Vaccine Issues--NYTimes Aug 9

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The New York Times

August 9, 2008

Doubts Persist Among Anthrax Suspect’s Colleagues

By ERIC LIPTON

WASHINGTON — Military personnel, under the threat of court-martial,

were refusing inoculations of an anthrax vaccine. The vaccine’s sole

manufacturing plant was ordered to shut down. Researchers were turning

up evidence possibly linking the vaccine to illnesses of soldiers

during the Persian Gulf war of 1991.

It was hardly the thank you that Dr. Bruce E. Ivins expected for his

years of labor to produce a vaccine that would protect military

personnel from an anthrax attack by the Iraqi leader Saddam Hussein or

some other adversary.

The criticism, which reached its peak in 2000 and early 2001, was

clearly starting to get on Dr. Ivins’s nerves. “I think the **** is

about to hit the fan ... big time,” he wrote in a July 2000 e-mail

message about the inoculation program, according to a government

affidavit. “It’s just a fine mess.”

This turmoil has now been cited by federal investigators as a key part

of the reason they believe that Dr. Ivins sent out anthrax-laced

letters in the fall of 2001 — as such an attack would, in a single

stroke, have eliminated the skepticism and second guessing about the

need for an anthrax vaccine.

The investigators suggest that Dr. Ivins had been struggling with

psychological problems, and was on medication and undergoing

counseling after being overcome by what he described as paranoid,

delusional thoughts. The trouble with the vaccine, they argue, may

have been enough to set him off.

But Dr. Ivins’s former colleagues reject that two-part theory, saying

it is just one of many flaws in the evidence presented by the

government in an unconvincing case.

There was a real threat, the former colleagues acknowledged, that the

anthrax vaccine Dr. Ivins had worked on during that period, known as

Anthrax Vaccine Absorbed or AVA, might be pulled from the market

Most troubling were problems at the Michigan manufacturing plant,

which had been shut down in 1998 after the Food and Drug

Administration uncovered serious flaws.

Dr. Ivins and other researchers, however, had been working on a more

advanced alternative vaccine — considered safer and more effective —

so there was no reason for such a rash act, his former colleagues say.

“There was a lot of consternation, a lot of pressure to rescue this

thing,” said Adamovicz, one of Dr. Ivins’s fellow researchers

at the time. “But if AVA failed, he had his next vaccine candidate. It

was well on its way to what looked to be a very bright future.”

The vaccine controversy erupted in the late 1990s, after the Defense

Department ordered the inoculation of all 2.4 million active duty and

reserve troops, starting with those most likely to confront biological

attacks in war zones, partly because Iraq had confirmed that it once

had a large stockpile of anthrax that was destroyed after the first

Persian Gulf war.

By 2000, more than 570,000 military personnel had complied with the

order, and hundreds had filed an “adverse event report” after

receiving the shots, citing reactions that included fatigue, dizziness

and muscle pain, and more serious conditions like thyroid disorders

and rhabdomyolysis, a muscle ailment.

Congressional hearings were held, and dozens of House members signed a

letter to the Pentagon calling the mandatory vaccination program “a

flawed policy that should be immediately stopped.”

Protests were also organized.

“What the government is doing is wrong, and it is time to wake up

America from its comfortable stupor and say ‘no more,’ ” said a

Pennsylvania woman, Gloria Graham, at a 2000 protest over the vaccine,

which Ms. Graham said had sickened her son.

The Army Medical Research Institute of Infectious Diseases, at Fort

Detrick, Md., where Dr. Ivins worked, had been assigned by the Defense

Department to help BioPort, the company that owned the Michigan

manufacturing plant, to fix any problems so production could resume.

“Unfortunately, since the BioPort people aren’t scientists, the task

of solving their problem has fallen on us,” Dr. Ivins wrote in a June

2000 e-mail message.

The situation became dire as the vaccine supply dwindled, leading Dr.

Ivins to speculate openly that the program might be halted. “That

would be bad for everyone concerned, including us,” he wrote. “I’m

sure that blame will be spread around.”

The pressure was intense for the team at Fort Detrick that had been

working on the effort, a group of about half a dozen scientists and

technicians, said Dr. Adamovicz, Dr. Ivins’s former colleague.

“It was a big concern for us,” Dr. Adamovicz said in an interview this

week. “We wanted obviously to see this vaccine succeed.”

The stakes were particularly high for Dr. Ivins, who, for nearly a

decade, had been leading experiments in which laboratory animals —

rabbits, monkeys and mice — were injected with vaccines that each had

slightly different additives in an effort to increase their

effectiveness.

Critics of the program were accusing the Defense Department of using

one of the experimental formulas, which featured an oil-based additive

called squalene, in vaccines given to military personnel in the gulf

war, a decision, they contended, that may have caused autoimmune

diseases among returning soldiers.

“It is well documented that the U.S. military has a history of

administering experimental vaccines to the troops,” said

Matsumoto, who was doing research on a book on the anthrax program and

who had submitted Freedom of Information requests to the Army

requesting access to Dr. Ivins’s laboratory notebooks.

The Defense Department denied conducting such experiments on troops

and defended the vaccine, saying it was both safe and effective, and

necessary to protect the military from a possible attack. Dr. Ivins’s

notebooks, which were released to the public, suggested, however, that

he had found that the vaccine might be making some of the test animals

sick.

“Although all vaccinated monkeys survived, they appeared to be sick

over the course of two weeks,” Dr. Ivins’s laboratory report said.

In his e-mail messages, Dr. Ivins expressed particular contempt for

Mr. Matsumoto and his requests for copies of internal Army test results.

“We’ve got better things to do than shine his shoes and pee on

command,” Dr. Ivins wrote, in August 2001, about Mr. Matsumoto. “He’s

gotten everything from me he will get.”

What the Justice Department has not produced is evidence documenting

that Dr. Ivins’s frustrations motivated him to retaliate with the

anthrax letters.

Gerard P. s, another of Dr. Ivins’s former colleagues, said he

knew that Dr. Ivins was frustrated, but that he doubted that Dr. Ivins

would consider such a step.

“Nothing is unimaginable,” Dr. s said. “But I would definitely

say it is doubtful.”

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Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

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