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In Ebola Outbreak, Who Should Get Experimental Drug? Ebola Drug Could Save a Few Lives. But Whose?
(about 4 hours later)
Some have said it is wrong that with hundreds of Africans dying from the outbreak of Ebola, extremely scarce supplies of an experimental drug went to two white American aid workers. With hundreds of Africans dying from the outbreak of Ebola, some commentators have said it is wrong that extremely scarce supplies of an experimental drug went to two white American aid workers.
But others wonder, what if the first doses of the drug — which had never been used in people and had not even finished the typical animal safety testing — had been given to African patients instead? But other commentators wonder: What if the first doses of the drug — which had never been used in people and had not even finished the typical animal safety testing — had been given to African patients instead?
“It would have been the front-page screaming headline: ‘Africans used as guinea pigs for American drug company’s medicine,' ” said Dr. Salim S. Abdool Karim, director of Caprisa, an AIDS research center in South Africa. “It would have been the front-page screaming headline: ‘Africans used as guinea pigs for American drug company’s medicine,’ ” said Dr. Salim S. Abdool Karim, director of Caprisa, an AIDS research center in South Africa.
A history of controversy about drug testing in Africa is just one of the complexities facing public health authorities as they wrestle with whether and how to bring that drug and possibly other experimental ones to the countries afflicted with Ebola. Who should get such a scarce supply of medicine? Health workers? Children? The newly infected who are not yet as sick?A history of controversy about drug testing in Africa is just one of the complexities facing public health authorities as they wrestle with whether and how to bring that drug and possibly other experimental ones to the countries afflicted with Ebola. Who should get such a scarce supply of medicine? Health workers? Children? The newly infected who are not yet as sick?
The World Health Organization is convening a meeting of ethicists early next week to discuss this sensitive and difficult dilemma. The United States government is also forming a group to consider the same issues, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases. There are virtually no remaining supplies of the drug, called ZMapp, that was used to treat the two Americans, United States officials say. And even a few months from now, according to various estimates, there may be no more than a few hundred doses.
The World Health Organization, which on Friday declared an international health emergency on Ebola, will convene a meeting of ethicists early next week to discuss this delicate and difficult predicament involving the drugs. The United States government is also forming a group to consider these issues, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.
At least two of the countries affected by the Ebola outbreak, Liberia and Nigeria, have asked for the drug, according to a spokesman for the Centers for Disease Control and Prevention.At least two of the countries affected by the Ebola outbreak, Liberia and Nigeria, have asked for the drug, according to a spokesman for the Centers for Disease Control and Prevention.
The debate about who should get the drug, which is called ZMapp, may be mainly academic in the short term, because there is virtually no supply left, Dr. Fauci said. By the time some modest supplies are available in a few months, the epidemic may have run its course. A perception in the region of unfairness in distributing the medicine could undermine the already shaky willingness of some Africans to trust the Western relief efforts. Dr. Armand Sprecher, a public health specialist for the aid group Doctors Without Borders, said it was unfortunate that the first doses went to white Americans “because it confirms all the suspicions people have.” But, he said, he did not foresee that perception as undermining the relief effort, adding that if effective drugs were available, it could bolster the effort’s credibility and give people an incentive to seek medical care.
Other experimental medicines might be available, but also probably in small amounts, like one from Tekmira Pharmaceuticals that has so far been tested only in healthy volunteers. Tekmira said Thursday that the Food and Drug Administration had determined that the drug was safe enough to be tried in infected patients. “At the moment, our big problem is finding the patients in a timely way and convincing them to come to the treatment center,” he said. “If you don’t have a carrot to hang out there and bring people in, then you can’t contain it.”
ZMapp is reported to have helped the two aid workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and are now at Emory University Hospital in Atlanta. But experts say it is too soon to conclude that it is truly effective. Other experimental medicines might be available, but also probably in small amounts, like one from Tekmira Pharmaceuticals that has so far been tested only in healthy volunteers. Tekmira said Thursday that the Food and Drug Administration had determined the drug was safe enough to be tried in infected patients.
ZMapp is being developed by Mapp Biopharmaceutical, a nine-person company in San Diego that is still doing animal studies with an eye toward beginning human safety testing next year. ZMapp is reported to have helped the two aid workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and are now at Emory University Hospital in Atlanta. But experts said it was too soon to conclude that it was truly effective. Dr. Brantly on Friday released a statement from his isolation room at the hospital, saying, “I am growing stronger every day.”
ZMapp is being developed by Mapp Biopharmaceutical, a nine-person company in San Diego that was doing animal studies with an eye to beginning human safety testing next year. But plans are now changing to help make the drug available faster to patients. 
According to federal officials, ZMapp was given to the two Americans because Samaritan’s Purse, the aid organization that employed Dr. Brantly, found out about it and asked for it, not because of any favoritism to Americans.According to federal officials, ZMapp was given to the two Americans because Samaritan’s Purse, the aid organization that employed Dr. Brantly, found out about it and asked for it, not because of any favoritism to Americans.
Some bioethicists said they did not find it troublesome that the first doses went to health workers, be they American or African. Still, Maina Kiai, a human rights activist in Kenya, said the seeming inequity was discussed on the sidelines of the summit meeting of African leaders held in Washington this week.
Health workers, they said, can best understand the risks in taking a drug not yet tested in people and give informed consent. Offering health workers priority is a way to encourage them to undertake the grave dangers of caring for people with such a deadly, contagious disease. And if nurses and doctors get better, they might go back to caring for other patients, in effect multiplying the benefit of the drug. “There was a sense of the same pattern,” he said, that “the life of an African is less valuable.”
