Wednesday, May 16, 2012

Obama's Smallpox Vaccine Shenanigans

Smallpox: terrorism's future weapon?
I've been doing a lot of reading lately about that most perfect terrorist weapon of mass destruction, Smallpox, and was disappointed to run across the following story.  By David Willman, Los Angeles Times:  "Cost, Need Questioned in $433 Million Smallpox Drug Deal: A company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist. Over the last year, the Obama administration has aggressively pushed a plan to buy an experimental smallpox drug, despite uncertainty over whether it is needed or will work. Senior officials have taken unusual steps to secure the contract for NY-based Siga Technologies Inc., whose controlling shareholder is billionaire Ronald O. Perelman, a longtime Democratic Party donor. When Siga complained that contracting specialists at the Dept of Health and Human Services were resisting the company's financial demands, senior officials replaced the government's lead negotiator for the deal, interviews and documents show. When Siga was in danger of losing the contract, the officials blocked other firms from competing. Siga was awarded the final contract in May 2011 through a "sole-source" procurement in which it was the only company asked to submit a proposal. The contract calls for Siga to deliver 1.7 million doses of the drug for the nation's biodefense stockpile. The $255 per dose is well above what the government's specialists had earlier said was reasonable, according to documents and interviews. Smallpox was eradicated worldwide as of 1978 and is known to exist only in the locked freezers of a Russian scientific institute and the U.S. government. There is no credible evidence that any other country or a terrorist group possesses smallpox. If there were an attack, the government could draw on $1 billion worth of smallpox vaccine it already owns to inoculate the entire U.S. population. The vaccine, at $3 per dose, can reliably prevent death when given within 4 days of exposure. Siga's drug, called ST-246, would be used to treat people who were diagnosed too late for the vaccine to help. Yet the new drug cannot be tested for effectiveness in people because of ethical constraints - and no one knows whether animal testing could prove it would work in humans. The government's pursuit of Siga's product raises the question: Should the U.S. buy an unproven drug for such a nebulous threat? "We’ve got a vaccine that I hope we never have to use, how much more do we need?” asks Dr. Donald A. "D.A." Henderson, the epidemiologist who led the global eradication of smallpox for the World Health Organization and later helped organize U.S. biodefense efforts. Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the FDA. He called the plan to stockpile Siga's drug "a waste of time and money." Negotiations over the price of the drug and Siga's profit margin were contentious. In an internal memo in March, Dr. Richard J. Hatchett, chief medical officer for HHS' biodefense preparedness unit, said Siga's projected profit at that point was 180%, which he called "outrageous." In an email earlier the same day, a department colleague told Hatchett that no government contracting officer "would sign a 3 digit profit percentage." In April, after Siga's chief executive, Dr. Eric A. Rose, complained in writing about the department's "approach to profit," he was assured that the "most senior procurement official" would be taking over the negotiations."  Hmmm ...