On the Hill

If you're scared witless by the anthrax horror spreading across the country, take heart: The government has an anthrax vaccine that will immunize you and let you chuck that recent Cipro prescription. There are, however, a few small drawbacks. There's only enough vaccine on hand for at most 4,000 people. The vaccine requires months of painful shots before taking effect. The one factory that produces it has been dormant for three years—and it's so tangled in red tape that no one knows when it will be running again.

In other words, for all practical purposes, there is no available anthrax vaccine. How did this happen? After all, while almost no one believes the current anthrax threat warrants nationwide inoculation, a plentiful and efficient vaccine would come in awfully handy right now for postal workers, police, firefighters, and perhaps even that segment of the public neurotic enough to risk minor side effects for peace of mind. What's more, some scientists think the anthrax vaccine could be a highly effective treatment for the disease, even after infection.

Unfortunately we're out of luck. And the reason is political shortsightedness, paranoid conspiracy theories, and bureaucratic sluggishness. Yes, a Manhattan Project-style effort against bioweapons may produce plenty of good anthrax vaccine within a couple of years. But try explaining that to the postal worker who has to sort the mail tomorrow morning.

ANTHRAX TERRORISM MAY have surprised most Americans, but it shouldn't have shocked any government leader who has been paying attention. Scientists and federal officials have been warning for decades that anthrax could become a terrorist weapon of choice—warnings confirmed by the discovery of large anthrax stockpiles in the arsenal of Saddam Hussein following the Gulf war. But, nonetheless, top military and government leaders didn't make countering the threat a priority. In 1991, for example, Army officials discussed creating a massive civilian vaccine stockpile--if for no other reason than to show that the United States was prepared. But at a time of shrinking military budgets, the plan never left the drawing board. (Pentagon officials questioned even the affordability of a more limited plan to inoculate U.S. troops.)

The Clinton years proved no better. The administration's response to the bioterror danger was typified by National Security Adviser Anthony Lake's response to a 1994 warning from renowned microbiologist Joshua Lederberg. "Do I really have to worry about that?" Lake said, according to the book Germs: Biological Weapons and America's Secret War. "I've got enough on my plate right now."

Over subsequent years, as terrorist episodes accumulated—the 1993 World Trade Center bombing, the 1995 Aum Shinrikyo gas attack in the Tokyo subway, the 1995 Oklahoma City bombing—administration officials paid greater lip service to the anthrax threat, but that was about it. In 1997 Defense Secretary William Cohen terrified Cokie Roberts with a five-pound bag of sugar on the ABC talk show "This Week," warning, "This amount of anthrax could be spread over a city—let's say the size of Washington. It would destroy at least half the population of that city." But Cohen's proposed response—a plan to vaccinate all 2.4 million members of the U.S. armed services—would have done little for the civilian population of Washington or any other city. What's more, it wasn't even fully implemented. The program was interrupted due to logistical problems after inoculations began on only 520,000 troops.

In 1997 Bill Clinton finally took a personal interest in bioterrorism—bizarrely, after reading Richard Preston's The Cobra Event, a pulp thriller about a killer virus that makes people claw out their own eyes. Soon afterward Clinton called a bioterror attack "highly likely" and, in his final two budgets, sought huge spending increases for biodefense. In 1998, for instance, he proposed $51 million to help create "a civilian stockpile of antidotes, antibiotics and vaccines"—including anthrax vaccine. But according to The New York Times, Health and Human Services officials talked Clinton out of new money for vaccines, convincing him to shift it to antibiotics and other priorities. The following year Clinton considered a plan to vaccinate police officers, firefighters, and other "first responders." But that idea, too, went nowhere. The United States didn't even have enough vaccine to inoculate its soldiers.

But indifference was only one reason the government didn't aggressively pursue a vaccine. Another was hysteria—in particular the minor frenzy provoked by the Pentagon's effort to vaccinate U.S. troops. The program began during the Gulf war, when then-Defense Secretary Dick Cheney and then-Joint Chiefs of Staff Chairman Colin Powell pushed to inoculate 150,000 American soldiers. Yet this relatively uncontroversial plan became a political disaster following Cohen's 1997 decision to extend the vaccinations to all U.S. troops. After early recipients of the vaccine complained of side effects ranging from ringing ears to swollen testicles, the program quickly became a vessel for free-floating distrust of the government, fueled by paranoia over a possible "Gulf War syndrome" that was still raging among well-organized veterans. Thousands of troops, most of whom had been stationed in the Gulf, complained about strange maladies that doctors were never able to identify and which some chalked up to psychological stress. Mistrust of the government skyrocketed when the Pentagon belatedly admitted that troops destroying Iraqi chemical weapons might have been exposed to them, kindling memories of Agent Orange.

