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How Should Drug Trials Be Conducted In The Middle Of An Ebola Outbreak?

Pictured is the anti-Ebola drug ZMapp, developed in San Diego.
CD Murin, EO Saphire and AB Ward / The Scripps Research Institute
Pictured is the anti-Ebola drug ZMapp, developed in San Diego.
How Should Drug Trials Be Conducted In The Middle Of An Ebola Outbreak?
How Should Drug Trials Be Conducted In The Middle Of An Ebola Outbreak?
How Should Drug Trials Be Conducted In The Middle Of An Ebola Outbreak? GUESTSDr. Jamal K. Gwathney, Commissioned Corps of the U.S. Public Health Service. He is also clinical director at the Metropolitan Detention Center, a federal jail in downtown San Diego. Michael Kalichman, co-founder and director, Center for Ethics in Science and Technology at UC San Diego. He is also the director of the Research Ethics Program at UC San Diego.

Our top story on Midday Edition, it was all over the headlines last fall. The ebola outbreak in West Africa which led to several cases of ebola in the US. Concerns ran so high that President Obama appointed an ebola czar and sent hundreds of US troops to help set up medical facilities in West Africa. But now those troops are coming home. Liberian students are going back to school. And health officials say it seems the ebola outbreak is slowing down. Today, we'll get an update on the fight against ebola and how clinical trials of ebola drugs are being conducted. Joining me is Dr. Jamaal goff knee with the commissioned corps of the US public health service, also director at the federal metropolitan detention center in downtown San Diego. Doctor, welcome to the show. Thank you for having me, Maureen. And Michael is here, cofounder and director of the center for ethics and science and technology at UC San Diego. Michael, welcome to the show. Good morning. Now, doctor, you are speaking to us from a world health organization ebola meeting in Geneva. What's the meeting trying to assess? Well, Maureen, the meeting is bringing together foreign medical teams from all over the country to try and address three main issues. One, maximizing the current foreign medical teams in-country. Secondly, to discuss best practices and innovations in ebola treatment, as well as to discuss the improvements in safety and quality for the ebola treatment units in-country. And lastly, planning for the repositioning of the foreign medical team assets and hopefully decommissioning some of the ETUs there in countries as the need is no longer as great. Right. What is the ebola outbreak like now in Liberia? Has it slowed down? It certainly has. Cases are definitely significantly lower than when the epidemic started. There are still some upticks in Sierra Leone and Guinea, but certainly everything is improving. As we all know, when -- when an epidemic like this hits and it has such a high mortality rate that we -- it not only affects the public health and medical systems, but also the economic and social systems. So the children going back to school is a great indicator that the medical and public health interventions actually have been working and that the Liberian government now has that confidence to send their children back to school safely. Doctor, tell us about what you were doing in Liberia. When did you go and who did you treat? So I was there as part of the commission corps public health service team that set up what's called the Monrovia medical unit. We were there from October 27th through December 19th, my particular team, the first team in. And we treated healthcare workers from Liberia and all over the world that were treating patients in Liberia and neighboring countries. We also extended that criteria to nongovernmental organizations staff that might not have been healthcare workers, who may have been suspected of having ebola or had ebola. And our survival rate for our treatment unit was a little over 60%, which is pretty good. Now, you already told us that you're part of the commission corps of the US public health service. What's been the role of the US public health service in the ebola outbreak in West Africa? So as the public health service is one of the seven uniformed services of the United States government and our job is to protect, promote and advance the health and safety of our nation. So that sometimes means going into harm's way at home and abroad. So we had a highly trained team of public health service officers that went into country and provided direct patient care to ebola patients. We also have public health service officers conducting the vaccine currently in trials and then implementing those trials. And lastly, we also have PHS officers here at home, helping with screenings of passengers as they come off of flights from affected countries. So our skill set is quite vast and we will serve wherever there is the need. Now, in your work in Liberia, you said that in your facility you had about a 68% survival rate. From the patients that you treated with ebola, what accounts for that? It was 60, a little over 60%. I certainly think the interventions that we had at our facility being IV, access to rehydration solutions, as well as being able to draw blood work and look at electrolytes, sodium, potassium levels, being able to individualize our care to those particular electrolyte imbalances was key in helping to not only keep them hydrated, but not cause more problems with high potassium or low potassium levels. Solely supportive care is responsible for a lot of people survival this deadly disease? It is, certainly. And there are certainly other interventions out there, convalescent blood and plasma. And as we will talk about, ZMapp and other interventions that could be utilized to help those that may need a little more intervention. Now, doctor, the Liberian government has given consent to start drug and vaccine trials. What about the other nations hardest hit by the ebola crisis, Guinea and Sierra Leone? Well, I am aware that there are trials, Phase III trials in Sierra Leone and Guinea right now. Some of them being run by the national institutes of health, NIH, as well as other vaccinations, other different vaccines that are being tried in five other countries outside of those three mostly affected in West Africa. So there's a lot of research going on in a lot of the countries. It's good to know that the strain of the virus that is affecting those three most affected countries is the same, so that studies done in one country will be beneficial for all three. And just finally, doctor, what is the hardest hit region now in West Africa? It's still probably Sierra Leone, the hardest hit from ebola right now. And we're doing everything and that's what we're here at WHO trying to impact that and get it down to zero as we say, Phase II, getting to zero. I've been speaking with the doctor from the world health organization ebola meeting under way in Geneva. Doctor, thank you for your time. Thank you. And I go to my guest in studio, Michael, the cofounder and director of the center for ethics in science and technology at UC San Diego. Let's talk more about the drug trials getting under way in West Africa. Clinical trial for the ebola drug ZMapp, that was the one that was