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octors, AGA, and Industry: Stepsoward Improving the Relationship

cholarly articles and editorials in the medical litera-ture and at times daily articles, editorials, and opin-

ons in the lay press document the intricacies and inap-ropriate relationships between doctors and corporateponsors.1–4 Some articles have claimed that medicine,nd academic medicine in particular, has sold itself toorporate sponsors and that the academic–industrialall has been breached.1,5,6 The most recent debacle

urrounds the conflicts when physicians, wittingly ornwittingly, inform investors about the perceived effi-acy of novel therapies under investigation.7,8

Relationships with industry are ubiquitous in medi-ine: they pertain to private practice gastroenterologists,cademic physicians, decision makers at gastroenterol-gy organizations, and those who serve as editors.earned bodies, such as the Association of Americanedical Colleges (AAMC), have addressed managementf individual conflicts of interest.9 Others have proposedanagement strategies for institutional conflicts of inter-

st.10–13 This editorial aims to identify current areas ofontroversy and proposes solutions for further consider-tion and discussion. The specific goal is to addressndividual conflicts, conflicts for the American Gastroen-erological Association (AGA), and conflicts in the clini-al practice of gastroenterology and hepatology.What are the conflicts of interest from the perspective

f a national organization, specifically the AGA? Manage-ent of individual conflict during activities of the AGA,

uch as disclosure in publications and presentations, isecessary, but not sufficient when it comes to protectinghe relationships between corporate sponsors and theGA. The Ethics Committee of the AGA has already

aken proactive steps to manage conflicts arising fromelationships with industry and to uphold the principlesf medical ethics endorsed by the American Medicalssociation.

The Need for a Strong AmericanGastroenterological Association–Industry Relationship and theAmerican GastroenterologicalAssociation Strategic PlanA clarified and optimized relationship between

he AGA and the corporate world (ie, industry) is nec-ssary so that discovery in the laboratory can be reducedo practice for the benefit of the patient. As stated in theGA Presidential Address of 2004, there are:

. . .two core commitments as the basis for the AGA

strategic plan. First, the AGA is committed to expanding w

CLI

the science of Gastroenterology by actively pursuing sup-port for research, education, and training so that we canimprove understanding of the causes, prevention, treat-ment, and cure of digestive diseases. Second, the AGA isequally committed to furthering excellence in the practiceof Gastroenterology by fostering innovation and insuringthe practice is scientifically based.14

Some perceive that academics should be driven tond the cause or reasons for disease and to find betterolutions to treat patients, unfettered by the commercialotential of the discoveries. There is a mandate fromociety through the enactment of the Bayh-Dole Act of980 to ensure that intellectual property is reduced toractice and that the proceeds from that commercializa-ion are used to foster the academic and other missionsf medical centers. Thus, institutions have a mandatend an interest to capitalize on the discoveries and this isntirely appropriate given the fact that society does notully fund research and that academic centers are ex-ected by society to provide charity care, training of

uture doctors and scientists, and an environment toacilitate research.

Collaboration between academic medicine and theevice, diagnostic, and pharmaceutical industry haseen instrumental in the development, practice and de-

ivery of medicine in the past 50 years with new antibi-tics, vascular modulators, proton pump inhibitors, can-er chemotherapy, analgesia and anesthesia, and jointrostheses, to name a few. Within our specialties ofastroenterology and hepatology, endoscopes, laparo-copes and anastomotic staplers, laser and other thera-ies, computed tomography and magnetic resonance

maging, and hepatitis C and human immunodeficiencyirus tests all have originated within the corporate worldnd revolutionized the practice of our specialty. Theseedical and scientific advances show the necessity ofreserving a healthy relationship between academicedicine and the corporate world.Industry also plays a key role in the implementation of

iscoveries obtained through federal funds. Patentedechnology has to be transferred or licensed to industry,s required by the Bayh-Dole Act, for it to be reduced tohe practice. Measures to manage individual and institu-ional conflicts of interest when these occur may includehe following: disclosure (in consent form, publications,nd presentations), recusal of the inventors (or in someases the institution) from further research with theame or allied technology, and consideration of compet-ng technology with institutional purchasing decisions

hen the institution is conflicted through sales-basedoyalties. Management of potential conflicts of interestesides with the individual and the institution; however,

here does that responsibility lie when there are poten-

NICAL GASTROENTEROLOGY AND HEPATOLOGY 2006;4:160–166

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ial conflicts with individuals who are elected or ap-ointed officers of national organizations, federal bodies,r foundations?

