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Susan Martinuk: Dying people can’t wait for clinical trial

In January, Mapp Biopharmaceutical Inc. identified a potential treatment for the Ebola virus. The drug, called ZMapp, is not a cure, but a cocktail of antibodies that bind the virus and neutralize its action.

In January, Mapp Biopharmaceutical Inc. identified a potential treatment for the Ebola virus. The drug, called ZMapp, is not a cure, but a cocktail of antibodies that bind the virus and neutralize its action.

Since Ebola carries a death rate of up to 90 per cent, any talk of neutralizing action is bound to raise hopes.

But timing is everything and, just as this discovery was being made, a West African Ebola outbreak was in the making. Since the speed of natural virus replication always exceeds that of clinical trials and scientific protocols, Ebola has since taken the lives of more than 1,000 Africans and threatens another 1,850.

Meanwhile, very little ZMapp has been produced and it remains in developmental stages only. There have been no published data on its effectiveness in animals and no clinical trials in humans.

When two American missionaries with the Christian aid organization Samaritan’s Purse (a doctor and a medical aid worker) became ill with Ebola, plans were made to airlift them to a special isolation ward at Emory University in Atlanta. Once there, they were treated with ZMapp.

Reports suggest that the two are improving. But is that improvement the result of ZMapp? Or is it the result of being in a modern environment with plenty of drugs, technology and the world’s best doctors to provide supportive care?

After all, a 75-year-old Spanish priest was the third person to receive a dose and he has since died. Did he have other influencing factors or does ZMapp not work?

We won’t know until proper clinical trials are done.

But rather than celebrating this possible victory, bioethicists, the World Health Organization and the media started asking why these white people should have access to this experimental treatment, while Africans don’t.

One Canadian reporter gave his obviously unbiased view on the issue by referring to it as “a lottery to live.” Dr. Arthur Caplan, one of America’s most prominent bioethicists, has called for “transparency” regarding how Mapp Pharmaceutical is rationing its drugs and asked what the moral basis is for treating these three individuals.

WHO said this can’t happen, and then did what any global bureaucratic agency would do — it convened a panel that said it was ethical to offer “unproven interventions.”

Mapp had a choice: To deny the request to help, saying ZMapp was years away from use in humans, or to agree to the request to provide a few doses to individuals who would have died anyway.

The benefit to medical research will be minimal because three people do not constitute a clinical trial, and from these patients, there is no way to accurately determine the drug’s safety, or the optimal dose, or distinguish its side-effects from the disease process. It might appear to be effective and help people — or it might have no impact on their survival.

That’s the problem with using experimental drugs in a crisis.

It’s for the best that these two doses were given to Americans who could be near the Atlanta-based Centers for Disease Control, and where proper procedures will enable them to collect as much data as possible and continue followup.

You could imagine the outcry if the first two doses of an experimental drug were handed out to poverty-stricken Africans. The media and ethicists would claim they were used as guinea pigs by evil drug companies.

But people who are close to death and in an epidemic don’t much care about research protocols. If you offer them one last chance, they will take it. White or black makes no difference.

The last of ZMapp has been sent to Africa, where it’s anyone’s guess as to how, where and to whom it will be given and whether its progress will be followed.

 

Susan Martinuk writes for the Calgary Herald.