FDA should not have approved Vioxx

That is what Dr. David Graham, Associate Director at the FDA's Office of Drug Safety, says in an interview with Fortune's John Simons. (Related articles: Vioxx approval may have been a mistake and Vioxx approval process was faulty). For those of you who may not know much about Dr. Graham, he was recognized by Forbes magazine as the Annual Face of the year, and he has criticized the agency since Vioxx was recalled. His name became even more famous because the FDA, which has sided with Merck in the Vioxx recall case, tried to destroy his career for criticizing the shoddy work of the agency.

Here are other comments from his interview with John Simons:

1. FDA's pushback on Vioxx was more intense than with other drugs. (Related article: How FDA started to work with drug industry instead of working for American people)
2. It is the FDA that is basically responsible for 100,000 people having heart attacks and as many as 55,000 people dying of those heart attacks. (Related article: Vioxx death toll revised upwards)
3. The FDA really let the public down. (Related article: How the FDA was hijacked by the drug industry?)
4. The people who approve a drug cannot be relied upon to regulate it. (Related article: Vioxx recall exposes the mess at the FDA)

Dr. Graham, a veteran at the FDA and respected worldwide for his credentials (Johns Hopkins, Yale, etc.) is now fighting for his job. It is no secret that the FDA and the current administration is full of pharmaceutical industry insiders along with over 600 lobbyists. Dr. Graham admits that he may lose his job soon. "The sense I get from management is that I am an enemy, a traitor, a pariah." What a treatment by a government agency for a person who is fighting on behalf of American people.

Dr. Eric Topol, world famous cardiologist and another critic of Vioxx, agrees with Dr. Graham's position. He has always held the position that Vioxx (and other drugs like Celebrex and Bextra) provide no benefits at all and were aggressively marketed directly to consumers by Merck and Pfizer. He writes in the Journal of American Medical Association, "With the considerably higher cost, marginal efficacy, and known cardiovascular risks of the remaining agents on the market, valdecoxib (Bextra) and celecoxib (Celebrex), it would seem prudent, at the least, to avoid using these agents as first-line therapy." (Related article: Celebrex should be recalled)

Dr. Topol, like Dr. Graham, believes that direct-to-consumer marketing of a drug that had too many side effects and hardly any benefits was responsible for the current crisis, "These drugs were mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection, and safety. Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative "real world" population, the unbridled promotion exacerbated the public health problem." (Related article: FDA warns Pfizer on misleading ads)

Recommended article: History of Vioxx and its recall by Merck