Until recently, ZMapp has only been used as a drug to treat Ebola virus infections in emergency cases, but that may be about to change. The drug is now being tested in patients with Ebola, in a joint effort by the United States and Liberian governments.
In order to qualify for the study, patients must be either (1) adults or children with EBOV infections admitted to Liberian health centers (2) healthcare professionals returning to the United States for treatment against EBOV infection or (3) adults or children infected with EBOV in the U.S. after exposure to an infected individual.
As treatment, patients in the study will receive three doses of ZMapp per day for 3 days. ZMapp is a collection of antibodies that function by targeting surface proteins of the Ebola Virus virion. In order to manufacture the drug, tobacco plants are genetically altered to synthesize the antiviral proteins.
Additionally, patients will receive supportive treatment, such as IV fluids. The control group in study will receive only supportive treatment, which also includes treating additional infections, maintaining blood pressure, and ensuring sufficient oxygen consumption.
Thus far, ZMapp has been administered as emergency treatment to only nine patients, but the study hopes to enroll 100 participants. Consequently, the joint effort by Liberian and American researchers is intended to assess how well ZMapp performs as an antiviral against Ebola.
Although control trials like the one just described appear to be common in assessing novel drug therapies, I question the ethical implications of administering potentially life-saving treatment to only a cohort of candidates. The efficacy of new drugs should be ascertained, but if we are to conduct clinical research with an explicit intent to do no harm, maybe it’s time to remodel clinical drug tests.
How do you withhold potentially life-saving treatment? How do you ensure that the treatment group is safe? I'm not entirely convinced that we're qualified to answer these questions.