Presidential Address

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Industrial relations with academichealth care and professional medicalassociations: What’s all the fuss? Whocares anyway?William Turnipseed, MD, Madison, WI

From the Division of Vascular Surgery, UW Hospital and Clinics, Madison, WI

THE HEALTH CARE SYSTEM IN OUR COUNTRY is experienc-ing increased scrutiny as political efforts of reformare coupled with ethical questions of propriety re-garding relationships between biomedical indus-tries, academic health centers, and professionalmedical associations. One of the core issues inboth political and ethical arenas is cost controland how to allocate monies to cover patient careand medical education, as well as research anddevelopment in an equitable, transparent, and un-biased manner. Another problem is the apparentbreach of integrity in the relationship betweenthe health care system and industry. Intentionaldeception, off-label marketing, failure to publishuntoward results, and huge salaries to surrogatephysicians exposed in criminal prosecution bygovernment and state agencies have fostered astormy debate within the medical profession itself,altered policy within professional associations, andrestructured physician interaction with the bio-medical industry. These revelations have fosteredcongressional passage of the ‘‘Sunshine Act,’’which mandates financial disclosure for medicalprofessionals involved in research and develop-ment activities with industry as part of the recentlyenacted health care reform act.1-5

At issue is a fundamental philosophical differ-ence between missions of the academic health caresystem (patient care, research, education, and

d for publication July 15, 2010.

requests: William Turnipseed, MD, Division of VascularUW Hospital and Clinics, 600 Highland Avenue,

, WI 53792. E-mail: turnip@surgery.wisc.edu.

2010;148:613-7.

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Mosby, Inc. All rights reserved.

016/j.surg.2010.07.026

service) and the biomedical industry (research,product development, marketing, and profit forinvestors). These 2 entities are bound in a complexrelationship that fosters the transition of ideas,concepts, and scientific facts into drugs, devices,and biologic products that are produced by indus-try for the advance of patient care. This interactionhas generated profits that run in the hundred ofbillions of dollars for industry and spectacularhealth benefits for the public. This apparentwin--win symbiosis, however, has created a seriousconcern among many that the interaction betweenthe medical profession and industry can and hasbeen corrupted and that the sacred bond of trustin the doctor--patient relationship is in danger.

The problem began in the 1970s when easyaccess to government-funded research dollars di-minished and academic biomedical scientists bychoice or necessity embraced venture capitalism,the strategic investment community of pharmaceu-tical and device companies, and entered the com-mercial marketplace to produce and distributehealth care products to the public. Since thattime, commercial investment in biomedical re-search and development has exceeded federaland nonprofit organization funding, which onlynow constitutes about 15% of the total, and thegap continues to widen.6

The industry--health care relationship has, inmany ways, been incredibly beneficial to the publicand rewarding to innovators and companies thatdevelop the ever-increasing number of drugs anddevices that have improved the length and qualityof our lives. Would the vaccines that protect usfrom pandemics, statins that have reduced thedeath and mortality from stroke and heart dis-eases, analgesics and nonsteroidal medicationsthat ease our daily pain, or the innovative surgical

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devices that make orthopedic, cardiovascular, orgastrointestinal operations safer and less invasivebe possible without the interaction between indus-try and medicine? Although the public benefit isundeniable, huge profit taking has rewarded in-vestors and inventors, but also abetted medicalcollaborators, many of whom have little to do withactual research and development and serve solelyas marketing ambassadors for products and theircompanies.

In 1987, the dean of the Harvard Medical Schoolconvened a committee to draft rules for preventingpotential financial conflicts of interest following anexpose in the Boston Globe documenting insiderstock trading on the part of university researchersinvolved in a company-sponsored clinical trial.7

Since then, investigative reporting and federal en-forcement of the anti-kickback and false claim actshave resulted in prosecution and criminal convic-tion of many well-known pharmaceutical and devicecompanies.2,3,8,9 These include Zimmer, Dupuy,Biomet, Medtronic, Schering-Plough, AstraZeneca,and Pfizer. Fines for illegal marketing and kickbacksto physicians and medical organizations exceeded 4billion over the past few years. This constitutes theequivalent of a financial slap on the hand consider-ing that the annual global biomedical budget formarketing alone is >$15 billion. A $400 millionfine against Pfizer for illegal marketing of Neuro-ntin constituted just 3 weeks of sales in 1 year; totalannual sales exceeded $10 billion.