Conflicts of Interest for Individuals

There are at least 4 broad categories of conflictingelationships for individuals: conflicts that arise out oforporate sponsorship of research, conflicts that resultrom academic involvement in education, those that mayrise in clinical practice, and conflicts that arise whenndividuals are appointed to national bodies. What cane done to preserve a healthy relationship between

ndividuals and the AGA with our partners in industry?he potential conflicts of the individual may be magni-ed when that person is called to be an officer of theGA. Hence, managing AGA conflicts of interest musttart with the management of an individual’s potentialonflicts. The recently published National Institutes ofealth Final Ethics Rules15 provide principles for guid-nce and these are summarized in Table 1.

Financial conflicts arising from corporate-fundedesearch grants to individuals. Clearly, there are somebsolute barriers to performing research of any kind ifhere is compromise of the safety of the patient.16–20

owever, in most instances, review by a local or nationalffice for protection of human participants in researchinstitutional review board) will have determined thathe level of risk is appropriate for the study to beerformed.Society is increasingly aware of the potential of signif-

cant conflict of interest among investigators. This mayrise because the investigators hold equity in the spon-oring company or have received consulting fees, orimply through the desire of investigators to receivenancial support for research.

Some patients perceive that when remuneration in re-earch does not result in personal gain, it is not conflicting.owever, what is the potential conflict of interest inherent

n incentives for recruitment to the research (eg, finders’ees) or other payment to the individual researcher ornstitution for conducting the research (eg, bonus payment

able 1. Summary of NIH Final Ethics Rules of August 25, 2

PrinciplesResearch decisions are based on scientific evidenceHigher standard of disclosure and divestiture for senioAllow interactions with professional associations, publ

Specific rulesBasic prohibition on outside consulting by NIH staffDivestiture of all holdings in substantially affected orgaReceipt of monetary awards from outside requires prioRequirement to disclose financial interests including aOutside activities with professional or scientific organizPermit outside genuine education or practice of medic

IH, National Institutes of Health.

or successful recruitment or completion)?

The academic livelihood of investigators who receiveorporate-funded research grants also may represent aonflicting situation because the funding supports sala-ies for research personnel, equipment, and even thenvestigator’s research time. The provision of such fundsor research provides the corporations access to theesearchers who often are considered thought or opin-on leaders capable of helping to form public opinion inn area of mutual interest.

There are several approaches to managing conflictshat arise through corporate-funded research:

. Consulting activities with a corporate sponsor ceasefrom the point in time where there is a good possi-bility that there will be sponsored research until thetime when the results of the research have beenpublished. Thus, there should be no personal finan-cial gain from the time when a research protocolstarts, and some may recommend no personal gainfrom the time when discussions begin. AGA journalsalready require full disclosure of consulting relation-ships pertaining to the manuscript submitted or be-ing reviewed. Given the threshold of more than$10,000 per year as an indicator of significant finan-cial conflict of interest in federal guidelines, it seemslogical to require specific disclosure when the aggre-gate annual personal income from any corporateentity exceeds $10,000.

. The consent form discloses the nature of the supportreceived by the investigators for performing the re-search.

. An official research budget is available and auditableto ensure that all expenses are realistic and commen-surate with the effort entailed, patient care costsincurred, and indirect expenses charged. Investiga-tor research time funded by such a grant should beappropriate for the effort involved, and paymentshould be made to the academic medical center aspart of an official research budget to ensure theinvestigator does not receive personal gain. An in-

nagement and people involved in research decisionslth activities, and genuine educational activities

ions �$15,000 per companyrovalts of investmentss with prior approval

nder existing government-wide rules and prior activities

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162 EDITORIALS CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 4, No. 2

the investigator or clinical research team definitely isconflicting and the budget should be constructed ina way that it passes the “straight face” or “laugh” test.

