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Updated Aug. 29, 2014 06:15 a.m. ET
ZMapp Cocktail Saved Monkeys When Administered Up to Five Days After Infection
An experimental drug cocktail has cured monkeys inoculated with a lethal dose of the Ebola virus, setting the stage for scientists to test the treatment in people.
While other drugs have shown some success in protecting monkeys against Ebola, they had to be dispensed within two days of exposure to the virus. By contrast, the latest treatment, known as ZMapp, saved the animals when it was administered up to five days after infection, when the monkeys were days or even hours from death.
"These results are very encouraging," said Peter Piot, co-discoverer of the Ebola virus and director of the London School of Hygiene & Tropical Medicine, who didn't participate in the study. Four decades after Ebola was first identified, "we may be on our way to an effective treatment."
There are currently no approved treatments or vaccines against Ebola. The latest study was published Friday in the journal Nature.
The scale of the current Ebola outbreak sweeping west Africa has highlighted the need for a powerful post-infection Ebola drug. At least 1,552 people have died after contracting the virus, and the World Health Organization has warned that the number of people infected could jump to 20,000 in the next nine months.
There also are worrying signs that Ebola is spreading beyond Guinea, Liberia, Sierra Leone and Nigeria. The Democratic Republic of the Congo, which stretches eastward to the center of the continent, recorded its first cases this week. On Friday, Senegal announced that a 21-year-old Guinean man believed to have contracted the virus was in quarantine in a hospital in Dakar, the state-run news agency reported.
In the study published in Nature, researchers described how they conducted tests on guinea pigs until they arrived at a particularly potent cocktail of three so-called monoclonal antibodies, which are designed to bind to the Ebola virus and neutralize it.
The cocktail, ZMapp, was tested on rhesus monkeys who were injected with a lethal dose of Ebola. Three groups of infected animals, consisting of six monkeys each, then received doses of the drug cocktail in varying intervals.
To the researchers' surprise, all 18 animals survived, with none having detectable levels of the virus three weeks after exposure. Severe symptoms of the disease—heavy bleeding, rashes and a large increase in liver enzymes—disappeared.
By comparison, three monkeys that didn't receive the drug died by day eight.
"The level of improvement was beyond my expectations," said Gary Kobinger of the Public Health Agency of Canada and a lead author of the Nature study.
It remains to be seen whether the drug will be effective in people. So far, seven people infected with Ebola have received the drug on a "compassionate use" basis. Some pulled through, but it is unclear whether, or to what extent, the drug was a factor in their survival.
It could be some two years before early-stage clinical trials determine whether Zmapp is safe for people, which makes it out of reach for those imperiled in the current epidemic. At that juncture, if the drug is shown to be safe, some countries may amass a small stockpile of the experimental medicine that can be administered in an emergency.
One complication is that there are different strains of Ebola, which may require different drug cocktails. The Ebola strain used in the Nature experiment is different to the new Zaire strain rampaging through west Africa. But Dr. Kobinger and his colleagues reported that ZMapp also worked against the new Zaire strain when tested in a lab dish.
ZMapp is made by Mapp Biopharmaceutical Inc. of San Diego. The drug is manufactured in tobacco plants that have been engineered so they mass-produce the antibodies that make up ZMapp.
Updated Aug. 24, 2014 09:45 a.m. ET
Uganda Provides A Model For Improved Ebola Detection And Prevention
In 2000, the deadly Ebola virus struck Uganda. And like the current outbreak in West Africa, now the largest in history, Uganda was completely unprepared.
Combating it in a remote northern district under siege from a rebel insurgency, Ugandan health authorities failed to stem an initial outbreak. Frightened residents—many displaced by militants and living in congested camps—hid their ill relatives, infecting themselves as they wiped away the sweat and blood of the sick or as they prepared infectious bodies for burial. Patients fled hospitals, spreading the disease. Health-care workers ran away too.
Uganda defeated the epidemic several months later, but by then, 425 people contracted Ebola, and more than half of them had died. It was the largest Ebola outbreak on record—until this year.
Today, Uganda has a different Ebola story to tell. The East African nation has had four more occurrences with the disease, but none has proved as deadly as the first in 2000. Authorities from the nation's president to village leaders exhort Ugandans to be on the lookout for people with symptoms. Health officials screen airline passengers and have stockpiled hospitals with supplies. Teams of veterinarians test wildlife for viruses like Ebola that can infect humans. Uganda has even sent doctors to West Africa to train medical staff there during the outbreak.
The contrast with the countries where Ebola is raging now—Liberia, Guinea and Sierra Leone—paints a picture of two Africas. One has built up a health and education system to shield itself against Ebola and other emergent disease threats. The other Africa is in chaos, its public health systems in shambles.
Uganda's experience offers the world a timely lesson as the outbreak threatens to burst beyond West Africa. It isn't only rich countries with sophisticated hospitals and expansive pharmaceutical industries that can squash outbreaks. Basic medical training, everyday vigilance and sustained political will go a long way. Propping up the health systems of poor nations with outside aid and workers—without passing on skills to locals—may provide a quick fix but won't immunize them from the next outbreak, which could be even bigger.
Uganda's three Ebola flare-ups since 2011 have fizzled out. There were a mere 18 cases of the disease. Eight people died. In one instance, a single case was isolated before the virus could spread.
Uganda is "really a model of what we want to see happen all over in low- and even middle-income countries in terms of better detection, response and prevention," said Tom Frieden, director of the Centers for Disease Control and Prevention, which has set up a high-security laboratory and helped fund other health system upgrades in the country as part of a U.S. government global health security initiative.
By contrast, Ebola-stricken countries such as Sierra Leone and Liberia are unraveling. Hospitals, schools and businesses have closed. In Liberia, doctors have gone on strike for want of protective clothing and gloves. In one Liberian neighborhood, residents looted a transit center for suspected Ebola patients.
A security crisis is now emerging: Earlier this week, Liberian soldiers fired on a crowd of young men who were trying to force their way out of a quarantined neighborhood in the stricken capital of Monrovia.
Despite a rising death toll, many of Liberia's residents are convinced that the virus is a government conspiracy. "It's a rumor," said Patrick Brandy, an electrician in Dolo Town, one of the nation's hardest-hit communities. "I've never seen anybody die of Ebola. I've only heard of it. So it's a rumor."
With at least 2,615 cases spanning West African countries, including 1,427 deaths, the epidemic is more than six times as large as the 2000 outbreak in Uganda's Gulu district. The World Health Organization says even that toll is "vastly" underestimated.
