Yale’s Global Health Justice Partnership has released a report warning the international community that scientific discoveries will not be enough to prevent the over 500,000 deaths that occur every year from Hepatitis C.
Last week, in partnership with the AIDS policy think tank Treatment Action Group and the Initiative for Medicines, Access and Knowledge, which aims to increase access to medicines worldwide, the GHJP cautioned that despite the development of Sovaldi — a Hepatitis C drug, marketed since 2013, with a 96 percent efficacy rate in some patients — there are numerous remaining hurdles to ending the “silent epidemic” of Hepatitis C, especially in low- and middle-income countries. In their report, “Ending an Epidemic: Overcoming the Barriers to an HCV Free Future,” the four lead student authors advocated for legal, economic and political solutions to the challenge.
“The bottom line takeaway is that if you make a breakthrough, there is no guarantee that it will get to everyone,” said co-author Kyle Ragins MED ’15 SOM ’15 . “You need innovation in your intellectual property law, your financing and the way care is delivered.”
According to co-author Allana Kembabazi LAW ’15, despite an incidence rate of 150 million people worldwide, very little attention has been given to the growing spread of Hepatitis C. Co-author Christine Monahan LAW ’16 said the disease can often take years to present symptoms, so its spread is often described as “silent.” Because so few people know that they are carriers, they are more likely to infect others.
Before 2013, most Hepatitis C drugs relied on interferon, a chemical component that caused severe side effects in patients, Monahan said. The drugs were also only 30 percent effective, she added.
While Sovaldi has been available in the United States for over a year, its exorbitant price has left it a distant hope for patients in low- and middle-income countries, Monahan said.
“When the drug was announced, there was a lot of hope out there — and then you hear that it costs $1,000 per pill,” Kembabazi said.
Ragins explained that while drug companies may sometimes reduce the price of life saving drugs in low-income countries, they are reluctant to do so in middle-income countries like Egypt or India because they do not want to lose out on potential profits. Major drug companies, including Gilead — which produces Sovaldi — are mainly based in the United States, whose government, Ragins said, has no incentive to encourage selling generic drugs in middle-income countries. If pharmaceutical companies were allowed to produce generic versions of Sovaldi, the price per treatment cycle would drop from $84,000 to $102, he added, citing the minimum predicted cost of the drug.
Ragins noted that universities like Yale also play a part in limiting access to life-saving drugs.
Universities conduct basic science research and sell the rights for those findings to pharmaceutical companies in return for a portion of sales profits. When those drugs are then sold at unaffordable prices, universities become complicit in hindering accessibility, Ragins said.
In the early 1990s, Yale researcher William Prusoff invented d4T, the first antiretroviral drug that was effective for HIV patients. After the University sold the patent to Bristol-Myers Squibb for $40 million a year, the company set the price of the drug at roughly $10,000, effectively pricing it out of reach for most patients in sub-saharan Africa, where HIV was taking its largest toll. Amy Kapczynski LAW ’03, faculty director of GHJP, led a campaign urging the University to allow a generic company in India to sell d4T at a price low enough to make it accessible in sub-Saharan Africa. That campaign, which was ultimately successful, reduced the price of the drug substantially.
The d4T events also led to the creation of the Office for Technology Transfers, which oversees the University’s licensing of technology to third parties, such as pharmaceutical companies.
According to Ragins, the same pricing-out phenomenon is occurring with Sovaldi, which varies in price from $300 to $84,000. While drug companies are still able to make a profit from selling the drug at prices in the low hundreds, they choose to mark it up to extract a larger profit, he added.
Monahan noted that solutions to drug accessibility lie beyond economic strategies. Membership in the World Trade Organization allows countries to contest patent awards and issue compulsory licenses, which unilaterally open a drug up to generic production in cases of public health crisis.
Brazil is known for contesting patents, Ragins said, and the Indian High Court recently released a ruling that takes away Gilead’s monopoly rights on Sovaldi. But it is expensive and difficult for countries to contest patents, which may be why India and Brazil’s example has not yet been followed by many other middle-income countries, Monahan said.
The Egyptian government contested the price of Sovaldi in March 2014. The drug’s price fell 99 percent from $84,000 to $900 for a 12-week course. But that price is still not low enough for many who need the drug, Kembabazi said.
Sovaldi reached the $10 billion revenue mark faster than any other drug in history.
Correction: March 7
A previous version of this article incorrectly stated that Hepatitis C drugs contained interferon-ribavirin. In fact, they relied on interferon. Also, Sovaldi can be produced at $102 per treatment cycle, not per pill, with the highest price for a cycle being $84,000. Finally, the Indian High Court, not Supreme Court, removed a patent from Sovaldi.