by Leslie Citrome MD, MPH
Dr. Citrome is Clinical Professor of Psychiatry and Behavioral Sciences at New York Medical College in Valhalla, New York, and is the Editor-in-Chief for the International Journal of Clinical Practice, published by Wiley-Blackwell. He is also a member of the World Association of Medical Editors, the International Society for Medical Publication Professionals, and a participant in the Medical Publishing Insights and Practices initiative.
Innov Clin Neurosci. 2014;11(3–4):14–16
In this new series of articles, Dr. Citrome will provide commentaries regarding the communication of clinical trial results. Topics to be covered include the potential impact of the Sunshine Act, the importance of quantifying clinical relevance, the use and misuse of meta-analyses, searching the “grey literature” beyond PubMed, the evolution of open access publication, and the changing transparency of the manuscript review process.
Funding: No funding or external editorial assistance was provided for the production of this article.
Financial disclosures: In the past 36 months Dr. Citrome has engaged in collaborative research with, or received consulting or speaking fees, from: Alexza, Alkermes, AstraZeneca, Avanir, Bristol-Myers Squibb, Eli Lilly, Envivo, Forest, Genentech, Janssen, Lundbeck, Merck, Mylan, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, and Valeant.
Key words: Acknowledgments, authorship, disclosure, pharmaceutical and device manufacturers, Sunshine Act, transfers of value
Abstract: The United States Physician Payments Sunshine Act requires pharmaceutical and device manufacturers that participate in United States federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. One of these “transfers of value” is the cost of expediting the preparation and publication of industry-sponsored journal articles with the use of outside editorial assistance. This can be problematic for those United States-based physician-authors whose home institutions have implemented policies to distance their faculty from pharmaceutical and device manufacturers. Potential strategies include using in-house editorial assistance when available, but transfers of value remain subject to further interpretation, and company policies are not uniform industry-wide.
The United States Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices, and biologicals that participate in United States federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. Although many companies were already required to collect these data as part of Corporate Integrity Agreements, all manufacturers have now been tasked with the collection and tracking of payments and “transfers of value” as of August 1, 2013, and are required to submit the reports to the Centers for Medicare & Medicaid Services (CMS) on an annual basis. Of note, the majority of the information contained in the reports will be available on a public, searchable website.
Initial data must be reported to CMS by March 31, 2014, with a view toward public disclosure of this information several months later, beginning September 30, 2014, and likely in several stages with differing degrees of detail. Delays are inevitable given the massive amount of information that must be sorted out. Although CMS emphasizes that the inclusion of a payment, or other transfer of value, ownership, or investment interest, on the public database does not mean that any of the parties involved were engaged in any wrongdoing or illegal conduct, misinterpretation of the data, either inadvertent or intentional, is a concern.
Physicians are worried about repercussions from their institutions if they are subject to rules regarding interactions with pharmaceutical or device manufacturers, such as accepting meals as part of a United States Food and Drug Administration (FDA)-regulated promotional presentation, participating in advisory boards, or receiving fees for speaking. All transfers of value are reported, even if the individual has not directly received the money him- or herself— for example, travel expenses (together with the travel destination) even when personal remuneration in the form of a fee is not received, research funding that goes to the institution, and the cost of services of graphic artists and medical writers when employed to help support the publication of research reports and reviews in the medical literature. Payments of less than $10 (unless in aggregate these payments exceed $100 in a calendar year) need not be reported. At the present time, the receipt of reprints or books from pharmaceutical or device manufacturers are considered reportable transfers of value, but not educational materials that directly benefit patients or are intended for patient use. Currently, payments to physicians for serving as speakers or faculty for accredited continuing medical education (CME) programs are not considered reportable under the Sunshine Act.
CMS defines a “covered recipient” as a physician (doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors who are legally authorized to practice by the state in which they practice) with the exception of physicians who are employees of an applicable manufacturer. CMS also includes teaching hospitals under the category of a covered recipient. Oddly, payments or other transfers of value to medical residents (including residents in medicine, osteopathy, dentistry, podiatry, optometry, and chiropractic) do not have to be reported.
Pharmaceutical and device manufacturers ordinarily partner with outside consultants in the conduct and reporting of clinical trials and often in the authorship of review papers. Some companies have the infrastructure to author publications without using outside consultants, and although this is more commonly seen, it is still the exception rather than the rule. For outside authors, compensation may have already been contracted regarding the development and execution of a clinical trial, as well as the reimbursement of travel expenses when presenting results at national and international congresses. The Sunshine Act does not concern itself with any issues such as who is “first author,” “corresponding author,” or “senior/last author,” or any issues relating to “ghost” or “guest” authorship. The Act is focused on the reporting of fees received and transfers of value.