“I think there are very special commitments that we must make ethically to the health care providers that are willing to go in and serve,” said Nancy Kass, a professor of bioethics and public health at Johns Hopkins University. The federal authorities say that when more ZMapp becomes available, it should be given to patients as part of research into the drug’s safety and efficacy.
Supplies of ZMapp, which is made in tobacco plants, are being scaled up, but that is expected to take a few months.
Federal authorities say that the drug should not just be given to patients but should also be connected with some sort of study to assess its safety and efficacy.
“You’ve got to balance the compassionate-use aspect with trying to figure out whether it works,” Dr. Fauci said.“You’ve got to balance the compassionate-use aspect with trying to figure out whether it works,” Dr. Fauci said.
Doing such a study in the midst of an outbreak could be difficult, especially in parts of Africa with limited medical infrastructure.Doing such a study in the midst of an outbreak could be difficult, especially in parts of Africa with limited medical infrastructure.
With enough drug for only a small percentage of infected people, who should get it? If the outbreak is not extinguished soon, there would be enough drug for only a small percentage of infected people.
Dr. Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center, said priority should go to health care workers. Others say more recently infected patients would be more likely to be helped by the drug. Some bioethicists said health care workers should be among those given priority. They can best understand the risks of taking a drug not yet tested in people and give informed consent. Offering doctors and nurses priority can encourage them to undertake the grave dangers of caring for people with a deadly, contagious disease. And if they get better, they might go back to caring for patients.
A senior F.D.A. official said priority might go to those who have access to other supportive care because they are most likely to benefit. But that could mean that the limited supplies might go to relatively privileged Africans. “I think there are very special commitments that we must make ethically to the health care providers that are willing to go in and serve,” said Nancy Kass, a professor of bioethics and public health at Johns Hopkins University.
Others say more recently infected patients would be more likely to be helped by the drug.
A senior official at the Food and Drug Administration said priority might go to those who had access to other supportive care because they were most likely to benefit. But that could mean that the limited supplies might go to relatively privileged Africans.
This, of course, assumes that people will want the drug. That might not always be the case because of suspicions about health care in general and Western pharmaceutical companies in particular. Many patients stricken in the current outbreak are fleeing rather than going to clinics.This, of course, assumes that people will want the drug. That might not always be the case because of suspicions about health care in general and Western pharmaceutical companies in particular. Many patients stricken in the current outbreak are fleeing rather than going to clinics.
“There are just an awful lot of Africans who are afraid of the health care system right now,” said Dr. G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.“There are just an awful lot of Africans who are afraid of the health care system right now,” said Dr. G. Kevin Donovan, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.
Northern Nigeria has a history of resisting the campaign to eradicate polio, for example, with rumors circulating that vaccinations are a plot to sterilize Muslim women. At least nine polio immunization workers were shot to death there in February 2013.Northern Nigeria has a history of resisting the campaign to eradicate polio, for example, with rumors circulating that vaccinations are a plot to sterilize Muslim women. At least nine polio immunization workers were shot to death there in February 2013.
Dr. Fauci said he had already heard from an aid worker who had just come back from the region of the Ebola outbreak that a Western drug marked as experimental “more likely will be met with resistance rather than welcoming.” There have been some controversies over testing of drugs in Africa and other developing regions, with critics saying that participants are exploited or not treated properly and that they help develop drugs that if on the market, might not even be affordable in poor countries.
The aid group Doctors Without Borders has also expressed some caution. “As doctors, trying an untested drug on patients is a very difficult choice since our first priority is to do no harm,” it said in a statement earlier this week.
There have been some controversies over testing of drugs in Africa and other developing regions, with critics saying that participants are exploited or not treated properly and that they help develop drugs that might not even be affordable in poor countries.
ZMapp would be provided free in studies, and it is too early to say how much it would cost if it ever got to market.ZMapp would be provided free in studies, and it is too early to say how much it would cost if it ever got to market.
Pfizer settled charges and lawsuits that accused it of improprieties in testing an experimental antibiotic during a 1996 meningitis outbreak in northern Nigeria. Eleven children in the trial died, five hadreceived the Pfizer drug, called Trovan. Other children suffered blindness, deafness and brain damage. Pfizer settled charges and lawsuits that accused it of improprieties in testing an experimental antibiotic during a 1996 meningitis outbreak in northern Nigeria. Eleven children in the trial died. Five were given Pfizer’s drug, and the others received a comparator drug. Pfizer denied any wrongdoing and said the deaths were from the disease, not its drug.
Families accused the company of not getting proper clearance for the study, failing to inform potential study participants that an approved drug was available and using a too-low dose of a comparison drug to make Trovan look better. Pfizer denied any wrongdoing or liability and said that Trovan actually helped the patients and that the deaths and injuries were from meningitis, not the drug. Arthur L. Caplan, director of the division of medical ethics at NYU Langone Medical Center, said that in the end, experimental drugs against Ebola were likely to make little difference in the current outbreak, and that resources would be better spent trying to stamp out the epidemic using quarantines and other public health measures.
Dr. Caplan of NYU Langone said that in the end, experimental drugs against Ebola were likely to make little difference in the current outbreak and that resources would be better spent trying to stamp out the epidemic using quarantines and other public health measures.
“Morally, everyone is keenly interested in who should get the drug,” he said. But the most important moral question is, “What is the best thing to do to bring that outbreak to a close? And I don’t think it’s drugs.”“Morally, everyone is keenly interested in who should get the drug,” he said. But the most important moral question is, “What is the best thing to do to bring that outbreak to a close? And I don’t think it’s drugs.”