Drug Makers Commonly Exaggerate Claims 7/9/2006 8:10:43 AM
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And Promote Unproven Uses Consumer Advocacy Group Says
TRENTON, N.J. -- Drug makers commonly exaggerate claims, promote unproven uses and underplay medicines' risks when marketing to doctors and customers, according to a report released Wednesday by a national consumer advocacy group. Doctors and consumers are inundated with false and misleading advertising on television, in print and through literature handed out by drug sales reps, and the Food and Drug Administration is ineffective at stopping the abuses, says the report, which was written by the New Jersey chapter of the Public Interest Research Group.
The watchdog group analyzed 170 enforcement letters the FDA sent to drug marketers over five years through 2005 detailing deceptive claims involving Vioxx, Paxil, and 148 other drugs. The report's author, Abigail Caplovitz, characterized the problem of false drug claims as "broad and serious. Drug marketers are pushing drugs in deceptive ways that put the public at risk," Caplovitz said. "Vioxx may be the poster child, but our report shows the problem is pervasive throughout the industry. This is not a matter of a single bad apple, 85 companies (received letters from the FDA)." Vioxx's maker Merck and Co. faces 11,500 lawsuits over the painkiller which the company removed from the market in 2004 after a study showed it doubled patients risk of heart attacks and strokes after 18 months of use.
The report recently released shows:
1. Some 62 percent of false or misleading messages documented in the report targeted doctors. In more than a third of those cases, physicians received information minimizing or misrepresenting a drug's risks;
2. Drug marketers turned clinical trials into marketing tools by suppressing unfavorable results, or misreporting results;
3. A letter from the FDA did not always deter deceptive advertising: One-third of the drug marketers received more than one letter from the agency for the same problem.
4. The monitoring that is happening is completely inadequate.
The report suggests that individual states can solve much of the problem by creating a comprehensive, searchable database of clinical trials and requiring drug marketers to register every human clinical trial.
An existing federal database http://www.clinicaltrials.gov is voluntary, and contains incomplete or selective information.
The report also suggests new legal rules to allow people to sue to stop deceptive advertising.
In the wake of a threatened lawsuit in 2001, the FDA instituted new guidelines in 2002 requiring more detailed financial disclosures for committee members meeting to consider specific drugs. An examination of the resulting information showed that almost 30 percent of advisory committee members and voting consultants had some degree of conflict, and that there was at least one member or consultant with a conflict in nearly three quarters of all meetings. However, only 1 percent of members were ever recused from attending meetings. Conflicts included consulting fees, stock holdings or investments and research grants ranging from $10,000-$100,000. The study also showed that for every voting member with a conflict of any type, there was a 10 percent greater likelihood that the meeting would favor the drug in question.
This is not too surprising since the drug companies have the largest number of lobbyists in Congress. However, it does not make the facts any easier to accept.
