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Critics lambaste bird-flu bill
SECRECY CREATES ACCOUNTABILITY VOID, THEY SAY
A bill moving through Congress to speed production of bird-flu vaccines and other drugs has ignited alarm from critics who claim it would not only shield manufacturers from lawsuits, but also prevent the public from learning if the medicines hurt people more than help.
Under the measure backed by Sen. Majority Leader Bill Frist, which critics hope to derail at a meeting today, bird-flu and bioterrorism preparedness would be overseen by a new agency able to operate in unprecedented secrecy. The Biomedical Advanced Research and Development Agency would be the first federal agency not required to make at least some of its activities public under the Freedom of Information Act.
The bill's supporters say the law is needed to encourage more companies to join the few firms, such as Chiron and Gilead Sciences in the Bay Area, making drugs to counter bird flu and deadly biological agents -- without fear of being sued if the drugs produce bad side effects.
But others including Barbara Loe Fisher, president of the National Vaccine Information Center, denounced the measure as dangerously misguided.
Without public scrutiny or the ability to take the companies to court, ``these drugs are going to be developed in secret, and if there are deaths and injuries, they're going to be covered up,'' she said. ``And there will be no way to hold anybody accountable...''
The bill was introduced in the Senate on Oct. 17 and approved by the Senate Committee on Health, Education, Labor and Pensions, but it's not likely to be acted on by the full Senate until next year. It would modify the Project Bioshield Act, passed in 2004, that provided $5.6 billion over 10 years to develop biodefense drugs.
A few Bay Area firms have won large federal contracts under this program, including VaxGen of Brisbane, which has gotten nearly $1 billion to make anthrax vaccines. Chiron of Emeryville has also won a contract under another federal agency to develop bird-flu vaccines, and Gilead Sciences of Foster City is likely to get federal money for its bird-flu treatment...
The insertion of blanket secrecy provisions into the bill has especially alarmed critics. Those provisions would let the new agency keep its activities quiet unless it decides ``disclosure would pose no threat to national security.''
Although the Biotechnology Industry Organization has sought the lawsuit immunity, its spokeswoman, Kim Coghill, declined to comment on the bill's secrecy provisions.
But Gerald Epstein, a senior fellow for science and security at the Center for Strategic and International Studies, a non-profit Washington think tank, said giving the agency broad authority to withhold information ``is not as scary as people make it out to be.'' He said the alternative is to have the agency set up a system of security clearances and classified data, which can be cumbersome and costly.
However, exempting the agency from public disclosure would be unparalleled, said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government, who plans to attend the meeting today with Burr's staff.
``There is no agency I'm aware of in the federal government which is in and of itself totally exempt from any public access provisions, including the CIA,'' he said.