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April
2002
Volume 66 |
Number
4
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WHAT'S
NEW
Professional Industry Relationships |
Elizabeth
A.M. Frost, M.D.
Paul L. Goldiner, M.D., D.D.S.
"With the increasing scrutiny of physician-industry
relationships, it is extremely important for
the anesthesiologist to recognize and adhere
to accepted guidelines when accepting industry
subsidies."
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The amount
that drug companies spend to court doctors has been rising for
several years. Almost $2 billion was expended on events for physicians
in the first 11 months of 2000 as compared with $1 billion for
all of 1997, according to the Physician Meeting and Event Audit
by Newton, Pennsylvania-based Scott Levin. The same company reported
that company-sponsored physician meetings and events skyrocketed
from 70,000 in 1993 to 280,000 in 1999. Given current drug costs,
especially as they relate to the elderly, concerns have been raised
as to the importance, necessity and even ethical considerations
of these escalating practices.
Most of us
have been the recipients of gifts in some form or another from
pharmaceutical companies, be it pens, notepads, dinners, fishing
outings or even more extravagant items. Indeed we depend on the
industry to introduce us to new drugs and techniques, to underwrite
some of our research, to support our meetings, to allow us a grant
to train their personnel and to fund symposia and other related
events. But medical society guidelines and regulations (in the
form of the Internal Revenue Service) exist, and all anesthesiologists
should be aware of which items are appropriate to accept and under
what circumstances gifts should be declined or declared as income.
Opinion 8.061,
"Gifts to Physicians From Industry," of the Code of
Medical Ethics of the American Medical Association (AMA) was originally
agreed upon between the pharmaceutical industry and AMA in 1990.
Since then, several addenda have been added and a full-length
report was published in The Food and Drug Law Journal. 2001; 56:1.
More information may be obtained at , and a printer-friendly PDF version may be downloaded. AMA began a campaign
in July 2000 to educate doctors on its ethics guidelines. The
18-month, two-phase initiative targets physicians and pharmaceutical
companies, asking them to comply with guidelines created by the
AMA's Council on Ethical and Judicial Affairs. Drug companies
paid about $700,000 for this campaign, which is expected to cost
more than $1 million. Further information may be obtained at www.ama-assn.org/go/ethicalgifts.
Also, a meeting was held in January 2002 in Washington, D.C.,
between representatives of the pharmaceutical industry and AMA
to further underscore the need to regulate the practice of gifts
to physicians. Education of both physicians and the industry was
emphasized.
Regulations
revolve mainly around seven guidelines: 1. Importance of
benefits to the patients 2. Individual gifts of minimal
value 3. Defining legitimate conferences 4. Subsidies
of medical education or conferences 5. Subsidies of travel
and expenses 6. Subsidies for students, residents and fellows
7. No strings attached. (For purposes of definition, "Industry"
includes all "propriety health-related entities that might
create a conflict of interest.")
Guideline
1: Gifts accepted by physicians should entail a benefit to
the patient and should not be of substantial value (i.e., less
than $100). Free pharmaceuticals for physicians and/or their families
are not acceptable. Dinner meetings may include a modest meal,
and a recognized speaker must present. Vouchers to reimburse for
uncompensated time are viewed as increased income.
Guideline
2: Individual gifts must be of minimal value related to the
physicianıs work (e.g., pens).
Guideline
3: A legitimate "conference" is held at an appropriate
location and the gathering is dedicated in time and effort to
promote scientific and educational activities with the incentive
to further knowledge.
Guideline
4: Subsidies to underwrite the costs of continuing medical
education are permissible, but payments to defray costs may not
be made directly to the physicians attending the conference.
Guideline
5: Subsidies from industry should not be accepted to pay for
costs of travel, lodging or other personal expenses, including
time reimbursement, for physicians attending conferences. Faculty
and bona fide consultants may accept reasonable reimbursement
and travel expenses. Renting of an expensive entertainment complex
during a conference and invitation of physicians do not fall within
the guidelines.
Guideline
6: Special funds to permit medical students and residents
to attend selected conferences may be permissible if selection
is made by the academic institution. Financial hardship should
not prevent fellows from attending an educational meeting.
Guideline
7: No gifts should be accepted if there are strings attached
such as gifts given in relation to prescribing practices.
These are
only guidelines, however. Are they of any consequence? Could there
be any retribution for those who ignore them? What will or could
happen to an anesthesiologist who has just placed a large order
for equipment or secured a change to another drug through the
pharmacy committee and then accepts tickets to a Broadway show,
a Caribbean cruise or even a "thank you" dinner for
the anesthesiologist and his or her spouse from the company that
benefits most? What could happen if the speaker at a continuing
medical education meeting, approved by the Accreditation Council
on Graduate Medical Education, accepts an additional $2,000 from
a drug company?
If there
are to be consequences for violating these guidelines, what might
they be, and where would they come from? This is not an easy question
to answer as we do not have a formal global process for oversight.
Potential enforcement might come from several different entities,
including the individual's home institution, the Food and Drug
Administration (FDA) and the Internal Revenue Service (IRS). Of
course, whenever a competitive leadership position is offered,
especially one with political overtones (surgeon general or chief
justice, etc.), personal scrutiny becomes intense, especially
from other equally interested parties.
Receiving
a gift after influencing the purchase of equipment or a change
in a supply contract certainly violates institutional conflict-of-interest
policy and constitutes grounds for censure and even dismissal
in most institutions. The acceptance of personal remuneration
in any form from the industry sponsor of a research protocol is
a direct violation of FDA standards and can lead to an individual
being barred from participating in future studies. (Small sums
may be allowed to cover costs of data collection, literature search,
etc.) Acceptance of gifts in the form of trips, dinners and other
gifts not directly related to participation in educational conferences
is considered a form of income by the IRS and should be reported
for tax purposes. The IRS considers the nonreporting of all such
gifts as income tax evasion, which can carry heavy penalties.
With the increasing
scrutiny of physician-industry relationships, it is extremely
important for the anesthesiologist to recognize and adhere to
accepted guidelines when accepting industry subsidies.
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Elizabeth
A.M. Frost, M.D., is Clinical Professor of Anesthesia, Mount
Sinai Medical School, New York, New York. |
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Paul
L. Goldiner, M.D., D.D.S., is Professor and Chair, Department
of Anesthesia, Mount Sinai Medical School, New York, New York. |
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