The West African epidemic illustrates the dangers that weak health systems in destitute, urbanized nations pose to the rest of the world—and the dangers of a tepid international response to their predicament. Like Uganda, the three West African nations are emerging from a past of war, dictatorship and corruption. But their wounds remain far more visible.
Until its first free election in 2010, Guinea was one of Africa's worst-led nations, its civil service systematically disemboweled over 50 years of dictatorship. Liberia's civil servants all but vanished too, fleeing in a 14-year-long civil war that erupted in 1989 and left 250,000 people dead after spilling into Sierra Leone and Guinea—the two fragile nations that now, not coincidentally, are also struggling to beat back Ebola.
Today, Sierra Leone has the lowest life expectancy on Earth, according to the World Bank. Guinea has the fewest number of hospital beds per person, according to a 2011 survey of 63 developing countries by the bank. Liberia has one doctor for every 71,428 people, the world's second-lowest rate, according to the WHO. All three have barely any public health expertise.
Liberia's Health Ministry spent months trying to persuade even senior government officials that Ebola was a real disease—not a scam perpetuated to draw aid money, as several officials suggested publicly. On a recent workday, Deputy Health Minister Tolbert Nyenswah was shouting with a secretary who brought in several stacks of papers in need of signatures.
"Only Ebola things I'm signing!" he yelled, adding to a reporter: "This is a public health catastrophe."
It's a public health threat to the rest of the world, too. Ebola has traditionally been a rural disease, infecting villagers who ate tainted bush meat or came into contact with bat droppings. They would then spread the infections to family members or health care workers who touched their bodily fluids.
The deadly virus emerged in a similar way this time. In December, the first known case was a 2-year-old who died in a village in Gueckedou, a rural prefecture in a forested area of Guinea near the borders with Liberia and Sierra Leone. The boy's mother, sister and grandmother died shortly after.
A Liberian health worker interviews family members of a woman suspected of dying of the Ebola virus in Monrovia on Aug. 14. John Moore/Getty Images
By late March, Ebola cases were cropping up hundreds of miles away on the Atlantic coast in Conakry, Guinea's congested capital, with a population of 1.7 million. The disease had also spread into Liberia, and then Sierra Leone, as nurses who treated the sick and villagers who attended their funerals all brought the virus into their homes and workplaces, sparking chain reactions.
It quickly became apparent how different this corner of Africa was from Uganda and other parts of Central Africa where Ebola has been striking sporadically since 1976.
Despite bad roads, West Africans are mobile; they travel long distances and carry the disease with them. In Uganda, just 16% of the population lives in cities, but that situation has become more the exception than the rule in Africa as economic growth picks up and more young people flood cities—and other countries—in search of work. In Guinea, 36% of the population lives in cites; in Liberia, it's 49%, according to the World Bank. Many also hew to traditional rather than modern medicine, making them suspicious of doctors and health officials trying to stop Ebola's spread.
In Guinea, officials recently have managed to turn a corner: Priests and imams recently convinced residents of 26 resistant villages to bring their sick to nearby clinics.
But Liberia and Sierra Leone are on an opposite trajectory. Governments there have simply cordoned off areas where the virus is spreading most. On Wednesday, Liberia's government blocked all entry and exit from West Point, a densely packed neighborhood of tin-roof houses overhanging the ocean.
The scenario playing out in West Africa could become more common. The number of new emerging diseases is increasing every year, and about three-quarters of them originate in animals, according to EcoHealth Alliance, a nonprofit organization that researches the animal origins of emerging viruses. At the same time, about 80% of the WHO's member states weren't able to meet original deadlines for strengthening their public health systems enough to comply with international health regulations that require a capacity to detect and respond to disease events and to report outbreaks to the WHO.
While government agencies and relief organizations had been working on some projects in the three countries to stem diseases such as malaria and Lassa fever, none are as robust as investments in countries like Uganda or Nigeria where governments have embraced change.
The WHO is trying to corral emergency funds of $100 million in international aid to carry out an Ebola action plan—an effort that is likely to take several months, with money that would have been better spent preventing such events in the first place. A spokesman said the agency has reached about 40% of that need so far.
The World Bank is providing up to $200 million in emergency funding to the three countries. The CDC has deployed 62 staff who are traveling to remote villages to train health workers, setting up mobile labs to test for the Ebola virus, tracking down people who may have been in contact with Ebola patients and other tasks.
But doctors, epidemiologists and other staff are all still in short supply. "We have reached our limit in what we can do," said Joanne Liu, international president of Doctors Without Borders, the nongovernmental group that is leading the effort to treat patients and is a veteran of multiple Ebola outbreaks. "We need the equivalent of the CDC from other countries to come in, and schools of tropical medicine that are used to working with hemorrhagic fevers. This is not happening right now."
The epidemic is also testing the limits of the WHO, which has been managing multiple public health crises this year, from Ebola to a flare-up of Middle East Respiratory Syndrome this spring. "We are extremely stretched," WHO Director-General Margaret Chan said earlier this month.
Despite its call for governments and other organizations to put more boots on the ground, the U.N. public health agency doesn't have the authority to compel any to rush in. "It's the coalition of the willing, not the coalition of 'you have to,' " said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a former government adviser on bioterrorism and public health preparedness. "There is really no incident commander on an international level."
In the long term, the answer for African nations is to build up their own public health systems so that they can fight disease battles mostly on their own, global health experts say. Nigeria is one example: To fight its own Ebola outbreak, sparked by a traveler from Liberia who died in Lagos, the country tapped public health expertise it has developed in recent years, said Health Minister Onyebuchi Chukwu. Six analysts from its emergency program to eliminate polio have helped lead the Ebola response. So far, 14 people have been diagnosed with Ebola, of whom five died.
"These are countries that just came up from civil war, and we have to help them," he said of Nigeria's West African neighbors. "We can assist with training." Nigeria runs a program set up by the U.S. CDC to train epidemiologists who track and help fight outbreaks, he said.
Before quashing Ebola, Uganda didn't win all its battles against the disease either. When people began dying of a strange and virulent disease in a small Ugandan town in the northern Gulu district in October 2000, chaos erupted. The scourge quickly spread to other villages and through camps full of people displaced by the rebel insurgency, as people infected themselves at funerals or patients fled Ebola treatment centers.