. The investigator may own equity in accordance withthe institution’s policy. This should include divesti-ture of equity before starting the research, or place-ment of equity in escrow until the publication of thedata, not just until the completion of the study, toavoid any chance of insider trading. At least, owner-ship of equity should be disclosed at scientific pre-sentations and in publications. However, even withinstitutional policies in place, the AGA still may bevulnerable given the variations in institutional poli-cies.21–23 The AGA Ethics Committee needs to con-sider developing additional policies for AGA electedofficers to supplement their institutional policies. Aneven greater concern is the potential conflict of in-terest when faculty holding equity participate inAGA-sponsored continuing medical education (CME)activities. This currently is addressed by Accredita-tion Council for Continuing Medical Education (AC-CME) policies, which are used in AGA educationalmeetings. However, resources needed to monitorand manage disclosures can be stretched during theannual AGA meeting in view of the large number ofspeakers at Digestive Diseases Week (DDW).

. Registering the clinical trial is essential along withensuring in the research contract that the results ofthe study will be published in a timely fashion withall conflicting relationships disclosed (eg, researchgrants and/or consulting fees received during theyear before the start of the research).24–26

. Disclosure of potential conflicts in the AGA Govern-ing Board meetings, publications, and presentationsshould be transparent and detailed. Ideally, the con-flicts should be brought to resolution (eg, by dives-titure of equity). However, at the least, disclosureshould include the nature of relationships (consult-ing, advisory boards, speakers bureaus, researchgrants, equity holdings). The size of personal finan-cial remuneration relative to the federal guidelines($10K/y) provides a gauge as to the significance ofany financial conflict of interest. It is important tonote that patients may perceive conflict of interest atfar lower levels of remuneration to the physician,and therefore they may question our motives, even atlevels that are well below the federal threshold forsignificant financial conflict of interest.

Conflicts arising from payment for participatingn speakers bureaus or authoring reviews or meta-anal-ses. There is a potential conflict of interest if an aca-emic physician belongs to a company’s speakers bu-eau because personal remuneration may be perceivedo be a form of remuneration for loyalty. Similarly, if an

cademic writes an independent review or meta-analysis p

or a fee, there is a perception of conflict of interest.isclosure in the publication and any related presenta-

ion of any payment received is essential. The disclosurehould clarify that the grant was used for bona fidexpenses such as library support or secretarial assis-ance. Moreover, it should be stated that publication ofhe manuscript was not contingent on review or ap-roval by the corporate sponsor, and the editor shoulddd a note that the article was submitted to peer reviewy outside reviewers who also were screened for poten-ial conflicts of interest.

Education companies owned by individuals.here has been a virtual explosion in the number ofducation companies, some privately owned, somewned by influential academic medical centers, and oth-rs that are subsidiaries of pharmaceutical or medicalevice companies. Some of these education entities pro-ide CME credits through unrestricted grants from com-ercial sponsors. In recent years, it appears that provi-

ion of CME credit no longer provides reassurance thathe education program will be devoid of marketing mes-ages or, indeed, bias.

This is an arena in which it appears academia has soldtself for personal or institutional benefit. Individual ac-demics now have significant ownership in such educa-ion companies and appear not infrequently as faculty—

practice that in itself may constitute a conflict ofnterest. There also are instances in which the academichysician who is a business partner authors “indepen-ent” reviews or meta-analyses on the subject contenthat they help to bring to practitioners through “unre-tricted education grants” from the corporate sponsors.

Conflict is compounded when individuals serve asditors or associate editors of independent society jour-als while they own part of such education companies.ppropriate management of this situation would be re-usal from discussion of submitted manuscripts that con-ict with the education company’s activities. Guidelineshould be developed by the AGA Ethics Committee sohat management strategies can be developed and ap-lied. There is also potential conflict of interest whenuch individuals participate in national organizations inuch capacities as education officials, conveners of edu-ational meetings, or selectors of speakers for promi-ent, heavily subscribed educational offerings such ashe AGA postgraduate courses, symposia, or state-of-the-rt lectures.

