Bioethics law professor Glenn Cohen

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The medical ethics expert reviews controversial health issues, including experimental Ebola drugs and prescription opiate use in the U.S.

One of the world's leading experts on the intersection of the law and bioethics (sometimes also called "medical ethics"), as well as health law, Glenn Cohen is co-director of the Petri-Flom Center for Health Law Policy, Biotechnology, and Bioethics and on the faculty of Harvard Law School—where, at age 29, he became the youngest professor, tenured or untenured. He previously served as a lawyer for the civil division of the U.S. Department of Justice, handling litigation in the Courts of Appeals and the U.S. Supreme Court. He's also one of the key co-investigators on a multi-million Football Players Health Study at Harvard, which is committed to improving the health of NFL players.


Tavis: So who gets first world medicine, how we establish protocols for dealing with epidemics, and what should be done about the explosive use of prescription opiates are just some of the questions for which there are no simple answers. Grappling with these and other often life and death issues is bioethicist Glenn Cohen.

He’s the author of an upcoming book called “Patients With Passports: Medical Tourism, Law and Ethics.” He’s also the director of the Petri-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard University. Glenn Cohen, good to have you on this program.

Glenn Cohen: Thanks for having me.

Tavis: Let me start with your assessment of — it’s been a little while now — your assessment of how this Ebola crisis has been handled to date.

Cohen: So I think the general sense of people who work in public health is that it’s not been a very strong handling of it. There were about 20 Ebola outbreaks since 1976. This was predictable that this was coming.

You had the first index case in December 2013 of this outbreak, but it took until August for the WHO to declare a public health emergency and only more recently has it issued its roadmap.

And in general, I think most people feel as though this could have been contained much more quickly. And one of the ways to have done that would have been to do more capacity-building of the infrastructure for healthcare in many of these countries.

Tavis: How can you predict that there’s going to be an outbreak of Ebola, or anything else for that matter?

Cohen: You know, the epidemiology on this is that basically there is a predictable pattern at which every single years you will have an index case like this. But to get from an index case to an outbreak, that really depends on how you manage it and how you handle it.

And the sense is that here we didn’t put enough resources quickly enough to basically quell the transmission here.

Tavis: When you say “we” didn’t do enough, who are we specifically indicting?

Cohen: Well, you know, I would never indict anybody without a good grand jury on my side. But in general, I think that what I’m talking about here is both the international community, to some extent, many of these African countries. But they are extremely resource-starved. Right now the WHO has predicted we’re going to have to have…

Tavis: We should say for those who don’t know…

Cohen: Yeah. The World Health Organization.

Tavis: Exactly, yeah.

Cohen: Who is a U.N. body and, again, they don’t have complete control over the situation. But they’ve now predicted that western and wealthier and more developed countries are going to have to invest about $500 million dollars at this stage to help reduce the spread of this outbreak and help tamp down on it. We could have probably spent a lot less a lot sooner over the last several years just to build infection control, better training.

There are less than 150 doctors in Sierra Leone and in Liberia, period. That’s really shocking. We’d have to multiply by about 20 times the number of doctors in Sierra Leone to get what we view in the public health community as acceptable doctor to patient ratio.

Tavis: Not always easy to get consensus, as you know, inside the U.N. But I suspect this money that you just referenced will come rather quickly and rather easily if, for no other reason, the countries don’t want this to spread inside of their borders.

Cohen: That’s right. I think part of what’s interesting here is, you know, if you go to the developing world — and I lived there for a period of my life. If you go to the developing world, you see all these deaths from neglected diseases, diseases we think were beaten in the west.

And for the most part, although there are some good Samaritans and people pushing for help there, we don’t see the same kind of public outcry as we do over Ebola. And I think the main reason is Ebola is threatening.

We’re worried that it’s coming to our territory. We’ve seen Americans become infected with it. So there’s a saliency there. I wish that we were motivated to cure chagas and infectious diarrhea and like, but Ebola seems to have caught the world’s attention.

Tavis: What more could the African countries have done since you said earlier that they were on your list of persons who could have done more?

Cohen: Again, I think they’ve done a pretty good job. But my main critiques here have to do with actually communication about burial techniques. So one of the things we’ve learned is that many of the burial techniques there have been responsible.

The other thing is just more generally encouraging trust of the public to the public health system. That’s easier said than done, right? I can say that that’s something I wish they had done better. Very hard to implement that, especially with the resources they have.

Tavis: Let me get now to some of these ethical questions which fascinate me about what you do when there is an experimental drug that has shown at least in the lab to work.

How do you decide who gets those drugs, who doesn’t get those drugs? ‘Cause the short and skinny on this is that there were a few folk in the west who got access to a drug and it took a minute for that drug to make its way to Africa.

So how do you make decisions whether or not, one, you should offer up an experimental drug and, secondly, how do you decide who gets to use that drug?

Cohen: Yeah. So the usual course in which we get a drug approved in the U.S., and it’s true in the European Union and in most places, is we run first animal trials to make sure it’s safe and effective in animals and have some good data that it’s actually going to work.

We then run a series of clinical trials. Phase One, looking at safety, Phase Two, looking at efficacy. Does it actually work? And Phase Three, looking at dosage in particular and side effects profiles.

And that’s your ideal way of doing this. But when you have an outbreak of something like this and a desperate need, often you have a question of whether you’re going to skip steps.

