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Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic I - First Questions

by: SusanC

Wed Aug 08, 2007 at 23:26:27 PM EDT


( - promoted by SusanC)

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The world of science is a strange place.  You would have thought that different people working on the same substance, one group set on figuring out how to use it, the other trying to find out how it harms people, will at least have heard of each other and hopefully talked to each other from time to time.  Apparently, that doesn't happen, not in ways that you can take for granted anyhow.

SusanC :: Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic I - First Questions
At least the group that is trying to find out about the harmful effects of oil adjuvants did quote the other group, those promoting their use,  in their references, but I suppose it would be too much to expect the latter to volunteer to their readers the existence of the former!

The thing is, if you were looking for possible side-effects of oil-adjuvants like MF59 in vaccine journals or in vaccine conferences, you would not come across the findings (eg induction of autoimmune antibodies) of those researchers who have been doing animal studies on precisely the same substance that would likely have disqualified it from even getting into human trials in the first place!

Let me backtrack a little, and give everybody a bit of background. 

We have all heard how our vaccine production capacity is nowhere near enough to produce pandemic vaccines to make a difference to the outcome of a pandemic (at least that is MY definition of what spending all these billions to produce a pandemic vaccine should be about), whether we look at this from the national or global perspective.  Among many ways of trying to make the small amounts we can produce go further ie dose-sparing techniques, the hottest game in town is adjuvants, substances which when added to a vaccine can make it so much more effective that you only need very small doses, thus instantly creating more with less!  Sounds good, right?

Another bit of background: Under 'normal' circumstances, for any pharmaceutical product or vaccine to get licensed, they have to go through many stages of testing.  The first one is always animal tests, cos unless you have very unusual attachments to animal rights, you don't really want to test something new on humans first thing, do you?  Regulatory agencies such as the FDA have specific requirements that need to be fulfilled before you can even begin human clinical trials, which consist of several phases designed to test efficacy, safety, dosage, etc, everything that they need to know before they can license a product for market.

Now, the case of MF59 is a rather unusual one.  Some of you may remember me writing about it in the old forum, based on the book Vaccine A, by Gary Matsumoto, a NY Times journalist also writing for Vanity Fair, as part of the controversy around Gulf War Syndrome and allegations that the DOD was/is using experimental vaccines including those with MF59 on service personnel without informing them (No consent is needed, apparently, if you are in the military - you gotta take whatever they give you.)  Anyway, I still haven't been able to make heads or tails out of that story, cos I haven't come across definitive evidence one way or the other, so I'm going to leave that well alone for now, and go somewhere else instead. 

I'm going to go specifically to Italy in 1992, when the first clinical trials using MF59 adjuvanted influenza vaccines started.  The rationale was that the elderly tend to have poor immune responses to flu vaccines, and they suffer most complications and deaths from flu, so it would make sense to find some ways of enhancing their immune response.  Animal studies then showed that certain oil emulsion compounds had the ability to stimulate and produce enhanced immune responses when given in conjunction with vaccines.  At least that is what we are given to understand from reading the (like I said) writings of vaccine scientists, although even then those working on the harmful effects of oil adjuvants had published studies just as prodigiously showing, well, harmful effects.

Be that as it may, the clinical trials went ahead in Italy, with groups of elderly (65 or older) people recruited from the community and duly given the vaccines for three consecutive years, and the results showing enhanced response were duly published.

Let me digress here a little and tell you what I discovered about vaccine safety, or specifically what kind of data from clinical trials would satisfy the requirements and the product be deemed 'safe' for licensing.  Now, this is only what I figured out from the various vaccine papers that I've read; I'm not privy to the exact technical specifications that regulatory agencies require.  It would appear that in most instances clinical trial subjects are monitored for 20-30 minutes at the clinic, then given a list of specified or 'solicited' symptoms that they are supposed to record for the next 7 days.  Sometimes, but not always, they also record 'unsolicited' symptoms, although whether the staff actively 'solicits' such 'unsolicited' symptoms is never quite apparent.

