EbolaQuantities of experimental Ebola drug used in U.S. too small to be shipped to West Africa

Nigerian health authorities said yesterday that West African patients infected with the Ebola virus will not have access to experimental drugs being used to treat American cases of the disease for several months, if at all.

Health minister Onyebuchi Chukwu told a press conference he had asked the U.S. health authorities about the unproven medicines used on two American doctors who became infected while treating patients in Liberia, but was told such small quantities of the drug existed that West Africa would have to wait for months for supplies, even if they were proved safe and effective.

The two Americans, Dr. Kent Brantly and Dr. Nancy Writebol of the evangelical Christian organization Samantha’s Purse, were given the drug ZMapp after being flown to the United States, and appear to be recovering.

A spokesman for the U.S. Centers for Disease Control and Prevention (CDC) said that “there are virtually no doses available” and they would take several months to manufacture (see CDC’s 2014 Ebola Outbreak: Information and Updates).

The Guardian reports that even if supplies of ZMapp do become available, medical ethicists are divided over whether they should be used in the current Ebola outbreak in West Africa. The World Health Organization (WHO) has called a meeting of experts next week to formulate guidelines for doctors and drug companies considering shipping experimental drugs to the four countries hit by the disease.

“We are in an unusual situation in this outbreak. We have a disease with a high fatality rate, without any proven treatment or vaccine,” said Dr. Marie-Paule Kieny, assistant director general at the WHO. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

Professor Jeremy Farrar, director of the Wellcome Trust, noted there were critical ethical questions to consider. He called for the fashioning of “rigorous protocols for the study of experimental interventions,” so that African countries could have the same opportunities to consider them as western ones and to ensure there would be equitable access to any treatment that worked.

Jonathan Ball, professor of molecular virology at Nottingham University, told the Guardian that there were many questions.

“Giving unlicensed and untested (at least in humans) treatments and vaccines is a very thorny ethical issue,” he said. “The infected US healthcare workers are receiving a type of treatment (antibodies that specifically target the virus) that has a reasonably long safety track record, so it isn’t surprising — given the high fatality rate in the current outbreak — that they are happy to receive the therapy.

“But not all drugs are safe — that’s why we have very stringent clinical trials. One could argue that the current outbreak provides a perfect arena in which to test new drugs, but that isn’t without risk. We don’t know their safety, we don’t know if they are likely to work — sure, they have been tested in animals, but these studies don’t always tell us what will happen in humans.”

Some of the new treatments have not been tried with human at all, said Professor Tom Solomon, director of the U.K. National Institute of Health Research (NIHR) health protection research unit in emerging and zoonotic infections. It is usual for drugs to be tried in healthy volunteers first, in case of side-effects. “The difference here is the desire for this ‘first in man’ experiment to be for a patient with the disease,” he told the Guardian.

“What is key is that if these new experimental drugs are going to be used, then this should only be done in the context of a clinical trial. Otherwise the worry is that we will have tried these drugs, including putting people through the potential risk of experimental treatments, and still be none the wiser about which are effective.”

Paul Hunter, professor of health protection at the University of East Anglia, said most doctors in a situation like that of West Africa would want to try a drug that might work.

“In my view, the ethical case is unequivocal. If a patient is likely to die and an experimental therapy has a reasonable chance to prevent death, then it should be given.

“However, this does not mean that any old drug could be given. For an experimental compound to be given, there should be good prior evidence that the therapy will work, the patient or his relatives should give informed consent wherever possible and whenever the therapy is given proper records must be kept and the outcome reported to WHO,” he said.