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Medical Communications and Disclosures: A Persistent Problem We Need to Fix

February 2019

Introduction

Conflicts of interest are known to compromise objectivity and integrity.1 That is why, among other reasons, there are guidelines for interactions between pharmaceutical companies and health care professionals and why authors of manuscripts and speakers at medical conferences are required to disclose potential conflicts of interest.2-4 That way, the reader or audience can draw informed conclusions. Although disclosure is widely implemented and promoted as an essential step in the medical communications process, it comes with important limitations. Most notably, it requires honesty. When authors or speakers declare they do not have a potential conflict of interest, their colleagues and the public in general should be able to trust that information. Sadly, recent studies suggest that trust is sometimes misplaced.

Research Results

In a study5 involving 5 medical conferences, the rate of speaker conflict of interest disclosures ranged from 26% to 100% (average 71%). The researchers also noted that, when disclosed, potential conflict of interest information often was displayed very briefly or not discussed by the presenter. One important limitation of this study was that the researchers could not assess if presenters were honest about their disclosures or about the lack thereof. By contrast, researchers who carefully examined journal publications and “must-read” medical textbooks were able to pinpoint what was — or was not — disclosed. Extensive research6 by the New York Times and ProPublica found dozens of doctors failed to disclose corporate affiliations in publications that (occasionally) had a profound impact on medical practice. One physician in particular omitted the disclosure of millions of dollars in payments from drug and health care companies from dozens of research articles in prestigious journals including the New England Journal of Medicine and The Lancet. Following publication of the article, staff members at Memorial Sloan Kettering Cancer Center (New York, NY) received orders to improve their disclosing practices, and although one of the named physicians insisted the guidelines for reporting financial relationships were “nebulous,” he said he would correct the record in 17 recent articles.7 This and other investigations left some physicians wondering whether failure to disclose financial conflicts should be considered research misconduct.8

Sadly, the problem also exists in textbooks, albeit sometimes for a different reason. In a 2018 study,9 financial relationships of 1152 contributors to 6 prominent medical, pharmacy, and dentistry textbooks were examined. Authors in these textbooks held a total of 677 patents and, between 2009 and 2013, 50% had received financial compensation totaling millions of dollars.   None of this information was disclosed to the readers, but this may have been because full transparency of author conflicts is not a standard practice for all textbooks.

Implications and Solutions

Clearly, a lack of transparency or honesty hurts all of us. It negatively affects the public’s trust in our profession and our trust in the veracity of the information provided in medical journals and textbooks and at medical meetings. If disclosures are not carefully considered, what else in the submission or presentation is less than truthful? We all lose if this problem is not addressed.

First, with respect to textbooks, all textbook publishers must adopt clear and unambiguous conflict-of-interest disclosure policies. In the meantime, readers beware!

Second, with respect to journals and medical meetings, we all have a role to play. Editors must carefully review and perhaps edit their standard disclosure language. Although I cannot for the life of me understand why receiving support of any kind is something to be dishonest about or why some authors apparently consider receiving samples or any kind of assistance as “no support” or “no financial support,” apparently some folks genuinely believe that if they did not receive a direct payment, they did not receive support (or something like that).6,7  Similarly, some authors appear to believe that serving on the board of a company involved in the development or marketing of a medical or medically related product or service is not considered a potential conflict of interest. Most of us would disagree. With that said, perhaps some disclosure forms should require more explanation of examples of potential conflicts of interest in order to reduce potential confusion.

Third, as a prospective author or speaker at a medical meeting, when in doubt it is always wise to err on the side of caution — that is, provide relevant information and leave it up to the editor and/or meeting organizers to decide what to do.

Finally, readers of medical journals and meeting attendees can help. We have to believe the vast majority of authors and speakers are honest and would not sign less-than-truthful statements. But if you read an article or attend a meeting and believe a potential conflict of interest has not been disclosed, you can help protect the integrity of our profession by asking the editor(s) and/or organizers to investigate. This may not be a responsibility we relish accepting but one we may have to assume at some point in our careers. We all have a role in protecting the veracity of the information we rely on to help guide patient care. What we may not know really can hurt us all. ν

References

1. Dunn AG, Coiera E, Mandl KD, Bourgeois FT. Conflict of interest disclosure in biomedical research: a review of current practices, biases, and the role of public registries in improving transparency. Res Integr Peer Rev. 2016;1:1–8.

2. Pharmaceutical Research and Manufacturers of America. Code of Interactions with Health Care Professionals. February 2, 2017. Available at: www.phrma.org/codes-and-guidelines/code-on-interactions-with-health-care-professionals. Accessed December 30, 2018.

3. Editorial Policy Committee Council of Science Editors. CSE’s White Paper on Promoting Integrity in Scientific Journal Publications. Wheat Ridge, CO: Council of Science Editors; 2018. Available at: www.councilscienceeditors.org/wp-content/uploads/CSE-White-Paper_2018-update-050618.pdf. Accessed December 31, 2018.

4. International Committee of Medical Journal Editors. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. December 2018. Available at: www.icmje.org/icmje-recommendations.pdf. Accessed December 31, 2018.

5. Grey A, Avenell A, Dalbeth N, Stewart F, Bolland MJ. Reporting of conflicts of interest in oral presentation at medical conferences: a delegate-based prospective observational study. BMJ Open. 2017;7(9). doi: https://dx.doi.org/10.1136%2Fbmjopen-2017-017019.

6. Ornstein C, Thomas K. Top cancer researcher fails to disclose corporate financial ties in major research journals. New York, NY: The New York Times; September 8, 2018. Available at: www.nytimes.com/2018/09/08/health/jose-baselga-cancer-memorial-sloan-kettering.html. Accessed September 8, 2018.

7. Thomas K, Ornstein C. MSK cancer center orders staff to “Do a Better Job” of disclosing industry ties. New York, NY; The New York Times; September 9, 2018. Available at: www.nytimes.com/2018/09/09/health/cancer-memorial-sloan-kettering-disclosure.html?module=inline. Accessed September 9, 2018.

8. Botkin JR. Should failure to disclose significant financial conflicts of interest be considered research misconduct? JAMA. 2018;320(22):2307–2308.

9. Piper BJ, Lambert DA, Keefe RC, Smukler PU, Selemon NA, Duperry ZR. Undisclosed conflicts of interest among biomedical textbook authors. AJOB Empirical Bioethics. 2018;9(2):59-68. doi: 10.1080/23294515.2018.1436095.

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