We’re all still waiting, Gilead ...

One year on from the company’s announcement it would reduce the price of a key drug for people living with advanced HIV, why are the prices still rising, not falling?

Jessica Burry, Pharmacist, MSF Access Campaign

Headline news: a corporate PR puff — or rather the lives lost through corporate greed?

Cryptococcal meningitis (‘crypto’) isn’t a disease that makes the headlines, but it should. It’s a fungal infection of the brain, and the second biggest killer of people living with HIV — a fact that is an avoidable reality. Almost 200,000 people die every year from crypto, despite safe and effective treatment options– but of course these only work for those who live in countries where it is actually made available and affordable.

The gold-standard treatment for people with crypto is a combination of liposomal-amphotericin B (L-AMB) and flucytosine. Both drugs have been around for ages but aren’t found everywhere they’re needed.

The issue is that the people most at risk of crypto infection are those living with HIV in sub-Saharan Africa, in markets that are not considered as financially lucrative for pharmaceutical corporations. Corporations don’t bother to register their drugs in these regions, leading to a cascade effect: if the drug isn’t registered, then it doesn’t get into national guidelines, essential medicines lists and tenders, and so doesn’t make it into public hospitals where people with HIV and crypto seek care.

This is the case for L-AMB, which is made by Gilead, a Big Pharma corporation well-known in the HIV world, which has made billions in profits on the sales of medicines for HIV and hepatitis C. L-AMB was first registered in Ireland in 1990 and was eventually acquired by Gilead in 1999.

Yet despite being manufactured for almost 30 years, L-AMB has only been registered in two countries in all of sub-Saharan Africa. In South Africa, for example, it is registered but available only in the private market — not surprisingly given it comes with a price tag of $200 per vial*, which is on par with the prices in the United States and Canada.

Because MSF treats people living with advanced HIV, we have been pushing Gilead for many years to make L-AMB available at a more affordable price for the treatment of crypto — just as they have done since 1992 for another disease it treats, called leishmaniasis. Finally, in September 2018, we thought we could celebrate because Gilead announced just that: a price of $16.25 per vial of L-AMB for 116 low- and middle-income countries (LMICs).

But fast-forward to one year later and there is nothing to celebrate. People in LMICs still have not accessed L-AMB; it has not been made available at this new price and even more troubling — in the case of India, where Gilead sells it via Mylan in the private market, the price has recently doubled.

This is likely to have a profound effect on access to treatment; In India, MSF recently opened a new project to treat people with advanced HIV in Patna, in Bihar state. Within a few weeks of opening, the thirty-six-bed ward was already full — with many of those people admitted needing treatment for crypto.

While the drug is registered and available in India, no price reduction followed Gilead’s announcement last year and despite on-going negotiations with the company, MSF continued to pay US$45 a vial.

Then news this month, that pharma companies including Mylan managed to convince the Indian National Pharmaceutical Pricing Authority to double the “Maximum Retail Price” for L-AMB in India, and all of a sudden the price jumped to over $100 per vial — outside MSF projects — certainly not improving access to this essential medicine for people living with HIV in India.

Elsewhere, there’s been no movement at all in prices. What this means is that without Gilead holding to their commitment to bring the price down, there is no hope that countries will be able to afford to use LAMB and bring it into their treatment guidelines for people living with advanced HIV.

MSF is treating patients with advanced HIV in Homa Bay, Kenya © Patrick Meinhardt

So, what’s the root of the problem? Gilead says they are waiting for approval of a new manufacturing site to scale up production. Meanwhile, they claim they are not able to make enough L-AMB to supply countries who need it as per their announcement last year (although we haven’t heard of any shortages in any high-income countries where it sells for $200 per vial!). So why did they bother to announce such a program in the first place? Was it simply a PR stunt to make positive headlines at a time when they were getting so much bad press because of their outrageous prices for hepatitis C medicines. (US$1000 a pill, but that’s another story…)

We know that competition from multiple suppliers — and not corporate PR stunts — is the best way to ensure more affordable prices and better availability of medicines in the long term. Currently, Gilead is the only supplier of quality assured L-AMB. This medicine is so old that it’s no longer patented, but Gilead manages to maintain its monopoly because of trade secrets — basically “know-how” on the manufacturing side that they don’t share with generic companies, who have thus taken more time to figure out the technology to make more affordable generic versions. Fortunately, there are now some generic companies that are getting close to getting the green light from the regulatory authorities on their products, so there is some hope ahead for a sustainable resolution to L-AMB access.

Until then, people living with advanced HIV must wait for Gilead to make good on their promise to reduce the price of L-AMB and to make it available to them. Too many have lost their lives while waiting. On the anniversary of Gilead’s price reduction announcement, let’s put that in the headline news.

Jessica Burry has been a pharmacist with the Access Campaign since 2015.

Before that, she worked in MSF projects in the Democratic Republic of Congo and eSwatini.

Want to know more? https://msfaccess.org/stopping-senseless-deaths



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MSF Access Campaign — Medicines Are Not a Luxury

MSF Access Campaign — Medicines Are Not a Luxury

This blog is a place to reflect on our experiences working for access to medicines. For the official MSF Access Campaign website please visit msfaccess.org.