Two public health groups have taken legal action to obtain access to clinical trial information about two new and expensive hepatitis C drugs, Sovaldi and Harvoni, manufactured by Gilead Sciences. A lawsuit was filed by Treatment Action Group (TAG), an AIDS research and policy think tank and member of AllTrials, and the Global Health Justice Partnership (GHJP), a health policy advocacy group at Yale University. Early research showed that the drugs could treat nearly all cases of hepatitis C which after a 12-week treatment had far fewer side effects than existing treatments. Because of these promising results, the FDA agreed to fast-track both of the drugs to market. Sovaldi was approved in December 2013 and Harvoni in October 2014. Since then, more than 210,000 people have been treated with these drugs, including patients belonging to sub-populations that were little studied in clinical trials.

In November 2014, TAG and GHJP asked Gilead Sciences to release the data on Sovaldi and Harvoni that was submitted to FDA. They received no response. As a result, in December 2014, TAG and GHJP filed a Freedom of Information (FOIA) request, seeking access to this information from the FDA.

The FDA told the groups that they should not expect to receive a response for 18 to 24 months and have made no guarantee that the data will be released. In response, TAG and GHJP filed suit on 25th June 2015 to enforce their FOIA request and seek prompt disclosure of the clinical trial data.

Researchers at Yale have agreed to help make any data the groups receive available through the YODA Project.

Hepatitis C affects at least 3 million people in the United States and is particularly common among people with HIV.

Amy Kapczynski, a Yale Law School professor and director of GHJP:

“This delay will leave doctors and patients in the dark for too long. Doctors write thousands of prescriptions for these drugs every week, straining budgets of state healthcare programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending. When the FDA informed us that they would not get to our request for two years, we had no choice but to file a lawsuit to enforce the public’s right of access to this information.”

Karyn Kaplan, TAG’s International Hepatitis/HIV Policy and Advocacy Director:

“This lawsuit is about access and answers. The astronomical price of these drugs requires Medicaid programs and other providers to make hard choices about how to allocate their resources. They are making these decisions now. Crucial policy determinations about who has access to treatment are being made on incomplete information.”

Gregg Gonsalves, co-director of GHJP:

“If this drug is as promising as it appears to be, what does the FDA have to hide? Independent scrutiny will ensure that any unresolved safety and efficacy concerns are brought to light as quickly as possible.”

Dr Doug Bruce, Chief of Medicine at Cornell-Scott Hill Medical Center and Associate Clinical Professor at the Yale School of Medicine:

“It’s good to get drugs on the market quickly for people who need them, but when the approval process is so accelerated, it is especially important that the public has access to raw data to allow independent oversight of the FDA’s safety and efficacy determinations. Raw clinical data allows clinical providers the opportunity to make the best decisions for their patients.”

“The FDA and the companies who conduct the studies make choices throughout the approval process about the design of clinical trials, how to interpret the raw data, and when to extrapolate conclusions about one group of people with specific characteristics based on studies of another, different population. These choices impact the FDA’s decisions about whether to approve drugs, and its recommendations about how they should be used. In order to evaluate the strength of the FDA’s recommendation and decide how to use drugs with real-life populations, it is essential to have independent analysis of the raw clinical trial data.”

Read the press release from TAG and GHJP.