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SPECIAL COMMUNICATION

Professional Medical Associations


and Their Relationships With Industry
A Proposal for Controlling Conflict of Interest
David J. Rothman, PhD
Professional medical associations (PMAs) play an essential role in defining
Walter J. McDonald, MD
and advancing health care standards. Their conferences, continuing medi-
Carol D. Berkowitz, MD cal education courses, practice guidelines, definitions of ethical norms, and
Susan C. Chimonas, PhD public advocacy positions carry great weight with physicians and the pub-
Catherine D. DeAngelis, MD, MPH lic. Because many PMAs receive extensive funding from pharmaceutical and
Ralph W. Hale, MD device companies, it is crucial that their guidelines manage both real and
Steven E. Nissen, MD perceived conflict of interests. Any threat to the integrity of PMAs must be
June E. Osborn, MD thoroughly and effectively resolved. Current PMA policies, however, are not
James H. Scully Jr, MD uniform and often lack stringency. To address this situation, the authors first
identified and analyzed conflicts of interest that may affect the activities,
Gerald E. Thomson, MD
leadership, and members of PMAs. The authors then went on to formulate
David Wofsy, MD
guidelines, both short-term and long-term, to prevent the appearance or re-
ality of undue industry influence. The recommendations are rigorous and would

P
ROFESSIONAL MEDICAL ASSOCIA-
require many PMAs to transform their mode of operation and perhaps, to
tions (PMAs), bringing to-
forgo valuable activities. To maintain integrity, sacrifice may be required.
gether physicians in the same
specialty or subspecialty, make Nevertheless, these changes are in the best interest of the PMAs, the pro-
many distinctive contributions to ad- fession, their members, and the larger society.
vancing the quality of medical care. In JAMA. 2009;301(13):1367-1372 www.jama.com
the first instance, PMAs play a vital role
in medical education. Their meetings, As the range and importance of these ate conflicts of interest, both real and
publications, journals, and continu- activities suggest, PMAs represent ex- perceived.6-8 The attention to this is-
ing medical education (CME) courses pertise and authority to those inside and sue reflects, first, an increasing aware-
inform members of new and estab- outside of medicine. Physicians and the ness of the extent of the financial links
lished diagnostic and treatment proce- general public rely on PMAs to pro- between pharmaceutical and medical
dures. The PMAs also issue detailed vide evidence-based information and device companies and medical practi-
practice guidelines that set the stan- recommendations. Therefore, any com- tioners and institutions.9-12 Second, an
dards for efficient and effective pa- promise of scientific integrity or of extensive literature has documented the
tient care. Moreover, PMAs define unqualified commitment to patient influence of gifts on individual physi-
ethical norms for their members, pro- well-being must be anticipated and cians.13-15 The fear, expressed by phy-
mulgating codes of conduct for profes- avoided.4,5 sician leaders, public officials, and the
sional behavior. At the same time, PMAs During the past decade, the relation- media, is that industry influence may
pursue a public agenda. They advo- ship between medicine and industry,
Author Affiliations are listed at the end of this
cate for the particular interests of their specifically involving pharmaceutical article.
members, for patients, and for what and medical device companies, has Corresponding Author: David J. Rothman, PhD, Cen-
ter on Medicine as a Profession, Columbia College of
they believe to be the best interests of come under intense scrutiny. The over- Physicians and Surgeons, 630 W 168th St, New York,
society.1-3 riding concern is that industry ties cre- NY 10032 (djr5@columbia.edu).

©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, April 1, 2009—Vol 301, No. 13 1367
MEDICAL ASSOCIATIONS AND RELATIONSHIPS WITH INDUSTRY

compromise clinical decision making, make important contributions to effect, to put the organization up for
adversely affecting health care deliv- medical progress. Their role in the sale.23
ery and undermining the reputation of development and testing of new com-
the profession.2,16 pounds and instruments is essential Proposed Recommendations
The problem has exceptional rel- for the diagnosis and treatment of dis- for Controlling Conflict
evance for PMAs because industry ease and disability. It may be appro- of Interest
funding of their activities, although priate in given instances for PMAs to The following sections explore the activi-
varying in degrees, is pervasive. Con- join with industry in research and ties most relevant to relationships
tributions from pharmaceutical and evaluation of new products. Resolving between PMAs and industry and pro-
medical device companies often subsi- issues of conflict of interest is not best pose recommendations and policies to
dize annual meetings by their pur- accomplished by avoiding all relation- help reduce or eliminate conflicts of
chase of booths in the exhibit halls at ships.23 interest.
