I'm Angry (or, The Shortest Version on What's Wrong with some Swine Flu Vaccines)

Canada, has ordered 50 million doses of vaccine

from GSK, with AS03 adjuvant.  The vaccine is supplied in 2 vials, one for vaccine, one for adjuvant, to be mixed just before use.  The vaccine is at 3.8ug per 0.25ml.  

There are 33 million Canadians.  Not everyone will want a vaccine.  If they just take the vaccines from GSK, throw away the adjuvant vial, and vaccinate people with 1ml of unadjuvanted vaccine at 15ug, they still can vaccinate 12.5 million people.

Ditto for the UK.  In fact, I made the suggestion in the summer, to the UK government, through a trusted source.

You think they'd listen?  Heck no!!  At least Canada has ordered some unadjuvanted vaccine for pregnant women, but NOT in the UK.

How do they sleep nights???



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 00:40:00 AM UTC

they could AT LEAST have done that

If they just take the vaccines from GSK, throw away the adjuvant vial, and vaccinate people with 1ml of unadjuvanted vaccine at 15ug

for pregnant women.  They still can.  But will they??



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 13:38:40 PM UTC

[ Parent ]

I agree with your concerns, particularly the danger to the fetus.

As you point out here:

concern about the lack of safety data for early pregnancy (ie concerned about possible early abortion)

they are narrowing the focus to the danger of early abortion, and saying there is none.  But what about effects on the developing embryo in early pregnancy?  Something that might not become apparent for years, but could prove devastating not just to individuals but to the whole of society for generations to come.  As you pointed out, the small changes they did discover in a rat brain could be a very very significant change in the much more complex - and thus more sensitive to damage - human brain.

I noticed that in the post just before this, someone was taking you to task for coming out so strongly against adjuvanted vaccines.

However in my opinion, the pharmaceutical companies bottom line is just Money. They may SAY they are producing these adjuvanted viruses in order to make more doses available to the public, but the skeptic in me says they are putting these adjuvants in primarily to make the vaccine go farther so they can make more money, in essense diluting the vaccine and replacing the real thing with these odd and toxic chemicals.

Always have a plan B.

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by: maryinhawaii @ Sun Oct 11, 2009 at 03:45:37 AM UTC

[ Parent ]

it isn't just money

at least not (just) directly from the sale of these vaccines, but it also has to do with breaking down the regulatory barriers, which have been very strong for decades against novel adjuvants, for DECADES, for safety reason.  There was/is or has been no OTHER reason to not license them, except for safety.  

It's a floodgate issue, and there are MANY vaccines lined up, including pediatric vaccines...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 04:00:43 AM UTC

[ Parent ]

and HIV vaccines ... n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 12:22:34 PM UTC

[ Parent ]

That actually argues even more strongly for the profit motive.

At least in the case of an ongoing pandemic they might have some degree of justification in wanting to make the vaccine go farther through the use of adjuvants, since it's rather an emergency where time is of the essence. But the fact that they want to use this particular emergency as a way to break down the regulatory doors so that they are able to use these adjuvants on all kinds of vaccines that are NOT an emergency or needed for sudden widespread use, that tells me that greed and profit are purely and surely behind it all.

Always have a plan B.

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by: maryinhawaii @ Sun Oct 11, 2009 at 21:33:40 PM UTC

[ Parent ]

Problem with that logic

If the problems are as serious or as frequent as suggested you have the opposite effect.  Children and others have serious reactions, backlash results and barriers become permanent.  Barriers are rarely relaxed following a train wreck.  Further, companies would take a beating with credibility is completely lost.    

If you were a major company working in this area why would you risk that on a low return product.  Drugs are where the money is and watch any commercial in the US and listen to the many side effects listed at the end including death.  Read the information in your prescription side effects are no secret. So why hide this.   I don't understand. It doesn't seem to me that this logic holds.    

 

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by: spartan @ Sun Oct 11, 2009 at 21:59:45 PM UTC

[ Parent ]

to be honest

personally, I"m less interested in speculating (not say you are, but I was, just for a minute...) about their motivations, than putting out factual information for the public, like the stuff from the EMEA files or FDA meetings or scientific journals.  Not to say others can't debate them, but there are many millions of people who need to decide, in a short while, whether they want to get vaccinated.  I'd prefer to keep the information reasonably focused and easy to find.  

And, to turn the profit debate around.  Companies are also making unadjuvanted vaccines for the US market.  There are yet other companies developing other vaccines, like the recombinant HA vaccine, that do not require adjuvant.  Some vaccines are safer than others.  All of them may, or may not, make profits.  Which is why I think that the profit discussion is IMHO peripheral to issues of vaccine safety...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 22:13:52 PM UTC

[ Parent ]

Would You Like To Qualify Your Remarks SusanC?

Would You Like To Qualify Your Remarks SusanC?

I think you should to avoid giving needless and possibly fatal alarm over vaccinations to parents worldwide.

Do I understand you to believe that unadjuvanted flu vaccines are perfectly safe, within the clinical meaning of the word "safety"?

Do I understand you to believe that the use of all adjuvants is dangerous or only squalene related ones?

Do I understand you to believe that all vaccine providers and the Government(s) are colluding in some kind of plot?

Do I understand you to believe that it is only the British that have this problem and that Americans and Australians can breath easy over this matter since their vaccines are not adjuvanted?

I suggest that without such qualifications you risk becoming labelled as the Orly Taitz of vaccination, through continually advancing a series of "prove me wrong" arguments. The onus is on you to prove that your contentions are correct.

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by: Walrus @ Sat Oct 10, 2009 at 19:48:35 PM UTC

[ Parent ]

Nothing is perfectly safe.

First of all, a big caveat.  Whenever someone says something, people are always going to have their own interpretations or 'understandings'.  You are entitled to your 'understanding', but please do not confuse it with what I actually said.  Thank you.

Do I understand you to believe that unadjuvanted flu vaccines are perfectly safe, within the clinical meaning of the word "safety"?

No, nothing is perfectly safe.  And, there actually is no 'clinical' meaning of 'safety'.  To quote the FDA, one slide that they frequently show says, safety is paramount, but safety is relative. It depends on 'as compared to what'?  In those with high risk of severe disease, in a pandemic with double digit CFR (I'm just using this as examples, not quantitatively), then the risk/benefit balance is very different.  Where the risk/benefit balance tilts heavily one way or the other (and everyone has to decide for themselves), the decision making is relatively easy. The biggest difficulty happens when you have both a high risk condition (eg pregnancy) and where they may ALSO be at higher risk of adverse effects from the intervention.  Which is what worries me, a lot.

Do I understand you to believe that the use of all adjuvants is dangerous or only squalene related ones?

No, I don't believe all adjuvants are dangerous.  This diary looks at MF59 and AS3, and I'm not even saying these 2 are 'dangerous', not least because it's a subjective word, like 'safety'.  Again, as compared to what?

I'm saying that there are signals that concern me, but there are limitations because of sample size.  Normally, when you license a vaccine, you know that there's limited data, based on several thousand subjects in clinical trials.  But you also know that you are not going to vaccinate 10s of millions of people as quickly as possible in the next couple of months.  There's more lead time to discover problems in that scenario.  A pandemic is really not the best time to roll out novel vaccines in massive numbers..And that's not even counting special populations like pregnant women or women who may potentially become pregnant...

I'm also saying, there are questions about the standard that the regulatory folks are applying to assess safety.  For example, if you compare a MF59-adjuvanted H5N1 vaccine, vs an MF59-adjuvanted seasonal flu vaccine, which is what they did for ALL of the kids in their pediatric trial. Is there any way, from those figures, that you can determine the safety of the ADJUVANT (or at least the safety of adjuvanted vs unadjuvanted vaccines) in kids??  The answer is NO.

If you find it possible to use such data to determine safety, then please show me...

Another example, if you inject something into mother rats, and then you test the offsprings for reflexes, with the intention of detecting potential signs of toxicity in the offsprings, and find that the 'treatment' group has 13 rats from 7 litters (which is NOT a small number) with a delay in one of the tests, as compared to ZERO in the control, would it be appropriate to conclude the test indicates no evidence for concern?  If that's what you think, again, please explain to me the logic.  I don't get it...

Do I understand you to believe that all vaccine providers and the Government(s) are colluding in some kind of plot?

I didn't say that.  You are putting words in my mouth.  See caveat above.

Do I understand you to believe that it is only the British that have this problem and that Americans and Australians can breath easy over this matter since their vaccines are not adjuvanted?

See above, re: nothing is perfectly safe, and safety is relative.  And that includes anyone in any country.  Ditto again about not putting words in my mouth..

I suggest that without such qualifications you risk becoming labelled as the Orly Taitz of vaccination, through continually advancing a series of "prove me wrong" arguments. The onus is on you to prove that your contentions are correct.

People will label whatever they want to label.  That is not my concern.  You read what I write, and if you think it proves anything, you're over-interpreting my comments.  I'm not here to 'prove' anything.  I'm just sharing my thoughts, same as everyone else..  Yes, I'm also going to add the references, but there are many and it takes time.  But since I'm NOT going to PROVE anything, there's no need for anyone to 'prove me wrong'.

I do welcome a genuine sincere discussion about these issues. Which IMHO doesn't have to be dichotomous, binary (right vs wrong, black vs white) nor contentious...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 21:54:49 PM UTC

[ Parent ]

actually there's a similar but mirror-image problem

The biggest difficulty happens when you have both a high risk condition (eg pregnancy) and where they may ALSO be at higher risk of adverse effects from the intervention.

with people who are at LOW risk from the virus.  And especially if they are currently healthy but may have familial/genetic predisposition to autoimmune diseases...

Again, as I said, this is what companies call a 'theoretical risk'. Everything is theoretical in the absence of data.  And data is d*****d hard to find, pre- or even post-licensure.  At least not soon enough to help anyone decide whether they ought to take these vaccines if they are the only ones offered in their country.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 01:31:58 AM UTC

[ Parent ]

I'll post references for every single claim I make tomorrow

and if I fail to find references (which is highly unlikely since I know this stuff by heart), then I'll edit out that part of the diary.

Thanks for listening.  You all are great.  I wish our governments are the same...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 01:49:36 AM UTC

Where are the regulators? Why are they being let alone?

Who's in charge??

It's shocking to read all this.  We think someone is watching out for us, they're even getting paid to do it, but it's a charade.

Sheesh, the UK has great muckrakers in their tabloids.  They even get photos of the guilty parties to illustrate their expose stories.  Probably there isn't the same level of interest as there is in cheating movie stars, but don't they like telling about financial shenanigans too?  

It isn't even just the regulators.  Scientific papers are peer reviewed.  Are they just like some business boards of directors, with interlocking membership rewarding each other for non-performance?  

