WASHINGTON — Shortly after the Sept. 11, 2001, terrorist attacks and the subsequent anthrax mailings, top U.S. science advisors said the country "urgently needed" a new, improved anthrax vaccine.
The existing vaccine often caused swollen arms and muscle and joint pain. Inoculation required six injections over 18 months, followed by yearly booster shots. The estimated shelf life was just three years.
The scientists' report, issued by the Institute of Medicine, called for "an anthrax vaccine free of these drawbacks" -- a vaccine that would require only two or three injections, achieve protection within 30 days, stay potent for a long time and cause fewer adverse reactions.
Yet nearly six years later, the old vaccine is still the only one available -- and the government is buying it in mass quantities for the Strategic National Stockpile.
The manufacturer, Emergent BioSolutions Inc. of Rockville, Md., prevailed in a bitter struggle with a rival company that was preparing what federal health officials expected to be a superior vaccine. The episode illustrates the clout wielded by well-connected lobbyists over billions in spending for the Bush administration's anti-terrorism program.
Emergent's rival, VaxGen Inc. of South San Francisco, had spent four years developing a new anthrax vaccine and had won an $877.5-million federal contract to deliver enough doses for 25 million people. The contract threatened Emergent's very existence. The old vaccine, its only moneymaker, would likely be obsolete if VaxGen succeeded.
Emergent responded by mobilizing more than 50 lobbyists, including former aides to Vice President Dick Cheney, to make the case that relying on the new vaccine was a gamble and that the nation's safety depended on buying more of Emergent's product.
The company and its allies in Congress ridiculed VaxGen and impugned the competence or motives of officials who supported the new vaccine. The lobbying effort damaged VaxGen's credibility with members of Congress and the Bush administration, a Los Angeles Times investigation found.
When VaxGen encountered a stubborn scientific problem and needed more time to deliver its vaccine, the firm found scant support, even among officials who had earlier backed its efforts. The government then imposed tougher testing requirements on the struggling company.
A senior federal scientist who oversaw the project said she sought authority to allow advance payment to VaxGen to help it work through the difficulties. Top administration officials blocked her requests, she said.
Finally, a year ago, officials canceled VaxGen's contract, all but capsizing the company.
Emergent, meanwhile, has won federal contracts worth at least $642 million for the old vaccine and is in line to win many millions more as the government expands the strategic stockpile.
Kimberly B. Root, a spokeswoman for Emergent (formerly BioPort Corp.), said the company's lobbying ultimately served the national interest.
"Had we just thrown up our hands, what position would we be in now?" Root asked. "Where would the government be? There wouldn't be, potentially, a vaccine in the stockpile."
Bill Hall, a spokesman for the U.S. Department of Health and Human Services, said VaxGen's "poor performance" sealed its fate. In canceling the contract, Hall said, officials acted "as effective custodians of government finances."
Yet Dr. Philip K. Russell, a vaccinologist and retired Army general who was a senior biodefense official in the Bush administration, described the outcome as "a big, dramatic failure."
"National security took a back seat to politics and the power of lawyers and lobbyists," said Russell, who supported the decision to award VaxGen the contract.
If officials had granted the company a bit more time, Russell said, it would likely have solved its scientific problem and delivered a superior vaccine. He noted that setbacks are common in developing vaccines and said VaxGen appeared capable of overcoming this one.
"It wasn't an insurmountable problem," said Russell, who after leaving the government did not lobby for or advise either of the competing vaccine companies. "It was a solvable problem."
Effort to contain threats
On the Sunday night after Sept. 11, 2001, Health and Human Services Secretary Tommy G. Thompson convened an urgent meeting of health officials and leading scientists.
"Tommy Thompson was really, really concerned that something could happen," recalled Dr. Donald A. "D.A." Henderson, a former World Health Organization physician who led successful efforts to eradicate smallpox. "There was intelligence information coming through and some chatter coming through, suggesting there was going to be a second event, that the second event could very likely be a biologic event.
"And anthrax and smallpox were both raised as possibilities."
The imperative was clear: Find a way to eliminate both threats.