September 29, 2014
Johns Hopkins Experts Critique Open Payments Database
September 29, 2014—The Berman Institute of Bioethics at Johns Hopkins University (JHU) in Baltimore, Maryland, announced the publication of an opinion article in Annals of Internal Medicine published to coincide with the launch of the Open Payments database by the Centers for Medicare & Medicaid Services (CMS). This federal, public database, created with the intention of bringing transparency to financial relationships between physicians and industry, may instead result in opacity and misinterpretation, according to the authors, who are experts in bioethics, clinical care, and public health at JHU.
The article, “Forecast for the Physician Payment Sunshine Act: Partly to Mostly Cloudy?” will be available online in Annals of Internal Medicine and was written by Charles Flexner, MD; Jeremy Sugarman, MD; Nancy E. Kass, ScD; and Stephanie R. Morain, MPH, PhD. The article will be available online on September 30, as will the Open Payments database.
According to the JHU press release, the article takes issue with the requirement of having the monetary value of drugs that are donated to clinical trials being counted in the database as “research payments” to physicians conducting those trials. The authors argue that this will likely greatly inflate the total dollar amount of research payments and dwarf actual cash payments to physicians. They then offer suggestions of how to reduce the potential for misinterpretation of drug donations.
Dr. Flexner is from the Division of Clinical Pharmacology at the Bloomberg School of Public Health at Johns Hopkins. Dr. Sugarman, Dr. Kass, and Dr. Morain are from the Berman Institute of Bioethics at Johns Hopkins. Dr. Morain, a Hecht-Levi Fellow at the Berman Institute, is the lead author of the commentary.
As noted in the JHU press release, 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.
In the Annals of Internal Medicine, the article states, “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 JHU announcement advised that the article provides 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 (Gilead Sciences, Inc.), a once-daily agent for hepatitis C virus infection whose retail value is approximately $1,000 per dose, with a 12-week course of curative treatment, or 84 doses. 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, 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 that provides additional context when disclosing drug donations—currently such context is allowed, but is not a requirement.
Dr. Morain commented in the JHU press release, “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. The effects of implementation should be monitored, and CMS should consider appropriate revisions to truly let the sun shine on important issues.”