The Ethical Basis for Journal Disclosure of Author/Editor Financial Interest

1. The Ethical Basis for Journal Disclosure of Author/Editor Financial Interest Sheldon Krimsky Tufts University, Medford, MA 02155 www.tufts.edu/~skrimky Rejuvenating Public Sector Science Center for Science in the Public Interest Ronald Reagan International Center, Washington, D.C. July 11, 2008 S. Krimsky

2. Before 1980 we never heard the words scientist and conflict of interest mentioned in the same breath. Why are America’s leading science journals struggling with their integrity in the face of public skepticism over their credibility? S. Krimsky

3. Articles on Conflict of Interest Cited Annually in MEDLINE, 1974 – 2005 1974 1984 1994 2005 ♦Articles S. Krimsky

4. Is Conflict of Interest an Ethical Problem? If having a conflict of interest is an ethical problem, then what are the reasons for that problem? Can scientists have multi-vested interests and still do good science? Can academic scientists get funds from industry and still remain independent? S. Krimsky

5. Stewardship: public funding of science. Transparency: openness is compromised Consequentialism: distorted science Scientific Integrity: loss of the norm of disinterestedness and appearance of objectivity. Ethical basis for COI Rules: Four Frameworks S. Krimsky

6. Anatomy of Conflict of Interest Antecedent Acts States of Mind Behavior of Partiality S. Krimsky

7. Antecedent Acts: The factors that condition the state of mind of an individual toward partiality • States of Mind: The affected sentiments, proclivities and affinities conditioned by the antecedent acts. • Behavior of Partiality: The outcome behavior that is affected by the antecedent acts and states of mind. S. Krimsky

8. Preventing COI in Public Life “Because we cannot prevent officials from mentally taking notice of their own interests, we prohibit the act of holding certain kinds of interests in the first place” A. Stark Conflicts of Interest in American Public Life, 2000. S. Krimsky

9. 1. Stewardship and Science We have rules preventing conflict of interest among government employees because they are the stewards of our public policies, laws, regulations and social resources. Government officials who use their position to gain personal financial interest are in conflict with their fiduciary role as stewards and trustees of public goods. Stewardship is not a useful principle for academic science. S. Krimsky

10. 2. Transparency in Science Openness is a hallmark of scientific ethics. This includes sharing data, disclosure of bias, real authorship, control over data and transparency of methods. In so far as a COI may be perceived to bias the outcome of results or establish hidden norms it should be disclosed. S. Krimsky

11. Ghostwriting in Science S. Krimsky

12. David J. Cullen, Ghostwriting in scientific anesthesia journals Anesthesiology 7(2):195-196 (August 1997). “Recently, I was shown a letter written to an academic anesthesiologist that seriously undermines the integrity of the publication process as it applies to scientific peer-reviewed journals. The full text of the letter, minus any identifiers, is reproduced herein:” S. Krimsky

13. Dear Dr. ___: Thank you for agreeing to review the enclosed article titled ___. As mentioned during our phone conversation, ___ is working with ___ on publishing this paper. We'd like to submit this article for publication as soon as possible. Please give the article a cursory review and let me know within a few days if you are interested in authoring this paper. If so, please send any revisions to me by Friday, September 6th. Please feel free to take complete editorial control, adding, changing, or deleting whatever you feel is necessary. (We'd like the neurosurgery section to be expanded (sic) a bit.) Indicate your changes on the enclosed copy. We will make these changes and return a manuscript, styled according to the journal's guidelines, for you to submit. ___ will obtain permission from the publishers to use borrowed figures/graphics. If you prefer to work from a disk, please let us know. We've targeted Journal of Clinical Anesthesia as the journal for this article. If you have another journal in mind, please let me know. ___ will pay you $1000 for authoring this article. If you have any questions, please call. My direct line is ___. I'm looking forward to talking to you. Thank you. Sincerely yours, Managing Editor S. Krimsky

14. 3. The Consequentialist Ethical Framework • In the consequentialist framework, the ethics of COI is viewed in terms of whether holding a conflicting interest correlates with one of the transgressions in science. The burden is to demonstrate a link between possessing a COI and some level of scientific misconduct or bias. • The generally accepted transgressions are: scientific fraud; failure to request informed consent; wanton endangerment of human and animal subjects; plagiarism; systematic bias; borderline cases: unwillingness to share scientific data; participation in ghost writing. S. Krimsky

