The use of experimental treatments for Ebola was endorsed on Tuesday by the World Health Organization, just hours after a Spanish priest who became the third patient to receive an unproven drug died from the disease.
But the WHO position left many questions — among them where hundreds of Africans infected by the disease would find such treatment. On Monday, Mapp Biopharmaceutical said that it had exhausted its supply of ZMapp, the experimental drug given to the two American aid workers infected with Ebola as well as the Spanish priest.
Several others treatments are in the pipeline. But the makers of ZMapp have said it takes months to create more, a process that involves growing humanized mouse antibodies in tobacco leaves.
It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions. What group should assess risk vs. benefit in permitting unapproved interventions to be tried? That cannot and should not be left to potential subjects.
Who, if anyone has the obligation to pay for unapproved drugs and access to them by the very poor? And what priority ought be given to particular groups such as health care workers when potential treatments or vaccines are in short supply?
Among the unanswered questions:
- Who should vet proposed treatments for ebola for soundness or “reasonableness”? There are homeopathic and other fringe ideas being floated.
- What can be done to require or compel companies to make new drugs available?
- Who will pay the costs of making drugs and moving drugs or vaccines to patients?
- What priority should be given to particular persons or groups when there is not enough drug to go around?
- What evidence would suffice to move a drug from compassionate use to therapeutic in a humanitarian emergency?
- What will be done to protect companies against liability should there be terrible adverse events from the use of an unapproved drug?
- Can a third party consent for children, persons with poor education, prisoners or others who might wish to try or be reasonable subjects for unapproved drugs?
Much more ethical work needs to be done to create a sound infrastructure for compassionate use in humanitarian emergencies such as the Ebola epidemic.