The Gulu outbreak, and another big one in 2007, prompted the nation's government to set up early warning systems and tools to fight an epidemic. Today, village health teams of between four to seven people monitor year-round for cases of diseases from hemorrhagic fevers to malaria, part of a push by President Yoweri Museveni to strengthen the country's public health system at all levels. Authorities broadcast health messages on more than 200 radio stations across the country when an epidemic strikes, as well as television and places of worship. "Every time I appear for my weekly radio talk show, I remind my people" to look for symptoms of Ebola given the West African outbreak, said Moses Awany, deputy residence district commissioner for the Gulu district.
In 2010, the CDC set up a new high-security laboratory at the state-run Uganda Virus Research Institute, overlooking Lake Victoria, to test for viral hemorrhagic fevers such as Ebola and Marburg. The agency had collaborated for years with the Ugandan government on a big U.S. government HIV/AIDS relief program; now it also wanted to respond more quickly to other emerging infectious disease outbreaks in the region. Previously, samples from possible Ebola patients had to be shipped abroad—often to the U.S.—for testing. Today, "we can test in one day," said Trevor Shoemaker, an epidemiologist in the U.S. agency's viral special pathogens branch. That allows responders to pinpoint and get to the scene of an outbreak much more quickly, he said. "The time savings for us being in country is huge," he said.
The agency tapped a system it had already built that collected blood samples for its HIV/AIDS program to collect samples to test for other diseases, including viral hemorrhagic fevers.
At the two-room lab Wednesday morning inside the gates of the institute, Stephen Balinandi leapt to his feet as a delivery man arrived with a square-shaped box. "Now that's another sample from the airport," he said, holding the door open for the delivery man.
A flood of suspected Ebola virus samples has poured in recently due to concern about the West African outbreak, Dr. Shoemaker said. While the lab normally receives five to 10 samples a month for testing, last week it got 10, including two from Rwanda, and three or four from an airport screening.
In an Ebola outbreak in 2012, CDC and Ugandan scientists set up a rapid diagnostic testing center in Luwero district, where cases were reported, gaining the ability to confirm cases quickly and enabling early diagnosis and treatment, Mr. Balinandi said. That helped stamp out the outbreak quickly; only six people were infected.
The CDC has also helped Uganda set up an emergency-operations center, a critical tool that it uses itself at its headquarters in Atlanta to monitor outbreaks and coordinate the response to them, said Dr. Frieden.
Uganda has a spottier record in its fight against HIV, with rates of infection rising after sharply declining in the 1990s. A Ugandan court earlier this month overturned a law signed by President Museveni in February that mandated life sentences for certain homosexual acts, which HIV advocates worried would make it harder to get people at risk to present themselves for testing and treatment.
The CDC investments in Uganda are paying off, said Dr. Frieden. "It's exceeded far beyond our expectations," he said. They are part of a larger U.S. government global health security project to help 30 countries upgrade their health systems. At least $40 million in existing funds are going toward the project in fiscal 2014 and another $40 million is included in President Barack Obama's fiscal 2015 budget request. "This is our No. 1 priority for global public health," Dr. Frieden said.
The agency will now help build public-health systems in Guinea, Sierra Leone and Liberia as part of its work to control the outbreak there. "It's in everybody's interest in the U.S. and globally, and there is a real need for us to invest in the weakest links, the blind spots, the places where the next SARS or MERS or Ebola or H7 or H1N1 or the next HIV will emerge," said Dr. Frieden of the global health security initiative. "There will be new health threats, and they will be very costly in terms of lives and economic impact. SARS cost the world $30 billion in just a few months. The current Ebola outbreak is going to devastate the economies in many West African countries."
He added, "Imagine how different the world would be today if we'd found HIV a couple of decades before we did."
Updated Aug. 13, 2014 05:31 a.m. ET
Ebola Virus: Experimental Drugs Approved for Use in Fighting Outbreak in West Africa
The World Health Organization gave a green light to the use of experimental drugs to combat the Ebola outbreak in West Africa, with demand for—and questions about—untested treatments growing after two infected Americans received some.
A panel of ethicists convened by the WHO said on Tuesday that it is ethical to use the treatments given the size of the outbreak, which has killed at least 1,013, and the challenges of controlling it through regular measures that have stopped other Ebola outbreaks.
"We find ourselves facing a dilemma," Marie Paule Kieny, a WHO assistant director-general, said about a handful of medications and vaccines that have been developed but never tested in humans. "Far too many lives are being lost right now."
Also Tuesday, the Canadian government said it would donate 800 to 1,000 doses of experimental Ebola vaccine to the WHO for use in combatting the outbreak. The vaccine has shown promise in animal research, said the Public Health Agency of Canada. The vaccine was developed by scientists at the agency's National Microbiology Laboratory. The Canadian government owns the intellectual property and licensed the rights to a U.S. company, BioProtection Systems Corp.
The WHO's endorsement came after Liberia's government confirmed that it had ordered three courses of the same treatment that was given to the Americans. Bernice Dahn, the nation's chief medical officer, said the drug, called ZMapp, should arrive in Liberia on Wednesday and would be given to three doctors.
Health authorities in Liberia expressed concern last week that the drug had been given to the two Americans, but not to infected Liberians, and said they would explore getting some on their own. But three courses of the treatment won't go far in a country that has had nearly 600 cases, including a recent resurgence, with 45 new cases between Thursday and Saturday.
The WHO's decision is meant to assure manufacturers that there will be a market for their drugs if they boost production for this outbreak. But it isn't clear whether the manufacturers would be able to meet demand quickly enough. The maker of ZMapp, San Diego-based Mapp Biopharmaceutical Inc., on Monday said it exhausted its available supply after filling its request from West Africa.
Moreover, it is far from clear what effect, if any, ZMapp actually had on the two infected Americans, Kent Brantly and Nancy Writebol, who remain in isolation at Emory University Hospital in Atlanta. A 75 year-old Spanish priest who had been airlifted to Madrid from Liberia last week was also administered the same drug, a representative of his religious order told Europa Press Television. Members of the order were hopeful for his recovery, but the priest, Rev. Miguel Pajares, died.
"Whether ZMapp works, this is difficult to state with any definitive opinion right now," said Dr. Kieny. "We have to see if this is a definite cure or not."
Emory and the charities for which the two work declined to comment on the condition of Dr. Brantly and Ms. Writebol. Ebola experts say most deaths from the disease occur during the eighth to 10th day of illness.
