Expert: Will new biological countermeasures program work?

Leonard A. Cole, a bioterrorism expert, questioned on Wednesday whether or not the new potentially $2 billion biological countermeasures program instituted by the U.S. Department of Health and Human Services would actually work.

The plan will create three Centers for Innovation in Advanced Development and Manufacturing that are meant to produce anti-virals, vaccines and other medicines while expediting their market availability and improving the training of the biopharmaceutical workforce. Kathleen Sebelius, the secretary for the HHS, said that the centers would help the department to fill preparedness gaps and improve the country's response to threats, the Bulletin reports.

The centers are expected to be operational by 2014. The program, which was announced on June 18, will cost approximately $400 million at first with a potential government outlay projected at $2 billion.

"While the HHS goals are laudable, whether they are likely to be achieved remains unclear," Cole said, according to the Bulletin. "The development of these centers went widely unnoticed not only by the mainstream press, but also by American bioterrorism experts; thus, much remains unchallenged. And questions about this initiative - including how the various partners will interact with one another - are especially poignant in view of the sizeable commitment of government dollars to the program."

The three centers, which will be led by Novartis, Emergent BioSolutions, Inc., and Texas A&M University, will include a mix of public and private partners.

Robert Kadlec, a former principal advisor to the White House on bioterrorism and pandemic influenza preparedness, is unsure how academic institutions as well as large and small pharmaceutical companies will work together, according to the Bulletin.

"I don't think anybody has an idea of how it's going to work," Kadlec said, according to the Bulletin. "The proof will be in the pudding, and I have a lot of questions about it."

Cole is unsure that the plan will be successful as well, but he holds out hope that the centers will succeed in their goals to create effective countermeasures against biothreats.

"Will these challenges be addressed nimbly and flexibly, to borrow terms of aspiration used by program proponents?" Cole said, according to the Bulletin. "Or with the bureaucratic rigidity that foretells failure? Creative tweaking will be necessary, along with luck, to keep the process on track."