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Sat Oct 10, 2009 at 01:51:21 AM UTC

tabloids? As in, newspapers?

You know who sits on the GSK board?  http://www.gsk.com/about/board...

Does the name James Murdoch ring a bell?  Like the Murdoch media empire?  http://en.wikipedia.org/wiki/N...

Scroll down on that link, to see how many newspapers, TV station, magazines, you name it, he/they control.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 01:56:01 AM UTC

[ Parent ]

Holy cow, an 5000-pound gorilla! n/t

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Sat Oct 10, 2009 at 02:05:54 AM UTC

[ Parent ]

ALSO on the GSK board

are Sir Crispin Davis, CEO of Elsevier, the biggest publishing house for scientific journals, who btw is/was tipped to be the next Chairman of ITV, the "UK's largest commercial broadcaster", or maybe not.

also Professor Roy Anderson, who used to sit on the UK Joint Committee on Vaccinations and Immunization or JCVI and was in the UK government's pandemic planning Scientific Advisory Group, at least right up to the end of that group  in December 2006.  The SAG has now been replaced by the Scientific Pandemic Influenza Advisory Committee (SPI)

Get this.  The UK pandemic vaccination plans were based on the scientific recommendations of the SAG, in this document Pre-pandemic and pandemic influenza vaccines

In other words, Anderson advised the UK government to develop the pandemic and prepandemic vaccine strategies.  And then he leaves and gets a directorship at GSK.

Convenient, huh?



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 02:21:44 AM UTC

[ Parent ]

Corruption = anti-vax attitudes

I just taught a class focusing on corruption in poorer nations but emphasized that corruption is said to be lower in rich countries because many of the corrupt practices are legalized, such as lobbying. The financial mess with risky (rated triple A!) mortgages was the example used, but SusanC's description of approving the use of vaccines quite possibly proven already to be dangerous is a great example. This quiet (but not illegal?) corruption explains a lot of the "irrational" anti-vax sentiment. In many cases, the injured party is not even allowed to sue for damages due to "greedy lawyers" - which do exist but how bad are they compared to medical regulators and drug companies that injure children? Any vaccine can have side effects, but they should be known, explicit, and well publicized. Then people can make their own decisions. I find it especially depressing that SusanC is writing about Canada, the UK and Europe - are their medical establishments so dependent on government that they are lazy and silent? Is this something to ponder in our health care debate? Can SusanC enlist some scientists or even religious figures to bring these issues to public attention? Would the BBC help? How about the Greens in Germany? (I know - one person with so little time and in a neck brace.) Get well and god bless Susan.  

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by: INFOMASS @ Sat Oct 10, 2009 at 10:59:10 AM UTC

Would the BBC help???

Read this diary BBC Panorama Programme Misleads the Public on Swine Flu Vaccine and decide for yourself, whether there is an innocent explanation for their 'omission'.

Then add that to the above information about media empires and the GSK board.  Consider what that tells you.

I should have known that at my age, ignorance and naivete about such worldly matters should have long gone.  But sometimes I forget, so I'm only getting what I deserve...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 13:07:46 PM UTC

[ Parent ]

I am getting the shot, but I found this interesting. you may too.

http://www.infowars.com/just-g...

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by: JonC @ Sat Oct 10, 2009 at 13:57:00 PM UTC

thanks, just in case anyone misunderstands.

if you are in the US, the above discussion does not apply.  The adjuvanted vaccines are NOT being used in the US.

And, again, it serves them FINE, when the world's focus is on the 1976 swine flu and thus on the US, so then no one is looking at adjuvants.  If you watched the BBC Panorama programme, this was EXACTLY what they did - bring the US debate, including interviewing the mother of the 2 siblings who died in the US, who of course said everyone should take the shot.

I find it sickeningly exploitative.

Comparing the vaccine in the US and the adjuvanted ones being used in Europe and Canada, is like comparing apples and cheeseburgers or something...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 16:44:12 PM UTC

[ Parent ]

If you watch the video. " hey!, this has happended before." n/t

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by: JonC @ Sat Oct 10, 2009 at 14:03:31 PM UTC

the potentials risks from adjuvants

are on a different order of magnitude as the risks from GBS, in 1976 or now.  In 1976, it happened in 4-11 per MILLION vaccinations.

Look at the GSK clinical trials.  There was 1 anterior uveitis AND 1 autoimmune hepatitis, in a pediatric trial that had ONLY 400 subjects.

Is that 'proof'?  No, but it's a d**** strong SIGNAL, IMHO.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 16:49:19 PM UTC

[ Parent ]

in addition

in another trial with only 512 subjects aged 18-60 followed for 6 months, there were 2 people with strokes, reported separately as 'cerebral infarction' and 'hemiparesis'.

According to the American Heart Association statistics, the risk of stroke for those aged 45-54, is 2.4/1000 person years.  For 500 people in 6 months, you should expect 0.6 cases, IF the median age of the cohort 45-54, less if they're younger.  

These 2 cases, along with several others, were listed as severe adverse events unrelated to vaccination.

Now, to determine causal relationship, a temporal association is not necessarily indicative.  You also need to have an idea of underlying biological mechanisms.  In other words, is there a biological plausibility that strokes or cerebrovascular events might be triggered by the vaccine?  Well, think inflammation and cytokines.  Check out the following:

Welsh 2008 Associations of proinflammatory cytokines with the risk of recurrent stroke.
Stoll 2006 Inflammation and atherosclerosis: novel insights into plaque formation and destabilization.

There is now a LARGE volume of data implicating inflammation as an important mechanism for atherosclerosis and associated conditions.  For example, just to give you an idea, look at search results for peer-reviewed articles on "stroke"+"inflammation" (2,450 results), or "stroke"+"cytokine" (639 results), just for instance.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 17:28:29 PM UTC

[ Parent ]

a few abstracts, from reviews

Inflammation in atherosclerosis.

Abundant data link hypercholesterolaemia to atherogenesis. However, only recently have we appreciated that inflammatory mechanisms couple dyslipidaemia to atheroma formation. Leukocyte recruitment and expression of pro-inflammatory cytokines characterize early atherogenesis, and malfunction of inflammatory mediators mutes atheroma formation in mice. Moreover, inflammatory pathways promote thrombosis, a late and dreaded complication of atherosclerosis responsible for myocardial infarctions and most strokes. The new appreciation of the role of inflammation in atherosclerosis provides a mechanistic framework for understanding the clinical benefits of lipid-lowering therapies. Identifying the triggers for inflammation and unravelling the details of inflammatory pathways may eventually furnish new therapeutic targets.

Inflammation and atherosclerosis: novel insights into plaque formation and destabilization.

BACKGROUND AND PURPOSE: The simplistic view of atherosclerosis as a disorder of pathological lipid deposition has been redefined by the more complex concept of an ongoing inflammatory response. SUMMARY OF REVIEW: Apolipoprotein E and low-density lipoprotein (LDL)-receptor-deficient mice develop accelerated atherosclerosis allowing in-depth pathophysiological investigations. Atherosclerotic plaques in these mice contain large numbers of T cells and macrophages. Crossbreeding apolipoprotein E-deficient mice with T-cell-deficient mice and mice with impaired macrophage function (osteopetrotic op/op mice) disclosed the important impact of immune cells on atherosclerotic lesion development. In contrast to the detrimental role of T cells and macrophages, B cells appear to be atheroprotective. These basic experimental findings have partly been confirmed in studies of the human carotid artery system. Inflammation is not only instrumental in the development of human atheromatous plaques, but, importantly, plays a crucial role in the destabilization of internal carotid artery plaques, thus converting chronic atherosclerosis into an acute thrombo-embolic disorder. Humoral factors involved in internal carotid artery destabilization include cytokines, cyclooxygenase-2, matrix metalloproteinases, and tissue factor. Antibodies to oxidized LDL can reflect disease activity on one hand, but can also confer atheroprotection. Novel MRI techniques may aid in the in vivo assessment of acute plaque inflammation in humans. CONCLUSIONS: The impact of inflammation on the development of atherosclerotic plaques and their destabilization opens new avenues for treatment. The effects of statins, acetylsalicyclic acid and angiotensin-converting enzyme inhibitors on stroke prevention may partly be attributable to their profound anti-inflammatory actions. Vaccination against modified LDL and heat shock proteins halt plaque progression in experimental atherosclerosis. Their potential for prevention of human atherosclerosis is currently under investigation.

Antigen-induced immunomodulation in the pathogenesis of atherosclerosis.

Atherosclerosis is a chronic inflammatory disorder characterised by the accumulation of monocytes/macrophages, smooth muscle cells, and lymphocytes within the arterial wall in response to the release of proinflammatory molecules. Such accumulation results in the formation of the atherosclerotic plaque, which would eventually evolve to complications such as total artery occlusion, rupture, calcification, or aneurysm. Although the molecular mechanism responsible for the development of atherosclerosis is not completely understood, it is clear that the immune system plays a key role in the development of the atherosclerotic plaque and in its complications. There are multiple antigenic stimuli that have been associated with the pathogenesis of atherosclerosis. Most of these stimuli come from modified self-molecules such as oxidised low-density lipoproteins (oxLDLs), beta2glycoprotein1 (beta2GP1), lipoprotein a (LP(a)), heat shock proteins (HSPs), and protein components of the extracellular matrix such as collagen and fibrinogen in the form of advanced glycation-end (AGE) products. In addition, several foreign antigens including bacteria such as Porphyromonas gingivalis and Chlamydia pneumoniae and viruses such as enterovirus and cytomegalovirus have been associated with atherosclerosis as potentially causative or bystander participants, adding another level of complexity to the analysis of the pathophysiology of atherosclerosis. The present review summarises the most important scientific findings published within the last two decades on the importance of antigens, antigen stimulation, and adaptive immune responses in the development of atherosclerotic plaques.

Note that fibrinogen is increased in animal studies for both MF59 and AS03.  Fibrinogen is a marker of systemic inflammation. And GSK actually admits, that there is systemic inflammation.  Which is why I find it surprising when they say, there's no effect on sysemic cytokines.... The following is from their EMEA file, toxicity as tested in rabbits:

There was evidence of an inflammatory response in haematology, clinical chemistry and pathological parameters.  Increases in fibrinogen and white blood cell counts were noted in temporal association with the erythema and oedema noted on observing the rabbits. Relative to body weight, the spleen weight was increased in all groups compared to the control (7 - 41%).

And, for MF59, Safety of MF59 adjuvant.

Consistent systemic treatment-related findings in animals treated with antigen plus MF59TM included increases in fibrinogen levels and slight increases in globulin.

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 21:25:45 PM UTC

[ Parent ]

did you get that last part?

What Novartis says?  These findings are

• Consistent
  
• systemic
  
• treatment-related

So don't tell me adjuvants have no systemic effects, that there effects are local...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 21:27:57 PM UTC

[ Parent ]

Comparing Frequency of Guillain-Barré Syndrome

I always have trouble translating numbers unless I actually engage in the math.