This is all well and good, if we can assume two things to be universally true:

  1. that we know ALL the possible or likely symptoms or reactions that may arise, enough to include them on the list of 'solicited' symptoms, and
  2. that adverse vaccine reactions are bound to start only within 7 days of vaccination and not beyond

(UPDATE I have since learned that the follow-up period is normally longer, 28 days or even more, but the method of follow-up remains the same.)

Well, in the case of swelling and pain of injection sites, for example, that might very well be true.  And if we are testing vaccines that are not too different, conceptually, from the many vaccines that have been in use for many years, such that we pretty much know what to expect (eg we don't expect your hair to turn green), then it would probably work well enough, I guess.

But what if, as in the case of MF59, we are talking about a whole new class of substances for which we had at the time very little data in human subjects, the mechanism of which was specifically designed to elicit enhanced immune responses in the first place, wouldn't it be prudent to ask ourselves how the heck would we know if the immune responses were to become TOO enhanced as to be harmful? And what if the problem that we worry about is a chronic disease that may take weeks or months to manifest instead of days?  After all, if our immune system is supposed to be activated by the vaccine to be able to mount responses against viruses months after vaccination, surely we should also expect abnormal immune responses to persist well beyond the 7 days?

The thing is, excessive response to the degree that is damaging instead of beneficial, specifically the induction of autoimmune reactions, is a lot less common in the elderly than the rest of the population.  In other words, one way to NOT have a particular adverse consequence be pegged with your product is to AVOID the kind of people who are most likely to have such adverse consequences in the first place.  Pick the group that is most unlikely to have problems, particularly since in this instance they are elderly and have all sorts of other health challenges such that it would be easy to say "there were no reports of vaccine-related serious adverse events after the first, second, or third immunization", to quote that first study by Minutello et al 1999.  Make sense?

To cut a long story short, the vaccine Fluad, an inactivated subunit influenza vaccine adjuvanted with MF59, was duly licensed in Italy, and by the quirks of EU regulations, in the EU, for use in the elderly.  And it has been used by now for thousands millions of people with apparently good safety profile.  It has even been used, I'm told, from time to time off-label in younger people when they ran short of the regular seasonal flu vaccine.

You might say, so what's the problem?  The problem is, in the meantime, scientists are finding stacks of evidence in animals that such kinds of oil adjuvants including squalene or MF59 were causing distinctive patterns of autoimmune responses and induction of lupus autoantibodies - antibodies that target the hosts' own cells, believing them to be foreign, thus causing inflammation, tissue destruction, and disease - antibodies that are involved in a host of autoimmune diseases, the most important one being systemic lupus erythematosis or SLE, a very nasty, often fatal, disease which typically appears in young females, black more commonly than Caucasians, and hardly ever happen to men except very occasionally in elderly ones.

NOW let's go back and re-visit the book Vaccine A, that I wrote about in the old forum, on what happened to Gulf war veterans.  Specifically, the very unusual finding of large numbers of autoimmune conditions including lupus in previously healthy young men.  As I said, I can't find evidence to prove anything one way or the other, but I did find one study that is particularly intriguing.

I came across this while trying to find information on lupus cos one FW mother on the old forum, the only one that I know of who participated in a clinical trial of adjuvanted H5N1 vaccines, developed symptoms shortly thereafter and was subsequently (as I understand it) diagnosed to be suffering from lupus.  In the process of looking up the literature, I found this review of 5 cases of post-vaccination lupus by Older et al, 1999 which I wrote about here  in the old forum.  Two pieces of information jumped out at me in this review

  1. all five were military personnel who had received vaccinations as part of a required protocol, and
  2. 2 out of these 5 patients, all young, were males.  The normal ratio of female to male cases is 10 to 1, falling to 3 to 1 in the elderly. Simard et al 2007

Now I know purists would call these cases 'anecdotal', and they would be right, technically.  But my point is, if we are talking about potentially vaccinating the entire population, or at least a large proportion of the young, surely we need to have a higher degree of certainty that we DO have, in our regulatory processes, the ability to discover such severe adverse consequences, even if they occur but rarely?  I once asked this question of a senior scientist/executive of a vaccine company, whether there are processes in the regulatory pathway that allow us to pick up chronic and delayed adverse reactions, and his response took the form of shrugging of his shoulders, more-or-less saying "if the government cannot come up with ways of discovering problems, who am I to help find them, eh?"

