[Ip-health] NYT Fixes: The Tasmanian Hep C Buyers Club
pmaybarduk at citizen.org
Tue Jul 25 17:40:52 PDT 2017
The Opinion Pages
The Tasmanian Hep C Buyers' Club
FIXES JULY 25, 2017
Greg Jefferys helps hepatitis C sufferers get access to generic medicines. CreditGale Bishop for The New York Times
CHENNAI, India - In 2014, when Greg Jefferys's urine started smelling like dead meat, he knew there was something seriously wrong.
For weeks, Jefferys, an Australian then 60 years old, had felt fatigued and noticed that just a slight bump would leave a dark purple bruise on his skin. Blood tests revealed to Jefferys that he had chronic hepatitis C - a disease he'd never heard of.
The hepatitis C virus attacks the liver. It infects an estimated 80 million to 150 million people worldwide. It's transmitted through blood and if left untreated can cause liver cirrhosis, cancer and ultimately death. The virus is closely associated with the use of injectable drugs - something Jefferys did briefly as a 19-year-old.
At the time of his discovery, the only treatment available in Australia was an unpopular interferon-based therapy - unpopular because patients had to inject themselves in the stomach for nine months. The injections were painful and had potentially devastating side effects, including blindness and permanent liver damage.
"I wasn't going to do it," Jefferys said from his home in Tasmania, an island state off Australia's south coast.
Jefferys, a tall man with a thick silver mustache and beard, knew Gilead Sciences had developed a better option: a highly tolerable 12-week oral treatment with high cure rates, called sofosbuvir and sold under the brand name Sovaldi.
While the drug had been approved in the United States and Europe, it wasn't yet approved in Australia. And in the United States, the retail price was $1,000 per daily pill - $84,000 in total.
But Jefferys also read that in late 2014, Gilead issued India a voluntary license to allow the manufacture of generic versions of sofosbuvir. The purpose was to allow patients in poorer countries to buy the drug. (Last week, the World Health Organization prequalified the first generic version of sofosbuvir, which means it can now be procured by the United Nations and other financing agencies. This raises hopes it will become available to more people in developing countries at a further discounted price.)
Jefferys wasn't poor, but he knew it was his only chance at a cure. He bought a ticket to Chennai, a city in southern India, and took $1,000 - the cost of a full 12-week regimen in India.
Having never been to India before, he found its traffic, smells and overwhelming poverty a stark contrast to his quiet island life, in which his spare time was mainly spent fishing.
Before he arrived, he contacted a doctor and a pharmaceutical supplier online. When he met them, he purchased three bottles of pills - a complete course.
"It was a high-price item, and I had to pay cash," he said. "I felt like I was doing a big drug deal."
The 12-week course was exactly what Australia's regulatory body, the Therapeutic Goods Administration, would allow him to import under its Personal Importation Scheme.
It worked. Eleven days into treatment, Jefferys's liver enzymes had returned to normal, and after four weeks the virus could no longer be detected.
After Sovaldi, Gilead released Harvoni, a combination of sofosbuvir and ledipasvir for patients with different types of hepatitis C. Its retail price for a course of treatment was even higher than Sovaldi's: $94,000. These were highly effective, easy-to-take drugs that cured a debilitating and often fatal disease suffered by millions - exactly the kind of medicines drugmakers should be developing. Although Gilead often discounted the drugs, many people couldn't get the discounts. And even with them, it still cost more than $40,000 for a course of treatment. The price meant that few people could take the medicine, especially in countries not covered by Gilead's voluntary licensing plan.
Today, the cost means that both public and private insurers ration the drugs. In some countries, including the United States, many public and private insurers put tight restrictions on patients' use of drugs and alcohol and will not cover the drugs if a patient's use of either is continual. (Substance abuse reduces the chances the patient will take the medicines correctly.) Other patients find they can't get coverage because their disease is not advanced enough - which is exactly what the drugs work to prevent.
"It's like someone being told they have cancer, but to come back when the cancer is bigger," Jefferys said. That said, he understands that if governments treated everyone who had the disease, "it would bankrupt any health system."
When Jefferys traveled to India and first blogged about his experience, he didn't know he was on to something bigger: large-scale personal importation that would bring treatment to thousands of people around the world.
He started receiving hundreds of emails a day from hepatitis C sufferers in other countries, asking for advice. He decided to start helping patients travel to India, or he connected them with trusted pharmaceutical suppliers who could send generic versions of Harvoni and Sovaldi to their home countries.
The demand grew so big he knew he couldn't do it alone. So he helped other former hepatitis C sufferers set up informal buyers' clubs in their own countries. He worked with an Australian doctor, James Freeman, who went on to set up a website that also facilitates people's access to generic medicines.