But if I understand, if (big if) the indications of frequency of anterior uveitis (same for autoimmune hepatitis) in this pediatric trial turned out to be accurate indications of vaccine-caused adverse side effects, their frequency would be similar to having seen 2500 times the frequency identified for Gullain-Barre Syndrome (GBS) ascribed to the 1976 swine flu vaccination.

In other words, instead of this:

4 to 11 GBS victims per 1,000,000

it would have been this:

10,000 to 27,500 GBS victims per 1,000,000

(Because 1 Million is 2500 times larger than 400 {number of subjects in pediatric trial}. )

Now, let's be clear, I am not saying anything is showing any increased risk in GBS for these new vaccines.  I am simply trying to place this current trial in perspective by comparing its results relating to these other conditions with an event in flu vaccination history that is familiar to many people.

Think about the public reaction to the 1976 Swine Flu vaccination program.

Now imagine what that public reaction would have been if the problem had been magnified so that in the place of each 1 victim, there had been 2,500.

Obviouly, this kind of study does not scientifically prove there is a causative connection between the vaccine on trial and these adverse events (nor that the math would stay the same even if there was.)

But equally obviously, this kind of study can not be used as the basis of saying that vaccine has been scientifically proven to not cause those adverse events.

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 

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by: Into The Woods @ Sat Oct 10, 2009 at 18:32:15 PM UTC

[ Parent ]

what worries me, A LOT are the autoimmune hepatitis cases.

AIH happens at a background rate of 1 in 10-20,000.  (Manns 2006).  In the GSK trials, they had 1 case out of about 400 kids in the pediatric trials (in addition to another adult case in the overall cohort, of around 5700 who received the adjuvanted vaccine, from the EMEA file).

Now, I'm looking at the 1 in 400, and thinking, what does this mean?   It could have been a random event, ie that GSK was simply unlucky, and happened to bump into a child with the condition.  Or there may be some causal relationship.  The problem is, to demonstrate an increased risk for a severe but rare AE, you'd need a much bigger sample size.  Which we don't have.  So how to make sense of this, if you are a parent trying to figure out whether to get your child vaccinated?

I'm going to tell you in plain English that I don't have the answers. I can't tell you whether the vaccine is safe or not safe.  I'm not an epidemiologist and not a statistician.  But I did want to know the ballpark range of certainties or uncertainties.  So, here's what I figure.  Take it FWIW.

Assuming a background incidence of AIH of 1 in 10,000, if I do 100 clinical trials, with 400 people each (ie a total of 40,000 subjects), then by chance alone, I would get the 1 in 400 result 4 times out of those 100 trials and it would not indicate an increased risk.  In other words, you might say that there's a 4% chance that the 1 AIH in 400 kids is a random or chance event, ie that GSK was just unlucky.

For a background rate of 1 in 20,000, then the probability that the 1 AIH in 400 kids is by chance alone, would be in the order of 2%.

In other words, in my very unscientific estimate, there's a 2-4% chance that this 1 pediatric AIH case out of 400 vaccinated kids is just a randome event with no significance for safety. Or something in the that low range.  

Does that prove causation?  No.  Does that prove the adjuvant or vaccine is dangerous?  No.  Does that prove ANYTHING?  No.  But is this a significant piece of information to take into acocunt?  You tell me.  I'd say, I'm concerned since we are going to vaccinate millions and millions in a short space of time, with not enough time to assess safety in bigger numbers, and particularly since there's another adult case in the bigger cohort, lending some support to some 'theoretical' biological mechanism in action...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sat Oct 10, 2009 at 21:05:33 PM UTC

[ Parent ]

correction

the total number of kids receiving AS03-adjuvanted vaccine is not 400.  That's the total size of the study. It was done in 3 phases, with different amounts of antigen and/or adjuvant in each phase..  While the file says Phase B and C had a 3:1 randomization (ie adjuvanted H5N1 vs unadjuvanted seasonal vax), it didn't say whether Phase A also had the same ratio for allocation.  And, the data is only presented in %, so you can't determine n=? in each subset.

But, for our purposes, and also based on a previous presentation of the same data by GSK to the FDA (transcripts here), it would be safe to assume that the number of kids getting the AS03-adjuvanted vaccine was 300, not 400.

Which makes it worse...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 03:06:59 AM UTC

[ Parent ]

I would like to pick out the pediatric data

and put them into tables so it's easier to see.  And maybe the adult data if I see anything significant.  But the files are, as I said, EXTREMELY difficult to read so it is very time consuming.  And I've very conscious of the time element, seeing as vaccines are about ready to be shipped, and people would be looking for information.  So I'd probably have to keep doing triage (as I have been doing for weeks already!!) and put up whatever appears most urgent or important or as issues come up.  Which means, don't expect it to be very systematic at this point.  



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Sun Oct 11, 2009 at 03:12:54 AM UTC

[ Parent ]

Weigh benefit against possible cost

If the event was not bad luck and there is a 1 in 400 of a serious adverse pediatric event from arthritis to stroke, the question is what is the chance of dying from H1N1 for an otherwise healthy child. I believe that about 2/3 of the child deaths thus far are associated with underlying conditions, so there have been about 25 deaths of children without underlying conditions in the US. If there are 150 such "healthy" pediatric deaths by the time the flu is through, and with about 82 million under 19, we are probably seeing a death rate of 2 per million among all children, or a bit more if "healthy" deaths are taken to healthy children. So if a death rate of 2.5 to 3 per million is likely vs. a 1 in 400 chance of a serious adverse event, it would appear the damage from vaccinations with adjuvants (not in the US but elsewhere) is a lot higher than not being vaccinated. For 10 million kids vaccinated, we would expect 25,000 serious adverse events vs. 25 deaths. This is speculative, but if the rough magnitudes are right, it would suggest many parents in the UK, Europe and Canada are rational if they refuse to have their kids vaccinated - and maybe themselves too? Even if the real adverse rate from vaccines is a tenth as much (1 in 4000), it is still 100 adverse events vs. 1 death.  

---

by: INFOMASS @ Sat Oct 10, 2009 at 22:34:48 PM UTC

[ Parent ]

Gary Matsumoto's new website is another resource for information on squalene.

WithoutConsent

What you don't know can hurt you.

WithoutConsent is about informed consent. We promote transparency in the pharmaceutical industry and the governments that regulate it ... because you can't make good choices with bad information - or no information at all.

Clinical trials with "fast-track" swine flu vaccines that contain an adjuvant - substances that turbocharge the immune system's response to the vaccine - are underway on four continents. The adjuvant is an oil called squalene, which causes incurable autoimmune diseases in animals. Autoimmune diseases occur when the immune system attacks the body instead of defending it.

Over the past 35 years, scientists in laboratories like UCLA Medical Center and the Karolinska Institute, which awards the Nobel Prizes in Medicine and Physiology, have published papers showing how squalene injected into rodents will cripple them. They used squalene to induce diseases like rheumatoid arthritis in animals (the animal version is called "adjuvant arthritis") in order to search for a cure in humans....

...The European Medicines Agency report on GlaxoSmithKline's new swine flu vaccine called "Pandemrix" says on pg. 17 that it contains 10.69 milligrams of squalene.http://www.without-consent.com/media/EMEASqualeneDose.pdf

An appendix to the report says on pg. 29 that subjects injected with the vaccine suffered "Headache, Tiredness, Pain, redness, swelling or a hard lump at the injection site; Fever, Aching muscles and joint pain." It says these complaints were "very common" - occurring with more than 1 in 10 doses of Pandemrix. http://www.without-consent.com...

In 1 out of 1,000 doses, subjects reported "Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death; Fits, Severe stabbing or throbbing pain along one or more nerves and Low blood platelet count which can result in bleeding or bruising." In 1 in 10,000 doses, volunteers reported "Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may spread across the body; and Narrowing or blockage of blood vessels with kidney problems."...

http://www.without-consent.com...
There are links to papers here.  Matsumoto suggests reading the abstracts, many of which are available for free (he gives directions for getting them).  

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Sat Oct 10, 2009 at 19:04:30 PM UTC

I think he made some great contributions

in terms of investigative journalism, and asked some pretty tough and important questions.  I do also think, based on my own improved (and evolving!) understanding of immunology in recent months, that adjuvants and adjuvanted vaccines have to be assessed as a whole, and that focusing only on squalene can tell us some pretty useful but still limited information that may have less correlation to clinical outcomes, than taking a broader view....



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sat Oct 10, 2009 at 22:01:45 PM UTC

[ Parent ]

about Gardasil

(btw, the reason why this is important, and relevant, is because the HPV vaccines are the most recently licensed adjuvanted vaccines, on both sides of the Atlantic.  How and/or to what degree regulatory agencies scrutinize safety is IMO at least partly informative, for our assessment of adjuvanted flu vaccines.)

So, the FDA advisory committee (VRBPAC) meeting to evaluate the safety and efficacy of the vaccine was held on May 18, 2006.  Here's the agenda.  Briefing documents for that meeting are available here.

In the background document submitted by the manufacturer Merck, you can find, on page 13, 2 concerns raised during evaluation, one of which was

..the potential for Gardasil™ to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine-relevant HPV types at baseline.

These subjects can be identified by blood tests for antibody (seropositive) AND/OR detecting of viral DNA for the relevant HPV strains, from cervical/vaginal samples (PCR +ve)  The following table shows a 44.6% INCREASE (ie negative efficacy) in grade 2/3 carcinoma-in-situ (CIN) after vaccination, for the subgroup who were both seropositive AND PCR +ve.

So the FDA queried the company, and they submitted additional data saying that there was an imbalance in risk factors, between the HPV vaccine group and placebo group, as follows (I'm sharing all these details so that you can determine if I've missed something, or, alternatively, you can download the documents and look at the originals directly.)

and they reanalyzed the data, this time including subjects who were seropositive AND/OR PCR +ve, with the following results.

Note also, in this and the previous table, the last columns where it says 95% CI (confidence interval), and the values are shown as <0.0.  This is a common way of showing whether the data is statistically significant.

So all of the above, are from the background document, and they all refer to Study 013.  However, on the same FDA page, there is ALSO a Final Briefing Document.  I actually don't understand the difference or relationship between these 2, but, no matter, let me show you what this document says.  

The following table is from page 55 of the Final Briefing Document, and it shows the results pooled from several trials.  The last row, are the subjects who were BOTH seropositive AND PCR+ve, ie corresponding in status to the very first table posted above but obviously this includes women from several studies combined.  Click on the table to enlarge.  What do you see?