Does that keep you awake nights?  It should.  Particularly if you are TPTB.

The rest of this series can be found via links here part II, part III, part IV, and part V
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No green hair from adjuvant,
if you don't test them until a pandemic arrives.

I don't remember where I saw this news a few days back. Apparently the HHS recently awarded separate contracts for pandemic or pre-pandemic vaccines and adjuvants to be stocked separately. It would appear that the plan was to defer mixing them into the final product until later.  This indicates to me that there may be some safety concerns that cannot be resolved but if a pandemic is severe enough, and the population is unprepared and therefore CMG fails, then the only option on the table will be relax the regulatory standards and mix these  adjuvants/vaccines and use them on the population.  Remember that HHS Sec Leavitt already signed a waiver of liability for these pandemic medical counter measures.

Your diary makes me shudder.

It explains why TPTB has been stalling and unwilling to tell the public the severity of the pandemic threat and a clear need to prepare.

Be ready to grow green hair or worse if you don't prep, and will be forced to use unsafe vaccines/adjuvants.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


you are committing the same mistake
that I haven't been able to create a name for, which is to assume that the sum total of actions of tptb to all be part of a grand plan.  I think we need to assume they are improvising badly the whole time.

Having said that, there IS a set of specific issues that my diary did not cover (otherwise it would be too long!) in relation to the mixing part.

There are several complexities.  First of all, adjuvants are devilishly difficult to work with and predict.  Apparently, each adjuvant can enhance and/or interact with each antigen in different ways to different degrees, and the net effect you will get cannot be predicted ahead of time.  What this means is that apart from testing the adjuvant and the vaccine for safety, the 2 has to be mixed and formulated (eg the proper mix or ratio figured out) and THEN tested again for safety and efficacy.  Which means that come a pandemic, there is going to be all this extra work that takes time, and there is no guarantee that the adjuvant that has been stockpiled will work in appropriate ways with the vaccine that you end up with!

Secondly, there are intellectual property issues.  Suppose, as is most likely, company A makes the adjuvant and company B makes the vaccine.  Suppose they solve all other problems and have successfully worked together to produce an adjuvanted vaccine.  Well, who owns it?  Which company is supposed to go to the FDA to file a BLA (Biologic license application)?  It would appear at this point that this should fall on the company that made the vaccine, but from the PHEMC meeting last week, I'm not sure that this is at all clear to even the FDA, let alone the companies.

Then of course you have liability issues.  Suppose someone takes the adjuvanted vaccine and gets lupus.  Suppose there is some data to suggest some cause and effect.  Assuming the problem does not fall under whatever liability waiver is available, which company is liable, the one that made the adjuvant, the one that made the vaccine, or the one that filed the BLA? 



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


[ Parent ]
Outcome is the same, intent notwithstanding n/t


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.

[ Parent ]
Mistake name
I duly hereby coin the name: "deductive aggrandizement".  The act of deducing via extrapolation a grand scheme or plan greater than the collective evidence may merit. 

Please note:  For proper deductive aggrandizement (DA) to occur one must step "outside the box" garbed in at least 300 square inches of tinfoil.  This should be upon the upper portion of the torso with proper headgear (also tinfoil) proportional to the size of the aggrandizement.  (Tinfoil in a camouflage "mossy oak" pattern is allowable in certain jurisdictions of the continental U.S.  Please refer to local rules and regulations pertinent to the area in which the DA is to be conducted.)


[ Parent ]
LOL!
I had to read that like 3 times to know what you're talking about!  Definitely not enough tin-foil!



