Managing Conflict of Interest Managing Conflict of Interest

The Challenge of Pharmaceutical The Challenge of Pharmaceutical Company Marketing to Medical Company Marketing to Medical

ProfessionalismProfessionalism David J. Rothman, Ph.D.Bernard Schoenberg Professor of Social MedicineColumbia College of Physicians and Surgeonswww.societyandmedicine.columbia.eduPresidentInstitute on Medicine as a Professionwww.imapny.org

Associate DirectorThe Prescription Project www.prescriptionproject.org

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INSTITUTE ON MEDICINE AS A PROFESSION

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PRESCRIPTION PROJECT

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Context: The Wind at Our Back

Increasing concern about marketing. Why?

• Surge in healthcare spending• Prominent legal cases (e.g. TAP, Vioxx, Guidant)• Media attention to physician-industry ties:

Gifts and meals to providers and formulary decision-makers

Undisclosed support to researchers Off-label promotion Industry ties to authors of treatment guidelines Cheerleaders as sales reps

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Press Coverage July 2006 The San Jose Mercury News, “Science Critics Make Issue of Financial

Ties”: Stanford psychiatrist accused of recommending a drug treatment in which he had a financial interest. Doctor co-founded company that would make and sell the drug.

The Wall Street Journal, “Financial Ties to Industry Cloud Major Depression Study”: Depression study authors failed to disclose financial ties to makers of anti-depressants. Study’s results were seen as a boon for the anti-depressant drug makers.

The New York Times, “Hospital Chiefs Get Paid for Advice on Selling to Hospitals”: Hospital executives receive substantial fees and lavish vacations in exchange for advising vendors on marketing to hospitals - seen as a way for industry to curry favor with those who control major purchasing decisions.

The New York Times, “Indictment of Doctor Tests Drug Marketing Rules”: Doctor arrested for receiving payments to widely market a prescription drug containing GHB, the “date rape” drug, despite dearth of clinical trial data.

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Press Coverage July 2006 (con’t)

The New York Times, “Our Conflicted Medical Journals” editorial: After disclosure failures at prominent medical journals, New York Times’ editors urge more forceful control of conflicts of interest.

The New York Times, “Rules Planned for Industry Ties to F.D.A. Boards”: F.D.A. responds with more guidelines after scandals over advisory board members’ financial ties.

The Boston Globe, “Article Urging Heart Exams Shows Conflict of Interest”: Recent cardiology scan recommendations tainted by pharmaceutical industry funding. Recommendations would lead to greater prescription use, industry profits.

The New York Times, “Drug Makers Pay for Lunch as They Pitch”: Drug companies give doctors lunch to listen to their marketing spiel. Doctors’ integrity questioned.

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What is “Conflict of Interest”?

“When primary responsibilities of professionals are compromised by pursuing interests external to their

responsibilities.” - Neil Smelser, University of California-Berkeley

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Conflict of Interest in the Polity and the Society

Should a loan department officer dine or gift the college student loan administrator to increase referrals?

Should a lobbying group dine or gift a state legislator or congressman to advance legislation?

Should a brokerage house dine or gift a mutual fund administrator to attract their stock purchases?

Should an apparel designer dine or gift the department store purchasing agent to seal the purchase?

Should a public agency dine or gift a journalist to spin a story?

Most will answer no to the above questions.

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Why We Say No: Core Principles

Commitment to organizational integrity and client welfare.

Decision-making should be free of personal bias.

Gifts of any size (even small ones) are influential.

Disclosure is not a sufficient cure.

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Conflict of Interest in Medicine

Is there any reason why doctors and drug companies should be allowed to

play by different rules?

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Research Findings Central to our Deliberations

Wazana, JAMA (2000; 283: 373-380)

Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice.

Company-sponsored continuing medical education (CME) preferentially highlighted the sponsor’s product(s) compared with other CME programs.

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Research Findings Central to our Deliberations

Wazana, JAMA (2000; 283: 373-280)

Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s products.

Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing.

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“Gimme an Rx! Cheerleaders Pep Up Drug Sales”

NY Times, 11/28/05

“Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force…. Drug companies have found that former cheerleaders are good at persuading doctors.”

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The Other Merck Manual

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Journal of the American Medical Association

January 25th, 2006 (295: 429-433)

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Recommendations to Academic Medical Centers for Controlling Conflicts of

InterestActivity RegulationGifts, meals directly to physician from industry

Eliminate

Provision of free samples, other patient-use products

An indirect distribution system

Speakers’ Bureaus and Ghostwriting

Eliminate

Payment for physician and trainee travel

Contributions to a conflict-free central facility

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Recommendations to Academic Medical Centers for Controlling Conflicts of

InterestActivity RegulationDirect support for CME Contributions to a conflict-free

central facilityConsulting, speaking honoraria, and research contracts

Transparency; Specify terms of service and be available for public inspection

Formulary and other purchasing decisions

Decision-makers must be conflict free

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“Seducing the Medical Profession”NYTimes Op-Ed, 2/2/06

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NY Times, 2/12/07

David J. Rothman:

“Gifts bring with them the felt need to reciprocate…We’re not saying you’re being bribed. We’re saying you’re being gifted.

Some of it could be raw monetary hustling. But some of it is this psychological – ‘Well, they just sent me out to Las Vegas, their

drug is as good as anybody else’s, why not just say thank you.’”

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AMCs Leading the Way

Yale University University of Pennsylvania Stanford University University of Michigan University of Washington Kaiser Permanente UC Davis UC System University of Arizona

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Catalysts for Change

Leadership Change was “top down” at many AMCs.

Sensitivity to Media Coverage Fear of institutional embarrassment through scandal.

An Opportunity to Exercise Professional Leadership

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Barriers to Change

Dependency on Drug Company Funding. Ignorance of What Leading AMCs and

Societies are Doing. Decentralized Hospital/Educational

Structure. Fear of Faculty Resistance.

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What would the new world of medicine Managing Conflict of Managing Conflict of

Interest Interest look like? Decisions by physicians would become more evidence-based.

Better patient outcomes.

Expenditures on prescription drugs would decline.

Increased use of generic products.

A decreased reliance on inappropriate pharmaceutical agents.

An absence of industry representatives at AMC meetings and lunches.

Increased sensitivity among medical students and house staff to the values of medical professionalism and scientific integrity.