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Compassionate Use and the Ebola Virus Epidemic

by Leah Greene, JD, LLM on August 12th, 2014

ebola

On August 8, 2014, the World Health Organization declared the Ebola virus a Public Health Emergency of International Concern (PHIEC). Specific information regarding the signs and symptoms of, history and current status of the Ebola virus epidemic can be found here. The mortality rate ranges from 50 to 70%. There is no proven treatment or vaccine for the Ebola virus.

By now, most have heard of Dr. Kent Brantly and Nancy Writebol, missionaries who contracted the Ebola virus in Africa and are being treated at Emory University Hospital in Atlanta. Their condition is reportedly improving and has been attributed to ZMapp, an experimental drug that has been tested only on monkeys. Dr. Brantly and Mrs. Writebol were allowed access to the drug through the “compassionate use” program of the Food and Drug Administration (FDA). The FDA considers requests for access to experimental drugs to people outside clinical trials if a patient meets the following criteria: (1) the disease or condition is serious or immediately life-threatening; (2) no comparable or satisfactory therapeutic alternatives exist; (3) the drug manufacturer and the patient’s doctor make arrangements to obtain the drug for the patient; and (4) the FDA authorizes these arrangements.

A request for the exemption may not result in access to it. Drug companies may balk at providing an experimental drug out of concern for bad publicity if the recipient dies or develops life-threatening side effects. A physician may not agree to the use of the drug out of fear of liability or exposing the patient to significant health risks.

The FDA warns patients seeking access of the following: the treatment may not work; the drug may have unknown health risks; and obtaining approval from the FDA may take some time, as there is no deadline for the FDA to respond to these requests. If access is granted, the drug manufacturer may charge the patient for the drug, which is typically expensive, and not paid for by insurance. After the initial cost of the drug, there may be associated costs for monitoring the drug’s effect.

According to the Center for Disease Control, however, ZMapp’s manufacturer has a limited supply of the drug. In addition, it has not started Phase 1 (of 4) of the clinical trial to determine its safety and effectiveness. On August 9, Reuters reported that The Centers for Innovation in Advanced Development and Manufacturing, which were set up by the US Department of Health and Human Services to partner with private industry to respond to any major public health threat, expressed willingness to assist with making experimental drugs to treat Ebola. We will continue to monitor whether this organization is asked to manufacture any experimental drugs for the Ebola epidemic in Africa.

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