Monday, December 13, 2004

FDA critic Dr. Graham recognized by Forbes

If you are a Vioxx victim, you have probably heard of Dr. David Graham. Otherwise, for vast majority of Americans, Dr. Graham does not exist. But Dr. Graham may have done the greatest service to the nation by exposing that the Food and Drug Administration Agency (FDA) was incapable of defending the American public against another drug disaster.

Now Forbes magazine has declared Dr. Graham as the annual Face of the Year for his "steadfast advocacy of drug safety and his willingness to blow the whistles on his bosses." According to Forbes.com Medical and Science Writer Matthew Herper, Graham was a steadfast watchdog on drug safety long before the Vioxx recall. "Without Graham, the Vioxx debacle might have been seen as an isolated event. But because he was willing to step into the spotlight, the withdrawal of Vioxx from the market looks like part of a systemic failure to properly weigh the risks and benefits of drugs."

Drug safety has been the big issue of the year, and Graham's actions will cast a long shadow for patients, doctors, and the $450 billion global drug industry. Do not forget that the current administration and the FDA have been denying the opportunity for poor Americans to import prescription drugs from Canada on the excuse that Canadian drugs may not be safe. Now what Dr. Graham is saying is that there is no guarantee that the drugs being sold in the United States right now are safe since the FDA is literally a lap dog of the pharmaceutical industry. Not only does it rely on the drugmakers for test data, it also is full of so many industry insiders that it dare not say anything against the industry - something that has been so obvious in the recent Vioxx scandal in which FDA has consistently sided with Merck rather than speak out to protect the interests of American people.

Why is the recognition of Dr. Graham by Forbes important? Because this is not a magazine that likes government or federal agencies or even government employees. Consistently coming up with anti-government themes, Forbes is not a magazine that likes anyone who criticizes greedy corporations. If the magazine has made an exception in the case of Dr. Graham, what it means is that folks like Matthew Herper understand that if Americans (and the world at large) loses confidence in the FDA, not only is it disastrous for the Americans, it is also disastrous for pharmaceutical companies. When you pop a pill, you are essentially putting your life in the hands of a drug company and when that trust is broken (as Merck did in the case of Vioxx), you will think ten times before popping a pill (particularly when it is made by Merck).

The Japanese government has never trusted the American drug approval process and an American drug trying for approval in Japan has to start from scratch. In the past, this process was described as anti-competitive behavior by the Japanese government designed to keep out competition but it seems that they were doing the right thing. What happens when other governments start questioning the credibility of the FDA?

Recommended article: Vioxx critic Dr. David Graham may lose his job for criticizing the FDA

Source for part of the article: Forbes