What you see is, that the incidence per 100 person years at risk, is 9.1 for the vaccinated group vs 7.1 for placebo.  Again, this shows an INCREASED risk after vaccination, for this particular subgroup.  But look at the 'Observed efficacy' column.  Instead of showing - 44.6% or - 33.7% as the above tables, it is now saying <0.0%.

Which is of course, strictly speaking, 'consistent' with their data.  But if you are not careful, and you are reading very quickly, it's very easy to miss it.  Cos a -ve value in the expected efficacy column is easy to spot.  But you see <0.0 so many times, in the 95% CI column, that it's just an unwary person (like me, if I wasn't looking for it specifically) would have missed it, ie the fact that their data indicate an increased risk of CIN2/3 for women who are already chronically infected.  Since the vast majority of girls/women who get vaccinated are NOT tested prior to vaccination, is there a 'theoretical' (a favorite word with industry...) excess cancer risk for these girls/women after vaccination??



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 00:59:47 AM UTC

I'm finding the information very interesting

and the Gardasil information made me even more interested. One of the Gardasil researchers, Dr. Diane Harper, is very vocal about Merck and several states (Texas to name one) trying to make the Gardasil mandatory for girls before clinical trials revealed any risks. We've been hearing about serious Gardasil reactions since it's been released and there's plenty of information on it. According to a CBS news report, 'she also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent".

I have disagreed with how this adjuvanted vaccine has continued to be pushed on young girls and their parents when even the researchers know there's a problem with it. Could the problem with this vac be similar to the discrepancies Susan points out in the tables above? I can't help but wonder.

I also wonder...if mistakes were made with something like Garadasil, a vaccine that had NO timetable, no second wave or "season" coming up, could the same problem arise in an adjuvanted H1N1 flu vaccine that had little time for the various Phases of safety and effectiveness studies?  It's not out of the realm of possibility.

I usually get a flu vaccine every year and I live in the U.S. where, hopefully, I'll be able to get a vaccine before i get the flu. But if we run into a shortage and they decide to pass out an adjuvanted vaccine, this flu is going to have to mutate into something far worse before I'd take it. That makes me anti-adjuvant, not anti-vaccine. That is how I view SusanC but I'll let her speak for herself.  

 



"History never looks like history when you are living through it." ~John W. Gardner

---

by: tess @ Sun Oct 11, 2009 at 10:22:05 AM UTC

[ Parent ]

one more thing

In that last table, the column under placebo, for "incidence per 100 person years at risk" describes the risk of getting CIN2/3 for those who did not receve the HPV vaccine.  If you compare the 4 groups (1st column), the baseline rate is highest in the sero+ve PCR+ve group.  These are the women with the highest risk of developing cancer, in the short-term (months or years as opposed to decades later).

An increased risk in this group means that the women who are most at risk of cervical cancer at the time of vaccination, not only do not benefit from the vaccine, but actually have a higher risk of cancer from the vaccine.

That is from the company's own data.  As far as I can tell.  I'm open to any other alternative interpretation if someone can show me the logic of how they arrived at that interpretation.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 12:36:10 PM UTC

[ Parent ]

which is why I keep having this question come up

I don't know how they sleep nights...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 12:38:09 PM UTC

[ Parent ]

also why I said this

from the top diary

everytime I wanted to find something to reassure me, I found something worse.

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 13:10:35 PM UTC

[ Parent ]

So, in Table 26

We have the accumulated results of 3 cohorts of patients who were treated per protocol and whose reduction in catching one of the 4 vaccinated viruses is 20%? That equals a Number Needed to Treat of 355?!

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by: Ruby Murray @ Sun Oct 11, 2009 at 23:32:37 PM UTC

[ Parent ]

sorry, which table are you referring to? n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 23:37:25 PM UTC

[ Parent ]

ok, I see it now

in the background document.  But I don't understand the 355 part.  Where?



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 23:41:00 PM UTC

[ Parent ]

I just plugged the figures from Table 26

into a stats package and that was the NNT = 355. 20% "observed reduction" sounds like a 5th of women will benefit but actually 355 women need to be treated in order for one woman to benefit. That's quite an expensive programme...  

---

by: Ruby Murray @ Mon Oct 12, 2009 at 00:19:06 AM UTC

[ Parent ]

Sorry, don't want to divert the thread away from panflu

but it does show how data can be manipulated. :-~  

---

by: Ruby Murray @ Mon Oct 12, 2009 at 00:23:03 AM UTC

[ Parent ]

oh, ok. Thanks! n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Mon Oct 12, 2009 at 00:23:33 AM UTC

[ Parent ]

I'm also very worried about

what happens if you give someone a vaccine that triggers a very strong systemic inflammatory response, when that person has just been exposed or is soon exposed to the H1N1 virus, before they develop immunity?  We only know that 'cytokine storm' is associated with very severe and potentially fatal influenza illness, but to what degree would a concurrent strong systemic inflammatory response (which WILL induce and also skew systemic cytokines, irrespective of what GSK says, until they can show data to the contrary!!!) affect the outcome?  

As I said, I've had discussions with 2 leading scientists, and neither of them thought it was a far-fetched worry.  We bounced ideas around, and the long and short of that is

1. we KNOW that host response does matter, but we don't know to what degree and how
   
2. we KNOW that disordered cytokines are part of the clinical picture of H5N1, other severe influenza, ARDS, etc, with very high death rates, but it's hard to separate which part is cause and which part is effect, since every disturbance can affect everything else.  
   
3. this scenario has NOT been tested in real life, because adjuvanted flu vaccines have so far been given mostly to elderly people AND only for seasonal flu, but not for a pandemic virus with a novel HA where we actually have close to zero data on host immune response at the micro-level, to such a situation.

That's what I'm thinking, for now.  I should go to bed.  More tomorros.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 03:45:24 AM UTC

fever and cytokines

here's an excellent review from scientists at the Scripps Institute, and it's free Cytokines and Fever.

ABSTRACT: Cytokines are highly inducible, secreted proteins mediating intercellular communication in the nervous and immune system. Fever is the multiphasic response of elevation and decline of the body core temperature regulated by central thermoregulatory mechanisms localized in the preoptic area of the hypothalamus. The discovery that several proinflammatory cytokines act as endogenous pyrogens and that other cytokines can act as antipyretic agents provided a link between the immune and the central nervous systems and stimulated the study of the central actions of cytokines. The proinflammatory cytokines interleukin 1 (IL-1), interleukin 6 (IL-6) and the tumor necrosis factor alpha (TNF) as well as the antiinflammatory cytokines interleukin 1 receptor antagonist (IL-1ra) and interleukin 10 (IL-10) have been most investigated for their pyrogenic or antipyretic action.

The experimental evidence demonstrating the role of these secreted proteins in modulating the fever response is as follows:

1. association between cytokine levels in serum and CSF and fever;
2. finding of the presence of cytokine receptors on various cell types in the brain and demonstration of the effects of pharmacological application of cytokines and of their neutralizing antibodies on the fever response;
3. fever studies on cytokine- and cytokine receptor- transgenic models.

Studies on the peripheral and the central action of cytokines demonstrated that peripheral cytokines can communicate with the brain in several ways including stimulation of afferent neuronal pathways and induction of the synthesis of a non cytokine pyrogen, i.e. PGE2, in endothelial cells in the periphery and in the brain.

Cytokines synthesized in the periphery may act by crossing the blood brain barrier and acting directly via neuronal cytokine receptors. The mechanisms that ultimately mediate the central action of cytokines and of LPS on the temperature-sensitive neurons in the preoptic hypothalamic region involved in thermoregulation, directly or via second mediators, remain to be fully elucidated

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 04:30:15 AM UTC

[ Parent ]

also excellent conclusion

The initial observation that the leucocytes activating factor, later named IL-1beta, acts as an endogenous pyrogen was followed by the discovery that several other cytokines can contribute to the fever response. The experimental approach to examine their effects on thermoregulation included direct peripheral and central application of cytokines, stimulation of their production, their neutralization with antiserum, soluble receptors or receptor antagonists and the use of transgenic models. This work demonstrated the importance of the rapidly inducible, intercellular messenger molecules cytokines that can mediate the body to brain communication during infection or disease and provided the basis for a deeper understanding of the molecular and cellular mechanisms that regulate the fever response. Although the molecules and mechanisms at play are likely to increase in number as novel cytokines are being discovered, it is possible to summarize some of the most important lessons learned so far.

1. Cytokine action in inducing fever is redundant, i.e. multiple pyrogenic cytokines are induced when fever response is evoked, in fact cytokines are among the most potent inducers of other proinflammatory/pyrogenic cytokines ;

2. Both pyrogenic (IL-1alpha/beta, IL-6, CNTF etc) and antipyretic (IL-1ra, IL-10 etc) cytokines are induced by most stimuli that cause fever response;

3. Cytokine action on fever can thus be and is, negatively regulated endogenously, explaining the multiphasic nature of the fever responses;

4. Both peripheral and central cytokines can modulate the fever response;

5. A complex network of cytokines exists in the periphery and in the CNS ; IL-6 production is modulated by TNF, IFN-gamma and IL-1beta (193), IL-6 receptor is upregulated in the brain during endotoxemia; IL-6 itself is able to induce the synthesis of its own receptor along cerebral blood vessels and that of the PGE2 synthesizing enzymes COX1 and COX2;

6. PGE2 acting at EP3 prostanoid receptor emerges as an important link between pyrogenic cytokines and fever response;

7. LPS induces its effects via Toll signaling; depending on dose it can activate Toll signaling directly (TLR4) or indirectly via induction of pyrogenic cytokines of which IL-1 acts at IL-1RI-IL-1RAcP, through the same Toll signaling pathway that can be initiated by the LPS-LPS binding protein association with TLR4.

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 04:46:10 AM UTC

[ Parent ]

again, did you get that??

cytokines are induced by MOST stimuli that cause fever response;

In other words, if you get a fever after receiving a vaccine, it is because the vaccine induced cytokines, whether the vaccine is adjuvanted or not.   And adjuvanted vaccines induce more fever, which means they induce more cytokines...

Now d'you understand how come I got so mad??!!



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 04:54:23 AM UTC

[ Parent ]

Orly Taitz?

Excuse me? Are you a health professional? I've invested over $1.2 million in AIDS vaccines, and I'm an engineer who has spent some considerable time around scientists engaged in vaccine research, including the developers of Relenza, and know enough to call this stuff self important Orly Taitz style B.S. of the "prove me wrong" school.

Vaccines induce an immumogenic reaction. That is their job. Your post reproduced below merely catalogues this action while scaring millions of parents. Despite protestations to the reverse, you are an anti vaccine activist, and a dangerous one at that, more so because you pretend that you aren't.

These posts about supposed vaccine "risks" bring this website into disrepute.

Vaccines do not make drug companies much money. That is why production capability is so woefully lacking. That is why research into vaccines is not well funded as well.

