Seeking to force faster disclosure of clinical trial data that helped Gilead Sciences win approval for two blockbuster hepatitis C drugs, two public health advocacy organizations filed a lawsuit against the FDA last month—the latest legal action where researchers and patient advocates have scuffled with drug makers and regulators over access to such information.
The organizations in the lawsuit—Yale University’s Global Health Justice Partnership and the Treatment Action Group, a nonprofit institute for HIV and AIDS—maintain doctors and patients deserve more information about the “enormously costly” drugs Harvoni and Sovaldi to make informed decisions about whether to use them. Both medicines are expensive—a full 12-week regimen of Sovaldi costs $84,000 and Harvoni costs $94,500—before insurance discounts.
Each oral medication is widely prescribed as they reportedly have very high cure rates. The treatments received accelerated FDA review as they were considered Breakthrough designations.
However, unlike similar lawsuits, the two health advocacy groups maintain this accelerated regulatory 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.”
Moreover, both advocacy groups claim that doctors lack the benefit of an independent assessment of the clinical research data. They also insist the paucity of openness to the clinical trial data and the medications’ high costs make it crucial to be able to evaluate their cost-effectiveness based on the underlying clinical data.
“Their lawsuit doesn’t look solely at the high cost of the drug,” said Zach Hallinan, director of patient communication and engagement programs at the Center for information & Study on Clinical Research Participation (CISCRP). “They want independent groups to be able to analyze the data and review initial approvals, which makes it a case that is also about data transparency. It is no longer acceptable in the eyes of patients and the public to keep the results of clinical trials secret, and organizations that resist the movement toward greater transparency and patient centricity will almost certainly continue to face lawsuits from patient groups.”
The plaintiffs said Gilead ignored their request for the trial data last November, prompting them to contact the FDA by submitting a Freedom of Information Act request for the data in December. However, the regulatory agency said it would require 18 to 24 months to decide merely whether the disclosure was proper to begin with. That was simply too slow for both groups. In January 2015, the plaintiffs filed an administrative appeal with the Office of the Assistant Secretary for Public Affairs and the FDA responded by providing approval data, but not the requested patient-level safety and efficacy data.
Some pharmaceutical firms, which have been under pressure from consumer and academic groups to release clinical trial data, maintain that certain disclosures would compromise patient confidentiality and company trade secrets.
Other major drug companies have taken steps to release trial data—a move that comes as regulators in the U.S. and Europe have begun issuing new guidelines designed to widen access and transparency to clinical trial data. Among the biopharmaceutical companies providing clinical trial data to the professional community is Johnson & Johnson, through a Yale Open Data Access program. GlaxoSmithKline recently created a website where requests for data are made to 10 different companies. AstraZeneca and Pfizer are providing clinical trial results to professional and patient communities. Shire, Roche, Sanofi and Amgen are among sponsor companies that now are providing clinical trial results to their study volunteers.
“The delay [in disclosing the data on Sovaldi and Harvoni] will leave doctors and patients in the dark for too long,” Amy Kapczynski, a Yale Law School professor who heads the Yale University Global Health Justice Partnership, said in a statement, citing how the hefty volume of prescriptions strains budgets of state healthcare programs. “Prompt disclosure of this information, which the FDA already collects, will allow doctors and policy makers to make more informed treatment choices with real and immediate consequences for public health and spending.”
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