-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.
Links can be posted as long as it is limited to two (2) links per comment. Otherwise it will be sent to moderation limbo.
Even if all Ken C. said is true, which I’ll reserve judgment on, it does not justify a 180% profit. This is exactly why most no-bid contracts are suspect. With no competition pricing tends to be monopolistic. Secondly, the 0.01% mortality rate doesn’t make the known effectiveness of the vaccine a poor alternative as a bargaining chip to lower Siva charges. The tipoff that the fix might be in is the change of contract manager.
Okay, here goes. I know WordPress doesn’t like one to post links, so I’m going to take the three w’s and the ht tp off the front.
These are links about Chimerix using MLA as lobbyists, and the contributions that were given to Darell Issa.
> In 2009, McKenna, Long, and Aldridge, spent $50,000 in lobbying contributions ON BEHALF OF CHIMERIX (Source: soprweb.senate.gov/index.cfm?event=getFilingDetails&filingID=8C3FF98C-4B9A-4ED9-BA62-5DF41BA74372 )
>
> In fact, over the past 10 years, McKenna, Long, & Aldridge has spent $950,000 on campaign contributions on Chimerix’s behalf. (Source: influenceexplorer.com/organization/mckenna-long-aldridge/c657cbc101734306b51786eec0e12e1d?cycle=-1 )
>
> Here’s the kicker: Congressman Darrell Issa himself has accepted multiple campaign contributions from McKenna, Long, and Aldridge.
>
> In 2008, McKenna, Long, and Aldridge gave Darrell Issa $3,500. (Source: opensecrets.org/politicians/contrib.php?cycle=2008&type=I&cid=N00007017&newMem=N&recs=100 ).
>
> In 2006, MLA gave him $2,500.
>
> As a matter of fact, at the source cited below this paragraph, you can find that Congressman Darrell Issa of California has accepted at least 11 contributions from McKenna, Long and Aldridge, every year from 2005 to 2010. And I think this is just the tip of the iceberg.
>
> maplight.org/us-congress/contributions?s=1&politician=300&office_party=Senate%2CHouse%2CDemocrat%2CRepublican%2CIndependent&election=2002%2C2004%2C2006%2C2008%2C2010&string=McKenna%20Long%20%26%20Aldridge&business_sector=any&business_industry=any&source=All
In terms of st-246’s 100% efficacy vs. poxviruses, I’m just going to give you a link to a primate study: aac.asm.org/content/53/5/1817.abstract?cited-by=yes&legid=aac;53/5/1817 and to these studies (100% survival rate if given within a week after infection): aac.asm.org/content/53/12/4999.full.pdf
and this one:ncbi.nlm.nih.gov/pmc/articles/PMC3185582/
“Treatment can be initiated as late as 72 hours post-infection for full protection. In one experiment in prairie dogs infected with monkeypox virus, treatment initiated 10 days post-infection resulted in 100% protection from death.”
And here’s a financial blog that states the 100% efficacy clearly, if you don’t like scientific reports.
/jimleff.blogspot.com/2010/05/another-siga-update.html .
If you want to see more, go to the Press Releases portion of Siga.com and see the press releases after each successsful
In terms of st-246’s perfect safety record (“no serious adverse events”), here’s a press release after the Fourth human safety trial: /siga.com/?ID=146 .
Re the number of people who get side effects: I was in truth thinking of those for whom vaccination won’t work, and not just those who get side effects. Anyone who is HIV-positive, or immunocompromised, for example, as well as several other conditions, is told not to get smallpx vaccinations on this New York City Dept of Health site: nyc.gov/html/doh/downloads/pdf/bt/pox11.pdf
In fact, it reads like this — including a group that is I believe is considerably MORE than 4% of the population:
“Anyone who has ANY of the following health conditions, or lives with or has close intimate contact with someone with ANY of these conditions, should NOT get vaccinated unless there is a smallpox outbreak:
Weakened immune systems – including persons with HIV infection or AIDS, cancer, leukemia, lymphoma, organ transplants, autoimmune diseases (like lupus), or problems producing antibodies (for example, the disease agammaglobulinemia {lack of normal antibodies}) or persons being treated with chemotherapy, radiation therapy, high dose steroids (such as oral prednisone for more than 2 weeks) or other medicines that weaken the immune system…. [And] A history of EVER having the skin diseases called ‘eczema or atopic dermatitis'”
Now you won’t find Chimerix’s disastrous primate test anywhere on the web, because they took it off their web site when they applied for the contract — and the RFP for the contract specifically said that efficacy against monkeypox was necessary to be awarded the contract. But what I say is true.
