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.

by Ann Rees

The Vancouver Province

June 25, 2000

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. Robert 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 Frank 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."