Dr. Brantly said last week that he felt initial symptoms on July 23, putting him at 20 days of illness on Tuesday. Ms. Writebol was diagnosed nearly at the same time as Dr. Brantly, also putting her past that critical stage.
ZMapp is a cocktail of three so-called monoclonal antibodies, which are derived from living cells and are designed to bind to and neutralize the Ebola virus. The product has shown promise in monkey studies, but the drug's safety hasn't been established in human clinical trials. A unit of tobacco-products maker Reynolds American Inc. RAI -0.39% manufactures ZMapp using tobacco plants in Kentucky.
Mapp last week said it was working with government agencies to increase production of the drug. The company declined to comment on Tuesday on the WHO's endorsement of the use of experimental drugs. A Reynolds spokesman last week said it could take several months to significantly boost production.
The U.S. Defense Threat Reduction Agency, an arm of the Defense Department, recently said it would expand a contract awarded to Mapp to include funding for the preparation of an application to the U.S. Food and Drug Administration to start human clinical trials of ZMapp, and to make sufficient quantities of the drug for a study.
Another Ebola drug developer, Canada's Tekmira Pharmaceuticals Corp. TKM.T +5.19% , also declined to comment on the WHO's statement. Tekmira is developing an experimental treatment called TKM-Ebola, which is designed to harness a drug technology known as ribonucleic acid interference to combat the virus. Tekmira has a contract valued at as much as $140 million from the U.S. Defense Department to develop the drug.
This year, Tekmira started a small safety study of TKM-Ebola in healthy volunteers. In July, the FDA placed a "clinical hold" that paused the study while the FDA assesses more information about how the drug works. Last week, the FDA modified its stance to enable testing of Tekmira's drug in infected patients, although the hold on healthy volunteers is still in place, the company said. Tekmira hasn't disclosed specific plans for further testing.
The WHO panel said given the fact that the drugs are untested in humans, health authorities and doctors have a "moral obligation" to collect and share data on their use in patients.
Eric Kodish, chair of the Department of Bioethics at the Cleveland Clinic, praised the WHO's endorsement, but said it must be made clear to patients that the drug they are being offered is untested.
"In times of desperation, the rules of the game need to be changed and there needs to be a lot of transparency around that change," he said. "Patients and loved ones need to understand the experimental nature of all this."
Updated Aug. 12, 2014 10:05 a.m. ET
Maker of Experimental 'ZMapp' Ebola Drug Says Supply Is Exhausted
The maker of the experimental Ebola drug that was given to two infected Americans said Monday that its supply has been exhausted.
Mapp Biopharmaceutical Inc. said in a brief online statement it had complied with every request for the drug that had the necessary legal and regulatory authorization. The company said it provided the drug, called ZMapp, at no cost in all cases.
San Diego-based Mapp didn't name any countries that requested the drug and didn't release additional details.
In a statement Monday, the office of Liberia's president said the U.S. planned to deliver sample doses of an "experimental serum" to Liberia later this week to treat Liberian doctors infected with Ebola.
Liberia said the shipment was in response to a request Friday sent to President Obama by Liberian President Ellen Johnson Sirleaf. The statement didn't name the drug.
The Spanish missionary priest who tested positive for Ebola has died, a hospital spokeswoman said Tuesday. The hospital wouldn't confirm if 75-year-old Miguel Pajares was treated the with experimental Ebola drug ZMapp.
ZMapp's safety hasn't previously been established in humans, but the drug has shown promise in monkey studies.
Last week, Mapp said it provided ZMapp to two Americans infected with Ebola in West Africa who have been taken to Atlanta for treatment. The company has said it is working with U.S. government agencies to increase production of ZMapp, which was in limited supply because the company was focused on animal testing and hadn't planned to start human testing until next year.
Health authorities in Liberia expressed concern last week that the drug had been provided to two Americans but not to infected Liberians. Liberian officials last week said they would explore getting the experimental drug for other patients.
The Defense Threat Reduction Agency, or DTRA, an arm of the Department of Defense that develops countermeasures to weapons of mass destruction, plans to award a contract to Mapp to help it begin clinical trials testing ZMapp in humans, according to a notice posted online July 22.
Updated Aug. 11, 2014 10:26 a.m. ET
Nigeria and Ivory Coast Restrict Flights From Countries Hit by Ebola Virus
Nigeria and Ivory Coast on Monday both restricted flights from Ebola-infected countries, in steps that underscore fears of the virus in West Africa spreading globally by air travel.
The Nigerian Civil Aviation Authority on Monday suspended Gambia Bird Airlines Ltd. until it "put in place acceptable and satisfactory measures to contain the spread of Ebola virus," according to a letter seen by The Wall Street Journal. There have been no recorded cases of Ebola in Gambia, the tiny West African nation where the airline is based. But the airline does fly to Guinea, Sierra Leone, and Liberia—the three countries fighting an Ebola outbreak. The airline didn't return calls requesting comment.
Meanwhile, the Ivory Coast went further, banning all flights and passengers coming from those three countries from entering its airports.
On Saturday, Zambia banned all citizens of Liberia, Sierra Leone, Guinea, and Nigeria from entering the country—the broadest move so far to block travelers from Ebola-infected countries.
The moves reflect the heightened state of global concern over Ebola and how fast and far it may travel. From Hong Kong to New York to Cape Town, hospitals are gearing up to treat potential patients but so far all that the vigilance has yielded is a series of false alarms.
Airports in Hong Kong, South Korea, Saudi Arabia and the Philippines have all hospitalized feverish passengers arriving from West Africa and sampled their blood for Ebola. All tests to date have been negative.
Ebola has killed more than 961 people since the current outbreak emerged from the forests of Guinea between last December and February of this year, according to the World Health Organization. The virus has likely sickened another 1,711.
Yet some health experts are cautioning governments against overreacting.
The World Health Organization on Friday said it saw no reason to cancel flight connections to the three West African countries overwhelmed by Ebola—even as it termed the epidemics there a global public health emergency. The U.S. embassy to Liberia echoed that view in a statement last week.
The virus, which causes a fever followed by internal bleeding, is difficult to spread by air travel: Most victims are far too ill to board a plane by the time they become symptomatic and contagious. In the 38 years the WHO has tracked the disease, no Ebola epidemic on record began with an infected airline passenger.
"Panic is the bigger issue right now," said Chief Operating Officer John Rose of iJet International, which advises companies on health-related travel issues. "We all know the chances of contracting Ebola are extraordinarily low—it's not an easily spread disease unless you're a caregiver."
