August 3, 2016

Question of the Week: Should the VA Circumvent the Patent System to Cut the Cost of Hep C Treatments?

By the C|C Whistleblower Lawyer Team

Hepatitis C afflicts about 130 million people worldwide, including over 3 million Americans.  A debilitating disease, it can lead to cirrhosis, liver cancer, and a host of autoimmune disorders.  The current U.S. opioid epidemic has caused a spike in Hep C diagnoses, as injectable drug use continues to be one of the more common mechanisms by which the disease is spread.  Veterans, who often suffer from drug addiction and insecure living situations, are one of the populations most at risk for Hep C.

No Hep C vaccine exists, but there are effective drugs to fight it.  The best option currently is sofosbuvir, marketed by Gilead Sciences as Sovaldi or Harvoni.  Raymond Schinazi originally developed Sovaldi with the help of a multi-million dollar grant from the Veteran’s Administration.  At the time, Dr. Schinazi was 7/8 employed by the VA, but he claimed he developed the drug during his 1/8 non-VA time.  Dr. Schinazi sold the patent along with his company Pharmasset to Gilead Sciences in 2011 for $11 billion. 

Gilead set the price tag for the drug at $1,000, meaning a full course of treatment can run to more than $80,000 in the U.S.  Given that Hep C disproportionately affects poor people and other at-risk populations, this price tag has led to accusations of price gauging.  The VA alone spends approximately $5 billion a year on Sovaldi and related medicines.  A few months ago, Congress had to provide an emergency funding increase because the VA simply could not afford the price and was being forced to decide the life-or-death question of who would get the drug and who would not.  The irony that a drug developed with the help of VA-funding by a doctor (mostly) employed by the VA then became too expensive for veterans is not lost on the government.  Congress is investigating how this was allowed to happen, following calls from former presidential candidate Bernie Sanders among others.  And, adding insult to injury, Gilead Sciences also reports most of its profits abroad, using its Irish subsidiary as a tax haven.

Last month, Senator Sanders called this one-two punch a “major health hazard.”  Gilead has responded to criticisms by bringing a newer, cheaper drug treatment to market.  Priced at $74,760 for a treatment, it is significantly less expensive for certain Hep C sufferers and at least a tiny discount for others.  Critics argue that this is simply a “price tweak” and continue to call for reforms to how medical patents are assigned.  Some prominent health policy advocates even argue that this situation calls for a kind of “eminent domain” for the Gilead patent, whereby a “government patent use” law would be used to reduce the price.

What do you think? Should the VA circumvent the patent system to cut the cost of Hep C treatments? Vote below.

Should the VA Circumvent the Patent System to Cut the Cost of Hep C Treatments?

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