Shopping for their lives
When David Cowley found out he had hepatitis C in 2004, the only treatment available was a daily painful injection with a low chance of success and potentially devastating side-effects such as blindness.
Hepatitis C, which primarily affects the liver, can initially be symptom-free or manifest mild symptoms. For Cowley it was six years later, in 2010, that his illness started taking hold, forcing the then 52-year-old from Cardiff, Wales, to quit his printing business. The fatigue, brain fog and cramps were severe. He didn’t want to take the current treatment so he spent most of his waking time researching new treatments, while simultaneously trying to cope with his symptoms.
When he found out Gilead had developed a highly effective, tolerable, oral 12-week treatment called sofosbuvir (sold under the brand name Sovaldi), which was approved in the US in 2013 (and then Europe in 2014), he was ecstatic. Until he saw its price tag: £35,000 ($45,100) for 84 pills.
But later, in 2013, Cowley’s luck changed: he was one of a handful from the UK to be accepted into a clinical trial for Gilead’s second hepatitis C drug that was soon to be released on the market: Harvoni. The drug is a combination of sofosbuvir and ledipasvir for patients with genotype 1 and 4 – there are six types of hepatitis C viruses which are grouped by their genetic make-up.
At £39,000 ($50,250) for a course of treatment, its retail price was even higher than Sovaldi’s.
Cowley was cured in 12 weeks.
‘I thought the drugs were fantastic and that everybody needs to have this,’ he said. So he started working to do just that.
An estimated 80 million people worldwide are infected by chronic hepatitis C, 215,000 of whom live in the UK. According to the World Health Organization, the disease kills almost 700,000 every year.
The virus is transmitted through blood and is closely associated with the use of injectable drugs – Cowley was a heroin addict for seven years.
While the development of a treatment with cure rates above 95 per cent brought hope to millions, the exorbitant price tag meant few could access it and had some protesters giving Gilead a new nickname – Killead.
In 2015, only one per cent of people with hepatitis C received treatment, a third of whom actually received old and less effective treatment.
A year previously Gilead had issued a voluntary license to India to produce generic versions of the drugs, so governments in 101 poorer countries including Malawi and Nepal could buy the treatment. The reality remains that many countries still cannot afford to spend even the much lower $900 per patient cost of the generics, according to Rohit Malpani, director of policy and analysis for Médecins Sans Frontières’ (MSF) Access Campaign. Moreover, the voluntary license excludes several middle-income countries with a high hepatitis C prevalence including Brazil, China and Ukraine.
Meanwhile, the prohibitive cost in wealthy countries means that both public and private insurers ration the drugs.
In the UK, as in other parts of Europe and the US, access to the drugs is based on liver disease stage. In other words, your liver function needs to worsen before you can access the drugs – exactly what the drugs work to prevent.
‘If you go to the hospital with a fractured leg they don’t tell you go away and to come back when it’s properly broken,’ Cowley said. ‘Simply because of the cost, people are being told they can’t have the treatment.’
While concerns around the high price of drugs was previously an issue confined to the Global South, it is now just as much of an issue in wealthy nations as Big Pharma’s grip on power and its domination of the market has increased over the past 15 years.
The situation raises numerous critical questions: how can a pharmaceutical company like Gilead hold the wealthiest of governments hostage using patent legislation? Why do the medicines cost so much? And what are the solutions?
Once a patent is granted for a drug in a country, it gives the patent holder the exclusive right to sell and produce the drug. But, as Malpani explains, exclusivity isn’t watertight – every government has the flexibility to overcome patent protection if it feels the drug price is too high.
‘They can produce low-cost generic medicines but this has been only done with AIDS drugs because HIV is a political disease as much as an infectious disease,’ he said.
‘In many respects countries in Europe and the US have their hands tied because through their own decisions they’ve made it difficult for themselves to take measures to negotiate effectively to bring down the cost of drugs and overcome generic medicine restrictions. That said, we don’t think that Gilead deserves patent protection for these drugs.’
Ellen ‘t Hoen, founder of the Medicines Patent Pool, an organization that works to increase access to treatment for HIV, hepatitis C and tuberculosis, said the rationing of drugs was ‘completely unacceptable’.
‘I think governments are irresponsible, given that today there are lower-priced generic medicines available,’ she said.
‘Governments shouldn’t be able to hide behind the fact there’s a patent available in their country. Proven effective medication needs to be affordable and available based on human rights.’
