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Health Groups Sue for Clinical Trial Data on Sovaldi/Harvoni


July 9, 2015 — The FDA has been hit with a federal lawsuit (PDF) in Connecticut filed by two public health groups who are seeking access to raw clinical trial data Gilead Sciences used to gain approval for its hepatitis C drugs Harvoni and Sovaldi.

Treatment Action Group (TAG) and the Yale-backed Global Health Justice Partnership (GHJP) want the data so doctors and patients can make informed decisions about treatment and cost-benefit, according to the Information Society Project.

According to Yale Law School professor Amy Kapszynski and director of GHJP:

“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.”

The groups asked Gilead for the data last November, but were ignored. In December, they filed a Freedom of Information Act (FOIA) request with the FDA, but were told it could take two years or more to get a response, and there was no guarantee that the data would be released.

Sovaldi and Harvoni have far fewer side effects than other hepatitis C drugs, but the groups also want an independent analysis of the clinical trial data to ensure any unresolved safety or efficacy concerns are brought to light as soon as possible.

Over 200,000 people have already been prescribed the drugs, which cost an average of $90,000 and cure over 90% of patients in just three months. Because they are so expensive, almost none of the estimated 3 million Americans with hepatitis C can afford treatment on their own.

The problem is that private health insurers and most state Medicaid programs have imposed non-evidence based restrictions on access to Sovaldi and Harvoni, limiting treatment to all but the sickest patients. Everyone else has been told they must continue to suffer through years of declining health before they are eligible for treatment. The longer patients go without a cure, the higher the risk of transmitting hepatitis C to other people.


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