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Medical Journal Questions FDA's Drug Control Procedures

Journal of the American Medical Association examines agency's ability to ensure safety of prescription drugs

MONDAY, Nov. 22, 2004 (HealthDay News) -- A spate of articles and commentary in the influential Journal of the American Medical Assocation (JAMA) criticizes the U.S. Food and Drug Administration's procedures for drug approval and control.

Citing "relevance to current events," JAMA's editors on Monday released six studies on the issue from the weekly magazine's Dec. 1 edition. The federal agency came under fire last week during testimony before the Senate Finance Committee about why the pain drug Vioxx -- made by Merck Pharmaceuticals -- had been allowed to continue to be distributed even though there was evidence that linked its use to an unusual number of heart attacks.

Among the articles and editorials are:

  • Criticism of the reduction in the amount of time it takes to approve a prescription drug.
  • Questions about the propriety of pharmaceutical firms and other medical product manufaturers spending almost $5 billion lobbying the FDA.
  • Recommendations to separate FDA regulatory procedures between pre-approval and post-approval to eliminate possible conflicts of interest.
  • A study that concludes drug safety monitoring has lapsed in the past decade.

In addition, an editorial pointed out, the FDA has decreased drug approval times from 27 months in 1993 to 14 months in 2001. At the same time, the drug recall rate has soared from 1.56 percent for 1993 to 1996 to 5.35 percent for 1997 through 2001, the commentary added.

"The FDA used to be a pretty darn good organization you could depend on," said Dr. Catherine DeAngelis, lead author of the editorial and editor-in-chief of JAMA.

DeAngelis called in the editorial for a separation of the pre- and post-marketing surveillance systems for prescription medications. Currently, the FDA handles both.

"It's like putting the fox in charge of the hen house," DeAngelis said. "It has to be a separate unit responsible for the post-marketing, free of any influence of the people who approved it in first place."

The approval and monitoring processes also need to be independent of influence from the pharmaceutical industry. "It bothers me that the pharmaceutical industry spent $4.9 billion to lobby the FDA," she said. "Why are they allowed to lobby the FDA?"

A study submitted to JAMA a year ago but coincidentally comes up for publication now, contends that during the past 10 years, "attention to improvements in drug safety has lagged behind the attention to rapid approvals," according to Dr. Bruce M. Psaty, lead author of the study and a professor of medicine and epidemiology at the University of Washington in Seattle.

"Appropriate safety responses include adding new warnings, suspension of sales and sometimes even withdrawal," Psaty said. "Pharmaceutical companies are now responsible for initiating these types of changes and may have too high a threshold for taking action in a timely fashion to protect the health of the public."

Psaty based his conclusions on a review of documents, including internal company documents, related to Baycol, a cholesterol-lowering drug that was yanked from the market in 2001 after evidence of increased risk of rhabdomyolysis (damage to the muscle tissue) came to light. The documents indicated that the company knew about the risks within months of the drug's launching, but did not ask that its marketing be delayed.

Psaty said that Baycol's maker, Bayer, made a decision not to publish data from clinical trials that would have shown the presence of muscle damage. "One clinical trial showed that high dose cerivastatin [Baycol] increased the risk of muscle damage but was not published," he said. "Deciding not to publish selected clinical trial results misrepresents the evidence of safety and efficacy for patients and physicians."

MedWatch, the FDA's voluntary system of reporting adverse effects from clinical trials, is only equipped to pick up rare events that are unrelated to what the drug is for (like rhabdoomyolysis and liver failure) but not the heart attacks that took place with Vioxx. A clinical trial or epidemiological study would be needed to find that association.

"It has a useful function, but it needs to be complemented," Psaty said.

Pressure from public interest groups has made at least a dent in this problem. The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the industry, announced in September that it was starting a central database to "better communicate the results of clinical studies of marketed drugs" completed since October 2002.

Psaty and his co-authors suggested several routes for action, including regular re-review of medications and setting up an independent office for drug safety.

"The drug approval process has been made more efficient but we haven't paid the same serious attention to the safety side," he said. "Additional serious attention needs to be paid to drug safety and post-marketing surveillance."

More information

Visit the Institute of Medicine for more on drug safety.

SOURCES: Catherine D. DeAngelis, M.D., editor-in-chief, Journal of the American Medical Association; Bruce M. Psaty, M.D., Ph.D., professor of medicine and epidemiology, University of Washington, Seattle; Dec. 1, 2004, Journal of the American Medical Association
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