Bio Shield
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ThunderDick
Sorry...I thought it would be known....
Bush Proposal Aimed at Germ Warfare Defense
Thu Jan 30,11:37 AM ET
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By Maggie Fox
WASHINGTON (Reuters) - Drug companies that may have been reluctant to pitch in to develop new vaccines or treatments against germ warfare agents should get a nudge from a new initiative proposed by President Bush (news - web sites), US health officials said on Wednesday.
The plan, called Project BioShield, would set aside permanent funds to guarantee that those who develop a new vaccine against a germ agent such as anthrax can sell it to the government, the officials said.
"We know that with vaccines in general it is difficult to get companies to engage," Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (news - web sites), told reporters. "One reason is the lack of a guarantee that the products will be used or that there will be any semblance of a profit margin for them."
The new plan, which sets aside funds outside the year-to-year budget process, has a projected cost of $6 billion over 10 years, although Fauci said this amount was not set.
"It says to companies that if you will produce this vaccine, we can guarantee you that two, three, four, five years from now, throughout that period we will have money to purchase this vaccine, and therefore, it's worthwhile for you to ramp up your production facilities," a senior administration official who asked not to be named told reporters.
Antex Biologics Inc., a Gaithersburg, Maryland, company that is working on several vaccines and drugs against possible germ warfare agents, welcomed the proposal.
"I believe that the need for these vaccines is urgent and, accordingly, Antex is currently conducting vaccine research on many of the pathogens that the president outlined," Antex president and chief executive officer Vic Esposito said in a statement.
The proposal also gives the US Food and Drug Administration (news - web sites) (FDA) more formal grounds to rush out an experimental drug or vaccine in case of a biological attack.
FDA commissioner Dr. Mark McClellan said the agency can already do this on a case-by-case basis, but the new proposal would strengthen and formalize the process.
"It would require a finding by the Department of Health and Human Services (news - web sites) that the benefits outweigh the risk," McClellan told reporters. It would provide for very special conditions for use, he added.
"What this program does is provide much more clear guidance to the public," he said.
One example of drugs that would be included is cidofovir, a drug made by Gilead Sciences Inc. for use against a herpes infection associated mainly with AIDS (news - web sites). But tests in animals suggest it may have action against smallpox, so it has been added to the national stockpile of drugs to be used in case of a germ attack.
New smallpox vaccines in development might also be included, McClellan said. The current smallpox vaccine, being given to 500,000 military personnel and meant to go eventually to 450,000 healthcare workers, is decades old and potentially dangerous. Several companies are working on new formulas.
Earlier on Wednesday Fauci told a hearing in Congress that tests on a vaccine against Ebola (news - web sites), a hemorrhagic-fever virus now seen only in Africa, would be ready for testing in people later this year.
He said it protected monkeys against the infection, which can kill up to 70% of victims.
Ebola, which causes internal bleeding, is considered a potential germ warfare agent.
Bush Proposal Aimed at Germ Warfare Defense
Thu Jan 30,11:37 AM ET
Add Health - Reuters to My Yahoo!
By Maggie Fox
WASHINGTON (Reuters) - Drug companies that may have been reluctant to pitch in to develop new vaccines or treatments against germ warfare agents should get a nudge from a new initiative proposed by President Bush (news - web sites), US health officials said on Wednesday.
The plan, called Project BioShield, would set aside permanent funds to guarantee that those who develop a new vaccine against a germ agent such as anthrax can sell it to the government, the officials said.
"We know that with vaccines in general it is difficult to get companies to engage," Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (news - web sites), told reporters. "One reason is the lack of a guarantee that the products will be used or that there will be any semblance of a profit margin for them."
The new plan, which sets aside funds outside the year-to-year budget process, has a projected cost of $6 billion over 10 years, although Fauci said this amount was not set.
"It says to companies that if you will produce this vaccine, we can guarantee you that two, three, four, five years from now, throughout that period we will have money to purchase this vaccine, and therefore, it's worthwhile for you to ramp up your production facilities," a senior administration official who asked not to be named told reporters.
Antex Biologics Inc., a Gaithersburg, Maryland, company that is working on several vaccines and drugs against possible germ warfare agents, welcomed the proposal.
"I believe that the need for these vaccines is urgent and, accordingly, Antex is currently conducting vaccine research on many of the pathogens that the president outlined," Antex president and chief executive officer Vic Esposito said in a statement.
The proposal also gives the US Food and Drug Administration (news - web sites) (FDA) more formal grounds to rush out an experimental drug or vaccine in case of a biological attack.
FDA commissioner Dr. Mark McClellan said the agency can already do this on a case-by-case basis, but the new proposal would strengthen and formalize the process.
"It would require a finding by the Department of Health and Human Services (news - web sites) that the benefits outweigh the risk," McClellan told reporters. It would provide for very special conditions for use, he added.
"What this program does is provide much more clear guidance to the public," he said.
One example of drugs that would be included is cidofovir, a drug made by Gilead Sciences Inc. for use against a herpes infection associated mainly with AIDS (news - web sites). But tests in animals suggest it may have action against smallpox, so it has been added to the national stockpile of drugs to be used in case of a germ attack.
New smallpox vaccines in development might also be included, McClellan said. The current smallpox vaccine, being given to 500,000 military personnel and meant to go eventually to 450,000 healthcare workers, is decades old and potentially dangerous. Several companies are working on new formulas.
Earlier on Wednesday Fauci told a hearing in Congress that tests on a vaccine against Ebola (news - web sites), a hemorrhagic-fever virus now seen only in Africa, would be ready for testing in people later this year.
He said it protected monkeys against the infection, which can kill up to 70% of victims.
Ebola, which causes internal bleeding, is considered a potential germ warfare agent.
OK...now you're scaring me.... 
drkavnger99
Member
do you have that burning feeling!! 
Well...these "enhancement" cremes aren't working...I gotta try something..
