Transparency in Medical Journals

https://www.nytimes.com/2018/12/16/opinion/letters/disclosure-medical-journals-financial-ties.html

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To the Editor:

“‘Broken’ System Lets Doctors Omit Industry Ties in Journals” (front page, Dec. 9) describes some welcome actions taken by institutions, professional organizations and journal editors to review and disclose previously unreported financial conflicts and to prevent future nondisclosures.

But the article doesn’t mention a critical ethical imperative: the need for research subjects to be fully informed about any relevant institutional and investigator financial interests before deciding on whether to enroll in a study.

Federal regulations require that institutional review boards must conduct prospective ethical review of studies, including approval of informed-consent language, before studies can begin. The Department of Health and Human Services has published guidance for institutions, the review boards and investigators on dealing with financial relationships and interests in research.

In addition to submission of conflict-of-interest forms, journal editors require authors to provide assurance of board review to document that studies were conducted ethically. Without full financial disclosure to research subjects, this will not occur.

Stuart L. NightingaleChevy Chase, Md. The writer, an internist, is a former deputy assistant secretary for preparedness and response (medicine, science and public health), Department of Health and Human Services.

To the Editor:

Your article discusses the failure of medical researchers to disclose financial ties to pharmaceutical and medical device companies and notes that such financial relationships “could have been easily detected on a federal database.”

As former Medicare officials responsible for starting the Open Payments database, we want consumers to know that it is easy for patients to check for themselves what payments their own doctors have received from drug and medical device companies on the Centers for Medicare and Medicaid Services’ website: https://www.cms.gov/openpayments/.

We designed this system to be user-friendly for patients, as well as for journalists and researchers, who may be wondering why a physician prescribed a particular medicine or device.

Peter BudettiTed DoolittleShantanu AgrawalWashington

To the Editor:

Journals should state their disclosure policy explicitly and prominently, along with the consequences of noncompliance, on the manuscript submission form.

Authors who knowingly submit false information to a journal by omitting required disclosures of conflicts of interest should be prohibited from all future publication in that journal.

Herbert RakatanskyProvidence, R.I. The writer is clinical professor emeritus of medicine at Brown University.

To the Editor:

To address conflict-of-interest disclosure in academic research, as medical ethicists, we propose adoption of an author-driven, electronic long-form, conflict-of-interest disclosure statement.

On such a form, an author will list not only financial relationships but also political or religious affiliations, fund-raising or anything else that might help readers assess possible bias in an article.

Since the author creates the form, full transparency doesn’t depend on the sufficiency of any one journal’s disclosure policy. The long form is updated continuously and made publicly available online, where authors have the space to explain the nature of relationships — not just that the author received funding from a drug maker but what it was for.

Our policy requires institutional or collegial oversight to prevent inadvertent omissions or errors, and its success relies on good-faith authors; it cannot police writers or researchers who wish to hide industry ties.

Lisa KearnsArthur CaplanNew YorkThe writers are, respectively, senior research associate and director of the Division of Medical Ethics at N.Y.U. School of Medicine.