National Institute Of Allergy & Infectious Diseases Director Anthony Fauci: An Interview With "The Pink Sheet" DAILY (Part 2 of 2)

Manufacturers must "do a lot better than Tamiflu" for pandemic flu therapies, Fauci says.

Anthony Fauci, director of the government's lead research agency for infectious diseases, spoke with "The Pink Sheet" DAILY recently about vaccine development, pandemic influenza and the drug discovery pipeline.

This is the second of a two-part interview. See ¹ (Also see "National Institute Of Allergy & Infectious Diseases Director Anthony Fauci: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 21 Nov, 2006.).

"The Pink Sheet" DAILY : In your speech at Mid-Atlantic BIO in Washington, D.C. Oct. 11, you suggested that an effort modeled on the resources the nation has devoted to HIV/AIDS could generate countermeasures for a host of emerging and reemerging infectious diseases. Could you elaborate on those comments?

Anthony Fauci: One of the points I made vis-a-vis HIV/AIDS and how that relates to other diseases is that we were challenged by HIV/AIDS. We poured an enormous amount of basic research, applied research and clinical research resources into it.

Twenty-five years after our recognition of AIDS as a disease in the summer of 1981, the advances in research have been absolutely breathtaking. They've provided the foundation for pharmaceutical companies, for example, to make a number of antiretroviral drugs that have really transformed lives.

The relationship between investment in research and the many good drugs that we have, and the understanding of the virus and the diagnostic tests - that should serve as a model of how investments in both basic and applied research with a particularly troubling disease can lead to enormous successes. If you could do that with HIV/AIDS you could also do that as a model for other emerging and reemerging infections of global health importance.

We've been gradually increasing our AIDS portfolio to the point that AIDS now occupies about $2.8 plus bil., which is a little bit more than 10% of the entire NIH's budget.

"The Pink Sheet" DAILY : Where are we in development of drugs and vaccines for influenza? What needs to be done?

Fauci: We're right now in a crisis mode of trying to get drugs and vaccines stockpiled, and that has forced us to reexamine how we have been handling seasonal flu each year.

We haven't done a very good job because we don't take seasonal flu very seriously, even though it kills 36,000 Americans a year and is responsible for 200,000 excess hospitalizations and tens of billions of dollars of economic costs. Globally it kills about 500,000 people a year.

As a society we undervaccinate. The most we've ever vaccinated in this country is 83 mil. people, and we have a population of 300 mil. We should probably be vaccinating close to 200 mil.

What happens? We don't vaccinate enough people, so the vaccine production industry is not incentivized to stay up to date, expand their capabilities or move to the next generation of vaccines. There's no incentive to pharmaceutical companies to invest in seasonal influenza vaccination.

"The Pink Sheet" DAILY: How are we going to break the cycle?

Fauci: You have to work in coordination. For example, this year the manufacturers are going to make about 115 mil. doses at the same time as the [Centers for Disease Control & Prevention] is pushing the envelope of recommendations so the message is that vaccination is not only for the somewhat restricted groups.

At first they only recommended that children from six to 23 months get vaccinated. Now they're talking about children from six months to 59 months, children who are several years old. They're also going to be saying that people who are otherwise healthy should probably get vaccinated.

The recommendations are a gradual expansion of who could be benefited individually by vaccine, and how society can benefit from seasonal vaccination of more and more people.

If you do it in a coordinated way, you'll have a smooth meeting of the supply and demand, and if we do that every year, it will be much less of a crisis of having to make a lot of vaccine if we ever had to make it for a pandemic flu.

"The Pink Sheet" DAILY: Why did you remark at Mid-Atlantic BIO that nations shouldn't be measuring their pandemic preparedness by the size of their stockpile of Tamiflu (Roche's oseltamivir)?

Fauci: We need to do a lot better than Tamiflu. It goes along with what I mentioned earlier, that we're not really handling our preparation for seasonal flu very well because we have been very complaisant.

We say, 'Yes, we have a drug, Tamiflu,' not fully realizing that the basis upon which Tamiflu was approved is that it just shaves off 1.3 to 1.5 days of symptoms if you give it within the first 24 to 48 hours.

That is not the kind of drug you like to have when someone comes in deathly ill with advanced respiratory disease from a pandemic influenza.

So, my point is if we want to address pandemic flu properly we should start trying to get better drugs for seasonal flu, and then they will be available for pandemic flu instead of all of a sudden start stockpiling what might be a suboptimal drug because we didn't put enough effort into getting the best drug we could get.

[Earlier this month, HHS awarded additional contracts to Sanofi Pasteur, GlaxoSmithKline and Novartis to expand the U.S. stockpile of pandemic flu vaccine (² (Also see "HHS Boosts Pandemic Flu Vaccine Stockpile With Contracts Totaling $200 Mil." - Pink Sheet, 20 Nov, 2006.)).]

- Shirley Haley ([email protected])