Doctor Behind Development of Sofosbuvir Comes Under Scrutiny

December 17, 2015
Bill Schu

Questions around the price of treatments for hepatitis C virus have been all over the news lately.

Questions around the price of treatments for hepatitis C virus (HCV) have been all over the news lately. A mini-tempest seems to be brewing, with a recent report from Senators Ron Wyden (D-OH) and Charles Grassley (R-IA) that Gilead Sciences charged more for its blockbuster hepatitis C virus (HCV) medications Sovaldi and Harvoni than required to recoup acquisition costs, clinical research, and marketing expenditures. This flammable mix seems like it’s about to get doused with gasoline.

CBS News and others have recently begun asking questions of Dr. Raymond Schinazi, a professor of Pediatrics at Emory University and a Senior Research Scientist at the Department of Veterans Affairs in Atlanta. Dr. Schinazi has worked for the VA for nearly three decades, but it is his “moonlighting” that has come under recent scrutiny. Known as a 7/8ths government employee (the term for a worker who devotes 7/8 of his time to the government and the other 1/8 to private pursuits), Schinazi has made the most of that remaining 1/8 of his time: he is the founder of several biotechnology companies focusing on antiviral drug discovery and development and a successful series of educational conferences around HIV. Several of the biotech companies Dr. Schinazi founded were later sold to larger pharmaceutical companies at a huge profit.

Among those companies was Pharmasset, Inc, which developed sofosbuvir before the company was sold to Gilead for $11.4 billion in 2012. Dr. Schinazi pocketed $400 million from that sale. The juxtaposition of a multimillionaire public servant working for an agency that in many cases cannot afford to cover the cost of the drug he helped develop has some crying foul and wondering if VA time, resources, and members were involved in the development of sofosbuvir and other medications. If so, the logic goes, is the development of sofosbuvir under the government’s domain?

In the interview with CBS News, Dr. Schinazi cited his efficiency and declared that he always fully disclosed any outside activities to the VA. For its part, the VA has issued only a brief statement affirming the legality of its employees investing in private companies. But that seems to sidestep the larger issue of whether time spent developing the cure was enhanced by the time and patient resources available through Dr. Schinazi’s VA connections.

Many questions remain to be answered. It’s clear, however, that there will continue to be a great deal of scrutiny around the cost of HCV treatments that amount to a cure but are still not accessible for many patients, including wounded veterans who contracted the condition during tours of duty.