which they distribute pamphlets and Second, both quantitative and quali- 1. General Budget Support From In-
branded items.17,18 These companies tative research demonstrates the power dustry. The general budget of PMAs
sometimes underwrite physician of gifts to bias physicians’ choices. Be- covers a wide range of activities, in-
attendance through grants for travel, yond the monetary value of the ex- cluding not only operational costs but
meals, receptions, and other social change, the very fact of the exchange annual meetings, research sponsor-
activities. Industry frequently provides creates a conflict of interest. Even gifts ship, journal publication, and devel-
honoraria for plenary sessions and of modest value foster a need to recip- opment of practice guidelines. The costs
lectures, and purchases mailing lists rocate, which then affects treatment de- associated with these activities are sub-
and advertising space from PMAs to cisions.24,25 stantial and at present are not sup-
increase attendance at their satellite Third, education must be carefully ported exclusively by membership fees
symposia paralleling the PMAs’ meet- distinguished from marketing. Profes- or even advertising revenues from jour-
ings. In many instances, industry also sional medical associations have a duty nals. Without greater transparency, it
funds the accredited CME offered by to bring to their members the best sci- is impossible to know how much in-
the PMAs and supports publication of entific evidence on the efficacy and suit- dustry funding supports these activi-
practice guidelines and information ability of drugs and devices. These ef- ties. In the absence of legal reporting
booklets, often stamping these materi- forts must be separate from and not requirements, the extent of each PMA’s
als with their company logo.3,19,20 affected by industry promotions. dependency on industry remains
Although many PMAs have issued Fourth, individual as well as the indeterminate.
guidelines on conflict of interest, PMAs’ organizational ties to industry This industry funding raises vital
there is little uniformity among take a variety of forms so the guide- questions about the standing and op-
them. Some critics suggest that these lines for PMAs must reckon with each erations of PMAs. How can the public
guidelines are not sufficiently strin- of them. For some individuals, indus- and the profession be certain that a PMA
gent or detailed enough to prevent try support for their research is a ma- dependent on industry for support is
the appearance or reality of undue jor component of their salaries; for oth- being faithful to its mission of conduct-
industry influence and bias.2,16,21,22 To ers, industry honoraria and consulting ing educational programs and setting
address this situation, model guide- fees supplement their salaries. In many practice guidelines that reflect only the
lines on conflict of interest, as pro- instances, it is not the individual phy- best scientific knowledge? Such a de-
posed herein, may serve to bring sician but the medical school division pendency inevitably creates the per-
both consistency and efficacy to the or department that receives industry ception and reality of conflicts of in-
governance of PMAs. The proposals funding. Conflict-of-interest policies for terest and jeopardizes public trust.
in this article discuss conflicts of PMAs, particularly as they affect the se- Accordingly, PMAs should work to-
interest as they pertain to the activi- lection of the organization’s leaders and ward a complete ban on pharmaceuti-
ties, leadership, and members of committee members, should reflect cal and medical device industry fund-
PMAs. The scope and specificity of these distinctions and differences, ing ($0), except for income from journal
the recommendations point to the weighing the nature of the conflict, the advertising and exhibit hall fees. Al-
intricacy of ties between industry type of activity, and its relevance to in- though attracting advertising and ex-
and PMAs. dustry.10,26,27 hibit hall fees might possibly bias the ac-
Fifth, PMAs must set their own agen- tivities of PMAs, officers and members
Underlying Principles das and priorities and remain faithful can easily distinguish these marketing ac-
and Premises to them. Proposed industry support for tivities from educational presentations
Several premises underlie these rec- a project should not alter the agendas and are free to ignore them. Pellegrino
ommendations. First, the pharmaceu- of PMAs. To allow commercial fund- and Relman21 have urged that member-
tical and medical device industries ing to dictate a PMA’s activities is, in ship dues and grants from the govern-
