(no subject)

[Guest guest]

- News

Their dangerous dose

Canadian soldiers were given anthrax vaccine to

protect them against biological warfare during UN and

NATO Persian Gulf operations in the '90s. Province

reporter Ann Rees discovered that the vaccines were

often contaminated, mishandled and even banned from

use.

Ann Rees

The Province

Canadian soldiers have received

thousands of doses of suspect

anthrax vaccine. They've been

given everything from batches

that may not be potent enough to

protect them from biological

warfare to a batch that was

highly contaminated with gasket

particles.

The Department of National

Defence had even planned to use

vaccine that it feared was

tainted with mad-cow disease.

That plan was foiled when DND

accidentally spoiled the entire

shipment.

Defence Minister Art Eggleton --

who has staunchly defended the

quality of anthrax vaccine used

by his department -- unknowingly

received his vaccine from the

batch contaminated with gasket

or stopper material, according to

documents released under Access

to Information.

Eggleton's vaccine was under

quarantine when he got his shot

in April 1998. About 100 doses

from the lot were given to

soldiers.

Soldiers also received several

hundred doses from other

U.S.-made batches that were

later placed under quarantine and

have since failed testing.

Lt.-Col. Dr. Greg Cook, the medical officer in charge of ensuring

the troops

received safe vaccine, testified at a recent court martial that

DND

and Health

Canada were also concerned about the use of British vaccine.

They feared " the incalculable risk of transmission of mad-cow

disease, "

Cook testified at the court martial of a soldier who had refused

to be

vaccinated.

Medical experts now believe there is no evidence mad-cow disease

can be

transmitted through a vaccine.

But concern was so great at the time that the British military

made the

vaccine voluntary. About two-thirds of their soldiers refused it.

The Sunday Province has also learned that the British military

purchased U.S.

vaccine to give to " high-ranking British defence officials, "

according to the

U.S. Food and Drug Administration.

The U.S. vaccine was from the same batch received by Eggleton.

Spoiling the British batch left Canada scrambling to obtain

vaccine

during its

1998 Operation Determination in the Middle East.

The only option was to use vaccines that had been manufactured

years

earlier

and for which the expiry date had been extended.

Until 1998 only a potency test by the manufacturer was required

for

approval

to extend the expiry date.

The U.S. FDA to this day does not have the capacity to test

anthrax

vaccine for

potency. Nonetheless, the FDA approved all requested extensions.

It has also never refused to approve a request to release a batch

of

vaccine

submitted for approval by the U.S. maker.

None of the U.S. anthrax vaccine has been tested for degradation

over time --

as requested by the FDA.

" We don't know how to look for that kind of phenomenon in this

vaccine, " said

Dr. Myers, chief operating officer of BioPort Corp., the

manufacturer.

In 1998, the U.S. military, which buys most of the U.S. anthrax

vaccine,

introduced supplementary testing.

The extra testing was initiated after the manufacturer, then

called the

Michigan Biologic Products Institute, was cited for poor quality

control and

record keeping and for substandard manufacturing practices.

In 1997, the FDA gave notice that it would revoke the

manufacturer's

licence

if it did not comply with regulations. The Canadian military

largely

dismissed

the notice.

" It's not an unusual letter, as I understand it, " Cook, who was

the

DND doctor

in charge of medical countermeasures, testified at the court

martial

of Cpl.

Mike Kipling, who had refused to take the U.S. vaccine in 1998

because he

feared it would harm his health.

Cook's understanding is incorrect, said Mark Elengold, the FDA

official who

signed the notice.

" In the three years I have been in this job, I have done it about

three times, "

said Elengold, deputy director for operations for the FDA's

Centre

for Biologic

Evaluation Research.

" It is a very serious tool. We view it . . . to be equivalent to

an

injunction . . .

where we get a court to order compliance. "

The company failed to comply completely and a year later still

faced the

possibility of losing its licence, according to Elengold.

The FDA held off pulling the licence, in part because it would

have

left the

U.S. Department of Defence -- which had just announced that all

soldiers

were to receive anthrax vaccine -- with no domestic source.

