For more than a week since two American patients responded well to an experimental Ebola medicine, one question has echoed around the world: Should more of the sick have access to such treatments?
As the death toll from the epidemic soared above 1,000, the World Health Organization responded Tuesday with a conditional “yes.” And the government of Liberia said it would soon receive a small quantity of the drug, which has never been tested clinically on humans, to treat two ailing doctors there.
But despite the ruling by the WHO that it is “ethical to offer unproven interventions” to Ebola patients in carefully monitored contexts, both the organization and regional public health experts caution that any rollout of unknown drugs should be treated with caution and cultural sensitivity. This is particularly acute on a continent with a history of being on the receiving end of “experimental” Western medicines.
“We can’t say for certain that these drugs are making people better, or what the medium to long-term complications might be — nevertheless we do need them,” says Dr. Clement Adebamowo, chairman of the National Health Research Ethics Committee of Nigeria. “But we also need to make sure people understand what they are taking. A low level of Western education in a community does not mean that individuals are unable to make rational decisions on the basis of information presented to them — but it means researchers have a very high level of responsibility to provide information in a way people can understand.”
African public health experts like Dr. Adebamowo, also a professor of public health at the University of Maryland, know better than almost anyone both the dangers and potential rewards of bringing experimental drugs to the frontline of deadly disease epidemics on the continent.
In 1996, for example, pharmaceutical giant Pfizer began a trial of its meningitis drug, Trovan, on children in northern Nigeria, then in the midst of severe outbreak of the disease. Eleven of the 200 children who participated in the trial subsequently died, and their families alleged they had never been told they were participating in a drug trial. The study’s supposed approval from a Nigerian medical ethics body was later found to be falsified. (The company denied wrongdoing, but eventually settled for $75 million with the regional government and made large payouts to families of victims.)
“Even in times of emergency, people must be made to understand that [untested drugs] are an experiment,” says Dr. Morenike Ukpong, an expert on medical ethics and research protocols at Nigeria’s Obafemi Awolowo University.Better gatekeeping in Africa
Many African countries, however, have significantly strengthened their pharmaceutical gatekeeping in response to scandals like the Pfizer trial, as well as through their experiences managing studies of frontline HIV/AIDS drugs, Dr. Adebamowo says.
“There’s been concern that the countries affected may not have the ability to handle these experimental treatments, which I think is an unfortunate case of seeing Africa as a homogenous and weak entity,” he says. While health care systems in the hardest-hit countries are generally under-resourced, “there are health facilities in all of them where these treatments could be dispensed and people treated,” he notes.
Dr. Ukpong says that companies like San Diego-based Mapp Pharmaceuticals, which manufactures ZMapp, the experimental Ebola treatment, have an ethical responsibility to make sure that if Africans become guinea pigs for this drug now, they must also be beneficiaries later, once more thorough testing is completed.
“You don’t want it to be the case that a company comes into a country, does a study, and then when the drug is actually marketed it’s too expensive for people in the same country to afford it,” she says.
But for now, she points out, the region has few other options than to proceed carefully with unknown drugs like ZMapp, if and when they become available in larger quantities.
“The healthcare system isn’t offering anything better,” she says. “[Without this drug] the chance of death is higher than life.”