FOR six years Paul Fleming was infected with the hepatitis C virus which, left untreated, often leads to liver failure or cancer. Recently, a medicine became available that can eradicate the virus within a few weeks, but doctors couldn’t treat him because the £35,000 regimen was too costly for the UK’s National Health Service (NHS).
Finally, late last year Fleming had had enough. “You have a contagious disease and it always preys on your mind,” he says. So he took a radical step: with his doctor’s help he bought a cheap version of the drugs from an Indian company, available for just £1200 thanks to differences in patent law. The package arrived three days later.
Fleming is one of a growing number of people using buyers’ clubs, which facilitate the unofficial purchase of cheap generic versions of branded drugs, often with tacit help from doctors. Hepatitis C medicines are the newest addition to these grey markets, thanks to the recent development of safe and effective therapies – and the enormous prices they command. But while buyers’ clubs may fill the gap for people like Fleming, is this any way to do medicine in the 21st century? Or is it a sign that we need to fundamentally rethink how we develop and fund new drugs?
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Concerns over high drug prices have been growing for years. But with hepatitis C, it’s the first time that such a large number of people with a potentially fatal condition have had a cure in sight and out of reach.
Viral hepatitis has recently jumped up the league table of the world’s top health threats joining HIV, tuberculosis and malaria, according to the World Health Organization (see “The big four”). The hepatitis C variant is especially deadly, accounting for but has no vaccine.
“Doctors helping patients get around patents is a direct assault on the global pharmaceutical industry”
Everything changed in 2013, with the arrival of breakthrough compounds that, unlike previous treatments, act directly on the virus, stopping it from reproducing. Depending on which strain of the virus people have, treatment tends to be a two-drug regimen that includes sofosbuvir, made by US multinational Gilead.
When sofosbuvir was launched, jaws dropped at its price of $84,000 (£65,000) for a 12-week course in the US – $1000 per pill.
“To have drugs so powerful that so few people can access – it’s almost the most extreme example of drug access that you can think of,” says Andrew Hill of the University of Liverpool, UK.
In the past couple of years, the company has been moved a little by pressure to drop prices in Western countries, but the brand-name medicine still typically costs tens of thousands of pounds per person. In developing countries such as India, where health services cannot afford Western prices, Gilead lets manufacturers make a cheap generic for a small fee. This system leaves some middle-income countries such as Ukraine ineligible for the generic and too poor for the brand-name version. Even in countries like the UK, health services struggle to treat everyone.
UK hospitals are given quotas for how many patients can be treated each month, and they prioritise the sickest. People without symptoms, like Fleming, stand no chance. Despite regular monitoring, he worried that the potentially deadly infection would progress and damage his liver, or that he might pass the virus on through sex.
He was able to take matters into his own hands because, as a gay man, he had heard about buyers’ clubs for medicines that stop people catching HIV. These are not offered by the NHS, but the health service will often support people who have obtained the drugs by checking the medicines’ levels in their blood.
Ethical issues
Although it’s not official NHS policy, Fleming also got help from his hospital. He couldn’t have done it without his doctor, who directed him to a buyers’ website called and provided the test results that indicated the correct drug combination, then monitored him during treatment.
After 12 weeks, Fleming’s blood tests for the virus were negative. “I’ve no regrets,” he says. “I’m cured of hep. C.”
But while many hospitals are now helping patients in this way, not all are. “Some doctors don’t want to take the responsibility of something going wrong,” says Hill. “Some doctors say this is crazy, I have no idea of the quality of this medicine.”
“Medicines purchased in this way could have the wrong active ingredient, no active ingredient, or an incorrect dosage,” says a spokesperson for the UK Medicines Healthcare and Regulatory Agency.
Such fears may abate given recent figures presented at , showing that cure rates in people self-treating through buyers’ clubs generics are as high as in people who get the brand-name versions.
But buyers’ clubs raise other ethical questions. Some doctors think “patients [are] queue-jumping by buying their own treatment and being monitored on the NHS,” says Graham Cooke of Imperial College London. On the other hand, he says, “they’re saving the NHS money.”
It’s not just doctors raising their eyebrows. Developing countries are allowed to make the generics for their own people because their health systems can’t afford the brand name versions. Westerners aren’t supposed to buy from them. Some think this phenomenon of doctors helping patients to import their own generics, happening first with HIV and now with hepatitis C, is nothing less than an assault on the global pharmaceutical industry.
Big pharma’s usual defence of its eye-watering prices is that they are justified by the high cost of developing the medicines. “The revenue that comes in funds the advances of the future,” says Julian Cole of Gilead.
But Melissa Barber, also at the University of Liverpool, says this is flawed reasoning. Most of the initial basic research in drug development goes on at universities, . Big pharma enters the picture only in the final stages of clinical trials. By some estimates, private money is on medical research. “It’s a small contribution,” says Barber.
What’s the alternative? Some, including Barber, are calling for a revolution in the way drug development is funded. Options include changing medical patent laws or giving governments and public bodies more rights over any medicines that arise from research they pay for. “I don’t think it’s inflammatory to say people should not die from preventable diseases because they can’t afford the medicines,” says Barber.
The latter step is already being considered for research into new antibiotics, partly because antibiotics are unprofitable, which makes drug firms reluctant to invest their own money.
If it seems idealistic to expect governments to take on big pharma, perhaps others will. A group of charities led by Médecins Sans Frontières is challenging Gilead’s patent on sofosbuvir at the European Patent Office. The patent has already been revoked by several other countries.
At the very least, the existence of generics is giving Western governments more bargaining power when it comes to agreeing prices with big pharma. Although it’s still secret, the Australian government is said to have achieved a substantial discount on sofosbuvir.
“There’s no reason why governments can’t negotiate harder with drug companies,” says Barber. She predicts people are going to start demanding they do just that when they see there are medicines widely available in other countries but not their own. “They need to hold their government accountable.”
“Something needs to be done about the drug companies,” says Fleming. “What is a reasonable profit margin?”
Infected by doctors
The hepatitis C virus was spreading unchecked for much of the 20th century, but we only discovered it in 1989. Like HIV, it is a microbe that can be spread through sex – especially anal sex – and through sharing drug and tattoo needles. But in the past, the most common way to catch it was from medical injections.
That’s the insight from a study of people in the US in their 60s and 70s, who are surprisingly more likely than average to carry the virus. When they were children in the mid-20th century, vaccinations were becoming common, but reusable syringes were not yet known to be dangerous – they were only phased out after the discovery of HIV in the 1980s. meant “most of the hep. C patients who are baby boomers were given the virus by doctors,” says James Freeman, a doctor in Hobart, Australia.
Contaminated syringes and blood transfusions may also be why rates are so high in developing countries. Egypt is thought to have the highest infection rate, with estimates as high as 20 per cent of the population – probably due to in the mid-20th century.
This article appeared in print under the headline “Making a killing”
