-Submitted by David Drumm (Nal), Guest Blogger
In 2004 President Bush signed the Project Bioshield Act that authorized $5.6 billion over ten years for “the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror.” The potential use of anthrax as a bioterror weapon is well documented, but smallpox has been eliminated and exists only in ultra-secure labs in Russia and the U.S.
The idea that terrorists are going to break into one of these labs and steal the smallpox virus is absurd. The best defense against this absurd idea is to destroy the remaining stockpiles. However, U.S. Health and Human Services Secretary Kathleen Sibelius said the U.S. and Russian stockpiles would remain in place for at least another five years. There is a reasonable explanation for the U.S. to keep smallpox virus around: to develop a smallpox vaccine against the possibility that Russia weaponizes its stockpile.
Smallpox is caused by the variola virus. According to the FDA, “During the smallpox era, the only known reservoir for the virus was humans; no known animal or insect reservoirs or vectors existed.” That is, any potential threat has to come from the virus in the stockpiles. According to the CDC, “the last naturally occurring case in the world was in Somalia in 1977.”
In 2007, the Bush administration issued a $505 million contract to a Danish company, Bavarian Nordic, to provide twenty million doses of smallpox vaccine for those whose immune system has been compromised. Vaccination is effective within three days of exposure and will remain effective for three to five years with decreasing effectiveness thereafter.
The Obama administration has been pushing a $433 million “sole source” contract to New York based SIGA Technologies Inc who bought the rights to an antiviral drug, ST-246. After complaints from SIGA that negotiations weren’t going to their satisfaction, senior HHS officials replaced the government’s lead contract negotiator, and SIGA was awarded the deal in May. The contract calls for the delivery of 1.7 million doses of the drug to the nation’s biodefense stockpile. The price per dose is $255, yielding a profit of 180%, well above what government specialists consider reasonable.
SIGA’s controlling shareholder is billionaire Ronald O. Perelman. Perelman has made political contributions totaling $620,870, with 40% going to Democrats, 14% going to Republicans, and the balance of 46% going to special interest groups. Perelman donated an additional $50,000 to President Obama’s inauguration.
The effectiveness of this drug on humans is unknown and, for ethical reasons, cannot be tested by exposing humans to the smallpox virus. Dr. Thomas M. Mack, an epidemiologist at USC’s Keck School of Medicine, has called the plan to stockpile SIGA’s drug “a waste of time and a waste of money.”
In addition to the dubious requirement of an untested, short shelf-life, smallpox drug, there’s the problem of getting approval from the FDA. Robert G. Kosko Jr., a manager in the FDA’s antiviral-products division, wrote that there was “no clear regulatory path” for approving antiviral drugs for smallpox — again because of the uncertainty surrounding evidence of effectiveness.
The Animal Efficacy Rule was adopted by the FDA in 2002 to address the problem of testing drugs on humans, when exposing humans to the disease presents ethical problems. However, guidance from the FDA, dated November 2007, on animal models for smallpox states:
Currently, available data do not establish specific preferred, well-characterized animal models for smallpox, and no animal models have been shown to replicate or to predict human responses to therapy for smallpox.
An FDA antiviral drug advisory committee will meet on December 14-15, 2011, to discuss “pathways for the development of drugs intended to treat variola virus infection (smallpox) in the event of an outbreak, including the use of animal models of other orthopoxviruses (the group of viruses that includes smallpox) as potential evidence of efficacy.”
The contract with requires SIGA to develop its drug “for ultimate approval by the FDA.” FDA approval will help determine whether the government exercises its options to buy more of the drug in the future, turning a $433 million contract into a $2.8 billion windfall.
From a SIGA webpage: “The FDA has designated ST-246 for “fast-track” status, creating a path for expedited FDA review and anticipated regulatory approval.” What would justify the anticipation of said FDA approval when the use of animal models has yet to be decided?
While ST-246 may be an effective antiviral drug against orthopoxviruses, the way this contract was negotiated stinks to high heaven.
H/T: David Willman (LA Times), CDC, FDA.
121 thoughts on “Smallpox And SIGA”
This smallpox stuff is a tempest in a teapot. I have a friend, a biochemist, who formerly worked for a government agency on top secret stuff. He cannot talk about it, obviously, but his knowledge of chemical and biological warfare is encyclopedic. He thinks the Siga thing smells like dead mackerel left out in the sun too long.
As for smallpox, there are much more dangerous vectors out there. There are strains of flu that are more dangerous and far more contagious. This is nothing more than home cookin’, and as Gene says, the hue and cry is all about a bit of political chicanery and not about true science. All the gnashing of teeth and hyperbole by investors who are going to lose their socks over this thing, notwithstanding.
LMFAO. Ignorance is bliss here. You continue to ignore Siga has the only antiviral for (small) pox viruses. If you ever get smallpox or genitically engineered form of it, you all should be last in line to ever receive the cure. Survival of the fittest. Obviously, folks here are not very fit (smart) Have a nice day, Dorks.
Or maybe all us smart people simply don’t like bribery even when it’s called campaign contributions.
