AMA Approves Key Items On APA's Agenda

The AMA wants to help physicians protect information about their prescribing practices from pharmaceutical companies seeking to use the information for marketing purposes.

And it is prepared to spend close to $200,000 to provide an“ opt-out” mechanism for the AMA's own Physician Masterfile that would restrict the release of physician-specific prescribing data to pharmaceutical sales representatives.

The move is in response to a resolution brought to the AMA House of Delegates in December 2003 by APA and the American Academy of Child and Adolescent Psychiatry (AACAP). That resolution called on the AMA to“ explore the current scope of physician- and/or patient-specific data collected by the pharmaceutical industry, the current use of such data, and the impact of such practices on the cost and quality of health care.”

At last month's House of Delegates interim meeting in Atlanta, AMA delegates adopted a report reviewing the use of prescribing data by the pharmaceutical industry and recommending an “opt-out” mechanism for physicians providing information for the AMA Physician Masterfile.

The masterfile is the property of the AMA and is sold to a variety of entities for any number of research and data-gathering purposes. But entities such as health care information organizations, which routinely obtain prescribing data from pharmacies, claims processors, and pharmacy benefit managers, can match and append that prescribing data to other physician databases, including the AMA Physician Masterfile.

These data are then packaged into various products and licensed to the pharmaceutical industry, which uses the information for marketing purposes.

The report and the “opt-out” mechanism, which will cost the AMA an estimated $197,000, received widespread support from delegates on the floor of the house concerned about the availability of information on prescribing patterns— among other kinds of professional information—to commercial and other entities.

The report also calls on the AMA to work with the pharmaceutical industry and other entities to develop guidelines and a code of conduct outlining appropriate use of pharmaceutical data, behavior expectations on the part of industry, and consequences of misuse or misconduct.

“I think information about my prescribing practices should be private,” said pediatrician Eugenia Marcus, M.D., of Newton, Mass.“ The way my office is configured, sales reps can catch me on my way between rooms. Sometimes they'll stop me and say, `Doctor, you're not prescribing enough of our drug.' How do they know what I'm prescribing and not prescribing? I would love to have an opt-out mechanism to protect my information.”

AMA delegates also approved a resolution from APA and AACAP seeking the elimination of restrictive covenants and clauses in agreements between physician researchers and pharmaceutical companies or manufacturers of medical instruments, equipment, and devices.

The resolution was a follow-up to an AMA Council on Scientific Affairs report at the June meeting of the house—also prompted by a resolution from APA and AACAP—on the influence of funding source on outcome validity and reliability of pharmaceutical research.

That report, documenting the existence of publication bias and the effect of funding source on research design and the dissemination of data, called for a national registry of all clinical trials—an idea that gained nationwide attention in the wake of the controversy concerning whether SSRIs are linked to youth suicide and has resulted in congressional legislation.

Specifically, the new resolution approved last month asks AMA to work with the Pharmaceutical Research and Manufacturers of America (PhRMA), the American Academy of Pharmaceutical Physicians, and all other appropriate organizations to develop guidelines that would eliminate the use of restrictive covenants or clauses that interfere with scientific communication in agreements between pharmaceutical companies or manufacturers of medical instruments, equipment, and devices and physician researchers.

“Physicians, patients, and researchers need and deserve access to as much information as possible about the methodology and outcome of clinical trials as possible,” said David Fassler, M.D., vice chair of the Section Council on Psychiatry and AACAP delegate, during reference committee hearings on the resolution. “As this resolution points out, the PhRMA ethical code already calls for dissemination of clinically relevant data. I suggest that restrictive covenants and clauses are inconsistent with this commitment and incompatible with the open exchange of ideas, which is the very foundation of scientific inquiry and medical practice.”

Shortly after the meeting, the resolution was endorsed by the Association of American Medical Colleges (AAMC).

“Collaborations between academic researchers and the pharmaceutical industry are essential to advancing the health care of our nation,” said AAMC President Jordan J. Cohen, M.D. “But negotiating the contracts that govern these partnerships is often a challenging and contentious exercise.”

Universally accepted contract language that would protect clinical trial participants and ensure that researchers are not inappropriately prevented from communicating scientific results would help preserve the public's trust in the integrity of research trials, according to the AAMC's statement on the resolution.