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FLU Vaccine & Squalene

 
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Trebor
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PostPosted: Thu Nov 25, 2004 12:31 am    Post subject: FLU Vaccine & Squalene Reply with quote

I hear alot of talk out there about how our flu vaccine shortage is linked to squalene being in the batches. I read bacteria was the cause. Does anyone have the intel on where this is coming from...Reuter's? BBC? UPI?

On CSPAN last week: Testifying before the Government Reform Committee, FDA commissioner Lester M. Crawford responded "very briefly" to a congressman's pressing question about "another" flu vaccine that's in plentiful supply right now in Europe. You could see the pause...he said something to the tune of "yes, that vaccine is only for persons 65 and over...that needs to go through the IND process first before it can be used." [paraphrased as close as I remember]. The word "FLUAD" wasn't mentioned, but you could only guess that's what he meant--MF59--the "two-fer" adjuvant. Strange thing is you can only find their initial "scripted" testimony each one was allowed to give in the first minutes. Not the hard pressed Q&A. This is all you'll find on the committee's website (www.house.gov). When I go to the C-SPAN video search they have every other 5 hr committee testimonial session--Full length--except for the one on the FLU Shortage hearing, which is conveniently truncated to only include Waxman's grilling. Nowhere can you find the full Q&A session. If I find it (which I won't), I'll post Crawford's verbatim quote regarding the "65 and over" vaccine. Maybe someone knows of where the "entire" transcript is? -Trebor
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Trebor
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PostPosted: Thu Nov 25, 2004 1:03 am    Post subject: CSPAN's "Truncated" Video Reply with quote

It starts getting interesting at 48:30 and suddenly is cut off at 1:09:00. What you don't hear is the Q&A about the "other" vaccine.
http://www.cspan.org/search/basic.asp?ResultStart=1&ResultCount=10&BasicQueryText=Flu+Vaccine+Shortage

The Reform Committee's site also doesn't list the Q&A transcript about the "65 and over" flu vaccine grilled out of the FDA commissioner.
http://reform.house.gov/GovReform/Hearings/EventSingle.aspx?EventID=1468
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Trebor
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PostPosted: Fri Dec 03, 2004 6:37 am    Post subject: AVIP's MF59/FLUAD References Reply with quote

Very Happy It's quite interesting when you scroll down to the bottom of AVIP's "Facts on Squalene" link http://www.anthrax.mil/resource/qna/qaAll.asp?cID=109. At the very very very bottom of the page are 8 references under the title "Related to Influenza and Other Vaccines with MF59 Adjuvant (which contains squalene as one component of the adjuvant)".

Here we see AVIP's last ditch effort to justify squalene's presence (just in case) it's in AVA. Here we also see the Merck/Vioxx problem. Upon looking at all 8 of these references AVIP gives in PubMed, you'll find vividly 4 of the 8 were done by CHIRON Employees themselves. If you dig a little deeper, you'll find 2 more in addition to the four under a scientist named "Podda A". Podda apparently is an employee of Chiron also so that makes AVIP's MF59 references appear even less objective--6 out of their 8 references on MF59 being safely used are RIFE with Chiron employees. Now we can't summarily dismiss this as not good research--we can't be cynics assuming the worst can we? Not always--but this does "beg the question". You see the problem really get's exposed when many of these DoD references are shredded to pieces with Gary's research on pages 210-214. Here you'll see problems with the age groups, the duration of the studies and the "definition" these studies use as an "adverse" reaction--it's ludicrous how they went about these tests! DoD is a master of misinformation--we have people who do this everyday where I work--Misinformation is good when it's for the enemy--bad when it's for a self-licking ice cream cone. It may taste good for itself, but it's disgusting when others see it.

So you could say AVIP is putting up some snow here for the folks who have better things to do than dig up every little detail of every reference. That's probably why they put these 8 references at the bottom of their webpage. It's a psychological thing AVIP's saying: "If you're not really convinced [now that the bottom of the page], then we'll resort to justifying that squalene is safe anyway with these 8 references." The problem is they're off point. Nonetheless, the mere fact that AVIP/Grabenstein uses these 8 references shows they're really not trying hard to convince investigators such as Gary that MF59/FLUAD is safe--Who they're really trying to convince is folks like us (us military out there). And why the heck is AVIP/Grabenstein even remotely interested in saying MF59 is ok? That it's been used in the FLUAD vaccine?

I know I personally wouldn't go to such lengths. Would you? MF59 is off point. Let's think about this. If you knew "good and well" that squalene was artificially brought into the 1999 FDA tests by fingerprints, why try to say it's safe when it's injected (by means of references to the 8 FLUAD/MF59 studies)? It would be moot. If you were AVIP wouldn't you "pursue" the fingerprint theory--and pursue it hard? Wouldn't you substantiate your fingerprint assertion with facts, details, processes, and description. Wouldn't you devote a whole webpage on this idea instead of a single line or two here and there? Wouldn't you want to dig up some historical references that show the same event happened before [show where scientists have found squalene in "trace" amounts" before, like a lawyer uses caselaw)? This isn't done by AVIP. Fingerprints: it's their soundbite. It's one sentence that Grabenstein uses to ward off the Denver Post saying, "We don't believe there was squalene in the lots; we believe the tester left a little bit of his own fingerprints behind http://www.denverpost.com/Stories/0,1413,36%257E53%257E2535720,00.html." So goes AVIP's "many shallow propositions". They're easy to do. They're weak. They're down AND the're looking for a sucker. We all know this as damage control. Cover all paths, be vague, very broad and seem very knowledgeable--For you military guys and gals don't fall for it.

So the adage still holds true: "The devil's in the details". . . for AVIP's case that is. Don't let AVIP tempt you to think otherwise Wink
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Gary M - Author
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PostPosted: Fri Dec 03, 2004 2:18 pm    Post subject: Reply to Trebor, RE: AVIP's MF59/FLUAD References Reply with quote

Dear Trebor: I have refuted at length, in another message string, the Defense Department's new assertion that the squalene in anthrax vaccine comes from someone's fingerprints. I won't reiterate the forensic chemistry reasons why this is a ludicrous proposition, but I think it bears repeating here that I interviewed the FDA scientist who analyzed the anthrax vaccine in response to my 1999 article in Vanity Fair, and he says he wore gloves. Even if he hadn't worn gloves, in what would have been a gross exception to common laboratory practice. This should not have happened at BioPort either. Even if BioPort's clean room workers handled equipment without gloves, thus violating GMP restrictions and BioPort's license to make vaccine, any greasy schmears of protective sebum from the skin's sebaceous glands, (an oil coating on skin which contains squalene in addition to a dozen other lipids) those schmears would have been on the outside of the tubes.

Have you ever seen a dose of anthrax vaccine up close? There's no way an adult finger, or even a child's finger, would fit inside the sealed vial that contains the vaccine. The same is true for the glassware used in GC/mass spec analysis. You can't stick your finger in it. The opening is too small.

DOD offers zero scientific data to support is assertion that fingerprints could contaminate anthrax vaccine with squalene. If the bacteria-laden, lipid-scheared fingers of BioPort workers truly have been coming into contact with anthrax vaccine, which for reasons I explained elsewhere would still not cause squalene contamination of the vaccine, then the FDA would have grounds to close the BioPort facility immediately.

Finally, Fluad's use in Europe is hardly proof of squalene's safety. Vioxx got licensed in America. That didn't mean it was safe to use in Europe, let alone here. So on those grounds alone, I would argue that Italy's licensure of Fluad, doesn't mean it's safe to use here.

Sincerely,
Gary Matsumoto
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