Still, African countries are seen as particularly vulnerable because of their generally weak public health systems and their proximity to the outbreak. Officials are under pressure to stop a disease that poses a danger to health workers battling the Ebola virus.
In Nigeria on Monday, Health Minister Onyebuchi Chukwu said that blood tests had confirmed Ebola in a ninth hospital worker who, like the previous eight, had treated a single Liberian-American man who flew into Lagos last month. She was a newly married nurse and her husband is also now under surveillance.
In East Africa, two people in Uganda and Kenya—who were quarantined after showing symptoms consistent with Ebola—also tested negative for the virus according to officials in those countries.
The Hong Kong Department of Health, meanwhile, cleared via blood test a suspected Ebola case on Monday of a visitor from Nigeria. It was the second suspected case to prove negative there. Tests on a man who died in Saudi Arabia, initially reported as a likely Ebola suspect, also returned negative.
Officials in Africa face a delicate determination in deciding how to increase border controls without shutting off too much travel and trade.
On the one hand, a pandemic on the world's poorest continent would be a devastating setback—potentially reversing gains that many nations here have made against poverty. That scenario has emerged as the biggest threat to Africa's economic outlook this year, said Chris Derksen, head of frontier and emerging markets at Investec Asset Management.
Last week, a bogus case of Ebola at a Cape Town hospital frightened many South Africans, after a city health official sent an email to colleagues saying a woman with the virus had been admitted. In fact doctors had already determined she didn't have the disease and the city has taken steps to make sure false diagnoses aren't made again, said Priya Reddy, a spokeswoman for the city.
A nightmare scenario remains improbable, officials say. "It is highly unlikely we will see sick persons getting on the plane and getting here," said South Africa's health minister, Aaron Motsoaledi. "It's not just like anybody can just spread the disease because they are breathing."
Even so, the travel bans and evacuations of expatriate staff are denting economies of several West African countries that were rebounding after civil war and military rule. Liberia had shown some promise shifting away from a 1989-2003 conflict, and Guinea had in 2010 held its first free and fair election in its history. Sierra Leone was forecast to be Africa's fastest-growing economy this year, before Ebola forced police to quarantine wide swaths of the population.
"We were just picking up," said Abdulai Baratay, a government spokesman. Now, he added, "We are diverting our meager resources that were going into areas like agriculture, education, infrastructure development into fighting Ebola."
Updated Aug. 8, 2014 6:09 a.m. ET
Ebola Virus Outbreak Is Public Health Emergency, World Health Organization Says
Outbreak in West Africa Requires Extraordinary Response to Stop Its Spread, Agency Says
The World Health Organization has declared the Ebola outbreak in West Africa to be an international public health emergency on Friday.
The outbreak is the largest and most severe in four decades, driven in part by the poor health infrastructure in affected nations and cross-border traffic, which has led to infections in Guinea, Liberia, Sierra Leone and Nigeria.
As of Monday, 1,711 cases had been reported to the WHO with 1,070 confirmed as Ebola, and 932 deaths. Some 140 or 150 health-care workers have been infected, with about 80 deaths, said Margaret Chan, the director general of the WHO.
A Liberian soldier in Bomi County restricted travel as a measure to try to curb the spread of Ebola virus on Thursday.
"The outbreak is moving faster than we can control it," said Dr. Chan. "We do expect to see more cases and we do believe there are more cases than what's being reported."
In addition to the inadequate medical resources in these nations, high anxiety and initial denial from local governments about the disease have contributed to a reluctance to seek medical care, further increasing the likelihood of infection among family and friends, said the WHO.
"Countries affected to date simply do not have the capacity to manage an outbreak of this size and complexity on their own," Dr. Chan said at a news conference in Geneva. "I urge the international community to provide this support on the most urgent basis possible."
Following an emergency meeting of experts over the past two days, the committee recommended that travel be restricted in the region where the Guinea, Sierra Leone and Liberia meet, considered to be a disease hot spot. The panel didn't recommend imposing a general travel or trade ban for these nations.
The current outbreak of Ebola began in Guinea in March. There is no licensed treatment or vaccine for Ebola and the death rate has been about 50%.
The impact of the WHO declaration is unclear; the declaration about polio doesn't yet seem to have slowed the spread of virus. During a WHO meeting last week to reconsider the status of polio, experts noted countries hadn't yet fully applied the recommendations made in May, there have been more instances of international spread and that outbreaks have worsened in Pakistan and Cameroon.
In the U.S., the Centers for Disease Control and Prevention have already elevated their Ebola response to the highest level and has recommended against traveling to West Africa. On Thursday, CDC director Dr. Tom Frieden told a congressional hearing that the current outbreak is set to sicken more people than all previous outbreaks of the disease combined.
"These are comprehensive and evidence-based recommendations based on current information, and clearly demonstrate the importance of the International Health Regulations and its emergency committees that can be called on virtually to make recommendations to the Director General based on available information at the time of international spread of infections such as Ebola," said David Heymann, professor of infectious disease epidemiology at the London School of Hygiene and Tropical Medicine, who wasn't involved in the decision, in a statement.
CDC Director Confident U.S. Won't See Large Ebola Outbreak
Frieden Says U.S. Officials Are Boosting Efforts to Fight the Disease in West Africa
The nation's top public-health official said Thursday he is confident a large Ebola outbreak won't occur in the U.S. and that U.S. officials are increasing efforts to combat the spread of the disease in West Africa.
Thomas Frieden, director of the Centers for Disease Control and Prevention, said at a congressional hearing that his agency was sending 50 disease-control experts to the region. Officials were also trying to improve their ability to identify cases to prevent the spread of infection, support patients' care and protect health-care workers.
"It is not impossible that there will be some travelers who become sick in this country," said Dr. Frieden. "But we are confident that a large Ebola outbreak in the United States will not occur."
He also warned that controlling the outbreak requires "meticulous attention to detail."
"It's like fighting a forest fire: leave behind one burning ember, one case undetected, and the epidemic could reignite," he said to three lawmakers who attended the emergency hearing convened while Congress is in recess. The CDC has moved to its highest response level, reserved for large-scale medical crises, to fight the Ebola outbreak.
Dr. Frieden said it wasn't clear whether an experimental Ebola treatment given to the two American volunteers— Kent Brantly and Nancy Writebol —while in Liberia was safe or could be made widely available. The two have since been flown to Emory University Hospital in Atlanta for further treatment.
