PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of mayoclinprocLink to Publisher's site
 
Mayo Clin Proc. 2010 February; 85(2): 201–203.
PMCID: PMC2813837

Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications–Reply–I

I concur with Dr Garber that there is far more commonality of interest than COI between industry, physicians, and academia and applaud the AACE for taking a clear stand. Although I used the term conflict throughout my commentary, I believe the time has come to stop its indiscriminate use. The term conflict of interest can prejudice the audience or reader to the material being presented and to the presenter(s), a form of framing bias that leads to presumptions of guilt until proven innocent; the term competing interests is much more neutral. Dr Garber's support for balanced and equitable implementation of COI-disclosure policies by journal editors is greatly appreciated.

The editors/staff of Neurology (Baskin, Knopman, and Gross) conclude that I wish to “cover up” medical writers' contributions, yet there is no such suggestion in my commentary. I argued that, although some writers might meet authorship criteria (due to meaningful intellectual contributions), others often do less and should simply be acknowledged, case-by-case. The example I gave of a first draft being revised “beyond recognition” may not be common, but there is no “one-size-fits-all” model.1 To wit, writing the first draft of a manuscript de novo often warrants authorship, but if an investigator interprets study results; chooses data displays, key references, and points of discussion; develops an outline for the paper; and then uses the services of a professional writer, the latter essentially acts as a [skilled] facilitator. The investigator makes the “substantive intellectual contribution,” and acknowledgment is more appropriate for the writer, in my view. This distinction is frequently not a simple black-and-white decision, as discussed in my commentary. I concur that the contributorship model of attribution may be preferable to current approaches.2

I did not state that someone who meets all 3 ICMJE authorship criteria3 “must” be intimately familiar with the work, able to defend it, etc. However, it stands to reason that someone who meets all 3 of those criteria is more likely to be able to “…take responsibility for the conduct of the research,”4 or to “…defend the entire work” than someone who meets only 1 criterion, as Neurology advises. Baskin et al contend that authors today are often named on a byline for doing far less than meeting the 3 ICMJE authorship criteria (for instance, obtaining funding or general research supervision). I could not agree more. I argued that such guest or honorary authorship due to “local academic politics” that is being positioned by critics of industry as acceptable solely because it does not involve the pharmaceutical industry5 is a kind of double standard. All would benefit if authorship criteria were applied evenly, regardless of a scientist's affiliation. The Neurology approach will be more inclusive; the traditional ICMJE standards more restrictive. Whether one approach is “better” than the other remains to be seen.

In their Position Statement for Myeloma Researchers and Educators, Fonseca et al concisely outline the value of industry interactions with physicians, medical associations, and academia, especially for the development of medical interventions, training of health care professionals in optimal use, and industry support of professional meetings and other CME activities. With appropriate disclosures and payments at market value for bona fide services, collaborations with industry by experienced clinicians, educators, and researchers are indeed beneficial and advance the state of health care. Yes, abuses of such interactions have occurred, but they are the exception, and Fonseca et al warn against the potential harms of overzealous forced disengagement of such partnerships.6 Note that the editor of JAMA was a coauthor on the article that advocated such disengagements, which was published in JAMA. Readers were asked to simply accept the disclaimer that the editor “…was not involved in the editorial review of or decision to publish the article”6 and the implication that this prevented any COI for the others at JAMA who were involved in those roles.

Jung raises skepticism about various issues related to industry-based research publications in peer-reviewed journals, from the perspective of a health information consumer. However, I believe she misunderstands and/or misrepresents many aspects of my commentary—it certainly was not a defense of or support for my “former employer's actions.” I objected to editors implementing very different degrees of disclosure depending on the apparent “tilt” of an article as generally supportive or critical of industry or of a product, the censoring of work from consideration for publication without review of content, etc.

Jung asks why drug companies do not produce their own publications to report their research. I cannot tell if this is a serious or rhetorical question. Companies cannot publish their research other than in independent, credible scientific journals, or it would be considered product promotion subject to regulation by the Food and Drug Administration.