In an editorial by Shader and Greenblatt, the importance of transparency was emphasized. They describe that editorial assistance might refer to transcribing of oral presentations, language editing, crafting figures and tables, manuscript formatting, checking references, or helping with online submission. They recommend that those individuals providing those services be named under “Acknowledgments.” On the other hand, actual aggregation and presentation of scientific data and interpretation and explanation of what was observed in the context of the existing scientific database is substantive, and individuals providing those services are rightly coauthors and should be included as such. Both types of “editorial assistance,” when provided by outside consultants compensated for their time, is a “transfer of value” to other non-industry authors who may not have received any direct monetary support. Herein lays the problem.
Non-industry physicians based in the United States may be more reluctant to be authors of industry-sponsored research reports and reviews if the transfers of value attributed to them are perceived negatively by their home institutions. Nor can some step up to the plate and write up the manuscript by themselves in a timely and efficient way. As noted by Shader and Greenblatt, “leaders of research teams may be outstanding clinicians and scientists, but they do not necessarily possess needed language or writing skills or have expertise in specific areas, such as analytical chemistry, molecular genetics, or biostatistics.” The reporting of transfers of value does not apply to physicians based outside the United States, physicians employed by pharmaceutical or device manufacturers, or to non-physicians. The reporting of these transfers of value will have little impact on those physicians who already are consulting and speaking for pharmaceutical and device manufacturers—the amount allocated to the production of a journal article will likely be a small fraction of the other income earned and disclosed. In any event, university and other institutional policies will need to be aware of, and recognize, the specific nature of these transfers of values and place them into perspective.
Attitudes vary among journals regarding papers authored exclusively by industry authors; however, an unintended consequence of the Sunshine Act may be an increase in the number of such papers.
From an editor’s perspective the disclosure of the use of outside editorial assistance has now been standard practice for many journals for some time now. The transfer of value issue does not change anything except perhaps for journals that have not required disclosure of editorial assistance or where this information was intentionally not provided by the authors (now they will be easily “outed”). It is unlikely that the dollar amount of any transfer of value would be included in any disclosure statement as monetary costs of doing studies are not ordinarily disclosed.
Pharmaceutical and device manufacturers
Several solutions that avoid the reporting of transfers of value for editorial assistance are available. As mentioned, the exclusion of United States-based physicians from authorship is one way. Another is the use of in-house editorial assistance from within the sponsor’s company, which may be unrealistic for many small or understaffed companies. More than likely, companies will gravitate toward those consultants who are able to navigate the transfer of value issue with their home institutions.
What gets counted as a transfer of value and when it gets reported appears to be up for debate among the different companies. Some plan on reporting nothing since CMS has not provided specific guidance on what to report while others plan to report anything attached to an external invoice. How these sums get allocated (or not) among the authors is completely unclear.
The United States Physician Payments Sunshine Act was intended to provide the public with the means of determining if their individual physician has a financial relationship with the companies that manufacture or supply the medicines or medical devices they may need. This goes beyond the receipt of meals at conferences, fees for speaking, or fees for consulting. It also includes the cost of reprints, books, or other educational materials not intended for direct use by patients.
The cost of expediting the preparation and publication of industry-sponsored journal articles with the use of outside editorial assistance can also be interpreted as a transfer of value to the non-industry United States-based physician who has participated as an author. This may come as a surprise for some and may lead to greater reluctance to be involved as authors or co-authors by physicians whose home institutions have implemented policies to distance their faculty from pharmaceutical and device manufacturers. Potential strategies include using in-house editorial assistance when available, but transfers of value remain subject to further interpretation, and company policies are not uniform industry-wide.
1. Department of Health and Human Services, Centers for Medicare & Medicaid Services. 42 CFR Parts 402 and 403 [CMSY5060YF] RIN 0938-AR33. Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests. Agency: Centers for Medicare & Medicaid Services (CMS), HHS. Action: Final rule. Rules and Regulations. Federal Register 2013;78(27):9458-9528. http://www.gpo.gov/fdsys/pkg/FR-2013-02-08/pdf/2013-02572.pdf. Accessed March 4, 2014.
2. American Psychiatric Association. Manufacturer reporting requirements under the Affordable Care Act. Commentary. February 5, 2013. http://psychiatry.org/File%20Library/Advocacy%20and%20Newsroom/APA%20on%20the%20Issues/Regulatory/2-5-13-APA-Analysis-on-Final-Physician-Payment-Act-Rule-2.pdf. Accessed March 4, 2014.
3. Shader RI, Greenblatt DJ. The sunshine act. J Clin Psychopharmacol. 2014;34(1):1–2.
4. Pepitone K, Citrome L, Crane E, et al. Panel presentation: the Sunshine Act: interpretations and execution. The 13th Annual International Publication Planning Association Meeting, San Diego, California, February 10–11, 2014.