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


[ Parent ]
Thinking outside the box, or brainstorming, or connecting the dots.
No matter how or who does the alignment, the ducks are in a row the same way. May be there is no master plan, just every one quietly falling in line. Works better if unspoken.

Now if you can call what happened random events, you can also call any one changing job random events.

If the statistics given thus far are not fictional, then the anticipated outcome is not fictional either.

Look for a green hair monster near you.

:-)

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
That Law...
...that I haven't been able to create a name for, which is to assume that the sum total of actions of tptb to all be part of a grand plan.  I think we need to assume they are improvising badly the whole time.

Do you mean:

Do not ascribe to conspiracy that which can be explained by {incompetence,stupidity,laziness}.

?  I've seen it called Taylor's First Law, Coyote's Law, and "an old sage".


[ Parent ]
but you are right
about the relaxing standard bit.  It's called EUA, or Emergency Use Authorization, which the secretary of HHS has the power to invoke in the event of a public health emergency.  This waives a lot of regulatory requirements, as long as the product has been used, eg in other countries, with some safety data.  THAT is my biggest concern, that they will take the European data on mostly elderly subjects, and consider that adequate for EUA purposes.

There is at least one study for MF59 adjuvanted seasonal flu vaccine in younger adults, Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults, supposedly aged 18-64, Frey et al, Vaccine 2003.  I'm going to quote the paragraph on description of test subjects, and see if you can figure out what exactly they have or have not proven.

A total of 301 subjects were enrolled into the original study, 150 in the FLUADTM arm and 151 in the FluzoneTM arm. Of these, 200 subjects were available for the extension, 104 in the FLUADTM arm and 96 in the FluzoneTM arm.  More than 90% of the subjects enrolled for the first immunization were Caucasian. The mean age and sex distribution were similar in the two groups. There were no important differences between the groups at baseline with respect to height or weight.

Here's the thing, we don't know the median age of this group.  It doesn't say that the test subjects are matched demographically to the population, only to the control group.  For all we know, they could have been testing all 60-64 year old males, just for argument's sakes.



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


[ Parent ]
If only 5 soldiers out of the hundreds of thousands probably vaccinated
with this adjuvanted vaccine got lupus, then in the case of Emergency Use, trying to prevent a lethal pandemic,  I suppose it could be argued the risk is worth it.

Otherwise not.

I think in general that there are alot of medications on the market today that may have long term side effects that have never been properly studied or ascertained. Sleep aids, male enhancement, anti depressants....it's big business. Happiness and the perfect life phramaceutically delivered. I take virtually nothing but the occasional tylenol and calcium tablet. I wont live forever and I'm not always cheerful, but it could be worse.

Always have a plan B.


[ Parent ]
If those numbers were correct for anthrax vaccine,
do we know if they apply to pandemic flu vaccine, or even seasonal flu vaccine?  I agree in an emergency, that 5 out of 500,000 is a very very small number.

If this started in 1992, what was the reason for not having more tests or clinical trials?


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
no, it's not 5 out of hundreds of thousands
it just happened to be 5 cases that they picked up, in this one study.  And they were not looking for cases in the military, just all the cases  of post-vaccination lupus that they could find in 3 centers over 7 years.  Post-vaccination lupus is so rare there is almost no literature on it.  What are the chances of them being ALL military personnel having received vaccine from the military?

This is a very distinctive cluster of case of lupus with common distinguishing features of post-vaccination onset AND being in the military.  When you find such rare events happening together with some common themes, you have to start thinking about cause and effect.

Let me give you an analogy.  Do you know of the stilbestrol babies?  In the 1950's pregnant women were often routinely given this new synthetic hormone stilbestrol to prevent miscarriage.  In the event stilbestrol was not even effective in that.  Anyway, a number of years later, in 1971, physicians at Mass General Hospital in Boston reported 7 cases of an extremely rare cancer of the vagina.  It was pure luck that this 'cluster' of cases appeared in one hospital, otherwise no one would have paid attention.  When they went to discover what these very young women had in common, they discovered that all of their mothers had taken stilbestrol during their pregnancy.  This was subsequently found in larger studies to have a causal link, that women whose mothers had taken stilbestrol during pregnancy had a much greater risk of this otherwise rare cancer!

