Released: May 04, 2006

Report finds drug marketers put patients at risk

Contact: U.S. Public Interest Research Group (PIRG)

A new PIRG report report takes a comprehensive look at some very troubling facets of prescription drug marketing and suggests effective solutions. Download a PDF of full report: Turning Medicine Into Snake Oil.

Findings in brief

False and misleading prescription drug advertising is common and dangerous. Prescription drug marketers are inundating doctors, and to a lesser extent, the public, with marketing that misrepresents risks, promotes unproven uses, and makes unsubstantiated claims. The false and misleading messages are communicated through conventional advertising, sales representatives, doctors speaking on behalf of drug marketers, and through clinical trial suppression, manipulation and misrepresentation. Sadly, the Food and Drug Administration (FDA) is ineffective at addressing the problems.

PIRG looked at enforcement letters FDA sent to drug marketers from 2001-2005 and its research reveals:

• From 2001-2005, 85 companies received 170 notices from the FDA explaining that the marketing for 150 different drugs was false and/or misleading.

• 62% of the false or misleading messages targeted doctors, and those messages were expressed by 38 different types of advertising. By contrast, the public was exposed to 17 different types of false or misleading ads.

• The false messages were serious: 35% misrepresented risk; 22% promoted unproven uses; and 38% made unsupported or misleading claims. For deceptive messages targeting doctors, 37% misrepresented risk; 24% promoted unproven uses; and 36% made unsupported or misleading claims.

• 28 companies—approximately 1/3 of the total— received more than one letter declaring their ads false or misleading in the five years we examined. In fact, these companies accounted for two-thirds of all the letters received.

• 26 companies received more than one letter relating to advertising for the same drug that was deemed false or misleading in the same way.

• Sales representatives, as a group, form long and deep relationships with doctors, beginning in medical school. Research suggests those early relationships increase doctors’ receptiveness to sales representatives once they are in practice.

• Perhaps reflecting those relationships, other research has shown that sales representatives have a profound influence on prescribing decisions.

• Sales representative statements accounted for 30 of the 869 deceptive messages in the FDA letters, an amount that is enormous given the very small percentage chance that the FDA will detect such statements. Other research suggests that as much as 11% of sales representative statements are false and favorable to the product they pitch.

• In the letters identifying advertising as false or misleading because it contained unsupported claims, FDA highlighted at least 82 times that the advertising cited clinical trials for propositions they did not support. In some instances, the cited trials even contradicted the claims.

• Drug marketers turn clinical trials into marketing tools by suppressing some unfavorable data; by using PR firms to write favorable reports (the PR firm does not appear as an author of the report, instead a doctor is retained to be the named author); by misrepresenting unfavorable data that is published; and, most subtly, by designing studies to get only the results they want.

• The FDA routinely reviews only “classic” advertising and does not comprehensively monitor sales representatives, doctors acting as pitchmen, or clinical trial data manipulation. Moreover, the FDA’s review of classic advertising is not complete; not all ads are submitted to it, and of those that are, the FDA only reviews some.

• The FDA letters rarely identify how many times, or where, an ad was used. A deceptive print ad may have run in several newspapers and magazines. Each of those print runs would be another dissemination of the deceptive messages in the ads.

• The FDA reviews advertising after it has been disseminated and only requires corrective measures a quarter of the time.

• The best measure is how many people internalized the deceptive measure, an impossible figure to determine. The 869 disseminations of deceptive messages that we were able to count from 2001- 2005 included TV ads, print ads, and other mass media. How many people are deceived by a single deceptive TV ad watched by a million viewers? Similarly, a single sales representative may convey deceptive messages to hundreds or thousands of doctors in a year.