Business And Research Ethics 2

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

(BMJ 2007;335:114)

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20 trials (10 unpublished).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- Searle did not provide unpublished data.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 amurder case in which the defendant could receive the death penalty.A scientist is asked to review an article that reports results that could refute ahypothesis that she has defended for over twenty years.

(Resnik, J Phil Sci Law 2007;7, April 16)

(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)

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 often limited.

- 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 trial reports.

2. Protocols for the first 44 randomised industry-initiated trials approved by the same committees in 2004.

Sponsor:has access to accumulating data 16can stop the trial for any reason 18

Total 32

Explicitly stated that the sponsor did the statistical analyses or wrote the trial report:

26 protocols from 1994-958 trial reports

Mentioned in:

0 of 44 the trial reports

22 of 44 protocols from 1994-9527 of 44 protocols from 2004

Mentioned in: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 Trials should be a public enterprise. Industry could a public enterprise. Industry could provide funds and comment on protocols, but should provide funds and comment on protocols, but should not be otherwise involved.not be otherwise involved.

Conclusions

- transparency

- 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