Feds' actions are disquietingAmericans deserve to be deeply concerned about reports that the federal Food and Drug Administration tried to bury a report suggesting a leading anti-inflammatory drug greatly increases the risk of heart disease and death.
The editor of the leading British medical journal, The Lancet, this week became the latest harsh critic of the FDA, which is supposed to oversee the safety and effectiveness of prescription medications in the U.S. One of the FDA's own scientists, Dr. Steven Graham, conducted a study estimating that FDA-approved drug Vioxx has caused up to 140,000 serious injuries or deaths since it was approved in 1999. The Lancet published Dr. Graham's peer-reviewed paper this week despite a last-ditch effort by FDA's acting director to raise suspicions about it.
It is obvious that any problematic drug should not be approved in the first place, but even more troubling are the FDA attempts to suppress and undercut its own scientist's findings about the medication manufactured by Merck.
Vioxx racked up $2.5 billion in sales for the company in 2003, while Pfizer's Celebrex - a similar COX-2 inhibitor - brought in $3.3 billion in 2004.
Equally impressive are the amounts drug companies and trade associations spend on campaign contributions and political lobbying. Between Jan. 1, 1991 and Dec. 31, 2002, the Pharmaceutical Research and Manufacturers Association and its members gave $57.9 million in political contributions at the federal level, according to Common Cause, the nonpartisan citizens organization. Drug firms spend $150 million a year on lobbying. Merck reportedly spent $500 million marketing Vioxx to consumers.
It's no wonder the political appointees who are supposed to keep citizens safe decided instead to delay public knowledge of Dr. Graham's study, only posting it on the FDA Web site a week before Congress began hearings on the matter.
Merck has now withdrawn Vioxx from the market, setting aside more than $ 600 million to fight lawsuits. There are now calls to withdraw Celebrex and Bextra, chemically similar to Vioxx.
There's plenty of blame to go around in the Clinton and Bush administrations on this issue. But it's far more important to clean up conflicts of interest and incompetence in the FDA.