This also happens for terminally ill patients with cancer who want something that’s experimental. So the FDA has a process by which you can request what’s called an experimental investigation on a new drug application or a small trial to run.

Here, we’ve gone through a different mechanism. What happened with the drug I think you’re referring to, ZMapp, which was the one given to two American health workers.

It appears as though Samaritan’s Purse which is a missionary organization, I think, run by one of Billy Graham’s sons, they called the NIH and said, “We have somebody who’s contracted this. Can you tell me who’s working on a therapeutic?”

And they pointed them to this company, the Mapp company, and from there it’s a little unclear what happened, but they basically decided to make this available.

Even though before these American health workers were given this, it had not been given to a single human being. It had only been done animal studies. And even now, we don’t know if it was effective or not. It’s just too small a number of people to be able to determine whether it works or not.

Tavis: So would we label that as unethical or would we label as these two patients were willing to take a risk? They could have died from this treatment, but they took a risk and it happened to work. So is it a good roll of the dice on the one hand or unethical on the other hand?

Cohen: Yeah. So let me separate out two issues. One is for those individual patients, their consent process. The other whether these two patients should have been the one given this incredibly scarce resource. I think there were 10 doses in total. In terms of the individual patients, you know, they were given information about their needs and about the risks involved.

I think many of them, this strain of Ebola, has somewhere between 50 to 60% fatality rate. I think that, for them, it was totally acceptable for them to evaluate that risk and to realize they wanted to try it rather than take a chance without it.

And, again, we still don’t know whether the drug made a difference. It could have been the excellent care they were given and their monitoring in American hospitals and the like.

So my sense there is about giving information. It’s about empowering patients and, especially in the case like this where it’s very likely fatal and you don’t have any other good substitutes, it doesn’t seem to me unethical to give patients that choice.

The other side is more tricky. So imagine we were not talking about experimental drug, but something like a kidney, right? Which is still scarce, but we know how it works.

Ordinarily you wouldn’t want first come-first serve to be the way you allocate something that’s scarce because people who are more sophisticated, have more resources, they know who to ask. They’re the ones who get it first and that seems unfair.

Instead, what we would like to do in bioethics with pandemic flu vaccines or kidneys is, first, we give priority for a flu vaccine, for example, to healthcare workers.

And the reason we do that is twofold. First, we think it’s a matter of justice. These people have put themselves at risk for Ebola in particular. Put themselves at risk of infection and we need to give it to them as a matter of fairness.

Then there’s a second reason which is we need to do this because we want to make sure doctors are willing to risk their lives and we need to make sure that it was favorable to them to go ahead and do this and to know they’re going to be taken care of. So healthcare workers first.

Then after that, you usually want to do a mix of what we call best outcomes. So the people who you think have the largest chance of success, which may be based on their age, based on their health, based on how far the disorder has progressed, as well as some conception of sickest first.

If there’s somebody who’s only a little bit sick and someone who’s very sick, sick is first. With Ebola, we know almost everybody who gets it is very sick.

Now it doesn’t look like that’s the way in which this particular drug was allocated, but there were so few doses of it that it’s hard to know whether we would have been able to have a very standardized system anyways.

Tavis: If we’re going to give it to healthcare workers first, we could have given it to healthcare workers in Africa.

Cohen: We could have, exactly. Now here, one of the things that’s complicated about the fact that it’s experimental is we also have to learn about how this is working and whether it’s working, right?

And in terms of getting it approved or in terms of being able to improve the product, there is a question whether this is the kind of drug that could have easily been administered in the typical Sierra Leone or Liberia or Nigerian hospital or whether the sophistication of monitoring we have in the U.S. increased the chance of a good outcome, but also allowed us to learn better. So that’s an extra kind of complication with an experimental drug.

Tavis: To the date, over a couple thousand folk dead from this Ebola virus. It’s called an Ebola outbreak. Your sense that we have contained this now? Is the worst behind us?

Cohen: Yeah, I would be hopeful to say so, but I don’t think I’m confident of that. I do think that now the decision makers and the funders understand what the stakes are. My guess is we’re going to have a major push.

But, you know, there is, as you said, GlaxoSmithKline is working on a vaccine. Maybe November, we’ll have 10,000 doses and we’ll know it works. Vaccines are very hard to test whether they work or not.

The people are taking this seriously and the resources are starting to be poured in. I just wish they’d been poured in in December, not in August.

Tavis: While I’ve got you here, I got just a minute to go, but let me ask you a quick question about these opiates and the fact that heroine is another scourge in our society.

Once again, you think of Philip Seymour Hoffman, of course, the most famous case of late. But I’ve seen a couple governors of late, the governor of Vermont, governor of Massachusetts, who’ve made this an issue in their major addresses.

Your sense of whether we’re entering into a phase now where we’re going to have put the issue of heroine back on the docket for something that we have to kind of get under control.

Cohen: I mean, absolutely. The new face of heroin users are 90% white, mostly young. The average age is 23. But I want to emphasize that the opioids themselves, the painkillers themselves, the overdoses from them are greater than the overdoses of almost all illicit drugs, including heroin, cocaine and everything.

So even if you forget the transfer over to heroine, these opioids themselves are a serious public health problem.

Tavis: Glenn Cohen of Harvard, good to have you on the program. Thanks for your insights.

Cohen: Thank you so much.

Tavis: Thank you, sir.

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Last modified: September 11, 2014 at 12:17 pm