 Dr.
David Graham, associate director in the FDA's Office of Drug Safety,
called the FDA's approval of arthritis drug Vioxx, "The single
greatest drug safety catastrophe in the history of this country or
the history of this world." Graham went on to cite the following
statistic: A staggering 88,000 to 139,000 Americans suffered heart
attacks and strokes as a result of taking Vioxx.
In addition to Vioxx, Graham named five
other drugs that are putting the lives of the public at risk. The
five drugs in question are:
- Meridia
- Crestor
- Accutane
- Serevent
- Bextra
Graham stated that the FDA's inability to protect Americans from
another case similar to the Vioxx case was clear evidence that massive
changes need to be implemented for the future protection of the
public.
One of the regulatory changes Graham proposed was granting the
Office of Drug Safety independent regulatory authority. Presently,
safety officers are faced with a conflict of interest in the event
they have to convince the Office of New Drugs that a drug is causing
side effects. The conflict arises because the very group that approved
the drug in the first place is also responsible for taking regulatory
action against any post-marketing activities.
Graham's Future
Tom Devine, Graham's lawyer, stated that Graham would be exiled
from his duties of reviewing drugs and placed in the office of the
commissioner. Devine described this position as "filling space
under the scrutinizing watch of a babysitter."
USA
Today November 25, 2004
British
Medical Journal November 27, 2004
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