Thus, one may reasonably question whether ownersf education companies who receive unrestricted grantsrom corporate sponsors should serve as reviewers orditors of review or peer-reviewed journals or as mem-ers of the AGA Council who plan the DDW meeting.he AGA places itself in a vulnerable position if it doesot manage this potential conflict. How is it perceivedy our patients if our journals publish reports about

roducts originating from a corporate sponsor with

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hom an author, associate editor, or editor has a rela-ionship that provides personal gain above that permis-ible by federal regulations and, therefore, is conflicting?ome may argue that corporate-funded research may beimilarly conflicting, although it is my belief that theanagement strategies discussed under �Financial con-

icts arising from corporate-funded research� and therinciple of avoidance of personal remuneration will golong way to manage conflicts in corporate-funded re-

earch.Personal remuneration from education compa-

ies while conducting research. Consulting for personalain should not be permitted when the investigator isndertaking sponsored research from the same com-any. However, what if the relationship is one-step re-oved? Is it a matter of significant concern when the

ducation company is insinuated between the corporateponsor and the researcher? Is there a conflict if theducation company that provides the personal compen-ation to the individual expert derives its funds from annrestricted education grant while the expert receives arant for research from the same corporate sponsor? Is itot likely that the physician’s personal income fromuch consulting will be viewed by society as potentiallynfluencing the conduct of a specific research study?hould the AGA provide guidelines for its members onuch ethical issues?

Individuals participating in corporate-owned edu-ation institutes. Academic medical centers and na-ional organizations also need to be aware of the changesn the playing field as corporate sponsors establish re-earch or education institutes. This is increasingly rele-ant because the training of future clinicians and aca-emics occurs through expensive simulation activitiesnd procedural laboratories (eg, endoscopic or laparo-copic surgery, coronary revascularization, arthroscopicurgery, or joint replacement) that are establishedhrough corporate-sponsored institutes. Often this typef training is required by society in general because theespective boards simply cannot keep up with the pacef introduction of the novel technology and societyeeds to have physicians trained and credentialed. Edu-ation at such institutes should require independent,ersonally unconflicted faculty, availability of devices orquipment from diverse sponsors, and so forth, beforehey should be endorsed by a national organization suchs the AGA. Physician participation at the vendors’ edu-ation booths at DDW also should raise concern aboutonflicts of interest. Although a special case may beade when a physician is involved in a discovery that is

icensed and commercialized by the industry and theicensed relationship is disclosed clearly, the AGA Ethicsommittee should make recommendations to the Gov-rning Board to determine whether such participation is

ermissible. a

Postmarketing surveillance and doctors partici-ating in direct-to-consumer advertising. The voluntaryeporting of adverse effects of medications is a subopti-al means to document the safety profile of medica-

ions.27 It is unclear whether personal incentives alterhe propensity to report such potential adverse reac-ions, a responsibility placed squarely on the shouldersf doctors when any drug or device is approved.

Society questions the benefit-to-risk ratio of direct-to-onsumer advertising and television advertisements. Is itot time to let real actors participate in these advertise-ents rather than doctors volunteering or being paid to

o so? Does this not portray a profession that is too closeo the marketing objectives of the corporate sponsor,specially if the person appearing on the advertisements recognized as a premier researcher in the field or is a

ajor fundraiser for research funds of national organiza-ions or the Foundation for Digestive Health and Nutri-ion?

Potential Conflicts Arising in the AmericanGastroenterological Association’s EducationMission

The AGA appoints independent scientific advi-ory boards to oversee the content of its CME programs.owever, gastroenterology professionals are at risk foreing accused of aiding and abetting marketing throughome education activities. Corporate sponsors have re-lized the importance of using an influential intermedi-ry to provide the messages regarding their products.cademics and national organizations should ensure thatarketing efforts do not inappropriately bias educational

ctivities conducted by the national organizations inME-accredited offerings from free-standing educationompanies or in the official publications of the AGA:astroenterology and Clinical Gastroenterology andepatology.