1368 JAMA, April 1, 2009—Vol 301, No. 13 (Reprinted) ©2009 American Medical Association. All rights reserved.
MEDICAL ASSOCIATIONS AND RELATIONSHIPS WITH INDUSTRY

ment and foundations should under- A. Industry Sponsorship of Confer- C. Gifting of Promotional Items at
write the activities of PMAs. Recognizing ence Programs. It is common practice Meetings. To distance PMAs from in-
that a goal of $0 support from industry for industry to fund conference pro- dustry marketing activities, and in light
cannot be achieved overnight without grams, including CME courses. Al- of the data on the power of gifts to in-
causing great disruption of PMAs’ ser- though the Accreditation Council for fluence treatment choices, conference
vices, a number of interim policies should Continuing Medical Education ex- meetings should not serve as a setting
be implemented to govern the accep- pressly prohibits industry influence over for industry to distribute branded items
tance or refusal of industry support. the choice of speakers and content of to members. No company logos should
All funds from industry should be programs, PMAs should establish ad- appear on tote bags, lanyards, pens,
truly unrestricted—given for the pur- ditional safeguards to ensure compli- notebooks, and publications distrib-
pose of supporting the mission of the ance with the spirit of this prohibi- uted to members at conferences. In
PMA. The donated funds should be tion. Each PMA might establish a CME 2009, the Pharmaceutical Research and
pooled and administered by each PMA committee whose members, free of all Manufacturers of America (PhRMA)
through a central repository. A PMA industry ties, would have the respon- and the Advanced Medical Technol-
must have the freedom to set its own sibility to distribute unrestricted, edu- ogy Association (AdvaMed) are adopt-
course and to modify both its goals and cational grants from industry. This com- ing this standard, but their codes are en-
priorities, including the freedom to take mittee would have exclusive authority tirely voluntary and make no provision
positions on health-related issues that to select program topics and speakers; for enforcement.28,29
may be unfavorable to its funders. industry would not be allowed to fund A PMA may choose to permit indus-
Professional medical associations or be identified with specific lectures try to purchase and occupy booths in
should immediately move to restrict or individuals. Alternatively, PMAs may adjoining exhibit hall space at confer-
total support from industry (except for turn to independent foundations or to ences. However, these booths should
journal advertising revenue and ex- relevant programs by the National In- not be in the obligate path to a scien-
hibit hall fees) to no more than 25% of stitutes of Health to fund specific tific or educational session, and must
their operating budgets. Although the courses or endow lectureships. In ad- be clearly delineated so that attendees
choice of this percentage is necessar- dition, it may be necessary to pass more understand that they are entering a mar-
ily arbitrary, meeting this goal would of the CME costs to individuals, rather keting site, and are free to do so or not
begin to wean PMAs from industry sup- than depend on contributions from in- to do so as they choose. Just like some
port without putting their survival into terested parties. readers skip the advertising pages in a
jeopardy. If that percentage is ex- B. Conflict-of-Interest Standards for journal, attendees can avoid exhibit hall
ceeded, the PMA should immediately Program Committee Members. Because booths. The PMAs should also set stan-
reassess its policies to reduce its de- of their ability to influence the con- dards for the conduct of an exhibit
pendency and protect the integrity of tent of educational programs, mem- booth, including a ban on all gifts and
its agenda. No single industry source bers of program committees for PMAs food.
