Anthrax Vaccinations Suspended -- 24 Dec 2003

[Guest guest]

http://www.washingtonpost.com/wp-dyn/articles/A26269-2003Dec23.html

Anthrax Vaccinations Suspended

Program for Military On Hold While Legalities Are Explored

By Vernon Loeb

Washington Post Staff Writer

Wednesday, December 24, 2003; Page A13

Senior Pentagon officials yesterday defended the military's anthrax vaccine as

" safe and effective " but said they were discontinuing a program of mandatory

anthrax inoculations for troops in high-threat areas until the program's legal

status is clarified.

The program's temporary suspension came one day after U.S. District Judge Emmet

G. Sullivan ordered the military to stop administering the anthrax vaccine to

service members without their consent, pending a trial on the matter.

" The department will stop giving anthrax vaccinations until the legal situation

is clarified, " Pentagon spokesman Whitman said last night, adding that

Pentagon lawyers are now reviewing legal options.

(Glad to see the Pentagon chose to " comply " with the order. I guess the idea of

being held in contempt didn't seem to appealling. I've always felt that was

goes around..... will eventually come around. (December 22, 2003, we will not

forget).

Sullivan gave the Pentagon until the end of January to file court papers

responding to his order, in which he held that U.S. soldiers receiving the

anthrax vaccine were being used as " guinea pigs for experimental drugs. "

The Pentagon could appeal Sullivan's order, proceed to trial or seek a

presidential waiver of service members' right of informed consent, a remedy

provided under federal law to ensure that military units are ready for all

contingencies.

Earlier yesterday, at a Pentagon briefing called to rebut Sullivan's findings,

Winkenwerder Jr., assistant secretary of defense for health affairs,

took strong exception to Sullivan's finding that troops receiving the anthrax

vaccine were being used as " guinea pigs. "

(Apparently Windenwerder is not familiar with the DoD's history of the treatment

of their soldiers).

In issuing a preliminary injunction halting mandatory inoculations, Sullivan

agreed with the contention by six unnamed Defense Department plaintiffs that the

anthrax vaccine is an experimental drug that has never been licensed by the Food

and Drug Administration for use against airborne anthrax spores. The vaccine has

been licensed for use against infection through the skin.

On that point, Winkenwerder disputed Sullivan's interpretation, saying the FDA

has certified the anthrax vaccine as " a licensed product against all forms of

anthrax. "

(Bologna once again.... If that be the case, an IND would never of been applied

for from the DoD to the FDA. And to think that Winkenwereder " interpreted " it

this way, knowing that the vaccine never had a clinical trial done for

inhalation anthrax for efficacy, and that the animal efficacy rule was never

enacted, really makes me ponder the " qualifications " one must have to be in a

position that effects millions of people)

Winkenwerder noted that a March 2002 study by the National Academy of Sciences'

Institute of Medicine concluded that the vaccine is effective " for the

protection of humans against anthrax, including inhalation anthrax, caused by

all known or plausible engineered strains of Bacillus anthracis. "

(More Crap. Though he held the IOM report in high regard as being an agency

" totally independent " of the DoD, again, the IOM thanked the DoD for their

involvement in helping them with the report all throughout. And again... the IOM

never took into consideration the other information sent into them that was

contrary to the DoD spin)

A million service members have received the vaccine since the Pentagon began a

program for mandatory inoculations in 1998, including 600,000 to 700,000 who

received the vaccine since June 2002 as the military prepared for war in Iraq.

Hundreds of other service members have refused to take the vaccine out of

concerns about its safety, and many have been court-martialed for refusing the

vaccine, forced out of the military and, in some cases, imprisoned.

Winkenwerder said that most of those who refused the vaccine did so in the early

stages of the program, in 1998 and 1999, and that only 10 have refused it since

the program accelerated this summer. " Our most recent experience in the last two

years is that our service members support the vaccine program and accept it, and

our refusal rate is very, very, very small. "

(Complete lie! Fortunately, for 2 years, the refusers stopped.... because the

program stopped due to short supply of the vaccine, because the manufacturer had

" challenges " of getting themselves to compliance. However, Winkenwerder would

be correct in saying that the refuser rate has been small afterwards. Not

because the troops " accept " it, but, because the troops were threatened and

coerced. Where do they find these people?)

In his order, Sullivan noted that the Pentagon recently updated the " adverse

reaction rate " associated with the anthrax vaccine from 0.2 percent to 5 percent

to 35 percent.

Army Col. D. Grabenstein, who helps administer the anthrax vaccine program

and appeared with Winkenwerder, said adverse reaction rates of 5 percent to 35

percent are comparable to those of other vaccines and flu shots, typically

indicating nothing more than headaches or swelling at the injection site on a

patient's skin.

(Ahh... here we go again.... do other vaccines however have these as side

effects?: Preliminary results of a recent unpublished retrospective study of

infants born to women in the U.S. military service worldwide in 1998 and 1999

suggest that the vaccine may be linked with an increase in the number of birth

defects when given during pregnancy; Approximately 6% of the reported events

were listed as serious. Serious adverse events include those that result in

death, hospitalization, permanent disability or are life-threatening;Other

infrequently reported serious adverse events that have occurred in persons who

have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris,

endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma,

aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma,

leukemia, collagen vascular disease, systemic lupus erythematosus, multiple

sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis,

Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes,

psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy,

hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis,

cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure,

spontaneous abortion and liver abscess. Infrequent reports were also received of

multisystem disorders defined as chronic symptoms involving at least two of the

following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included sudden cardiac arrest (2), myocardial infarction

with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central

nervous system (CNS) lymphoma (1).

" These are not scary numbers, " he said.

(What would be scary numbers then? 5-35% of the above from 2.4 million people

having this forced on them, scares the hell out of me, and the future

generation.)

Mark S. Zaid, a Washington lawyer who filed the suit challenging the anthrax

vaccine program, disputed Winkenwerder's claim that the vaccine is licensed by

the FDA for use against airborne anthrax spores.

" The only thing [defense officials] received from the FDA was a letter from a

political figure at the FDA " saying the vaccine is effective against airborne

anthrax, he said.

" This letter means nothing, " Zaid said. " It is a personal opinion. The FDA is

the linchpin of this entire situation. The reason the judge ruled the way he did

was because the FDA did not answer the questions that he wanted addressed. "

(Next question would be... what now will happen to the FDA? Is it not their job

to protect the citizens of this country?)