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Costly program with a shady past

Costly program with a shady past
By Deborah Rudacille
Examiner Correspondent 11/20/08

Bacillus anthracis vegetative cells and spores are pictured in this undated photomicrograph from the official U.S. Department of Defense anthrax information Web Site.

Anthrax is an infectious disease caused by the spore-forming bacteria Bacillus anthracis.

The FBI on Monday, Oct. 8, 2001, took over the investigation into the anthrax death of a Florida man after the germ was found in the nose of a co-worker and on a computer keyboard in their office.

Anthrax Vaccine Immunization Program

The Food and Drug Administration licensed Anthrax Vaccine Adsorbed in 1970, based on a 1950s study of textile mill workers who processed imported goat hair. Each year, several mill workers contracted anthrax, a disease that humans get by touching, breathing or ingesting the pathogen bacillus anthracis from infected animals.

Of the 400 vaccinated workers, three contracted anthrax, and all of them developed cutaneous anthrax, a skin infection that is rarely fatal if treated with antibiotics.

The FDA then approved AVA as safe and effective against cutaneous anthrax.

When anthrax is inhaled, however, its spores germinate in the lungs, releasing toxins that cause internal bleeding and death.

For nearly two decades, scientists studying B. anthracis in biodefense programs — like the one at Fort Detrick in Frederick — received the vaccine that the Michigan State Department of Public Health produced under contract to the Pentagon.

During the first Gulf War the fear of billowing clouds of weaponized anthrax engulfing U.S. troops led to mass immunization. About 150,000 troops received AVA in 1990-91, although the vaccine had never been licensed by the FDA for that purpose.

“There were those who were against it and who made a great fuss about this being an experimental vaccine,” says D.A. Henderson, former chief of the Office of Public Health Emergency Preparedness.

“But it was the only vaccine we had.”

In 1998, the Pentagon mandated all active duty and reserve troops to receive the shots.

That same year BioPort Corp. bought the Michigan plant and the state’s license to manufacture AVA. The newly formed company was facilitated by the late Adm. William Crowe, former chairman of the Joint Chiefs of Staff under Presidents Reagan and George H.W. Bush.

Crowe was friendly with Fuad al-Hibri, the Lebanese-German businessman who became a naturalized American citizen while bidding for the vaccine production facility.

With a limited stockpile, BioPort secured a $45.1 million contract with the Pentagon to ramp up production of a new vaccine, with $16 million upfront for renovations to the aging Michigan facility.

Despite the gush of cash, from 1999 through 2001 the company failed a series of FDA inspections and failed to ship a single dose of new vaccine. The new product also failed potency tests, but the contract signed with BioPort obliged the Pentagon to pay for the unusable product.

The cost was steep: $10.64 per dose versus the previous price of $4.36 per dose under Michigan’s ownership.

With supplies short, the government then injected troops with the old vaccine. Some troops developed symptoms similar to those of Desert Storm veterans suffering from the mysterious collection of maladies lumped together as “Gulf War syndrome.”

In April 2000, the Department of Defense assigned a team of anthrax researchers from the Army Medical Research Institute for Infectious Diseases in Frederick to work on BioPort’s vaccine. The team included Bruce E. Ivins, who, with two of his colleagues, was awarded the Decoration for Exceptional Civilian Service for the role they played in getting production moving again.

Ivins’ job was enhancing the potency of the formulation.

The FBI later accused Ivins of salvaging the program by creating “a situation, a scenario, where people all of a sudden realize the need to have this vaccine.”

That “situation” was the anthrax letter attacks of 2001, which killed five people and sickened at least 17 others.

Sen. Tom Daschle, D.-S.D., received one of the anthrax-loaded letters, nearly two months after he wrote to Secretary of Defense Donald Rumsfeld challenging the vaccination program and punishment of soldiers rejecting the anthrax vaccine.

The FBI insists Ivins sent the letter, even though several leading scientists say it would have been impossible for Ivins, who died this past July 28 after overdosing on prescription Tylenol, to have committed the crime. (Read Part I of this series at baltimoreexaminer.com.)

“The case is solved. We are 100 percent sure that Dr. Ivins was the sole perpetrator of the anthrax mailings,” said FBI spokeswoman Debbie Weierman.

