[CTRL] Fwd: [cia-drugs] Wanted: Drugs to Fight Bioterror

Thu, 03 Jun 2004 07:24:33 -0700

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-Caveat Lector-
Wanted: Drugs to Fight Bioterror
By Randy Dotinga, Wired News
Jun 02, 2004
 
Amid new warnings about a possible summer of terror, the U.S. government is preparing to spend billons to coax pharmaceutical companies to develop drugs to fend off a biological or chemical attack. But experts say the infusion of cash may be little more than a good start.
 
The entire proposed allocation for manufacturing and stockpiling bioterrorism drugs is $5.6 billion over a decade. By contrast, a single cholesterol drug -- Lipitor -- rakes in $9 billion in revenue each year.
 
"We're buying what we can afford," said Julie Fischer, who studies bioterrorism at the nonpartisan Henry L. Stimson Center. "It doesn't mean it will fall dramatically short, but it isn't on the scale of what pharmacological companies invest to develop a new drug. It's not a tremendous amount of money, and it might not be adequate to get where we want to go."
 
The so-called BioShield bill, which passed the Senate on May 19 after months of delays, is expected to land on President Bush's desk soon. In addition to allocating money, the legislation allows waivers in emergencies to let companies bypass the usual years of testing before drugs can go on the market.
 
At stake is the health of 293 million Americans and perhaps countless people abroad.
 
The government is especially worried about the Big Six biological threats: anthrax, smallpox, plague, tularemia, botulism toxin and viral hemorrhagic fevers (like the Ebola virus). While less well-known than the other diseases, tularemia and botulism toxins could conceivably be aerosolized, causing severe respiratory illness and paralysis, respectively.
 
To various extents, antibiotics can treat the bacterial threats, including anthrax, plague and tularemia, but supplies could be a problem. And while an anthrax vaccine is available, it's complicated to administer and painful to take, said Jim Matthews, associate professor of clinical pharmacy at Northeastern University.
 
Meanwhile, effective treatments for the hemorrhagic viruses and smallpox remain elusive. Scientists are working on an Ebola vaccine. And they are trying to tinker with the traditional vaccine for smallpox, a disease that could pose a major threat to millions of Americans, including AIDS patients, chemotherapy patients and people who have ever suffered from the skin disease eczema.
 
While scientists continue to study the Big Six threats, drug companies are much more interested in developing profitable drugs to treat long-term conditions like cancer, high cholesterol or heart disease. A pill a day for life is a better financial proposition than a medication people would take for just a week or two until they recover from an infection.
 
In fact, a study released in the May issue of the journal Clinical Infectious Diseases reports that only six of 506 drugs currently in development are antibiotics, even though doctors continue to sound the alarm about drug-resistant bacteria.
 
"That's a really small percentage, a pretty striking snapshot of the state of industry research into these sorts of diseases," said Brad Smith, an assistant professor at the University of Pittsburgh School of Medicine and a fellow at the university's Center for Biosecurity.
 
Drug companies also have to worry about lawsuits, a huge potential threat if, say, everyone in the United States ends up getting vaccinated against smallpox and something goes wrong. Then there's the matter of spending millions to develop drugs to treat diseases that may simply never emerge as a threat.
 
BioShield will indemnify manufacturers, meaning the government would be on the hook if something goes wrong, and would pay companies even if no one ever needs to take one of their new drugs, vaccines or antitoxins.
 
"The goal of BioShield is to demonstrate a good-faith gesture on the part of the government to say that ... you're not developing drugs for a nonexistent market," Fischer said. "This makes sense because pharmaceutical companies are in the business of making money, as well as producing tools and drugs to help human health."
 
But will the drug companies bite? The recovering economy is creating boom times for biotech firms, which may not need to look for capital in the capitol.
 
"I don't think politicians in this case were very savvy," said Winton Gibbons, a biotech analyst at William Blair, an investment firm in Chicago.
 
While companies had trouble raising cash for three years after the market crashes of 2000, the money train went back on track last fall, spawning 23 initial public offerings for biotech firms, he said. "Now is not the time for the government to say, 'We've got $6 billion, do you want it?' If I can get the money from investors to work on a program with a higher degree of success, why do I want government funding?"
 
Despite the call of Wall Street startup money, several companies are working on bioterrorism-related drugs, and the Senate's approval of BioShield boosted some of their stock prices earlier this month. Among other things, companies that may receive federal money are looking into drugs to treat anthrax, smallpox and radiation sickness.
 
It helps that scientists are well-acquainted with several of the potential biological threats, including smallpox, plague and anthrax. In another bit of luck, the germs that cause anthrax and plague happen to be fairly simple. "They're not nearly as difficult to analyze as a virus like HIV," Fischer said, meaning that vaccines and treatments may be easier to develop.
 
Even the scary Ebola virus could be vulnerable because exposure appears to provide immunity to survivors. "If people in real life can be exposed, survive and be protected, it will probably not be impossible or technically difficult to develop a countermeasure, especially a vaccine," Fischer said.
 
But even if drug companies develop plenty of effective treatments and vaccines, it's not the end of the story. "There are lots of other pieces to the puzzle," said Smith of the University of Pittsburgh. "Just having a drug in a stockpile does not mean you're prepared to deal with a rapidly emerging epidemic that could (be) starting in several different cities at once by a human being with malicious intent."
 
In other words, the best medicine can still fall victim to the worst human planning.
 


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