should be responsible for the majority should adhere to strict conflict-of- D. Satellite Symposia. It is common
of total industry funding to an indi- interest guidelines. The choice of top- for pharmaceutical and medical de-
vidual PMA, although limited and tem- ics and speakers is so essential to the vice companies to hold satellite sym-
porary exceptions may have to be made integrity of conference offerings that in- posia in conjunction with PMA meet-
for small and specialized societies. dependence of choice must be fully pre- ings. Some of these symposia may
Even this level and distribution of in- served. At a minimum, members of the provide CME credit. The information
dustry support has the potential to bias program committee should disclose any disseminated at these satellite events is
a PMA because pharmaceutical com- financial ties with industry to the com- not necessarily incorrect, but the sat-
panies often share common interests, mittee chair, the PMA’s legal counsel, ellite programs often appear to be de-
for example, legislation affecting Medi- or both, who should, in turn, request signed to serve a marketing agenda. To
care Part D or drug importation from recusal of the committee member when gather an audience, some companies
Canada. However, PMAs will learn how a relevant area is under discussion. All have paid PMAs to obtain members’ ad-
best to move to a $0 position by adopt- PMAs should strongly consider going dresses or to have the symposia listed
ing these interim guidelines. beyond this standard. They might se- in the conference agenda.2,30
2. Annual National Conferences and lect program committee members who Under no circumstances should
Periodic Regional Meetings. Almost all are completely free of financial ties to PMAs collaborate in industry market-
PMAs conduct an annual meeting for industry, and consider making conflict- ing activities or profit from them. To
members, and many also hold re- of-interest disclosures from officers and maintain scientific integrity and to en-
gional conferences. Industry supports speakers at CME meetings public sure that educational programs are
these meetings in a variety of ways, pro- through their Web site or through other evidence based, PMAs must distance
viding substantial funding to the PMA. means. themselves completely from industry
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, April 1, 2009—Vol 301, No. 13 1369
MEDICAL ASSOCIATIONS AND RELATIONSHIPS WITH INDUSTRY

promotions. Although PMAs cannot crucial for building a cohort of skilled Professional medical associations
prohibit companies from running sat- clinicians and investigators. But as in should be encouraged to appoint to
ellite programs, it must be made clear the case of funding for research, deci- these committees only individuals who
to all participants that the PMA is not sion making about which residents or have no ties to industry. At a mini-
endorsing the industry’s programs, fa- fellows are chosen and the specific dis- mum, PMAs must exclude from such
cilitating their operation, or profiting ciplines from which they are selected committees persons with any conflict
from them. must be determined by the PMAs alone. of interest ($0 threshold) involving di-
Accordingly, PMAs should not en- Fellowships should not be named af- rect salary support, research support,
dorse, facilitate, or accept funding for ter the pharmaceutical or medical de- or additional income from a company
satellite symposia. This may be accom- vice company sponsors. No condi- whose product sales could be affected
plished by not allowing satellite sym- tions may be attached to the gift such by the guidelines.
posia to take place immediately be- as compelling the appointee to meet One concern might be that such re-
fore, during, or immediately after the with company representatives or ac- strictions will exclude the most quali-
conference, by not sharing the names knowledge the company by name in a fied individuals from guideline com-
and addresses of members, and not publication or curriculum vitae. Ap- mittees. However, there is a tendency
sharing conference space. To enforce pointees should not know which com- to confuse the most qualified with the
this policy, PMAs may ban a company pany’s funds underwrote their fellow- most visible. Moreover, any difficul-
that violates these rules from exhibit- ship or travel so they are not under a ties can be easily circumvented by cir-
ing at future meetings. sense of obligation to a particular com- culating drafts of guidelines widely for
3. Industry Funds for Research by pany during the course of their ca- comment, but leaving the drafting of the
PMAs and Members. Many PMAs fund reers. Small specialty societies that pri- final document to a group of knowl-
research projects that they or their marily relate to a single company should edgeable professionals, who are free of
members conduct. Research is essen- consider avoiding all such support. As conflict of interest insofar as a particu-
tial to medical progress and PMAs must with gifts more generally, PMAs should lar class of drugs or devices is con-
be responsible for determining re- not allow industry payment for such cerned.