The initial observation that the leucocytes activating factor, later named IL-1beta, acts as an endogenous pyrogen was followed by the discovery that several other cytokines can contribute to the fever response. The experimental approach to examine their effects on thermoregulation included direct peripheral and central application of cytokines, stimulation of their production, their neutralization with antiserum, soluble receptors or receptor antagonists and the use of transgenic models. This work demonstrated the importance of the rapidly inducible, intercellular messenger molecules cytokines that can mediate the body to brain communication during infection or disease and provided the basis for a deeper understanding of the molecular and cellular mechanisms that regulate the fever response. Although the molecules and mechanisms at play are likely to increase in number as novel cytokines are being discovered, it is possible to summarize some of the most important lessons learned so far.

  1. Cytokine action in inducing fever is redundant, i.e. multiple pyrogenic cytokines are induced when fever response is evoked, in fact cytokines are among the most potent inducers of other proinflammatory/pyrogenic cytokines ;

  2. Both pyrogenic (IL-1alpha/beta, IL-6, CNTF etc) and antipyretic (IL-1ra, IL-10 etc) cytokines are induced by most stimuli that cause fever response;

  3. Cytokine action on fever can thus be and is, negatively regulated endogenously, explaining the multiphasic nature of the fever responses;

  4. Both peripheral and central cytokines can modulate the fever response;

  5. A complex network of cytokines exists in the periphery and in the CNS ; IL-6 production is modulated by TNF, IFN-gamma and IL-1beta (193), IL-6 receptor is upregulated in the brain during endotoxemia; IL-6 itself is able to induce the synthesis of its own receptor along cerebral blood vessels and that of the PGE2 synthesizing enzymes COX1 and COX2;

  6. PGE2 acting at EP3 prostanoid receptor emerges as an important link between pyrogenic cytokines and fever response;

  7. LPS induces its effects via Toll signaling; depending on dose it can activate Toll signaling directly (TLR4) or indirectly via induction of pyrogenic cytokines of which IL-1 acts at IL-1RI-IL-1RAcP, through the same Toll signaling pathway that can be initiated by the LPS-LPS binding protein association with TLR4.

---

by: Walrus @ Sun Oct 11, 2009 at 07:07:46 AM UTC

[ Parent ]

I will let the content of what I write

the sum total of it, all 160+ diaries that I have ever written, speak for themselves.  I do not believe personalized attacks that do not speak to the issues under discussion, deserve a response.  Also, I have found that it is impossible to query the safety of vaccines or adjuvants, without attracting attacks and accusations of being anti-vaccine.  

It doesn't happen when you query the safety of food, for example - no one accuses you of being anti-food when you do...  THAT in itself should tell you something.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 11:40:23 AM UTC

[ Parent ]

this reminded me

I've invested over $1.2 million in AIDS vaccines,

It's customary to declare any conflicts of interest when addressing official on-the-record meetings like the FDA ones I've been to, so I'll state it here for the record.  

I have never received money (or anything more than stuff like pens or notepads given out in conferences, for that matter) nor invested in vaccine companies or indeed any pharmaceutical company, nor from any other company or any other interests, including for-profit or non-profit organizations that work on ANY aspect of vaccination (ie 'pro-'or 'anti-' included).

The above also applies to all members of my immediate family.  Ditto for my extended family - as far as I know, since I have a VERY large extended family...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 11:53:27 AM UTC

[ Parent ]

No Conflict Of Interest Whatsoever..

I have no conflict of interest whatsoever in relation to any vaccine research as the project is dead in the water and has been for years and I have no ownership rights anyway.

However, interacting with scientists who were members of our team that reached all the way to the Institut Pasteur taught me a little about vaccines and vaccination.

It also taught me a lot about what is called "Junk Science" and the charlatans and scaremongers who inhabit the fringes of the scientific community, and who produce reams of scientific papers for the consumption of the less discerning reader.. Were I interested enough, it would be possible I believe to chase all the 160+ rabbits raised in the papers you have so laboriously collected on the internet down their holes and put each and every one in their correct context so that we can judge their true worth instead of having to take your word for it.

I have a physiologist colleague who used to delight in my interpretations of scientific papers on medical matters  that I had read and would always correct me with a firm "Yes you are right, but no you are wrong" and put the findings in their correct context. What is lacking in your work I suggest, is that independent source of advice that can put your evidence in its context.

I also take exception to the allegations you have raised from time to time about vaccine producers engaging in corrupt activities of one sort or another to maximise profits from vaccines.

Not to put to fine a point on it, vaccines make little or no money for any drug company, which is exactly why we have a woeful shortfall in global production capacity today. While the possibility of corruption in  big pharma is relevant to discuss, the idea that anyone in that industry would bother risking their reputation on something as trivial as a flu vaccine is just plain laughable. The real money in pharma is made treating Western life style diseases, not making vaccines for poor Africans and Asians.

To put it another way, if we were talking about the holy grails of big pharma - obesity, hair loss, ageing and sexual dysfunction - the real money makers, I could believe allegations of corruption, but vaccines and adjuvants????? These companies would spend more on stationary and paper clips than their entire vaccine revenues!

---

by: Walrus @ Sun Oct 11, 2009 at 21:13:46 PM UTC

[ Parent ]

whether vaccine companies make profit

is in fact not very relevant to me (nor to this debate).  They are commercial enterprises.  They exist to make money.  I'm fine with that.  Some of them succeed, some of them don't.  I really don't care.  What I care is whether regulatory agencies are doing a good job of looking after the public interest, when commercial entities with their intrinsic lack of transparency, are tasked to provide public health solutions that impact many.  

And, to turn the argument the other way round just for a minute.  Is a 'potential/probable'* lack of profit a good justification for lower standards or less accountability?  Or what other solutions can we find?  We need to resolve such questions as societies...

*(until someone posts actual information to support the 'not so profitable' part, it remains a speculation, which I don't care about one way or the other, but it's a speculation nevertheless.)  



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 22:07:50 PM UTC

[ Parent ]

"vaccine producers engaging in corrupt activities of one sort or another to maximise profits"

Yeah, like that could happen:

Swine flu vaccine supplier has to pay back millions

Baxter, the US pharmaceutical giant, reached at least seven huge settlements over the past 12 months, some of them for millions of dollars. The company had been accused of fraud amid allegations that it had overpriced medicines by as much as 1,300%.

The Guardian, 11th October 2009

http://www.guardian.co.uk/worl...

---

by: Ruby Murray @ Sun Oct 11, 2009 at 22:12:13 PM UTC

[ Parent ]

Vaccines not a normal profit center

Walrus is correct that in the past the combination of low rates of use (relative to, say, Statins), low pricing (often bought by governments), and liability considerations made vaccine research unattractive for most pharma companies. The prospect of required vaccinations and higher prices for some vaccines make it much more attractive but still less than a medicine used over and over. I agree with SusanC that money is not the main point here. The corruption I spoke of was of big pharma leaning on politicians through political contributions to not allow Medicare to bargain on drug prices. This is costing the program billions of dollars. On the other hand, IF significant adverse events are (a) not even being reported and (b) minimized or hidden in drug company reports of phase I, II or III trials, that is certainly unethical and could be immensely damaging.  

---

by: INFOMASS @ Mon Oct 12, 2009 at 02:24:46 AM UTC

[ Parent ]

HPV Vaccine cost

Normally I would agree about companies not making money on vaccine.  But then I learned the price of Gardasil

How much will the HPV vaccine cost?
The retail price of the vaccine is $120 per dose ($360 for full series).

from  http://www.cdc.gov/VACCINES/vp...

And here is where we find how the price was chosen - http://discovermagazine.com/20...

Gardasil took more than 20 years to develop, is complex to manufacture, and must be constantly refrigerated, but that's not why it's so expensive. Instead, Merck calculated the price based on the money the vaccine will save the entire health-care system-and the CDC approved the price, as it does with other vaccines. "We based the price on a number of factors, most importantly the value Gardasil brings to individuals and society," says Jennifer Allen, a spokesperson for Merck. "HPV-related diseases cost the U.S. health-care system about $5 billion every year, and we took that into consideration."

And there clearly is profit
http://www.bloomberg.com/apps/...

Merck & Co.'s first-quarter profit rose 12 percent as demand for asthma and cholesterol drugs along with the cancer vaccine Gardasil made up for the loss of sales of older medicines to generic competition.

 

---

by: Public_Health_Networker @ Mon Oct 12, 2009 at 03:49:26 AM UTC

[ Parent ]

I read somewhere they had a $1.5bn market share n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Mon Oct 12, 2009 at 04:31:31 AM UTC

[ Parent ]

In Australia The HPV Vaccine Is Free.

In Australia the HPV vaccine is free to women under 26 years old.

We are also considering giving it to young men so that they cannot spread HPV.

---

by: Walrus @ Mon Oct 12, 2009 at 08:40:59 AM UTC

[ Parent ]

again for the recor

the "quote" that you attributed to me, is actually a direct quote from the paper from Scripps, a very prestigious research institution, link posted in the comment above it.  It wasn't written by me.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 11:58:03 AM UTC

[ Parent ]

Vaccines can cause reactions

Walrus: The tone of your contribution seems to ignore the well-established fact that vaccines can and do cause reactions in some individuals. SusanC has gathered an heroic amount of data - much of it not easily available - to try to see what the balance of costs and benefits might be. Her major concern focuses on adjuvants, especially in some population sub-groups. She is not an "anti-vax advocate" so far as I can see. Nothing you wrote contradicts the findings of vaccine trials which she has quoted. Indeed, your own background as an engineer would not seem to make you especially qualified to assess her arguments, though your list of seven points about immune response suggests you have also done a lot of learning and reading. The fact you have invested (your own money?) is good to disclose but MIGHT compromise your own analysis. The fact that the FDA has decided to forgo adjuvants in H1N1 vaccines while others have not suggests, at the least, that this is a debatable point. FW has been a forum for these discussions. I myself am a social scientists and what got my suspicions aroused was the instructions to UK HCW not to report many adverse HPV events. This is what stokes suspicions of cover-ups and screwy conspiracy theories.  

---

by: INFOMASS @ Sun Oct 11, 2009 at 13:51:35 PM UTC

[ Parent ]

oy, we're at risk here LOL

of playing a game of 'telephones'!

though your list of seven points about immune response suggests you have also done a lot of learning and reading

Those seven points were not written by Walrus.  He copied it from my post, thinking I wrote them, but I didn't either.  I copied them from the paper from Scripps, in this comment http://www.newfluwiki2.com/sho...

