The Cost of a Cure

By Hannah Bassett

August 30, 2014

Part of an international reporting project on Brazil’s hepatitis C epidemic. The project was supported by the Open Society Foundations

RIO DE JANEIRO, BRAZIL - Eloan Pinheiro sits on the edge of the patterned yellow couch in her living room, gently turning the pages of a binder resting on the coffee table before her. Glued to each faded pink page are handwritten notes from her former colleagues commemorating her retirement from the World Health Organization (WHO). Seeing one note with the message “Keep on making noise and trouble,” her husky laugh fills the room.

“They always said I was so loud,” she says, shaking her head.

For over thirty years, Eloan dedicated her life to securing affordable HIV/AIDS treatment in Brazil and beyond. Due in large part to her work with Brazilian pharmaceutical manufacturers and later at the WHO, Brazil is now able to guarantee free antiretroviral (ARV) therapy for all of its citizens living with HIV or AIDS.

Despite turning 70 later this year, Eloan is retired in name only. She maintains a vigorous schedule from her house in the suburbs of Rio de Janeiro, meeting with doctors, scientists, and up-and- coming activists who are fighting a new global health threat taking hold in Brazil: hepatitis C.

Known as a “silent killer” among medical professionals, hepatitis C infections are asymptomatic in 80 percent of cases, leaving infected individuals unaware of their status until the virus has already caused extensive liver damage. Of the 1.5 million Brazilians living with hepatitis C, as few as 40 percent of infected individuals are receiving treatment. But hope is on the horizon—a development so great that it is reminiscent of the breakthroughs Eloan helped orchestrate during the HIV/AIDS epidemic decades earlier. A new medication, Sovaldi, is making its way to the market, and it can cure hepatitis C in 90 percent of patients.

The only catch? The medication costs $84,000 for a 12-week course of treatment.

***

In the 1980s, when Eloan was just starting her career, Brazil found itself facing the HIV/AIDS epidemic without a feasible treatment option for infected citizens. ARV medication had the potential to dramatically lower the morbidity rate, but Brazil’s health system was unable to afford the medication at the pharmaceutical companies’ prices and lacked the infrastructure to produce generics domestically.

Eloan had the expertise and determination to take on the challenge. Raised in a poor family, she entered university in Rio de Janeiro on a scholarship. After a military dictatorship interrupted her studies for three years, she graduated with a degree in chemistry and was hired as a manager by

Winthrop Pharmaceuticals, where she began her journey that would eventually lead her to roles in the Brazilian government, civil society groups and the World Health Organization.

“I started my career very strong,” she says. But she struggled to reconcile her moral beliefs with her career at Winthrop. At a time when Brazil was trying to provide affordable access to ARVs, she found herself working for the system that was keeping medication inaccessible.

“My feeling when I was working for them was that they only wanted profitability. They don’t look at if the medicine is affordable or not. I saw that they rejected products without high profitability, even if the product was useful for the people. They look for profit, profit, and profit.”

Ultimately, her moral objections about working at Winthrop grew too great, and she walked away.

“It was a moment when I decided to change a lot of things in my life. I was very conflicted, because at the same time that I was fighting for a better society, I was working for multinational companies. These people [at Winthrop] didn’t have the feeling necessary to serve people right. My life was so contradictory. So I decided to leave.”

She was quickly hired by the Brazilian government to work as a consultant for its pharmaceutical laboratory, FarManguinhos, a far cry from the modern facilities of Winthrop. Her first few years at FarManguinhos proved difficult as she faced the dual challenges of modernizing the laboratory’s outdated facilities and rushing to produce the generic HIV/AIDS medication Brazil so desperately needed. So Eloan convened her “more clever” colleagues, and they put their minds together until they found a viable path forward. After months of failure and setbacks, they found a way to affordably produce generic ARV medication on mass scale.

“It was incredible–nights and days and nights and days doing developing; we made six [ARVs] in four years. For us, it was one victory.”

The new production capabilities also enabled the Brazilian government to negotiate far lower prices with foreign manufacturers, making ARV medication not only accessible but also affordable for the millions in need in Brazil.

Suddenly, the country had the ability to control the HIV/AIDS epidemic that had been worsening for nearly 15 years. Brazil became a success story for the rest of the world, proving that local medication production could be both sustainable and effective. When Eloan attended a WHO conference in New York later that year, attendees received her as a champion.

“Our example was seen as a good example for all, saying you can produce generic for all. You can do the generic. You can do it, and you can save lives.”

