The Spark

“The emancipation of the working class will only be achieved by the working class itself.” — Karl Marx

Vioxx is only a very tiny tip of a very big iceberg

Dec 6, 2004

Dr. David Graham, associate director of science at the FDA's Office of Drug Safety, recently told the Senate Finance Committee that the U.S. public is "virtually defenseless" against dangerous medicine. He listed five drugs that should be subjected to closer investigation. These five drugs, shown in studies to cause serious complications, are Bextra, a painkiller similar to Vioxx, the cholesterol lowering drug Crestor, the anti-asthma drug Serevant, a weight-loss drug called Meridia, and the acne medication Accutane.

Nonetheless, the FDA, despite warnings from its own scientists that the dangers associated with these drugs could outweigh their benefits, continues to give its approval to the drugs. Graham explained that senior management at the FDA emphasizes speedy approval of new drugs rather than reducing the medical risks associated with them.

In other words, the issue is not just Vioxx and not just Merck. There is a systemic problem with the way new pharmaceutical products are reviewed.

Graham is not the only FDA scientist to criticize the way the agency performs. In a confidential survey carried out in 1998, one third of the FDA's medical officers responded. In total, they mentioned 27 drugs approved by the FDA over the previous three years overriding the recommendation of the FDA scientists in charge who had opposed approval.

Scientists working for the FDA or the pharmaceutical companies often find themselves in a Catch-22 situation. Their insider status allows them to investigate risks they wouldn't otherwise know anything about. But if they go public with their findings, they stand to lose their insider status. When Graham publicly released information about the dangers of Vioxx, he came under attack, accused of "unprofessional conduct."

Ironically, Graham testified to these problems in front of the Senate Finance Committee, which opened hearings once the Vioxx excrement hit the fan.

The FDA today may give speedier approval to new drugs and it therefore ends up with more risky drugs on the market. But it's just following guidelines to speed-up the renewal process laid out in legislation passed by Congress in 1992, and renewed again in 1997.

Truly, the problem is a systemic one and not just of the FDA approval system, but of the whole system, starting with a government which puts profit before all else, including health.