Medical Experts Look For New Ways To Test Ebola Drugs : Goats and Soda Can you run a clinical trial without a placebo group? That's one of the questions facing researchers in West Africa.
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Medical Experts Look For New Ways To Test Ebola Drugs

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Medical Experts Look For New Ways To Test Ebola Drugs

Medical Experts Look For New Ways To Test Ebola Drugs

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We're also tracking this news - medical experts are meeting at the World Health Organization in Geneva today and tomorrow. And they're asking how to test experimental Ebola drugs in West Africa. Naturally people want to test whether the experimental treatments will work. The trouble is resolving ethical issues. NPR's Richard Harris reports.

RICHARD HARRIS, BYLINE: When American health care workers developed Ebola in Africa, they flew home and received medical care vastly better than what Africans were getting. Nancy Kass, a bioethicist at Johns Hopkins University, notes those treatments included experimental drugs.

NANCY KASS: We still have no idea whether those treatments made any difference in their recovery. They also got exquisitely high-quality supportive care, which undoubtedly made a huge difference.

HARRIS: But their treatment sent a clear message to Africans - the best care seems to include experimental drugs. But that's not the standard that will be applied in the tests in Africa.

KASS: People get suspicious whether there's a secondary level of care.

HARRIS: And the care seems inferior because not everyone in these trials will get an experimental drug. Researchers need a comparison group to see whether a drug makes a difference. The standard way to do this the world over is to provide some people with a potential drug and a comparison group with a placebo. Martin Friede at the World Health Organization says some in West Africa find that concept objectionable.

MARTIN FRIEDE: The word placebo it carries a lot of connotations to it that I think rather people are talking about controlled trials.

HARRIS: There are other ways to come up with a comparison group, not as rigorous, but still potentially useful, especially if a given experimental drug has a powerful effect.

FRIEDE: This can be done through historical records. It can be done through comparing to what's been done in other sites. There are various mechanisms of doing this.

HARRIS: Those are under discussion this week at the meeting in Geneva. Scientists know the farther they stray from the most rigorous standards, the less likely they are to get clear, rapid results.

FRIEDE: What we do not want are trials that are conducted where at the end of the study, we are unable to say whether the drug is safe or not or whether the drug is effective or not.

HARRIS: Numerous research groups are planning trials, and they're using a variety of strategies. For example, scientists at Oxford University say they aren't going to use placebos at all. U.S. scientists aren't drawing that bright line. Cliff Lane at the National Institute of Allergy and Infectious Diseases says they're hoping to start tests with Liberian health researchers early next year.

CLIFF LANE: This study initially would almost certainly be a randomized, controlled trial.

HARRIS: That means not everyone will get an experimental drug. That said, the study will offer everyone who enrolls a higher standard of overall medical care. So in theory, everyone will benefit. That is, unless the experimental drug proves to be harmful.

LANE: People always think about the investigational drugs as being, you know, wonder drugs, miracles. They're going to make the patient better, when in point-of-fact, some of these agents can have pretty serious side effects. And in fact, the patients might do worse for having gotten the agent. Without a control group, you wouldn't know that, or you wouldn't know it until a large number of patients might potentially have been harmed.

HARRIS: All the experimental drugs have at least had very basic safety testing, but there's almost no experience in giving them to people who are sick with Ebola. Scientists have been tossing around other ideas to minimize the number of people who are in a comparison group. One idea is to have a small comparison group and a large treatment group. Another idea is to give people varying doses and see whether people who get more drug did better. Again Nancy Kass from Hopkins.

KASS: I think that this is a time, as is often true in deep, ethical challenges, where thinking a little bit outside the box may be the answer that works best for everyone.

HARRIS: After all, this isn't simply a test-tube experiment. Clinical trials involve real people. And they need to agree to participate or the studies won't go forward. Richard Harris, NPR News.

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