Cost, Need Questioned In $433-Million Smallpox Drug Deal

[+wolfgang]

http://discussions.latimes.com/20/lanews/la-na-smallpox-20111113/10

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.y David Willman, Los Angeles Times

November 13, 2011

Reporting from Washington— Over the last year, the Obama administration has aggressively pushed a $433-million 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 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.

 

When Siga complained that contracting specialists at the Department 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 its grip on the contract a year ago, the officials blocked other firms from competing.

 

Siga was awarded the final contract in May 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 price of approximately $255 per dose is well above what the government's specialists had earlier said was reasonable, according to internal documents and interviews.

 

Once feared for its grotesque pustules and 30% death rate, 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 and quickly treat people exposed to the virus. The vaccine, which costs the government $3 per dose, can reliably prevent death when given within four days of exposure.

 

Siga's drug, an antiviral pill called ST-246, would be used to treat people who were diagnosed with smallpox 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?” — Dr. Donald A. Henderson

 

"We've got a vaccine that I hope we never have to use — how much more do we need?" said 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 under President George W. Bush. "The bottom line is, we've got a limited amount of money."

 

Dr. Thomas M. Mack, an epidemiologist at USC's Keck School of Medicine, battled smallpox outbreaks in Pakistan and has advised the Food and Drug Administration on the virus. He called the plan to stockpile Siga's drug "a waste of time and a waste of money."

 

The Obama administration official who has overseen the buying of Siga's drug says she is trying to strengthen the nation's preparedness. Dr. Nicole Lurie, a presidential appointee who heads biodefense planning at Health and Human Services, cited a 2004 finding by the Bush administration that there was a "material threat" smallpox could be used as a biological weapon.

 

Smallpox is one of 12 pathogens for which such determinations have been made.

 

"I don't put probabilities around anything in terms of imminent or not," said Lurie, a physician whose experience in public health includes government service and work with the Rand Corp. "Because what I can tell you is, in the two-plus years I've been in this job, it's the unexpected that always happens."

 

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," Lurie assured him that the "most senior procurement official" would be taking over the negotiations.

 

"I trust this will be satisfactory to you," Lurie wrote Rose in a letter.

He is such an idot robbing and raping the folks,and yet our congress and senate sit on their asses.

 

 

It's the same with his new relization that Medeical Marijuana is all of the sudden so bad. He has the big pharmaceutical companies in his front pocket now and has effectively become one of 'them'.

Wheras when he knew and stated going into this presidency that Marijuana needed to be afforded a degree of respect regarding the States who have voted for it's use. He now disregards all of that in the name of the big profit companies who want to insure that they maintain their stranglehold on the illegal and legal drug market.

It is not a coincidence that the top 3 industry donors to Drug Free America are the Alcohol, Tobbacco and pharmaceutical industries.

We are all being taken on a long, stupid, and (hopefully for them) expensive ride. The ONLY person with your family's best financial or medical interest in mind is YOU. The GOP and the DEM's, law enforcement, pharmaceutical companies etc etc.. they all just want their piece of the pie and will sell you down the road to get it.