While doubt about Ivins’ guilt lingers in the science community, there is strong evidence the attacks saved the program.

Three months after the attacks, the FDA relicensed BioPort’s Michigan plant, and by the end of 2003, the company (now Emergent BioSolutions Inc.) signed a new $245 million contract with the Pentagon. The next year the company built a $95 million anthrax vaccine plant in Frederick and secured a $122.7 million contract from the Department of Health and Human Services to provide five million doses of the vaccine for civilian use in the event of an emergency.

In December 2005, the FDA issued a final order declaring the vaccine (now called BioThrax) safe and effective for use against inhalation anthrax.

To date, no enemy has assaulted U.S. troops overseas with anthrax.

Anthrax vaccine timeline

» February 1998 — Michigan Biologics Products Institute halts production of anthrax vaccine to renovate facility after stockpiled vaccine fails Food and Drug Administration tests for potency and contamination.

» September 1998 — Facility and license sold to BioPort Corporation for $25 million and $7.9 million of stockpiled vaccine. BioPort signs a Pentagon contract for $45 million worth of vaccine, including $16 million in immediate cash for renovations. FDA suspends shipments from the facility because of quality-control problems.

» September 1999 — Pentagon approves a $24.1 million bailout of the new company after the facility fails FDA inspections.

» April 2000 — Bruce Ivins is appointed to the Anthrax Potency Integrated Product Team from the U.S. Army Medical Research Institute of Infectious Diseases assigned to assist BioPort.

» July 2000 — Pentagon curtails vaccine program because of supply problems. Committee on Government Reform recommends suspension of anthrax vaccination program.

» April 2001— White House Chief of Staff Karl Rove concedes to Deputy Defense Secretary Paul Wolfowitz that AVIP is a “political problem.”

» June 2001 — Sen. Tom Daschle (D-SD) and Rep. Richard Gephardt (D-Mo.) write to Defense Secretary Donald Rumsfeld challenging AVIP.

» August 2001 — Two undersecretaries of defense recommend minimizing use of the vaccine.

» September 2001 — Chairman of the Joint Chiefs of Staff Gen. Henry H. Shelton rejects the recommendation, insisting that AVIP is the centerpiece of a bio-defense program.

» September, October 2001 — Anthrax letters mailed, killing five and sickening 17. Daschle receives one of the letters.

» January 2001 — FDA approves BioPort license to manufacture and distribute anthrax vaccine under new trade name BioThrax.

» June 2002 — Pentagon restarts AVIP. All military personnel required to receive anthrax vaccinations in run-up to Iraq war.

» March 2003 — Ivins wins award for work on BioPort’s vaccine.

» November 2004 — VaxGen of San Francisco awarded a contract to produce 75 million doses of next-generation anthrax vaccine, for which Ivins holds two patents.

» October 2004 — U.S. District Judge Emmett Sullivan suspends AVIP, ruling troops cannot be forced to comply with mandatory vaccination.

» May 2005 — Pentagon appeals judge’s order, seeks to resume mandatory vaccinations.

» May 2006 — Government Accountability Office report says vaccine has not been adequately tested on humans, long-term safety has not been studied and data on short-term reactions is limited.

» October 2006 — Pentagon begins voluntary vaccination program for select personnel.

» December 2006 — VaxGen’s contract for new vaccine canceled after it misses clinical trial deadline.

» February 2007 — Pentagon resumes mandatory vaccination of select troops.

» May 5, 2008 — Emergent BioSolutions Inc. (formerly BioPort) buys rights to VaxGen vaccine.

» July 29, 2008 — Ivins commits suicide.

» August 2008 — Ivins is fingered as culprit in anthrax attacks. FBI says he was concerned that Congress would end the vaccine program.

» September 2008 — PharmaThene Inc. of Annapolis and Emergent win government vaccine contracts worth more than $1 billion; Rep. Rush Holt, D-N.J., proposes a bipartisan commission to investigate the anthrax attacks and the government's response and investigation.

» Oct. 1, 2008 — Emergent wins second order from Department of Health and Human Services for 14.5 million doses of BioThrax worth $404 million.

» Oct. 9, 2008 — Emergent shielded from lawsuits related to anthrax vaccine by Department of Health and Human Services.