Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments.
Researchers and patient advocates have long fought with drug makers and regulators over access to such information, the Wall Street Journal reports.
Late last year, Treatment Action Group and the Global Health Justice Partnership asked Gilead for patient-level trial data for Sovaldi (sofosbuvir) and Harvoni (ledipasvir), the WSJ reports. These widely prescribed drugs have high cure rates, and the FDA approved them as part of a regulatory process known as a breakthrough designation, which speeded the review. The health groups are concerned that the accelerated process “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” according to the lawsuit. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”
The groups hope the trial data will yield information about the different responses experienced by different patients during clinical trials, according to the WSJ. Tracy Swan of Treatment Action Group noted relapses in a Harvoni clinical trial that occurred only among African-American patients. The groups want to perform an independent analysis of poor prognosis factors among people who were not cured. The groups claim in the lawsuit that doctors “lack the benefit of any independent assessment of the data.” Given the high cost of the drugs, the groups argue in their lawsuit that it is “crucial that policymakers be able to evaluate the cost-effectiveness… based on the underlying clinical data.” Sovaldi and Harvoni cost $84,000 and $94,500, respectively, for 12-week regimens, before any discounts.
Gilead never replied to the requests for trial data, and in December 2014 the groups submitted a Freedom of Information request to the FDA because Gilead had submitted the data to the FDA as part of the approval process. The FDA denied “expedited processing” of the FOIA request and said it would take from 18 to 24 months for them to turn over the data, the WSJ reports. Amy Kapczynski, a Yale Law School professor who heads GHJP, said the delay “will leave doctors and patients in the dark for too long.” Doctors are writing thousands of prescriptions for these drugs and the expense can put a strain on state health programs, according to Kapczynski.
Researchers and consumer groups are pressing drug makers to release trial data for all new drugs. At issue is the ability of researchers to independently verify study results and, consequently, improve patient treatments, leading to better health and lower costs, according to the WSJ. But drug makers argue that releasing some trial data would compromise trade secrets and patient confidentiality.
Gregg Gonsalves of the GHJP said the groups “have a right to see what’s there.” A drug studied for “a certain set of patients” is later prescribed for a “wider set of patients,” and trial data may contain information that will affect doctors’ treatment decisions.