15. Is there evidence that privately-funded studies tend to draw pro-industry conclusions? Tobacco company research Drug research Consequentialism:Does financial COI bias science? S. Krimsky

16. Manufactured Tobacco Science • Placed articles in the medical literature without revealing their support for the research. • Financed a large number of studies, literature reviews, and scientific conferences conducted by front organizations or consultants without revealing their support for the research. • Sought to create an ostensibly independent coalition of scientists to critique studies that linked tobacco to disease; supported research on new epidemiological standards that would cast doubt on second hand smoke evidence of cancer. S. Krimsky

17. Does the Source of funding affect the outcome of research? “Evidence suggests that financial ties that intertwine industry, investigators, and academic institutions can influence the research process. Strong and consistent evidence shows that industry-sponsored research tends to draw pro-industry conclusions.” (p. 463). Bekelman et al. Scope and Impact of Financial Conflicts of Interest in Biomedical Research JAMA 289:455 (2003) S. Krimsky

18. Authors who supported the use of calcium-channel antagonists were significantly more likely than neutral or critical authors to have financial relationships with manufacturers of calcium-channel antagonists.” 96% vs 60% vs 17% Calcium Channel-Antagonist StudyNEJM 338:101-106(1998) S. Krimsky

19. Funding Effect in Science • JAMA 290:921 (2003) An association found between funding and conclusions in randomized drug trials. • British Medical Journal 325:249 (2002): Association between competing interests and author’s conclusions. • Addiction 92:1423 (1997). “researchers acknowledging tobacco industry support were much more likely to arrive at conclusions favourable to the tobacco industry than were researchers not acknowledging industry support.“ • JAMA 282:1483 (1999) “Studies funded by pharmaceutical companies were nearly 8 times less likely to research unfavorable qualitative conclusions than nonprofit-funded studies and 1.4 times more likely to reach favorable qualitative conclusions.” • Family Practice 18:565 (2001): “Our findings show an association between financial support of published RCTs by commercial interests and outcomes favouring the use of the products being tested.” S. Krimsky

20. Toxicology of Bisphenol A Table 1: Biased outcome of low-dose bisphenol A research * * F. vom Saal & C. Hughes. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113:929 (2005). S. Krimsky

21. Is Disclosure the Antidote to Conflict of Interest? S. Krimsky

22. Judicial DisclosureA judge about to sentence a convicted felon makes the following disclosure I will be sentencing the defendant , who has now been tried by his peers, to be incarcerated in a for-profit prison in which I have an equity interest. The extra money I earn from this partnership between my court and a reputable penal institution helps to compensate my low salary and allows me to serve the public interest and render more thoughtful and objective decisions.” Judge I. D. Clair S. Krimsky

23. 4. Protection of the Integrity of Science • Unless there is a firm rejection of such [venal] behavior, the public will be perfectly entitled to conclude that the scientists are more interested in profits than results….Public confidence in its own objectivity is the best thing science has going for it; but without some care we may find one day that “scientific objectivity” has become an oxymoron, a self-contradiction like “express mail” or “easy credit.” • Donald Kennedy in a lecture 1982. S. Krimsky

24. John Ziman: Social Objectivity of Science • “In the eyes of the public, the major virtue of academic scientists and their institutions is that, even when they disagree, they can be trusted to present what they know ‘without fear or favour.’ Whether or not this high level of credibility is really justified, it is what gives science its authority in society at large. Without it, not only would the scientific enterprise lose much of its public support: many of the established conventions of a pluralistic, democratic society would be seriously threatened.” John Ziman Real Science, p. 175. S. Krimsky

25. Loss of the Appearance of Scientific Objectivity • “ If we contaminate the wellspring of knowledge by mixing other interests, in particular corporate agendas, then we lose the pure reservoir for dispassionate and independent critical analysis. Individual universities, because of their institutional conflicts of interest, will be seen as another stakeholder—another self-interested party in a cynical political arena where truth is all too often seen as a social construct and not as an objective outcome of rigorous scholarly investigation.” • Science in the Private Interest p. 230. S. Krimsky

26. S. Krimsky