The public exposure of inappropriate activitybetween production companies and the healthcare system has prompted criticism from govern-ment officials and enactment of more stringentstate and federal regulation, as well as a reevalua-tion of professional behavior within the healthcare community.10-13

The need for change is highlighted by recentpublications that document common industrialmarketing strategies to promote sales and profitthat were excerpted from class action suit records.These tactics included targeting physicians asrecipients of promotional rewards and the use ofeducational and research venues to increase pre-scriptive use of their products. A classic exampleoccurred in 1998 when the Pfizer Company budg-eted $40 million for advertisement of off-label usesof a drug (Neurontin) that they produced. Severalgroups of physicians were targeted for payment,including frequent users of the drug, trainedspeakers for peer-to-peer selling programs, andthought leaders, including department chairs anddirectors of academic programs who in returnwere offered honoraria and educational research

grants for their institutions. In addition, physiciantrainees were targeted for ‘‘educational events’’and rewarded with meals, books, equipment, andmeeting travel costs.1

The same company indirectly funded continu-ing medical education (CME) programs for aca-demic centers and professional associations bylaundering the money through medical educationcompanies that had contracted agreements withthe industrial sponsor to set up teleconferences,advisory boards, consultant meetings, and to trainspeakers to give grand round presentations atacademic and community hospitals (speaker bu-reaus) and to prepare original articles, reviewpapers, and editorial commentary for physiciansengaged in the research process (ghostwriting).Records from numerous legal cases against othercompanies reveal that such strategies are common-place within the biomedical industry.

Such revelations foster a growing concern thatcommercial interests may influence clinical deci-sion making for patient care by promoting druguse for which there is no good scientific evidenceof benefit; that industry-sponsored studies aresusceptible to biased trial designs and conclusionsfavoring the sponsors; that control of data releasedelays or prevents publication and exposure ofnegative outcomes; and that direct health carecosts are higher than need be because of undueinfluence on prescriptive use of more expensive,newer drugs and devices that are protected bypatent for which there are cheaper and equallyeffective alternatives.

Why should academic health centers and pro-fessional medical associations be concerned aboutthis? The answer is because our failure to acknowl-edge and address the issue undermines the prin-ciples of the profession, threatens public trust, andinvites expanded governmental regulation. Aca-demic health centers and professional associationstraditionally provide leadership in areas of patientcare, education and research, and are obliged toestablish evidence-based standards of care forpublic and governmental agencies. Many questionhow scientific objectivity can be preserved whengifts, grants, royalties, and equity holdings arereceived by individuals and institutions that areinvolved in industry-funded research. For a varietyof reasons, academic medical centers are begin-ning to adopt policies for governing faculty andinstitutional interaction with industry. These in-clude a growing awareness of the problem amongmembers of the profession, a commitment toteach responsible behavior to trainees, and adesire to avoid media scandal. Of the 125 medical

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schools in the Association of American MedicalColleges, only 30 have established conflict ofinterest policies. The University of Wisconsin andthe University of Michigan are the most notable inthe Midwest. Unfortunately, there are no consen-sus agreements regarding the content of conflictof interest policy or consistent mechanisms forenforcement. Guidelines have been proposedby the Institute of Medicine, the American Associ-ation of Medical Colleges, the Office of the In-spector General (Health and Human Services),and the Accreditation Council for ContinuingMedical Education. The specific focus of mostpolicy guidelines include the abolition of giftingof any form to individuals within the employ ofacademic health centers, restricted access by in-dustrial representatives to individual physicians,and a restriction of onsite, industry-sponsorededucational events to Accreditation Council forContinuing Medical Education-approved pro-grams requested by faculty and presented in nonpatient care areas. These policies generally suggestthat industry-sponsored educational funds shouldnot go to individuals, sections, or departments, butbe meted and vetted by a central clearing commit-tee that independently decides use of those funds.They also commonly prohibit ghostwriting andspeaker bureau participation by faculty members.

Guidelines also agree that the drug samples toindividual physicians and formulary purchasingdecisions by physicians with company ties shouldnot be allowed.14-18 They suggest that CME shouldbecome less dependent on industrial support(half of the $3 billion annual CME budget comesfrom industry support). Unfortunately, no realisticalternatives for financial funding of CME programshave been proposed.19-21 Finally, these guidelinesacknowledge that company consulting by facultyand research support from industry should be al-lowed, but rigidly defined by contract agreementfor payable services and that personal royaltiesshould not be derived from institutional use of pro-ducts developed by their faculty members. Thesepolicy guidelines originally designed for academichealth centers are now being applied to profes-sional medical associations as well.22-29 These orga-nizations are an important mechanism for medicaleducation, and a valued source of expertise formembers of the medical profession as well as publicand federal health care policy agencies. Budgetsupport from membership dues and journal sub-scriptions is inadequate for funding educationalvenues at regional and national levels, and histori-cally, industry support in the form of exhibits,branded items, as well as funding for CME

accreditation and publication of consensus careguidelines have made it possible to continue the ed-ucational mission of these associations. However,the pervasive level of exterior financing supportfor PMAs creates the potential for bias in terms ofprogram content and practice guidelineendorsements.

