An Ebola cure emerges from the pharmaceutical valley of death

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Last week marked an extraordinary advancement in our global health security as clinical drug trials treating Ebola, one of the most deadly known pathogens to mankind, in the eastern Democratic Republic of the Congo (DRC), saw a 90 percent survival rate in patients where past outbreaks claimed up to 90 percent of their victims.

While an experimental vaccine was in use to protect people from catching Ebola, this is the first effective treatment for those infected with the hemorrhagic fever.

Never before has a drug been developed and administered during an ongoing epidemic, jumping what can be a decade-long queue through regulatory agencies for neglected diseases, which some call the pharmaceutical valley of death.

“This is the first time that a randomized, controlled trial has shown quickly and successfully what the best drugs are in the middle of an ongoing outbreak,” said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH).

But what is more astonishing is that despite all the obstacles faced — a transmission rate tripling one year after Ebola was identified in August 2018, a neglected healthcare delivery system, a stalled international response, distrust of authorities within the affected communities and violence against healthcare workers — something went so right.

And at the intersection of painstaking scientific study and small miracles, we now have a road map to get ahead of the Ebola chain of transmission in the DRC, which has led to the infection of 2,900 people and the deaths of 1,900, as well as a framework for future international collaboration.

Last August, shortly before the outbreak was declared, the government of the DRC approved four medicines for “compassionate use” in Ebola-infected patients, permitting researchers from the NIAID and the World Health Organization (WHO), the government of the DRC and other non-governmental organizations, to devise a clinical-trial ensuring that every person who participated received one of the treatments. There were no placebos.

Working in the conflict zone of eastern Congo where rebel forces, mercenaries and the military collide, researchers were forced to adapt, preparing drug trials for disruption, including evacuations when Ebola responders came under attack.

Violence notwithstanding, scientists enrolled more than 700 participants, vaccinated nearly 170,000 people, and sequenced the genomes of more than 270 Ebola samples.

Two of the drugs, ZMapp and Remdesivir, are antivirals advanced during the West Africa Ebola outbreak of 2014, but as there was no proof then of their safety or efficacy, clinical assessments did not begin until the outbreak was near its end, limiting patients’ treatments solely to rehydration therapies and other symptom management. As a result, some 11,000 persons died across Sierra Leone, Guinea and Liberia, roughly 2 out of every 3 who were infected.

A survivor emerging from an Ebola Treatment Unit (ETU) during the West Africa outbreak was a rare event — a muted celebration with awareness of all those who did not make it: children, parents, brothers, sisters, extended family and other loved ones.

The two other drugs in the DRC trials, mAb114 and REGN-EB3, developed following the West Africa outbreak, are monoclonal antibodies. The former, mAb114, was developed using antibodies harvested from survivors of Ebola; the latter is from antibodies generated within mice infected with the disease.

During the study, 49 percent on ZMapp and 53 percent on Remdesivir died, compared to 34 percent on mAb114 and 29 percent on REGN-EB3. The newer drugs proved 3 times more effective. Moreover, the survival rate among patients with low levels of the virus in their blood was as high as 94 percent when given REGN-EB3 and 89 percent when on mAb114. 

“It’s really good news,” says Sabue Mulangu, an infectious-disease researcher at the National Institute for Biomedical Research (INRB) in Kinshasa and an investigator on the trial. “Now we will be able to stress to people that more than 90% of people survive if they come into the [ETU] early and get this treatment.”

It is hoped that these two drugs will turn the tide of  the outbreak, which was declared a public health emergency last month, by changing the behaviors of the local Congolese, where infected people are reassured to self-identify and seek treatment at the ETUs — heretofore viewed as a place where sick people go to die. Even so, the risk of transmission across international borders will remain high.

The DRC Ebola heroes and heroines are many: scientists and researchers, front-line healthcare workers, including Médecins Sans Frontières, OXFAM, Mercy Corps, the International Rescue Committee (IRC), the International Federation of Red Cross and Red Crescent Societies (IFRC), the WHO, the NIAID, the DRC’s Institute National de Recherche Biomedicale, the community mobilizers… and the tens of thousands who grew sick and died. Each has helped conceive the urgency for scientific discovery and global mobilization to save the next generation of lives.

But this army of practitioners would never have been assembled on the DRC battle field if it weren’t for the leadership of the United States in the fight against global infectious diseases, a consistently bipartisan mission across successive U.S. administrations and Congresses, including the passage of a $5.4 billion urgent supplemental appropriations for response, recovery and preparedness following the 2014 outbreak — and, most recently, fending off successive foreign aid cuts and proposed rescissions from President Trump’s office of Management and Budget (OMB).

Jamie Bay Nishi, director of the Global Health Technologies Coalition, said “government investment is essential to advancing products for any neglected and emerging diseases. In the case of Ebola, U.S. funding and political commitment were key to the recent achievement, as was the collaboration of other states and humanitarian organizations.”

In OMB’s latest $4 billion rescission plans, global health was taken off the table, a small victory but choked by a misguided belief that health security stands alone and outside of an ecosystem of access to education, water, sanitation, job creation, democracy and human rights.

It looks like Members of Congress have a job to do upon their return from recess — but maybe they can take inspiration from Dr. James Lawler, an infectious disease expert at the University of Nebraska Medical Center.

“Doing clinical trials in ideal settings is difficult. Doing those trials in the middle of a public-health emergency is even more difficult,” he says. “All of those barriers were overcome in some of the most austere environments that you could potentially devise for an outbreak setting. If we can do it in that setting, I think it demonstrates that we can do it just about anywhere.”

NOTE: This post has been updated from the original to clarify that ZMapp and Remdesivir were advanced during the outbreak of 2014.

K. Riva Levinson is president and CEO of KRL International LLC, a D.C.-based consultancy that works in the world’s emerging markets, award-winning author of “Choosing the Hero: My Improbable Journey and the Rise of Africa’s First Woman President” (Kiwai Media, June 2016). Follow her on Twitter @rivalevinson

Tags Anthony Fauci CDC Democratic Republic of Congo Donald Trump DRC Ebola Ebola virus disease MAb114 NIAID Western African Ebola virus epidemic

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