At a press conference in New York City yesterday, a group known as the Institute for Medicines, Access and Knowledge (I-MAK) announced that it was filing legal challenges in Argentina, Brazil, China, Russia and Ukraine to invalidate patents on the hepatitis C drug Sovaldi. That drug was developed and is sold worldwide by the pharmaceutical company Gilead Sciences.
The disease that Sovaldi treats, hepatitis C, is a life-threatening illness caused by a blood-borne virus of the same name. Approximately 150 million worldwide are infected with hepatitis C virus, with most of those living in poorer regions of the world, particularly Asia and Africa. This is more than five times the number infected with HIV. Most of those livin with hepatitis C are undiagnosed. Fewer still have access to care and treatment.
This is in part because acute infection by the hepatitis C virus is usually asymptomatic, although some people may develop fever, fatigue, nausea and, in a few cases, the jaundice (or yellowing of the skin) characteristic of hepatitis. About of quarter of patients will clear the virus from their bodies, but the majority of those exposed will develop chronic hepatitis C infection. In individuals with chronic infection, the virus slowly causes long-term damage to the liver. Around one third of those with chronic infection will develop liver cirrhosis or cancer within 20 years.
Until recently, the only cure for hepatitis C was treatment with a combination of antiviral drugs like ribavirin and interferon, often given as injections or intravenous infusions three times weekly over the course of a year. This course of treatment was effective in less than 50% of patients, and many suffered from debilitating side effects. Moreover, the nature and intensity of treatment made it impractical for most patients living in the countries with less developed health care systems. For the vast majority of people infected with hepatitis C, both in the US and in other parts of the world, a cure was thus largely out of reach.
In that context, the development of Sovaldi (and more recent drugs like Harvoni and Viekira) was a godsend. Sovaldi is a once-a-day pill which, when taken in combination with oral ribavirin for twelve weeks, effectively cures 90% of patients. Many doctors also prescribe Sovaldi in combination with another oral antiviral drugs, with similar effectiveness and fewer side effects. In addition to being more effective, the use of oral-only formulations also makes this drug more accessible to patients who live in less developed regions. Patients no longer it require intravenous treatment with hard-to-procure and hard-to-deliver drugs like interferon.
So why is there a brewing controversy about this miracle drug? Why is I-MAK challenging Gilead's patents on Sovaldi in Argentina, Brazil, China, Russia and Ukraine? The answer is quite simple: money.
Sovaldi is an incredibly expensive drug. Gilead charges nearly $1,500 for a single pill, so a twelve-week course of treatment can cost a patient (or their insurance company) over $100,000. This is well beyond the means of most of those living with hepatitis C worldwide.
Recognizing this, Gilead does allow drug manufacturers in India to make a generic version of Sovaldi, which is sold for less than $10 a pill to patients in 91 low-income countries. However, Gilead does not allow generic Sovaldi to be sold in Argentina, Brazil, China, Russia and Ukraine, relatively wealthy countries where nearly 40 million people infected with hepatitis C currently live. Rather, in those countries, Gilead sells the brand-name drug to patients and health agencies at a slightly reduced cost of approximately $100 a pill.
That is a generous discount, but one that would still cost the cash-strapped governments of those five countries over $250 billion if they were treat all of the 40 million people who need care. Given this, physicians and policymakers in Argentina, Brazil, China, Russia and Ukraine instead have to make tough decisions about who to treat and who to let die from hepatitis C-related liver failure.
This is why I-MAK, in collaboration with local patient advocacy groups, is pushing those governments to break Gilead's existing patents on Sovaldi. This would allow drug manufacturers in of Argentina, Brazil, China, Russia and Ukraine to make and sell their own generic version of Sovaldi.
But is this fair? It costs billions of dollars for a company like Gilead to develop, test, and get approval to sell a single drug like Sovaldi. That money has to come from somewhere, and it is the profit from selling these blockbuster drugs allows provide pharmaceutical companies to recoup those costs. It also provides drug manufacturers with the financial incentive to develop the dozens of miracle drugs that have come on the market over the last thirty years.
At some point, however, those costs (and more) have been recouped. Gilead has earned over $15 billion this year alone from selling Sovaldi in the US and overseas, more that enough to cover the costs of developing and testing this drug. There's a fine line between maintaining a healthy profit margin versus exploiting the misery and suffering of those living with hepatitis C.
I have a good deal of respect for pharmaceutical researchers (and the companies they work for), and I believe that intellectual property rights should be recognized. But sometimes it takes a threat like this to get those companies to do the right thing.
I-MAK's efforts to invalidate Gilead's patents may not be fair, legal, or even successful, but they may force that company to offer better price reductions on Sovaldi to patients who live in resource-poor regions of the world. This same approach was used successfully some years back to get companies like Gilead to drop the price of anti-HIV medications, allowing millions of people living with HIV/AIDS worldwide to finally have access the treatment they needed. It's time to offer the same hope to those living with hepatitis C.
A public health researcher and ethicist by training, Dr. Sean Philpott-Jones is Director of the Bioethics Program at Union Graduate College-Icahn School of Medicine at Mount Sinai in Schenectady, New York. He is also Director of Union Graduate College's Center for Bioethics and Clinical Leadership, and Project Director of its two NIH-funded research ethics training programs in Central and Eastern Europe and in the Caribbean Basin.
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