Sunday, May 27, 2018
News Roundup

Ethical issue: Who gets experimental Ebola treatment?

Two American aid workers were gravely ill, fighting to survive infection with the deadly Ebola virus. A San Diego drug company had three doses of an experimental Ebola treatment that showed promise in monkeys but had never been tested in humans.

Getting the medication to the two patients in Liberia seemed like the obvious thing to do. The Centers for Disease Control and Prevention, the National Institutes of Health and the Christian aid organization Samaritan's Purse worked together to make it happen.

Patient advocates who believe the drug is helpful are asking when it can be made available to the hundreds of West Africans who are ill.

The decision to offer two Americans the experimental treatment — while dozens of African doctors and nurses have perished — has provoked outrage, feeding into African perceptions of Western insensitivity and arrogance, with a deep sense of mistrust and betrayal still lingering over the exploitation and abuses of the colonial era.

"It's very important that our doctors get access to the antiserum," said professor Alani Sulaimon Akanmu of the Lagos University Teaching Hospital, saying it would be scandalous and criminal to deny West African doctors the drug.

Three leading experts on the Ebola virus said that experimental drugs should be provided to Africa, and that if the deadly virus was rampant in Western countries it would be "highly likely" that authorities would speed access to the medications despite the risks inherent in an untested drug.

But what looks like a simple case of humanitarian goodwill could lead to some unintended and very negative consequences, experts said this week.

Although there could be a short-term gain for a dying patient, in the long run it would undermine scientists' ability to determine whether the drug was actually safe and effective.

"I don't think we want to say these drug companies are obligated to suddenly mass-produce these drugs," said Jennifer Blumenthal-Barby, a medical ethicist at Baylor College of Medicine in Houston. "That would subvert the whole FDA-regulated process of trying to do solid research on these drugs."

The Food and Drug Administration has elaborate rules for evaluating drugs before they are approved for widespread use. The process can take years, involving hundreds or thousands of patients and costing drug companies millions of dollars.

The rules are designed to make sure that a medication doesn't make patients more sick than they are and that it fights the disease it was created to fight. They are also used to figure out the minimum dose needed to get the desired effect.

The centerpiece of these rules is the clinical trial, which allows researchers to show that patients who took the drug fared better than patients who didn't.

In this case, there will be no way to tell whether Dr. Kent Brantly and hygienist Nancy Writebol were helped by the experimental Ebola drug, said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases.

The two aid workers are being treated in a specialized isolation ward at Emory University Hospital in Atlanta.

The experimental drug given to Brantly and Writebol is a cocktail of three monoclonal antibodies designed to prevent the Ebola virus from latching onto and inserting itself into a host cell. If the virus does enter the cell, it begins to produce copies of itself.

The drug, called ZMapp, is one of several under development to fight Ebola. Allowing any of them to be given to patients without proper vetting would be problematic, said Arthur Caplan, director of the medical ethics division at the New York University Langone Medical Center.

Even if the drug were deemed safe for immediate use and a donor were found to pay for it, it could take months or longer to produce enough to treat everyone who wanted it.

"You'll be in shortage right away and you'll have some hard choices to make," Caplan said.

   
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