Monday, June 16, 2003

BY ROBERT COHEN
STAR-LEDGER WASHINGTON BUREAU

WASHINGTON -- Six months after President Bush laid out plans to protect the nation from a bioterrorist attack, Congress is moving ahead on a $5.6 billion program to develop and stockpile massive quantities of vaccines against such deadly threats as the plague, the Ebola virus and anthrax.

The measure, known as Project Bioshield, is intended to encourage pharmaceutical research on breakthrough vaccines and antidotes and guarantee their purchase by the government for use if terrorists unleash deadly pathogens.

"The need for medical countermeasures for biodefense is exigent and real, and we have a responsibility to the American people to make these products available now," Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told a congressional committee recently.

While there are vaccines to combat smallpox and anthrax, none exist for the plague, tularemia, the Ebola virus, botulism and a host of other potential threats.

The danger was crystallized by the anthrax attacks aimed at Congress in the fall of 2001. The recent outbreaks of SARS, or severe acute respiratory syndrome, and monkeypox, the exotic African disease spread by prairie dogs, have underscored the speed with which pathogens can spread.

Although the legislation has been slowed by congressional resistance to a Bush demand for unrestricted authority to spend the money as the administration sees fit, lawmakers believe a compromise will be reached soon. Committees in the Senate and House have approved the legislation, and lawmakers say both chambers could vote by this summer or early fall.

But enactment of the law will be just a first step.

The government must designate the biological agents it believes pose the greatest threats, solicit drug industry interest and then award contracts. Some of the vaccines and antidotes could succeed while others could fail, leaving gaps in the safety net and requiring additional research and investment.

The legislation gives the government power to bypass normal competitive bidding procedures and to relax safety and testing rules when necessary. Under extreme circumstances, the government could use vaccines or medicines not yet approved by the Food and Drug Administration.

Rep. Rob Andrews (D-1st. Dist.), a member of the Select Committee on Homeland Security, said the need for the legislation is urgent. He said the intelligence community believes biological agents could easily be the weapon of choice for terrorist groups, potentially causing hundreds of thousands of deaths.

"I'm sure we won't have all of these vaccines and medicines ready in six months or even a year from now, but I think five years is in the realm of reality," Andrews said.

"This is not a new enterprise. It is not like we are asking the pharmaceutical industry to fly to Mars. We're asking them to intensely focus on something they do very well," he said.

Matthew Lyons, director of government relations for the Biotechnology Industry Organization, said large and small companies already are researching certain vaccines and antidotes and are interested in taking part in Project Bioshield.

Lyons said it is hard to predict how long it would take to develop new medications, but he noted that some of the smaller innovative biotechnology companies may team up in joint ventures with larger pharmaceutical firms for production and development.

"Some companies feel it would be lucrative," Lyons said. "But it will involve enormous investments."

Since there is no commercial market for any of these products, Lyons said, the linchpin of the legislation is the guarantee that the government will buy and stockpile the approved medicines to make it financially worthwhile for the companies.

He said the industry is fearful of being subjected to the whims of the annual appropriations process, with the possibility that Congress might curb funding for projects under way but not completed.

The industry also has other concerns, including a desire to be protected from lawsuits should people die or be injured by their bioterror remedies.

"Manufacturers that develop countermeasures may be exposed to devastating product-liability lawsuits," Alan Pemberton, of the Pharmaceutical Research and Manufacturers of America, recently told a congressional panel.

"Some of these would arise out of adverse events that are unavoidable given the nature of the products, and some could simply arise because the products were made available without the usual battery of clinical trials required for FDA-approved products," Pemberton said.

Concerned that a fight over liability might derail the bill, the House and Senate committees have not provided immunity to the companies in the pending bills.

Andrews said he believes some protections ultimately will be enacted, possibly in a separate bill at a later date or when House and Senate negotiators meet to resolve differences over the final legislation.

The Bioshield legislation is designed to complement another measure approved in 2002 that provided $4.2 billion to stockpile smallpox and anthrax vaccines and the anthrax-fighting drug Cipro. It also allocated money for the Centers for Disease Control and Prevention and targeted $1.6 billion in grants to state and local public health agencies this year.

Ron Bialek, director of the nonprofit Public Health Foundation, agreed that vaccines must be developed to thwart a potential bioterror attack. But he added that the government must also provide extra money for public health agencies to prepare for a possible crisis.