Drug Ads Often False, Misleading

Pharmaceutical companies often overstate the benefits of their medications, understate risks and promote unapproved uses in advertisements to physicians and consumers, and FDA has not adequately addressed the issue, according to a report released on Wednesday by the New Jersey Public Interest Research Group, the AP/Bergen Record reports.

For the report, the NJPIRG analyzed 170 enforcement letters that FDA sent to pharmaceutical companies during the five-year period through 2005 over false or misleading ads for the COX-2 inhibitor Vioxx and 149 other medications. According to the report:

About 62% of the false or misleading ads targeted physicians, who received information that understated or misrepresented the risks of medications in one-third of those cases;
Pharmaceutical companies in a number of cases concealed negative clinical trial results or misreported results; and
One-third of pharmaceutical companies that received letters from FDA received more than one letter for the same problem.

The report recommends that states establish comprehensive, searchable databases of clinical trials and require pharmaceutical companies to register all trials. In addition, the report states that individuals should have the ability to file lawsuits over false or misleading ads from pharmaceutical companies.

Comments

"Drug marketers are pushing drugs in deceptive ways that put the public at risk," report author Abigail Caplovitz said, adding, "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)."

In addition, Caplovitz said, "Perhaps most disturbing, we found that a lot of drug marketing isn't being monitored all," adding, "The monitoring that is happening is completely inadequate."

However, Ken Johnson, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that the report "grossly misleads the public about the safety of America's drug system and the goals, practices and results of prescription pharmaceutical marketing and advertising."

Merck spokesperson Janet Skidmore said that she had not reviewed the report and could not comment, and GlaxoSmithKline spokesperson Gaile Renegar said that the report used outdated information and did not provide a balanced or complete examination of the issue.

FDA spokesperson Susan Bro declined to comment on the report (Delli Santi, AP/Bergen Record, 5/3).

The report is available online. Note: You must have Adobe Acrobat Reader to view the report.

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