Sharing the miracle
When news of Gilead’s issuance of a voluntary license to India in 2014 reached Greg Jefferys in Tasmania, he jumped on a plane to the south-Indian city of Chennai.
Earlier that year the then 60-year-old had found out he was infected with hepatitis C. At the time Australia had not yet approved the use of Gilead’s new drugs but he knew they were out of his reach anyway.
Instead, he went to India and purchased the 12-week course of treatment for $900 – a fraction of the price they were being sold for in wealthy countries. The 12-week supply was exactly what Australia’s regulatory body, the Therapeutic Goods Administration, would allow him to bring home under its Personal Importation Scheme.
Eleven days into his treatment, his liver enzymes had returned to normal levels and after 14 weeks, his viral load was undetectable.
‘It’s a miraculous discovery. It’s just a great pity it’s been exploited so heavily for profit and is being denied to so many people,’ he said.
Jefferys blogged about his experience and overnight attracted the attention of hundreds of hepatitis C suffers, desperate to access drugs.
He wanted to help. So he decided to start facilitating people’s trips to India or connecting them with trusted pharmaceutical suppliers who could send generic versions of Harvoni and Sovaldi to their home countries, now along with Epclusa, a newer drug that treats all genotypes of hepatitis C and was released last year.
While countries including the UK and US allow the importation of a three-month supply of medicine with certain regulations, others such as Canada and parts of Europe ban it altogether.
‘From a legal point of view, I’m just facilitating the whole thing,’ he said. ‘But I’m perfectly happy to break laws and get people treatment – you’re talking about lives.’
Cowley had been following Jefferys’ blog and was inspired to set up his own buyers’ club from his home in 2015.
He set up a Facebook group and just like Jefferys, along with people in other countries including Russia, Belarus, Romania and Spain, organizes for generic medicines from India to be sent to people’s doorsteps.
So how does it work? Well, you send Cowley or Jefferys $1,000 along with an identification form and a prescription from a medical practitioner. If you can’t get a prescription, then a medical report showing you have hepatitis C will suffice. Within 10 days you receive your generic medicines shipped from India. Both men ask for a fee for their service but it’s optional and depends on the individual’s circumstances – neither want those who are poor or cash-strapped to miss out.
But what if you live in a country that bans personal importation? This is something Cowley is reluctant to speak about on the record.
‘The reason I’m doing what I’m doing is that I’m absolutely outraged at the price,’ he said.
‘I don’t hide what I’m doing – it’s facilitating people getting the right medicine so they don’t get ripped off. We don’t do it for the money, we do it because someone has to.’
Waiting for the breakthrough
Narcyz Ghinea, a researcher from the University of Sydney whose work focuses on medicines’ governance, said the increasing popularity of personal importation – which is also happening for other drugs – could change the way access to medicines is viewed.
‘It’s a very disruptive innovation,’ 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?’
He said personal importation could be a useful negotiating tool to bring down the price of medicines but feels it could simultaneously discourage innovation.
Gilead’s stated concern with buyers’ clubs is counterfeit drugs. A spokesperson said the source and quality of hepatitis C medicines secured through buyers’ clubs are unknown. But given that Cowley and Jefferys source their medicines from Gilead-licensed pharmaceutical companies, this concern seems unwarranted. In fact, a 2016 study in Australia showed the same treatment outcomes among those who acquired treatment online and those using branded medicine.
Switzerland and Italy recently took steps to create legal means for people to travel to India and purchase generic medicines, with some insurers even footing some of the medicines’ cost.
The prohibitive cost of hepatitis C treatment highlights a global challenge: how to finance the development of affordable new medicines.
‘The more fundamental issue is, how are we going to pay for research and development? How are we going to continue to finance drugs and vaccines?’ Malpani said.
While the pharmaceutical industry justifies charging high prices by playing up its investment in research and development, critics say innovation can also come from the public domain; indeed, that industry often builds on publicly-funded research. But even the public domain is under threat with funding constraints in areas such as HIV prevention.
‘The pharmaceutical industry has become powerful globally and negotiating with [it] is very difficult,’ said ‘t Hoen.
‘Ultimately how we finance the development of new medicines is where the change will have to come from.’
For now, Cowley remains tied to his computer 18 hours a day, with no end in sight.
‘I might get into trouble for this but fundamentally it doesn’t matter,’ he said.
‘There are enough good cheap medicines out there to solve the problem of hepatitis C. There is no justification for the price Gilead is asking for the medicines. It’s absolute nonsense.’