Science, Ethics and Profits:An Editor’s Perspective

H. David Crombie, M.D.Editor, Connecticut MedicineNAHSL October 16, 2006

““The Evidence is In”The Evidence is In”

8/21/918/21/91

Medical Ethics

The Four Principles• Autonomy• Beneficence• Non-maleficence• Justice

Elements in the Discussion

• The Medical-Industrial Complex• Honesty and Integrity to Determine when the

evidence is in• Dealing with Bias• Direct-to-consumer marketing• Protection of Human Subjects• Regulation: Self or Government?• “Do No Harm”

Medical-Industrial Complex TOTAL: $1 Trillion

$94 Billion for Biomedical Research(5.6%)increased 2X past decadeFunding Sources57% Biotech and Pharm companies28% NIH15% Other

-State and local govts-not-for-profits-non-NIH federal gov.

Big Profits

• 1980 Bayh-Dole Act -- Universities and corporations could patent discoveries

• Research –Publicly supported- a profitable, salable good

• High stakes rewards for favorable reports• Opportunities for fraud, withholding adverse

outcomes• Pressure to gain early drug approval• Doctors as consultants, stockholders, owners,

and advisors to Wall Street

Determining Honesty and Integrity

• Harvard- Dr. John Darsee• Pittsburgh-Dr. Breuning• MIT-Dr. Imanishi-Kari• Norway-Dr. Jon Sudbo• Hwang Woo Suk

Dr. Robert GalloDr. Robert GalloDr. Bernardine HealyDr. Bernardine Healy

The Vioxx DebacleThe Vioxx Debacle

Editorial Approaches

• Choosing peer reviewers• Knowledge of statistics and epidemiology• Provide supplemental literature• Blinding of authors• Masking of co-reviewers• Open vs. closed review• Internet pre-and post-publication

Medical Professionalism

“To the degree that medicine has stressed its technical proficiency, to the exclusion of other traditional traits of professionalism such as concern for the good of patients, it has unwittingly contributed to what has grown into the most serious threat to its existence that the profession has ever faced.”Sullivan, W. Hastings Center Report

March-April 1999

Conflict of Interest

• A set of conditions in which professional judgment regarding a primary interest

(patient welfare or validity of research) tends to be unduly influenced by a secondary interest (like financial gain).

Bias and Conflicts of Interest

• Direct employment of researcher or family• Consultancy• Company ownership• Stock ownership• Honoraria• Provider of expert testimony• Outright gifts• Expense-paid trips (ski/golf)• Free meals

Conflict of Interest

Era of tacit prohibition now succeeded by era of disclosure

““We believe the scientific community and the public will be best We believe the scientific community and the public will be best served by the open publication of financial disclosure for readers served by the open publication of financial disclosure for readers and reviewers to evaluate. While financial interest, in itself, does and reviewers to evaluate. While financial interest, in itself, does not imply [prove] any bias in the results of a paper. . . ., readers and not imply [prove] any bias in the results of a paper. . . ., readers and reviewers are deemed the best judges.”reviewers are deemed the best judges.”

Krimsky and Rothenberg, 1998Krimsky and Rothenberg, 1998

Recommendations

• No drug samples• No gifts• No proposed changes to drug formularies by

MDs with a financial stake• No direct support of CME• No travel funds direct to doctors• No speaker bureaus• No ghostwriting services

Brennan et al,2006

Direct-to-consumeradvertising

• Rise of autonomy/patient as decision maker• Decline of MD as “learned intermediary”• Patient as promoter of drugs to the doctor• Drug as panacea rather than comprehensive

approach• Newer drug widely requested without

appropriate need• Release by FDA before adverse side effects

adequately assessed

Protection of Human Subjects

• 1974 Response to Tuskegee –Natl Res Act• Created National Commission for Protection

of Human Subjects of Biomedical and Behaviorial Research

• Belmont (Maryland) report published in 1979 ”Ethical Principles and Guidelines for the Protection of Human Subjects of Research”– Respect for persons “informed consent”– Beneficence—risks and benefits– Justice—selection of subjects

The Values of theMedical Profession

• Service• Advocacy• Altruism• Application of special knowledge• Standards set and maintained internally• Humanism• Long-term goals• Meeting society’s needs