A booster shot for pandemic preparedness

[Guest guest]

A booster shot for pandemic preparedness

By M. Clerici

Originally published July 31, 2006

WASHINGTON // The threat of bioterrorism, along with the global spread of

infectious diseases such as avian flu and SARS, has put a spotlight on the

critical need to improve America's fragile public health system. Outstanding

progress has been made during the last year in biodefense and pandemic planning,

but the United States needs to be ready for any significant worldwide threat.

More preparation is still necessary.

In biodefense, the Department of Health and Human Services has acquired 10

million doses of safe, FDA-licensed anthrax vaccine to better prepare for

another attack like the one in October 2001. HHS has also announced the

long-awaited purchase of anthrax therapeutics for post-exposure treatment, as

well as treatments for botulism poisoning. All of the purchases were made under

the landmark Project BioShield Act of 2004, first proposed by President Bush in

his 2003 State of the Union address as an effort to leverage the capital markets

and the innovation of the biotechnology industry to secure the nation.

In research and development for pandemic vaccines, more than $1 billion in

advance development contracts for next-generation, cell-culture influenza

vaccines has been awarded to five companies pursuing multiple technologies.

Given the recent challenges HHS has faced in delivering experimental anthrax

vaccine from an unproven supplier, it is clear that the agency has learned not

put all its eggs in one basket.

Perhaps most important, Mr. Bush in December signed the Public Readiness and

Emergency Preparedness Act into law. The PREP Act greatly improves the country's

ability to prepare for naturally occurring or terrorist-related public health

emergencies by offering targeted liability protection to those involved in the

development, manufacture and deployment of pandemic and epidemic products and

security countermeasures. Vaccine and countermeasure developers are now better

protected from the mass of lawsuits that have eviscerated the U.S. vaccine and

biodefense manufacturing base, leaving it ill prepared for threats such as avian

influenza. Sen. M. Burr, Republican of North Carolina, has also

introduced new legislation creating the Biopharmaceutical Advanced Development

Research Agency to further stimulate advance development of needed

countermeasures for both bioterrorism and emerging infectious disease. Coupled

with the president's commitment to fund the effort

with nearly $200 million in his fiscal year 2007 budget, this is a positive

development. While bioterrorism remains a significant threat, pandemic

preparedness, while foremost an issue of public health, is also an issue of

business continuity, ensuring American global competitiveness. It has been

estimated that only 7 percent of U.S. companies have established budgets for

pandemic preparedness/business continuity, compared with 12 percent of European

companies and 25 percent of Asian businesses. Congress should act now to

provide additional incentives, such as expanded liability protection to

businesses that make reasonable and prudent efforts to prepare for a pandemic.

Companies must plan for the contingency that 40 percent or more of their

employees might not be able to come to work during a pandemic. Any proper

response will also require major supply-chain automation among pharmaceutical

and medical supply companies, health care providers, and security

organizations because significant numbers of workers may be sick or afraid to

leave their homes. Congress should work now to ensure information technology

provides protection from counterfeiting and theft of vaccine supplies, and

should develop effective tracking mechanisms to safeguard the data needed for

the supply chain to function. Congress must act now to bolster our fragile

public health infrastructure, in particular the country's hospital system.

Should a pandemic strike, the surge on hospitals from both the sick and the

merely worried has the potential to cripple our health care system. Painfully

difficult triage decisions would be certain to generate a flood of liability

litigation. The last thing the nation will need is baseless lawsuits, so

Congress should work to protect the health care industry from pandemic-induced

tort claims. The U.S. also has a rare opportunity to fortify its public health

infrastructure to support improved access to an influenza

vaccine and better immunization for annual influenza, which kills more than

30,000 Americans each year. If we are better prepared to deal with the annual

flu, we will be far better off should a pandemic strike. Even if a

devastating pandemic never happens or a bioterrorist attack never materializes,

all of the preparation we undertake will not be lost if it helps to vastly

improve the nation's emergency response infrastructure. If pandemic preparedness

upgrades our public health and corporate supply chain, it will be well worth the

effort. M. Clerici is a partner in a Washington law firm who

specializes in homeland security policy. This article is adapted from his recent

testimony before the Senate Appropriations Committee's Subcommittee on Homeland

Security. His e-mail is jclerici@....