Nicole Lurie, MD, assistant HHS secretary for preparedness and response testified at a Senate hearing last month.

WASHINGTON — U.S. health officials can prepare for all manner of health threats — biological, radiological, chemical or nuclear — but it is the threat that the country does not see coming that most worries HHS leaders.

“I worry most about a threat we’ve never thought about and anticipated before coming our way,” said Nicole Lurie, MD, assistant HHS secretary for preparedness and response at a Senate hearing last month. “I worry about our ability to recognize it when we see it and act quickly on it. That’s why there’s so much focus on the rapid, nimble, flexible, capacity to make a countermeasure against something we’ve never seen before. It’s also why we place so much focus on capabilities instead of planning for scenarios. What capabilities do we have to have in place so that we can mix and match and shuffle to deal with whatever comes our way?”

Lurie also worries that the recession has left state and local governments financially strained in areas where a robust public health response is needed. “The federal government can’t do this all alone,” she said. “Our state and local partners and private sector partners are in this with us. In these really tough financial times, when everybody’s stretched to the limit, I’m worried that we could backslide on some of our progress, and that’s a dangerous position to be in.”

Fostering Countermeasures

As they prepare to reauthorize the Pandemic All-Hazards Preparedness Act (PAHPA) — a law originally passed in 2006 to help create a national health security — legislators grilled Lurie on the state of HHS’s preparedness efforts and the nation’s current ability to respond to health threats. Many of the questions and much of Lurie’s response centered on HHS’s ability to coordinate private industry with FDA regulatory efforts in order to meet the country’s needs for medical countermeasures.

Lurie cited the recent contract issued by the Biomedical Advanced Research and Development Authority (BARDA) to a private contractor to fund late-stage development of an antiviral drug to treat smallpox infection. “We’re talking about a product without a commercial market, taking that product through research and advancing it under BARDA to the point where it can be procured [for the stockpile]. This significantly strengthens our country’s ability to protect itself from a biothreat.”

There are other success stories in which the latitude given to HHS to procure and develop countermeasures filled gaps in existing research and development activities. Several years ago, HHS began looking to add to the nation’s pharmaceutical stockpile countermeasures for thermal burns caused by radiation, only to find little available on the market. 

“I think at first we thought maybe we could just go out and buy them or that having a fund for procurement would be enough of an incentive for industry to come and make all the products that we need. But it turns out that there really just wasn’t much in the pipeline. Countermeasures for thermal burns is a great example of where there really wasn’t much there to start with,” Lurie said.

HHS found it had to make research grant investments through NIH to help develop new countermeasures.

“We’ve tried really hard to reach back into the system and have developed, through BARDA, very sophisticated, advanced research and development programs so that we can develop these products to the point where they can be used under an emergency authorization, if not through licensure, and then procured through the stockpile.”

Thanks in part to BARDA’s work, a number of companies have pharmaceuticals targeting radiation burns and sickness in the research and development pipeline.

By helping push research through from its early phase to more advanced testing, HHS is targeting one of the process bottlenecks identified by recent reviews. Another bottleneck is the lack of encouragement that exists for private industry to take on the financial risks of developing countermeasures.

“The president’s budget is calling for the authority to create what we’re calling ‘strategic investors’ to help companies to leverage venture capital on the business end so that we can move some of these [products] forward,” Lurie said. Page 2