Without industry support or alternative fundingoptions, many organizations may fail to grow andsucceed in their educational effort. It is suggestedin new guidelines that no more than 25% of theoperational budget for any organization be derivedfrom revenues outside of exhibit fees and generalsubscriptions and that these funds should not bederived from a single company sponsor. Further-more, branded items such as convention bags andpens, should be eliminated and satellite meetingssponsored by industry not promoted in conventionpublications. Research grants to association foun-dations should be unrestricted with no quid proquo and exhibit venues separate and apart fromeducational program areas. Finally, program com-mittees, board members, and leadership appoin-tees should be free of or temporarily divested ofaffiliations during the tenure.

So how does this relate to the Central SurgicalAssociation?

For years, our organization functioned indepen-dent of external financial support. Somewhatreluctantly, however, our leadership made a neces-sary decision to change that policy almost 10 yearsago because of rising meeting costs and the desireto minimize annual dues and registration fees. Ourrelationship with industry over that period of timehas produced benefits for both parties. I think thatmany of the concerns expressed in this presenta-tion may be directly or indirectly addressed by theeffects of the current economic downturn anddisclosure requirements for industry. The financialreality for smaller regional surgical societies thatdo not have the high marketing profile identity forpharmaceutical and device companies is that in-dustrial sponsorship will be harder to obtain.Marketing budgets are strained and sponsorshipdecisions are being made at higher levels withinindustrial organizations than the field contactsthat we have dealt with in the past. I think thatorganizations like ours cannot depend as heavilyon the external support in the future as we have inthe past. We need to design new mechanismswithin the organization to foster transparent,long-term support from both industry and govern-ment sources.

So what is all the fuss about? Some would suggestthat there is no convincing evidence to suggest that

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physician-based interactions with industry have ac-tually harmed patients or destroyed the patient--doctor relationship.27-29 Unfortunately, there arefar too many examples of public and personalharm occurring from a failure of companies to pub-lish adverse drug reactions and device flaws to ac-cept this as fact. Although there is abundantevidence to suggest that physicians in most casesdo not choose to put personal gain over the bestinterests of their patients, many may unwittinglyprescribe medication and treatments that aremore expensive and downplay adverse side effectswhen marketing strategies are woven into our edu-cational database, thereby impacting managementdecisions. The reevaluation of our relationshipwith industry is not about weeding out bad applesin our profession but about developing a better un-derstanding of the origin of bias and to improveddecision making in the care of our patients. Cer-tainly, personal disclosure of company affiliationsis not a deterrent to unconscious and unintendedself-serving bias. It is important to understand thatbias is inevitable in human interactions, does notconnote evil, is not commonly recognized by the in-dividual affected by it, and is rarely intentional.30-32

Furthermore, public disposure does not examinethe financial or intellectual relationship of aspeaker with a represented company and certainlydoes not guarantee objective or scientifically accu-rate presentation of information to study patientsor professional audiences. In fact, social science re-search suggests that disclosure may have the per-verse effect of biasing the audience because ofacademic position of the speaker and the createdillusion of honest objectivity. In conclusion, disclo-sure alone does little to assure the public that datapresentation is accurate or objective.33

Who really cares then? Patients want good careand still trust doctors despite the intense scrutinyof investigative reporters and media that try to fanthe fires of public unrest. There are no riots in thestreets demanding doctors abandoned companyaffiliations.

Politicians care. They are facing the reality ofuncontrolled increases in health care costs and seethe biomedical marketing agenda as a big reasonfor this. The anti-kickback and -fraud abuse lawswill be more aggressively pursued, and mandateddisclosure legislation is seen as the first step incontrolling physician behavior and their participa-tion in agencies that determine policy. Finally, asthe physician group we should all care. We mustaddress ethical concerns, real or perceived, andformulate a plan that protects patients, providesobjective and ethical learning opportunities for

our trainees and supports that translation ofscientific principle into new and better healthcare products for the public. As the health care--industry relationship evolves, it is possible that theuse of marketing dollars available34 can be moreeffectively used to enhance the mission of bothparties and to curb the escalating cost of patientcare. It is often easier to define a problem thanto solve it. Hopefully, this presentation will at leastget you to consider the issue of our changing rela-tionship with our industrial partners and to take amore active role in the process of change.

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