Military's Sole Supplier of Anthrax Vaccine Still Can't Make It
By STEPHEN KINZER   
New York Times
October 6, 2001

LANSING, Mich., Oct. 5 ÷ With concern growing over the possibility of biological weapons being used against Americans, anthrax vaccine should be pouring out the door of the only laboratory in the United States licensed to make it.

But although the laboratory is working frantically to meet government standards so it can begin producing the vaccine, it has failed to do so. As a result, the government program aimed at vaccinating all American soldiers against anthrax is at a standstill.

On Monday, National Guard sentries arrived to guard the plant, which is owned by BioPort Corporation, but the sole supplier of anthrax vaccine to the military has not produced a single dose since 1998, when it bought the plant from the state.

Problems have plagued BioPort from the beginning. It failed Food and Drug Administration inspections in 1999 and 2000; inspectors cited problems including poor documentation and improper procedures in the room where the vaccine was packaged. Corporate managers hope to begin producing anthrax this year, but that depends on the outcome of a third F.D.A. inspection, which has not yet been scheduled.
At a hearing of the Senate Armed Services Committee last year, Senator Tim Hutchinson, Republican of Arkansas, called BioPort's record "an unmitigated disaster." Mr. Hutchinson said its failures were "costing the American taxpayer millions and millions of dollars and jeopardizing the safety of our troops who we're not able to provide that anthrax vaccination."

Others say that problems are not all the fault of the laboratory, which started life as the Michigan Biologic Products Institute before it was bought by BioPort.

"There's a lot of criticism of BioPort," said Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University, "but to be fair, there's also a lot of talk that the Defense Department significantly underfunded the whole effort and didn't give it the priority it deserved."

"In retrospect," Ms. O'Toole said, "the whole notion of turning this over to a new contractor instead of an established pharmaceutical company looks questionable."

Plant officials say that since the terror attacks last month on the World Trade Center and the Pentagon, their 220 employees have been working with new fervor.

"Our commitment has deepened measurably," said Kim Brennen Root, a BioPort spokeswoman. "People are getting up every morning thinking: `I know what my job is. I know what I have to do and I have a very clear purpose.' "

The only other plant that produces anthrax vaccine, Ms. Root said, is in Britain.

Many experts believe that if terrorists were to launch an attack using biological agents, anthrax would be among their most likely choices. Although anthrax is said to be difficult to produce and spread in large doses, an enemy that managed to do so could inflict considerable damage. A 1993 government study found that spraying just 220 pounds of aerosol anthrax over Washington could kill up to three million people.

The Soviet Union was known to have experimented with military uses of anthrax, as have about 10 other countries, including North Korea and Iraq. Some reports say that Osama bin Laden, whom Bush administration officials describe as head of the world's principal terror network, has also taken an interest in chemical and biological warfare.

"It's a good bio-terror weapon and even better for biological warfare, and it's lying on the ground in places like Afghanistan" said William Dietrich, an assistant professor at Harvard Medical School who is researching the anthrax bacterium. "If you have a collection of soldiers you want to kill without infecting your own population or soldiers," Professor Dietrich said, "anthrax has good properties with regard to that. If you can produce it and disperse it on a battlefield, you can kill a lot of people very quickly. It's a very terrible, high-fatality kind of illness that we don't have enough tools in our arsenal to stop."

In the Persian Gulf war, when what is now the BioPort plant was still run by the State of Michigan, thousands of American soldiers were given an anthrax vaccine made here. Some later charged that it contributed to the mysterious illnesses, sometimes referred to as gulf war syndrome, that afflicted some veterans of the conflict. In recent years, more than 400 soldiers have been disciplined for refusing to take the anthrax vaccine, and others have complained of adverse reactions. Supporters of the vaccination program, however, say no credible evidence has been produced to show that it causes serious side effects.

The vaccine BioPort wants to produce involves six shots over 18 months. Critics have called this approach impractical and unreliable, urging BioPort researchers to concentrate on developing a new one.
"They've got a pretty profound problem," said Lawrence Halloran, staff director of the House Subcommittee on National Security, which investigated BioPort after it fell behind in its efforts to provide the vaccine to the military. "They can't demonstrate within any range of certainty that their vaccine is scientifically valuable."

Even if the company passes its next Food and Drug Administration inspection and is allowed to resume production, the first several million doses will be assigned for military use.

In recent days more than 1,200 people, including many doctors, have called BioPort asking to buy anthrax vaccine. They are transferred to a recording that says, "All the stockpile that currently exists is owned by the Department of Defense. At this time there is no opportunity for any commercial sales." The government has said it has no plans to vaccinate civilians.

The Defense Department is BioPort's only customer, and it has invested $126 million in the Lansing plant over the last decade. Military commanders say they want to immunize all 2.4 million active and reserve troops against anthrax but have so far managed to begin immunizing only about 500,000, mostly those in the Persian Gulf. There is no figure on the number who have received the full course of vaccination.

Michigan began producing anthrax vaccine in 1970, selling it to small numbers of animal handlers, mill workers and others who might be exposed to the disease. After the gulf war, demand grew.
In 1998, the state sold the plant to BioPort, a newly formed company whose most prominent board member is Adm. William J. Crowe Jr., a former chairman of the Joint Chiefs of Staff and former ambassador to Britain.

Some Lansing residents opposed the plant's privatization in 1998 and have been sharply critical of it since.

"They have never met their responsibilities," said Lingg Brewer, a former state legislator from Lansing. "They bought the company at a fire-sale price with the help of political connections, and since then they have not been able to make any vaccine that meets F.D.A. standards. They're doing a lot of chest-thumping about protecting the nation's interest, but they're actually unwitting allies of our enemies because of their incompetence and their greed."

Robert Kramer, president of BioPort, who has been at odds with Mr. Brewer for years, rejected his charges.

"Mr. Brewer has made the same claims over and over again, and they have all been discounted by courts, by Congress and by appropriate state and federal agencies," Mr. Kramer said. "I find it unconscionable that at a time when our country is uniting around our military and the national assets that serve it, he will continue to make his irresponsible and unsubstantiated allegations. He is doing a disservice to the 220 employees of BioPort and, more importantly, to his country."

Concerns about BioPort are especially acute as officials in Washington begin reassessing the country's readiness to fend off biological attacks. One group of senators has introduced a bill calling for $1.4 billion to improve defenses against this form of terrorism.

The National Guard soldiers took up positions at BioPort on Monday and quickly installed a series of low concrete barriers near the front gate and began unrolling barbed-wire fencing. But until then the plant was separated from public streets by no more than a chain-link fence that a child could climb over.

"It's a joke," said a woman working at a state office building across the street. "We're nervous. Anything could happen."