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can anyone medical [like Musukebba?] comment on this study please?

12 replies

pofacedandproud · 23/11/2009 11:48

Still struggling with whether to get Pandemrix [asthmatic] Can someone with medical insight look at these animal studies on squalene for me please?I find them worrying [for those with auto immune history] but would like your take on them...

here

here

Thankyou.

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pofacedandproud · 23/11/2009 13:08

bump

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Bodenbabe · 23/11/2009 13:55

I haven't had time to read it all - is it only a concern for those with auto immune history or should everyone be worried about it?

pofacedandproud · 23/11/2009 14:00

Well it says it caused arthritis in susceptible rats I think. I don't want to panic everyone as it is obvious most people are going to tolerate the jab well, squalene has been used in flu vaccines before, but I just wanted to get someone like Musukebba's interpretation of these studies.

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Bodenbabe · 23/11/2009 14:03

I will be watching this thread with interest - hope you get an answer!

pofacedandproud · 23/11/2009 14:07

Well yes if I don't get any response it won't be of any use! Can imagine printing it out and handing to my gp and getting the rolling eyes, 'oh no, not her again'

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pofacedandproud · 23/11/2009 14:08

There are some scientists around here often aren't there?

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pofacedandproud · 23/11/2009 16:43

bump

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Musukebba · 23/11/2009 17:15

Hi pofaced: sorry I just saw this but am at work and can't reply ATM. I'll try and get a chance tonight...

pofacedandproud · 23/11/2009 21:42

Thanks Musukebba sorry to bother you but it would be great if you get the chance to look.

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Musukebba · 24/11/2009 00:26

OK pofaced: having looked at both papers I interpret the following:

  1. These are studies of a specific animal model of rheumatoid arthritis, with the animals being genetically inbred to be prone to that disease. Injection of squalene intradermally appears to provoke an arthritis along the lines of their genetic susceptibility.
  2. The first paper shows that intradermal injection of squalene can cause a flare of arthritis in these susceptible rats, peaking at 21 days but subsiding thereafter. It is suggested that the immune response is CD4-mediated rather than via CD8 cells.
  3. The second paper attempts to track injected squalene to various body compartments using a radioactive labelling technique. The results suggest the injection of squalene has a direct effect on the immune system cells in the lymph nodes - rather than an accumulation in the joints themselves - and that the arthritic effects of activated immunity can be transferred to squalene-naive rats via the immune cells.

I guess you might be wondering whether this has a link with squalene adjuvant in humans...

First of all, these studies are in rats, and rats aren't always a great model for what happens in humans. For immunity and infectious diseases, mice are the more consistent model.

Secondly, if you look at how much squalene these rats are getting (200-300 uL per 0.5kg rat), it is huge: multiplied up to a 70kg human dose that's about 35mL per person. Since squalene is lighter than water and has a specific gravity of ~0.88, that makes about 28g per equivalent inoculation. Now, the MF59-based seasonal flu vaccine has 10 micrograms of squalene per dose: approx three million times less. That's very significant on a biological scale and probably why squalene adjuvants have not been shown to cause or aggravate chronic immunological conditions in humans.

Animal modes are a valuable first step in evaluating drugs and vaccines, but the best demonstration remains with the human trials. If ten years worth of MF59-based seasonal flu vaccines in Europe isn't enough of a demonstration, then the GSK trials of the AS03-based H5N1 vaccine specifically looked for neurological and chronic immunological developments for 6 months post-vaccination in about 10,000 people, versus non-adjuvanted seasonal vaccination in about 12,000 people. The autoimmune syndromes looked for were thyroiditis or Graves disease, polyarteritis nodosa, Sjogren?s syndrome, ocular myasthenia, uveitis, PMR / temporal arteritis... and there were 6 in the AS03 group and 5 in the non-AS03 group.

So basically the rats studies are interesting in their own right as studies of what might cause rheumatoid arthritis in rats, but for the above reasons I would discount their relevance to the human world; especially when there is a large amount of direct human comparative data available.

pofacedandproud · 24/11/2009 08:17

Thankyou so much for having a look Musukebba, and once again you have been extremely helpful. Very kind of you to look so late at night after work when you should be sleeping! It does make me feel more reassured about squalene as an adjuvant. And it is also reassuring that you confirmed it was a temporary flare of arthritis which then receded - did the second study find this too?

One of my concerns is that my father started developing myasthenia gravis over the two weeks following a seasonal flu jab last year [I don't know if he was given one containing squalene or not] and ended up on a ventilator for two months. Of course it is hard to know if the flu jab was co incidental but he'd never had anything like that before. And also most people tolerate seasonal flu jab without any problems and as my family seems to have a genetic susceptibility to auto immune illness I do wonder if we are higher risk for reactions. Hard to know of course.

I wonder why they looked at rats not mice though if mice are a more useful indicator of what happens in humans. But thankyou so much for your insight on the studies.

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centrifugalFork · 24/11/2009 09:37

Good post musukebba - thanks from me too. I didn't post asking but was following the thread - was esp. wondering about the 200-300uL and how that would compare to what was in a jab,didn't know how to find out.

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