Patrice Harris, M.D., presents a check to orthopedic surgeon Tom Price,
M.D., on behalf of the APA political action committee at last month's meeting
of the AMA's House of Delegates. Price, a Republican state senator from
Georgia, was elected in November to the U.S. House of Representatives. Harris
is a member of the AMA's Council on Legislation.
Psychiatrist Jeffrey Akaka, M.D., tells AMA delegates that provisions in
the U.S.A. Patriot Act can potentially compromise medical confidentiality and
the doctor-patient relationship.
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
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
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
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
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
Medical confidentiality was the focus of debate about the U.S.A. Patriot
Act, approved by Congress in the wake of the September 11 attacks.
A resolution brought to the House by APA and AACAP sought not only
recommendations from AMA for how physicians should respond to requests for
medical records but called on the medical association to advocate for
modifications in the act that may be necessary to protect patient
confidentiality and minimize legal liability for physicians.
During reference committee hearings, APA President-elect Steven Sharfstein,
M.D., emphasized that the Patriot Act is unique from other laws requiring
disclosure of patient records because of what amounts to a gag order—a
provision in the act forbidding the physician from informing the patient or
anyone else that records have been taken.
"It would mean the treatment relationship would have to end,"
Section council member Jeffrey Akaka, M.D., summed up the dilemma:"
The foundation of the doctor-patient relationship is trust,"
Akaka told delegates. "The act requires that, if applicable, we are
bound to breach this trust. How are we to deal with this?"
Support for the sanctity of the patient-physician relationship was
unanimous during hearings on the resolution, as was the call for guidance from
the AMA with regard to conflicts the Patriot Act might entail with other
federal laws protecting patient confidentiality. But a number of physicians
said the AMA should not inject itself into matters of national security by
advocating for revisions of the act.
In the end, delegates voted to refer the resolution to the AMA board with a
request from the reference committee for guidance on the issue.
The AMA house acted on these other items of interest to psychiatry:
The report recommends that the Federal Trade Commission consider taking
actions against purveyors of bulk dextromethorphan for sale to individuals,
particularly those committing unfair or deceptive acts in conducting business
over the Internet; and that the AMA assist the Consumer Healthcare Products
Association and the Partnership for a Drug-Free America in publicizing
educational efforts and resources on dextromethorphan abuse.
APA delegate Judy Linger, M.D., told house delegates that in Florida the
recreational use of dextromethorphan by minors is on the rise. "I
personally treated a 14-year-old who swallowed nine bottles of Robitussin for
the dextromethorphan high," she said.
More information on the AMA's 2004 interim meeting is posted online