FDA: Public Watchdog or Corporate Dog?

Questions about the FDA are being raised in the wake of Merck's decision to take the drug Vioxx off the market. A new study reveals a strong link between Vioxx and heart attacks, but strong signs existed weeks ago and evidence existed years ago. The FDA did nothing.

The Ledger-Enquirer reports:

Dr. David J. Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, told Senate investigators he faced stiff resistance within the regulatory agency to his findings. "Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,'" Sen. Chuck Grassley, R-Iowa, said in a statement after Finance Committee investigators interviewed the researcher Thursday.

The Government Accountability Office, an investigative arm of Congress, already has been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from the market on Sept. 30, the GAO was asked to roll the FDA's handling of that controversy into its inquiry.

In testimony before a congressional panel in mid-September, Andrew Mosholder, an FDA epidemiologist, said his bosses asked him to soften recommendations about antidepressants. Mosholder's analysis pointed to increased suicidal thoughts and behaviors among children taking antidepressants well before federal advisers pushed for strident warnings on the drugs. He suggested preferential use of Prozac, the only drug approved to treat depressed children and - according to his review - the one with the lowest risk.

The FDA is supposed to exist to protect consumers — it's a government agency that is should be accountable to the people and the interests of the public. Today, though, it has stronger ties to the industries it is supposed to regulate than the people it is supposed to protect. Perhaps something needs to be done in order to change the FDA and prevent too much collusion with the industries.

Read More:

• Guide to Ethics and Morality
• News About Ethics
• Bioethics