Jung's comment that drug companies would not “ever” publish research that shows that their products lack efficacy is uninformed. Every week top-tier medical journals publish “negative” industry-supported clinical trials; a few examples of large randomized studies during my tenure at Merck that were not positive for the Merck product are referenced.7-9 Her concern about medical experts working as consultants to industry is addressed in the Myeloma Position Statement by Fonseca et al. Jung's suggestions for long-term moratoriums, up to 10 years for experts to sit on national guideline advisory committees, are precisely the kind of damaging forced disengagements between industry and physicians, academia and medical associations that Fonseca et al warn against and which are not supported by analyses of several hundred Food and Drug Administration Drug Advisory Committee deliberations.10

Regarding statin trials, Jung should know that most of the major statin outcome studies performed since 1994 have been sponsored or supported by industry, and there is no apparent difference in the outcomes of such studies vs the few that were sponsored or funded by government or other agencies.11,12 I do not argue to “put statins in the drinking water,” but patients would fare better if we had more interventions for chronic diseases with the safety, tolerability, and effectiveness profiles of the statins. We should appreciate the enormous amount of high-quality research funded by industry to develop these drugs and demonstrate their value.

Ross and Krumholz question the validity of my commentary on a number of grounds, one of which was my supposed lack of disclosure regarding my work at Merck that was related to clinical trial publications, for Vioxx (rofecoxib) in particular, and about my “current financial relationship with Merck with respect to company stock options…,” etc. I spelled these out both in my disclosure statement and early in the body of my article; however, I will add that the Medical Communications Department that I headed did not play a role in 2 major Vioxx publications—the VIGOR trial and the ADVANTAGE trial. Both were written and submitted before the department was formed. I addressed at some length the development of the Vioxx 078 publication in my commentary and rejected the notion by Ross et al13 that it had been ghostwritten, as did the authors.

Regarding my financial relationship with Merck, I wish I had more to report. Merck stock peaked in the late 2000-January 2001 period and progressively declined during the ensuing years, dropping 35% to 40% immediately when Vioxx was withdrawn. Stock options awarded from 2001 forward, and even those for 2 or 3 years before 2001, quickly went “underwater.” When I left Merck in 2006, only my option grants of the last year or 2 had any positive value (a few dollars per share) and had to be exercised within 3 months of leaving the company. I earned approximately $9400 for all options I could exercise when I left Merck. Restricted stock units, a relatively new form of long-term compensation for some employees, had not vested and had zero value. I purchased 400 shares of Merck stock outright at that time, thinking it was probably a good long-term investment. The commentary caused no reaction in financial markets, nor did I expect it to. The implication that I might have been motivated to write my article because of my financial relationship with Merck is baseless.

What I objected to in my commentary regarding disclosures in the 3 articles published by Ross, Krumholz, and Hill et al13-15 on rofecoxib were statements that are as vague and uninformative as the classic acknowledgment about a medical writer: “We thank Mary Smith for editorial assistance.” There is practically universal agreement today that such disclosures are inadequate. In the first of their articles,14 there is only a statement in the opening paragraph that the authors “…[participated] in litigation at the request of plaintiffs…” and the formal disclosure that “All authors have been consultants at the request of plaintiffs for recent suits against Merck related to rofecoxib.” To reiterate my objection, there was no mention of any of the authors being compensated, nor of appearing as expert witnesses in court, etc. The disclosure statements in the 2 other publications mentioned that the authors had been compensated.

I sincerely regret and apologize to Dr Krumholz for misstating his income received for work as a consultant to attorneys such as Mark Lanier in plaintiffs' litigation against Merck. I said it was “more than $300,000” as of January 2007. In fact, the total was “roughly $300,000” for Dr Krumholz and his assistants at that time,16 and court testimony indicates that about half, or $150,000, was for Dr Krumholz.17 A very recent article reports that Dr Krumholz personally received “some $200,000” for his work related to rofecoxib litigation.18 Again, I apologize for misstating Dr Krumholz' income.

Ross and Krumholz contend that because documents obtained in legal discovery proceedings have been used previously for “research” publications, this validates their work on rofecoxib as published. I disagree and objected to the 1-sided nature of all such tort-based publications, facilitated by editors of leading journals with clear biases against “industry.” I never argued to prevent publication of such work. Instead, I suggested that editors provide some balance in this process by providing a small, finite period for the company or organization accused of misconduct in manuscripts [based on legal discovery] to be able to respond, at the same time, in the same issue. “Research” based on legal discovery proceedings, whether called a case study or other euphemistic term, deserves distinctly different handling by editors of medical journals.