;-D



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 18:07:25 PM UTC

[ Parent ]

Walrus, did you miss the whole point of this argument,

which is not about "vaccines" but about adding adjuvants to vaccines?   What's of concern here are the effects of adjuvants in non-elderly persons. Those effects are not completely understood by scientists, and some are even "adverse events" which are irreversible.  Why would we want to deny that it's gambling with the health of 2 generations (if not more)??   (For H1N1 in its present strain, it isn't worth the risk, IMO.  We aren't facing H5N1, with a 60-80% fatality rate.  If we were, we would close the schools and take other community-mitigation measures, anyway, and might still be able to avoid the use of adjuvants until they are better understood.)  

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

---

by: Jane @ Sun Oct 11, 2009 at 15:03:57 PM UTC

[ Parent ]

The publication date

of the dossier that SusanC is referring to is 2008. It seems quite clear to me that the EMEA were imagining an H2H H5N1 pandemic when they approved AS03-adjuvanted vaccines. As we are not in that situation (yet) this approval should be revoked, imo.

If I weren't feeling so goddam awful I would be being a bit more proactive about it but I've barely been able to raise my head for the past 3 days. No RTI, but such malaise - could it be???

---

by: Ruby Murray @ Sun Oct 11, 2009 at 15:14:26 PM UTC

[ Parent ]

the EMEA documents I refered to in this diary

which you can find from here http://www.emea.europa.eu/huma... and here http://www.emea.europa.eu/huma... are both dated 24 September 2009.  But your point is also valid, that the approvals of the mock-up applications upon which the current approvals are made, were originally based on data on H5N1, and possibly with corresponding risk assumptions.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 18:12:12 PM UTC

[ Parent ]

also hope you get well soon n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 18:15:26 PM UTC

[ Parent ]

Anterior uveitis in children

Cunningham 2000, Uveitis in children.

PURPOSE: To summarize the prevalence and patterns of uveitis in children. METHODS: Pertinent articles were reviewed. RESULTS: Children constitute 5-10% of the patients with uveitis seen at tertiary referral centers, and girls appear to develop uveitis slightly more frequently than boys. Among all children with intraocular inflammation, anterior uveitis accounts for 30-40%, posterior uveitis accounts for 40-50%, intermediate uveitis accounts for 10-20%, and diffuse uveitis accounts for 5-10%. The most common cause of anterior uveitis is juvenile idiopathic arthritis (JIA), whereas the most frequent type of posterior uveitis is toxoplasmic retinochoroiditis. Most cases of intermediate and diffuse uveitis are bilateral, chronic, and idiopathic. The most common causes of vision loss in children with uveitis are cataract, band keratopathy, glaucoma, and cystoid macular edema. Up to one-third of the children with uveitis are left with severely impaired vision as a result of these complications. CONCLUSIONS: Uveitis is an important cause of ocular morbidity in children. Prompt diagnosis and treatment is essential to minimize the risk of long-term vision loss.

Pivetti-Pezzi 1996 Uveitis in children

Uveitis is diagnosed more often in adults than in children but in children the prevalence of chronic inflammation and the difficulty of an early diagnosis may worsen the visual prognosis. The different incidence of the presumed or defined etiologies in the various ages is probably responsible for the better classification of uveitis in childhood (71% versus 55% in adult patients). Juvenile rheumatoid arthritis is the most common identifiable etiology of pediatric anterior uveitis (28%). However, its long-term prognosis is not satisfactory and ophthalmic surveillance protocols are necessary especially for ANA and HLA DR11 positive girls with the pauci articular form of the disease.

Molina 2001 Uveitis and juvenile idiopathic arthritis

This paper is from Spain, relevant because the GSK pediatric trials were done in Spain.

OBJECTIVE: Anterior uveitis is one of the most important extra-articular manifestations of juvenile idiopathic arthritis (JIA). The objective was to analyze the frequency of uveitis in patients with JIA and to describe its clinical and evolutive characteristics. PATIENTS AND METHOD: Among the 234 children diagnosed with JIA in our hospital, those presenting uveitis were studied. RESULTS: Seventeen children, 16 girls and 1 boy, presented uveitis in 28 eyes, representing a prevalence of 7.3%. Among patients with pauci- or oligo-articular forms of the disease, the percentage increased to 13.3%; polyarticular forms accounted for 10%. Only one of the 12 patients with psoriatic arthritis developed uveitis. Mean age at diagnosis of the ocular condition was 4.5 years and the interval between diagnosis of arthritis to detection of uveitis was 661.5 months. In two patients uveitis was diagnosed before arthritis. Thirty-seven episodes of uveitic activity were identified, of which 27 were asymptomatic. Fifty-three percent of the affected eyes developed complications (posterior synechias in 43%, cataracts in 25%, in-band keratopathy in 18% and glaucoma in 7%). Surgery was required in six eyes. A marked loss of vision occurred in four eyes, despite ophthalmologic treatment. Conclusions Anterior uveitis is a cause of morbidity in JIA. Periodic ophthalmologic explorations are essential for early diagnosis and treatment.

This next one is from the NIH.  Levy-Clarke 2005 Management of chronic pediatric uveitis.

PURPOSE OF REVIEW: The diagnosis and management of chronic pediatric uveitis can be particularly challenging, with an estimated 25-33% of childhood uveitis cases resulting in severe, life-long visual disability. This paper reviews the recent literature on the management of chronic pediatric uveitis. RECENT FINDINGS: This review highlights recent advances in the diagnosis and medical and surgical management of pediatric uveitis. Several systemic diseases associated with chronic uveitis in children are highlighted, including juvenile idiopathic arthritis, sarcoidosis and Behçet's disease. The treatment of primary ocular diseases associated with chronic pediatric uveitis such as intermediate uveitis and Fuchs' heterochromic iridocyclitis is discussed. The management of infectious causes of pediatric uveitis is not covered in this review. SUMMARY: Knowledge of the ocular complications of chronic pediatric uveitis can help to customize efficacious therapeutic regimens for each patient, maximize the visual potential and minimize complications of these diseases. In addition a close relation should be fostered between pediatricians, pediatric rheumatologists and ophthalmologists to effectively monitor these patients who have multiple medical, surgical and refractive needs. Finally, surgical intervention must be appropriately timed with expert perioperative management of immunosuppressive medications with pediatric concerns in mind.

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 18:48:45 PM UTC

the literature to support these issues

ie the concerns about triggering some really awful long-term disabling autoimmune diseases in children, is SO vast that it only took 5 minutes for me to find the above abstracts.  (I've read other studies on uveitis and juvenile rheumatoid arthritis in full but these abstracts are easier for the non-technical folks.)



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:00:31 PM UTC

[ Parent ]

I really fail to understand this belabored point

and what it has do do with vaccinations. Uveitis is associated with autoimmune dieases, especially JRA. So? Since it's relatively common, if it appears in a background trial, so what? Where is the link to vaccination? You cetainly can't make it in a small number trial.

---

by: DemFromCT @ Sun Oct 11, 2009 at 19:41:09 PM UTC

[ Parent ]

the point that I'm making

is that the manufacturers themselves, FOR ONCE, are admitting that this autoimmune condition is possibly linked to vaccination.  

Because they have, repeatedly and in different venues, maintained that there is NO risk of autoimmune disease with adjuvants.  Those 2 opinions, from the SAME company on the SAME product, are self-contradictory.

That is my point.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:44:38 PM UTC

[ Parent ]

also because their opinion

about possible potential causal relationship with uveitis, is hidden in one single sentence in a very difficult-to-comprehend file submitted to EMEA, a massive bureaucrasy of the EU, such that 99.9% of the public will not know to how to look for that information nor even that such information exists.  Which makes it easier for them to repeat, in public, like in the FDA meeting, that there is no possibility of inducing autoimmune disease.  

From GSK:

I think all the manufacturers have presented data that shows that the effects of the adjuvants are limited in time, limited to the space where it is injected and in the draining lymph nodes. They don't have widespread activation of the immune response, and there isn't plausibility that they would activate autoimmunity in organs separate from the muscle where they are injected.

which btw was said on July 23, 2009.  The pediatric data was submitted to EMEA on Sept 1, 2009 (as far as I can tell, from their file).  Does anybody believe that on July 23 2009, GSK did NOT know about this case and their own assessment of possible causal relationhip?

I'm talking about the credibility of information from companies.  With very limited data, and with millions or tens of millions going to be vaccinated in the very near future in a short time, is it important to assess their credibility?  I personally think so, your mileage may differ...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:30:06 PM UTC

[ Parent ]

note that there were journalists in the FDA meetings

especially the July 23 one on H1N1 vaccines.  So these statements get recorded by MSM.  Do we think that these same journalists would go and look up the file from EMEA (assuming they even know that it exists) and WADE through it to get that bit of information?  

In a way, it all goes back full circle, to the earlier discussions about news media and BBC etc...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 21:05:44 PM UTC

[ Parent ]

and to cut through the 'clinical' euphemisms

visual disability = blindness!



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:42:19 PM UTC

[ Parent ]

what's that got to do with vaccines?

jeez, this is really over the top, Susan. Uveitis can be a significant illness (that's the hard fact in your posts) buit I await data on the rest of it.

---

by: DemFromCT @ Sun Oct 11, 2009 at 19:48:53 PM UTC

[ Parent ]

because I said I would post references

and information on the comments I made in the main diary.  For the lay public who may have varying degrees of understanding of scientific or medical language.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:30:59 PM UTC

[ Parent ]

and in that context

also because I also said I would edit out anything that is unsupported by data.  The comment about blindness is to say, THIS is the reason why I got so mad, because it isn't a mild illness like conjunctivity we are talking about.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:36:01 PM UTC

[ Parent ]

uveitis is significant

but the implication of how it's related to vaccine needs to be carefully explained. One can easily get the wrong impression.

---

by: DemFromCT @ Sun Oct 11, 2009 at 20:41:50 PM UTC

[ Parent ]

the only implication I'm stating

is what the manufacturers themselves said, that this MAY be causally related.  The rest of it, has to do with exploring what is pediatric uveitis, PLUS about the credibility of the ocmpany.

Anyway, I'm done on this point (if you are).  I'm moving on to the next piece, which is pregnancy.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:44:09 PM UTC

[ Parent ]

from the GSK file, page 57

In Phase C one subject in the AS03 group developed an AE of uveitis for which subsequent details specified a unilateral anterior chamber uveitis at 8 days after the second dose of the H5N1 vaccine, which was considered to have a potential causal relationship to vaccination.

The children in those trials were aged from 3-9 yrs.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:04:59 PM UTC

[ Parent ]

again, to belabor the point

if adjuvants only have local effects, ie only on the injection site, WHY would they consider a case of uveitis (ie inflammation in the eye) as having "potential causal relationship to vaccination"??

It just makes me so mad, when they make those statements, and with a perfectly straight face!!