codeveloped here in San Diego, is set to begin this month in Monrovia, Liberia. Do clinical trials need to be conducted differently when they are taking place in the middle of a disease outbreak? Absolutely. This is an example of how extraordinarily difficult a trial can be. Almost everything you could imagine that would make it difficult is in place here, because your first priority is to be sure that the people who participate in the trial understand what they are getting into when they enter a trial. The purpose of the trial is to say that a drug is safe and effective. We don't know if it's safe and effective, and that's particularly challenging in this environment. And one of the problems that has been noticed and responded to by groups like doctors without Borders, the fact that when you have patients who are desperately ill conducting a clinical trial in the normal manner where some people would be given the drug and other people would not be given the drug, rather they would be given a placebo doesn't seem to have a lot of ethical support in a situation as dire is still found in some areas of West Africa. Absolutely, and maybe it would be useful to step back a moment and talk about what placebo means. The idea of a placebo to many people, they think of sugar pill. You're giving somebody something that has no effect. Now, that is true, that what you want in a clinical trial is something to compare to so you know what the baseline is. The reality is that when we choose placebo, when we say a controlled study, we still have to maintain the minimum standard of care. So if we know that something is useful, the doctor just talked about the importance of supportive care, for example, if we know that that rehydration, monitoring the electrolytes is helpful, we have to do that as a minimum. Other than that, if we don't yet know if something is safe and effective, we don't know if that's the way to go. In response to some criticism from groups like Doctors Without Borders, the national health institutes and other people conducting these trials are saying we're not going to use a placebo, but we are still going to use a control group. We'll give some people the ZMapp, other sick people we will not give the drug and continue supportive care. Do you find that ethically challenging, considering that these, both of these people are ill with a deadly disease? Well, it's ethically challenging in the sense that we don't know what's going to happen. If we knew the answer, it would be easy to choose what to do. However, imagine the two possible scenarios. One is that it works wonderfully well. Then what a tragedy we didn't give it to everybody right from the beginning. The other possibility is that it makes things worse. Perhaps people die more -- die sooner, mortality rate goes up. Perhaps the disease itself is even worse than it already is. Again, you won't know until you try. So it'setticly challenging because we have to make a tough choice. Who do we give what to? Right now, the best place to start from is, say, we don't know if it's safe and effective. Let's try treating one group with this new possible treatment and a second group will get the best care we have available now. Is there a percentage of people who need to be secured by the drug to know that it works? Well, since I'm not working directly in the field, it would be hard for me to say exactly what that percentage is, but I can talk about the issues you would want to think about. The one that's most on people's minds and the reason this disease is so prominent in the media and politics is because of the high death rate. So certainly if you could reduce that death rate, everybody would be thrilled. That's probably the first place to look because the death rate is so remarkably high. But if the death rate were brought down and what if we have treatments that can bring the death rate down to 10%, 5% or 1%, then you'll start asking other questions about how severe the side effects are of the drug, how much you can limit the other types of effects and disabilities that go with the disease. Now, we've been talking about ZMapp, one of the treatments that has been -- that is in clinical trials for people who already have the disease. Let's talk for a minute about the vaccine trials under way, giving this vaccine to people who do not have ebola. So how do those trials need to proceed in an ethical sense? Well, those trials in some ways are easier. We know a lot about vaccines. Most are relatively safe. That doesn't guarantee safety, but it's still -- it's easier to go that route. And second, the population of people you're dealing with are not already in the throes immediately of suffering with the disease and not knowing what to do. Imagine being a family member or somebody with this disease where the likelihood of death is high and somebody comes to you and says we have a clinical trial, would you like to participate? It would be hard to say no because you would just hope that this would be good for you, when in fact it might be worse. It's so different when you're talking about a vaccine because somebody isn't sick yet. We still have to do the trials. We still have to find out. And it will take some time before you can tell whether that was useful. But the issue of consent is still really rather important in this context, because people have seen so many of their family, their friends, their neighbors, their patients die of this disease. And so when you come with a vaccine, you also have to make sure that they know there are risks involved, isn't that right? Absolutely. And all of these -- no action you take is disconnected to all other possible actions. You give somebody this vaccine and what if you think this makes me immune, I'm safe and I can do anything I want. So now you have somebody who might be risking exposure in situations they wouldn't have before. If you try and do a trial in anyplace, it's really difficult to meet that standard of truly informed consent. In this country, we talk about that all the time. Imagine what it's like now in a poor, undereducated community, as many of these communities are where we're dealing with ebola. For those people to understand what it even means to do the research, much less that this is a study to find out if something works and it may not be helpful. I'm going to take a slight curve with my last question to you, Michael. Sure. That is that there's been an outcry in America over parents who refuse to get their children vaccinated for diseases like measles and mumps, et cetera. Do you think these new ebola drugs and vaccines, if successful, will change perceptions about vaccinations? I think perceptions on either side are very hard to move. One of the things that I've learned from my social science colleagues and friends is that attitudes are so strong that facts often don't make a difference. Having said that, this will be one more example of a reminder that you can have a disease that is frightening and difficult and we might be able to stem it by the use of vaccines. Okay, then. I've been speaking with the cofounder and director of the center for ethics in science and technology at UC San Diego. Thank you so much for speaking with us. Thank you. [ MUSIC ]

