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World Health Body Endorses Use of Experimental Drugs Against Ebola Virus World Health Organization Endorses Use of Experimental Ebola Drugs
(about 5 hours later)
GENEVA — The World Health Organization on Tuesday endorsed the use of untested drugs to combat the Ebola virus, just hours after a Spanish priest who had been supplied with experimental medication became the first European to die of a disease that has claimed more than 1,000 lives in West Africa and which ranks as the worst known outbreak. GENEVA — The World Health Organization on Tuesday endorsed the use of untested drugs to combat the Ebola virus, just hours after a Spanish priest who had been supplied with experimental medication became the first European to die in the world’s worst known outbreak of the disease.
Citing medical confidentiality rules, hospital officials in Madrid declined to say whether the priest, Miguel Pajares, 75, had been treated with an experimental drug, ZMapp, made in the United States, which the Spanish Health Ministry said on Monday it had obtained for him. No proven cure or vaccine exists for the Ebola virus, which the World Health Organization says has killed 1,013 people in four West African countries — Guinea, Liberia, Nigeria and Sierra Leone. Around half of the people infected in the outbreak, first reported in March, have died. Last week, the World Health Organization declared the outbreak a global health emergency.
In Geneva, the World Health Organization convened an ethics panel on Monday to debate the broader use of untested drugs and said in a statement on its website on Tuesday: “In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.” The Spanish priest, Miguel Pajares, 75, worked in a hospital in Liberia and was the first European to return home after being infected with Ebola. Citing medical confidentiality rules, hospital officials in Madrid declined to say whether the priest had utlimately been treated with the experimental drug, ZMapp, made in the United States, but the Spanish Health Ministry said on Monday that it had obtained the medication for him.
The provision of ZMapp, a previously untested drug in extremely limited supply, to foreign aid workers evacuated from West Africa has raised broad ethical questions about the disparities in treatment between white outsiders and the Africans who form the overwhelming majority of the victims. Two American aid workers, Dr. Kent Brantly and Nancy Writebol, who were were evacuated to Emory University Hospital in Atlanta, received the drug as well, prompting questions from some African officials about why their nations had not received the medication.
Then on Tuesday, the government of Liberia announced that it would receive ZMapp after a request to the United States by its president, Ellen Johnson Sirleaf. It said the drug would be used to treat two doctors battling for their lives against the Ebola virus.
That would be the first known use of the drug to treat Africans, but it also might be the last for a little while. The manufacturer, Mapp Biopharmaceutical, said that it had complied with a request received over the weekend from a West African nation, though it noted in a statement that the available supply of the drug was now “exhausted.”
In Geneva, the World Health Organization convened an ethics panel on Monday to debate the broader use of untested drugs. In a statement on its website on Tuesday, it said that given “the particular circumstances of this outbreak,” the panel had reached a consensus that “it is ethical to offer unproven interventions with as yet-unknown efficacy and adverse effects, as potential treatment or prevention.”
The panel said the use of untested drugs should be guided by ethical criteria, including transparency about all aspects of the care provided, informed consent of the patient, freedom of choice and patient confidentiality.The panel said the use of untested drugs should be guided by ethical criteria, including transparency about all aspects of the care provided, informed consent of the patient, freedom of choice and patient confidentiality.
No proven cure or vaccine exists for the Ebola virus, which the World Health Organization reported has now killed 1,013 people in four West African countries — Guinea, Sierra Leone, Liberia and Nigeria. Around half the people infected in the outbreak, which was first reported in March, have died. World Health Organization officials said another meeting would be held at the end of the month to deal with another delicate and politically charged question: how to allocate scarce treatments.
Last week the World Health Organization declared the outbreak a global health emergency. Dr. Marie-Paule Kieny, assistant director-general of the World Health Organization, said at a news conference in Geneva on Tuesday that there were several drugs and vaccines that have shown some promise in animal testing that might conceivably be deployed in the outbreak.
So far, experimental medication has been made available to only a handful of patients, all of them foreign aid workers evacuated from West Africa, prompting ethical concerns about disparities in the availability of treatment between white outsiders and the Africans who form the overwhelming majority of the victims. However, she said, none “is available in unlimited supplies right now.” She added, “I don’t think that there could be any fair distribution of something which is available in such a small quantity.”