search priorities and which teams to items as journal subscriptions or books. 6. Industry Support of PMAs’ Pub-
support. Industry should not be al- 5. Committees That Formulate Prac- lications. Given the importance of the
lowed to provide a grant for a project tice Guidelines or Outcome Mea- findings and recommendations of
of its choosing or be associated with a sures. One of the most significant ac- PMAs, both the creation and distribu-
specific project. Research funds from tivities of many PMAs is to formulate tion of guidelines and other advisory
industry, like educational support from practice guidelines and devise perfor- materials should be independent of in-
industry, should go to a PMA’s central mance and outcome measures. These dustry funding. No PMA publication
repository or committee as described activities guide physician diagnostic and should bear the logo of a drug or de-
above. The research awards should be treatment decisions and set evidence- vice company. The PMAs should not ac-
peer reviewed without any involve- based standards for decision making. cept industry funding for journal
ment from industry. In addition, the By so doing, PMAs also influence re- supplements. Companies are free to
PMA and the investigators, not indus- imbursement policies by third-party purchase the materials, distribute them,
try, should control the data, determin- payers and carry weight in malprac- and refer to them in their promotional
ing when and where findings should be tice litigation. Clearly, pharmaceuti- materials. However, PMA documents
presented and published. Although cal and medical device companies have should always stand alone, and not be
these standards are more stringent for a stake in all of these activities. associated with a commercial brand.
PMAs than for academic medical cen- For these reasons, the establish- Just as it can be acceptable for PMAs
ters, PMAs have a more immediate and ment of guidelines and registries must to derive revenue from industry for ex-
direct influence on setting standards for be independent of all industry influ- hibit hall displays at scientific meet-
the medical profession, and for the spe- ence, actual or perceived. Under no cir- ings, revenue from industry advertis-
cialties and subspecialties. cumstances should PMAs accept fund- ing in PMA journals can be acceptable
4. Industry Funds for Fellowships ing from industry to develop practice when the advertising is clearly identi-
and Training Programs. It appears to guidelines or outcome measures. As fied as such. Some journals separate ad-
be common for industry to offer fund- Sniderman and Furberg 22 recently vertisements from the scientific and edi-
ing to PMAs to support fellowships and urged, PMAs must hold the individu- torial content (both in print and online
training programs for resident physi- als who write guidelines and outcome publications) so that readers can choose
cians and fellows. Providing these phy- measures to the most stringent conflict- to ignore the advertisements or can re-
sicians with the opportunity to under- of-interest standards. Disclosure of in- move the print advertisements from the
take intensive study, training, travel to dustry relationships by committee journal. However, PMA journals must
educational meetings, and research is members is not sufficient protection. have policies governing journal-based
1370 JAMA, April 1, 2009—Vol 301, No. 13 (Reprinted) ©2009 American Medical Association. All rights reserved.
MEDICAL ASSOCIATIONS AND RELATIONSHIPS WITH INDUSTRY

advertising to ensure that scientific and tion and are most visible to the public Each PMA should have a formal
editorial integrity is maintained, for in- and the profession. The PMA’s leaders mechanism for reviewing disclosures of
stance, by prohibiting editorial deci- also exert the greatest influence on conflict of interest. In many organiza-
sions to be based on the likelihood of policy, deciding which issues are to be tions it would be most efficient and ef-
generating advertising revenue and by addressed and the composition of the fective for some combination of presi-
prohibiting advertising placement to be committees that will conduct the evalu- dent, CEO, general counsel, and
based on upcoming journal content. As ations and issue the findings. There- compliance officer to have this respon-
with PMA guideline publications, com- fore, it is essential that the president of sibility. Questions about an individu-
panies should be permitted to pur- the PMA, its officers, and its board of al’s conflict of interest might be raised
chase reprints of articles published in trustees be held to the highest stan- with the PMA’s ethics committee chair
PMA journals, but these documents dards in avoiding conflict of interest. and members. Disclosure forms should
should stand alone, and should not bear At a minimum, the president and be detailed and explicit, including pro-
the name or logo of the industry pur- officers (eg, president-elect, immedi- viding descriptions of activities and the
chaser. ate past president, vice president, sec- sums received so that appropriate de-
7. Product Endorsements. Al- retary, and treasurer) of a PMA should cisions can be made about recusal or
though some PMAs have endorsed be conflict-free ($0 threshold) during removal for an individual.
commercial products, ranging from their tenure. For these individuals, no 10. Guidance for PMA Members.
