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Researchers find new drugs carry unknown side effects

By Hempology | May 3, 2002


Friday, May 3rd, 2002

By Lindsey Tanner (Associated Press)

One in five new drugs has serious side effects that do not show up until well after the medicine has received government
approval, according to a study that exposes what one researcher calls an alarming game of medical Russian roulette.

The researchers went so far as to suggest that doctors should prescribe older drugs when possible, unless the new one is
truly superior.

“It’s like playing Russian roulette when a doctor prescribes a newly approved drug that doesn’t have a big breakthrough,”
said Dr. Sidney Wolfe of Public Citizen Health Research Group, one of the resarchers who worked on the study.

Pressure from pharmaceutical companies and doctors’ failure to closely read warning labels are partly to blame, the researchers
said. They said the findings should prompt the Food and Drug Administration to consider raising its threshold for approving
new drugs when safe and effective alternatives exist.

The findings are based on ana analysis of 548 drugs approved from 1975 through 1999. Of these, 56, or more than 10 per cent,
were later given a serious-side-effect warning or tkaen off the market for safety reasons.

The number climbed to approximately 20 per cent when resarchers took into account drugs that were approved toward the
end of the period studied.

The study, led by Dr. Karen Lasser of Cambridge Hospital and Harvard Medical School, appears in today’s
Journal of the American Medical Association

An accompanying editorial by two FDA experts said the analysis overstates the problem.

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