An unusual cluster of cases in a specific population, or an unusual age or sex distribution, is a red flag for possible linkage to causation that physicians should pay attention to.

In addition, there were 2 male patients, one Caucasian, one African American.  The overall incidence of lupus varies between a low of 1.4/100,000 in Caucasian americans to 22/100,000 for African Americans.  Of these only 1 in 10 are male, which means we need to shift those figures by 1/10, to 1.4/million to 22/million, which are both extremely rare events, for all lupus cases, of which post-vaccination lupus constitutes a minuscule fraction. 

What are the chances of these 2 male post-vaccination lupus patients being also members of the military?



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


[ Parent ]
I just looked at the centers
on that paper.  One is a Army Medical Center, another one is Veterans Affairs Medical Center, third one is University of Iowa.

The research was funded by US government, possibly DOD money.

I wonder if those researchers ever got any more funding for stuff like that again ...



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


[ Parent ]
or maybe that was why
the authors presumably 'missed' the great big elephant in the room, that they were all military personnel receiving DOD vaccines.

If I were to take some of Okieman's tin-foil, I would say perhaps one way of making sure such cases are not reported as lupus induced by adjuvants, is to report them as lupus induced by vaccination, have the cases be published and then cited by others, and very quickly this will become established as the 'truth'.

Not a very happy thought...



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


[ Parent ]
Yes, was there any follow up studies done on this possible causal link
between lupus and adjuvants in military personnel. It would seem relatively easy to do, since the military keeps records on all their peeps. Find out who got vaccines with adjuvant, then find out how many of these now have lupus.

Always have a plan B.

[ Parent ]
well, the problem is
they are not admitting the use of adjuvants, or experimental vaccines of any kind.  All that is classified info.  I believe there are an unknown number of cases where litigation is ongoing.



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


[ Parent ]
also check out Gary Matsumoto's site.
Here's a link to a chapter from his book The Greatest Story Never Told and to their discussion forum



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


[ Parent ]
It is all about money i'm afraid
Generally, in a non-pandemic world, vaccine manufacturers may not be soo keen on adjuvants - there has been a lot of problems with them on health grounds - generally.

Aluminium and mercury based compounds - thiosermal- have been widely used as adjuvants, and there are many, many people who think that their use is associated with autism and ADHD and other problems.  Net result is that your average vaccine manufacturer is happy to produce vaccines, but, on the whole wants someone else to take liability for the adjuvant that is added.

That way if there are side effect problems, its dubious as to which entity may have caused it, and the responsibility is 'shared'.  That said, there are not too many companies around wanting to get into the business of adjuvants.  Each vaccine has to be trialed for both safet and efficacy with a new adjuvant (substantial costs), and the pay per adjuvant dose - compared with what is already on the market and presently available - is commercially considered too high.  There is very little government funding around on either side of the water, and at the moment the issue does not rank high enough to rate research funding in a big way.  It sucks - I agree.

A company I work for occasionally has something that could be a good and safe (most probably) adjuvant for flu vaccines at least, but the internal funds are not there to go through the development process itself, and at the moment, no-one seems too interested in it ... strange world.


we don't need many company
there are not too many companies around wanting to get into the business of adjuvants.

wanting to get into adjuvants.  Right now, just one is enough, this MF59.

The problem is not whether there are companies doing it.  The problem is whether the government has the properly regulatory processes that will prevent such disasters from happening.

Rare adverse reactions when multiplied by hundreds of millions will become a catastrophe.  We already have too many lives ruined from GWS, do we want even more of same or similar problems for thousands and thousands of families?

In 'normal' circumstances, you can still depend on post-licensing reporting of adverse reactions to catch some problems, although even there as I said it is hard to 'prove' causation if the effect is not immediate.  But in the case of a pandemic vaccine, we do not have that luxury of time, to discover any post-licensing adverse events in smaller populations.  We will be rolling it out to everyone as fast as we can, if we want to use it to save people from dying from the pandemic.

