http://dailynews.yahoo.com/h/ap/20011220/us/anthrax_vaccine_1.html
Thursday December 20 4:01 AM ET
By LAURAN NEERGAARD, AP
Medical Writer
WASHINGTON (AP) - Before the government begins giving anthrax vaccinations, health
officials must figure out how to explain the complex pros and cons to thousands
of confused people.
A consent form written in layman's terms, attempting to lay out the risks of
vaccination, was undergoing scientific review Wednesday night, said Dr. Jeffrey
Koplan, director of the Centers for Disease Control and Prevention (news
- web
sites).
Shots could begin Thursday.
But a day after the CDC announced it would offer either experimental
vaccinations or 40 more days of antibiotics to thousands who were heavily
exposed to anthrax during the bioterror attacks-by-mail, confusion escalated
over just who the government thinks really needs the extra therapy.
``We're in a state of quandary,'' said U.S. Postal Service vice president
Azeezaly Jaffer.
Thousands of postal workers in several states, including Jaffer, are
potential candidates for extra therapy but can't tell if they're at high enough
risk to seek it out, he said. Nor do they know where to get it.
``The employees are hungry for information, and they're trying to understand
what it is that the medical community wants them to do,'' Jaffer said.
``I fully understand the frustration,'' Koplan told The Associated Press.
But because anthrax attacks have never happened before, ``there's no scientific
literature that says `you get it and you don't.' It ends up being a judgment
call.''
The worry is that animal studies suggest in rare cases, anthrax can lurk in
the body for more than the 60 days of antibiotic therapy typically prescribed.
There's no evidence that has ever happened in people, but because the mailed
anthrax was so potent, and doctors have little experience treating people, the
CDC decided to be excessively cautious and offer certain people additional therapy.
Koplan said three groups should consider seriously accepting the options:
-People who had significant contact with an anthrax-laced powder or
envelope, which mostly includes 70 Capitol Hill workers nearby when a heavily
contaminated letter to Senate Majority Leader Tom Daschle was opened.
-People who worked in areas where someone became infected with inhaled
anthrax.
-People in environments heavily contaminated with anthrax.
Those last two groups include workers in Washington's central Brentwood and
New Jersey's Hamilton Township postal facilities, he said.
But even those people must weigh if they're willing to take more antibiotics
or three vaccine injections, both options that can cause side effects, he said.
People who can see a doctor easily for any anthrax-like symptoms might choose
merely to monitor their health closely for another month, he said.
``There really is value in people with any of these potential exposures to
discuss it with someone they trust who is a medical authority,'' Koplan said.
CDC officials spent several hours answering questions and, in a few cases,
handing out additional antibiotics to some Senate workers Wednesday. Koplan
said similar help would be available to post office workers.
Anthrax vaccine itself is not experimental, used for decades by
veterinarians, scientists and the military. But it has never been given after
exposure to anthrax, so it is uncertain whether it will work for these people.
Thus, anyone seeking vaccination must sign the CDC-written consent form,
which will outline side effects including swelling, sometimes severe and
lasting weeks, at the injection site and rare but sometimes serious allergic
reactions.
Another complication: the vaccine was made by BioPort Inc. of Lansing,
Mich., which has not been allowed to sell the shots for several years because
the Food and Drug Administration (news
- web
sites) has repeatedly cited the company for improper manufacturing
practices. BioPort took a step toward resuming routine vaccine production
Wednesday when the FDA completed an inspection that found a handful of problems
yet to be fixed. The FDA cautioned that full licensing awaits at least one more
inspection, of a BioPort contractor, next month.
However, the FDA has tested the 10,000 doses of vaccine that the CDC is
offering to people exposed to anthrax and certified its safety.
-
On the Net: CDC's anthrax site: http://www.bt.cdc.gov/
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.