Assessment of the facts of the case (incl. scientific facts)
Consequential considerations (utilitarianism)
- consequences for those involved in the case
- consequences if all did so in similar cases
Deontological considerations (duties, regardless of consequences)
Distributive justice (e.g. just distribution of limited resources)
Ethical intuition (after having considered the above)
There is a chapter on ethical reasoning in this book:
Gøtzsche: Rational Diagnosis and Treatment. Wiley 2007 (230 pages)
Wulff & Gøtzsche: Rationel Klinik. Munksgaard 2006 (304 sider)
Wharton Business School suggests following Kant:
quot;We should all follow the ethical rules that we would
wish others would follow otherwise social life would
be chaos .
To the graduates, Greenspan, former Chairman of US
Federal Reserve, said: It will be your reputation for
integrity that will determine your success. A generation
from now, as you watch your children graduate, you
will want to be able to say that you dealt with people
the way you would want them to deal with you .
The US Surgeon General ( the nations s doctor ) was
forbidden by the Bush administration to speak about:
- stem cell research
- emergency contraception
- sex education (abstinence programmes have no effect)
- health of prisoners
- mental health
- secondhand smoking
- global health issues
Political and industry censorship:
primrose oil for atopic dermatitis
1989, meta-analysis of 9 trials (7 never published): striking effects.
- Large, independent trial excluded; false claims on problems.
- Author denied publication rejecting the false claims, also in other journals.
1990, independent review article, showed to company as a courtesy.
- Company threatened legal action, proof-stage article never published.
1995, commissioned individual patient-data meta-analysis by Dept. of Health, UK,
20 trials (10 unpublished).
- Searle intervened, not allowed to publish, reasons never specified.
2000, Health Technology Assessment systematic review.
- Searle did not provide unpublished data.
2002, Medicines Control Agency withdrew product licence.
2003, Another large trial published, excluded a clinically relevant effect.
(Williams H, BMJ 2003;327:1358)
A father is asked to referee his daughter's soccer game.
A judge presides over a trial involving a close friend.
A researcher owns $50,000 worth of stock in a medical device company that
makes a product that he is testing.
A pharmaceutical company invites a physician to an all-expense-paid seminar
in the Aspen, Colorado to learn about its products.
A county commissioner votes on a zoning law that will increase the value of his
land by $10,000.
A woman, who is adamantly opposed to capital punishment, sits on a jury in a
murder case in which the defendant could receive the death penalty.
A scientist is asked to review an article that reports results that could refute a
hypothesis that she has defended for over twenty years.
(Resnik, J Phil Sci Law 2007;7, April 16)
A university conducts a clinical trial sponsored by a private company. The
university owns $100,000 worth of stock in the company and has licensed
several inventions to the company.
The Director of one of the National Institutes of Health's institutes submits one
of his human research protocols to the institute's institutional review board.
A government agency responsible for regulating a company's products
receives financial support from that company.
A professional organization that provides financial support for a peer-reviewed
journal attempts to influence editorial decisions.
A hospital receives substantial donations from a company that is sponsoring
clinical trials conducted at the hospital.
(Resnik, J Phil Sci Law 2007;7, April 16)
The only person who does not have some vested
interest in a subject is somebody who knows
nothing about it (Richard Smith)
Udvælgelse af data
Torture your data until they confess
virus, nationale forskelle
Indkaldelse af forsøgspersoner, kolleger
Medforfatterskab, alle skal være med
Hvem frygter ikke denne mand?
Konkurrenter, hvem publicerer først?
Afdeling for kvinde- og kønsforskning
Symptomer eller helbredelse, outcomes
AIDS medicin, pris?
- declarations of conflicts of interest if people might
think you have any
- ethical guidelines can be very helpful if problems occur
- Advisory Board (arbitrators, ombudsmen) can be very
helpful if problems occur
Constraints on publication rights in industry-
initiated clinical trials. JAMA 2006;295:1645
Peter C. Gøtzsche (MD DrMedSci) (1)
Asbjørn Hróbjartsson (MD, PhD) (1)
Helle Krogh Johansen (MD, DrMedSci) (1,2)
Mette Haahr (BSc) (1)
Douglas G. Altman (DSc) (3)
An-Wen Chan (MD, DPhil) (4)
(1) Nordic Cochrane Centre, Copenhagen, Denmark
(2) Institute of Medical Microbiology and Immunology, Univ. of Copenhagen
(3) Centre for Statistics in Medicine, Oxford, UK
(4) University Health Network, University of Toronto, Canada
Surveys have shown
- that the academic freedom of clinical
investigators in industry-sponsored projects is
- that reports of drug trials are frequently
favourable of the sponsor s product because of
flaws in design or analysis, selective
publication of trials, or selective reporting of
outcomes within trials.
1. Protocols for all randomised industry-initiated trials
approved by the Scientific-Ethical Committees for
Copenhagen and Frederiksberg in 1994-95 that were
subsequently published (N=44) and corresponding
2. Protocols for the first 44 randomised industry-initiated
trials approved by the same committees in 2004.
has access to accumulating data 16
can stop the trial for any reason 18
Explicitly stated that the sponsor did the
statistical analyses or wrote the trial
26 protocols from 1994-95
8 trial reports
0 of 44 the trial reports
22 of 44 protocols from 1994-95
27 of 44 protocols from 2004
none of the protocols from 1994-95
14 protocols from 2004
(but were never available in any documents filed
with the Scientific-Ethical Committees)
The tight sponsor control over randomised trials should
be changed to ensure research integrity.
Transparency and reporting should be be improved.
Trial protocols, investigators agreements, and other
relevant documents, should be publicly available.
Trials should be a public enterprise. Industry could
provide funds and comment on protocols, but should
not be otherwise involved.