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Just when Americans are learning to cope with the horror of September 11, a new threat is spreading fear. Letters containing deadly anthrax bacteria have killed a Florida man, sickened others in New York and Florida, and caused the federal government to close much of the Capitol. What once-unthinkable attack could be next? Smallpox? Plague? Ebola virus? And how can we protect ourselves?
In a nation that tamed the atom and cracked humanity's genetic code, you would think it would be possible to get vaccinated against these potential scourges. But you can't -- the vaccines just aren't available. As for post-infection treatments for anthrax, there are fears that one of the best antibiotics -- Cipro -- could soon be in short supply.
The Bush Administration is responding with a $1.5 billion proposal that includes boosting the nation's stockpiles of antibiotics for anthrax sixfold and accelerating production of smallpox vaccine, the only treatment for smallpox. Meanwhile, Congress is mulling use of an existing law that allows the government to buy patented products like Cipro from generic-drug makers, as long as the patent holder can ask for compensation.
POOR STEPCHILD. These steps aren't enough, however, especially on the vaccine front. "Medicine has no better way of preventing diseases" than with vaccines, says industry veteran Dr. Stanley A. Plotkin, emeritus professor at the University of Pennsylvania. "If you start from that recognition, we need to promote their development and production."
The basic problem is that vaccines -- despite their stunning successes against such scourges as polio, smallpox, and yellow fever -- have been a poor stepchild to drugs for the pharmaceutical industry. Why? Compared with drugs, "the return is so low," explains Harriet L. Robinson, a microbiologist at Emory University. Companies can typically sell only one dose per person, vs., say, hundreds of painkiller pills. And many of the countries that most need vaccines can't afford to pay much.
In addition, the industry has been plagued by lawsuits alleging that childhood vaccinations cause autism and other problems. "Through the 1980s, a number of companies exited the business because it no longer seemed an economic business to be in," says Paul R. Drayson, CEO of vaccine maker PowderJect Pharmaceuticals plc in Oxford, England. And for vaccines against many bioterrorist threats, the government is the only customer.
GENETIC WIZARDRY. As a result, most vaccines are decades old -- which is ironic at a time when the support for science is undergoing a revolution. The current anthrax vaccine, for instance, is a crude, four-decade-old design. In essence, it's a mix of protein material extracted from a vat of bacteria. Because of the impurities, it causes reactions in as many as 45% of those who get it.
It's also not clear if it actually protects people from the more dangerous inhaled version of the disease. "We now know how to make better vaccines," says Dr. Thomas P. Monath, vice-president for research and medical affairs at Acambis, a British biotech company in the process of making smallpox vaccine.
With today's genetic wizardry, scientists can read the genetic code of anthrax and other pathogens and determine which parts might best stimulate the immune system to fight the bug. "Any lab in the field can select the pieces and stuff them into a known safe vaccine, inject it into a mouse, and get it to neutralize anthrax," says Andrew McMicheal, director of Oxford University's Institute of Molecular Medicine. That lab work could be done in a few months -- though proving that the vaccine is safe and effective in people takes years.
TOO RISKY. The smallpox vaccine could also be improved. The current product is a live virus called vaccinia. It's similar enough to smallpox that, when a vaccination causes a vaccinia infection, the immune response that's triggered also neutralizes smallpox.
"Who will invest $100 million for development if there's no market?"
However, vaccinia itself can cause disease or even death. The U.S. stopped vaccinations for the general public in the early 1970s, before smallpox was eradicated worldwide, because the risk from the vaccine was greater than the risk of getting the disease. Now, it makes sense to use it only to combat an actual epidemic. The vaccine is already being made at an accelerated rate by Acambis and will be stockpiled for such an emergency. A safer product, however, could be given to everyone -- freeing Americans from the fear of a bioterrorist smallpox attack.
Developing better vaccines costs big bucks. "Who will invest $100 million for development if there's no market?" says Acambis' Monath. "That's where the government has to step in." The good news is that in the past couple of years, vaccine development for Third World diseases has gotten a $1 billion-plus boost from new philanthropists, such as Bill and Melinda Gates through their eponymous foundation.
"Their efforts have rejuvenated the entire field," says Dr. Peter J. Hotez, chairman of the Microbiology & Tropical Medicine Dept. at George Washington University. A matching grant from the federal government could piggyback on the innovative ideas being spawned by foundation money, as well as on the wealth of expertise in big pharmaceutical companies. The result would be a new generation of vaccines to protect against bioterrorist threats.
LIABILITY PROTECTION. No vaccine is completely safe. To prevent manufacturers from quitting the business after hundreds of lawsuits were filed alleging injury from a vaccine for diphtheria, tetanus, and whooping cough, Congress was forced to enact a law in 1986 providing compensation when children are proven to be harmed. That liability protection needs to be extended to adults before it would be possible to have widespread vaccination for bio-agents wielded by terrorists.
What's more, vaccines are only part of the answer. It typically takes years to prove that a new vaccine is safe and effective. So if rogue scientists create a diabolical genetically engineered virus, even a crash program to develop a vaccine would take months at best -- too late to quash an epidemic. That's why vaccine experts say another crucial piece of the puzzle is tackling the sources of lethal germs, such as the huge stocks made in the former Soviet Union.
"We need to make sure that the Russian stockpile of biological agents is contained or destroyed, and that scientists involved in their biological warfare campaign don't use their skills for countries that might foster terrorism," says Dr. Harry L. Keyserling of Emory University. How? One simple way would be to make sure those scientists are offered good jobs at home or in the West.
SHARING THE BLAME. There's plenty of blame to go around for America's current vulnerability to bioterror, from agencies that didn't take the threat seriously and scientists who wanted money for sexier projects to a Defense Dept. that skimped on vaccines for its own troops. But under President Bill Clinton, who was galvanized into action by reading about the threat of exotic viruses, the government began pumping hundreds of millions into measures that thwart bioterrorism, including boosting smallpox-vaccine production. Now, the U.S. needs to step up vaccine development, which will have the added benefit of helping to tame other diseases around the world.
Today's anthrax-laden envelopes may seem scary. But we faced far graver dangers from diseases like polio and smallpox just a half-century ago. New vaccines solved the problem then. They're a big part of the solution now.
With Heidi Dawley in London and Amy Barrett in Philadelphia Edited by Douglas Harbrecht
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Copyright 2001 , by The McGraw-Hill Companies Inc. All rights reserved.
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