" This is a one-source product so we tend to try to work with

firms

and put

additional monitoring steps in to avoid revoking the licence, "

said

Elengold.

The prestigious British medical journal Lancet reported at the

time

that " a

plea from the Pentagon has prevented an 'eleventh-hour' closure

of

the only

U.S. producer of anthrax vaccine, " according to an e-mail to DND

medical

headquarters in February 1998.

Elengold confirmed the Pentagon sat in on a crucial call to the

company in

which he discussed revoking the licence.

A compromise was reached when the company agreed to voluntarily

quarantine 11 questionable vaccine lots containing more than one

million

doses.

But the FDA had earlier approved release of 10 of the lots. Three

were used on

Canadian troops.

Elengold insists the quarantines do not imply any proven health

risk.

" A product was adulterated if it was not prepared, packed, held,

manufactured, shipped, stored in accordance with the good

manufacturing

practice, " he said. " That doesn't mean that there is anything

physically,

scientifically, measurably defective in the product safety. "

But despite the severe shortage, none of the 11 suspect batches

have ever

been released from quarantine. The U.S. military could run out of

vaccine later

this summer.

Elengold said there was no formal recall because he was told only

DOD had

any in storage.

" I don't think any of us knew it had been shipped out of the

country, " said

Elengold. " We thought that the entire shipments were under DOD

control. "

That lack of a formal recall was taken as a vote of confidence in

the vaccine

by Cook and other DND medical officers. Use of quarantined

vaccine

continued.

Some of DND's top medical officers also speculated that even if

the

vaccine

lots proved to be unsafe, the Americans, not Canada, would be

held

responsible.

" Even in the off-chance I'm wrong about our lot numbers being

proven

safe,

the vaccines we DID administer to our soldiers were provided by

DOD

in good

faith, " says a June 1998 e-mail from Grant McNally, officer

responsible for

force protection against biological warfare, to Souter, DND

medical

liaison officer in Washington. " If history was to show the stuff

wasn't 'safe'

then it was DOD's error, not Canada's. "

---------------------------------------------------

Art goes out on a limb

Defence minister's anthrax shot meant to prove

military vaccine was safe

The Province

Defence Minister Art Eggleton got

more than he bargained for in his

anthrax shot.

He was inoculated with vaccine

from a batch that was heavily

contaminated with gasket and

stopper particles.

The vaccine was under quarantine

and had been pulled from

distribution two months before

Eggleton received it in April

1998, before visiting troops in

the Middle East for Operation

Determination.

Canadian soldiers were also given

about 100 doses from the same

lot -- as were the U.S. Joint

Chiefs of Staff and high-ranking British officers.

The vaccine from lot FAV 016 had been placed under quarantine

with

10 other

lots in February 1998 at the request of the U.S. Food and Drug

Administration,

which controls release of the vaccine.

" We asked [the manufacturer] to suspend lot release and rather

than

force a

recall, we asked that they agree to voluntarily hold it and agree

not to

distribute it without further clearance from us, " said Mark

Elengold, deputy

director for operations in the FDA's Centre for Biologic

Evaluation

Research.

" They should have stopped using it once it is quarantined, " said

another FDA

spokesman.

The lot remains under quarantine, according to the manufacturer,

BioPort

Corp.

" We will keep them in quarantine here until any outstanding

issues

we have

with the FDA [are] resolved, " said Dr. Myers, chief

operating

officer of

BioPort.

Amazingly, DND officials denied last week that the Eggleton lot

was ever

quarantined by the FDA.

" FDA had no concerns about the safety or efficacy of vaccine from

this lot and

did not request a quarantine or a recall, " DND said in a fax on

Wednesday.

By late Friday, DND had discovered there was a quarantine -- but

it

could find

no evidence the FDA had " forced " it.

The Wednesday fax says: " There were no problems associated with

vaccine

distributed by the manufacturer from lot FAV 016. "

But lot FAV 016 may be the worst lot Canada ever purchased.

