WASHINGTON - December 15 – 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.