1 / 30

Science, Ethics and Profits: An Editor’s Perspective

“The Evidence is In”. Science, Ethics and Profits: An Editor’s Perspective. H. David Crombie, M.D. Editor, Connecticut Medicine NAHSL October 16, 2006. 8/21/91. Medical Ethics. The Four Principles Autonomy Beneficence Non-maleficence Justice. Elements in the Discussion.

onofre
Download Presentation

Science, Ethics and Profits: An Editor’s Perspective

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. “The Evidence is In” Science, Ethics and Profits:An Editor’s Perspective H. David Crombie, M.D. Editor, Connecticut Medicine NAHSL October 16, 2006

  2. 8/21/91

  3. Medical Ethics The Four Principles • Autonomy • Beneficence • Non-maleficence • Justice

  4. 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”

  5. Medical-Industrial ComplexTOTAL: $1 Trillion $94 Billion for Biomedical Research(5.6%) increased 2X past decade Funding Sources 57% Biotech and Pharm companies 28% NIH 15% Other -State and local govts -not-for-profits -non-NIH federal gov.

  6. 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

  7. Determining Honesty and Integrity • Harvard- Dr. John Darsee • Pittsburgh-Dr. Breuning • MIT-Dr. Imanishi-Kari • Norway-Dr. Jon Sudbo • Hwang Woo Suk Dr. Robert Gallo Dr. Bernardine Healy The Vioxx Debacle

  8. 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

  9. 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

  10. 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).

  11. 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

  12. Conflict of Interest Era of tacit prohibition now succeeded by era of disclosure “We believe the scientific community and the public will be best served by the open publication of financial disclosure for readers and reviewers to evaluate. While financial interest, in itself, does not imply [prove] any bias in the results of a paper. . . ., readers and reviewers are deemed the best judges.” Krimsky and Rothenberg, 1998

  13. 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

  14. 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

  15. 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

  16. 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

More Related