In an opinion published in Annals of Internal Medicine to coincide with the launch of the Open Payments database by the Centers for Medicare & Medicaid Services (CMS), the authors take issue with the monetary value of drugs donated to clinical trials being counted in the database as “research payments” to physicians running those trials. They argue this will likely greatly inflate the total dollar amount of research payments, and dwarf actual cash payments to physicians. Authors Stephanie R. Morain, Charles Flexner, Nancy E. Kass, and Jeremy Sugarman then offer suggestions of how to reduce the potential for misinterpretation of drug donations.
The Open Payments database is an implementation of the Physician Payment Sunshine Act (PPSA), passed as part of the Affordable Care Act healthcare overhaul in 2010, which requires manufacturers of drugs, devices, biologics, and medical supplies to track and report “all transfers of value” to physicians or teaching hospitals.
“Attributing such large payments to individual physician-investigators seems inconsistent with the PPSA’s intent. Donated drugs are intended for use by patients and do not provide direct monetary value to physician-investigators. The PPSA rules cloud this critical distinction,” the commentary states.
The authors provide a real, illustrative example of how the costs of drugs for some clinical trials add up quickly and distort financial relationships: “The NIH recently initiated a trial of sofosbuvir, a once-daily agent for hepatitis C virus infection whose retail value is approximately $1000 per dose, with a 12-week course of curative treatment, or 84 doses (6). An investigator enrolling just 10 patients would be reported as receiving $840,000 from Gilead Sciences, sofosbuvir’s manufacturer.”
According to the commentary, the potential for such misleading information could deter some physicians from participating in research, to avoid the appearance of unethical financial relationships with study funders.
“One may presume that the public may have difficulty distinguishing between donated drugs for research and transfers of financial value to physicians. Such confusion frustrates the purpose of the PPSA, casting shadows where bright light had been promised,” the commentary states.
Acknowledging that new legislation amending the PPSA is unlikely, the authors offer other potential solutions for avoiding misinterpretation of drug donations:
1. Drug donations could be attributed to research sites (such as medical centers) rather than to individual physician-investigators.
2. CMS could add a category for reporting research payments, to distinguish donations for which the physician receives no direct financial benefit.
3. Manufacturers could be required to include a brief descriptive statement when disclosing drug donations that provides additional context (currently such context is allowed but not a requirement).
“Financial conflicts of interest present clear risks for research integrity, and transparency can play an important role in mitigating these risks. However, care must be taken to ensure that regulations don’t discourage participation in socially valuable research,” says Stephanie R. Morain, a Hecht-Levi Fellow at the Johns Hopkins Berman Institute of Bioethics and lead author of the commentary. "The effects of implementation should be monitored, and CMS should consider appropriate revisions to truly let the sun shine on important issues."
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Links and more info:
Commentary (online September 30, 2014): “Forecast for the Physician Payment Sunshine Act: Partly to Mostly Cloudy?” Annals of Internal Medicine http://www.annals.org/article.aspx?doi=10.7326/M14-1683.For pre-publication copies, journalists may contact Angela Collom, 215-351-2653, [email protected]
Open Payments (database online September 30, 2014): http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html
Stephanie R. Morain: http://www.bioethicsinstitute.org/people/fellows/stephanie-morain
Nancy E. Kass: http://www.bioethicsinstitute.org/people/nancy-kass-4
Jeremy Sugarman: http://www.bioethicsinstitute.org/people/jeremy-sugarman-4
Charles Flexner: http://www.jhuclinicalpharmacology.org/faculty/flexner.asp
About the Johns Hopkins Berman Institute of BioethicsOne of the largest bioethics centers in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental and private sector organizations to address and resolve ethical issues. Institute faculty members represent diverse disciplines including medicine, nursing, law, philosophy, public health and the social sciences. More information is available at www.bioethicsinstitute.org.
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