In 2013, Gilead Sciences Inc. filed an application with the FDA for a new drug that they claimed could cure hepatitis C. The drug was nothing short of a miracle.
The new wonder drug was named Sovaldi. Where previous hep C treatments had a minimal success rate and involved 6-12 months of grueling treatment that involved a slew of harsh side effects, Sovaldi cured people at a 94%+ rate in one 12-week treatment. It was so good, that Gilead received the FDA’s Breakthrough Therapy Designation, which is given to drugs that show a tremendous advance over existing options and treatments.
After an astonishingly fast review process and approval by the FDA, Gilead filed a patent for Harvoni which is Sovaldi combined with an NS5A inhibitor. Demand for Harvoni skyrocketed globally because currently there are approximately 130 million to 150 million people living with hepatitis C around the world.
To call this a medical advance of historic proportions would be putting it mildly. The unfortunate fact is that the very thing that makes Harvoni so wonderful is what makes it absolutely terrible – if you happen to live in America.
In the U.S., a 12-week course of Harvoni costs $84,000 – $94,000. It works out to approximately $1000 per pill. If you lived in India, the cost per pill is $4.
I get it. The cost to develop a drug can be staggering. Research and development work, plus the employees who perform it, are not free. Then there are trials and further tests. It all gets expensive. But here is the problem; Gilead didn’t do any of these steps. It turns out, Sovaldi was already invented by a group called Doctors of the World at Cardiff University in 2007.
DotW is claiming that Gilead merely copied their publicly funded research, rushed it through FDA approval and patenting, and then immediately jacked the price to reap an absolutely insane profit. It worked. In 2014, Gilead had a total revenue of $24.9 billion compared to $11.2 billion in 2013.
Comparing this to India, you start to see the disgusting truth of it all. The Indian government denied Gilead a patent in their country, on the grounds that they couldn’t prove that the drug was more effective at treating hep C than what was invented at Cardiff University in 2007. This has forced Gilead to actually compete in a free market.
Due to not having a government-sanctioned monopoly in India, Gilead was forced to sell their pill at $4. This results in a total cost to save your life of about $340.
For the cost of the same treatment with the same pill in America, where we have “the most amazing healthcare system in the world,” you could literally move to India, live there for about 2 years, take the drug for a few weeks during that time, get cured, then move back and still come out saving money.
How freaking ridiculously insane is this?!
A lawsuit was filed by Doctors of the World against Gilead as well, on the basis that the drug molecule was not sufficiently innovative to warrant a patent. Seeing as India’s regulatory agencies and patent office has already concurred with the opinion in this lawsuit, things do not look to be going well for Gilead in the future. I personally wouldn’t be buying their stock.
This brings us to the heart of the problem. Gilead essentially ripped off publicly funded work, copied a drug, then “innovated” by mixing it with a secondary drug to call it unique. This justified the technicalities required for a patent, but it violated the spirit for which patents are intended. If the FDA and U.S. patent office did some due diligence and used India as a precedent, denying Gilead their vulture capitalism cash cow, this would not be an issue.
The FDA has a problem with revolving door crony capitalism. One example is FDA member Milton Packer, who chairs the Cardiovascular and Renal Drugs Advisory Committee. Packer reviews applications for drugs submitted to the FDA for regulatory approval. He is also financed by Novartis and has spoken on their behalf to the advisory board he himself chairs. He has also gone to bat in his own committee for GlaxoSmithKline in 2003, Spoke for Sanofi in 2009, and consulted for Pfizer in 2010.
Packer’s activities, while part of a government board meant to impartially regulate pharmaceuticals on behalf of the nation, scream conflict of interest. And he is only one person among many who participate in this sort of nonsense.
Government involvement in a market, especially one like pharmaceuticals, is desperately needed. However, when that government involvement ends up being corrupted to where it serves the needs of corporations over people, it becomes a government-sanctioned monopoly that is enforcible by law.
Real progressive regulatory and patent reform is so desperately needed in America, and any presidential candidate who is serious about helping the middle class should make it a primary focus of their campaign.
Featured image via drugs.com