Merck manipulated FDA in Vioxx recall case

Two out of three FDA scientists lacks confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market.” And this survey was not conducted by a third party. These are the results of a survey by the US Government itself. Would you trust an agency that is not trusted by its own employees? No wonder then that Senator Chuck Grassley (mind you that he is a Republican, who are notorious for being very cozy with the drug companies that pump millions of dollars into their campaigns so that they would not allow prescription drugs to be imported from Canada or make life better for Americans in any way because that could hurt their profits) is now asking, "Is the FDA too cozy with the drug companies to ensure proper oversight?" (Related article: FDA did not disclose conflicts of interest of panel members reviewing Cox-2 drugs like Vioxx, Celebrex, and Bextra)

Since the recall of Vioxx and disclosures of dangers of such drugs as Celebrex and Bextra, Senator Grassley has come to the rescue of American people because the FDA still does not seem to be working for them. He was among the very few senators to speak out against the process used by the FDA to allow Vioxx sales to resume in the US and Celebrex/Bextra to stay on the market. All those who did not believe that the FDA was in bed with the drug industry learned that ten of the FDA panel members who voted in favor of these decisions were all recipients of money from the drug makers like Merck and Pfizer. (Related article: FDA panel recommendations in doubt due to conflicts of interest)

In a recent speech, Senator Grassley discussed the Vioxx recall mess and how the enormous help provided by world-famous FDA scientist Dr. David Graham was useful in saving lives of American people despite strong opposition from FDA and Merck officials (Related article: 140,000 Americans injured by Vioxx). In his words, "Vioxx example showed that the FDA and Merck were too close for comfort. Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck."

Here are a few other observations/charges that Senator Grassley makes:

1. When Dr. Graham found an increased risk of heart attacks and strokes in patients taking Vioxx, his immediate supervisor at the FDA dismissed it as “scientific rumor.”
2. The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx, the FDA approved the use of Vioxx for children.
3. The director of FDA’s office of new drugs suggested that Dr. Graham water down his Vioxx conclusions.
4. After it was found in 2000 that heart attacks were five times higher for Vioxx patients than for patients on another drug, Merck aggressively marketed Vioxx through direct-to-consumer advertising. Merck and the FDA knew that consumers and doctors were largely unaware of the cardiovascular risks. The FDA’s overriding concern should have been the health and safety of the American people. Unfortunately for some, the FDA’s priorities were misplaced. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Cox-2 drugs)
5. Merck managed to negotiate the cardiovascular risks of Vioxx right out of the “warnings” section on the drug’s label. Contrary to the FDA’s own scientist’s recommendation, the risk information went in the less prominent “precautions” section. (Related article: Merck dragged its feet on changing the Vioxx label to point out risks)
6. The Medicaid program paid more than $1 billion for Vioxx before Merck withdrew it from the market. Or in other words US taxpayers (with the help of the FDA) helped Merck market a dangerous drug and profit from it.

Recommended article: Merck has a very weak defense in Vioxx class action lawsuits