- The Washington Times - Monday, December 9, 2002

The recent revelations that Soviet-era scientists might have passed on a genetically modified strain of the smallpox virus to Iraq probably surprised everyone except the American researchers closest to our country's secret cookbooks. Scientists at the U.S. Army Medical Research Institute of Infectious Diseases, (many call it "you-Sam-rid") or simply the Rid, the country's principal biodefense lab, have been fretting for years that a super-hot strain of smallpox could easily burn through our vaccines. But few inside health-policy circles have been listening.
Its mission is to develop defenses against biological weapons. But the scientists at the Rid have been on the losing side of a debate gripping Washington about the best way to prepare for the possibility that smallpox might be used as a weapon.
Public-health officials are placing their faith in the efficacy of smallpox vaccines. Scientists at the Rid are worried that the vaccines might not work against designer strains of smallpox, and are searching for antiviral drugs that could target the virus' core machinery. If antiviral drugs disrupted a piece of the viral gears responsible for the bug's replication or survival, it should be harder to design strains that could outwit them.
But it's the public-health crowd that's advising Secretary of Health and Human Services Tommy Thompson, and it's their policy prescriptions that are prevailing. The result is that the development of promising antiviral drugs that could target smallpox is muddling along on a collection of piddling government grants. Nobody with access to the purse strings is taking these efforts seriously.
A souped-up strain of smallpox isn't hard to envision. Two years ago, a group of Australian researchers was looking for a way to exterminate rodents, and engineered a deadlier strain of mousepox, the close cousin of the smallpox virus that only attacks mice. They added a single gene, called the IL-4 gene, to natural mousepox virus. It produced a virus strain so deadly that it crashed through the defenses of mice that had been vaccinated to mousepox and killed them all. If such a strain was made for mice, many scientists theorize that it could be made for humans. It was a formula for a super-weapon, published in a medical journal for everyone to see, and even the Australians eventually regretted the implications of their work.
Naturally occurring strains of smallpox that are hotter than the ordinary virus called hemorrhagic smallpox or black death because they trigger massive bleeding could also break through people who've been vaccinated. If a country stockpiled smallpox as a weapon two decades ago, which strain do you think they chose to put into their fridge? The vanilla virus, or the one that packs a maximum punch? And, if people are evil enough to use smallpox as a weapon, surely they would be willing to tweak it to make it more deadly. The requisite technology, called recombinant science, is easy enough that undergraduate students work with it every day.
One promising antiviral is being developed by Chimerix, a San Diego startup. The drug is an oral formulation of the intravenous drug Cidofovir, and both are believed to be active against the smallpox virus. But Chimerix, like others in its situation, is limping along on a little private capital and crumbs of public grants, because private investors don't see a market potential for drugs aimed at mitigating bioterrorism and public officials don't see a need. Antivirals are hard to design, but the success with AIDS should serve as is evidence of what deliberate effort can generate.
Keep in mind: It's also impractical to administer the vaccine to patients with compromised immune systems, like those with AIDS or organ transplants. In most patients, the virus contained in the vaccine, called vaccinia, causes a harmless viral infection no more serious than a common cold. But people are left with a collection of protective antibodies that are also active against smallpox. In patients with depleted immune systems, vaccinia could rage out of control. For these people, antiviral drugs could be substituted in place of vaccination.
For everyone else, the terrorist threat is likely to linger longer than the protection afforded by their vaccines. As a result, we'll be revisiting these issues again and again. There's no reason the two tasks making vaccines widely available and vigorous research into new drugs can't be pursued simultaneously.
But the rift that prevents such efforts is amply chronicled in Richard Preston's new book, "The Demon in the Freezer," which should become required reading for policymakers. Public health officials are drawn from a culture that regards biological warfare as such a perversion of science that they find it simply unimaginable. They're too invested in the success of the vaccine and its role in their eradication efforts to see that the dream of eradication failed and a new threat has emerged.
The same cultural orientation prompted these officials to misinterpret the threat posed by the anthrax attacks last year. They missed the weapons-grade product they were dealing with, and its propensity to spread widely, and at least three postal workers died because nobody thought they could get sick. That track record extends beyond the individual people who called the shots a year ago, who are now all private citizens, and to an entire way of thinking that comes along with a masters in public health.
The cookbook for concocting a designer virus is a four-volume series titled "Current Protocols in Molecular Biology." I have a copy. You can too it's sold on Amazon. Recombinant viruses have tiny pieces of foreign DNA inserted into their genetic instruction set, and designing one is as simple as following a recipe-style protocol outlined in Volume Four, Section 16. So long as you have a stock of smallpox, any genes that you'd want to insert can be ordered through the mail.
This isn't what some public-health advisers have been telling President Bush. As a result, the hope of creating antiviral drugs is being given short shrift. Only the Army researchers seem to be taking these efforts seriously. It ought to tell us something that the scientists closest to the classified files see a broader threat.

Dr. Scott Gottlieb is a resident fellow at the American Enterprise Institute and author of the Gilder Biotech Report.

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