12:00 AM
Sep 12, 2011
 |  BioCentury  |  Politics, Policy & Law

Biodefense report card

U.S. biodefense score card 10 years and $20B after 9/11 and the anthrax attacks

Ten years after 9/11 and the subsequent anthrax attacks alerted America to the threat posed by bioterrorism, progress in developing and procuring vaccines and drugs to protect the civilian population has been frustratingly slow. An investment of over $20 billion has yielded a few new medical countermeasures, but there is nothing for most of the pathogens that top government threat lists.

The Department of Homeland Security has identified a dozen pathogens as serious bioterrorism threats. Of these, the U.S. has stockpiled sufficient smallpox vaccine for the entire population and sufficient vaccine for post-exposure anthrax protection for about 9.6 million civilians. The stockpile also includes treatments for anthrax and botulinum toxin.

"Progress has been far too slow," Thomas Ingelsby, CEO of the Center for Biosecurity of the University of Pittsburgh Medical Center, said on BioCentury This Week, BioCentury's public affairs television program. "We have [added] only a few new medicines and vaccines in our stockpile since 2001."

Even worse, Ingelsby said, "we don't really have a clear sense of the priorities going forward, and the money for these programs is due to run out next year unless Congress appropriates more."

An HHS report released in August 2010 noted the "well-known problems of having insufficient numbers of reasonably mature advanced products in the pipeline" for future addition to the U.S. stockpile.

Robin Robinson, who heads U.S. efforts to develop and procure medical countermeasures, argued that progress has been impressive considering the biodefense effort was started from scratch a decade ago.

Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA), told BioCentury that the U.S. biodefense effort is on track to have medical countermeasures against the full range of probable bioterror pathogens procured or under development within four to five years.

This projection is based on what might be viewed as extraordinarily optimistic assumptions about the speed and success of drug development, including development and procurement of new classes of broad spectrum antimicrobials that have yet to reach proof-of-concept (POC) studies (see "BARDA Bioterror Pipeline," A3).

Former senior government officials, current government advisors and academic experts all warn that the combined efforts of government and industry are not on a trajectory that is likely in the foreseeable future to lead to the development, stockpiling and deployment of countermeasures to protect the civilian population from a sophisticated biological attack.

According to the National Biodefense Science Board, dramatic improvements would require substantial increases in congressional funding and oversight, elevation of the stature of biodefense preparedness to a top priority for the White House, and better coordination among government agencies.

NBSB is a congressionally chartered advisory body that includes biodefense experts from industry, academia and government. In a March 2010 report, "Where Are the Countermeasures," it noted that government "has failed to mobilize the productive skills and efforts of industry."

The expertise to develop and manufacture medical countermeasures resides in industry, but unlike efforts to combat pandemic influenza, the pharmaceutical industry is almost completely disengaged and most of the biotech industry is on the sidelines.

Companies say this is because the potential rewards are not sufficient to interest big pharma, while a lack of confidence that the government will fulfill its commitments has deterred biotech companies and their investors.

Even if industry and government researchers had a broad portfolio of bioterrorism countermeasures in development, the regulatory science has not been developed that would allow FDA to review most of them. The agency received its first substantial appropriation for medical countermeasures regulatory science last year and is scrambling to build its biodefense capacity.

The threat

Any consideration of the adequacy of U.S. bioterrorism countermeasures must start with an assessment of the nature, magnitude and probability of the threat.

The anthrax attacks that began with the mailing of an anthrax-laced letter on Sept. 18, 2001, alerted the country to the threat. That letter and subsequent mailings killed five and injured 17 Americans, briefly shut down Congress, and caused widespread disruption and panic.

The attacks prompted Congress and the Bush administration to launch a biodefense effort, but critics warn it does not represent the scale of the threat.

"Too many of our senior leaders think of bioterrorism as something like we saw in October 2001," Randall Larsen, CEO of the Bipartisan WMD Terrorism Research Center, said on BioCentury This Week.

A November 2009 National Security Council report, "National Strategy for Countering Biological Threats," concluded that 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 report projected costs exceeding $1 trillion for each incident, as well as "significant societal and political consequences that would derive from the incident's direct impact on our way of life and the public's trust in government."

The Commission on the Prevention of WMD Proliferation and Terrorism, an advisory committee established by Congress in response to a 9/11 Commission recommendation, predicted in December 2008 that a terrorist attack with a biological weapon was likely to occur "somewhere in the world by the end of 2013."

The U.S. should assume that terrorists are planning a large-scale attack with a biological agent, Philip Russell, former commander of the U.S. Army Medical Research and Development Command, told BioCentury. Russell served as a special advisor to the HHS Secretary following the anthrax attacks and directed the development and acquisition of smallpox and anthrax vaccines for the Strategic National Stockpile.

"Since our intelligence has been so abysmal in the past - we totally missed the...

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