food and toothpaste to sunscreen prod- personal income and no research sup- As PMAs strengthen their organiza-
ucts, the propriety of doing so is now port should be derived from industry. tional conflict-of-interest policies, they
highly suspect. Nevertheless, the Ameri- Because their election or selection typi- should use the principles and stan-
can Academy of Dermatology is pre- cally occurs 2 or more years before they dards developed by the organization to
pared to give its seal of approval to cer- take office, they should be conflict- influence and lead their members in
tain sunscreen products, charging a free from that starting point. This may adopting similar standards. Each PMA
sizeable fee for the endorsement.31-33 A require would-be office holders to de- should make explicit that the prin-
contract with one or another com- lay assuming the leadership position ciples underlying ethical organiza-
pany sullies the reputation of the PMA, until an already existing and multi- tional behavior apply to physician be-
implying that the PMA’s name appar- year grant expires. They should make havior.16,34 Thus, both physicians and
ently is purchasable by the highest bid- every effort to maintain that standard medical societies should avoid market-
der. Accordingly, PMAs should never in the period immediately following ing industry products. Just as industry
solicit or accept any offer that would their service. gifts influence a physician’s decision
attach its name or logo to a commer- A PMA should be governed by a making, they also can bias a PMA’s de-
cial product, service, or activity. board of trustees that is free of conflict cision making. A number of academic
8. Affiliated Foundations. Many of interest. Board members should be medical centers and the Association of
PMAs have established affiliated re- asked to sever all financial ties to in- American Medical Colleges have re-
search and education foundations that dustry during their term of service; ide- cently adopted conflict-of-interest poli-
share their name and their mission. Al- ally appointments could be made far cies for faculty that can serve as useful
though separate from a governance and enough in advance so that board mem- models.35
taxation standpoint, these organiza- bers would be conflict-free for a 2-year
tions are generally closely aligned with period before assuming the position. If Conclusion
and indistinguishable from the parent this is not yet feasible—it may take a Enacting these recommendations will
PMA. Accordingly, the affiliated foun- few years to change the culture of an require PMAs to transform their mode
dation must be held to the same stan- organization—a PMA should require its of operation and perhaps even give up
dards on conflict of interest as the par- board members to disclose all con- activities of considerable value. The pro-
ent PMA. Gifts and grants from industry flicts of interest and not to participate posals are rigorous: PMAs should work
should be governed by the policies in when any activity bearing on their con- toward a goal of $0 contributions from
effect at the parent PMA. Moreover, in flicts arises. industry; they should not collaborate
accepting funding directly from its af- The PMA’s executive and opera- in or profit from industry marketing ac-
filiated foundation, the parent PMA is tional staff should have no financial ties tivities; PMA leaders and executive staff
not absolved of the need to avoid or with industry and should be prohib- should be free of conflict of interest and,
minimize conflict of interest. ited from accepting gifts or other fa- in time, so should the entirety of the
9. Conflict of Interest Among PMA vors. So too, industry should not be per- board and the members of the prac-
Presidents, Officers, and Board Mem- mitted to fund any board activity. All tice guideline committees. To main-
bers. The reputation of a PMA is often travel and meeting costs, including tain integrity will require sacrifice. Nev-
based on the quality and integrity of its food, are the financial responsibility of ertheless, these changes are in the best
leaders. They speak for the organiza- the PMA. interest of the medical profession, of
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, April 1, 2009—Vol 301, No. 13 1371
MEDICAL ASSOCIATIONS AND RELATIONSHIPS WITH INDUSTRY

PMAs and their members, and of the Financial Disclosures: None reported. dustry: is a gift ever just a gift? JAMA. 2000;283
Funding/Support: This work was funded by the Pew (3):373-380.
larger society. Charitable Trusts. 16. Carey B, Harris G Psychiatric group faces scru-
These proposals are likely to gener- Role of the Sponsor: The funder of this study did not tiny over drug industry ties. New York Times. July 12,
play a role in the design and conduct of the study; col- 2008:A13.
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1372 JAMA, April 1, 2009—Vol 301, No. 13 (Reprinted) ©2009 American Medical Association. All rights reserved.

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