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FDA Panel Advises Approval of Bird Flu Vaccine
Fox News ^ | 2/27/07 | AP

Posted on 02/27/2007 5:22:27 PM PST by khnyny

WASHINGTON — Federal health advisers recommended Tuesday that the government approve the first bird flu vaccine as a stopgap measure, despite evidence it wouldn't protect most people.

In separate votes, the outside panel said the vaccine was both safe and effective. A vaccine must meet both standards to win FDA approval. The votes came after Food and Drug Administration officials said the Sanofi Aventis SA vaccine still could play an important role in protecting against the increased likelihood of a pandemic, despite its limited effectiveness.

"I am of the view that anything is better than nothing," said panel member Dr. Robert Couch, of Baylor College of Medicine in Houston, prior to the vote.

The FDA isn't required to follow the advice of its advisory committees, but usually does. The vaccine is the first against the H5N1 influenza strain to seek government approval.

The vaccine already is being stockpiled, even without FDA approval, for eventual interim use to protect emergency workers and others in a pandemic. It would be used until better vaccines could be developed. Though not required, FDA approval would state the agency's opinion on the vaccine's safety and effectiveness, said Dr. Jesse Goodman, FDA's chief of biologic products.

(Excerpt) Read more at foxnews.com ...


TOPICS: Business/Economy; Culture/Society; Government; News/Current Events
KEYWORDS: birdflu; fda; pharma; sanofiaventis
Sanofi-Aventis is a French pharma company that recently had problems with their antibiotic "Ketek" due to it causing severe liver damage. This new bird flu vaccine will hopefully not be mandated, but the stockpiles sure will boost Sanofi-Aventis' bottom line. I guess that's good for their stockholders at least, and should pay for some of the lawsuits due to Ketek.

ketektrialfraud

"The move comes in the wake of an ongoing government investigation into serious allegations that the FDA approved French firm Avenits's antibiotic drug Ketek despite unresolved questions about the drug's safety and efficacy, with full knowledge that some of the clinical data submitted to support the drug's approval was fraudulent."

1 posted on 02/27/2007 5:22:30 PM PST by khnyny
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To: khnyny; Paleo Conservative

FYI ping.

They going to require this, too?


2 posted on 02/27/2007 5:23:53 PM PST by metmom (Welfare was never meant to be a career choice.)
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To: metmom

Not at this point, but who knows what will happen, lol. What a scam, imho.


3 posted on 02/27/2007 5:26:44 PM PST by khnyny
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To: khnyny

Nothing would surprise me.


4 posted on 02/27/2007 5:31:15 PM PST by metmom (Welfare was never meant to be a career choice.)
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To: metmom
Me either. Here's what may be behind some of this stuff:

vaccines immune from lawsuits

In addition to extra spending, the federal government has taken steps to accelerate flu vaccine approvals and offered companies immunity from lawsuits.
5 posted on 02/27/2007 5:59:43 PM PST by khnyny
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To: khnyny

What a racket. Develop a product, don't test it thoroughly, have the government mandate it so people have to buy it, then have the government prohibit people from suing you when they are harmed by your poorly tested, unsafe product.

I guess it doesn't get much better than that.


6 posted on 02/27/2007 6:11:19 PM PST by metmom (Welfare was never meant to be a career choice.)
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To: metmom
To be fair, I'm sure it's tough on the pharma companies, what with the costs of R&D, lawsuits, etc., and there are other factors at work, but it certainly looks suspect.

IIRC, there is legislation out there that protects pharmaceutical companies from child vaccine lawsuits, some of which goes back to the late 80's, but it looks like that protection has been expanded. Perhaps there are other FR's more knowledgeable who can supply additional info.
7 posted on 02/27/2007 6:46:18 PM PST by khnyny
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To: metmom

FDA IS KILLING US!!!!

THEY ARE WORRIED ABOUT BIRD FLEW? UHHH, LET ME THINK....
BIRD FLEW KILLED HOW MANY?

CANCER IS KILLING THOUSANDS EVERY DAY, AND FDA IS 100% BEHIND IT, MILK PRODUCED IN THE UNITED STATES IS ONE OF THE WORST CANCER CAUSERS... FDA DOES NOT HAVE TO TELL YOU THAT THERE IS EXTREMELY HIGH LEVELS OF CF-1 ( GROWTH HORMONE) INJECTED INTO THE COWS THAT PRODUCE THE MILK THAT WE CONSUME.
FDA HAS NEVER DONE ANY KIND OF RESEARCH WHAT SO EVER ON CF-1, NOT ONE!
THEY DONT HAVE TO TELL YOU THIS BECAUSE A COW NATURALLY PRODUCES A TINY BIT OF CF-1 ON THIER OWN, YOU WILL NOT FIND ANYTHING ON THE INGRIEDIENCE LABEL THAT SAYS ANYTHING ABOUT CF-1, BTW THERE IS ANOTHER NAME FOR CF-1 CALLED BHQ.

BHT IS ANOTHER HUGE CANCER CAUSER THAT IS IN ALMOST EVERYTHING PACKAGED, IT IS A PRESERVATIVE.
"IT IS INHUMANE AND WE AS AMERICANS NEED TO BE MORE AFRAID OF OUR OWN GOVERNMENT THAT WE DO THE TERRORISTS


8 posted on 03/14/2007 9:56:20 AM PDT by ANTI_FDA
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