Via Vox.com, Julia Belluz writes: Why using unproven Ebola medicine is bad science. Excerpt:
This week, the World Health Organization announced that it is ethical to give untested drugs to Ebola sufferers in what is the worst-ever outbreak. The announcement came after uneasy questions about Ebola medicine emerged following the treatment of two Americans with the experimental drug ZMapp. Some critics asked why Africans didn't have the same access.
Wider use of experimental medications, the WHO said, could be helpful at a time when there are no approved treatments or cures for Ebola. But not everyone agrees. Dr. Philip Rosoff, who specializes in clinical ethics at Duke University, says he's concerned that the decision to test experimental drugs during this outbreak may hurt more people than it helps. Here's a transcript of our conversation.
Julia Belluz: The WHO endorsed the use of experimental treatment in this outbreak, but you disagree with that decision. Why?
Philip Rosoff: If you read the WHO release on the ethics of using these drugs, they emphasize a couple of points: it should be okay to use them, but informed consent should be gotten. That seems to be self-evident but I'm not sure what informed consent means under situations of such desperation when a drug that's never been used in people is held out as a life saver.
JB: Some might say that's a necessary evil: One of the main reasons for approving the use of these medicines was that, with proper data collection after they're given out, we may be able learn about whether they work so that we have more tools to help people in future outbreaks.
PR: That's the second problem: the WHO talks about collecting data but that's going to be almost impossible to do. It'll be impossible to decide whether it's effective or not because it's not going to be used under controlled circumstances. When people get better, we'll have no idea whether it was because people are using the drug, or if somebody dies after getting the drug you don't know whether it's the disease or the drug. Because these patients are so sick, it may not be possible to detect side effects that you could under more controlled circumstances.
All of these drugs have never been tested in humans. Animal experiments are good and important to do prior to testing in humans. But they're only of limited value. Only a small percentage of drugs that start being tested in labs as potentially interesting finally make it to being approved as safe and effective by the Food and Drug Administration.
JB: Are you concerned about precedent — that we could be rushing to this decision, and if all doesn't go well, it may set a low bar for how we handle future outbreaks?
PR: I think people have been rushing a little too quickly and not thinking about some of the more complex and intricate issues that are raised by this situation. I think that if this goes forward, and people start using this drug and we make a precedent that we're going to use highly experimental, never-before-tried drugs in desperate situations, then we might make more mistakes than see benefits.
Desperation doesn't necessarily breed good science or good medicine. I think desperation breeds desperate measures that aren't the best measures.