On September 11, Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) at Yale Law School and the Yale School of Public Health ended a two-year Freedom of Information Act case, winning an important victory for clinical research transparency.
The case sought to obtain clinical trial data from the U.S. Food and Drug Administration (FDA) on two costly Hepatitis C drugs, Sovaldi and Harvoni, in order to enable the research community to independently assess their safety and efficacy. However, the drug company Gilead Sciences Inc., refused to adopt industry norms for data sharing and the effort was only partly successful. Through the litigation, TAG and GHJP received important documents shedding light on the drugs’ clinical trials previously unavailable to independent researchers. These documents include clinical study reports and detailed summaries of study results, as well as study protocols, case report forms on adverse events, and selected correspondence between Gilead and the FDA.
While the FDA released a large amount of information, it withheld and redacted individual patient-level data (IPD), specifically the raw analyzable datasets critical for reanalysis of drug safety and efficacy by the scientific community, according to the groups. TAG and GHJP engaged in subsequent talks with Gilead to press the company on data sharing for Sovaldi and Harvoni, as well as other drugs it produces, but the talks were unsuccessful.
“Gilead continues to refuse to systematically share the data most critical for scientists, showing its leadership has little regard for the public and no genuine commitment to transparency in clinical research. We are deeply disappointed at Gilead’s stonewalling,” said Ms. Amy Kapczynski, a law professor at Yale and the GHJP’s co-director. “Gilead has refused to open its data to systematic independent scrutiny, though many others companies in the industry have begun to do this. These other companies recognize that transparency serves company interests, as well as those of patients and the public health.”
Other major pharmaceutical companies such as Johnson & Johnson and GlaxoSmithKline currently make such data available through third-party platforms that protect patient privacy through data-use agreements. While data sharing by other companies is voluntary, the process is also becoming a regulatory standard elsewhere in the world, with Canadian and European regulatory agencies committing to ensuring IPD access in some form. Such data sharing has been endorsed by leading scientific groups and agencies including the National Academies of Sciences and Engineering and Medicine.
“Our aim, as advocates and researchers, was always two-fold: to show that the FDA should release much more data to researchers than it typically does, and to press Gilead to join its peers in voluntarily making their data available to outside review and analysis,” said Dr. Gregg Gonsalves, assistant professor at the Yale School of Public Health and co-director of the GHJP. “We succeeded in our first goal. But when the FDA expressed the view that it could not turn over certain data sets without compromising patient privacy and commercial interests, we proposed a compromise: that Gilead follow what others have done, and work with a third-party to create a secure platform to share data or set one up themselves. They flatly refused, and refused even to create a timeline. In the end, Gilead told us they are not yet committed to any sort of systematic data-sharing with the research community. They’ve claimed that can only handle ‘bespoke,’ that is, one-off requests at this time.”
While this case secured important information about two drugs important in the treatment of HCV, members of GHJP and TAG said they are disappointed that Gilead continues to eschew emerging best practices on data sharing, setting back open scientific inquiry on some of the more important therapeutic advances in recent years.
“Gilead gives no explanation for failing to join its peers in committing to ethical open-access data,” said Mr. Mark Harrington, TAG’s executive director. “They say they are just starting discussions internally and have no timeline for when they might publicly launch a comprehensive data-sharing policy. It’s disappointing that a major pharmaceutical company with $30 billion in revenue last year has yet to show the will or the resources to join its peers in what’s becoming an industry best practice. Data-sharing is not only critical for improving scientific knowledge about drugs and other medical products.”
“When researchers have the ability to review and re-analyze the data from clinical trials, patients can have greater certainty about the results of these studies. In addition, with independent scrutiny of IPD, new insights may be uncovered that can reshape patient care,” added Ms. Annette Gaudino, TAG’s HCV project co-director.
GHJP is a joint initiative between Yale Law School and Yale School of Public Health that trains the next generation of scholars and practitioners to tackle the complex interdisciplinary challenges of global health. The GHJP works with international partners at the interface of law and governance, public health and medicine to theorize, build analytical frameworks, create knowledge, and mobilize research to help drive the social change necessary for improving the health and wellness of people around the world.
TAG is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, or HCV receive lifesaving treatment, care, and information. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end HIV, TB, and HCV.