Thursday , February 9 2023

Ebola treatment is a turning point in the development of drugs, experts say


Two new drugs have shown remarkable prospects for treating Ebola in a clinical trial and have raised the survival rate of people who have recently been infected with the disease to 89-94%. This is incredible for a virus that usually kills about half of all infected people.

"From now on, we will not say that Ebola is not treatable. In the future, this progress will help save thousands of lives that have had fatal consequences in the past, "Jean-Jacques Mumbé, Director-General of the National de Recherche Biomedicale of the Democratic Republic of the Congo, told a news conference.

Since the discovery, the ongoing outbreak in the Democratic Republic of the Congo is viewed by experts not only as a major turning point in Ebola research and development, but also in the way medicines are developed for future emerging diseases. In the past, Ebola has flared up in poor and conflict-ridden communities with limited access to health care. This is a challenge when it comes to securing investment to fund treatment and making drug tests in the midst of crises even more difficult.

This makes the success of these two drugs even more exciting for scientists. "This is the first time a randomized, controlled trial has been able to quickly and successfully identify which drugs are best in the midst of a continuing onset," says Anthony Fouchie, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Medicine. health research, tells on border,

Ebola was created more than 40 years ago and has triggered worldwide fears of massive outbreaks in West Africa between 2014 and 2016. More than 11,300 people have been killed. Small outbreaks continued, including the ongoing crisis in the Congo, which diagnosed nearly 2,800 people and killed more than 1,800 people. In July this year, the World Health Organization declared it a public health emergency.

In the midst of an epidemic of this magnitude, Fauci explains, there is often pressure to publish drugs that appear promising in the laboratory, but lacking rigorous clinical trials to prove their safety and efficacy. The result of this study is proof that even in the most difficult situations, research can be conducted to ensure drug safety.

This specific process began in November 2018 as part of the international emergency response to the Congo epidemic. The combined efforts of several Congolese and international medical organizations have resulted in approximately 700 patients attempting four experimental drugs. The two more promising treatments are called REGN-EB3 and mAb114 and are administered by intravenous infusion of a combination of monoclonal antibodies into the patient's blood. The other two drugs, Remdesivir and ZMapp, are no longer given because they lead to three times the mortality rate in patients with low viral load compared to the other two drugs.

The two successful Ebola medicines are offered for "compassionate use" free of charge, although they are technically experimental. The process of actually administering the drug through regulators is tedious and cumbersome. It can take up to 12 years between patenting the drug and launching it. And the cost to switch a drug from concept to commercial availability can reach $ 1 billion.

There may be additional barriers to medication, often referred to as orphaned or neglected diseases. These diseases usually affect communities in the global south that lack the financial resources or political clout to make the medicine viable. Without incentives or investment, drug candidates can be lost in the so-called pharmaceutical "valley of death".

"There is no natural market or need for a product until an epidemic actually emerges and since outbreaks are sporadic and unpredictable, the size and scope of this market is unclear," advises Jamie Bay Nishi, director of the Global Coalition for Health Technology Research and Development neglected diseases, narrates The edge in email. "Private sector companies have only a limited incentive to invest actively, so we don't need tools to manage these crises."

Daniel Bausch, Virologist and Director of the UK Public Health Rapid Response Team The edge"Ebola is really a canary in the coal mine of a population where the right to health is not maintained. His team contributed some training and preparation for drug testing in the Congo.

Bausch has been studying and working in Ebola Answer since the mid-nineties. Like Fawkey, he believes the recent success of finding a cure is a major change in the way the world can respond to threats of infectious diseases in the future. It is a "different world," he says, compared to "this idea that we were deeply rooted for in West Africa." [Ebola outbreak] The development of the drug has taken decades and cost several million dollars. "Ebola has shown that the process can be accelerated.

Nonetheless, Bausch warns that Ebola will become an exceptional case due to several factors. First, it is a common disease. "Everybody was willing to speed up, contribute and do things with Ebola that they routinely don't, because Ebola is such a bad situation," he says. "There are many bad diseases in the world, but not many that cause the same reaction and one-sided approach on deck."

Another interesting thing about Ebola: years before the outbreak in Africa, the US Department of Defense had signed several hundred million dollars worth of contracts with various pharmaceutical companies to study Ebola drug therapies. This is partly because the disease has been classified as a bioterrorism threat by the Centers for Disease Control and Prevention since 2004. Ebola is a biological weapon, "Bausch says. This is not the case with many other diseases tested without a vaccine or medicine, such as the Nipah virus.

Nonetheless, Bausch adds, "Thanks to a recent DRC study in the Congo, I think we need to be very optimistic and very proud that we can provide truly credible scientific evidence and answers in the most challenging conditions." spread to other people's outbreaks Illnesses in the future.

According to Nishi, government investment is critical to stimulating product development for all neglected and emerging diseases. In the case of Ebola, US funding and political commitment, as well as cooperation from other states and humanitarian organizations, were the key to the recent success story. But it can also raise additional questions about the future of Ebola treatment.

"Who pays and will pharmaceutical companies be motivated to switch to a FDA-approved commercial product? Provided, who will pay next time? "Says Bausch The edge, "We haven't gotten there yet, these questions will come up now as we move step by step."

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