Education, Labor and Pensions Committee charged that the administration's record "on protecting us from harmful prescription drugs is a catastrophic failure."

Sen. Edward Kennedy of Massachusetts said in a statement: "We need an FDA that looks out for the health of patients and not just the health of the pharmaceutical industry. Lives are at stake, and the president should put an FDA leadership team in place right away, with no ties to the industry it regulates, and that's committed to reform."

An internal FDA survey made public last week found that about two-thirds of agency scientists are less than fully confident in the FDA's monitoring of the safety of prescription drugs now being sold. Also, more than one-third of those scientists had some doubts about the process for approving new drugs.

The chairman of the Senate Finance Committee, GOP Sen. Charles Grassley of Iowa, has suggested that an independent board of drug safety may be needed to ensure the safety of medications after FDA approval.

Pfizer's chairman and chief executive Hank McKinnell defended the extensive research on Celebrex Sunday and said several studies showed "the risk with Celebrex is less than any other treatment option and is even less than people not being treated at all."

He added, "I'm not sure we really understand yet the relevance of this new data."

But David Graham, a whistle-blower who works in the FDA's office of drug safety, said, "The fact that the FDA says now that it's concerned about Celebrex to me is a serious signal. I would be very concerned."

Graham contended in a broadcast interview Sunday that the agency is "more concerned with getting drugs onto the market than it is with getting safe drugs onto the market. And so rather than dealing with issues such as cardiovascular safety with Celebrex or Vioxx or Bextra before approval, the FDA is willing to allow the experiment to occur after approval."

Bextra is Pfizer's other cox-2 inhibitor, the class of drugs that includes Vioxx and Celebrex.

Graham testified before a Senate committee last month that the FDA fumbled in its handling of Vioxx and had mishandled safety problems with five other widely used drugs.

Pfizer disclosed last week that Celebrex had increased the risk of heart attacks, strokes and death among some patients in a study, reports The Early Show Medical Contributor Dr. Mallika Marshall.

Celebrex more than doubled the risk of heart attack in a large cancer-prevention trial, a setback that comes just weeks after Merck & Co. recalled its similar Vioxx drug due to heart safety risks.

Pfizer said that the trial had found that patients taking 800 milligrams a day of Celebrex had 3.4 times the risk of heart disease as those given a placebo, while those taking 400 milligrams had 2.5 times the risk.

However, a second study, sponsored by Pfizer, found no increased risk of heart disease in a similar patient group given 400 milligrams a day.