WHO Experts Give Nod to Using Untested Ebola Drugs
Move would be justified in 'particular circumstances' of current outbreak, ethicists say
"Some people look at the word 'expedited' as very favorable," said Dr. Samuel Packer, chair of the ethics committee at North Shore University Hospital in Manhasset, N.Y. "Who wouldn't want something expedited? It can be very hard to say that's not a good thing to do. But history says a lot of time when we rush things through, people are harmed."
ZMapp is an antibody cocktail made by a small San Diego-based biotech firm. The two U.S. aid workers who received it, Dr. Kent Brantly and Nancy Writebol, have been evacuated to the United States and appear to be recovering, according to media reports.
In the meantime, desperation has opened the floodgates. Other drug manufacturers have also come forward to urge the use of their own untested Ebola medications.
Waiving the usual requirements of waiting for the results of rigorous clinical trials may seem appealing -- particularly since Brantly and Writebol appear to have benefited from the therapy. But have they really? And the drug was not enough to save Pajares.
"The problem is you have no idea whether the medication worked or didn't work," said Dr. Ezekiel Emanuel, chair of the department of medical ethics and health policy at the University of Pennsylvania's Perelman School of Medicine. "You can't know after treating only two people, with a disease like this."
There's also the sticky question of choosing who of the thousands infected will get the drug. According to medical ethicist Jennifer Blumenthal-Barby, that bridge has already been crossed, in part, with the decision to give the few existing samples of ZMapp to Brantly and Writebol, rather than to any of the nearly 1,800 West Africans who have been infected by Ebola.
"One hopes that it was on the basis of sound moral reasoning and not just biased affinity for Americans by Americans," said Blumenthal-Barby, who is assistant professor with the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston.
"Who is going to be the body of people choosing the patients?" Packer added. "I worry about the representation of the four countries involved, for example. Are they going to be fairly represented?"
He is also concerned about how health care workers in the field in West Africa will help desperate patients understand the potential risks of an untested drug.
The outbreak has particularly affected rural parts of Guinea, Liberia, Sierra Leone and Nigeria, and many people in these areas may be unsophisticated in their knowledge of modern medicine.
"You really worry how people in a vulnerable population will understand the risks," he said. "Do you think you can give informed consent, or are you likely to be coercive? How would I explain the risk of a brand-new drug to an African patient?"