Search This Blog

Monday, July 24, 2006

The FDA Can't Do It's Job

The FDA is trying to decide if they should ban scientists with financial interests in certain drugs from serving as advisors to the agency. There are review panels set up by the FDA to assess the value of a drug. The FDA argues that banning certain scientists would deny the FDA access to advisers with the expertise and experience it seeks.

"We probably couldn't recruit department chairmen. It would hinder us from recruiting all but junior faculty members" said Dr. Scott Gottlieb, the FDA;s deputy commisioner for Medical and Scientific Affairs.

Congress argues that scientists with a financial interest in a drug, serving as advisors for the scientific assessment of the drug have a conflict of interest. The FDA does not deny this fact. They just don't want to admint that the conflict of interest manifests itself as decisions based on financial gain. They believe that what they do is pure science and thus they need scientific advisors.

The question is however, why can't the FDA do their job without having to hire consultants? They hire people to explain things they should really have a firm grasp on themselves. The budget for approving, labeling, and monitoring drugs is roughly $290 million per year.. Still they cannot make decisions without consulting with the experts who have a conflict of interest?

Congress is simply trying to get the FDA to make better decisions. The conflicts of interests cause the FDA to make bad decisions. The reason the FDA was set up was to protect the American people from potencially harmful food and drugs. We needed a government agency who had only the interest of the people to protect. We needed people who could protect us from harmful products sold by people whose main interests were in making money. Now our FDA is telling us they can't make good decisions without hiring people who cause them to make bad decisions.

"It just doesn't make any sense to me. When you have this problem-conflicts of interest on critical panels-the solution is eliminate the conflict. It's simple and easy to do," said Rep. Maurice Hinchey D-NY.

1937 — Over 100 people died after consuming a raspberry-flavored sulfa elixir which had been rushed to market by the S.E. Massengill Company without any testing. About 70 percent of the elixir was diethylene glycol, which is now known to be poisonous (related to antifreeze). However, the FDA was able to remove the sulfa elixir from the market because elixirs at the time were to contain alcohol as a solvent (not diethylene glycol).

1938 — The resulting sulfa elixir scandal and public outcry led to the passage of the Federal Food, Drug, and Cosmetic Act of 1938, which gave the FDA the power to preapprove all new drugs introduced into interstate commerce.

It is important to point out that the scientist who developed the rasberry-flavored sulfa elixir was so devestated by what happened that he committed suicide. Most of the deaths he caused were young children. No one in their right mind would purposely kill young children by poisoning their medicine. This was a tragic mistake that was corrected by making the FDA our guardians. They are now telling us that they can't do their job.

No comments: