Arguing that the U.S. system for monitoring drug safety is haphazard and ineffectual, editors of a leading medical journal called Monday for a radical overhaul and suggested the creation of a new independent drug safety board.
The bluntly worded editorial in the Journal of the American Medical Association says the country’s surveillance system of prescription drugs on the market is inherently flawed, largely relying as it does on pharmaceutical manufacturers to investigate the adverse effects of their own products.
“The drug approval process must be decoupled from the post-marketing safety and surveillance system,” the editorial says. “It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong.”
In response, a Food and Drug Administration official said the JAMA editorial proposal “warrants serious consideration.” But, he said, the Institute of Medicine, an arm of the National Academy of Sciences that advises the government on health issues, has already been asked to study the drug safety system. The editorial noted that the institute’s study would take too long to complete, and that urgent steps were needed to restore confidence in the FDA.
“I reject the concept that there’s a crisis of trust” in the agency, Dr. Steven Galson, the FDA’s acting director of drug evaluation and research, said in a telephone interview.
Segregating the drug approval and safety monitoring arms of the agency could be problematic, Dr. Galson said. “To make sound public health decisions you need to consider both the risks and benefits of a drug. … An organization that just considers the risk can come up with one-sided decisions.”
The drug manufacturing industry also supports waiting for the study. “We are not convinced there is a need for change,” said Jeff Trewhitt, a spokesman for the trade association that represents the Pharmaceutical Research and Manufacturers of America.
The editorial in JAMA comes on the heels of scandals surrounding popular prescription drugs, including the arthritis drug Vioxx, which was yanked off the market in September by Merck &Co., and questions surrounding the safety of anti-depressants for children. Last month, the FDA strengthened warnings on anti-depressants to stress the risks for children and teens.
The medical journal also contains several reports on topics related to prescription drug safety. One found that the adverse effects of Baycol, a cholesterol-lowering drug recalled in 2001, were known to the manufacturer shortly after the drug’s launch. The article suggests the company’s analyses that found an increased risk of rhabdomyolysis – a breakdown in muscle that can cause kidney damage – were never made public.
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