Isabel Wallace: Untested drugs harmed many in the past

The World Health Organization announced last week that it endorses the use of experimental drugs to combat the Ebola outbreak in West Africa. While Ebola has no known cure, and 1,229 people have died during this epidemic, three experimental medicines offer hope for the more than 1,000 people battling the viral hemorrhagic fever in Liberia, Guinea, Sierra Leone and Nigeria.

All three experimental drugs have Canadian connections. The Public Health Agency of Canada holds the intellectual property rights for the VSV-Ebov Ebola vaccine, and the agency collaborated in the development of ZMapp, a post-infection serum.

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Finally, a Vancouver pharmaceutical firm developed the post-infection drug TKM-Ebola for the U.S. Defence Department. The latter treatment began human trials earlier this year, but neither VSV-Ebov nor ZMapp have passed the animal-testing phase.

The public health agency has pledged to provide 1,000 vials of VSV-Ebov vaccine to the region. However, post-infection treatments have largely been reserved for western Ebola patients. Mapp pharmaceuticals says it has exhausted its supply of ZMapp after supplying it for American missionaries Kent Brantly and Nancy Writebol, and the now-deceased Spanish missionary Miguel Pajares. Consequently, only 12 doses of ZMapp were sent to Africa.

The ZMapp shortage raises important questions about why westerners were given the treatments first, and who should receive the remaining doses. But the larger problem is what Doctors Without Borders has called the “impossible dilemma” of deciding whether or not it is ethical to administer an untested drug with unknown side-effects. This question factored heavily in the decision not to give the serum to Sierra Leone’s leading viral physician, Dr. Sheik Umar Khan, who died without treatment in July.

Dr. Melvin Korkor, the first Liberian doctor to survive Ebola without treatment, cautions against the use of these drugs in West Africa, adding that he would not have taken any untested “cure” for the disease. Korkor thus reminds us that disease victims are not guinea pigs, and that testing experimental treatments on patients can be highly problematic.

There are many instances in history when experimental vaccines, post-infection treatments and medical procedures have seriously harmed vulnerable populations.

In the mid-1800s, the American-born surgeon J. Marion Sims, widely remembered today as the “Father of Gynecology,” developed a treatment for vesico-vaginal fistula — a condition stemming from childbirth — by testing his technique on slave women. Sims worked on seven slaves without anesthetics.

The United States Public Health Service deliberately infected 700 men with syphilis in Guatemalan prisons and mental institutions between 1946 and 1948. To observe how certain types of exposure spread the disease, PHS doctors inoculated some subjects with syphilitic material and exposed others through prostitutes.

A collection of Canadian nutritionists, working with different federal agencies, performed nutrition testing in aboriginal communities between 1942 and 1952. Researchers starved some residential schoolchildren by drastically reducing their caloric intake and deprived others of essential nutrients.

Beginning in 1956, American researchers began to test Enovid, the first birth-control pill, in Rio Piedras, Puerto Rico. Test subjects were not informed that they were receiving an experimental treatment and many developed severe side-effects from Enovid’s high estrogen content. Three women died during the drug trial.

More recently, Pfizer Pharmaceuticals tested Trovan, an experimental post-infection treatment for meningitis, on 100 Nigerian children in 1996. Five children died after taking Trovan, and others became paralyzed, deaf and blind during the study.

These and many other examples from history indicate that, while experimental treatments might help contain the current Ebola epidemic, after the outbreak is over it would be dangerous and ethically egregious to adopt experimental field medicine as standard operating procedure in global health practice.

 

Isabel Wallace is a sessional lecturer in history at Trent University.

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