The FDA singled out the lot in a scathing report in February

1998:

" Lot FAV

016 had 6,579 vials rejected due to particulates during

post-filling

inspection.

" These particulates were not identified, nor was an investigation

conducted.

The batch was released. "

BioPort's Myers says 30 per cent of the lot was discarded because

of

visible

contamination.

DND admits " inert gasket or stopper material was detected in some

of the

vials from this lot during the quality control process. "

The vials are sealed with a stopper to prevent spoilage.

DND says it was never told the vaccine was under quarantine and

should not

be used.

" If the FDA had said, for any reason, we don't think you should

use

it, we

would not have used it, " said Lt.-Col. Jean- Bernier,

assistant chief of

staff operations for medicine at the Canadian Forces medical

headquarters.

At the time Eggleton received his vaccination, Bernier's second

in

command,

Lt.-Col. Greg Cook, had temporarily taken over responsiblity for

vaccine

procurement.

Cook testified at a court martial earlier this year that he knew

few

of the

details contained in the FDA inspection report when it was

released in

February 1998.

" At the time our personnel went to the Gulf and they got the

anthrax

vaccine,

I wasn't aware of all the actual details . . . of the actual

reports

from the

FDA, " Cook testified. " We were waiting for that to come out on

the web. "

Cook was testifying at the court martial of Mike Kipling, who had

refused to

be vaccinated.

But Bernier, who is Cook's commanding officer, said there was

frequent

contact between Cook and Americans who knew the details of the

FDA

report.

" I know that he [Cook] had handwritten notes from frequent

contact

with DOD,

which was in direct contact with BioPort every day, " Bernier said

last week.

" He was in frequent regular contact. Sometimes it was daily.

Sometimes it

was weekly and there were meetings that occurred even before that

Gulf

deployment " in February 1998.

Cook refused an interview.

Ironically, Eggleton didn't need to be vaccinated.

While the vaccine was mandatory for the soldiers, Eggleton got it

because he

insisted.

" The minister has asked to receive his vaccination before he

leaves for

Kuwait and not during his visit, " said an internal military

document.

The minister was told he did not face any real danger of coming

under an

anthrax attack while in the Middle East. But he wanted the shot

to show

troops that the vaccine was safe.

" While it is not required, according to medical staff, it is

considered

important from a leadership perspective, " said a military e-mail.

A DND memo dated April 3, 1998, notes: " It appears our best shot

(no pun

intended) would be to arrange for the 'shot' in St-when he

is

doing some

French-language training. "

Eggleton has since staunchly defended the safety of the anthrax

vaccine given

to Canadian troops.

" I took the vaccine myself and I have never felt better, " he told

the House of

Commons.

Eggleton wouldn't be interviewed.

-----------------------------------------------------

Airman stood his ground on vaccine

The Province

Retired airman Mike Kipling was

cleared in a court martial for

refusing a shot from a lot of

vaccine that the top military

judge ruled was unsafe.

And that batch was the best of

the bunch, a Province

investigation has found.

Canada's chief military judge,

Col. Guy Brais, ruled that the

batch of vaccine that Kipling

refused may have caused health

problems in other soldiers.

" It was sufficient and the court

is satisfied on the balance of probability that the defence

demonstrated that

the anthrax vaccine contained in lot 020 was unsafe and hazardous

and could

be responsible for the important symptoms reported by so many

persons who

received that vaccine, " the judge ruled last month.

Most other vaccines the Department of National Defence forced on

Canadian

soldiers were even worse and were quarantined for concerns about

potency

and contamination.

The judge said forced inoculation violated Kipling's Charter

rights

to life,

liberty and security of person.

DND is appealing the ruling, claiming it could affect its ability

to

operate.

The officer in charge of the anthrax vaccine program dismisses

any

suggestion that the vaccine is unsafe.

" You have to keep in mind that legal opinion is a totally

different

thing than

scientific, " said Lt.-Col. Jean- Bernier.

