This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at http://www.nytimes.com/2014/08/13/world/africa/ebola.html

The article has changed 6 times. There is an RSS feed of changes available.

Version 4 Version 5
World Health Organization Endorses Use of Experimental Ebola Drugs Opting Against Ebola Drug for Ill African Doctor
(about 9 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 in the world’s worst known outbreak of the disease. The doctor who had been leading Sierra Leone’s battle against the Ebola outbreak was now fighting for his own life, and his international colleagues faced a fateful decision: whether to give him a drug that had never before been tested on people.
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. Would the drug, known as ZMapp, help the stricken doctor? Or would it perhaps harm or even kill one of the country’s most prominent physicians, a man considered a national hero, shattering the already fragile public trust in international efforts to contain the world’s worst Ebola outbreak?
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 treatment team, from Doctors Without Borders and the World Health Organization, agonized through the night and ultimately decided not to try the drug. The doctor, Sheik Umar Khan, died a few days later, on July 29.
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. The doses of the drug that were not used were eventually sent to Liberia, where other doctors made the opposite decision and two American aid workers became the first people in the world to receive ZMapp. Both of them survived and are now being treated at Emory University Hospital in Atlanta.
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. “It’s a little political; that’s what it looks like to me,” Alhajie Khan, Dr. Khan’s brother, said of the decision. “Why would you not give it to him? The guy who helped all of these people.”
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.” The provision of ZMapp, which is in extremely limited supply, to foreign aid workers has raised broad ethical questions about the disparities in treatment between white outsiders and the Africans who form the overwhelming majority of victims in the epidemic.
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.” Those concerns were heightened further after Spanish officials confirmed that they had obtained a supply of ZMapp for a third patient, a 75-year-old Spanish priest who died Tuesday after having been evacuated to Madrid from Liberia.
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 previously untold story of Dr. Khan, recounted by two doctors involved in discussions about whether to use ZMapp, offered an unusual glimpse into the wrenching ethical dilemma of when and how experimental drugs should be used to combat the Ebola epidemic in West Africa. Had the treatment team decided differently in his case, the first person treated with the drug would have been African.
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. On Tuesday, the World Health Organization endorsed the use of untested drugs to combat the outbreak, which has already killed more than 1,000 people and continues to spread. But ZMapp and other potential treatments are in such short supply that another politically charged question remains: Who should get them?
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. Marie-Paule Kieny, assistant director general of the World Health Organization, said at a news conference in Geneva on Tuesday that several drugs and vaccines had shown some promise in animal testing and might conceivably be used.
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.” But none are “available in unlimited supplies right now,” Dr. Kieny said. “I don’t think that there could be any fair distribution of something which is available in such a small quantity.”
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. On Tuesday, Liberia’s government announced that it would receive ZMapp after its president, Ellen Johnson Sirleaf, requested the drug from the United States. It said the drug would be used to treat two doctors who have Ebola.
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. That would be the first known use of the drug to treat Africans, but it also might be the last for a while. The manufacturer, Mapp Biopharmaceutical, said that it had complied with a request from a West African nation, but noted in a statement that the available supply of the drug was now exhausted.
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. In the case of Dr. Khan, who has been called “the arrowhead of the fight” against Ebola in his country, the doctors involved said there was no intention to save the drug for Americans. They said it was not known that the American aid workers were sick at the time of the decision not to treat Dr. Khan, around July 23. Instead, they said, doctors feared stoking the considerable suspicion of Western medical institutions in the country, which was already making it harder to contain the outbreak.
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. “What they really didn’t want to do was kill Dr. Khan with their attempt at therapy,” said Dr. Armand Sprecher, a public health specialist at Doctors Without Borders. “If word got out that M.S.F. killed Dr. Khan, that would have implications for outbreak control,” he added, using the initials for the French name of the relief group.
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. Dr. Sprecher, who is involved in the procurement and use of drugs for Doctors Without Borders but was not directly treating Dr. Khan, said another factor was that Dr. Khan’s virus levels were so high it was believed the drug would probably not work.
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. He said the treatment team never discussed the option of using the drug with Dr. Khan himself, deciding it would do so only if it decided to go ahead with the treatment.
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. “There are an awful lot of people who are very traumatized by the whole event,” Dr. Sprecher said in a telephone interview from Brussels on Tuesday.
Mapp, the manufacturer of ZMapp, said it had complied with every request for the drug that had the necessary legal and regulatory approvals. At the time the decision was made, less was known about ZMapp, which may have helped the two American relief workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and then evacuated.
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. Dr. Sprecher said the Spanish priest, the Rev. Miguel Pajares, had received the first of three recommended doses of ZMapp. He said the drug sent to Spain had originally been obtained by Doctors Without Borders and the World Health Organization for use in emergencies. It was kept at the University Hospital of Geneva, which had the authority to decide how the drug was used.
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. Father Pajares worked in a hospital in Liberia and was the first European to return home after being infected with Ebola. The Spanish Health Ministry confirmed that it had obtained ZMapp for him, but hospital officials in Madrid, citing patient confidentiality rules, declined to say whether Father Pajares had ultimately been treated with ZMapp. Officials said he would be cremated in a sealed coffin, with no autopsy, to reduce the risk of any further contagion.
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. Also on Tuesday, the press in Canada reported that the country’s Health Ministry planned to offer hundreds of doses of an experimental vaccine for use in Africa.
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. Dr. Kieny of the W.H.O. said Tuesday that intensifying public health measures to contain the outbreak was more important than supplying drugs. “It is very important to not give false hope to anybody that Ebola can be treated now,” she said.
A string of coincidences led to the decision in Dr. Khan’s case, Dr. Sprecher said. A Canadian team setting up a laboratory had taken some of the drug with it to Sierra Leone. It set up shop next to the Doctors Without Borders treatment center in Kailahun, and let the relief organization know the drug was available.
Dr. Khan was in charge of the Lassa fever ward in Kenema, which had become the Ebola ward. But when he became ill he was moved to Kailahun so he would not be treated by his own colleagues. Dr. Khan was going to be airlifted to Switzerland, where he would receive better care, making the drug less necessary, his treatment team reasoned. But after the decision was made, and just before he was to depart, Dr. Khan began vomiting and having diarrhea, and the transportation company refused to take him.
Dr. Daniel G. Bausch, an associate professor of tropical medicine at Tulane University who was involved in the discussions, said that he disagreed with the decision and that if he were sick with a life-threatening disease he would have wanted the drug, even if it had not undergone safety testing.
He also said he thought Dr. Khan should have been asked for his own opinion. “Dr. Khan was the perfect patient, I think, to understand the complexities of that gray area,” he said.
Nonetheless, he said that it was a close call and that he respected the decision of the doctors on the ground. “There was considerable difference of opinion even within M.S.F.,” he said.
Dr. Bausch, who has been a consultant to the W.H.O., said he had been a close friend of Dr. Khan and had recruited him in 2004 to take over the Lassa fever ward at the hospital in Kenema, a dangerous job given that the previous holder of the position had died from Lassa fever.
Dr. Bausch was in Sierra Leone until July 16. When he and Dr. Khan said goodbye to each other that day, Dr. Khan felt well. But he became sick within hours and tested positive for Ebola virus around July 21 or July 22, setting the stage for the decision.
"We were willing to try anything,” said Dr. Khan’s sister, Umu Khan. “It was not right; we should have had a say.”