These days, affordable, effective medication has made HIV/AIDS a chronic disease in Brazil, no longer threatening the lives of everyone that it infects. FarManguinhos continues to produce and supply the ARV treatments guaranteed by the government for all of its citizens.

The pressing question facing the country now is how it will respond to the growing hepatitis C epidemic within its borders. While global awareness is on the rise, there is still significant work to be done if the successes of HIV/AIDS treatment access are to be repeated. But Eloan is confident that it is possible.

“What we did for HIV, FarManguinhos can do for hepatitis C. I know it.”

***

In Eloan’s eyes, the current state of the hepatitis C epidemic in Brazil is eerily reminiscent of the early days of HIV/AIDS control effort: treatment exists but options are limited, and the side effects of available medicines are severe. In Brazil, the most common hepatitis C medication is an antiviral that patients must have injected into the abdomen each week. Its efficacy rate is slightly lower than 50 percent and, while it is the most effective option available, it comes with debilitating side effects that range from flu-like symptoms to clinical depression. Many patients cannot keep up with the treatment’s demanding weekly regimen, even if they can withstand the side effects.

Sovaldi, the new treatment catching the world’s attention, has the potential to change all this. Patients can take Sovaldi as a pill, and studies show an efficacy rate between 94 and 97 percent with minimal side effects.

But before Brazilians can access Sovaldi, either under its brand name or as its generic, sofosbuvir, the medication’s patent must first make its way through both a maze of patent approval, and rounds of negotiations between the pharmaceutical company and the government. The process is meant to be efficient, but it frequently takes medicine patents several decades to become available.

Ana Claudia Dias de Oliveira, a Brazilian attorney who has been working on patent law for the past seven years, has seen the weaknesses of the system firsthand.

“There are 2,000 or more patents pending, only for medicine. There is one Brazilian patent that took over 37 years. Our system in Brazil has failed.”

Assuming the government approves the patent, which de Oliveira expects eventually will happen, the next challenge will be government-led negotiations with the company that developed Sovaldi, Gilead Sciences, to determine its market price. Activists are bracing for what that might look like, having seen Sovaldi enter the United States marketplace at the cost of $84,000 for a full course of treatment–far out of reach of many Brazilians.

Gilead Sciences argues that the price is justified, citing high costs of research and development and its potential to yield long-term health and economic benefits thanks to its efficacy rate above 90 percent.

“Sovaldi is more effective and has fewer side effects than prior treatment regimens,” says Nick Francis, a representative of Gilead’s public affairs department, “resulting not only in significant health benefits for patients, but also substantial economic benefits to patients, payers, and society at large.”

Francis also says that Gilead has developed a pricing scheme that will accommodate individual country’s health needs and economic limits.

“It is our goal to make Sovaldi accessible in as many places as possible, as quickly as possible. In developing countries, we are pursuing a number of strategies to expand access to Sovaldi and future Gilead HCV medicines, including voluntary generic licensing, direct pricing negotiation with local governments, tiered pricing, and partnerships with non-governmental organizations.”

The FarManguinhos labs that Eloan helped rehabilitate will play a crucial role in helping the Brazilian government negotiate a market price that is within reach of affected Brazilians. Unlike during the early days of the HIV/AIDS epidemic, when Brazil lacked its own pharmaceutical manufacturing capabilities, FarManguinhos stands ready as a state-of-the-art facility, capable of producing 20 different medications on its expansive production grounds.

“FarManguinhos has the tradition and the structure that is favorable [to sofosbuvir’s production],” says Marcos Targino, an analyst at FarManguinhos, “We have all the conditions to produce. The government can put its trust in us.”

But for now–as the patent slowly makes its way through the approval process and government officials prepare to negotiate–everyone must wait.

***

Speaking from her home outside of Rio on a cloudy morning, Eloan wonders aloud about what will happen in the coming months and years for hepatitis C treatment. Although conditions are more favorable to producing affordable and effective medication in Brazil than they were at the beginning of her career, systemic obstacles remain.

“It can be done. It’s not a technological problem; it’s not a financial problem,” says Eloan. “It’s a political problem. If hepatitis C has a lot of pressure, the government is going to [negotiate an affordable price]. I cannot drive it more–in factories, at FarManguinhos, nothing. The only thing I can do is to talk.”

And so she’s doing just that—talking with journalists, scientists, government officials and young advocates about her journey to improve access to medication in Brazil, and the lessons others can take from her decades of work. If today’s advocates are able to emulate her success in the fight for affordable, accessible HIV/AIDS medication in Brazil, then they, too, just might find themselves sitting back comfortably in their living rooms twenty years from now, reminiscing on their successful fight to end the silent epidemic.