Aug. 7, 2014
Editor’s note: Harriet A. Washington, a fellow at the Black Mountain Institute at the University of Nevada, Las Vegas, is the author of “Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present” and “Deadly Monopolies: The Shocking Corporate Takeover of Life Itself — and the Consequences for Your Health and Our Medical Future.” The opinions expressed in this commentary are solely those of the writer.
(CNN) — One of the many questions surrounding the revelation that Americans Kent Brantly and Nancy Writebol received a little-known, experimental serum for their Ebola infection is: “Why did we hear nothing about it earlier, and how did they gain access to it?”
Ebola has no cure, although potential medications and vaccines are in various states of development. The serum ZMapp, an experimental product of Mapp Biopharmaceutical, hasn’t been tested in humans, which means it doesn’t meet a primary requirement for FDA approval — so its obscurity is no surprise.
The Americans managed to gain access to what more than 1,660 infected people in Guinea, Sierra Leone, Liberia and now Nigeria did not: medicine that seems to work — although, of course, we don’t know for sure yet. Some reports indicate they received ZMapp under the FDA’s “compassionate use” rule, which permits untested drugs to be given to consenting patients who might otherwise die. This is a triumph of common sense and compassion over bureaucratic red tape.
One of the chief concerns about using unapproved medications is that we don’t know what the risks are: The drug may not work, it may work with serious adverse effects, or it may prove as deadly as the disease. But as a doctor, Brantly understood the risks, and like him, Writebol had no other options. Most people with Ebola die.
Compassionate use is certainly ethically defensible. But apparently only three doses were available, and they were given to Westerners. The lack of broader access to ZMapp highlights what is often a very serious ethical failing.
Why didn’t Dr. Sheik Umar Khan, the chief Sierra Leone physician who died while treating Ebola patients, receive this medication? Because another method of determining who gets medications is at work here — the drearily familiar stratification of access to a drug based on economic resources and being a Westerner rather than a resident of the global South.
We don’t know how quickly ZMapp could be made in large quantities. If it were to be made available, who should receive it? Some think Ebola doctors and caregivers should, because their survival is essential to treating and quelling the epidemic. This makes sense, but it’s not that simple.
First, it violates the principle of distributive justice: The benefits of the drug are being inequitably distributed, with skilled, economically secure professionals more likely to benefit.
Also, by what reckoning do we decide that the doctors’ role increases their value and dictates they should be given a preferential chance to survive? Distributing the drug through a clinical trial would allow us to know whether and how well the medication works and what caveats might apply.
Africans must participate in any clinical trial, which would benefit the pharmaceutical company as well as, it’s hoped, Ebola victims. This would mean their lives have irreplaceable value, too, in the equation of who should get the drug.
So, will Africans receive this potentially lifesaving medication?
A U.N. official suggested that drugs cannot be tested in the middle of an epidemic — but he is wrong. Such tests are conducted all the time.
Dr. David Ho tested AIDS drugs in Uganda in the midst of the pandemic, and the meningitis drug Trovan was tested in Kano, Nigeria, in the midst of an epidemic. One of every three industry trials is conducted in developing countries; scientists often point to high disease rates, including epidemics, as a rationale for conducting them there.
The problem is not testing the drug amid an epidemic. The question is how ethically such trials are conducted.
Read full : http://edition.cnn.com/2014/08/06/opinion/washington-ebola-zmapp-drug-africa/index.html?hpt=iaf_c2