Kipling said of the appeal: " It is coming down to an issue of

rights. Do we have

rights as Canadian citizens if you serve for the Canadian

government as a

military person? "

He refused the vaccine because he lacked confidence in the safety

of the

vaccine and in the military for attributing soldiers' unusual

illnesses to

stress rather than the vaccine.

" I also have a hard time believing when the military say the

vaccine

is no

different from a helmet and a rifle to protect you, " said

Kipling,

who lives in

Edmonton.

" The thing is, when I retire I can give them back their helmet

and

rifle.

" I cannot give them back their vaccine. "

Anthrax vaccine has been the subject of international debate

since

shortly

after the 1991 Gulf war, when high numbers of veterans complained

of

serious health problems.

Kipling says he is in contact with half a dozen soldiers who have

suffered

strange symptoms since receiving the anthrax vaccine during the

1998

Operation Determination in the Middle East.

" I know of Canadian troops that are sick right now, " he said.

" They

phone me. "

Health problems range from severe chronic fatigue to unexplained

skin

growths.

Some can no longer work.

He said the soldiers won't file an official complaint blaming

anthrax vaccine

because they fear it might damage their military careers.

Bernier says DND has received no official complaints of illnesses

linked to

the vaccine.

BAD MEDICINE CHRONOLOGY

Canada has forced soldiers to be inoculated with anthrax vaccine

from one

questionable batch after another.

The military purchased the vaccines from a U.S. manufacturer

after

the U.S.

Food and Drug Administration approved distribution.

In February 1998, the FDA requested that 11 previously released

lots,

including three sold to Canada, be quarantined and not used

because of

problems with sterility, potency and contamination.

Canadian troops received vaccine from the lots listed below:

- Between 1995 and 1997, Canadian United Nations inspectors in

the Middle

East were inoculated with vaccine from lots FAV 018 and FAV 022,

which the

FDA requested be pulled from distribution and quarantined.

Both lots failed subsequent potency testing, meaning they would

not

provide

adequate protection.

- In February 1997 Canada bought 80 doses from lot FAV 014. It

was also

pulled from distribution and remains in quarantine.

- In September 1997, Canada purchased 120 doses from lot FAV 016,

which

was pulled because of a high contamination rate -- about 30 per

cent

of the

lot was destroyed before release because of visible gasket and

stopper

particles. The FDA also cited handling problems for lots FAV 008

to

FAV 016

that could have led to mixups.

" For anthrax vaccine lots #FAV 008 through #FAV 016, the firm

unpacked the

vials from the cartons and removed the labels . . . the firm does

not have

documentation of performing reconciliation of the vials before

and

after this

operation, " said the FDA.

(Canada purchased about 320 doses of FAV 008 between 1991 and

1996. The

batch, manufactured in 1991 and twice extended beyond its

original expiry

date, is now being used by U.S. troops.)

- In March 1998, troops in the Middle East's Operation

Determination

received

vaccine from lot FAV 020, which had been manufactured in 1993 and

extended

with FDA approval to 1999. The FDA has no capacity to test

anthrax

vaccine

for potency and therefore cannot verify the company's result.

The lot did pass supplemental testing by the U.S. military, which

did its own

tests following FDA findings of serious violations at the

manufacturing plant.

Canada purchased 2,400 doses of lot FAV 020.

- In May 1998, Canada bought 3,000 doses from lot FAV 030, which

had also

been extended beyond the expiry date, based on the potency tests

only. It, too,

passed additional testing by the U.S. military.

" In the production of every . . . vaccine there are going to be

little hiccups

here and there, " said Lt.-Col. Jean- Bernier, assistant

chief

of staff

operations for medicine for the Canadian Forces.

" As long as they don't affect the safety and the efficacy, " he

insists, the

vaccines are " safe and effective. "

Ran with factbox entitled " BAD MEDICINE CHRONOLOGY " which is

appended to

the end of the story.

==============================================================================

Ann Rees

Staff Reporter

Addresses: The Province

200 Granville Street

Suite 1

Vancouver, B.C.

V6C 3N3

arees@...

Phone: (604) 605-2084

Fax: (604) 605-2759

============================================================================

==