Pfizer refuses to recall Vioxx alternative Celebrex

This weekend was not a quiet one after the news Friday that Celebrex, like Vioxx, also caused major heart problems. It is expected that the FDA will make an announcement on the fate of the drug sometimes this week. Most analysts expect that FDA will ask Pfizer to recall Celebrex. Lester Crawford, head of the Food and Drugs Administration, the US medicines supervisor, told the Financial Times of London in an interview, “We are looking at all the Cox-2s and will make an announcement shortly. All the regulatory options are open. . .including withdrawal. . .I have serious concerns about Cox-2s as a class.” Most experts believe that a recall of Celebrex at this time is the right thing to do considering that tens of thousands of people are already dead from Vioxx and there is enough evidence against Celebrex.

It is indeed correct, as the Pfizer CEO kept pointing out this weekend, that the data is not conclusive and Celebrex and Vioxx are two different drugs despite belonging to the same class of drugs, but when it comes to health of people, it is better not to play with their lives, as Merck decided to do.

It was generally expected that after the flawed Vioxx recall strategy pursued by Merck, Pfizer will be wiser and pull the drug immediately, apologize to its customers, and announce a compensation program, but it is evident that Pfizer is actually following an identical strategy. In fact, it almost appears that the two companies are coordinating their campaigns.

In a report in The New York Times, however, Pfizer has announced that it will suspend all direct-to-consumer advertising immediately (though some ads may still be seen in the print media due to the time delays involved). The company will continue to market the drugs to doctors and advise them of adverse side effects so that they can prescribe the drug more carefully. (Related article: Vioxx recall leaves drug advertising unchanged)

It may be pointed that Pfizer, like Merck, is also a very aggressive direct-to-consumer marketer and embarked on an aggressive advertising campaign (the company had already spent as much as $71 million in the first 9 months of 2004) for Celebrex after the recall of Vioxx in late September. Pfizer is also notorious for misleading ads and FDA had to step in a few times to stop some of Pfizer's ads from running.

While this confusion about drugs has made Americans very nervous, the White House is perfectly pleased with the situation. In fact, Andrew Card, the White House chief of staff, 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." Looks like the view from the White House is quite different since tens of thousands of Americans are dead due to Vioxx because the FDA failed to protect the lives of Americans. Many more Vioxx victims are seriously injured. (Related article: White House to push for legislation that will take away the rights of Americans to file class action lawsuits)

Senator Edward Kennedy captured the mood of Americans who are disappointed by the lousy performance of the FDA and lack of accountability in the administration. He said, "I know that this is the Administration that never admits a mistake, but its record on protecting us from harmful prescription drugs is a catastrophic failure. 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. Early action on bipartisan FDA reforms is possible in Congress, and I hope that the White House and congressional leadership will not stand in the way."

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