Prescription drug claims criticized

TRENTON, N.J. — Drug makers commonly exaggerate claims, promote unproven uses and underplay medicines’ risks when marketing to doctors and customers, a report released on Wednesday by a national consumer advocacy group says.

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 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.

Merck didn’t immediately return a call for comment.

The Pharmaceutical Research and Manufacturers of America, a drug and biotech company trade association, also did not immediately return calls for comment.

The report released Wednesday shows:

“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;

“Drug marketers turned clinical trials into marketing tools by suppressing unfavorable results, or misreporting results;

“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.

Susan Bro, a spokeswoman for the FDA, did not immediately return phone or e-mail messages seeking comment.

Caplovitz said the report understates the problem because it relies on letters from the FDA, an agency that reviews only a portion of drug marketers’ advertising and a tiny fraction of the marketing to doctors at conferences and by sales reps who visit their offices.

“Perhaps most disturbing, we found that a lot of drug marketing isn’t being monitored all,” said Caplovitz. “The monitoring that is happening is completely inadequate.”

Laurie Yorke, a nurse at Overlook Hospital in Summit, cautioned parents about allowing their children to take powerful prescription without researching accepted uses for the medication and becoming familiar with its possible side effects. She said her teenage son had psychotic episodes after taking the antidepressant Paxil.

A spokesperson for GlaxoSmithKline, Paxil’s maker, did not immediately return a message for comment.