As treatment of two Americans with Ebola continued in Atlanta on Wednesday, an international debate was rising over the experimental drug widely credited with helping to save their lives.
At the heart of the debate: should ZMapp, a drug developed by a San Diego company and previously untested in humans, be fast-tracked in development and distribution to help stop the spread of Ebola in West Africa? Next week the World Health Organization will assemble a panel of medical ethicists to take on this very question.
“We are in an unusual situation in this outbreak,” said Dr. Marie-Paule Kieny, assistant director-general at the WHO, in a statement Wednesday. “We have a disease with a high fatality rate without any proven treatment or vaccine. We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”
The WHO is also in discussions on whether to declare an international health emergency as the Ebola epidemic in West Africa intensifies. By Wednesday afternoon, Nigeria and Saudi Arabia each reported a death from the virus, and the WHO raised the death toll in Liberia, Sierra Leone and Guinea to 932.
This crisis recalls arguments made at the start of the AIDS epidemic, when experimental drugs were being created but kept out of the hands of patients because the treatments were unregulated. For others the potential harm of administering an untested drug to masses of people is too great.
There is no vaccine for Ebola. And yet, after missionaries Dr. Kent Brantly and Nancy Writebol were given doses of ZMapp, their dire health conditions improved enough for them to be flown back to the U.S. for further treatment. Both are being treated in an isolation unit at Emory University Hospital. Writebol’s son, Jeremy, said in a statement on Wednesday, “Mom is tired from her travel, but continues to fight the virus… . We were able to spend a few minutes with her to encourage her and be encouraged by her condition.”
So, if the serum was as effective as it appears to have been, why not make it immediately available to Africans in the center of danger?
“It is highly likely that if Ebola were now spreading in Western countries, public-health authorities would give at-risk patients access to experimental drugs or vaccines,” three public health experts said in a statement posted on the Wellcome Trust website Wednesday. “The African countries where the current outbreaks of Ebola are occurring should have the same opportunity. African governments should be allowed to make informed decisions about whether or not to use these products, for example to protect and treat health-care workers who run especially high risks of infection.”
The three who signed the statement were Dr. Jeremy Farrar, a specialist in tropical medicine and the director of the Wellcome Trust, a health care charity based in Britain; David Heymann, head of the Chatham House Centre on Global Health Security; and Peter Piot, director of the London School of Hygiene and Tropical Medicine and a co-discoverer of the Ebola virus.
But their view is hardly universal. In a statement, Doctors Without Borders, the international aid organization treating infected patients in West Africa, said it was “keen to contribute to research efforts,” but not in the middle of a potential epidemic.
“Trying an untested drug on patients is a very difficult choice since our first priority is to do no harm and we would not be sure that the experimental treatment would do more harm than good,” the statement said.
Opinions are split worldwide, and also in the West African community here.
Leo Mulbah, a member of Liberian Association of Metro Atlanta, said he is grateful to the work and sacrifice made by American aid workers Kent Brantly and Nancy Writebol, who are being treated at Emory University Hospital after contracting Ebola in Liberia. But he has mixed feelings about the use of the serum and the “politics” behind it.
“This drug has been given to two people, but you have hundreds of thousands who (need it) as well,” Mulbah said. “If two people can be given this, what about the sub-Saharan region?”
Cynthia Oremi Jarrett-Thorpe, Hon. Consul of Sierra Leone, is still sorting through that question.
“If it works and is tested, then yes,” Jarrett-Thorpe said. “But we must be cautious. You don’t know what will happen in the next two weeks or two months.”
ZMapp is not the only drug being developed for treating Ebola, but it is the one that Writebol and Brantly agreed to take. Like other drugs in development, the serum has not been through rigorous human trials and the lengthy approval process required by the U.S. Food and Drug Administration. As such, Mapp Biopharmaceutical, posted a statement on its website saying that “very little of the drug is currently available” but that the company was “cooperating with appropriate government agencies to increase production as quickly as possible.”
So far the drug has been tested in animals, and that is a big difference from testing in humans, said Paul Root Wolpe, professor of bioethics and director of the Center for Ethics at Emory University. He mentioned drugs such as fen-phen, (fenfluramine) the once-promising obesity drug that was pulled from the market after it caused fatal side effects.
In cases like this there is always tension between between treatment of the disease and proving that the treatment works well, he said. It is central to the concept of compassionate use, which argues that administering an experimental drug may represent the best option for saving a patient. A good example of that, Wolpe said, was during the height of the AIDS crisis, when activists staged aggressive campaigns to lower the cost of some experimental drugs and speed up the development of others.
There is also the question of cost when it comes to potential distribution of ZMapp. It is unclear what the serum costs per dose and whether some kind of agreement could be worked out with the affected nations to pay for treatments.
“Compassionate use is tricky and problematic, because if a company is developing a drug for Ebola and you can’t test it here because we don’t have Ebola in the U.S., and now we’re using Africans as our test subjects so this American company can make money, well this situation is unique,” Wolpe said. “If this turns out to be a valuable treatment for Ebola, then we have an ethical mandate to make it available at reasonable prices to the affected African nations.”
