Vioxx recall shows FDA hijacked by drug industry

The mystery of why Food & Drug Administration (FDA) will favor the drug industry over American people is starting to solve somewhat as more research is published. (Related article: FDA sides with Merck in the Vioxx recall mess)

According to a paper published in the Journal of American Medical Association by Phil Fontanarosa, Drummond Rennie, and Catherine DeAngelis (all doctors):

• Since adoption of the 1992 Prescription Drug User Fee Act, which augmented the budget of the FDA by charging "user fees" to pharmaceutical firms, the FDA has received approximately $825 million in fees from drug and biologic manufacturers from fiscal years 1993 through 2001.
• During that time, median approval times for standard (i.e, "non-priority") drugs decreased from 27 months in 1993 to 14 months in 2001, but as an inevitable consequence of faster approvals, drug recalls following approval increased from 1.56% for 1993-1996 to 5.35% for 1997-2001.
• In addition, an investigation of 18 FDA expert advisory panels revealed that more than half of the members of these panels had direct financial interests in the drug or topic they were evaluating and for which they were making recommendations.
• In 2003, the pharmaceutical industry earmarked $4.9 million to lobby the FDA.

The authors see several major problem with the current system for ensuring the safety of medications in that drug manufacturers are largely responsible for collecting, evaluating, and reporting data from post-marketing studies of their own products. It is similar to testing your own driving skills and then asking the Registry of Motor Vehicles to issue a driving license to you.

The recent withdrawal of Vioxx (rofecoxib) has raised major concerns about the undue control of industry over postmarketing safety data. EJ Topol writing in the New England Journal of Medicine pointed out that although he and his colleagues published a clear warning about the cardiovascular toxicity of rofecoxib in 2001, the FDA never insisted on a trial to determine the extent of the problem and Merck countered with a "relentless series of publications . . . complemented by numerous papers in peer-reviewed medical literature by its employees and their consultants.

Recent reports in the media suggest that Merck was well aware of the dangers of rofecoxib as early as 2000, but made concerted efforts to conceal those findings. Yet, more than 3 years later, when the cardiovascular risks of rofecoxib were documented by FDA researchers several months before the data that ultimately led to removal of the drug from the market became publicly available, FDA officials allegedly attempted to "suppress" the conclusions of the report, according to the Washington Post and the Wall Street Journal.

Recommended article: Complete coverage of Vioxx recall