Most people are familiar with the scrupulous claims against the
FDA's inability to protect Americans from unsafe drugs. It has been
an issue flooding the headlines of newspapers and the nightly news
for the past few months.
Accusations against the FDA started when Merck was pulled Vioxx
from the market in 2004. Apparently the FDA had been aware of the
drug's adverse side effects as early as 1999. Since Vioxx's removal,
other drugs have been placed under the microscope and the agency's
credibility has been questioned. One FDA drug safety reviewer, Dr.
David Graham, told a Congressional panel that federal drug regulators
were "virtually incapable of protecting America."
Previously "Approved" Drugs
in Question
- Crestor (cholesterol-lowering drug): Causes acute kidney failure
- Bextra (painkiller): Increases risk of heart attack in those
undergoing cardiac surgery and may also cause a fatal skin reaction
- Meridia (weight-loss pill): Causes substantial increases in
blood pressure and has been associated with 124 reports of serious
cardiovascular problems
- Serevent (asthma medication): Increases risk of asthma-related
deaths and life-threatening episodes
- Accutane (acne drug): Causes birth defects
The director of the FDA's Center for Drug Evaluation and Research
opposed Graham's accusations; arguing Graham's findings and numbers
"constitute junk science" and were nonetheless "irresponsible."
The director continued on by stating that all of the agency's decisions
and drugs are not only safe but also effective.
New
York Times November 19, 2004
