But 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.
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.
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 somewhat more ample but still modest supplies are available in a few months, the epidemic may have run its course.
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 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 it is truly effective.
ZMapp is being developed by Mapp Biopharmaceutical, a nine-person company in San Diego that was still doing animal studies with an eye toward beginning human safety testing next year.
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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 to health workers, be they American or African.
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.
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“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.
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 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.
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?
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.
A senior Food and Drug Administration 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.
This, of course, assumes 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.
Northern Nigeria has a history of resisting the campaign to eradicate polio, for example, with rumors circulating that vaccinations were 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.”
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 gets 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 of them who received the Pfizer drug, called Trovan. Other children suffered blindness, deafness and brain damage.
Families accused the company of not getting proper clearance for the study, of failing to inform potential study participants that an approved drug was available and of 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.
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.”
Source: New York Times
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