Transcript Humanities in Surgery Who needs them? What are they anyway?

“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
• 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 decade
Funding Sources
57% Biotech and Pharm companies
28% NIH
15% 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
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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
Editorial Approaches
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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
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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
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
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-consumer
advertising
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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
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Service
Advocacy
Altruism
Application of special knowledge
Standards set and maintained internally
Humanism
Long-term goals
Meeting society’s needs