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A Booster Shot for Pandemic Preparedness - Op-Ed - Bioport Lobbyist

McKenna Long & Aldridge:

Baltimore Sun
John Clerici

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. Richard 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.

John 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@mckennalong.com.

-------------------------------------------------------------------------------------VAXGEN reply -- letter to editor

Vaccine contract given careful review

The column "A booster shot for pandemic preparedness" (Opinion Commentary, July 31) referred to my company as an "unproven supplier" of an "experimental anthrax vaccine" and stated that the Department of Health and Human Services has apparently learned not to "put all its eggs in one basket." Readers should take what was presented in the column with appropriate caution.

Its author, John Clerici, was identified as a partner in a Washington law firm. But the column failed to disclose that Mr. Clerici is a key lobbyist for Emergent Biosolutions (formerly known as BioPort), the maker of a decades-old anthrax vaccine with a potential side-effect profile that has caused persistent concern among servicemen and women.

And these are the facts about how our contract was awarded: Multiple expert reviews concluded that the existing, licensed vaccine produced by Emergent Biosolutions was inadequate. The government then determined that VaxGen was the best-qualified supplier to develop, manufacture and deliver 75 million doses of a next-generation anthrax vaccine for the country's strategic national stockpile.

The government not only considered other companies but weighed VaxGen's performance under two previous anthrax vaccine development contracts.

Piers Whitehead
Brisbane, Calif.
The writer is a vice president of VaxGen Inc.