Ross and Krumholz complain that they were not provided longer space to address allegations and errors and to defend their research integrity, etc. I understand (and note the irony in this) because it is usually a company that is in that position. I received dozens of e-mails from readers in the United States, United Kingdom, Europe, and Latin America after publication of my commentary and Dr Lanier's editorial. With a single exception, roughly 90% were supportive; the remainder spoke of appreciating a different perspective, including 1 or 2 from journalists. In this regard, I believe my commentary was successful, and I stand by what I wrote.

References

1. Strange K. Authorship: why not just toss a coin? Am J Physiol Cell Physiol. 2008;259(3):C567-C575 [PubMed]
2. Norris R, Bowman A, Fagan JM, et al. International Society for Medical Publication Professionals (ISMPP) position statement: the role of the professional medical writer. Curr Med Res Opin. 2007;23(8):1837-1840 [PubMed]
3. International Committee of Medical Journal Editors Uniform requirements for manuscripts submitted to biomedical journals: ethical considerations in the conduct and reporting of research: authorship and contributorship. http://www.icmje.org/ethical_1author.html. http://www.icmje.org/ethical_1author.html Accessed January 7, 2010.
4. Neurology® Information for authors. http://www.neurology.org/misc/auth2.shtml. http://www.neurology.org/misc/auth2.shtml accessed January 7, 2010.
5. Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007;4(9):e286 [PMC free article] [PubMed]
6. Rothman DJ, McDonald WJ, Berkowitz CD, et al. Professional medical associations and their relationships with industry. a proposal for controlling conflict of interest. JAMA 2009;301(13):1367-1372 [PubMed]
7. Pitt B, Poole-Wilson PA, Segal R, et al. ELITE II Investigators Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial: the Losartan Heart Failure Survival Study ELITE II. Lancet 2000;355:1582-158 [PubMed]
8. Weintraub WS, Boccuzzi SJ, Klein JL, et al. Lovastatin Restenosis Trial Study Group Lack of effect of lovastatin on restenosis after coronary angioplasty. N Engl J Med. 1994;331:1331-1337 [PubMed]
9. Topol EJ, Moliterno DJ, Hermann HC, et al. TARGET Investigators Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization. N Engl J Med. 2001;344:1888-1894 [PubMed]
10. Lurie P, Almeida CM, Stine N, Stine AR, Wolfe SM. Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings. JAMA 2006;295(16):1921-1928 [PubMed]
11. Cholesterol Treatment Trialists' (CTT) Collaborators Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366:1267-1278 [PubMed]
12. Delahoy PJ, Magliano DJ, Webb K, Grobler M, Liew D. The relationship between reduction in low-density lipoprotein cholesterol by statins and reduction in risk of cardiovascular outcomes: an updated meta-analysis. Clin Ther. 2009;31(2):236-244 [PubMed]
13. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib. a case study of industry documents from rofecoxib litigation. JAMA 2008;299(15):1800-1812 [PubMed]
14. Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? BMJ 2007;334:120-123 [PMC free article] [PubMed]
15. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: A review of internal documents. Ann Intern Med. 2008;149(4):251-258 [PubMed]
16. Mayer TVH. Rapid response letter to the British Medical Journal re: What have we learnt from Vioxx? February24, 2007. http://www.bmj.com/cgi/eletters/334/7585/120#160396 Accessed January 7, 2010
17. Transcript of Record at 3131-35, Messerschmidt v. Merck & Co., No. ATL-L-5520-05MT (N.J. Super. Ct. Law Div. Feb. 7, 2007)
18. Basken P. Ex-Merck spokesman points finger at paid consultants in drug lawsuits. http://chronicle.com/article/Ex-Merck-Spokesman-Points-F/49439/Chron Higher Educ December13, 2009. Accessed January 3, 2010

Articles from Mayo Clinic Proceedings are provided here courtesy of The Mayo Foundation for Medical Education and Research