The biotech industry is stepping in to fill the void. Under the Project BioShield plan just approved by the House Energy & Commerce Committee, the federal government would spend $5.6 billion to counter bioterror threats over the next 10 years. That has inspired dozens of biotech outfits to tackle anthrax, smallpox, and other pathogens, using the latest drug-development tools and techniques.
Many companies are focusing on anthrax, for several reasons. "Weaponized" strains are known to have found their way into terrorists' hands. And the military is desperate for an alternative to the current anthrax vaccine, which requires six injections over 18 months, as well as annual booster shots. What's more, drugs currently used to treat anthrax victims are imperfect at best. Cipro and other antibiotics work best when they're administered soon after exposure.
Human Genome Sciences Inc., in Rockville, Md., is one of the companies answering Washington's call. Its antibody-based drug, called ABthrax, doesn't target the anthrax bacteria, as antibiotics do. Instead, HGSI's drug attacks the toxins emitted by the bugs, preventing them from entering and killing cells. It seems to work with a single dose. And, says HGSI CEO William A. Haseltine, "It may prevent and treat infections by antibiotic-resistant strains."
San Diego's Vical Inc. is working on an anthrax vaccine. It began by creating a chemical copy of anthrax DNA, then altering the structure. The concoction, administered in two injections, stimulates immune cells to make antibodies against anthrax -- but won't transmit the disease. In one test, 40 rabbits that were given the vaccine and then exposed to anthrax survived, while 17 that were left unvaccinated died.
The trick will be getting these treatments over the regulatory hurdles. Because human tests aren't feasible or ethical when dealing with a disease such as anthrax, the Food & Drug Administration had no formal process for reviewing chemical or bioterror remedies -- until last spring. In May, 2002, the FDA passed a regulation known as the "animal rule," which allows drugmakers to rely heavily on animal tests in such cases. Still, biotechs will have to work closely with the FDA to determine which animals will serve as appropriate test subjects. And they'll have to run human trials to show that their products are safe. "It isn't a shortcut," says Dr. Una S. Ryan, CEO of Avant Immunotherapeutics of Needham, Mass., which is working on vaccines for anthrax and plague. "We have to feel our way through this process."
The government's desire to get bioterrorism remedies on the market is already reaping dividends. In February, the FDA approved a chemical called pyridostigmine bromide to treat soldiers exposed to the nerve gas Soman. Says Army Colonel John D. Grabenstein, deputy director for clinical operations at the Military Vaccine Agency: "It's important to explore new advances to see how they might be applied to our existing capabilities." The biotech industry has never been better equipped to help. By Arlene Weintraub in Los Angeles