WASHINGTON - While the Bush administration is sending its top scientists and health care professionals to Capitol Hill to score votes for Project BioShield, a number of lawmakers are refusing to be easily swayed by promises of countermeasures for deadly diseases intentionally introduced by terrorists.
Project BioShield, an ambitious program introduced by President Bush in his State of the Union address, is designed to streamline government research, create incentives for companies and give the government the ability to make products widely available in a public emergency. (See BioWorld Today, April 7, 2003, and March 28, 2003.)
The House Subcommittee on Labor, Health and Human Services and Education Wednesday took a stab at gaining an understanding of the Bush proposal that includes a provision for "mandatory" funding as opposed to "discretionary" funding. That element bothers some members because in his January address, Bush said the plan would cost $6 billion over a decade. Now, Bush team members are saying they can't predict the price because there's no telling what scary diseases could emerge.
Indeed, take severe acute respiratory syndrome (SARS), for example. Rep. Roger Wicker (R-Miss.) asked Julie Louise Gerberding, director of the Centers for Disease Control and Prevention in Atlanta, if the CDC had considered whether SARS is some form of bioterrorism. Gerberding said the thought had been discussed, but scientists are certain SARS is natural. As of Tuesday evening, she said there were 2,600 cases worldwide and 89 deaths.
Again using SARS as an example, Gerberding said it's a new disease and there's nothing to treat it.
But if BioShield were in place (and if SARS were a bioweapon), "we would have the money to rapidly develop a countermeasure," Jerome Hauer, assistant secretary for public health emergency preparedness, told the committee.
In the event of a smallpox attack, the U.S. would likely be in a better position today than it was a year ago. Hauer said ACAM2000 (from Acambis plc, of Cambridge, UK), the government-contracted smallpox vaccine, will enter Phase III trials in August. "That's pretty good progress since they only received the government award in November 2001," he said.
The government has focused on a countermeasure for smallpox because there's no treatment for it, and if it were unleashed in the U.S., the economic and psychological impact could be devastating, Hauer said.
Others have questioned officials from the National Institutes of Health about whether investing in countermeasures for eradicated diseases such as smallpox would take money away from research in other more common maladies such as cancer or heart disease.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the NIH, has said that's not the case. But on Wednesday, he fielded basic questions from Rep. Nita Lowey (D-N.Y.), who last week in another House hearing said she would be "upset" if large pharmaceutical companies failed to invest in countermeasures because of potentially low profits.
Fauci said large companies are not likely to invest in research if there's no market for the product.
"Companies are not afraid of failure, they're afraid they will succeed and two years down the road no one will want to buy the countermeasure," Fauci said, in explaining why the government needs mandatory funding to guarantee companies it would purchase FDA-licensed drugs. (FDA Commissioner Mark McClellan last week said the FDA would not pay for countermeasures that fail to receive FDA approval.)