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Government Pushes Smallpox Drug Deal Despite Doubts About Need

Smallpox was eradicated worldwide by 1978. If a rogue regime ever acquired the virus and tried using it in a bioterrorism attack, Americans would be protected by the nation’s $1 billion stockpile of smallpox vaccine.

Even so, according to an investigative report in the Los Angeles Times, the Obama administration over the last year has aggressively pushed a $433 million deal to buy an experimental smallpox drug called ST-246. Its purpose would be to treat people diagnosed with smallpox too late to be helped by the vaccine, which can reliably prevent death only when given within four days of exposure.

It’s not certain ST-246 would actually work — for ethical reasons the anti-viral drug can’t be tested in humans.

Senior Health and Human Services officials, however, have taken unusual steps to secure the contract for New York-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, one of the world’s richest men and a longtime Democratic Party donor.

Those steps include replacing the government’s lead negotiator on the deal when the company complained that federal officials were resisting its financial demands. The cost per dose under the $433 million deal awarded in May is estimated at $255.

Some experts say spending large sums on the drug is a waste. “We’ve got a vaccine that I hope we never have to use — how much more do we need?” said Dr. Donald A. Henderson, the epidemiologist who led the global eradication of smallpox for the World Health Organization and later helped organize U.S. biodefense efforts under President George W. Bush. “The bottom line is, we’ve got a limited amount of money.”

While Health and Human Services officials have supported the drug deal, it could face a roadblock at the Food and Drug Administration. That agency’s stance is pivotal because the contract requires Siga to develop its drug “for ultimate approval by the FDA.”

The FDA has set a public meeting for next month to discuss ST-246 and a competing drug made by Chimerix. Yet since researchers are prohibited from infecting humans with the smallpox virus, the companies could face a tough battle in persuading the FDA their products are safe and effective.

STUART SILVERSTEIN