Despite El-Hibri's experience marketing anthrax vaccine at Porton, Crowe's strong ties with the defense establishment, and growing interest from the Pentagon in protecting troops from anthrax, BioPort's problems quickly mounted after it acquired the MBPI facility.
Troubles seemed unlikely, because in May 1998, shortly before BioPort's bid for MBPI was finalized, Defense Secretary William Cohen announced plans to require all 2.4 million U.S. soldiers and reservists to be inoculated against anthrax, which looked like a windfall for the new venture.
In testimony to Congress, Adm. Crowe has adamantly denied that he had any insider knowledge that led to his purchase of the anthrax vaccine facility. "It has on occasion been rumored that the decision to inoculate all service personnel was made to benefit BioPort Corporation and indirectly me, presumably because of my past associations with the military and the administration," Crowe told the House Committee on Government Reform in October 1999. "If this charge were not so ridiculous, it would be offensive. It outrageously exaggerates my influence. Let me be completely clear. I never, repeat never, solicited any official of this administration to install or promote a mandatory inoculation program."
Despite the Pentagon's decision to require anthrax vaccination for all troops, which clearly could have been lucrative for the new firm, BioPort was struggling. Only three months after their acquisition of MBPI, El-Hibri and Crowe were prevented from shipping any new vaccine, by a scathing FDA inspection that found over 40 items wrong with the plant, the vaccine, its consistency, the firm's accounting, and other problems. Indeed, by September 1999, BioPort was already appealing to the DoD for relief from a contract requesting BioPort's delivery of some 8 million doses of anthrax vaccine. It simply could not deliver, and certainly not at that price.
A Defense Department audit from July 12, 2000, shows that shortly after BioPort bought MBPI, the DoD awarded it a $29.4 million contract to supply 8.7 million doses of anthrax vaccine at the price of $4.36 a dose. But a year later, unable to ship product, BioPort requested and the DoD granted $24.1 million in relief to BioPort, reduced the number of doses demanded from 7.9 million to 4.6 million, and agreed to raise the price per dose from $4.36 to $10.36.
Even after a full-scale yearlong renovation of its manufacturing facilities, and significant efforts to meet FDA requirements to get its new facility reapproved, BioPort continues to wait for FDA approval to ship doses of the vaccine it has been manufacturing all this time. Problems have been found not simply with BioPort's process, but with the doses of the anthrax vaccine already produced. FDA tests found a lack of consistency in dosage and other problems with the finished product.
The delay has prevented the Pentagon from vaccinating all but the troops it is currently sending abroad, and has forced some soldiers to actually suspend vaccination mid-process.
"Now we're in a situation with the terrorist attack that we still have this company that has still not met FDA approval," Rep. Walter Jones says, "and we're spending almost $3 million per month on this company that is still months away from having FDA approval."
So why did the DoD stick with BioPort all these years of their failing to get final FDA approval -- until now, when the U.S. faces a real anthrax crisis?
"I blame everybody," says a congressional staffer well versed in the BioPort controversy. "The buyer -- the Pentagon -- kept BioPort alive. The DoD should have pulled the plug on this outfit a long time ago."
To be fair to the Pentagon and BioPort, however, it's not as if major pharmaceutical companies have been clamoring for the contract. A reliable anthrax vaccine has proven hard to make, and questions about its safety have likely scared off other manufacturers (although the Defense Department agreed to protect BioPort against lawsuits by military personnel.)
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