FDA tries to protect Merck and Pfizer

The last thing that you would expect from a Republican senator is to go after pharmaceutical companies, particularly at a time when the pharmaceutical industry association is lead by a former Republican Congressman Billy Tauzin. But contrary to what anyone would expect, Senator Charles E. Grassley has indirectly decided to take on both Merck and Pfizer. It is no secret that pharmaceutical companies have contributed millions of dollars to election of Republicans, including President Bush, and have succeeded in get their favorite legislation passed. In addition to that, the president (and the FDA) has done everything possible to help the industry by not allowing import of prescription drugs from Canada and working to change the laws related to class action lawsuits.

Since the recall of Vioxx by Merck in September of last year, the FDA has consistently sided with Merck. Not only did FDA fail to act earlier on concerns about Vioxx and could have thus prevented injuries to 140,000 Americans, it also has since decided to protect Merck. Many experts speculate that there is something more to the story. This speculation has become even more widespread because of the treatment meted out to renowned scientist Dr David Graham, an expert at the FDA, who has been harassed since the day he came out with his revelations against Vioxx and the role of Merck and FDA. He has even argued convincingly enough that Vioxx should have never been approved.

So any reasonable person would expect that when the FDA holds its meeting to decide if other Vioxx type drugs (for example, Celebrex, Bextra, Arcoxia, Prexige, etc.), often referred to as Cox-2 drugs, should be on the market, Dr. David Graham should be allowed to present his arguments. But top officials of the Food and Drug Administration have forbidden Dr. David Graham to discuss before the panel a large study of that very question, according to Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham's co-author, quoted in the New York Times. Dr. Singh is no stranger to the Vioxx controversy. When he started to look at Vioxx as part of his research, he was actually threatened by Merck officials. (Related article: Merck knew of Vioxx risks)

Senator Grassley, who has held hearings in the past on Vioxx recall and is leading the investigation on behalf of the US Congress, has now written a letter to FDA's acting commissioner, Dr. Lester Crawford, asking him to explain why FDA is not allowing facts to come out. It is also important to point out that Dr. David Graham was about to lose his job until Senator Grassley intervened. Since then Dr. Graham has been treated like a pariah at the agency (as he said in an interview with the Fortune magazine) and has been granted a whistleblower status. His crime: Fighting for American people. (Related article: Why Merck did not recall Vioxx earlier?)

It is very likely that the FDA will come up with some complicated explanation why Dr. Graham's research is not good enough for presenting. That is exactly what happened when Dr. Graham came up with the estimate on injuries caused by Vioxx. It was only after the intervention by Congress and persistence of Dr. Graham that the study was finally published. (Related article: Vioxx recall controversy shows that reform needed at the FDA)

For those who are watching how Merck and Pfizer deliberately hid damaging information about Vioxx, Celebrex, and Bextra, the behavior of FDA officials is no surprise. Not only does the pharmaceutical industry employ approximately 600 lobbyists in Washington, it actually has dedicated teams and budget to lobby FDA officials exclusively. In fact, there are reports that FDA tried to influence Health Canada's decision to recall Adderall.

Recommended article: Update on Celebrex, Bextra, Arcoxia and Prexige