The anthrax vaccine scandal

Why did the Pentagon allow BioPort Corp. to remain the sole U.S. supplier of a crucial weapon against bioterror, despite years of failure to deliver the vaccine?

By Laura Rozen

Oct. 14, 2001 | WASHINGTON -- With each new confirmed anthrax infection raising fears of a wider bioterror attack in the U.S., pressure is mounting on the Defense Department and the Food and Drug Administration (FDA) to give the green light to Michigan-based BioPort Corporation, the nation's lone anthrax-vaccine manufacturer, to ship new lots of the vaccine to the Pentagon.

Anthrax vaccine shipments from BioPort have been suspended by the FDA since 1998 because of questions about the facility's quality control, forcing the Pentagon to dramatically reduce its program to vaccinate all 2.4 million U.S. soldiers and reservists against anthrax. Now the lack of the vaccine threatens to become a scandal, as the U.S. is sending thousands of soldiers overseas and calling up reserves, and as the public is clamoring for access to protection from the deadly bacterium.

After three years of getting bailed out by the Defense Department, BioPort could be poised to make a fortune -- as its CEO Fuad El-Hibri did working with the British seller of anthrax vaccine, Porton International, during the Gulf War a decade ago. But only if the FDA approves the company's renovated plant, as expected, sometime in the next week. The decision could open the door for BioPort to market the drug to a worried public, as new anthrax scares are reported daily.

The story of the troubled U.S. anthrax-vaccine program is a tangled saga of science, politics, private-sector deal-making and national security. There have been persistent questions about the vaccine's safety and effectiveness. Critics say Defense Department studies have never proven the vaccine works against the more dangerous inhaled form of anthrax, only against cutaneous, or skin anthrax. Some military personnel have complained of mysterious illnesses after taking the vaccine, and at least 400 have been disciplined for refusing the mandatory inoculation. But the Pentagon insists the vaccine is both effective and safe. Even now, some researchers say the vaccine is seriously outdated, as BioPort gears up to ship more.

Then there are questions about BioPort's role as the nation's only anthrax-vaccine maker. How did Fuad El-Hibri, 43, a German-born entrepreneur and former director of British vaccine-maker Porton Products, come to have so much control over the West's supply of anthrax vaccine? Why didn't the Pentagon turn to a larger, more established drug maker for the crucial anti-biowarfare weapon? And how could it let BioPort remain the sole maker of the vaccine after it failed repeatedly to gain FDA approval for its renovated facility?

"It speaks to DoD culture more than anything else," says a congressional staff aide who asked not to be named. "The Pentagon just does not have a corporate culture. Once they decided to go with this program (BioPort), they stuck with it, even though oversight indicated they had built their biodefense program on a foundation of sand, and they had an unreliable producer. The DoD is simply incapable of admitting a mistake. They genetically just can't back out."

The Pentagon and BioPort deny they made a mistake, of course, and they believe their problems will be solved, perhaps next week. Government sources close to the process say as early as Monday, the FDA will approve BioPort's renovated facility, and enable it to resume shipments of the vaccine it has been stockpiling since 1999.

A government official who asked not to be named says while BioPort is "70 percent on the way there" in terms of improvements in quality control demanded by the FDA, political pressure due to the terrorism scare is playing more of a role than quality control in expediting FDA approval. But BioPort officials say FDA approval for their renovated facility is long overdue.

"We have heard the process will be speeded up, and it has taken an incredibly long time," said Jay Coupe, a longtime aide to Adm. William Crowe, who with Fuad El-Hibri serves as one of BioPort's owners, and who served as chairman of the Joints Chiefs of Staff during the Reagan administration. (Fuad's father, Ibrahim El-Hibri, also well-connected to the defense establishment, is a third partner in the venture.) "While BioPort certainly supports the FDA, and doesn't want any special consideration and wants a safe and effective vaccine, the approval process has gone on for a very long time for most vaccine manufacturers. This is one of the reasons people are getting out of the vaccine business."

"We have been manufacturing vaccine," BioPort spokeswoman Kim Brennan Root said. "As we submit final documentation for approval from the FDA, we have been manufacturing vaccine and contributing it to the stockpile so when approval comes we can be in a position to release the vaccine."

But critics of BioPort say that repeated FDA inspections have shown the company has failed to prove it can produce the same dose of vaccine twice.

"The most fundamental problem has to do with the quality of the process of vaccine manufacture," a congressional aide, who asked not to be named, told Salon. "They cannot show they can produce the same vaccine of the same potency and consistency twice in a row. The quality of the process is not validated. That means they don't have the data to show that, within this process, within this heat range, this process produces this vaccine. They are trying to retrofit a modern inspection and validation process on an old system."

"BioPort has tried to say it didn't know how much it would cost to bring the company to 2001 FDA standards," another congressional staffer told Salon. "But that is kind of a hard pill to swallow. They consistently showed deviations from good manufacturing practices. Some of the FDA complaints are substantive. There were contaminants in the lot. There were some deficiencies in packaging. There were problems with paperwork and record keeping. There was an inability to show consistency from one lot to the next."

"They have come a long way," he added, "at significant taxpayer support."

Next page: BioPort hopes to sell the vaccine to the general public