Dr. Frieden told lawmakers and reporters that while officials were "encouraged" by efforts to explore the treatments, they already had the means to stop the outbreak through "plain and simple" methods. Those include case tracking and public health warnings to avoid contact with people sick with Ebola or the bodies of those who died from the disease.
Late Thursday, Canadian drug developer Tekmira Pharmaceuticals Corp. said the U.S. Food and Drug Administration had cleared the way to allow Tekmira to provide an experimental Ebola treatment to infected patients.
The FDA last month had issued a "clinical hold" to pause an early-stage study of Tekmira's drug in healthy volunteers, citing the need to assess how it worked. Tekmira said Thursday the FDA had modified the hold to enable the drug's potential use in patients infected with Ebola. The hold on providing the drug to healthy volunteers remains in place. Tekmira said it was evaluating options for use of its drug.
The FDA declined to comment specifically on Tekmira, but said it sometimes permits studies that have been placed on clinical hold to proceed if a drug's emergency use in patients with disease has an acceptable risk-benefit balance. Tekmira is jointly developing the drug under contract with an arm of the Defense Department that develops medical countermeasures to biological threats to the military.
Ariel Pablos-Mendez, assistant administrator for global health at the U.S. Agency for International Development, said his agency had dedicated $14.55 million to its response to the disease in West Africa since March.
Ken Isaacs, the vice president of international programs and government relations for Samaritan's Purse, an aid group treating victims of the outbreak, criticized the lack of attention before the U.S. aid workers' illness.
"It took two Americans getting the disease in order for the international community and the United States to take serious notice of the largest outbreak of the disease in history," he said. "The disease is uncontained and out of control in West Africa."
Mr. Isaacs said the ministries of health in Liberia, Guinea and Sierra Leone "do not have the capacity to handle the crises."
The U.S. military is supporting Mapp Biopharmaceutical Inc.'s efforts to develop its experimental treatment for Ebola called ZMapp. The drug, which was given to Dr. Brantly and Ms. Writebol, hadn't been tested before in humans.
The Defense Threat Reduction Agency, or DTRA, an arm of the Department of Defense responsible for developing countermeasures to weapons of mass destruction, plans to award a contract to Mapp to help the company begin clinical trials testing ZMapp in humans, according to a notice posted online July 22.
Mapp said earlier this week it is working with government agencies to increase production of ZMapp, which is in limited supply because the company was focused on animal testing and hadn't planned to start human testing until next year.
The fact that Americans received the treatment—and that Africans haven't—has prompted complaints.
Sheik Humarr Khan was the top Sierra Leone doctor fighting Ebola and died July 29 of the disease. On Thursday, his brother Sahid Khan said news that two American volunteers infected in Liberia received an experimental Ebola treatment was "very disappointing," because his brother never had the chance for such medicine.
Officials were trying to fly Dr. Khan, 39 years old, to Europe or South Africa, but he died in Sierra Leone before being taken anywhere, said his brother who lives in Philadelphia.
The Ebola outbreak in West Africa has so far infected more than 1,450 people and killed close to 800. But while the outbreak is a frightening and formidable challenge.
Like influenza, the viruses that cause SARS and MERS are primarily transmitted through droplets in the air and on surfaces, droplets released when an infected person coughs or sneezes. While we could vaccinate against MERS or SARS, the current risk of disease is too low to warrant wide-scale vaccine campaigns. There have been no cases of SARS since May 2004, and the virus responsible for MERS does not typically cause severe disease in otherwise healthy people.
Ebola, in contrast, has a high mortality rate (up to 90%) but is spread only through intimate contact with bodily secretions such as vomit, blood or feces. There is no risk in sitting next to an infected traveler on an airplane. In principle, therefore, transmission can be prevented by isolating people with the disease.
About 70% of emerging infectious diseases, including HIV/AIDS, West Nile, influenza, SARS, MERS and Ebola, are animal infections that have jumped to humans, frequently through a domesticated animal. Pigs are a common intermediate for respiratory viruses including influenza. Opportunities for such cross-species jumps are increased by the loss of wildlife habitat to development as well as the human consumption of bushmeat due to poverty or cultural preference. A warming climate may also increase the geographic range of insects like mosquitoes and ticks that can carry diseases such as dengue, malaria and chikungunya. By analogy to a related virus, Marburg, scientists presume that Ebola originated in bats, although there is no proof.
We may not be able to directly address the drivers of infectious disease, but we can invest in surveillance in the developing world where cross-species transmission is likely to occur. We also can improve diagnostics and pursue new strategies for rapidly developing and manufacturing drugs and vaccines.
What else can be done to mitigate risk in America? Nonessential travel to areas where Ebola is active should be curtailed, and individuals returning from these areas must be monitored.
There is also more we can do to reduce the risk of pandemic disease. The economic downturn of the past several years has reduced funding for the World Health Organization, U.S. national health agencies such as the Centers for Disease Control and the National Institutes of Health, impairing their ability to respond to outbreaks such as Ebola. But clinical, laboratory and support staff and supplies are urgently needed in Guinea, Sierra Leone and Liberia for patient care, infection control, contact tracing and community engagement.
The U.N.'s International Health Regulations, adopted in 2005, commit all member states to respond to the spread of diseases throughout the world that pose risks to public health without unnecessarily disrupting international traffic and trade. The U.S. must honor this commitment by investing in science and public-health surveillance at home and abroad. This is the right thing to do. It is also—for more threatening infectious diseases if not for Ebola—in our own self-interest.
The Ebola outbreak in West Africa has infected more than 1,300 people since February in Guinea, Sierra Leone and Liberia. The escalating outbreak has underscored the challenges of quelling a deadly disease in countries with poor health infrastructure. The infected include two Americans who were working at a treatment center in Africa.
1. Outbreak Is Largest In History
The outbreak in Liberia, Guinea and Sierra Leone has infected more than 1,300 people and killed more than 700 this year. World Health Organization Director-General Margaret Chan warned Friday that the outbreak was spiraling out of control, and that the consequences could be “catastrophic” in lives lost and economic disruption, if greater efforts aren’t put into place now.
2. Some Survive Infection
While the fatality rate for Ebola can be as high as 90 percent, health officials say the current death rate is about 70 percent. Those who fared best sought immediate medical attention. There is no vaccine or cure.