Someone above said that they smelled a PR person. I WISH that Siga would defend itself against Chimerix’s onslaught with a wave of PR that is just half of what Chimerix’s wicked version is. No, I’m just a person who has lost all of my savings as a result of the attack on Siga over the past several years. I have been deeply involved because I put all my savings in the stock, and I did that because it does have the CURE for smallpox, and no one else does. For some reason I thought that would be enough for them to get the government contract immediately — any sane person looking at the facts would give Siga the contract rather than Chimerix. But I was foolish enough not to realize the depths to which Chimerix would sink.
Again, one thing that will be important to any of you reading this blog is that Siga and st-246 were the darlings of BARDA (the government agency that is responsible for bioterror countermeasures) in the Bush days as well. In other words, it is not a case of Democrat vs. Republican here. It’s a case of one company against another.
But don’t take my word for it. Read up on it. Try to find a single bad test result for st-246. You won’t find it. The contract was awarded on the merits, and the share price is down from $15 to under $2. So you tell me who is the bad guy in this scenario.
You could be right OS.
Gene,
180% profit sounds so small when compared to defense contracts!
Especially in defense of something as ludicrous as a 180% profit.
If so, it would not be the first time……nor the last.
raff, do you suppose we have a PR guy posting here? Hmmmmmm….
The plot thickens!
Ken Chowder:
Willman, in the linked article, mentions Chimerix five times.
Ken Chowder:
According to the CDC (the link in my post):
In the past, about 1,000 people for every 1 million people vaccinated for the first time experienced reactions that, while not life-threatening, were serious.
That’s 0.1%, not 4%.
Which I mentioned in my post and provided a link.
Ken Chowder makes some claims that come awfully close to CT. I want to see some credible links–especially on the 100% efficacy claim. If it cannot be tested via any ethical scenario I can envision, how do they know?
And Ken, keep in mind that several of us here are not lawyers, but scientists. We know how to read and interpret scientific papers. I want to see some links. Keep in mind that blogs and and promotional literature papers are not credible sourcing.
Blouise,
thanks for asking for the links. You took the words out of my mouth.
Ken Chowder,
Keep in mind if you provide the links that if there are more than two, to break them up into two links per post … it’s a wordpress thing
Ken Chowder,
I read your comments. Would you please provide the links to which you refer.
WTF? There are only 2 reasons I can think of for this. One is political pay off but what a sloppy way to go. The other is if the government thought there was a chance of a smallpox outbreak. Certainly while the Soviet Union was falling apart there was some chance that money could have liberated some virus from there. But now it seems they have better control so the only other source would be the US.
Can you imagine a war-gaming scenario where we had to take down a very large, over crowded nation without invading? The CIA believed the old Soviet Union had a ‘dooms day’ machine that if it was not checked in with regularly would explode all of their nuclear weapons. Small pox could work that way today and be even ‘better’ if one side had the cure.
Frankly, did you read my comment? THe US and the Soviet Union are not the only sources of smallpox bioterror. A graduate-level biologist with access to any pox disease (there are MANY of them) could make variola.
The doomsday machine you refer to is from a film, Dr. Strangelove.
There were many serious errors in David Willman’s two articles on Siga’s federal contract for a smallpox antiviral. And your own piece above not only keeps those errors alive, but makes a few more.
First, to refute what you’ve said — indicating that you think the smallpox virus cannot by used by bioterror organizations. It is known that Syria has a Camelpox program. Genetically, Camelpox is only 5-6 pairs removed from the Variola (Smallpox) virus. It is not a difficult alteration for a scientist to make. A graduate level student in molecular biology could reproduce smallpox in a properly equipped lab in just a few WEEKS. So the idea that Variola is locked away in a dungeon forever is very wrong. Not only that, but an article in the New Yorker detailed the fact that a lot of the Russian virus supply went missing. No one knows, even now, where it went, or who has it.
Years before the Obama administration came to Washington, smallpox was placed near the top of the DHS priority list for desired countermeasures. Why would they do that, if there was no possibility that smallpox could be used as a bioterror weapon?
There are reasons why vaccines are NOT as useful as an antiviral, which is what Siga’s drug is. First, the regular variola virus can be genetically altered, which would render all of our vaccines useless, while Siga’s drug st-246 works against ALL POXVIRUSES. Second, an approximate 4% of the population experiences serious side effects (such as death) to the vaccine (while st-246 has a 100% safety record in human clinical trials). Thirdly, the vaccine only works if a person gets it before exposure or within four days after exposure. But Smallpox does not even show its symptoms for much longer than that. A few human “bombs” with smallpox could infect thousands, who could infect tens of thousands more, before anyone even knew what was going on. Yet Siga’s antiviral could still save them all.
Yes, save them all. It is a cure, not a vaccine. Willman’s article, which you took at face value, claims that, “because of ethical restraints that prohibit infecting human volunteers against smallpox, no one knows whether the new drug would work in patients.” You don’t know, but Willman must surely know, that Siga’s st-246 has proven effective in four cases involving human patients, including an immuno-compromised two year old child in Chicago. A fair article would mention that.
