Read full text of the article on the Journal of Public Health Policy‘s website.
WASHINGTON, D.C. – More than half the drug makers that participated in the 2002 American Psychiatric Association (APA) convention violated drug marketing rules set up by the association or the Food and Drug Administration (FDA), Public Citizen writes in a study in the current issue of The Journal of Public Health Policy.
The study, funded by the Greenwall Foundation and the Medicine as a Profession Program of the Open Society Institute, examined 24 drug company booths at the 2002 APA convention by documenting interactions with pharmaceutical company representatives and collecting the gifts provided by the companies to physicians. Seven research assistants also gathered information by filling out a questionnaire with a checklist of potential promotional violations of the APA convention guidelines immediately after visiting the booths.
The researchers found 16 violations of the APA’s exhibit rules: Eight companies had one violation and two companies (Eli Lilly and Pfizer) had four violations each. The most common APA violations were providing gifts valued at more than $10, booths with “glaring lights,” promotional activity outside of the booth and giving away toys or stuffed animals. The companies distributed a range of items including CDs, personalized luggage tags, palm pilot cases, bags, travel guides, mugs in velvet bags and phone cards. Other giveaways were invitations to meals, entertainment and art-related events.
Four companies were in violation of the FDA off-label marketing rules, either mentioning products for uses not approved by the FDA or discussing drug use at doses higher than what is recommended. Mallinckrodt violated both FDA and APA guidelines.
“This is strong evidence that the APA’s voluntary guidelines have failed to adequately reduce inappropriate pharmaceutical company promotional activity,” said Peter Lurie, deputy director of Public Citizen’s Health Research Group and one of the study’s authors. “Other voluntary codes now in effect … are likely to be similarly ineffective, in part because they lack enforcement capacity.”
The following is the abstract of the article, as published in the December 2005 issue of the Journal of Public Health Policy. The full text of the article can be found on the Journal of Public Health Policy‘s website.
We conducted a cross-sectional study of all exhibit booths for the 24 pharmaceutical companies at the 2002 American Psychiatric Association (APA) convention. We collected and categorized one of each item distributed by the companies at each booth. A total of 268 items were collected from 24 companies (median = eight). The most common categories of items were “reprints or pamphlets” (37 percent) and “noneducational gifts” (27 percent), including music CDs and invitations to dinners and museums. There were a total of 16 violations of the APA’s own exhibit rules: eight companies had one violation and two companies had four violations. Four companies engaged in FDA-prohibited off-label promotion; one also violated the APA code. Over half of all companies (54 percent) were in violation of either APA rules or FDA regulations. The APA’s voluntary code has failed to adequately reduce inappropriate promotional activity at the annual APA meeting.
Lurie P, Tran T, Wolfe SM, Goodman R. Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting. Journal of Public Health Policy 2005;26:389-99.