The virus is not airborne. People would have to come into contact with bodily fluids including blood, sweat, vomit, urine, saliva or semen of an infected person. Patients aren’t infectious until they are sick—and even when they begin to develop symptoms, they aren’t highly infectious, experts say. The most contagious patients are those who are very sick and unlikely to be moving around much.
5. What's Being Done To Fight Ebola
The World Health Organization said it would lead a $100 million campaign with its member countries to put more money and disease fighters in the three countries, including 50 additional staff from the U.S. Centers for Disease Control and Prevention.
Infected American Said to Be Improving in Hospital
An update on the condition of the two Americans infected with Ebola and how getting early care improved their survival chances, plus all the latest on efforts to quell the epidemic in Africa.
An American infected with Ebola in Liberia was being treated and monitored in the U.S. on Sunday, as doctors worked to provide care in what will be a crucial few days in his attempt to recover from the deadly disease.
About a week after his first symptoms of Ebola were reported, Kent Brantly, a doctor, was in an Atlanta hospital's special isolation unit. He had arrived Saturday, flown from Liberia in a chartered air ambulance, and he appeared in fairly good condition as he walked, covered from head to toe in a protective suit, into the unit at Emory University Hospital.
Plans to soon bring a second American Ebola patient from Liberia to the same hospital were on schedule, according to the air-charter company hired to do the job.
Dr. Kent Brantly in an undated photo. Samaritan's Purse/Reuters
An Emory spokeswoman wouldn't comment Sunday on the condition of Dr. Brantly, a 33-year-old from Texas, who was infected while working at an Ebola treatment center operated by two U.S. faith-based organizations. Tom Frieden, director of the Centers for Disease Control and Prevention, which is based in Atlanta right near Emory, told Fox News on Sunday that Dr. Brantly "appears to be improving, and that's encouraging."
Samaritan's Purse, one of the charities operating the center and the group that brought Dr. Brantly to Liberia, also said Sunday that the doctor's condition was improving, and Dr. Brantly's wife, Amber, said in a statement that she was able to see her husband and that he was in good spirits.
The next several days will be critical for the two patients. Ebola has taken the lives of as many as 90% of those it has infected in past outbreaks.
American Ebola patient Dr. Kent Brantly arrived from West Africa for treatment at Emory University Hospital on Saturday. His is the first known case of Ebola to be treated in the U.S. Another infected patient, charity worker Nancy Writebol, is expected to arrive in the coming days.
There is no vaccine or treatment for the viral hemorrhagic fever, which causes symptoms such as fever, headaches, vomiting and diarrhea and can puncture blood vessels to cause internal bleeding. But good supportive care, such as fluids to replace those lost in vomiting and diarrhea, medication to bring down fevers, and antibiotics for complications can improve a patient's chances by keeping the immune system as strong as possible to fight off the virus.
In fact, early treatment may have helped keep the death rate lower in the current outbreak in West Africa, according to Stephan Monroe, an emerging infectious diseases expert at the CDC. Of 1,323 cases, 729 have died, according to the World Health Organization, putting the death rate at 55%.
Dr. Brantly and Ms. Writebol began receiving supportive care as soon as they were diagnosed, according to their respective charities. Dr. Brantly also got a blood transfusion from a 14-year-old boy who survived Ebola under Dr. Brantly's care, in the hope that antibodies would help him, too, fight off the virus. Both Dr. Brantly and Ms. Writebol received an experimental serum, the charities said, though they didn't specify what the treatment was.
An Emory spokeswoman wouldn't comment on what treatments are being used at the Atlanta hospital.
There are several vaccines and drug treatments in development and testing for Ebola, but none have been approved by regulators. Commercializing them is a challenge given that Ebola is a rare disease, said Thomas Geisbert, who works on potential Ebola vaccine platforms as a researcher at the University of Texas Medical Branch at Galveston.
"Ebola is very rare—there is not a financial incentive for large pharmaceutical companies to make vaccines for Ebola," he said. "It's really going to require government agencies or a foundation."
Vaccines would be helpful not only as a preventive tool, but to stop transmission during outbreaks, said Thomas Ksiazek, director of high-containment laboratory operations at Galveston National Laboratory. They can be given shortly after infection, and having a vaccine to offer could help draw out contacts of a patient, he said—something that has been hard to do in this outbreak.
"If you identify all of these people at risk, that would reduce the chance of them becoming ill and transmitting it on to others," he said.
Dr. Ksiazek, a veteran of multiple Ebola outbreaks as a former special pathogens branch chief at the CDC, is heading to Sierra Leone Aug. 11 to help with outbreak-control efforts, part of an all-hands-on-deck call by the WHO. Ebola is such a rare disease that no more than 300 medical and public health professionals have experience with outbreaks, said Dr. Ksiazek's former colleague at the CDC, Pierre Rollin, who has been in West Africa for most of the past four months.
"People with this experience are getting to be overwhelmed," Dr. Ksiazek said of the reasons he was asked to come. He said he would help lead a team of epidemiologists tracking the outbreak.
Samaritan's Purse said it expected to finish evacuating this weekend all but its most essential personnel from its operations in Liberia. SIM USA is evacuating nonessential personnel, too, though sending in another American doctor to help at its Ebola treatment center near Monrovia, Liberia.
Liberian Authorities Question Why Two Received Experimental Treatment; Second U.S. Patient Returns From Africa
A second American aid worker infected with Ebola arrived at Emory University in Atlanta for treatment. Both patients there have been given an experimental drug to combat the virus.
As the second U.S. Ebola patient arrived in Atlanta on Tuesday, health authorities in Liberia raised questions about how the woman and an American doctor were given an experimental U.S. treatment unavailable to the hundreds of Africans sickened by the deadly virus.
While still in Liberia, both Nancy Writebol, who was working at an Ebola center for a Christian charity, and Kent Brantly, a physician there, received an experimental drug known as ZMapp. The drug's safety hasn't been tested in humans, and experts said it is too soon to know if it is effective.
For the drug to be used in Liberia, it would have to be approved by the country's Ministry of Health Ethical Committee, said Bernice Dahn, Liberia's chief medical officer.
Dr. Dahn said she wasn't aware of the committee approving any experimental Ebola treatment, though she also wasn't aware of any being disapproved. It is conceivable a treatment was approved without her knowledge, she said. Liberia's assistant health minister, Tolbert Nyenswah, didn't know of any approval. Liberia's presidency also wasn't aware, said Information Minister Lewis Brown.
