Aggressive drug marketing may endanger people

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - Quicker drug approvals and sophisticated marketing campaigns may be putting more patients at risk of dangerous side-effects but the same techniques might be put to use to protect them, a researcher argued on Tuesday.

New U.S. Food and Drug Administration procedures have clearly sped up some drug approvals, said Dr. David Kao of the University of Colorado Health Sciences Center.

For example, Merck & Co Inc's anti-inflammatory drug Vioxx, or rofecoxib, had been tried by 20 million patients before it was withdrawn in 2004 because of its heart dangers.

Writing in the British Medical Journal, Kao said the 1992 Prescription Drug User Fee Act, or PDUFA, which authorizes fees from companies to beef up the FDA and speed drug approvals, cut the time needed to review a new drug from 33.6 months during 1979-86 to 16 months by the 1997-2002 period.

The revenue from the fees accounts for 43 percent of the FDA budget for drug oversight. Similar fees make up 75 percent of the funding for the European Agency for the Evaluation of Medicinal Products and all of Britain's Medicines and Healthcare Products Regulatory Agency funding.

"It's probably not helping drug safety," Kao said in a telephone interview.

The closer to deadline that a new drug is approved, the more likely it is to later need strong safety warnings or to be withdrawn, he noted.

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