Misha Hussain / Courtesy Reuters A scientist tests blood for Ebola at the European Mobile Laboratory in Gueckedou, Guinea, April 3, 2014.

An Unnecessary Plague

Why Ebola Vaccines Don't Reach the People Who Need Them

The patient zero for the latest outbreak of the Ebola virus is believed to have been a person in a remote, mountainous area in southern Guinea, a country with just one doctor per 10,000 people. Experts believe that he or she contracted the virus by eating bush meat (likely fruit bats, which are considered a delicacy in the region), died, and then passed the virus at the funeral, where mourners traditionally touch the deceased body before its burial. By March, the highly contagious disease, which is transmittable by any bodily fluid, had made its way to the capital, Conakry, prompting panic among the city’s two million residents. Since then, the disease has spread to neighboring Liberia, with additional cases suspected in Sierra Leone, Ghana, and Mali. The World Health Organization (WHO) estimates that this latest outbreak has already claimed more than 100 lives.

Any outbreak of Ebola -- whose symptoms include high fever, debilitating fatigue, and uncontrollable bleeding from the eyes, the nose, and the mouth -- is highly distressing for those afflicted. Suspected and confirmed patients are usually put into isolation wards and treated by doctors who wear plastic jumpsuits, despite central Africa’s extreme heat. “It’s a difficult place to work, but much more difficult to be a patient,” said Henry Gray, an emergency coordinator with the NGO Medecins sans Frontières who has been working on front lines of the outbreak in Conakry. Even in death, its victims can suffer indignity: they are often denied ritual burials, and are instead buried in isolation, after disinfection, by medical workers.

What’s particularly disturbing about the present crisis, however, is that some infections could have been prevented. For years, the United States has been developing preventatives and treatments for Ebola, which would both provide defense if Ebola were used in warfare and reduce the spread of an outbreak of the disease. But, despite lobbying from scientists amid this latest outbreak, the drugs have not been put to the test. 

That the United States government is interested in Ebola has less to do with humanitarianism than with national security. The Ebola virus is classified by the U.S. Center for Disease Control and Prevention as a Category A bioterrorism agent -- the same category as anthrax. For over a decade, the U.S. Department of Defense has been funding research into developing effective Ebola vaccines and cures.

Among the recipients of that funding is the Canadian pharmaceutical firm Tekmira, which has a $140 million contract to develop an Ebola treatment called TKM-Ebola. The drug has shown a 100 percent success rate in monkeys; in January, Tekmira announced that it had given the first trial dose to a healthy human. In March, the U.S. Food and Drug Administration granted TKM-Ebola fast track status to speed up the drug’s development.

Some scientists have argued that the latest outbreak in Africa should have been seen as an opportunity to put drugs like TKM-Ebola to the test. “It is fair to assume that TKM-Ebola, the most advanced Ebola antiviral in development, will do more good than harm in a disease without alternatives besides supportive care,” Dirk Haussecker, a biologist and medical consultant, recently argued. “If I were the U.S. government, I would be eager to take advantage of the unique opportunity at testing efficacy before spending billions on an agent for which there is only theoretical human efficacy.”

Bringing a drug through trials to market is estimated to cost somewhere between $500 million and $2 billion. In this case, it’s unlikely that a pharmaceutical company would ever foot the bill; the prospect of selling an Ebola drug to a relatively small number of poor Africans (or to a handful of NGOs) is not an enticing enough financial incentive.

Despite the attractions of fast-tracking trials, most health experts caution against distributing untested drugs. National regulators strictly prohibit pharmaceutical companies from using unlicensed drugs such as TKM-Ebola. And these regulations exist for good reason. Absent clinical trials, it becomes impossible to know whether drugs have side effects, or what their severity might be. “We can’t just take drugs that may not be safe and move them into emergency situations for the sake of testing them out on people. That’s not an ethical or responsible thing to do,” said Katherine Harmon, the director for health intelligence at the risk management firm iJET, which specializes in global medical, chemical, and biosecurity analysis. Distributing drugs before such trials have been conducted would violate a key tenet of medical ethics: Primum non nocere -- first, do no harm. (The same rule has also guided humanitarian aid since at least the 1990s, when the American economist Mary B. Anderson argued for its importance.)

Just as significant, from the perspective of governments and pharmaceutical companies in the West, is that using drugs in the field before they’ve been tested could do irreparable damage to their reputations among vulnerable populations in other countries. “Local populations don’t understand Phase IV or V trials,” said Harmon. “It builds mistrust for drug companies trying to help them in future events if the drugs do not help, or render side effects. Then they turn to local health practitioners, which can do more harm than good.” 

There are practical limitations to conducting drug trials of any sort when it comes to Ebola -- researchers, after all, can’t infect human beings with the virus in order to test a cure. Instead, drugs are first tested on animals who are given the disease, and later trialed on healthy individuals in a clinical setting to prove safety. Testing the drugs on people who contract Ebola is extremely difficult, not least because their numbers are so small. (The WHO lists fewer than 3,000 confirmed cases to date.) In contrast to HIV-AIDS drug trials, the window of opportunity for treating Ebola is very narrow. The disease has a rapid onset, a high fatality rate, and an unpredictable distribution. Epidemics usually flare up and die down again within a few months. Last year, researchers at the University of Texas published an article in the journal Biodrugs emphasizing the need for "novel pharmaceutical approaches to refine and overcome barriers” associated with Ebola treatments.

If anything is capable of expediting the release of safe and effective Ebola drugs, it may be the U.S. government. Washington, after all, has played a significant role in these drugs’ development. And there are precedents for the public sector pushing pharmaceutical research toward completion. After U.S. troops contracted malaria during the Vietnam War, the U.S. government initiated the first public-private venture between the U.S. Defense Department and a pharmaceutical company. In the 1970s, scientists at a U.S. Department of Defense research facility developed mefloquine, an antimalarial often called Larium; the Department of Defense then put it through Phase I and II trials, before giving it as a free good to the Swiss pharmaceutical company F. Hoffmann-La Roche. The drug, which skipped Phase III safety trials, went straight to market. Some side effects later emerged, but the process proved that drugs could be quickly made available to the public. “This idea that it’s very, very expensive and takes an awfully long time and therefore only the private sector can do it is widely contested,” a former aid worker, who asked to be anonymous, said. 

For now, Gray and his team in Conakry are still using the same simple treatments that have been used by doctors since the Ebola virus was first discovered on the Ebola River in the Congo basin in 1967 -- namely, soap, clean water, rehydration salts and fluids, nutritious food, and isolation, to prevent the spread of the disease. “We’re honest: there’s no vaccine, no cure, but if you come to our centers, we’ll give you the best chance for you to heal yourself, for your own body to fight the disease,” said Gray.

So far, more than forty people have managed to walk out of Gray’s clinic on their own. Of course, if an effective vaccine or treatment were approved for use, some may never have had to walk in to begin with.

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