In this climate, conspiracy theories ran rampant. Websites promoting a Black Helicopter view of the world sprang up across the Internet. "ANTHRAX VACCINE: CURE OR CONSPIRACY?" asked one. "President Clinton won't take the vaccine because he's no fool." Zealous lawyers, including Mark Zaid of the James Madison Project, a crusader against government secrecy, took the opportunity to dredge up every embarrassing Pentagon document that he could legally acquire. For instance, when Zaid found a draft army memo that would indemnify potential vaccine manufacturers from the "unusually hazardous" legal risks of the job, he treated it as proof the Pentagon didn't trust its own program. In a typical press release, Zaid said the Pentagon might have used methods similar "to that which we condemned the Nazis [for] performing 50 years ago ... our troops have been used as guinea pigs." Zaid had willing allies in Congress, like Clinton-hating Indiana Congressman Dan Burton, whose House Government Reform Committee released a scathing report last year accusing the military of a "post Gulf War panic over apparent weaknesses in chemical and biological warfare defenses." And the mass media took the paranoiacs seriously, with newspapers around the country—as well as glossy magazines like People and Vanity Fair—writing sympathetic accounts of the vaccine critics. Soon the Pentagon was confronted with hundreds of troops who were risking court martial or leaving the service altogether rather than take the vaccine.

To be sure, the vaccine isn't perfect. Its regimen of six shots over 18 months is slow and difficult to administer. And, says Gigi Kwik of the Johns Hopkins University Center for Civilian Biodefense Studies, "It's not pleasant. It burns." But it's still basically safe, according to the Food and Drug Administration and the Centers for Disease Control. In February 2000, The Wall Street Journal reported that just 620 of the 400,000 vaccinated troops reported side effects, and only six of them had vaccine-related symptoms requiring hospitalization.

Ironically, the same paranoia that resisted inoculation with the current vaccine has also impeded research into better ones. When a researcher in Amherst, Massachusetts, began work on a promising new anthrax vaccine in the late 1980s, for instance, he was protested by the Quaker-led American Friends Service Committee, which petitioned local officials to declare the town "a biological warfare research-free zone." And when, less than a week before the September 11 attacks, The New York Times reported that the Pentagon had been secretly conducting advanced anthrax vaccine research in Ohio, the news was presented as a disturbing sign that the United States might be violating the spirit of a global bioweapons ban.

IN ADDITION TO negligence and paranoia, there is a final culprit: good, old-fashioned, bureaucratic boondoggle. It had been clear for years that the creation of an effective and plentiful vaccine couldn't be left to the private sector--bioweapon vaccines have never promised much in the way of profits. Until recently, pharmaceutical companies didn't believe there would be widespread public demand and worried that production might be hazardous and would permanently contaminate their equipment. Indeed when the army encouraged drug companies to develop a better anthrax vaccine as far back as 1985, according to Germs, none so much as bid for the contract.

In the aftermath of the Gulf war, the Defense Department decided it needed plentiful doses of anthrax vaccine. A special team of scientists, known as "Project Badger," was charged with figuring out how they could be made. At the time the sole U.S. supplier of the vaccine was a small, antiquated laboratory owned by the state of Michigan. In 1994 Project Badger recommended that the military create its own federal vaccine facility in Arkansas or Maryland. Military scientists also recommended that the United States invest in a new vaccine, based on recent breakthroughs in DNA research, that might be easier to produce and administer. But the military stuck with the Michigan lab instead, issuing it a large contract and leaving the parallel research with scant support. "DoD picked the wrong fork in the road, primarily because they thought it was cheaper and easier," says Larry Halloran, a House Government Reform Committee staffer.

Things got worse in 1998, when the state of Michigan sold the lab to BioPort, a company whose board of directors included retired Admiral William Crowe, the former chairman of the Joint Chiefs of Staff and one of the few highranking military officers to endorse Bill Clinton in 1992. Since the sale to BioPort, the lab has not made a single dose of anthrax vaccine. Despite receiving $126 million in Defense Department expenditures over the past three years, it has failed to meet FDA regulations--despite warnings that date back to the mid-'90s. "In retrospect, the whole notion of turning this over to a new contractor instead of an established pharmaceutical company looks questionable," Tara O'Toole of the Johns Hopkins biodefense center told The New York Times this month.

So now the United States must wait for BioPort--itself still awaiting FDA approval to resume production--to begin churning out the millions of doses it agreed to deliver years ago. Of course, once the doses are delivered, it will still be another 18 months before anyone is safely inoculated. The government could always abandon BioPort and build its own plant--but that, according to Halloran, would take about seven years. Which means that if the Defense Department had made the proper decision in 1994, the assembly line would be running today.

This article originally appeared in the November 5, 2001 issue of the magazine.

Notebook - December 17, 2001

By The Editors

Long Shot

By Michael Crowley

Page 1