Vioxx, Bextra decision in doubt due to conflicts of interests

Ten of the scientists who recommended that Vioxx sales be allowed to resume and Bextra continue to be sold in the United States all had financial ties to Merck and Pfizer, according to publicly available information analyzed by The Center for Science in the Public Interest and The New York Times. In other words, any reasonable person cannot expect them to be fair, though some of the panel members claimed that their ties to drugmakers did not influence their decisions. (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

In fact, had these ten members not been on the panel, the panel would have voted to ban both Vioxx and Bextra. In other words, FDA that has sided with Merck and Pfizer in the Cox-2 drug safety debate put together a panel so that it could make favorable recommendations. Prior to the panel hearings, FDA tried to stop Dr. David Graham and Professor Curt Furberg from attending these and gave in only after pressure from lawmakers. Both scientists had criticized the drugmakers and the FDA for mishandling of Vioxx recall. After the favorable vote from the panel, stocks of both Pfizer and Merck surged and some analysts are starting to speculate that the legal problems of the companies may be less of an issue going forward. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

FDA helps Merck and Pfizer, even if it means risking American lives

• FDA has done everything in its power to help Merck and Pfizer so far. Cox-2 drugs, whose safety has not been studied yet, got fast-track approval. Then the agency failed to act after disclosures about deaths and injuries started to come in. It tried to silence its own expert, Dr. David Graham, who presented solid evidence that Vioxx should have never even been approved.
• Since the recall of Vioxx, Merck actually became even more aggressive in its stance and surprised many on Wall Street by refusing to make any provisions for its Vioxx liabilities which are estimated to be as high as $55 billion by some analysts. Now it is becoming clear that Merck must have known that FDA will come to its rescue. 140,000 Americans are estimated to have been injured by Vioxx and death estimates range from 30,000 to 50,000.
• Similarly, despite publication of research that highlighted risks of Celebrex and Bextra, Pfizer continued to stand by the safety of the drugs and refused to recall them. It too knew that FDA will put together a panel that will make favorable recommendations. (Related article: Pfizer may have known Celebrex risks)

The decision to recommend that Vioxx sales be allowed shocked most industry observers particularly because of the background of Vioxx recall. Merck voluntarily recalled the drug after it found that the drug was just not safe to be on the market. Then a series of studies released from October 2004 to middle of February highlighted that:

1. All Cox-2 drugs raise the risk of heart attacks and strokes.
2. These drugs do not provide any more benefit than an Aleve or Ibuprofen for almost all arthritis patients but cause serious side effects.
3. Merck and Pfizer fought Coke-Pepsi style over Vioxx, Celebrex, and Bextra.

It is no secret that FDA has become a dysfunctional agency due to its strong ties to the pharmaceutical industry. Not only does the pharmaceutical industry employs lobbyists to lobby the FDA, it is also one of the largest contributors of campaign funds (almost all go to the Republican Party).

Doctors and scientists often have unacceptable conflicts of interest

• It is also impossible to find many scientists and doctors in the United States that do not have ties to pharmaceutical firms. Since these folks are so desperate for research grants, they often rely on the drugmakers to fund these research projects.
• When researchers conduct research and if they come up with conclusions that could damage drug sales, the drug companies do not allow publication of the research or discussion of the results by the scientists.
• Until recently, researchers did not disclose conflicts of interests when publishing papers in medical journals.
• Doctors and scientists often get invited to all expenses paid trips, supposedly for education and technical discussions, but are in reality luxurious vacations for them, all paid for by drug companies. It is also common for doctors to be showered with gifts and giveaways from the drugmakers.

Related developments

Louisiana Medicaid restrictions for Celebrex and Bextra

New Zealand bans/restricts Cox-2 drugs

Australia limits/bans Cox-2 drug prescriptions

Merck could have found out Vioxx risks earlier