"I HAVE TO SIGN A LETTER SAYING WHAT?"
- "I HAVE TO SIGN A LETTER SAYING WHAT?"
OCTOBER 29, 2004. There is some very slippery doublespeak
in the AP dispatch below. It appears the feds have found
some flu shots they want to bring into the US from Canada
On the one hand, they say the FDA will inspect these doses
for safety and efficacy before allowing them to be used.
On the other hand, every American who gets one of these
imported shots will have to sign a letter stating he knows
the shot comes from out of the country.
Gee, I thought ALL the shots come from outside the US. Isn't
that Chiron plant that was shut down in Liverpool? Isn't
Aventis Pasteur a French company?
And what is the purpose of the letter? I think we all know
the answer to that. Although the vaunted FDA will certify
the imported vaccine as safe, it is the recipient of the shot
who has to assume LEGAL RESPONSIBILITY for whatever adverse
consequences may ensue.
As in, covering all the bases and all the important asses.
So what are they saying? "The FDA is here to protect you and
does a damn fine job, but in case we screw up and you are
maimed or die, it's your problem and your family's problem.
Don't come after us. We're off the hook."
Now that I think about it, how many successful suits have been
brought against the FDA for certifying a drug as safe when, in
fact, the drug then maims and kills? I can't recall ONE.
"TRUST US. WE'RE THE FDA. BUT SIGN THE LETTER."
The Associated Press
Updated: 6:37 p.m. ET Oct. 28, 2004
WASHINGTON - The Bush administration said Thursday it is working
to buy another 5 million doses of flu vaccine from manufacturers
in Canada and Germany, mixing the ticklish issue of prescription
drug imports with the flu shot shortage.
Health and Human Services Secretary Tommy Thompson said government
inspectors next week will visit plants where the vaccine is made
to assess whether it is safe for Americans' use.
If the vaccine eventually makes it to this country, patients who
receive it would have to sign a form acknowledging they are aware
their flu shots come from abroad, Thompson said.
The administration has refused to approve widespread importation
of prescription drugs, saying it can't assure their safety. Sen.
John Kerry and other Democratic candidates have used the issue to
paint President Bush and the Republican party as too cozy with
drug manufacturers, who also oppose drug imports.
But with 48 million doses of flu vaccine, roughly half the
anticipated U.S. supply, unexpectedly withdrawn from the market
because of bacterial contamination, the administration is
scrambling to make up the shortage.
With those 5 million doses, the administration will have found
11 million additional flu shots, roughly a quarter of the
shortage, since early October. Thompson said federal agencies
are turning in another 300,000 doses that will be shipped to
states for use in priority populations people aged 65 and
over, children younger than 5 and the chronically ill.
Vaccines must first be inspected
Thompson said there is a "big difference" between medicines
imported by individuals that are not subject to inspections
and the flu vaccine.
"This vaccine is going to be inspected by FDA inspectors, based
upon efficacy and safety," Thompson said. "Drugs that are
imported into America don't have that protection."
Canadian flu shot maker ID Biomedical has just over 1 million
doses to sell to the United States, while British drug
manufacturer GlaxoSmithKline can provide 4 million doses from
a German plant, Thompson said.
At the same time, the FDA is reacting warily to the state of
Illinois' proposal to purchase flu vaccine for its residents
from a British wholesaler. Gov. Rod Blagojevich has a tentative
deal to buy 262,000 doses of an Aventis Pasteur flu vaccine that
was manufactured for use in Canada and Europe.
Blagojevich has asked the FDA for permission to proceed.
Acting FDA Commissioner Lester Crawford said his agency would
meet with Illinois officials on Friday to talk about the source
of the vaccine and whether the state is willing to back the
safety of the flu shots...
end of AP excerpt