TPTB will be caught between a rock and a hard place - to vaccinate or not vaccinate.  This is 1976 all over again, except much much worse.



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


[ Parent ]
1976 again? As in swine flu? History repeats?

TPTB will be caught between a rock and a hard place - to vaccinate or not vaccinate.  This is 1976 all over again, except much much worse.

I don't think the high up really knows, just listen to what Adm Agwunobie said about adjuvants, while double checking the text of his speech:

http://nmr.rampard.c...

He opened his speech with the "plausible deniability" statement, but half way into the speech, by the time you forget that, he said:

we are particularly interested in some of the very positive yet preliminary findings that we are seeing relating to the use of adjuvants in vaccines

That seems to be the HHS position, which the President will hear. If there are no more findings, a mixing decision will be made without further info if pandemic starts "too early".

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
well, that's why I'm writing this
Most policymakers do not have the time or inclination to dig under the surface.  They accept whatever they have been briefed on.

It took a lot of effort on my part to even get this far in finding information.  Do you think people like Agwunobi, Leavitt, or even Venkayya has the time to go do that, unless they have been alerted to the possibility that a disaster is lurking under the surface?

Right now, everyone is singing their praises for adjuvants, including Rajeev Venkayya, our 'good guy'.  That's what worries me, and prompted me to re-visit this issue.



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


[ Parent ]
btw this is a classic situation
where each 'player' has access to limited information.  Were it not for my own interests both in issues around GWS/automimmune diseases and pandemic flu, I would not have connected the dots between what happened with military personnel and their significance (if any) for pandemic flu.

For example, the paper by Older et al on the 5 cases of post-vaccination lupus.  The authors did not seem to realize the significance that all 5 are military personnel.  In addition, all of their discussion, and in other papers that cited this one, everyone assumed this was a set of cases of lupus induced by VACCINES.  Older et al commented on how rare that is, without realizing of course that what these people were receiving may NOT be the same as what most people are receiving in commercial vaccines. 

I don't think they were aware of the controversies around adjuvants and DOD use of 'experimental' vaccines, cos it's not something the DOD advertises, if you know what I mean.



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


[ Parent ]
on second thought
maybe they WERE aware, as per my comment above here http://www.newfluwik...

I have to get used to using more tin-foil.  Too trusting of people's good intentions, that's my problem.  ;-(



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


[ Parent ]
How come regular users of tin foil
have nothing to say about this story?

On a subject like this, I can understand why the technically qualified closet vaccine promoter won't participate:

http://fluwikie2.com...

but where are the other 'experts'?

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
btw I would recommend
for those interested, that you go and read the old forum threads as well, cos there's a lot of info there that I didn't want to repeat here. 

Here are the links to the MF59 Story, part 1 and part 2



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


[ Parent ]
I keep forgetting
the new ASPR RADM Vanderwagen, and the new BARDA office.  I wonder how much this will affect vaccine procurement direction and how much real room there is for new regulatory thinking. 

The new draft BARDA Strategic Plan for Medical Countermeasure Research, Development, and Procurement certainly reads like there is a lot of focus on transparency and creating opportunities for change, but I'm not sure whether this is enough to overcome vested interests.  There are some very  powerful conglomerates behind the whole idea that seems to pervade the US government, that adjuvants is the way to go for pandemic vaccine dose-sparing. 

I'm not sure that good intentions are sufficient to help us get some answers to these serious questions.  I'm sure they don't want another 1976 (and, like I said, it's likely to be a lot worse, if there is anything to this!), but at this point, as far as I can see, we really do not have built-in mechanisms to detect more chronic but catastrophic effects, so I'm not too optimistic right now.

Unless, of course, they really mean what they say...



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


[ Parent ]
A decision to purchase or stockpile the adjuvant,
while the findings are still preliminary, indicates a willingness to use it if "there are no better options".

Otherwise known as fait accompli.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
absolutely!
and we would have been none the wiser.