It works like this: If you're a patient who doesn't want to travel to India, you send Jefferys $1,000 along with an identification form and a prescription. Within 10 days you receive your generic Sovaldi or Harvoni, shipped from India.
If you can't get a prescription (some countries prohibit doctors from prescribing generic medicines), a medical report showing that you have hepatitis C will suffice. Jefferys asks for a $200 fee for his service, but it's optional. "I don't want to profit from people's sickness. There's enough of that going on already, so I will remove my fee if you ask," his website says.
If the story sounds familiar, that's because it's similar to the model set by Ron Woodroof, an AIDS patient in the United States who in the 1980s began smuggling unapproved medicines from Mexico into Texas to treat his symptoms, and then began distributing the drugs to other patients. His story was adapted for the film "Dallas Buyers Club" in 2013.
While Australia, Britain and the United States allow the personal importation of a three-month supply of medicines under certain regulations, some countries, like Canada, ban personal importation altogether.
Jefferys is reluctant to talk about his work with people in Canada. "From a legal point of view, I'm just facilitating people's access to drugs," he said. As for his methods, he said, "I cannot reveal all because some are illegal. I'm perfectly happy to break laws and get people treatment. You're talking about people's lives."
Narcyz Ghinea, a researcher in health ethics at the School of Public Health at the University of Sydney, says the online facilitation of access to unapproved drugs raises a lot of questions.
"It's a very disruptive innovation that could change the way we think about medicines' access," he said. "If you can buy medicines online that aren't approved in your own country, then what is the role of the regulator? The government doesn't approve it - so what?"
Ghinea believes the popularity of personal importation could become a powerful negotiating tool to reduce drug prices. But he worries that the purchase of cheaper generic drugs overseas could undercut the market and reduce pharmaceutical companies' incentive to develop drugs like Sovaldi and Harvoni. It could also compromise discount plans provided to low-income countries.
Another risk is that the drugs could be fakes. Gilead, like other pharmaceutical manufacturers, said that counterfeit drugs are its foremost concern, because the source and quality of medicines obtained through buyers' clubs are unknown. But those who run the informal buyers' clubs insist they work only with licensed pharmaceutical suppliers.
Some research backs the clubs' claims. A recent study in Australia showed the same treatment outcomes among those who acquired treatment online and those using branded medicines.
Demand for such drugs is rising - and not just to treat hepatitis C. In Britain, for example, the I Want PrEP Now website provides guidance to residents about how and where to buy generic versions of unsubsidized medicines for H.I.V. prevention. While the brand-name versions of these medicines are available through private clinics in Britain, generics are available online for a 10th of the price.
Parag Jain is the chief executive of Bull Pharmachem in Mumbai, a licensed wholesale distribution house. It provides hepatitis C drugs to those referred through Jefferys's club and other buyers' clubs around the world. He said that demand for other generics is high. "I'm shipping drugs for cancer, hepatitis B and C and H.I.V. to close to 25 countries at the moment," Jain said.
"Drugs for these diseases are available in Russia, U.S., Europe, South America and the U.K.," he said. "But you have to look at what available actually means in the broader context. The fact you can't afford it means that it's not available to you."
Jefferys doesn't see much fishing in his future. "Personal importation is happening more and more," he said. "I was very happy doing nothing much but fishing, but I'll continue doing this until there's no need for me to do it anymore."
Elle Hurley, 39, from Fort Worth, found out that she had hepatitis C in 2010, when she was pregnant with her second daughter. There was no cure at the time. In 2014, when she found out about Harvoni through a friend and anticipated beating the disease, it turned out that she was too early. She couldn't afford the drugs, and Medicaid deemed her not sick enough to cover them.
But when she came across the story of Jefferys online, she thought, why not go to India? She'd always been fascinated by Mumbai.
"I could either take a leap of faith or die a miserable death," she said.
After she landed in Mumbai in June 2016, she had the medicine within five days, with Jain's help. The bottles immediately went into the hotel safe before she called her family. "I was crying, and I told them I was coming home," she said.
Hurley vividly remembers taking her first pill: in the car when her husband picked her up from the airport. Nine weeks after beginning treatment, the virus was undetected.
"It was the best day of my life," she said.
Personal importation is not the way the world will get access to a hepatitis C cure. It's a short-term stopgap for a few, one that highlights problems with drug costs, access and the role regulatory bodies play.
"It's a miraculous discovery," Jefferys said of Sovaldi. "But it's just such a pity it's being exploited so heavily for profit and being denied to so many people."
Sophie Cousins is a freelance health journalist based in South Asia.
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