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:16:48 PM UTC

[ Parent ]

systemic disorders associated with uveitis

(as background information, not implying any causal relationship here)  From Wikipedia

Systemic disorders that can be associated with uveitis include: [4]

   * Ankylosing spondylitis
   * Behçet's disease
   * Chronic granulomatous disease
   * Enthesitis
   * Inflammatory bowel disease
   * Juvenile rheumatoid arthritis
   * Kawasaki's disease
   * Multiple sclerosis
   * Polyarteritis nodosa
   * Psoriatic arthritis
   * Reiter's syndrome
   * Sarcoidosis
   * Systemic lupus erythematosus
   * Vogt-Koyanagi-Harada syndrome
   * Whipple disease
   * Lyme disease



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 19:21:57 PM UTC

[ Parent ]

the 'not implying any causal relationship" is huge

and should be in 45 point block letters.

Looks like you're fishing for something, finding anything, and calling it significant.

---

by: DemFromCT @ Sun Oct 11, 2009 at 19:42:17 PM UTC

[ Parent ]

you're inferring something that doesn't exist

which is also explicitly stated.  I did NOT call it signficant.  Don't apply your own interpretation to what I didn't say.  

Again, see here for why I'm posting all this extra information  http://www.newfluwiki2.com/sho...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:41:55 PM UTC

[ Parent ]

okay

If it's not significant, why are you so angry (see diary title)? I still don't get it.  

---

by: DemFromCT @ Sun Oct 11, 2009 at 20:43:52 PM UTC

[ Parent ]

if I can explain why I"m so angry

in a short comment here, I wouldn't have needed this whole diary, plus all these additional explanations, to say what I want to say.  But all that is just sharing how I feel, and trying (it is actually quite hard, cos the issues are so complicated) to explain it.  Take it FWIW.  Nobody has to agree.  

You can read EXACTLY the same information and not get angry.  Fine by me.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:47:20 PM UTC

[ Parent ]

thanks!!

I know it's complicated. I am as concerned as you are that the casual reader gets the picture.

---

by: DemFromCT @ Sun Oct 11, 2009 at 20:49:58 PM UTC

[ Parent ]

the 'not significant' part

refers only to that ONE comment, from wikipedia, that I LABELED as not implying causal relationshp.  In response to your query.  It doesn't apply to anything else.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:49:07 PM UTC

[ Parent ]

I see a single case of a temporally related

event that requires reporting and further investigation. I see that any temporally related event needs the caveat that correlation is not causation. I see clear need for further studies and further data.

my understanding is that the prevalence of uveitis is approx 1 in 118 or 0.85% or 2.3 million people in USA (source).

http://www.wrongdiagnosis.com/...

---

by: DemFromCT @ Sun Oct 11, 2009 at 20:54:57 PM UTC

[ Parent ]

I see the company making contradictory and misleading statements, to the FDA and to the public n/t

All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 11, 2009 at 20:58:40 PM UTC

[ Parent ]

Vaccine Safety issues

Here in the USA this debate has been taken out of the hands of individuals.  In the state of Mass. they passed a new law that requires (It the Law) all medical personnel to take the new H1N1 vaccine.  There is no; repeat, no excuse not to.

This new law was protested by various medical groups including nurses, Doctors, and many other professional medical personnel. The Governor felt that it was for the greater good that all medical personnel would have taken the vaccine..  Other states are reviewing this law to see if they need to copy it.

The protest was over the lack of data and the small number of test subjects used for the H1N1 vaccine.

  No warning - no way to fight - no way to win!  
We need help in our local communities to survive. Remember that quote:    "...No man is an island..."

---

by: RICHARD-FL @ Sun Oct 11, 2009 at 23:50:18 PM UTC

NY, not MA

I believe.

While no state has gone as far as New York, many other institutions have grappled with the concept of mandatory vaccination.

http://www.cbsnews.com/blogs/2...

---

by: DemFromCT @ Mon Oct 12, 2009 at 01:55:51 AM UTC

[ Parent ]

Just Had H1N1 Vaccination

For the record, I just had  H1N1 vaccination a few hours ago.

I took my 87 year old Mom to the doctor for a consultation, our doctor mentioned that he had a few doses left over from his  Ten dose vial. Mom and I were both vaccinated.

Brief discussion advised that the pandemic around 1958 seems to provide immunity, in that my Doc (who had that flu) hasn't had H1N1 while all his staff has had it.

The oldest patient who he has treated for H1N1 was 48 years old.

The risk from his point of view was that older people  who didn't have that pre-existing (1958?) immunity who got H1N1 got very, very sick, as in ICU level sick, as did the younger folk.

Anyway, Son and Partner are getting vax tomorrow, so I guess I can start eating my preps (not).

---

by: Walrus @ Mon Oct 12, 2009 at 08:48:56 AM UTC

[ Parent ]

And P.S.......

If I start growing Two heads, a snout, or a curly tail I will post accordingly. I did have to sign a consent form covering potential risks (Anaphylactic shock, GB syndrome, etc. etc.) which indicates that the Government who provides this vaccine for free, are being extra careful, despite this being grown exactly like seasonal vaccine.

---

by: Walrus @ Mon Oct 12, 2009 at 08:54:49 AM UTC

[ Parent ]

is Australian vaccine adjuvanted?

Just curious, cos you say "this being grown exactly like seasonal vaccine".

You arm yourself to the teeth just in case.  You don't leave the gun near the baby's hand.

---

by: lugon @ Mon Oct 12, 2009 at 09:26:53 AM UTC

[ Parent ]

not that I know of

can't compare the two.  Apples and cheeseburgers...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Mon Oct 12, 2009 at 10:05:59 AM UTC

[ Parent ]

Curious. Consent form or Waiver of Liability?

Informed consent rightfully discusses potential risks to allow patients an informed judgment that balances risks.

Waiver of liability would attempt to insulate parties from civil damages for breach of standards or duties owed to the patient.  

I am assuming this is just a fairly standard consent form , but interested if a pandemic vaccine is treated differently.  

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 

---

by: Into The Woods @ Mon Oct 12, 2009 at 20:39:19 PM UTC

[ Parent ]

Informed Consent

My reading of the document (I do read before I sign) suggested informed consent in that I warranted that the risks/complications whatever had been explained to me.

---

by: Walrus @ Mon Oct 12, 2009 at 21:58:22 PM UTC

[ Parent ]

US has vax liability limit in emergency

Once a public health emergency has been officially declared, there is an automatic limitation of liability for vaccine manufacturers in the United States according to 2005 legislation. http://www.nvic.org/vaccines-a... It does not matter what you sign.  

---

by: INFOMASS @ Tue Oct 13, 2009 at 00:34:30 AM UTC

[ Parent ]

amendment to PREP Act declaration on Oct 5, 2009

http://edocket.access.gpo.gov/...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Tue Oct 13, 2009 at 01:31:58 AM UTC

[ Parent ]

Probably not but Big Pharma likes belts

with its suspenders.  

ITW(Joel J)
Courage is resistance to fear, mastery of fear - not absence of fear.
- Mark Twain
 

---

by: Into The Woods @ Thu Oct 22, 2009 at 06:19:27 AM UTC

[ Parent ]

Wasn't it in 1957 that the seasonal virus changed

and became unlike the H1N1 from 1918, and therefore not helpful with this one?  My family had a bad flu earlier than 1957, and I'm hoping that protects DB and me with this one.  (I'm planning to get the vaccine when it's available, though, because there's no way to be sure.)

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

---

by: Jane @ Mon Oct 12, 2009 at 14:33:02 PM UTC

[ Parent ]

yes

1957 was the conversion to H2N2 and 1968 to H3N2 because of the pandemics that year.

---

by: DemFromCT @ Mon Oct 12, 2009 at 17:41:48 PM UTC

[ Parent ]

Swine flu vaccination: A test subject speaks out.

(Comment: I'm not putting this into the news diary cos the credibility of the source is uncertain, ie Facebook, and translated, but the GSK file does say that they conducted their H1N1 trials this summer in Germany)

A swine flu vaccine test subject from Munich complains about horror side-effects - researchers deny allegations

http://adventuresinautism.blog...

Original German article

21.08.09|Munich iFacebook

Translation into English by Erwin Alber

Munich - A harmless prick - and thereby possibly save thousands of people. This is what several hundreds of volunteers thought, who each collected a payment of 250 Euro for their participation in the study of the swine flu vaccine trial at the Ludwig-Maximilians-University.

One of them has now quit the trial: The Diploma-businessman Axel Sch. (40). He claims : "The vaccination has made me ill! - the test is irresponsible." He says that within a few hours after the vaccination, on August 10, he had sweat on his forehead. "I felt totally beat. On the third day, my kidneys and head were aching and I got a fever. I then had a coughing fit - and the wash basin was suddenly red - it was blood!"

LMU-medical researcher Frank von Sonnenburg, who is in charge of the country-wide study, doesn't consider these accounts credible. He says that such side-effects cannot be related to the vaccine. He does not deny that, as with other flu-vaccinations, flu-like symptoms may occur as a reaction to the vaccination. "Additionally, there may be light pain, redness or swelling at the injection site."

[snip]

Was the vaccine admitted too quickly to the study? The fact is that in this composition, the vaccine has not yet been applied to humans. The Federal Health Minister Ulla Schmidt explained on Wednesday that she had felt put under pressure by the pharmaceutical industry from the beginning. Criticism is being voiced with increasing frequency. The Paul-Ehrlich-Institute points out that side-effects to this vaccine are to be more expected than in connection with a normal flu-vaccine. The Paediatric Association points to a possibly increased number of unknown side-effects.

[snip]

Axel Sch. however insists that his complaints were a result of the vaccination. "Surely it is no coincidence that they occurred directly after the vaccination." He criticizes the university, saying that he was not properly informed prior to the study. He said that for three days he was flat on his back during this heat. "When I phoned the LMU, they simply asked me the question needed to fill in their form and told me to see my doctor." He now wants the medical costs and loss of earnings compensated by the medical insurance covering the trial.

Axel Sch. has participated in medical trials even when he was a student. He had also had good experiences with an LMU flu-vaccine study. "This is the reason why I immediately consented when they asked me if I would test the new vaccine."



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Tue Oct 13, 2009 at 02:47:44 AM UTC

Very unfortunate

neurological reaction to the seasonal flu vaccine, recent incident.
http://thepeopleschemist.com/b...

Worth watching.

---

by: beehiver @ Fri Oct 16, 2009 at 04:09:03 AM UTC

this is an example

an unfortunate one, of what I meant, that nothing is perfectly safe.  Although this unadjuvanted seasonal flu vaccine overall has a very good safety record, it does have rare side effects, like any other vaccine.  It really comes down to a risk/benefit calculation - what are the risks of getting a vaccine vs not getting it.  Remember that (again rare) neurological events can follow influenza infection as well, so you have to put that into the equation...