A male patient who recently returned from West Africa with symptoms consistent with the Ebola virus is being tested for the disease at Mount Sinai hospital in New York City, where he was admitted early on Monday morning, officials said.
Now, Dr. Nyenswah said, officials have been beset with requests from dying patients and their relatives for the same treatment.
"This is something that has made our job most difficult," Dr. Nyenswah said. "The population here is asking: 'You said there was no cure for Ebola, but the Americans are curing it?'"
Liberian officials were set to meet Wednesday with the World Health Organization to see about getting the experimental drug rushed into use for other patients, said Dr. Nyenswah.
Ebola, which is usually fatal, causes fever, headaches, vomiting and diarrhea and can cause internal bleeding. The virus is transmitted through bodily fluids. The Ebola outbreak, the largest in history, started in February and has spread through Liberia, Guinea and Sierra Leone.
Details of how ZMapp was administered to the patients in Liberia—and who authorized its use—remained sketchy Tuesday.
Bruce Johnson, president of SIM USA, the Charlotte, N.C.-based charity with which Ms. Writebol, 59, and her husband, David, went to Africa, said at a news conference Tuesday that the decision to use the drug was left to the patients, their families and their doctors.
Nancy Writebol, who contracted Ebola while working foraChristian charity in Liberia, arrived Tuesday at Emory University Hospital in Atlanta. Journal & Constitution/Associated Press
An Obama administration official said Tuesday that the treatment was arranged by Samaritan's Purse, a humanitarian organization that sponsored Dr. Brantly in Liberia. The National Institutes of Health provided Samaritan's Purse with contacts at the company developing this treatment, the official said.
"The NIH did not procure, transport, approve or administer the experimental treatments in Liberia," the official said.
A spokeswoman for the U.S. Food and Drug Administration said the FDA can provide access to experimental treatments by a mechanism known as an emergency investigational new drug application, and that the agency's approval is required before an experimental drug can be given in the U.S.
Mapp Biopharmaceutical Inc. of San Diego, which developed ZMapp, describes the drug as a cocktail of three "humanized" monoclonal antibodies that are manufactured using tobacco plants. A monoclonal antibody is a laboratory-engineered version of natural antibodies found in humans and animals that help combat disease. Monoclonal antibodies are typically injected or infused; some already on the market treat diseases ranging from cancer to rheumatoid arthritis.
ZMapp was derived from mouse cells that were "humanized," or infused with human components, to work in people, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
The cocktail comprises components of two older experimental drugs: MB-003, which was developed by Mapp; and ZMab, developed by Defyrus Inc. of Toronto and the Public Health Agency of Canada. MB-003 showed promise in treating monkeys infected with Ebola, according to a study published last year in the journal Science Translational Medicine.
ZMapp is made by infecting tobacco plants with certain proteins, growing them in the plants, then extracting and purifying the proteins, according to David Howard, spokesman for tobacco-products maker Reynolds American Inc. A Reynolds unit, Kentucky BioProcessing LLC, has a contract to make the drug in Owensboro, Ky., Mr. Howard said.
Kentucky BioProcessing is working with Mapp and government agencies to increase production of ZMapp, he said. In addition, the company complied with a request from Emory University, at whose hospital the two patients are being treated, and Samaritan's Purse to provide a limited amount of ZMapp to Emory, said Mr. Howard. He declined to say how much was provided. An Emory spokeswoman wouldn't confirm the request.
Ms. Writebol, the patient who arrived in Atlanta on Tuesday, is in stable condition and was able to have potato soup and coffee on Sunday, according to SIM USA. Her husband, who isn't infected, is expected to arrive in Atlanta in a few days.
For 12 years, Emory University Hospital has housed a specially built isolation unit equipped to treat patients exposed to deadly infectious diseases. Ms. Writebol will be in the unit with Dr. Brantly, a 33-year-old doctor from Texas who was infected at the same Ebola center where the two worked. Samaritan's Purse had no updates on his condition Tuesday, but it reported over the weekend that his condition was improving.
Separately, the Centers for Disease Control and Prevention is testing blood from a man who recently returned from West Africa with symptoms consistent with Ebola and has been hospitalized in New York.
Also Tuesday, British Airways said it was suspending flights to Liberia and Sierra Leone this month due to the Ebola scare.
Mapp Biopharmaceutical Says Treatment Wasn't Slated for Human Trials Until Next Year
The president of the company that made an Ebola treatment given to two Americans said Wednesday that the drug maker hadn't expected to use it in humans this soon.
Mapp Biopharmaceutical Inc., which makes the treatment called ZMapp, had planned to start testing ZMapp's safety in humans in clinical trials next year, President Larry Zeitlin said in an email. The company, which has nine employees, had been focused on making a limited amount of ZMapp for testing in animals, which is why so little is available.
Now the company is working with the Food and Drug Administration to figure out the quickest and safest route to making it widely available, he said.
FDA officials declined to address specifically the question of whether they played a role in getting ZMapp to the two American volunteers working with humanitarian groups—Nancy Writebol, 59, and Kent Brantly, 33—who contracted Ebola and now are at Emory University getting treatment. Ms. Writebol worked for SIM USA, while Dr. Brantly was from Samaritan's Purse.
Bruce Johnson, president of SIM USA, said at a news conference Tuesday that the decision to use the drug was left to the patients, their families and their doctors.
The drug was administered in Liberia. Its use was arranged by Samaritan's Purse, according to the Department of Health and Human Services and Mr. Johnson at SIM USA.
The officials said the agency can approve such individual treatment with experimental drugs by deeming the drug to be an "emergency investigational new drug." In general, it can allow for the use of such unapproved drugs, and often does so, in response to requests by individual doctors.
Responding to the criticism from African officials that West African patients weren't able to get the drug, U.S. officials said there is "a very limited supply" and that the company "does not have the capacity" to make large amounts of it. In any event, they stressed, there is no evidence that the drug is either effective or safe in humans, at this point.
FDA officials said their ability to talk about the specific case of ZMapp is limited, but that in general it helps make such drugs available regularly to doctors who hear about investigational drugs. In most cases, these are drugs that are in clinical trials.
The agency says such cases are "extraordinarily expedited" and that there is limited paperwork. It can involve giving an investigational drug to just one patient who isn't part of a clinical trial but who may benefit, in the judgment of the treating doctor. There are cases like this almost every day, FDA officials said.
The FDA said that drugs for Ebola are largely tested in animals, and not humans, for the reason that it is unethical to infect a patient with Ebola.
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