Conflicts of Interest in the Clinical Practiceof Gastroenterology

Although the AAMC guidelines originated fromhe need to ensure patient safety in the context ofuman research, the same concerns about potentiallyonflicting decisions apply even more clearly in clinicalractice. Society is becoming more concerned with theotential conflicts of interest of physicians whose prac-ice decisions are determined or may be perceived toave been influenced by a profit motive. Examples al-eady under public scrutiny include physician-ownedadiology suites, endoscopy facilities, or hospitals.28

owever, there are far more subtle ways in which suchonflicts may influence the practice of medicine, andhese may include consulting, ownership of equity, re-eipt of gifts for research that do not result in anyersonal gain but can be linked to purchasing practices,

nd so forth. Consulting is of special concern when it

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164 EDITORIALS CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Vol. 4, No. 2

ccurs with a single corporate sponsor, when the com-ensations are not justified in terms of activities or effort,nd when it can be perceived that the fee serves as aetainer or loyalty fee.

The AGA endorses the American Medical Associa-ion’s Principles of Medical Ethics (Table 2).29 Althoughhe Professional Code of Conduct of the AGA may note enforceable, the AGA has an opportunity to clarify itsosition on this code of conduct and to provide educa-ion on ethical behaviors in the practice of gastroenter-logy and hepatology. A proactive approach that informsociety of the expectations of the AGA may enhanceociety’s level of comfort with medical ethics in clinicalractice. Proactively establishing such standards for therofession may reduce society’s inclination to imposeore regulations on physicians’ activities.

Managing Individual Conflicts Arising fromParticipation in the Activities of NationalOrganizations and Federal Bodies

National organizations, including the AGA, needo establish and require conflict-of-interest managementtrategies for their leadership decisions, developmentctivities, publishing efforts, and organization of the an-ual meeting program. These all are activities in whichonflicts of interest of individuals can spill over into theiresponsibilities in the national body’s activities. Organi-ations need to apply the same standards for conflict ofnterest that are required of individuals and institutions.iven the fact that there is no federal guidance onanagement of conflicts for national organizations and

he voluntary nature of adherence to guidelines provided

able 2. Principles of Medical Ethics Adopted by the AMA’s H

reambleThe medical profession has long subscribed to a body of ethical smember of this profession, a physician must recognize responsibiprofessionals, and to self. The following Principles adopted by thethat define the essentials of honorable behavior for the physician.

rinciples of medical ethicsA physician shall be dedicated to providing competent medical carA physician shall uphold the standards of professionalism, be hondeficient in character or competence, or engaging in fraud or deceA physician shall respect the law and also recognize a responsibiliinterests of the patientA physician shall respect the rights of patients, colleagues, and otprivacy within the constraints of the lawA physician shall continue to study, apply, and advance scientific kinformation available to patients, colleagues, and the public, obtaiindicatedA physician shall, in the provision of appropriate patient care, exceassociate, and the environment in which to provide medical careA physician shall recognize a responsibility to participate in activitibetterment of public healthA physician shall, while caring for a patient, regard responsibility tA physician shall support access to medical care for all people

MA, American Medical Association.

y organizations such as the AAMC, it is critical that the v

GA set up a rigorous review of potential conflicts for allppointed officers. As indicated below, when physiciansre appointed to Food and Drug Administration (FDA)dvisory committees, the AGA should consider whetherGA leadership should be asked to avoid all consultingpportunities during their tenure of such leadershipositions.