In fact, Siga’s drug st-246 has a 100% EFFICACY RECORD in trials against many different kinds of animals, including primates. (It also has a 100% safety record in human tests, which no vaccine has!)
A expert in Willman’s article suggests that we have enough vaccines stockpiled, and Willman implies that this means we shouldn’t stockpile ANY antivirals. But that is not what the expert SAID: he said we have enough vaccines, and that does NOT mean that we have enough antivirals.
Now here’s the unholy part of Willman’s article, which you know nothing about — because he doesn’t mention it.
Willman describes SIGA shareholder Ron Perelman’s contributions to the Democratic Party, yet he does not mention that Perelman also gave $200,000 to Republican causes. In other words, this is NOT an Obama vs. the Republicans issue.
More importantly, Willman mentions nothing about SIGA’s competitors, Chimerix — the only other company that would like to sell their smallpox antivirus to the government. He certainly doesn’t mention Chimerix’s contributions. Why not? Because The law firm McKenna, Long, and Aldrige (MLA) is the lobbying arm of Chimerix; they’ve been given $950,000 to lobby for Chimerix, and made multiple contributions (I believe it is teh such contributions; I can provide the links) to Rep. Darrell Issa. Issa also appeared at the featured speaker at an MLA brunch-conference a few weeks ago. It was Darell Issa who first publicized the story of Perelman’s contributions, and Willman probably got the letter written by CEO Eric Rose (to HHS) either from Issa or from MLA, since Issa asked HHS to provide him with all its correspondence around the contract.
I have reason to believe that the source of Willman’s information was MLA and Chimerix; that in fact he met Chimerix CEO Ken Mock and John Clerici in MLA’s offices. To get information from a corporate competitor and not mention that company’s attempts to put a roadblock on the entire process of the antiviral acquisition by ANY MEANS possible is unethically telling only part of the story.
For this Willman article is not the beginning of Chimerix’s attempt to derail the Siga contract. By my count, Chimerix made approximately 8 protests to BARDA over quite-unrelated aspects of the process and the award — protests that enabled Chimerix to stall the contract award by over two years. They protested at every stage possible, on every grounds. Three times, in comparing Chimerix’s product CMX-001 to Siga’s st-246, the government picked Siga’s product (you’ll see why in a minute); each time Chimerix blocked the decision with an unrelated protest.
The final no-bid contract which Siga won ONLY CAME ABOUT as a result of the delay caused by the many legal challenges by Chimerix to the earlier forms of RFPs, all of which resulted in BARDA giving SIGA the contract on the merits of their product. But Willman doesn’t mention the earlier attempts by BARDA to do different forms of RFPs — implying that BARDA just decided one day to give SIGA the contract. No, it was only after Chimerix protested every earlier attempt.
Perhaps Willman doesn’t know the entire history of Chimerix’s attempts to thwart BARDA’s acquisition. But he must surely know that it is Chimerix’s product, CMX-001, that has had exactly one test on primates given a poxvirus (monkeypox). All the monkeys died. Not one. All. All the monkeys DIED.
St-246, in contrast, has had 100% effectiveness in all animal tests on all poxviruses; it has had a 100% safety record in all human safety tests (the most serious side effect was a single person with a headache). And it has been 100% effective in its four human cases against poxviruses. An award to CHIMERIX would be a miscarriage of justice; a contract to SIGA is just plain not.
This is clearly part of the story: the SIGA product has demonstrated an efficacy that the ONLY competitor has not. Vaccines are not competitors, and they are not relevant.
Not only that, but the timing of the rising short position in Siga’s stock has been, how would you say, uncanny. Note the increased short position (and drop in share price) before Willman’s most recent article, for example. This is anecdotal, but someone at Chimerix or MLA is either shorting Siga or telling someone else to do so.
This is a long and unholy story, and unfortunately the LA TIMES shenanigans are part of that story. You should write about the untold second half of the story. Willman mentions Chimerix nowhere. Yet he and you are telling their side of the story only.
Unlike Willman, I’m telling the whole truth, and nothng but the truth. This includes the fact that I own Siga stock. I bought it because they’ve made a 100% cure to a dangerous bioterror weapon, and I believe in it.
Liars, crooks, and thieves.
This leaves me scratching my head. We have smallpox vaccine technology available, and I have the scar on my upper arm to prove it.
On top of the obvious, we can expect the conspiracy theorists to come out of the woodwork in full battle cry if the need ever did arise for vaccination.
Having for awhile been the Director of Contracts for a large NYC agency, I know first hand that no-bid contracts are usually shady and represent political pressure. The original contract manager did the right thing but probably hurt his career in the process.
Where the hell do I sign p for one of these contracts…..