Controversy over the price of Gilead's hepatitis C (HCV) drug Sovaldi (sofosbuvir) continues. On Aug. 13, ACT UP New York (ACT UP NY) sent a letter to the U.S. Senate Finance Committee Chairman Ron Wyden (D-OR), demanding a 90% reduction in the price of Sovaldi and outlining two ways in which the government could "break Gilead's monopoly" on the potent treatment.
The letter follows the Finance Committee's own letter to Gilead CEO John C. Martin questioning the ethics of the pricing and informing Martin of an investigation into the matter. ACT UP NY applauded the committee for launching the Senate investigation, and also commended House member Henry Waxman (D-CA) for initiating a similar probe.
ACT UP, founded in 1987 when the death toll from AIDS was devastating in the U.S., has brought new meaning to the word "activism" throughout its history, staging protests such as shutting down the New York Stock Exchange and placing an inflatable condom on conservative Senator Jesse Helms' house.
The high rate of HIV and HCV coinfection raises ACT UP NY's interest in fighting the cost of Sovaldi, which it believes will benefit all people living with HCV, estimated at three to four million in the U.S.
According to ACT UP NY member Luis Santiago, "The fact that Gilead Sciences Inc. now controls the main drugs for treating both HIV and HCV, made it clear to us that it was within our goals to address the issue of Sovaldi's price and any additional barrier for people with or without HIV to access this breakthrough treatment."
ACT UP NY activist Timothy Lunceford says that ACT UP NY will be reaching out to American Liver Foundation and the American Association for the Study of Liver Diseases to work together on advocacy efforts.
The Ethics of Pricing
The ACT UP NY letter cites a study presented at the recent International AIDS Conference in Melbourne, Australia, which found that "the predicted minimum production cost is estimated at approximately $102" for a 12-week course of Sovaldi, which currently costs $84,000. For some -- especially those coinfected with HIV -- 24 weeks of treatment is necessary, doubling a price that is already, the group asserts, "simply unacceptable."
As the first HCV cure that doesn't require interferon, sofosbuvir was granted "breakthrough therapy" status by the U.S. Food and Drug Administration and approved on an expedited basis. Thousands die from HCV every year, and many advocates and clinicians believe that if Sovaldi were priced low enough to be taken by more people, it could be the best chance for ending the epidemic. The letter notes, "In order to end the hepatitis C epidemic as soon as possible, we need a significant drop in the price of Sovaldi, to make it available to all Americans who need it. What good is a cure that costs $102 to produce if it takes decades to implement nationwide due to high prices?"
Two Paths to Access
Laid out clearly in ACT UP NY's letter are two ways the federal government could step in and help: a patent buyout and a patent waiver.
With a patent buyout, the government would negotiate from the standpoint that the patent for sofosbuvir would be "more valuable to society if the product were available at a reasonable price." All stakeholders, including Gilead, would negotiate a reasonable price for the buyout.
If a patent buyout turned out to be impossible to negotiate, the government could then waive the patent and have the drug made and sold at a lower price. The letter cites a precedent for such a patent waiver: in 2001, when anthrax attacks brought about a threat to seek a waiver of the patent for the antibiotic Cipro (ciprofloxacin). In that case, Bayer, Cipro's manufacturer, agreed to lower the price and a waiver wasn't pursued.
Sue Saltmarsh has worked in the HIV/AIDS field for over 20 years, the first 10 as an herbalist and energy therapist at Project Vida, the last six as a writer and copy editor for Positively Aware magazine. She is now a freelance writer and editor and is also able to devote more time to her passion as founder and director of the Drive for Universal Healthcare (DUH).