Membership in Food and Drug Administrationdvisory committees and consulting at the Food andrug Administration. Those selected to serve on an FDAdvisory committee should be able to pass the straight-ace test on expertise, objectivity, and conflict of inter-st. Members should consider recusing themselves fromhe opportunity for personal financial gain (consulting,quity) during the period of appointment. Although thiss likely to be unpopular, this recommendation is crucialf there is to be public confidence in the recommenda-ions of the advisory committees. Recent analysis of theay the votes on the retention of approved cyclooxy-

enase-2 drugs appeared to be based on the relationshipf the FDA advisory committee members with the cor-orate world. The analysis has provided new insight onhe public scrutiny of the votes cast during these meet-ngs, which are open to the public and are web castimultaneously by the FDA.30

Given the intertwining of interests and potential com-etition of new medications with those that already arepproved, recusal only from adjudicating new drug ap-lications between companies with whom the commit-ee member may have a significant relationship also maye deemed insufficient. For example, it may be prudento require recusal when the member’s relationship in-

e of Delegates, June 17, 2001

ents developed primarily for the benefit of the patient. As apatients first and foremost, as well as to society, to other health

rican Medical Association are not laws, but standards of conduct

h compassion and respect for human dignity and rightsall professional interactions, and strive to report physicians

, to appropriate entitiesseek changes in those requirements that are contrary to the best

ealth professionals, and shall safeguard patient confidences and

edge, maintain a commitment to medical education, make relevantsultation, and use the talents of other health professionals when

emergencies, be free to choose whom to serve, with whom to

ntributing to the improvement of the community and the

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ogical conclusion, this means that members should vol-nteer to avoid all consulting opportunities during theireriod of membership on the FDA advisory committee.ome may argue that this would exclude those mostapable of providing the best advice to the FDA and toociety. Nevertheless, it may be necessary to take such aigh road if we are to retain the confidence of societynd our credibility in the drug or device-approval pro-ess. Further discussion is needed to determine whetheresearch sponsorship with no personal gain also shouldesult in recusal.

For those who attend meetings at the FDA as companyxperts, it should be strongly recommended, if not re-uired, that they perform such services for no personalnancial gain and that they restrict their comments tohe basic or applied science, experimental design, and soorth, rather than to the safety or efficacy of the newrug or device under consideration for approval. It is notnreasonable for the expert’s institution to be compen-ated for the loss of revenue resulting from the timeway on FDA duty. Would it not be preferable for theompany to propose to the FDA a slate of names ofeople who could be invited by the FDA (rather than theompany) to serve as experts on the mechanism tar-eted by the medication or device? Physicians should beegarded as experts giving testimony at FDA activities,ot as hired guns. The FDA then can review the disclo-ures on consulting or research grants received andetermine whether participation or recusal are appropri-te, in accordance with current practice and federaluidelines.

Conflicts of Interest of the NationalOrganization Itself

There are several ways in which corporate spon-ors relate to national organizations, including the AGA.xamples include the generous grants provided as seedoney for basic and clinical research, the generous con-

ributions to the Foundation for Digestive Health andutrition, and sponsorship of individual initiatives. Theonflict is compounded when the grants are intended toupport research related to a company’s strategic goals.here is a need to draw up parameters that govern thereadth of the research that would be eligible for fund-

ng through a call for applications.When these donations truly are unrestricted and there

s an independent and auditable process for designationf awardees or initiatives supported, such donationsould appear to be in the best interest of the organiza-

ion and society at large and they should be permitted.owever, the AGA should enhance the annual disclosuref the organizations and the personal disclosures of itslected officials. Just as members of an institutional re-iew board or conflict of interest review board at theocal level of academic medical centers and members of

n FDA advisory committee at the national level are w

nder increasing scrutiny to ensure that their decisionsre unimpeachable, so also should the activities of theGA and its most influential officials, including the edi-

ors of the AGA journals, be under scrutiny.The AGA also should review carefully the content of

ME-accredited symposia that are conducted under theuspices of the DDW consortium or conducted by spe-ialist education companies through unrestricted, if notlways disinterested, grants from industry. These sympo-ia provide important revenue for the national organiza-ions but they often are portrayed to the participants asart of the education or even research activities of theDW. The AGA should consider whether strategic place-ent or timing of such industry symposia during DDW

nadvertently endorse the credibility, transparency, andbjectivity of such symposia through association withhe AGA’s meeting. At the least, these symposia shouldot clash with official business or academic offeringshat form the DDW consortium (eg, early morning sym-osia).

