Over the past five years, drug regulators in the U.S. have approved a flurry of new medications that effectively cure hepatitis C (HCV) in just a few weeks with negligible side effects.
These cures should come as a welcome relief considering the fact that the U.S. is suffering from an HCV epidemic, with one in 100 Americans chronically infected. But this extraordinary scientific achievement is undercut by a sobering statistic: Only 15% of those diagnosed with hepatitis C have received treatment.
That's according to a new analysis by the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), which has argued that the high price of these medicines places them out of reach for most people.
I-MAK's cofounder Priti Krishtel is trying to reframe the national conversation about access to medicines to focus on people rather than profits.
"We're in the middle of a drug pricing epidemic in the United States,' says Krishtel. "The prices of medicines have tripled in the last decade. [But] the national conversation is about companies and profits and R&D, and pharma is very easily able to flip the narrative" to focus on research costs rather than unmet need, she says.
Instead, Krishtel is trying to raise awareness that only 154,000 to 256,000 patients are treated each year -- a small fraction of all those diagnosed. And, worryingly, hepatitis C transmission rates are growing at an alarming rate among vulnerable groups, such as prisoners and injection drugs users -- people who are unlikely to be able to afford expensive therapies.
Journey to Now
In 2013, Gilead Sciences launched the first hepatitis C cure blockbuster, sofosbuvir (Sovaldi), setting a price that caused many to balk: $84,000 for a full course of treatment or about $1,000 per pill.
Krishtel and her colleagues immediately set to work improving access to this drug on a global scale, fighting Gilead's patent to bring a more affordable version of sofosbuvir to people in lower-income and developing countries. To a large extent, they've been successful, with governments rejecting Gilead's patent applications in countries such as India and Brazil, paving the way for lower-cost medicines to be brought into those markets.
But, at the same time that Krishtel and other advocates were working in low and middle-income countries, outrage over the phenomenon known as "price gouging" was brewing within the U.S.
In 2014, congressional leaders sent a letter to Gilead's CEO demanding an explanation for sofosbuvir's high price, which the company has argued is necessary to offset the cost of research and development. But that argument didn't sway congressional leaders, who published a scathing 134-page report lampooning Gilead's pricing strategy in 2015.
That report was a wake up call for advocates like Krishtel, who realized the time was right to apply her patent-fighting tactics in the U.S. and other wealthy nations.
But first, she wanted to understand exactly how many people with hepatitis C have been suffering because medicines are out of reach. Her organization crunched the numbers, comparing Gilead's sales estimates against Centers for Disease Control and Prevention data on the total number of diagnosed patients in the U.S.
It found that 85% of people with diagnosed hepatitis C have not received treatment. Armed with that information, in October 2017, I-MAK filed the first patent challenge against Sovaldi in the U.S., arguing that Gilead "obtained unmerited patents" because the drug's core patents don't "meet the legal standards for novelty and non-obviousness."
While it's unclear whether these efforts will be successful, Krishtel is hoping the current political climate will lead to broader reform.
"We need an acknowledgement that the pharmaceutical market is broken, and some meaningful steps are needed -- including patent reform," she says.
Reform Under Trump
Initially, fair pricing advocates found an unlikely ally in President Donald Trump, who campaigned on a populist promise shared by Senator Bernie Sanders to use the purchasing power of the government to negotiate for lower drug prices. And, during Trump's first month in office, he accused the pharmaceutical industry of "getting away with murder" because of high drug prices.
But Trump's message later became fractured. On the one hand, he argued that the pharmaceutical industry needed to be held accountable for price gouging, but on the other hand, he argued that developing countries such as India and Brazil are "freeloading" and should also be held accountable.
However, the administration has not explained why low prices in other countries might create high prices in the U.S. Nor is it clear that if other countries paid more for drugs, then American consumers would ultimately pay less. On Friday May 11, President Trump gave a speech to outline his drug pricing agenda, but largely targeted pharmacy benefit managers (PBMs) as the source of high pharmaceutical costs, and early analyses have suggested his proposals aren't impactful enough to even worry the pharmaceutical industry.
Meanwhile, the hepatitis C epidemic is getting worse. The number of acute cases has skyrocketed since 2010, with the rise directly linked to the growing opioid epidemic.
I-MAK notes that 205,000 new people will be treated in 2018, which represents only 12% of the 1.75 million people who have been diagnosed. Further, the non-profit is projecting that at least 80% of diagnosed patients will be without treatment each year until 2024.
What's worse, only half of the nearly four million people living with hepatitis C are aware of their status, meaning that only 6% of all HCV-positive people have been, or are expected to be, treated.
With this research, Krishtel hopes to spark renewed discussion on how to fix the drug pricing problem -- a discussion focused on the people who are suffering rather than a back-and-forth debate on pharmaceutical companies' drug pricing rationale.