Something else this tragedy illustrates, is the potential for vaccine adverse effects to be long-lasting or even permanent, which is rarely seen with other pharmaceuticals.  Vaccines by their very nature are different in that they utilize immune memory to produce long-lasting protection, but for the same reason, such immune-mediated adverse effects can also become long-term as well.

Here's a quote, from Brennan FR, Dougan G. Non-clinical safety evaluation of novel vaccines and adjuvants: new products, new strategies. Vaccine. 2005 May 2;23(24):3210-22.

Vaccines are unique medicinal products in that even single doses (e.g. of a live attenuated or toxoid vaccine) given in childhood could lead to a prolonged pharmacodynamic effect (i.e. life-long immunity) through the generation of immune memory.

No other medicinal product has such a prolonged pharmacodynamic effect.

Which is why I believe we should always go for safer alternatives when they are available and feasible.  Which is the situation with the GSK vaccine right now.  With the lukewarm demand from the public, governments would do both their citizens and themselves a favor, by giving it unadjuvanted, as suggested here http://www.newfluwiki2.com/sho...   At the very least, it will save them from the embarrassment of very low uptake, which I think is very likely.



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Fri Oct 16, 2009 at 05:39:12 AM UTC

[ Parent ]

What makes some people more susceptable to bad reactions?

Susan, Have you seen any studies on who is more likely to have a bad reaction to the flu vaccine?  

(Your posts are so important, because you ask the questions I'm curious about, but I lack the medical background to research myself.  Thank you!)

---

by: mare @ Sat Oct 17, 2009 at 03:25:30 AM UTC

[ Parent ]

that's a good question

Have you seen any studies on who is more likely to have a bad reaction to the flu vaccine?  

No, I haven't seen any, specifically, for any vaccine, let alone the flu vaccine.  Research on vaccine reactions is very scanty, most of them are epidemiological ones, ie analysis of cohort and/or adverse event reporting data, rather than investigation of the biological mechanism of such reactions.  

That said, immunology is advancing in leaps and bounds, and some of the insights may well be useful.  The problem is, immunologists don't normally work on vaccination-related research.  The bulk of research on vaccines (try looking up any vaccine on PubMed) is done by researchers trying to make vaccines, and very little by researchers trying to find out what might go wrong with them.  



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sat Oct 17, 2009 at 05:31:33 AM UTC

[ Parent ]

So What? This Does Not Change The Equation - People Need To Be Vaccinated.

While perhaps tragic, so what? This does not change the equation - People Need To Be Vaccinated for without vaccination many more will die.

---

by: Walrus @ Fri Oct 16, 2009 at 19:49:01 PM UTC

[ Parent ]

Update - well, sort of...

I waanted to write follow-up diaries on this issue, but a relapse of an old injury (slipped disc) stubbornly refuses to heal if I spend more than a few minutes at a time on the computer.  It's unfortunate but with hindsight it was bound to happen.  So, probably not much more than occasional comments for the next couple of weeks.  Sorry.  ;-(



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

---

by: SusanC @ Sun Oct 18, 2009 at 14:36:25 PM UTC

Sounds like a message: take a little time off

and relax!  (Must be frustrating, though, with all you planned to do. :-(  )

Hope you feel better soon!!

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

---

by: Jane @ Sun Oct 18, 2009 at 15:58:48 PM UTC

[ Parent ]

German Medical Association: concerns re adjuvanted infl vaccine

Some medical professionals in Germany are having doubts about use of the adjuvanted vaccine for certain groups of people:

http://www.irishtimes.com/news...

Germans want swine flu vaccines swapped
Wednesday, October 21, 2009

DEREK SCALLY in Berlin

THE GERMAN Medical Association (BAK) has advised against giving young children and pregnant women the new swine flu vaccine Pandemrix, containing an immune system-stimulating compound.

Instead the BAK, the equivalent of the Irish Medical Organisation, has called for the federal government to hand over to high-risk groups another, standard vaccine - Celvapan - which was ordered for use on armed forces and state employees.

"It would be wise to swap - the federal government should use the normal vaccine and make its own doses available to those who should be using the better-tested vaccine," said Dr Frank Ulrich Montgomery, vice-president of the German Medical Association.

"We know the effects of the various ingredients in adjuvant vaccines but not the combined effect. It's understandable that people are wary of getting jabs of drug cocktails."

Health authorities in Ireland and Germany have recommended swine flu vaccination and have ordered the same two vaccines - Celvapan by Baxter and Pandemrix by GlaxoSmithKline (GSK).

The latter was licensed last month by the European Medicines Agency (EMA) for use on all people except children under six months.

But Pandemrix has divided health professionals in Germany.

Many leading paediatricians, virus experts and medical organisations are concerned about the "adjuvant" booster compound it contains and oppose its use in high-risk groups until more long-term data are collected.

"While Pandemrix contains no components that are completely unknown to us, the more components a vaccine has, the greater the chance of side effects," said Prof Lothar Wieler of the Institute for Microbiology and Animal (Epizootic) Diseases at Berlin's Free University.

"Thus I think young children would be better off with non-adjuvant vaccines."

[snip]

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by: beehiver @ Fri Oct 23, 2009 at 19:28:24 PM UTC

see I'm not the only one

among medically-trained people, who holds such opinions...



All 'safety concerns' are hypothetical.  If not, they'd be called side effects...

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by: SusanC @ Fri Oct 23, 2009 at 20:33:43 PM UTC

[ Parent ]

German Chancellor and ministers to get additive-free vaccine

Spiegel Online is reporting that German Chancellor Angela Merkel and government ministers will receive a special, additive-free H1N1 vaccine. "The Vakzin [vaccine] does not contain disputed additives - contrary to the vaccine for the remainder of the population," reports the newspaper.

Angela Merkel, the German Chancellor, is shown here hobnobbing with fellow minions of the elite, Gordon Brown and Nicolas Sarkozy.

Translation result for http://www.spiegel.de/wissensc...

"Critics argue that Adjuvantien [adjuvants in the vaccine] could lead to increased inoculation reactions such as headache or fever." The German government elite and the armed forces will receive Celvapan, an adjuvant-free vaccine manufactured by Baxter. The German public will receive a vaccine produced by GlaxoSmithKline with adjuvants.

"Critics argue that Adjuvantien [adjuvants in the vaccine] could lead to increased inoculation reactions such as headache or fever." The German government elite and the armed forces will receive Celvapan, an adjuvant-free vaccine manufactured by Baxter. The German public will receive a vaccine produced by GlaxoSmithKline with adjuvants.

Employees of the Paul Ehrlich Institute will also get the adjuvant-free vaccine. Johannes Löwer, president of the institute, said in August that the vaccine causes worse side effects than the virus. Löwer's comment came after German lung specialist Wolfgang Wodarg said the vaccine increases the risk of cancer. The nutrient solution for the vaccine consists of cancerous cells from animals.
http://www.politics.ie/health-...

[I used http://translation.babylon.com... for translation of first 2 paragraphs from spiegel online: Berlin - until the last few days, hardly anyone but the word of Fachzirkeln adjuvant belongs. But now is a public debate on the composition of the vaccine for the coming soon forthcoming Schweinegrippeimpfung aflame. It appears constantly refers to work with the an additive to Wirkverstärkung.

Critics argue that adjuvants to increased Impfreaktionen headache or fever. Supporters maintain that the vaccination with the additives safe, and that they have more Wirkstoffdosen be produced. A few days ago the armed forces announced that it for their soldiers a vaccine without additives ordered....]  

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Fri Oct 23, 2009 at 22:19:38 PM UTC

German army to get adjuvant-free vaccine

German Army first in line to get cutting-edge swine flu shot

Full story: www.thelocal.de
The German army has ordered a stock of special swine flu vaccine that does not contain controversial additives that will be given to the general public, the Defence Ministry confirmed on Monday.
http://www.topix.com/forum/hea...

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Fri Oct 23, 2009 at 22:22:25 PM UTC

[ Parent ]

Translation by a German,

with comments.  [Some comments are angry and political, about his government.  Mods remove if it crosses the line.]

...For the chairman of the Drug Commission of the German Medical Association, Mister Wolf-Dieter Ludwig, the whole vaccination campaign is "a scandal",...

"Risk of harm outweighs the benefits"

Meanwhile a open rebellion is on, according to "SPIEGEL" in general practitioners of healthcare, Doctors and paediatricians ( Doctors specialized on children). The President of the German Society of General Medicine and Family Medicine, Mister Michael Kochen, advises the German Doctors strictly to not ( make use ) of the vaccine ( in a manner so that everybody would get vaccinated as a precaution ) . "The risk of harm outweighs the benefits," said the Gottingen professor.

Wolfram Hartmann, president of the Professional Association of Child and Adolescent Physicians, accuses the government of "scientific misinformation before. As with pregnant women as true of children under three years: "The vaccine is not tested on them at all, so the risk is simply too big to use it now without hesitation."

Children have an immune system which tends to overreact. Exactly, and exactly these could be triggered by the addition of Wirkverstärkern/Additives. In addition, the vaccine was included also a preservative containing mercury. "There is a good reason that such stuff is kept out in today's vaccines for young children" said Hartmann.
http://www.godlikeproductions....
[my bolding]

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Fri Oct 23, 2009 at 22:30:28 PM UTC

[ Parent ]

Wolfram Hartmann is a practicing pediatrician

("children and youth") in Germany, as well as being president of the Professional Association of Child and Adolescent Physicians.  His practice's website has a full page about vaccinations and scheduling, showing that he is not anti-vaccine.  

[Google translation)
Dear parents, autumn is it is time for the Grippeimpfschutz children with special risks (e.g. congenital heart disease, chronic diseases such as Diabetes mellitus, bronchial asthma, Inhalationsallergien, M. Crohn, ulcerative colitis, Chromosomenstörungen, Immune system disorders, etc. ) refresh. The current vaccine is from October, please contact one of us are combined.
http://translate.googleusercon...

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Sat Oct 24, 2009 at 15:28:28 PM UTC

[ Parent ]

Doctors at Children & Youth Network news

For the process used by the Bundeswehr, the new vaccine against influenza - Celvapan - there are no data relating to the use in children and pregnant women.  This information, which is also found in the Summary of vaccine, is also confirmed by the manufacturer Baxter on request. ...

... Also for use in adults are in contrast to the adjuvanted vaccines so far only limited data.  Recommendations, this new vaccine against influenza, especially for children and pregnant women prefer to do without at present a scientific basis.  It is alarming that many so-called experts report apparently without sufficient knowledge of the facts to speak out and demand the use of a limited vaccine tested on children and pregnant women, "criticizes Dr. Fred Zepp, director of the Children's Hospital of Mainz....

 

http://translate.googleusercon...

"The truth does not change according to our ability to stomach it."  Flannery O'Connor

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by: Jane @ Sat Oct 24, 2009 at 15:34:35 PM UTC

[ Parent ]