ConclusionsIn summary, the medical profession needs to es-

ablish strategies to manage conflicts of interest in prac-ice, education, and research. The AGA and related or-anizations need to review, extend, and enforce strictereneral guidelines on the relationships with industry ofheir officers and of the societies themselves. Althoughhe focus is often on research, relationships arising fromducational activities also need review. There are alreadyoo many examples of doctors on the take,31–34 and callsave been made for self-regulation of the profession,35,36

erhaps in anticipation of the inevitable (ie, federal pros-cution).36 Accusations regarding insider trading by ahysician working for an academic medical institutionnd industry37 and portrayal of physicians as naive orilling partners influencing the price of stock7,8 suggest

hat our profession is in dire need of education andentoring.The AGA has addressed some of these issues in the

ast. It already has a corporate compliance structure,onflict of interest policies, disclosure forms, and reviewrocess through its active Ethics Committee. The mem-ers, editors, and officers need to embrace the moreigorous guidelines on professional conduct, ethics, andonflict of interest as the Governing Board empowershe Ethics Committee to educate the members of theGA and the organization itself. Our patients, benefac-

ors, and society expect nothing less.This is also a call to other societies in the fields of

astroenterology, hepatology, nutrition, and endoscopy, asell as the Foundation for Digestive Health and Nutrition

o embrace the challenge and enhance these recommen-ations and others from their ethics committees.

There is, of course, an opportunity cost associated

ith embracing such recommendations. From an orga-

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izational perspective, industry provides the resourcesor many activities and governance of the AGA. Membersill need to think about what services currently pro-

ided as part of their membership dues are worth payingor if the support of industry is not available to subsidizeome of those activities.

It is critically important to preserve a healthy relation-hip between academic gastroenterology and the corpo-ate world. The AGA has an opportunity to shape theseelationships for the future. What is at stake is the pres-rvation of future hope in the development and applica-ion of novel therapies, most of which will likely con-inue to originate in the corporate world. What is equallyt stake is the opportunity of the medical profession toetain its self-respect and the respect of our patients andociety at large.

MICHAEL CAMILLERI, MD, EDITOR

Mayo Clinic College of MedicineRochester, Minnesota

eferences1. DeAngelis CD. Conflict of interest and the public trust. JAMA

2000;284:2237–2238.2. Korn D. Conflicts of interest in biomedical research. JAMA 2000;

284:2234–2237.3. Campbell EG, Louis KS, Blumenthal D. Looking a gift horse in the

mouth: corporate gifts supporting life sciences research. JAMA1998;279:995–999.

4. Rothman KJ. Conflict of interest. The new McCarthyism in sci-ence. JAMA 1993;269:2782–2784.

5. Bekelman JE, Li Y, Gross CP. Scope and impact of financialconflicts of interest in biomedical research: a systematic review.JAMA 2003;289:454–465.

6. Martin JB, Kasper DL. In whose best interest? Breaching theacademic-industrial wall. N Engl J Med 2000;343:1646–1649.

7. Timmerman L, Heath D. Drug researchers leak secrets to WallStreet. The Seattle Times, August 7, 2005. Available at:http://seattletimes.nwsource.com/html/businesstechnology/drugsecrets1.html. Accessed August 12, 2005.

8. Editorial: When doctors advise investors. The New York Times,August 17, 2005. Available at: www.nytimes.com/2005/08/17/opinion/17wed2.html. Accessed August 17, 2005.

9. Protecting subjects, preserving trust, promoting progress—policy and guidelines for the oversight of individual financialinterests in human subjects research. AAMC report. Availableat: http:/www.aamc.org/research/coi/firstreport.pdf. AccessedDecember 28, 2005.

0. Moses H III, Braunwald E, Martin JB, et al. Collaborating withindustry—choices for the academic medical center. N Engl J Med2002;347:1371–1375.

1. Kim SY, Millard RW, Nisbet P, et al. Potential research partici-pants’ views regarding researcher and institutional financial con-flicts of interest. J Med Ethics 2004;30:73–79.

