For most of the 38 years since its discovery, the story of Ebola has been a story of neglect and failure: a disease of impoverished Africans in obscure countries, of little interest to drug companies, ignored by almost every government.
Today, with an Ebola outbreak raging out of control and even Western citizens dying, global researchers are rushing to catch up to the crisis – even if it means breaking the normal rules for testing and approving new drugs.
A panel of medical ethicists and other experts, hastily convened by the World Health Organization, announced on Tuesday that it was ethical for experimental drugs to be given to those who have fallen ill during the worst outbreak of Ebola in history, as long as certain conditions are met.
The decision to allow “compassionate use” of unlicensed drugs is a response to a global storm of outrage over the apparent unfairness of giving an unproven drug treatment to two American missionaries who were infected with the Ebola virus in Liberia, while Africans had no access to those same drugs.
The two Americans, now in an Atlanta hospital, have dramatically improved since they began receiving the experimental drug treatment, known as ZMapp, officials say. Yet many scientists view the issue as a moral conundrum, since the broader use of unproven drugs could see Africans used as guinea pigs for potentially risky or worthless treatments with unknown side-effects.
A sense of historical injustice weighed heavily on the ethicists, including a Canadian professor, as they debated the issue. “The fact that there is currently no registered drug for Ebola is a market failure,” said Marie-Paule Kieny, assistant director-general of the World Health Organization (WHO).
“It’s a market failure because this is typically a disease of poor people in poor countries, where there is no market. If it hadn’t been for the investment of a few governments in the development of these drugs, we would be nowhere.”
Allowing the use of unproven drugs for Ebola patients is “an opportunity to right a wrong of history,” Dr. Kieny said, quoting one member of the ethics panel. “It is only relatively recently, in the last decade, that researchers have begun investigating interventions for Ebola. Now is the time to catch up.”
The WHO says the death toll in the mounting Ebola crisis has climbed to 1,013 as of Aug. 9 in the four affected countries: Liberia, Guinea, Sierra Leone and Nigeria. The total number of confirmed and suspected cases has increased to 1,848.
Among the latest deaths is a Spanish priest, 75-year-old Miguel Pajares, who died in Madrid after he was infected with the Ebola virus in Liberia. Unconfirmed reports say that he was given the ZMapp drug treatment in the final day before he died.
So far, most of the research on Ebola treatments has been financed by the U.S. government, often because of fears that the Ebola virus could be used as a form of bioterrorism. But the Canadian government has also been “very active” in financing Ebola treatments, Dr. Kieny told a media briefing in Geneva on Tuesday.
While ZMapp was produced by a California company, some of its components were developed at Canada’s National Microbiology Laboratory in Winnipeg, and a Toronto company collaborated in developing it. Canadian scientists have also developed an experimental Ebola vaccine and another Ebola treatment drug.
The Public Health Agency of Canada is reportedly ready to donate several hundred doses of a made-in-Canada unapproved Ebola vaccine for use in Africa.
The Liberian government, meanwhile, says it has obtained a supply of ZMapp after making a request to the U.S. government. But only a small number of doses was sent to Liberia, and ZMapp’s manufacturer says it has now exhausted its last supplies of the drug.
Dr. Kieny said it is important not to create “false hope” of an imminent cure for Ebola. She is seeking an accelerated pace of development, so that possible Ebola treatments and vaccines can be tested and approved as fast as possible – perhaps even as early as December.
The WHO ethics panel, which included University of Toronto professor Ross Upshur, said the use of experimental Ebola drugs must be guided by ethical criteria: informed consent, freedom of choice, confidentiality, respect for the patients and their dignity, community involvement, and transparency about all aspects of care.
There is also a “moral obligation” to collect and share all data generated from the use of unproven Ebola drugs, the panel said.
Margaret Chan, director-general of the WHO, warned on Tuesday that the Ebola outbreak is unprecedented in its size, severity and complexity. “No one is talking about an early end to the outbreak,” she told a briefing of UN member states in Geneva. “This is a severe health crisis, and it can rapidly become a humanitarian crisis if we do not do more to stop transmission.”
About a million people live in the “hot zone” of Ebola transmission near the intersecting borders of Liberia, Guinea and Sierra Leone, she said, and they need food and other daily support because of the increasing isolation of the zone.