therapeutic as well. Even 48 to 72 days after the viral challenge, we still get very significant therapeutic effects.
A novel approach like ours would not be possible without the support of the national biodefense effort and NIAID. We are several months from filing an investigational new drug application, and we are hoping to go to clinical trials quickly. Our scientists are working day and night, but the limiting factor is still funding. I'm here to urge continued public-sector funding because private-sector funding is hard to come by. When we talk about pandemics, the market is not there.
Companies like ours can do such research with many fewer resources. With less than $14 million, we believe we can take the drug all the way through phase III clinical trials. So, important progress is being made with public funding.
PARTICIPANT: Dr Gerberding alluded to the fact that we are exploring an expanded surveillance effort in Southeast Asia, with partnering between DOD and CDC. DOD has a fairly significant global surveillance system for emerging infections, with laboratories in Cairo and Jakarta, Peru, Thailand, and elsewhere around the world. Our folks in Jakarta commented on the opportunity after the tsunami to greatly enhance surveillance efforts in Vietnam and Cambodia with modest funding.
Specific suggestions for the types of studies that need to be done would be very helpful. We are certainly willing to partner with others, including with WHO and Dr. Stohr, to expand this effort. We have some funding that we could apply right away, but we need to know what we need to do.
PARTICIPANT: Several speakers touched on the stockpiling of antivirals. It is very difficult to know when we should pull items out of the stockpile and start shipping them for use in the field. Tamiflu is under patent from Roche. It costs about $3 a pail to buy the drug in bulk. Under the World Trade Organization’s TRIPS agreement [trade-related aspects of intellectual property rights], a country can issue a compulsory license during a public health emergency to allow other companies to manufacture the drug. I am interested at what point the panelists think the United States should evoke the TRIPS agreement to start producing its own Tamiflu. And at what point should we deploy non-vaccine interventions?
DR. GELLIN: I think all countries are grappling with that issue. As you said, a single manufacturer now has a patent, and it is the only feasible player in a pandemic setting. Unlike the H5 vaccine, which is still being evaluated, anyone can purchase that product today. The question is how nations handle that on a public health basis. Nobody knows how much of the drug to buy and exactly when to pull the TRIPS trigger. I hope this workshop will shed light on how to refine the models so we can understand some of these trigger points more precisely. I don't have the answer, but clearly how much of the drug we buy and how we deploy it are issues of great importance, given that there will not be enough vaccine to go around.
DR. STOHR: The international trigger point for WHO would be the emergence of a virus with effective human-to-human transmission. In the next couple of days WHO will publish a new pandemic preparedness plan that will not only recommend what countries should do during different phases of a pandemic but also clearly outline what countries can expect from WHO during those phases. The plan will include trigger points for national use of antivirals from a