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Mon Thru Fri Commentary By Regush

Wednesday, October 10, 2001

PANIC BUTTON?

In times of upheaval, people are on the lookout for reassurances.

Last night on a

Chicago radio station affiliated with ABC NEWS, the two talk show

hosts who

interviewed me for an hour wanted to find something hopeful to say

in light of

growing concerns about the threat of anthrax. Maybe the vaccine

could work.

Maybe anthrax would be too difficult to weaponize. And so on. I was

on the show

because of my SECOND OPINION column that I wrote this week for

ABCNEWS.com, which raised questions about the anthrax vaccine’s

effectiveness. My questioners were well-prepared to discuss the key

issues

surrounding the vaccine and asked all the right questions. Still,

my conclusion that

the vaccine had not been tested adequately, caused them concern and

they tried to

bleed some words of reassurance from me. I didn’t give them any,

except to

suggest that preparing the vaccine as a weapon required a lot of

skill. This is not a

time to bend the truth as you see it. Or to live in a fantasy

world. Far too much is at

stake. Free up an inadequate vaccine for military service members

and possibly a

worried public and you do everyone a terrible disservice.

MEDIA: I saw a segment on CNN yesterday which included the anchor

chatting

with a reporter about the anthrax vaccine. The reporter obviously

had never even

considered the possibility that the vaccine’s efficacy was

problematic. He and the

anchor were wondering whether enough could be quickly produced to

meet a

significant anthrax threat. Both were way in over their heads on

this one.

Unfortunately, in this type of situation, the word gets out to the

public that an

available anthrax vaccine could be their lifeline – if only it

could be produced in

sufficient quantities.

THE MANUFACTURER OF THE ANTHRAX VACCINE: Right now, the

military, which controls access to the vaccine, probably has less

than 60,000

doses. That’s because the vaccine’s current manufacturer, BioPort,

of Lansing,

Michigan, has had the Food and Drug Administration on its tail

since September 3,

1998 for manufacturing irregularities. Since BioPort took over the

vaccine about

three years ago from its original maker, the FDA has not given the

struggling

company the green light to release more vaccine. BioPort stated

this week that it

has made the necessary changes and is hoping to get clearance soon

because the

vaccine “is the centerpiece of protection for the U.S. military.”

PRESSURE: The media’s focus of attention is now mainly on whether

BioPort has

gotten its manufacturing act together sufficiently to receive the

FDA’s go-ahead.

The key issues of whether the vaccine works and is safe may well go

by the boards

in this time of crisis.This is not a time for softie interviews

with BioPort or the

military. Pressure is mounting for release of the anthrax vaccine.

CONGRESSIONAL HEARING: On October 19th, there will be a

congressional

hearing on bio-terrorism, which will include an assessment of the

anthrax vaccine’s

status. There is also some talk that the United States Government

Accounting

Office (GAO) will have a report on the vaccine ready in time for

the hearings.

Keep in mind that previous GAO reports on the vaccine have raised

serious

questions about its safety and efficacy.

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