Two Yale University Health Info Groups Sue FDA, Gilead for Hep C Drug Trial Data

Two Yale Health Info Groups Sue FDA, Gilead for Hep C Drug Trial Data
June 30, 2015
By Mark Terry and Riley McDermid, Breaking News Staff

Two public health organizations, the Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) affiliated with Yale University, have filed a federal lawsuit to obtain information that Gilead Sciences, Inc. provided the U.S. Food and Drug Administration (FDA) concerning its hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosvubir/ledipasvir). TAG and GHJP could not be reached for a statement in time for deadline.

The lawsuit points out that, “Despite the high cost of the drugs and their approval for widespread use, the underlying clinical trial data has not been made available to the public or even to the scientific community.”

The pricing for Sovaldi is about $84,000 for course of treatment and about $94,500 for Harvoni, or about $1,000 per pill. Gilead has been involved in a price and distribution war for the last seven or eight months with competitor AbbVie , which markets a similarly priced product called Viekira Pak.

The lawsuit argues that public access to the raw clinical data is important so that “doctors and patients can make informed treatment decisions and cost-benefit determinations.”

Although the drugs were tested on a specific population, they are administered to a wider population, so the groups argue that gaps in drug efficacy, side effects or drug interactions may not be identified and that “Independent analysis of patient-level clinical trial data is essential to bring to light unresolved safety and efficacy issues.”

The organizations requested the data from Gilead in November 2014, but the company did not reply. So the groups submitted a Freedom of Information request to the FDA. The FDA apparently denied the request for “expedited processing,” indicating it would take 18 to 24 months to release the data. The lawsuit is designed to hurry the process along.

This appears to be a trend with various organizations requesting access to drug companies’ raw clinical data. Not surprisingly, many companies argue that this will compromise proprietary processes and information. The advocates argue, however, that since the public is being treated by the drugs and that insurers and government agencies are paying for the drugs, full access to the data should be granted.

Institute of Medicine (IOM) published a set of guidelines and recommendations in January 2015 for the release of clinical trial data.

The IOM’s gave four recommendations. They are:

1. Stakeholders in clinical trials need a culture of data sharing.

2. Sponsors and investigators should share the clinical trial data no later than specific times in the report, for example, no later than 18 months after study completion.

3. Clinical trial data holders should implement “operational strategies that include employing data use agreements, designating an independent review panel and making access to clinical trial data transparent.”

4. Study sponsors should take the lead with impartial organizations to hold multi stakeholder meetings to address any issues associated with sharing trial data.

Several drug companies have either set up their own way of releasing data or are working with the Yale Open Data Access program. Johnson & Johnson is working with Yale. GlaxoSmithKline has developed the website where 10 different pharma companies take trial data requests. Participating companies include Astellas Pharma Inc. , Bayer , Boehringer Ingelheim, Eisai Company, Ltd., Eli Lilly and Company , Novartis AG , Roche , Sanofi , Takeda Pharmaceuticals , UCB and ViiV Healthcare. Pfizer Inc. and AstraZeneca PLC have developed their own approach.

“To an extent, this is part of the larger quest to obtain data and open up trials,” said Gregg Gonsalves of the GHJP to The Wall Street Journal. “There is no smoking gun. We’re not asking just because we think there’s some horrible side effect lurking in the data. But the drug was studied for a certain set of patients and is being used for a wider set of patients. Maybe there’s nothing new, but I think we have a right to see what’s there.”

Gilead Sciences, Inc. (GILD) may also be feeling pressured by a new experimental hepatitis C drug being developed by Achillion Pharmaceuticals, Inc. , which has shown promising Phase II results when combined with Gilead’s own blockbuster near-cure Sovaldi. The shortened treatment duration could take a bite out of Gilead’s sales, warned market watchers this week, as the drug, ACH-3102, continues to meet important milestones.

With a standard 12-week course of Sovaldi costing $84,000, a drug that can cut that timeline in half would be a significant threat to Gilead’s bottom line.

Achillion attracted a lot of notice last fall when it said a combo of ACH-3102 and Sovaldi had functionally cured 100 percent of the patients involved in a small, 8-week trial. Then in February, it released results that showed that the combo was able to replicate that 100 percent cure rate after only six weeks of treatment—a truncated timeline that could eventually cost Gilead millions of dollars in lost revenue.

“The success of ACH-3102 suggests that it could be a better drug than ledipasvir, and that opens up the potential for ACH-3102 to be paired up with other Sovaldi alternatives,” wrote Todd Campbell, a columnist at the Motley Fool. “Achillion Pharmaceuticals hopes that its own in-house option, ACH-3422, can prove to be just as potent as Sovaldi, and if it is, that it can achieve similar short-duration cure rates when paired up with ACH-3102.”

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