With global anxiety rising on Ebola, medical ethicists are weighing how best to use a limited supply of experimental drugs that have shown early promise in fighting a disease that’s killed almost 1,000 people this year.
The urgency to access the treatments has increased as health officials in the U.S., Canada and Hong Kong
have isolated and tested travelers with Ebola-like symptoms, before ruling out the disease. Medical experts have said they wouldn’t bet against Ebola traveling outside of West Africa.
A panel of ethicists convened by the World Health Organization Monday will begin weighing whether drugs that haven’t been widely tested for safety should be used in an outbreak where about 40 percent of infected people survive with just supportive care. If so, the panel members must address who gets the medicines, which so far only exist in small amounts.
“This is the first effort to have a long-overdue, transparent, public discussion about how to distribute life-saving medicines in an emergency,” said Arthur Caplan
, director of the division of medical ethics at NYU Langone Medical Center, in a telephone interview. “A ton of attention is going to follow this panel.”
U.S. regulators last week said a treatment by Tekmira Pharmaceuticals Corp.
could be tested in infected patients, while a drug by Mapp Biopharmaceutical Inc. has already been used to treat two Americans infected in Liberia. While relatives and supporters have said the two Americans are improving, it remains unclear if the drug helped.
There is no cure for Ebola. The disease is normally treated by keeping patients hydrated, replacing lost blood and using antibiotics to fight off opportunistic infections. The hope is that a patient’s immune system will eventually fight off the virus’s aggressive attack.
If it’s decided an experimental drug should be used, the next question will be “under what conditions should people get it,” said Caplan, who will not be part of the WHO panel. “Only people with informed consent? Do you think you’ll ever get informed consent from the poorest person in Guinea? Does the government say yes for them?”
The limited supply also creates problems, he said, questioning whether a patient’s condition should matter.
“The more recently you’ve been infected, the more likely you’ll respond better than if you’re 20 days out,” he said. “How about young versus old? Do we care if you’re 10 or if you’re 80?”
Death Toll of 961
Ebola has killed 961 people
and sickened 1,779 in West Africa since it was first reported, the WHO said on Aug. 8. It began in December with a two-year-old child in Guinea, according to research
published April 16 in the New England Journal of Medicine. Since then, the disease has raced through Guinea, Liberia and Sierra Leone, and recently entered Nigeria. Health officials worldwide are on high alert for new cases.
Hopes for a treatment were raised when two American health workers, Kent Brantly and Nancy Writebol, were reported to have improved after receiving an antibody cocktail dubbed ZMapp, made by San Diego-based biotechnology firm Mapp. Brantly and Writebol were flown to Atlanta, where they are being treated at Emory University Hospital.
Local and foreign aid workers like Brantly and Writebol, who made the decision to use the drug, should be first on the list to receive the new treatments, said Erica Ollmann Saphire
, a molecular biologist at the Scripps Research Institute.
“They are taking care of others at great risk to themselves,” Saphire said in an e-mail. “If the treatments help them survive, they could return to care for other patients, so the effect of the treatment would be compounded. Further, the health-care workers that survive may even become immune, and much better able to help in the future.”
G. Kevin Donovan
, director of the Pellegrino Center for Clinical Bioethics at Georgetown University, argued that African doctors should be getting the same chance at potentially life-saving intervention.
“There is no reason why African doctors shouldn’t be considered as eligible” to be flown to Western countries for treatment, Donovan said in a telephone interview. “The sad truth is they are working in their own countries which are terribly under-funded and terribly under-staffed. The reason it worked for these two Americans is their organizations had the will and resources to pluck them out of danger.”
The inability of West African aid workers to get top-notch treatment is “a reflection of the inherent inequalities in the world and it doesn’t make it right. It makes it sadder and even more admirable for these local doctors and nurses to be placing themselves in such a position.”
Another question is whether the companies making drugs will let their treatments be used widely, Caplan said. The WHO can only make recommendations, and cannot compel drugmakers to share their treatments, he said.
“They may be nervous if they have a drug that needs to be refrigerated, transported, and may not be handled properly. If lots of people die, it’ll be held against their drug,” which could hurt the therapy’s chances of eventually reaching market, Caplan said. “They may be accused of experimenting on illiterate, poor people.”
Besides Mapp’s drug, Vancouver-based Tekmira is also developing a treatment, which is stalled in clinical trials due to safety concerns. Still, the U.S. Food and Drug Administration said it could potentially be used in an emergency situation. The U.S. National Institute of Health is also developing a vaccine, which may begin enrollment in a Phase 1 clinical trial by this fall.
Mapp is “cooperating with appropriate government agencies to increase production as quickly as possible,” Mapp said in a statement
on its website. Tekmira spokeswoman Julie Rezler did not return a call asking about treatment availability.
The WHO, which is organizing the ethics panel, has come under criticism from some aid organizations for not being aggressive enough in fighting the growing outbreak. On Aug. 8, the WHO designated the outbreak as an international public health emergency, eight months after it began.
“There is a lack of coordination among all the different partners.” Koen Henckaerts, a health expert at the European Commission’s humanitarian aid division, said in a telephone interview from the Liberian capitol of Monrovia. “The WHO has a big responsibility to do more than just give technical advice.”
Doctors Without Borders, with almost 700 workers in the affected region, also was critical, saying in a statement
that it has been repeating for weeks that “a massive medical, epidemiological and public health response is desperately needed to save lives and reverse the course of the epidemic.’
Guinea has closed its border with Sierra Leone until the virus is under control. It also shut its border with Liberia, Reuters reported, citing Health Minister Remy Lamah
. Health authorities in Nouadhibou, Mauritania’s second-largest city, set checkpoints at port, airport and land routes, online news site Mauriweb reported.
At this point, stopping further spread of the outbreak is the top priority, as available quantities of experimental treatments are too low to make an impact, Caplan said.
‘‘At this point, is it even worth arguing about it?” he said, referring to the WHO’s discussion on experimental treatment use. “Even if they ramped up production of the Mapp drug tomorrow, they may be able to get 30 doses of the drug. It’s not going to stop the outbreak.”
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