Anthrax Vaccine Lab in Michigan Is on Verge of Winning Approval to Supply the Pentagon

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Anthrax Vaccine Lab in Michigan Is on Verge of Winning Approval to Supply

the Pentagon

 

 

> Anthrax Vaccine Lab in Michigan Is on Verge of Winning Approval

> to Supply the Pentagon

>

> By Kathy Barks Hoffman Associated Press Writer

> Published: Jan 23, 2002

>

> LANSING, Mich. (AP) - In 1998, the buyers of the only U.S. laboratory

making

> the anthrax vaccine thought they had a can't-miss deal.

>

> The aging state-owned lab in Michigan needed millions in renovations on

top

> of the $24 million purchase price. But the Pentagon already had announced

it

> would require all 2.4 million American military personnel to take a series

> of six shots of the vaccine, and turning the lab into a profitable

> enterprise seemed childishly easy.

>

> Four years later, Lansing-based BioPort Corp. has yet to ship a single

dose

> of the vaccine to the Pentagon.

>

> Unable to pass inspections by the Food and Drug Administration, BioPort

has

> intermittently produced the vaccine but has not been able to release it.

>

> Now, the company appears to be on the verge of finally winning FDA

approval

> to begin shipments, possibly as early as this month.

>

> " It's clearly a very positive story for the company, " said BioPort

> spokeswoman Kim Brennen Root.

>

> A laboratory in Washington state that puts the vaccine into vials still

> needs FDA approval, and the vaccine still must be tested for purity,

potency

> and sterility before batches will be released by the FDA.

>

> The vaccine was held up by contamination, inadequate record-keeping and

> unapproved procedures at the laboratory.

>

> " I'm glad it took four years. That stuff needed to be done right, " said

Rep.

> Mike Rogers, R-Mich., whose district includes BioPort.

>

> BioPort is under contract to the Pentagon to supply 4.6 million doses for

> $53.5 million.

>

> Pressure to get the lab approved has grown since U.S. troops began heading

> overseas in the war on terrorism and since last fall's anthrax outbreak

> killed five people on the East Coast. Because of the standstill at

Bioport,

> the Pentagon stockpile of the vaccine is dwindling.

>

> Over the past four years, BioPort has received at least $16.8 million from

> the Pentagon to renovate and expand the lab. The Pentagon also agreed in

> 1999 to more than double the per-dose payment, from $4.36 to $10.36.

>

> Considering who owns BioPort, it was something of a surprise that the

> project did not turn out to be as easy as the new owners expected.

>

> BioPort's chief executive and major investor, Fuad El-Hibri, is a former

> director of a British maker of an anthrax vaccine. A major shareholder in

> BioPort is retired Adm. William J. Crowe, former chairman of the Joint

> Chiefs of Staff, who brought his experience dealing with the Pentagon to

the

> fledgling company. Also, the former director of the state-owned lab is

> BioPort's chief operating officer.

>

> Even so, BioPort continued to fail FDA inspections. It contracted with

> Hollister-Stier Laboratories in Spokane, Wash., to put the vaccine into

> vials when its own packaging procedures could not make the grade.

>

> BioPort also was cited for not following approved manufacturing

procedures,

> for contamination problems and for inaccurate or incomplete testing

> documentation. Several lots of the vaccine failed sterility tests.

>

> The company also was criticized for not investigating reactions to the

> vaccine that were different from those listed on the package insert. Among

> other things, an Army cook died in 2000 from a form of anemia and other

> complications. BioPort denies the vaccine caused the death.

>

> Amid the anthrax scare and the war on terrorism, some have questioned

> whether the FDA is being pushed to overlook problems at BioPort.

>

> " The FDA is under tremendous pressure to cave on this, " Lingg Brewer, a

> former state lawmaker, said last fall.

>

> Health and Human Services Secretary Tommy Thompson said in October that

the

> FDA would give the laboratory close scrutiny and that science, not

politics,

> would decide when it got the OK.

>

> " I can assure you nobody is pressuring FDA to approve this, " he said.

>

> Even if the FDA gives BioPort the green light, more problems lie ahead.

>

> Some military personnel say the vaccine they were given in the late 1990s

> made them ill, leading to congressional inquiries and lawsuits. Opponents

to

> the vaccine have asked the FDA to declare all stockpiles adulterated and

to

> revoke BioPort's license.

>

> BioPort officials have said the vaccine is safe, and the Pentagon said

> severe side effects happen only about once per 200,000 doses.

>

> Also, questions remain over the vaccine's effectiveness against the

inhaled

> form of anthrax, which has killed five people in the recent outbreak.

> BioPort and the Pentagon said the vaccine protects against the inhaled

form.

>

> But even the Pentagon says a better vaccine is needed, one that does not

> require a series of six shots over 18 months and has fewer side effects.

> BioPort wants to work on such a vaccine, but so do others.

>

> http://ap.tbo.com/ap/breaking/MGA4ZTRRSWC.html

>

>

>

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