TESTIMONY OF THOMAS V. INGLESBY, [M.D.]  /  DIRECTOR AND CHIEF   EXECUTIVE OFFICER, CENTER FOR BIOSECURITY, UNIVERSITY OF  PITTSBURGH MEDICAL CENTER

Dr. Inglesby. Mr. Chairman and Members of the Committee,  thank you for the chance to speak to you today about U.S.  biopreparedness 10 years after the anthrax attacks. My name is  Tom Inglesby. I am the director of the Center for Biosecurity of UPMC, and as you requested, I will focus my testimony on medical countermeasure development, biosurveillance, and other  issues raised in our recent center report, ``Crossroads in Biosecurity.''

• • • [NOTE:    \1\ The prepared statement of Dr. Inglesby appears in the Appendix   on page 1196.]

The potential biological threats to the United States are serious. We could face a new flu pandemic that spreads like H1N1, but kills like H5N1, or a novel virus that jumps from  animals to humans and spreads across the world quickly, or another biological weapon.

The anthrax letters of 2001, as shocking as they were, were a very small case of the use of biological weapons. Attacks in the future could affect extraordinary numbers of people.

In 2009, President Obama's National Security Council said:  ``The effective dissemination of a lethal biological agent within an unprotected population could place at risk the lives  of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths.''

One of the most important components of our defense against biological threats is the development of medical countermeasures. DHS has issued 12 Material Threat Determinations for top biological threats to the American public. Countermeasures for just three of those--anthrax, smallpox, and botulism--have so far received the majority of  funding in advanced development and procurement. Here are my suggestions for making more progress in the future on countermeasure development.

First, BARDA should convey its specific priorities, predicted budget requirements, and timelines for delivering them. Right now it is not clear, or at least it is not clear from the outside, what the top priority products are, how long it will take to develop them, or how much it will cost. And for each priority product that is to be developed, it should be made clear to what extent its development requires more basic science versus more advanced development, and the funding for this work should be allocating accordingly. If specific regulatory problems are the problem, then funding should be directed to FDA to resolve them.

When decisions are made to purchase a particular countermeasure in the National Stockpile, an explanation should be provided, to the extent possible in the public, that explains the choice and the quantity and the way it will be used in crisis.

BARDA's recent Strategic Plan places a priority on broad spectrum antimicrobials and multi-use platforms. In the long term, we absolutely do need to develop multi-use platforms and broad spectrum products. But we also need to make sure expectations are not unduly raised in the short term. There are few experts who think a shift like this is likely in the short term. So in the short term, we need very applied, very directed advanced development of products that address the greatest material threats to the country. And we should certainly stretch our biosecurity resources in the smartest possible ways, for example, by extending the shelf life of products already in the stockpile, wherever possible, and by investigating the feasibility of shortening the course of antibiotics for various diseases that we might be exposed to, and by completing dose-sparing studies that could help us vaccinate more people while decreasing costs.

In the realm of countermeasures, there are serious funding issues. There has not been enough advanced development funding as compared to basic science funding in the Federal budget for this mission, and BARDA has received a small fraction of what a private company would have required to make the same number of products. It is also our understanding that the BioShield fund will be depleted this year, and without a BioShield fund, we will not get new products procured.

And, finally, FDA was funded properly to deal with medical countermeasures for the first time this last year, but that program's budget was reduced from $170 million to $19 million in the Senate and to zero in the House. Its work would be significantly set back if the FDA got that budget allocation.

Biosurveillance is also another critical area of U.S. biopreparedness, and there have been gains but much work remains to be done. In many places biosurveillance is still too slow to discover or keep up with fast-moving epidemics. A few recommendations to improve it:

    First, a small portion of the $18 billion that is now going into the electronic health record incentive program should be moved to public health in order to allow them to be able to process and analyze information related to outbreaks.

    We also need to improve electronic laboratory reporting. All notifiable diseases should be automatically reported from the lab to health departments and continue to be transmitted throughout the course of an outbreak, and that does not happen now, although all in public health agree it is a top priority.

    In addition, as Dr. O'Toole said, we should place higher priority on rapid diagnostics. Right now we are investing heavily in the basic science side of diagnostics, but it trails off as we get to commercialization and development, and we could change that and make a big difference.

    And, finally, I want to emphasize how important public health preparedness is to U.S. biosecurity. Prior to 2001, many health departments lacked even the most basic expertise and infrastructure, and after 2001, incredible things have happened in the public health arena. New Federal funding has built a lab network, funded epidemiologists around the country, developed 24/7 response capacity, and much more. But recent declines in public health funding have directly, and very directly, threatened public health gains around the country. Federal funding for public health preparedness programs has declined by 27 percent since 2005 with a cut of more than $100 million since fiscal year 2010 alone.

    If the proposed cuts take place in this year's CDC preparedness budget and preparedness efforts around the country will suffer. For example, the cuts would diminish or eliminate CDC's ability to prepare for nuclear or radiological terrorism, CDC's diagnostic program for emerging infectious diseases, their chemical laboratory and response programs, the Laboratory Response Network, and all of the academic centers for public health around the country, which is the only CDC external funding for preparedness research. I think this would be a real loss for the country, and I really would urge Congress to consider reversing the funding cuts that are planned.

    So, in conclusion, the country has made real strides in preparedness over the last 10 years. I have detailed them in my written testimony--some of them, I should say--but a lot of work remains to be done. I hope the Committee and its colleagues working on the reauthorization of the PAHPA bill now in the Senate and the House will ensure we continue to make progress in the time ahead.

    Thank you.