2. Holmes DR Jr, Firth BG, James A, et al. Conflict of interest. AmHeart J 2004;147:228–237.

3. Camilleri M, Gamble GL, Kopecky SL, et al. Principles and pro-cess in the development of the Mayo Clinic’s individual andinstitutional conflict of interest policy. Mayo Clin Proc 2005;80:1340–1346.

4. Podolsky DK. American Gastroenterological Association. Presi-

dential address. Gastroenterology 2004;127:1838–1840. D

5. NIH announces final ethics rules. NIH News, August 25, 2005.Available at: http://www.nih.gov/news/pr/aug2005/od-25.htm.Accessed December 28, 2005.

6. Lo B, Wolf LE, Berkeley A. Conflict-of-interest policies for investi-gators in clinical trials. N Engl J Med 2000;343:1616–1620.

7. Shalala D. Protecting research subjects—what must be done?N Engl J Med 2000;343:808–810.

8. Morin K, Rakatansky H, Riddick FA Jr, et al. Managing conflicts ofinterest in the conduct of clinical trials. JAMA 2002;287:78–84.

9. Department of Health and Human Services. Draft: financial rela-tionships and interests in research involving human subjects:guidance for human subject protection. Federal Register 2003;68:15456–15460.

0. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of humanparticipants research: identifying problems to evaluate reformproposals. Ann Intern Med 2004;141:282–291.

1. McCrary SV, Anderson CB, Jakovljevic J, et al. A national surveyof policies on disclosure of conflicts of interest in biomedicalresearch. N Engl J Med 2000;343:1621–1626.

2. Cho MK, Shohara R, Schissel A, et al. Policies on faculty conflictsof interest at US universities. JAMA 2000;284:2203–2208.

3. Johns MME, Barnes M, Florencio PS. Restoring balance to indus-try-academia relationships in an era of institutional financial con-flicts of interest promoting research while maintaining trust.JAMA 2003;289:741–746.

4. Friedman LS, Richter ED. Relationship between conflicts of inter-est and research results. J Gen Intern Med 2004;19:51–56.

5. Lipton S, Boyd EA, Bero LA. Conflicts of interest in academicresearch: policies, processes, and attitudes. Account Res 2004;11:83–102.

6. Steinbrook R. Gag clauses in clinical-trial agreements. N EnglJ Med 2005;352:2160–2162.

7. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveil-lance—lack of vigilance, lack of trust. JAMA 2004;292:2647–2650.

8. Iglehart JK. The emergence of physician-owned specialty hospi-tals. N Engl J Med 2005;352:78–84.

9. Steinbrook R. Financial conflicts of interest and the Food andDrug Administration’s advisory committees. N Engl J Med 2005;353:116–118.

0. American Medical Association: Principles of medical ethics. Avail-able at: http://www.ama-assn.org/ama/pub/category/2512.html.Accessed: September 16, 2005.

1. Kassirer J. On the take: how medicine’s complicity with bigbusiness can endanger your health. Oxford, UK: Oxford UniversityPress, 2004.

2. Angell M. The truth about the drug companies: how they deceiveus and what to do about it. New York: Random House, Inc, 2004

3. Steinbrook R. Conflicts of interest at the NIH—resolving theproblem. N Engl J Med 2004;351:955–957.

4. Blumenthal D. Doctors and drug companies. N Engl J Med 2004;351:1885–1890.

5. Blumenthal D. Academic-industrial relationships in the life sci-ences. N Engl J Med 2003;349:2452–2459.

6. Studdert DM, Mello MM, Brennan TA. Financial conflicts of inter-est in physician’s relationships with the pharmaceutical indus-try—self-regulation in the shadow of federal prosecution. N EnglJ Med 2004;351:1891–1900.

7. Steinbrook R. The controversy over Guidant’s implantable defi-brillators. N Engl J Med 2005;353:221–224.

PII: 10.1053/S1542-3565(05)01102-XSupported by grants RO1-DK54681, RO1-DK67071, and K24-

K02638 from the National Institutes of Health.