Citing insufficient professional guidance on how to interpret certain elements of the Physician Payments Sunshine Act, a group of seven medical writers and editors has concluded that difficulty could have a “chilling effect” on physicians’ ability to participate in clinical trials and publish results.

The 2010 law, administered by the Centers for Medicare & Medicaid Services, was designed to create greater transparency around the financial relationships of manufacturers, physicians and teaching hospitals. Commonly known as the Sunshine Act, it took effect in August 2013. The law requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value—such as gifts, honoraria and ownership interests—that are given to physicians and teaching hospitals.

Writing last month in Postgraduate Medicine, a peer-reviewed journal for physicians, the seven authors—all members of the International Society for Medical Publication Professionals—found professional associations providing guidance to their physician membership told them that the Sunshine Act was not specific on the interpretation and significance of nonmonetary or “transfers of value” (TOV) assistance for the development of medical publications.

Typically, the industry provides non-monetary assistance to authors to help with the development of medical publications, including peer-reviewed journal articles and reviews, abstracts, and oral and poster presentations. The support, under the direction of the authors, often is in the form of medical writing, copyediting and creating artwork for the publications.

Since physicians turn to their professional associations for guidance, the researchers examined the websites of 11 of those organizations to obtain a sufficiently diverse sample that included a mix of general medicine and specialty associations. Nine of them, however, failed to provide information on the Sunshine Act as it relates to publications.

“Although the rules mention support for medical publications related to research, it is unclear, under the rules, how and to what extent the TOV reporting obligations should be applied,” the journal article states.

The only citations in the Sunshine Act related to publications were payments for medical research writing, ghostwriting (prohibited by many industry publications) and journal reprints that are not relevant to author support for the development of publications.

Pharmaceutical companies, according to the study, suggest that publication support should be reported as a TOV, while others suggest the rules are written too broadly to provide the required clarity. Still others cited in the report said there is no clear direction on how to report industry support of authors, which is notably different from direct monetary payment. Without clear guidance, companies have taken varied approaches; many regard physician support as a TOV but have different interpretations of the specific reporting requirements, according to the study.

“There is a disparity in the interpretation of the transfer-of-value rules from these associations,” said Kim Pepitone, senior author of the study. “Pharmaceutical companies have strong ethical concerns about getting studies published with authors not receiving financial support. Instead the authors help the industry by interpreting and publishing their clinical research that meets ethical guidelines, [is] accurate and [provides] important help in interpreting results—all with nonmonetary support to physician authors.”

As for the “chilling effect” on the participation of investigators in industry research, the study forecasts that some investigators potentially may decide not to participate, in order to avoid the perception of payment for authorships.

“If authors decline the offer of publication support there may be a negative effect on manuscript development timelines, which may in turn affect industry’s ethical obligations to publish clinical trial results in a timely manner,” the report states. “Equally concerning may be the potential for the loss of crucial review and input provided through industry: healthcare provider (HCP) partnerships. Although many companies have qualified physicians who can author clinical publications, they are usually not practicing clinicians. Thus the clinical practice interpretation and real-world application of the data may be lost if practicing HCPs decline to participate.”

In putting some perspective on the lack of guidance, another author of the study noted that publications are not a unified monolithic category.

“Some papers are written directly by academic researchers, some by research scientists or clinicians within industry, some by medical writers within companies and still others by agencies,” said Lisa M. DeTora, assistant professor in the Department of Writing Studies at Hofstra University. “Other aspects of clinical research are more consistent and regulated, making it easier to quantify value.”

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 35, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »