US pharmas challenge JAMA report on new medications

30 April 2002 22:23  [Source: ICIS news]

WASHINGTON (CNI)--A new study that cautions doctors against prescribing recently approved drugs when older medicines might be equally effective is "misinformed and misleading," the pharmaceutical industry said Tuesday.

The study published in this week's Journal of the America Medical Association (JAMA) warned that "the safety of new agents cannot be known with certainty until a drug has been on the market for many years."

It said that of the 548 drugs approved by the US Food and Drug Administration (FDA) between 1975 and 1999, 56 were later given new warnings or taken off the market altogether.

"Pharmaceutical companies frequently market new drugs heavily to both patents and clinicians before the full range of [adverse effects] is ascertained," said the study from the Cambridge Hospital and Harvard Medical School in Cambridge, Massachusetts.

However, the Pharmaceutical Research and Manufacturers of America (PhRMA) said today there is no such thing as zero risk for new drugs and that the level of problems is relatively small.

"While all medicines, including aspirin, involve some risk, the FDA approves medicines when the benefits are shown to outweigh the risks," said PhRMA spokeswoman Jackie Cottrell.

"Pharmaceutical companies study the safety and effectiveness of all drugs before and after they are on the market, and respond promptly and appropriately when problems are discovered," she said.

Of the five drugs withdrawn from the US market between September 1997 and September 1998, the study said three had been on the market for less than two years.

Part of the problem, the JAMA article said, is that doctors report less than 10% of adverse reactions to FDA's post-market monitoring system.

"Clinicians should avoid using new drugs when older, similarly efficacious agents are available," the study cautioned. "Patients who must use new drugs should be informed of the drug's limited experience and safety record, and be observed for possible [adverse effects]."

But PhRMA's Cottrell said patients and their physicians want access to the benefits of new medicines as soon as the FDA deems them safe and effective.

"The physician who knows the individual patient is the best judge of whether a patient should use a new or an older medicine," she said.

By: Glenn Hess
+1 713 525 2653

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