But please wave the anti-terrorism flag some more.
That schtick never gets old, especially when it’s used to justify actions that ostensibly appear to be criminal.
You can try to make the issue here about the effectiveness of the medication, but in the end and from the beginning, the one and only issue was the apparent pay-to-play behavior of Siga in procuring a no-bid contract. See, to many of us smart people, the rule of law actually means something. Something that is more important than profits or the survival of a corporation engaging in corruption in the name of profits.
You’re free to bleat about how great Siga is all you want, cantthinkofanythingbutmoney.
We’re free to keep saying that your rationalizations are weak bullshit apologetics for corporatist corruption.
Oh…and did you happen to notice there are EIGHT SIGNATURES on the justification document? Maybe you all ate too many “potatoes” and fell asleep before the end of the document. LMFAO
Well, you “smart folks” failed to understand that Siga has the ONLY ANTIVIRAL CURE for pox viruses. Chimerix, the one and only contender has a product that doesn’t work. Monkey’s infected with the pox virus and given their drug, DIED. There are no other drugs out there. You must have also missed the part that national security is the goal here. Security from terrorism. Does that makes sense to you, or are you too dense to understand that? Issa made a big stink about a congressional investigation back in June. Guess what? Not a peep from his camp since. Do you know why? Why don’t you call his office and ask, Dummies.
It is also my experience that no-bid RFP requirents are tailored for the desired contractor. Sometimes the contractor has input into creating the RFP. Back when I worked in contracts those pushing a particular one were always obliquely hinting at benefits for rendering favorable results. All I saw was the attempt to leave me as a fall guy for whatever legal actions would subsequently ensue. I refuse to be anyone’s patsy, or compromise my integrity.
Mike, the doppelganger of no-bid contracts are those written specifically so that only a single entity will qualify. Those often slip under the radar because they are not as obvious. I have seen a number of municipal contracts thrown to a single company through clever use of “requirements” that only one contractor can meet.
The deal is this. I don’t care about the effectiveness of Siga’s drug. I don’t see the threat of Smallpox as so emergent that it requires a no-bid contract.
You and the others who have posted here appear to have a vested interest and so think 180% is reasonable. Why should I care about your investment follies? I have been a Director of Contracts for a municipal government. I ever saw a no-bid contract that wasn’t a political payoff. I refused to negotiate them because I would not take part in possibly illegal activity.
You can broken record all you want. The contract was a political job, not based on any facts that I can discern. There is no such thing as a no-bid contract that can truly pass the smell test. There is nothing else to discuss.
I know how no-bids work–I have seen them up close and personal and they are ugly. Really ugly. It is easy to write an RFP for a no-bid. Home cookin’ at its best.
Anything else is just some of that famous barnyard product.
I’m still waiting for a response from somebody who has read my link. Hmmm. Oh, I see, you have read it and have no rebuttal. My bad.
Shall we talk about “potatoes”, Dan? Hilarious!
Again, I’m waiting for some logical debate from the “lawyers and scientists” here after giving you all a layup of information that supports the contract and protecting American citizens from biological attack.
Crickets, nothing but crickets from the alleged intelligent ones here. Quite funny, actually. Maybe you are struggling to read through the big words.
Gene, you forgot to mention the spelling. “postes” Heh!
Only thing is, we should not make fun of the handicapped.
“I’m sure my postes will be deleted by the “Cut-and-Paster of The LA Times Host here.”
Probably not. You haven’t threatened anyone with violence nor have you tried to assume the identity of other posters falsely. In truth, we like the ignorant and those who would rationalize crime in the name of profits around here. They give a good negative example from which to teach.
Are those mashed spuds?!
“I will stop wasting my time on this worthless blog.” (email@example.com)
Please pass the potatoes.
Hopefully Rakoff’s ruling will make their (Schneiderman and Biden) jobs a little easier.
Hey cantthinklottanumbers, you forgot something. When randomly scattering insults in lieu of rationality, you forgot to go Godwin. I suppose that is next. Your lack of culture and good manners, not to mention lack of training in logic is showing when you come onto a blog to argue contracts with well trained lawyers and scientists. Heh!
I will stop wasting my time on this worthless blog.
I’m sure my postes will be deleted by the “Cut-and-Paster of The LA Times Host here.
do you see the little link you can click on there that says
” Justification for other than full and open competition ”
try reading it. You might garner some understanding and stop spouting ignorance
Hey Otterey Ignorant One-
Did you read the justification for the RFP?
Is there anybody with intelligence here arguing your points. Hilarious!
WTF???? That is a link to the government notice of a no-bid RFP. I have seen hundreds of those over the years and time does not make the stink go away.
One of the other ways contractors can jack up the price is every time a change order is made. That is the Great Unspoken Secret the general public does not know about and never makes the news. When I worked for a missile contractor, management absolutely loved change orders. It was relatively easy to double the original bid amount through change order pricing, which is effectively a no bid process because the contractor will charge whatever the traffic will bear and the government is not going to get out of paying it.
When a pig squeals, you can bet that something is poking it. We have been hearing a lot of squealing the past few days.
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