ZMapp, the drug sent to Madrid for Mr. Pajares, was reported last week to have helped two American aid workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and were evacuated to Emory University Hospital in Atlanta. Dr. Kieny said that intensifying public health measures to contain the outbreak was more important than drugs. “It is very important to not give false hope to anybody that Ebola can be treated now,” she said.
The Spanish priest, Mr. Pajares, was flown back to Spain with a nun who worked with him, Juliana Bohi, who has tested negative for the Ebola virus. He was treated at Carlos III hospital in Madrid. The priest worked for a Roman Catholic order based in Spain that runs hospitals in many parts of the world and had been treating Ebola patients in Liberia. His death from the Ebola virus was the first reported on European soil. The Spanish priest, Father Pajares, was flown back to Spain on Aug. 7 with a nun who worked with him, Juliana Bohi, who has tested negative for the Ebola virus. He was treated at Carlos III hospital in Madrid. The priest had worked for a Roman Catholic order based in Spain that runs hospitals in many parts of the world. His death from the Ebola virus was the first reported on European soil.
Tuesday’s statement from the World Health Organization came as Liberia announced that it would receive ZMapp after a request to the United States by its president, Ellen Johnson Sirleaf. Upon their arrival in Spain, the two were kept separated and in isolation on a floor of the hospital in Madrid. A dozen doctors and nurses looked after Father Pajares, who died early Tuesday morning, although the hospital and Spain’s Health Ministry made no official statement about the exact circumstances of his death. He will be incinerated in a sealed coffin, without carrying out any prior autopsy, to reduce the risk of any further contagion.
The World Health Organization played no part in that decision, a spokeswoman, Fadela Chaib, told reporters in Geneva. The Spanish authorities said they had obtained a supply of ZMapp from Geneva last week, without giving details. On Monday, José María Viadero, the director of Juan Ciudad, a nongovernmental organization linked to the religious order Father Pajares belonged to, told Europa Press that Father Pajares was “stable” and was being treated with the experimental drug ZMapp since the weekend.
Mapp Biopharmaceutical, the San Diego company that developed ZMapp, said in a statement that it had complied with a request received over the weekend from a West African nation that it did not identify but which was apparently Liberia. It said that in doing so, the available supply of ZMapp was now “exhausted.” The hospital and Spain’s Health Ministry, however, would not comment on Tuesday about how Father Pajares had been treated, nor offer any assessment of the efficiency of the ZMapp experimental drug.
The company said that it had complied with every request for ZMapp that had the necessary legal and regulatory approvals. This apparently means that the government involved had to approve use of the drug and that the patient involved had given informed consent to use the experimental treatment. Father Pajares was a veteran missionary who joined his religious order as a teenager. He had previously worked in Ghana before settling in Liberia in 2007, where he worked in Saint Joseph’s Catholic Hospital in Monrovia, Liberia, alongside others from the brotherhood of Saint John of God.
One person briefed on the provision of the treatment, who requested anonymity because of the legal and political sensitivity of the matter, said that enough of the drug to treat three people was being sent to Liberia. The repatriation of Father Pajares set off some debate in Spain last week, with some questioning why some of his African, Ebola-suffering colleagues had not also been allowed on the flight. On Tuesday, Prime Minister Mariano Rajoy offered his condolences for Father Pajares’s death, alongside other Spanish politicians and the royal family.
Mapp, the manufacturer of ZMapp, said it had complied with every request for the drug that had the necessary legal and regulatory approvals.
Mapp and the United States government, which has financed most of the company’s work, are making plans to increase supplies of ZMapp. But it is expected to take several months to increase supplies, and even then, there may be no more than a few hundred doses available, and perhaps less, according to federal officials and corporate executives.
The drug consists of three monoclonal antibodies, which are proteins designed to bind to the virus and neutralize. The drug has been manufactured in the leaves of tobacco plants at a facility in Owensboro, Ky., that is owned by Reynolds American, the cigarette company. Federal officials are looking at using other facilities to manufacture the drug as well.
Dr. Kieny said similar therapy might be provided using the blood of patients who have recovered from Ebola, because those patients apparently have effective antibodies. She said the World Health Organization was looking at helping blood centers in the affected countries gather such blood.
She said two vaccines to prevent disease could be ready for human testing by the end of September. If so, data would be available on their safety as early as the end of the year.