Although U.S. troops are coming home from West Africa after aiding in the Ebola outbreak — the fight against the disease continues.

Tens of thousands of people have been infected with the potentially deadly disease, including four in the U.S. Concern ran so high last fall that President Barack Obama appointed an Ebola czar.

Health officials will soon begin clinical trials of an anti-Ebola drug, ZMapp, but they'll face ethical challenges.The drug was developed by the San Diego-based company Mapp Biopharmaceutical.

Michael Kalichman, co-founder and director of the Center for Ethics in Science and Technology at UC San Diego, said it can be ethically challenging for doctors to decide which patients will be given the anti-Ebola drug.

RELATED: San Diego Doctor Returns From Ebola Mission In Liberia

Kalichman said some patients will be given supportive care while others will be given ZMapp.

"What you want in a clinical trial is something to compare to," Kalichman told KPBS Midday Edition on Monday. "One group gets Zmapp and the other gets the best supportive care. This is an example of how extraordinarily difficult a trial can be."

Kalichman, who is also the director of the Research Ethics Program at UC San Diego, said there are two possible outcomes from the clinical trial.

"One is that it works well. The other possibility is that it makes things worse, perhaps the disease itself is already worse," he said.

Jamal Gwathney, a doctor with the Commissioned Corps of the U.S. Public Health Service who worked in Liberia for nearly two months last year, said the number of new cases has decreased, but health officials have a goal of eliminating all cases.

"The cases are definitely significantly lower than when the epidemic started," said Gwathney, who is also the clinical director at the federal jail in downtown San Diego. "Sierra Leone is the hardest hit of Ebola right now. We're doing everything, trying to impact that and getting it down to zero."

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