We begin this week with a step back from the Ebola crisis to consider the big picture. Now that one person has died here in the United States and visitors from West Africa are being screened as they arrive in this country, we wanted to explore what happens next in the search for a treatment or a vaccine, something that could help turn the page on this epidemic. To do that, we turn to an infectious disease expert who is both a physician and a pharmacist. Dr. Tim Franson worked in this field at Eli Lilly and Company and now works with other life sciences companies going through that process.
Lewis: Given how rare a disease Ebola is, do you find it unsurprising that there's no really established treatment for it?
Franson: Not surprising at all. There are so many diseases that medicine does not understand. So, if we don't know how the diseases are caused, it's difficult to intervene and difficult to develop medicines or vaccines or other ways to confound these variety of disease processes. With something like Ebola, we have a good idea of what is causing it, which is a virus. How to approach it has been a bit of a problem because no one has had the opportunity to really study this.
Lewis: Not having the opportunity to study it, I think some pharmaceutical companies take it to task, saying it's a deadly infectious disease. It's kind of an orphan disease 20 years ago and now here it is threatening not only Africa, but also our borders. Can you talk a little bit about the FDA's ability to kind of fast-track drugs, certainly what we are seeing in Africa now. And maybe there's another case that you can point to.
Franson: Sure, there are actually a number of things that have already been done for Ebola, and things that have been done for diseases in the past, where I think we've had some very good learning points. When you think about the concerns folks had several years ago with anthrax, there were fortunately compounds that were already approved in the United States for other purposes that could then have an expanded use, and FDA has the authority to be able to declare usage beyond how a product has been tested and labeled. And those things are intimately intertwined: what you test for is what you get to advise physicians that can be used for. In that case, there were a variety of drugs which appeared effective for anthrax and in fact, in some cases, had been tested. Ebola is a bit more of a dilemma, but FDA has at its disposal a number of powers to be able to collaborate with the Centers for Disease Control, to be able to give companies the opportunity to have things provisionally approved for use under what's called "investigator status." That means you have to keep very diligent records, but it's not quiet the same thing as a clinical trial because it's a use in practice. There's actually something called the "animal rule," where if a compound has been shown in animal testing to have likely affect on the given disease, and there's reason to presume that how it acts in that animal is predictive of what happens in humans, than those kinds of things can also be approved for that use. So rather than having to go through those proactive trials that may take up to twelve years to develop a drug, there are ways to immediatley be able to intervene. And I understand that people are worried because of international travel. There are Doctors Without Borders which are very important. And people are now worried that these are now Viruses Without Borders that can travel in easy ways. Fortunately, for us Ebola and similar viruses don't appear to travel by public transportation. That is they are not airborne, so you aren't likely to be exposed to it other than very direct contact with an infected patient, so I think of that more as a private transportation. You would really have to have some kind of significant contact with bodily fluids to have that happen, and as we've seen handled very well by the health care workers who have been brought back from Africa, primarily Sierra Leone and that area to be cared for at Emory University and other hospital that there are strict infection control practices that are used to contain things for health care workers as well as exposure to anyway else. And I'd have to say the infection control practices in institutions in the United States are really second to none. Folks really know how to run that drill. They've had experience with AIDs. They've had experience with other communicable diseases of this nature. So, folks are very well prepared for this, even if they've never seen exactly the Ebola virus. There are several ways that FDA can expedite drugs or at least make them available. And there are things called "compassionate use." I believe FDA's terminology is now called "expanded access," where beyond a formal study that a drug sponsor may be making for the purpose of a submission. They can provide things under these investigation circumstances. There are certain rules that have to be followed, and record-keeping that has to be done, but given that very simple formula, folks can have access. Now, it may well be with Ebola, folks would say they don't want any such patients referred to Emory hospital or other designated centers, but again the access to experimental medicines should, at least within the U.S. borders, should be something that FDA can and will help with.
Lewis: I'm talking with Dr. Tim Franson about the chances that lie ahead for the developers of any possible vaccines and treatments for Ebola. I asked him if drug makers could ramp up production for the Ebola drug in time to meet the growing demand.
Franson: That's a really difficult question, because without knowing what their stage of manufacturing progresses or capabilities, usually in early phase studies (which at least were led to believe from all of our reading, that both Zmapp and ... are at), they probably have very small-scale manufacturing. And scaling up from making something in a test tube to making something in a 600-gallon is a very daunting challenge. So whether these things can be scaled up depends on how complex their chemistry or biology might be. And I guess it remains to be seen. I wouldn't want to disparage any of these companies or discourage hope but it's just an unknown.
Lewis: Are we breaking some new grounds here when it comes to providing drugs and providing experimental drugs in this Ebola outbreak. Are there some new avenues that you are watching very closely?
Franson: I think all of these programs have already been established at least in some forms, so folks are building off programs that have already been present. Again, another good example in addition to Anthrax, is how FDA expedited the ability of the flu vaccine in 2009. When there were new strains, folks were very worried about whether or not they were covered by the initial vaccine. And so, FDA was able to and did expedite the availability of those compounds. And it turned out that was a very good thing. So, this is not a drill FDA is doing for the first time. It's just with Ebola, in our current world of hypercommunications, is kind of there and available for us to see 24/7. So, we are perhaps more aware of the availablity.