The US has bought most of the world’s remdesivir. Here’s what it means for the rest of us (from The Conversation)

Dimitri Karastelev/Unsplash, CC BY

Barbara Mintzes, University of Sydney and Ellen ‘t Hoen, University of Groningen

To beat the coronavirus pandemic, countries need to collaborate. We need the best possible science to develop vaccines and drugs, and to test, track and contain the virus. If we’ve learned anything from the rapid global spread of this virus, it’s that we’re all in this together.

It was therefore shocking to hear, on June 29, that the US government has bought more than 500,000 treatment courses of the antiviral drug remdesivir, representing manufacturer Gilead’s entire production capacity for the next three months and effectively excluding other countries from accessing this drug.

Read more: Is remdesivir a miracle drug to cure coronavirus? Don’t get your hopes up yet

The purchase raises concerns, not only about access to remdesivir in other countries, but more broadly about how to prevent profiteering from the COVID-19 pandemic.

Gilead announced its global price for remdesivir on June 29 as US$390 per vial. The Guardian has reported the cost to the US government will be US$3,200 for a six-day treatment. In contrast, production costs for remdesivir are estimated at 93 US cents for one day’s treatment, or less than US$6 for an entire course.

The profit motive

It was hardly a secret that Gilead was seeking to profit from its product. Earlier this year, it applied for seven years of “orphan drug exclusivity” for remdesivir – a status that extends a drug’s period of patent protection, and is meant to act as a regulatory incentive to develop drugs for rare diseases. If only COVID-19 were rare!

The US Food and Drug Administration granted the exclusivity 12 days after the World Health Organisation declared COVID-19 a pandemic. The move was met with strong criticism and Gilead has since rescinded the orphan drug status.

US consumer group Public Citizen estimates taxpayers in the US, Europe and Asia have contributed US$70.5 million in development costs for remdesivir. The list of US government grants is impressive and begs the question of whether remdesivir should be in the public domain. Instead, Gilead maintains a monopoly on sales, holding patents in many countries, the latest of which lasts until 2036.

Remdesivir’s revenue this year could be US$2.3 billion, which would make the drug a blockbuster.

We might criticise Gilead, but this is how commercial drug companies function – in non-pandemic times, at least. But it does call into question pharma’s lofty promises of ensuring “equitable global access” to COVID-19 treatments.

Read more: Gilead and the billion-dollar odyssey

Is remdesivir worthwhile anyway?

If remdesivir doesn’t work, the US purchase would be a waste of money. The first report of benefit was a small follow-up study of 53 patients with no comparison group. This was followed by a more rigorous randomised controlled trial from China, published in the Lancet, in which remdesivir did not outperform placebo. However, fewer patients were recruited than anticipated.

A third, mainly publicly funded trial by the US National Institute of Allergy and Infectious Diseases found patients given remdesivir recovered four days earlier, on average, than those not treated with the drug. But it also found no statistically significant difference in death rate between the two groups.

That study was also stopped early, which can lead to exaggerated estimates of treatment benefits. A British Medical Journal editorial highlighted the study’s financial links to Gilead as another source of bias.

Read more: Remdesivir explained – what makes this drug work against viruses?

More trials are ongoing, but until more evidence becomes available we really don’t know whether remdesivir significantly helps COVID-19 patients. If it does, it would be needed not only in the US but globally. Now Gilead’s supply is confined to the US, what can other countries do?

As a stopgap measure, Gilead has donated a stockpile of remdesivir to Australia, but it’s unclear whether this is a one-time-only act of generosity, or indeed why Gilead would donate its products to a wealthy country like Australia.

Bypass Gilead’s patents?

Gilead has voluntary licence agreements with manufacturers in Egypt, India and Pakistan to supply remdesivir to 127 lower-income countries. Under these agreements, Gilead allows generic manufacturers to produce remdesivir with specified conditions, such as limits on where it can be sold. A company in Bangladesh, where Gilead holds no patents, also produces generic remdesivir.

Where Gilead holds patents, countries could nevertheless gain access to generic remdesivir by issuing a compulsory licence. This is a recognised measure under both international trade law and the patent laws of many countries, including Australia. A compulsory licence grants the right to produce and sell a patented drug without the permission of the patent holder, both domestically and to other countries that have also issued a compulsory licence.

Boost international solidarity

The remdesivir saga highlights the need for greater international solidarity and a more public health-oriented approach to the development of new treatments. On June 1, 2020, the World Health Organisation addressed this by launching the COVID-19 Technology Access Pool (C-TAP), which offers a way to share knowledge and intellectual property in response to COVID-19.

Countries and charities spending billions of dollars on developing new vaccines and drugs should require that technologies developed with public funds are shared with C-TAP.

Unfortunately, Australia has not yet pledged its support to C-TAP. Perhaps the recent experience with remdesivir will help the government realise that an open and collaborative approach is a much-needed alternative to one country hoarding the world’s supply of an overpriced and largely unproven drug.

Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of Sydney and Ellen ‘t Hoen, Global Health Law Fellow, University Medical Centre Groningen, University of Groningen

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Don’t Eat Me (Dr. Siri Paiboun #13) by Colin Cotterill

‘Life sped by in Vientiane like a Volkswagen van on blocks.’

Dr Siri Paiboun, the former national coroner of Laos, and his friend Civilai want to make a movie. They have a film camera, which they’ve managed to purchase and smuggle into the country, and they have a plan.  But there are two problems:  the first is learning how to operate the camera, the second is obtaining script approval from the Ministry of Culture.

‘Every elderly person deserved a period of insanity to combat the boredom of decay.’

But things suddenly get complicated (they always do in a Dr Siri novel).  A woman’s skeleton is found in a public place: who put it there, and how did the woman die?

Inspector Phosy investigates.  Nurse Dtui helps, and so does Dr Siri.  They establish quickly that the woman’s death was comparatively recent, and it seems that small animals have been gnawing at her bones.  Their search for more information leads them to uncover illegal animal trafficking and corruption.

‘We only blackmail you if we think you’re wandering off the path of righteousness and into the brambles of evil.’

Everyone gets involved: Madame Daeng, Mr Geung and his girlfriend, and many of those who frequent Madame Daeng’s noodle shop.  Dr Siri infrequently (but annoyingly) vanishes when his spirits take over.  It takes him a little while to understand the message(s) being delivered, but fortunately he gets there eventually.  Just as well, because Inspector Phosy is charged with corruption and he needs all the help he can get.

This is the thirteenth instalment in the Dr Siri Paiboun series, and while I didn’t enjoy this one as much as most of the others, the series is worth reading (in order, because character development and backstory are important).

Mr Cotterill tackles the uncomfortable but important issues of animal and people trafficking in this novel.  But the last word really belongs to Mr Geung:

‘… wish this day, is that we all stop comparing the size of our brains and learn to see the size of each other’s hearts.’ (Well said, Mr Geung!)

I now have the fourteenth book in the series to read.

Jennifer Cameron-Smith