Fears have been raised over the distribution of an experimental Ebola drug after a Spanish priest, believed to have been treated with the serum, succumbed to the virus, becoming the first European death.
The development comes just hours after it was announced two Liberian doctors who contracted Ebola will given the ZMapp serum, which has so far only been given to Westerners.
Lewis Brown, Liberia's information minister, told Reuters that the drugs could be in Monrovia within 48 hours. The San Diego producer of the drug, Mapp Biopharmaceutical, said it had provided the drug at no cost to everyone who had requested it, but now its supply was exhausted.
“It is our understanding that all patients offered treatment, treated, or expected to be treated were or are highly capable of providing informed consent for the use of an experimental drug not yet evaluated for safety in animals or people,” the company said in a statement. “Additional resources are being brought to bear on scaling up. The emergency use of an experimental medicine is a highly unusual situation.”
Liberia had been vocal about the injustice of white Americans receiving cutting-edge treatment for the virus while Africans had been offered little more than infection control. Bernice Dahn, Liberia's chief medical officer, told the Wall Street Journal last week that word is beginning to spread that the Americans have a cure. "This is something that has made our job most difficult," she said. "The population here is asking: 'You said there was no cure for Ebola, but the Americans are curing it?'"
The serum has been previously used to treat two American aid workers and a Spanish priest, who died of the disease on Tuesday. Father Miguel Pajares was airlifted from Liberia last week and flown to Spain for treatment. He was quarantined with a nun who worked with him in the country, who has since tested negative for the disease.
Spain's Health Ministry said on Monday that it had obtained ZMapp over the weekend to treat Pajares, who caught the disease early last week. But a spokesman for Madrid's Carlos III Hospital told reporters it would not confirm whether he had actually been treated with the serum.
The two Americans who received the drug are reportedly responding to treatment, but it is not known whether they may have recovered naturally or because of the drug. The mortality rate from Ebola can be as high as 90%, though this particular strain of the virus has caused death in around 60% of cases.
The US government's National Institutes of Health has said it gave the American charity Samaritan's purse the contacts, but did not "procure, transport, approve or administer the experimental treatments [for the two Americans] in Liberia," the official added. The LA Times quoted Larry Zeitlin, president of Mapp Biopharmaceutical, last week as saying that the cocktail of three monoclonal antibodies is one of several currently in development, but "very little of the drug is currently available."
The United States Army Medical Research Institute of Infectious Diseases has tested the drug on monkeys, with four of the six animals that were treated 48 hours after infection surviving, with two untreated animals dying. If the reported timings are correct, Pajares, if he did receive the serum, was in far later stages of the disease.
More than 1,000 people have now died in the worst outbreak in recorded history, according to the World Health Organisation.
“The US Government assisted in connecting the Government of Liberia with the manufacturer,” the US Department of Health and Human Services said in a statement. "Since the drug was shipped for use outside the US appropriate export procedures had to be followed.”
The ethical dilemma over giving experimental cures to desperate victims had divided medical professionals. The issues of "ethics surrounding use of therapies when safety is unproven, ethics governing priority setting for access to these therapies and principles for fair distribution" were discussed at Monday's meeting at the World Health Organisation in Geneva.
he panel said research efforts had been invested in developing drugs and vaccines for the disease over the past decade with some showing "promising" results in the laboratory, but they had not yet been evaluated for safety in human beings.
"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 UN health agency said in a statement.
"Ethical criteria must guide the provision of such interventions. These include transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community."
The panel included UK experts Professor Peter Smith of the London School of Hygiene and Tropical Medicine and Professor Jeremy Farrar, director of the Wellcome Trust. Farrar had been particularly vocal in the past month about the need to trial experimental treatment. "Not a single individual has been offered anything beyond tepid sponging and 'we'll bury you nicely'," he told Reuters. "It's just unacceptable."
Dan O’Connor, head of humanities and social science at the Wellcome Trust said it was a "very welcome outcome".
"It is crucial that ethical considerations guide the use of any interventions and that the moral duties both to ensure the consent and understanding of participants and to share resulting data are properly met," he added. "The safety and efficacy of interventions must be assessed as fully as possible, and the only real way to do that is to assess them in affected countries in genuine and transparent partnership with the communities and individuals involved.”
But Grazia Caleo, an epidemiologist with Médecins Sans Frontières who has spent the last four weeks treating Ebola in Sierra Leone, told The Huffington Post UK that seeing people survive the disease had made her more cautious about the idea of offering up "experimental" treatments.
"People are recovering from Ebola, we don't want to give people something that could potentially harm their chance of survival," she told HuffPost. "We should push to increase access to safe and effective treatment, but we still don't know what the outcome of these serums will be on those patients in America."
Professor Jonathan Ball, professor of molecular virology at the University of Nottingham, told the Press Association that the panel's findings did not come as a "huge surprise".
But he warned that using experimental therapies was not without risks, including that of generating "mistrust" among African countries. "You certainly cannot say definitively that something which works and is safe in animals will work and be safe in humans; I think there is a risk," he said. "However, when you weigh that against the fact that there is 60% chance that you will die of Ebola infection, you can understand how they reached the decision."
He said he was concerned too about how clinical trials could be conducted effectively in the current situation. "I can absolutely understand why they have said they (the experimental therapies) can be used but it worries me that we might end up none the wiser at the end," he added.Suggest a correction