And leave a large part of the world – for now – empty-handed.
We are in a global crisis. A virus has already infected more than ten million people worldwide and killed more than half a million, and in many countries the number of new infections is still increasing rapidly. Meanwhile, a second wave of contamination is lurking in countries that seem to be controlling the virus. There is no effective treatment. There is no vaccine.
Remdesivir
What we do have at this stage are some medications that could potentially make a difference. Remdesivir is one of them. The drug was originally developed to fight Ebola, but clinical research indicates that it also benefits corona patients. Patients who receive the drug recover faster. It is not a panacea. But perhaps the best we can hope for at this stage. No wonder, last week, the European Medicines Agency already advised the European Commission to authorize the use of the drug in the treatment of corona patients.
But whether it will get this far in the short term is unclear. Because yesterday it was announced that the US has reserved almost the entire world stock of brake desivir. The smiling third? Gilead. The pharmaceutical company behind brake desivir.
Almost everything is gone
The U.S. has reserved more than 500,000 doses of Remdesivir. And that’s the full July brake desivir inventory and 90 percent of the inventory that would be produced in August and September. So there is very little left for the rest of the world. “The fact that the US has purchased 500,000 doses of Gilead’s brake desivir is not only worrying for other countries, but also raises the question of how we will avoid benefiting from the COVID-19 pandemic and how we will ensure it that patients in need of treatment will receive it, ”says Barbara Mintzes, a pharmaceutical policy expert at the University of Sydney, in response to the news.
costs
It is now certain that Gilead will earn a braking service. A six-day treatment would cost roughly 2850 euros, Mintzes says. “Production costs are estimated at $ 1 per day or $ 6 for a six-day treatment (usually required, ed.).” Interesting detail: the development of the drug was partly funded with (American) tax money. However, after receiving a large number of free doses for clinical research, the US will also have to pay the full pound for the drug from today. And that obviously creates quite a stir. Not only in the US, but also beyond. The issue, for example, re-ignites the debate about whether pharmaceutical companies should profit so much from the corona crisis. There are also serious concerns about the availability of the product.
Unusual
The fact that the US has bought the drug – at a high price – is very unusual, according to Philip Reece, a consultant in the pharmaceutical industry and affiliated with the University of Melbourne. “It is unusual for the US to purchase the full stock of Gilead’s braking service. Pharmaceutical companies normally make their products available internationally, so that governments can approve them. ” Politically, it is easy to explain why the US has taken this unusual step. “Remdesivir has been shown to be cautiously successful as a treatment for COVID-19 in clinical studies,” said Dr. Roger Lord, affiliated with The Australian Catholic University in The Prince Charles Hospital in Brisbane. And it is not surprising that the US government has bought almost all of the stock for the next three months, as 2.5 million confirmed contaminations have been reported in the US. The virus continues to spread in the US, which is why the government is under enormous pressure. ”
Other countries
The agreements with Gilead do not, however, give the US exclusive access to brake desivir. Because before, Gilead made agreements with producers in Egypt, India and Pakistan. These producers are now allowed to produce the product and supply it to 127 low- and middle-income countries. They also seem to have the means at their disposal in the short term. The agreements between the US and Gilead therefore pose a particular threat to high-income countries, Mintzes said. “It is not possible to buy the drug at a high price from Gilead – as the US has done – and it is not possible to obtain the drug at a low price from generic manufacturers, as low-income countries can.”
Plea for cooperation
It gives us a unique insight into the true nature of the pharmaceutical industry and that the US government, both of which – now that the need is really being addressed – unabashedly choose for themselves. It is disappointing, according to Reece. “It is a pity that there is no international cooperation between governments and the pharmaceutical industry, aimed at scaling up the production of brake desivir. Such a collaboration was set up in the 1940s to scale up the production of the newly discovered antibiotic penicillin. Collaboration between companies and government laboratories in Britain and the US – led by both governments – led to a massive upscaling of penicillin production, after which the drug could be used to treat wounded soldiers during WWII. We seem to have forgotten such a collaboration in the current crisis. ”
Tensions
“The COVID-19 pandemic has brought innovation and speed to health systems, but has also shed light on tensions that remain around equal access to health care,” notes University of Sydney professor Andrew McLachlan. “And the many factors that influence timely and affordable access to essential medicines… According to the WHO, access to medicines is a human right, but the challenges of national sovereignty, commercial interests and political relations underpin people’s rights worldwide pressure.”
Dwanglicentie
Other countries that still want quick access to brake desivir, according to Mintzes, can do little at this stage than move to a so-called compulsory license. In doing so, they force Gilead to issue a license for the production of brake desivir, after which a generic producer can make the drug. Several countries are already considering using such a compulsory license.
Scaling up
Gilead, meanwhile, has announced that it will make every effort to scale up the production of brake desivir to meet international demand for the drug. And what about the profit margins? The company is absolutely not ashamed of that. In fact, in an open letter on the pharmaceutical company’s site, CEO Daniel O’Day says the drug is relatively a bargain. Experiments show that patients can be released from the hospital about four days earlier after using the drug. If you consider that a day admission in the US costs about $ 3,000, it saves $ 12,000 per patient. And so the drug is actually worth it. But “we have decided to price the drug much lower,” said O’Day.
Incidentally, it is not the first time that Gilead has been discredited with the drug remdesivir. For example, the company first tried to register the medicine as a so-called ‘orphan medicine’. An orphan drug is a rare disease drug that can be developed and marketed with much government support and accelerated development, and that – in the US – is accompanied by seven-year market exclusivity. Much to the surprise of many, remdesivir was granted orphan drug designation. It caused a huge fuss, after which Gilead decided to abandon that status.
While the turmoil surrounding remdesivir continues to rage, many experts are hopefully looking at other treatments that can quickly become widely available. Consider, for example, dexamethasone, the first agent that has been shown to actually increase the survival chances of COVID-19 patients. The product is already on the market, is no longer covered by a patent and can be produced relatively cheaply and on a large scale.
It also hopefully looks at the dozens of clinical studies currently underway that are looking for a safe and effective vaccine. At the same time – certainly as a result of the remdesivir story – there is now also some tension about when such a vaccine is found. Because who will be the first to get their hands on that?
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