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Bill to develop bioterror vaccines sent to
Bush $5.6 billion plan to stockpile medicine
by Bernadette Tansey
July 15, 2004 San Fransisco Chronicle



The House of Representatives approved the $5.6 billion anti- terrorism initiative Project Bioshield late Wednesday, ending more than a year of delay in Congress over the Bush administration's plan to stockpile remedies against deadly germs that could be used in a biological attack.

By a 414-2 vote, the House passed a bill creating a 10-year funding reserve for large public supplies of drugs and vaccines to battle potential bioterror weapons including anthrax, smallpox, plague and the Ebola virus. The bill awaits only President Bush's signature.

"This is the largest first-responder program ever enacted in American history,'' said Homeland Security Committee Chairman Christopher Cox, R- Newport Beach (Orange County).

A Brisbane biotechnology firm, Vaxgen Inc., is among the leading bidders for one of the largest government grants to be paid from Project Bioshield money: a contract for about $700 million to produce 75 million doses of an improved anthrax vaccine.

Vaxgen spokesman Lance Ignon said passage of the bill will encourage companies to devote resources toward the development of anti-bioterror drugs that might have no market outside of government contracts.

"The passage of Bioshield is important because it reaffirms the government's commitment to purchase biodefense products, and that is an important signal to the country as a whole and certainly to industry,'' Ignon said.

Bioterrorism preparedness moved to the top of the national agenda in late 2001, when anthrax-laden letters were mailed to Congress and media offices while the nation was still reeling from the Sept. 11 terrorist attacks. The anthrax mailings -- an unsolved crime -- killed five people, sickened more than a dozen others and required cleanup costing millions of dollars.

Bush proposed Project Bioshield in January 2003, but the proposal stalled in Congress as legislators tangled over the ground rules for disbursements from the huge fund.

A compromise version, approved by the Senate in May, resolves concerns by some lawmakers that Congress would lose control over the bioterror allocations. Under the original proposal, the fund would not have been subject to the usual congressional appropriations process. That provision raised alarms, coming under consideration just as the administration was under fire for large cost overruns in military support contracts for the Iraq war that had been awarded to Halliburton Co. Vice President Dick Cheney was formerly the chief executive of the firm.

The final bill restores discretion to Congress over specific awards from the fund. But it also guarantees that a full $5.6 billion will be dedicated to anti-bioterror drug stockpiles and can't be diverted to other government programs. That allays some of the concern among private drug developers that federal government investment in anti-bioterror medicines might wane as the anthrax attacks of 2001 fade into the past, said John Clerici, a Washington attorney who worked on modifications to the bill as a representative of several drug firms.

Bush said in a statement that he looked forward to signing the bill, which would not only help protect Americans but also "break new ground in the search for treatments and cures while strengthening our overall biotechnology infrastructure.''

Government funding had already started flowing to companies like Vaxgen while the Project Bioshield bill was on hold. Vaxgen has received several grants to develop a next-generation anthrax vaccine based on Army research, and to make an initial supply of 3 million doses.

Vaxgen is vying with one other leading contender, Avecia Group PLC of Manchester, England, for an additional contract to manufacture 75 million doses of the vaccine, enough to inoculate 27 million people or about 9 percent of the U.S. population. The government's decision is expected by late summer.

The House bill passed Wednesday allows the government to distribute such newly developed drugs in emergencies, even if they have not received FDA approval. But nothing in the bill authorizes the government to force individuals to take anti-bioterror drugs, Clerici said.

Clerici said he is working with members of Congress on "Bioshield II,'' which could address some industry concerns left unresolved by the bill passed Wednesday. The final version includes no language relieving drug manufacturers of any liability they might face if bioterror vaccines or drugs ordered by the government turned out to cause injuries, Clerici said.

Such indemnification provisions are important if the government wants to increase the participation of large pharmaceutical companies in bioterror defense contracts, Clerici said. Many grants have gone to smaller firms that have not insisted on such guarantees, he said.

"These (small firms) are great companies, and they're the innovative engines of America,'' he said. On the other hand, he said, Project Bioshield hasn't done enough to enlist the firms with the resources of "the GlaxoSmithKlines, the Pfizers and the Mercks.''

"It's like fighting a war without Lockheed Martin, Boeing or Northrup supplying the government,'' Clerici said.

Ignon rejected the argument that large firms are essential to bioterror defense because smaller ones could be easily ruined by a single big liability suit. He said Vaxgen has obtained private liability insurance, and the cost will be factored into the price of its anthrax vaccine.

Project Bioshield, though huge, is just one element of the government's expenditures on bioterror defense. For example, Sunnyvale biotech firm Cepheid has helped develop biodetectors for the U.S. Postal Service that pick up signs of mail tainted with pathogens such as anthrax. Lawrence Livermore National Laboratory is spending $60 million in federal funds this year on advanced biodetection systems and technologies to decontaminate buildings.

Public health agencies throughout the country have been receiving extra federal grants to prepare for their role as the first line of defense against a bioterror attack. Dr. Marty Fenstersheib, Santa Clara County public health officer, said agencies like his are constantly training to handle the responsibility of administering anti-bioterror vaccines supplied by the government.

"Even though they may bring it to our doorstep, we then have to distribute it to the community, and that's the real challenge,'' he said.


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