Clinical Trial Results Disclosure by Large Biopharmaceutical Companies Falls Below Legal and Ethical Standards, Study Published in BMJ Open Shows

NEW YORK, Nov. 12, 2015 /PRNewswire/ -- Bioethics International, a not-for-profit organization focused on the ethics and governance of how medicines are researched, developed, marketed and made accessible to patients around the world, today announced the publication of a study ranking large pharmaceutical companies by transparency of clinical trial results in BMJ Open. In the study, only two-thirds of clinical trials per drug that supported new drug approvals in 2012 were disclosed, falling below legal and ethical standards. In addition, almost half of all reviewed drugs had at least one undisclosed Phase 2 or 3 trial.

The rankings are the result of a study to evaluate clinical trial registration, reporting and publication rates for 15 new drugs approved by the FDA in 2012 by both legal requirements, as established by the 2007 U.S. Food and Drug Administration Amendments Act (FDAAA), and the ethical standard that all human subjects research should be publicly accessible to contribute to generalizable knowledge. Wide variation in practices among drugs and their sponsors was observed.

Three of ten companies—GlaxoSmithKline, Johnson & Johnson, and Pfizer—publicly disclosed all clinical trial results for at least one of their reviewed drugs, whereas the lowest scoring company, Gilead, disclosed 21 percent of the trial results for its HIV medicine Stribild. Sanofi's multiple sclerosis drug Aubagio also ranked low for publicly available information.

Incomplete disclosure of clinical trial results impacts the ability of healthcare decision-makers, including physicians, prescription guideline writers, payers and formulary committees, to effectively evaluate the appropriate use of a drug.

In conjunction with the publication of this pilot study, Bioethics International launched its Good Pharma Scorecard (GPS), a system designed to independently rank biopharmaceutical companies and new drugs based on key ethics, human rights, and public health criteria, beginning with R&D and clinical trial transparency. This novel framework has been developed over the last six years in collaboration with multiple stakeholders, and Bioethics International is now expanding the rankings to include drugs approved in other years as well as additional trial sponsors. The organization plans to release these rankings annually with goal of improving biopharmaceutical company compliance with legal and ethical standards and the quality of medical knowledge.

"A critical issue facing the biopharmaceutical industry today is the loss of public trust," said Jennifer E. Miller, Ph.D., president of Bioethics International, assistant professor of medical ethics in the Department of Population Health at NYU Langone Medical Center and lead author on the paper. "Only 17 years ago, the pharmaceutical industry was among the most admired business sector in the world, and today only 12 percent of Americans believe that pharmaceutical companies are honest and ethical. The Good Pharma Scorecard enables the biopharmaceutical industry to evaluate its performance across key areas of ethical and legal concern and offers companies the ability to publicly demonstrate meaningful improvement in trustworthiness over time."

Arthur Caplan, Ph.D., professor and the founding director of the Division of Medical Ethics in the Population Health at NYU Langone Medical Center, said, "Transparency is a critical component of the ethical practice of medical research, and this ranking system has the potential to become a useful vehicle for change by outlining best practices and identifying areas that need improvement."

Joseph S. Ross, M.D., M.H.S., associate professor of medicine and public health at Yale School of Medicine, and author on the paper said, "Medical decisions are made every day by physicians and formulary committees and should be made based on all available trial information, not only the data that has been selected for public dissemination."

David Korn, M.D., professor of pathology, Harvard Medical School, and author on the paper, said, "As part of our validation strategy for the results of the study, we shared our final datasets for each drug with its sponsor to verify accuracy. Notably, all companies responded to our requests for input. Many companies scoring lower on our ranking scale were interested in ascertaining where and how they were not transparent with the intention of improving, and those who scored highly offered recommendations for maintaining best practices."

Joanne Waldstreicher, M.D., Chief Medical Officer of Johnson & Johnson, said, "At Johnson & Johnson, we believe that sharing clinical trial data advances the science that is the foundation of medical care. Clinical trial data transparency is in the best interest of the patients who use our products and the providers who prescribe them."

About Bioethics International

Bioethics International's (BEI) mission is to empower professionals and organizations in healthcare, life science and biotechnology to make responsible decisions – on issues that impact patients the most. Currently, we focus on the ethics and governance of how medicines are researched, developed, marketed and made accessible to patients around the world. For more information, please visit www.bioethicsinternational.org.

Funding Disclosures

The conceptualization and pilot of this study and index (now called the Good Pharma Scorecard) were supported by Harvard University's Edmond J. Safra Center for Ethics; Duke University's Kenan Institute for Ethics, Trinity College of Arts and Sciences and Fuqua School of Business; Fordham University's Global Healthcare Innovation Management Center; Susan G. Komen Foundation; Raskob Foundation; and Bioethics International. Dr. Ross is supported by the National Institute on Aging (K08 AG032886) and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program and receives research support through Yale University from Medtronic, Inc. and Johnson & Johnson to develop methods of clinical trial data sharing, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, and from the Food and Drug Administration (FDA) to develop methods for post-market surveillance of medical devices. Miller and Korn receive no financial support from pharmaceutical companies.  Miller is the founder and president of Bioethics International (BEI).  BEI and the Laura and John Arnold Foundation will financially support further development and implementation of the ranking system described in this paper. This paper remains an independent work product and the views expressed do not necessarily represent those of the funder(s).

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