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Who should get the Ebola serum, and why?

Who should get the Ebola serum, and why?

Arthur L. Caplan, director of the Division of Medical Ethics at New York University’s Langone Medical Center’s Department of Population Health writes:

What should happen if a massive viral outbreak appears out of nowhere and the only possible treatment is an untested drug? And who should receive it? The two American missionaries who contracted the almost-always-fatal virus in West Africa were given access to an experimental drug cocktail called ZMapp. It consists of immune-boosting monoclonal antibodies that were extracted from mice exposed to bits of Ebola DNA. Now in isolation at an Atlanta hospital, they appear to be doing well.

It’s an opportunity the 900 Africans who’ve died so far never had. Is there a case to suspend ethical norms if lives might be saved by deploying an experimental drug?

The answer, he says, is “partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies.” But, he adds, that privileged people always get the first shot at experimental drugs in an emergency.

Is that as it should be? Is there anything that can be done about it?

Meanwhile, a legislator who is both anti-immigrant and none-to-bright is attempting to use the Ebola outbreak in Africa as a club against refugee children from Central America and the usual suspects are attempting to prove which of them is the most hard-hearted.

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IT

Interestingly, the recent administration of ZMapp to the two medical workers is prompting some re-evaluation

:

Just a few weeks ago, Sprecher told Science that it might be counterproductive to bring experimental drugs or vaccines to the field; the affected population might see themselves as guinea pigs for Western companies, he said, which could increase hostility and complicate the fight against Ebola.

Although he still has those worries, a bigger concern now looming is that the treatment given to Brantly and Writebol apparently isn't being made available to Africans. This week, The Wall Street Journal reported that dying Liberian patients and their families are already asking for the therapy—and wondering why it appears to be for Americans only. "This is something that has made our job most difficult," the paper quoted Liberia's Assistant Health Minister Tolbert Nyenswah as saying.

"The shoe is on the other foot now," Sprecher says. "It's not that we would inflict horrible things on them, but that we failed to inflict good things on them."

Susan Forburg

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IT

Sorry, that Science-y post is by Susan Forsburg

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IT

There's an article about this debate in a recent issue of Science.

First of all, the treatment given these workers is completely experimental. That means no safety trials, no efficacy trials. As medical workers, these patients are able to give informed consent with a full grasp of the consequences. And let's be clear, there is no evidence that the treatment has had any effect (correlation is not causation-they may well be improving because of the strong support of a high-end hospital).

Second, there is a huge, HUGE problem on the ground amongst the local population. From the article:

Quote: [T]he organizations fighting Ebola on the ground say they simply can't bring an untested, unlicensed drug to a population that's already distrustful of the teams trying to stamp out the outbreak. “Some people are throwing stones at us,” says Armand Sprecher, a public health specialist at the Brussels office of Doctors Without Borders. “There are rumors that we are spreading disease, harvesting organs, and other horrible things. Bringing in unlicensed things to experiment on people could be very counterproductive.” A representative for the World Health Organization (WHO) adds that using vaccines now “would not be ethical, feasible, or wise.....”

And no drug or vaccine is going to work once patients are very ill, says Ebola researcher Thomas Geisbert of the University of Texas Medical Branch in Galveston; if patients seek care too late, that could create the mistaken impression that the interventions are useless. “If something goes wrong this could be a disaster,” Feldmann says. “So we have to work hard and come up with a really good plan for the next outbreak.” EndQuote

Can you imagine the consequences if an untested drug proved to have deleterious side effects in those given it? Can you imagine if it killed people? Can you imagine the accusations of racism that Western cultural hegemony allows us to test unsafe drugs on poor Africans ?

I can, because it's happened before.

Don't you remember the uproar when the anti-HIV drug AZT was tested on African patients? There was a huge scandal because of informed consent issues. AZT was an early treatment for HIV, and as far as I know, there was no evidence for harm, but it doesn't matter.

And, just recently, again over issues of informed consent on test subjects in China, anti-GMO campaigners have tried to get a paper on Golden Rice retracted. Golden Rice produces beta-carotene, which is a precursor of vitamin A. Vitamin A deficiency is a leading cause of blindness in impoverished children. There's no claim that the findings of the study were invalid, no evidence that the children were harmed -- indeed, evidence suggests Golden Rice does exactly what it was intended to do --but nevertheless, there is a call to retract the paper solely over consent issues, in an ongoing effort to prevent the distribution of Golden Rice. (One of the early leaders of the virulently anti-GMO group Greenpeace has left the group in disgust over these sorts of tactics that manifestly harm people.)

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Marshall Scott

Ellen, I appreciate your comments. There is another issue behind Caplan's comments, I think, that has troubled Americans involved in health care research for some time. There have been many drugs that were tested first in Africa and in other areas where people lack both economic resources and education. Our understanding of respect for persons requires informed consent, as best we can provide information. Some of the drug trials in those other places have had questionable processes for informing participants, assuming that the patients/study subjects had the education to understand information given to them. This has long been considered a combination of ethical issues: were these people taken advantage of, put at inappropriate risk without proper information? Did this really benefit them? Did it really benefit future patients? Did it primarily benefit the drug company, who was able to do a (perhaps questionable) study cheaply and with little oversight? That is one of the concerns.

Another, and Caplan's final comment, is that we don't have a real public policy about distribution of scarce resources among our own folks. Recent concerns about SARS or bird flu, or about possible weaponized smallpox, have been places where the health care community and emergency planners have done a lot of talking. In most metropolitan areas emergency planners have a pretty specific idea how many isolation rooms and how many ventilators there are; and they're almost certainly not enough if we have a pandemic with a really virulent influenza. However, civic leaders haven't really engaged the general public in the conversation. So, while there is an issue about equitable distribution of resources between rich societies and poor societies, there is also one of distribution in crisis within our own society.

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Linda Horton

I have to agree with Ellen Lincourt. In addition, imagine the fallout if the drug had not helped and instead increased the tragedy involving large populations in Africa, or anywhere else. I'm hoping the research can be fast-tracked, now that we know it helps. So many people are suffering.

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