The race is on for vaccines to protect us against biological weapons. The spreading risk of anthrax has made Americans realize how relatively easy it is to spread terror with germs.
Yet there is only one factory in the United States currently equipped to produce anthrax vaccine, and it has effectively been shut down, awaiting clearance from the Food and Drug Administration. The vaccine it makes has won FDA approval, but its revamped plant and machinery in Lansing, Mich., have not yet passed newly rigorous standards imposed by the agency.
The company's name is BioPort, and if you haven't heard of it, you soon will. It supplied anthrax vaccine for American troops during the Persian Gulf War and got caught up in the controversy over the vaccine's safety. More than 500,000 U.S. troops were inoculated, and a tiny percentage of those suffered side effects. There was one death reportedly connected to the vaccine, which BioPort disputes, but which has resulted in an ongoing lawsuit. Vaccines are risky. The smallpox vaccine, which was once widely dispersed in this country, kills one of every million who are vaccinated, and hospitalizes one in every thousand.
It wasn't faulty science that halted vaccine production at BioPort. The company's problems had more to do with plain old politics. Various maladies suffered by the military during the gulf war were attributed to the vaccine, and anecdotal claims of the government deliberately trying to poison its troops took hold on the Internet. Retired Adm. William Crowe, who sits on BioPort's board and served as chairman of the Joint Chiefs during the Reagan administration, calls the medical lore that bounced around in cyberspace "the dark side of the Internet." But the stories grabbed people's attention, and when President Clinton's secretary of Defense, William Cohen, made anthrax vaccine compulsory for American troops, he was greeted by a storm of criticism.
Hundreds of troops, fearful for their safety, were court-martialed and left the military rather than submit to the vaccine. That's when Congress got into the act. Some members suggested Cohen make the vaccine voluntary, but he balked. By then, anthrax had been recognized as the No. 1 threat facing the military. Hearings held by the House Government Reform Committee, chaired by Republican Dan Burton, provided a forum for right-wing skepticism of the vaccine and its Clinton administration sponsors. Burton showed a photo of a seriously ill soldier, claiming the illness resulted from the vaccine. Later investigation revealed the illness was unrelated. The committee skewered BioPort and suggested that Crowe may have had insider knowledge about Cohen's decision to encourage widespread use of the vaccine, which would make BioPort a lucrative investment. "If this charge were not so ridiculous, it would be offensive," Crowe bristled. One of only a few senior military officials to endorse Bill Clinton in 1992, Crowe had become a convenient target for Clinton haters on Capitol Hill.
The poisoned political climate prompted greater scrutiny of BioPort, and the company, under orders from the FDA, was prevented from shipping any new vaccine. That meant BioPort couldn't fulfill its contract with the Defense Department. But there evidently was no serious thought of abandoning BioPort. There was no obvious alternative, and despite BioPort's problems, it was much further along in providing an anthrax vaccine than any other laboratory.
The pharmaceutical industry has long been wary of producing vaccines for humans because of the risk, and the potential for lawsuits. And until the recent anthrax scare, there didn't seem to be a huge profit potential in making anthrax vaccine. The vaccine itself is not an instant cure. Protection requires six shots over 18 months, and annual maintenance shots. But given the alternative, the treatment is suddenly looking a lot more attractive than it once did. There is also some evidence that people who have been exposed to inhalation anthrax have a better chance of surviving if their treatment combines an antibiotic like Cipro with the vaccine.
The government has asked BioPort if it can double its capacity once it gets operational, and the FDA is speeding up the clearance process to certify the plant and equipment at the public urging of Health and Human Services Secretary Tommy Thompson. BioPort did not just spring up as a commercial enterprise. It has its roots in a small laboratory created by the state of Michigan more than 30 years ago in response to an outbreak of anthrax among textile workers who contracted the disease through contact with animal hides. The lab was privatized in 1998 by Michigan Gov. John Engler and sold to BioPort.
Given its troubled history, Republicans are now having second thoughts about whether BioPort can handle the country's anthrax needs. Virginia Gov. James Gilmore, who chairs an antiterrorism panel, recommended in a report to Homeland Security Director Tom Ridge that the government create its own vaccine laboratory because of uncertainty over whether the free-market system can handle "the surge capacity" of a bioterror attack.
On the other end of the political spectrum, liberal Democrats who traditionally champion government intervention are doing what they can to bolster private industry in meeting the nation's vaccine needs. Massachusetts Sen. Ted Kennedy sat down with pharmaceutical industry representatives three weeks ago and asked, "What do you need?" Kennedy supports changes in antitrust laws to allow pharmaceutical companies to talk to each other as they move ahead to develop vaccines. He also wants changes in liability provisions to protect them from lawsuits. As new vaccines are created to protect people from some 30 biological agents, Kennedy said there will be ethical problems. These vaccines cannot be tested on humans, and they could pose substantial risk.
In the face of a potential bioterrorist attack, rules get bent. Kennedy noted that the Soviets have weaponized eight biological agents and developed vaccines to counteract each of the eight. The United States hasn't tested those vaccines, but Kennedy implied that such testing was on the horizon. In the race for a cure, all the old boundaries disappear.