Would you have known, if I hadn't posted about this?  Would I have known, if Gary Matsumoto didn't write his book and I just 'happened' upon in on browsing on Amazon?



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


[ Parent ]
There is always hope.
Fund research on an antidote.

Who knows? We might find a cure for lupus, or GWS, or ...

Forget about essential oils, or any thing from a witch doctor. :-)

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
you wish!
I wish, that such chronic debilitating diseases as lupus and GWS have magic bullets.  At least in the case of lupus, huge amounts of research have been done, and to this day it remains one of the most devastating life-threatening diseases that have no easy treatment options.  Most of the time, it's a choice of the least bad among several bad options, including steroids and immunosuppressive drugs.

I know, cos I have been down that path myself, not with lupus, but with another autoimmune condition that required massive doses of steroids as well as immunosuppressive drugs. 

Trust me, when I say there are no good options in such situations.



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


[ Parent ]
the problem with adverse event reporting
is perfectly and tragically illustrated by the story of mom11 on the old forum.  She said that on the follow-up visit after her second vaccination, she was suffering from what was probably pleurisy, with severe pain and grating sensation on breathing.  She had pain all over from arthritis and/or myalgia, she was so tired she could hardly pull herself out of the chair.  And yet, at the clinic, no one asked her anything about it, and no one even listened to her chest, despite here telling them she had difficulty breathing.  It was as if they were doing their best to ignore the obvious, that she was seriously ill.

None of that, of course, ended up on the official reporting, cos her symptoms supposedly started more than 7 days after the vaccination, although according to her even that was arguable.  And yes, they DID argue with her about it, as to whether those symptoms counted.

This is as far as I understand, from reading her posts and her emails at the time.



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


[ Parent ]
btw mom11's symptoms
were very similar to those described in the study.  2 of the 5 people, both male, also had pleuritic pain and difficulty breathing. 

Mom11 also said her arm (the injection site) was swollen by about 4 inches.  Case 1 in the series described the swelling of the arm as 'grapefruit size'.  Polyarthritis, fatigue, fever, were all common in all these cases, as was in mom11's case.



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


[ Parent ]
There is plenty of bad information around
Thimerasol isn't an adjuvent.  It's a preservative and has generally gone away because of concerns about vaccine-related autism.  It is also used in contact lens solutions.

Be kind, for everyone you meet is engaged in a great struggle.--Philo of Alexandria

[ Parent ]
Not gone away yet
Melanie - the use of thimerosal has not gone away.  I am extremely allergic to it (my doctor said he had never seen a worse reaction on a patch test before - my skin bled).  Thimerosal is in a lot of things and while it is getting better, I need to constantly check that it is not in the eye drops, ear drops, and injectables (is still in seasonal flu shots and tetanus shots as well as many other vaccines).  They are changing over children's vaccines first, so as an adult, my options are still limited. 

Wouldn't it be my luck that they would create an influenza pandemic vaccine and use thimerosal as the preservative.  I would have better odds surviving the flu than taking the vaccine....


[ Parent ]
My error
on thiosermal and i stand corrected.  however, there are concerns over the aluminium used as an adjuvant amidst concerns over links to alzheimers etc.

[ Parent ]
My error
on thiosermal and i stand corrected.  however, there are concerns over the aluminium used as an adjuvant amidst concerns over links to alzheimers etc.

[ Parent ]
Green hair means safey
Well, if it gives those vaccinated green hair at least we will know from a safe distance who is safer to get in the food lines with.  Green magic markers for those of us with a "Yule Brenner" hair cut.

Now if it would just GROW hair (green, purple, whatever), many men would line up for a shot, no matter what the dangers..

Sorry about the levity in a serious thread, the heats getting to me (not enough green hair?)


that's funny!
Now if it would just GROW hair (green, purple, whatever), many men would line up for a shot, no matter what the dangers..



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


[ Parent ]
I'll dye my hair green instead. No, thanks.
But then I won't get near the food lines.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.

[ Parent ]
Here are a couple of case histories, for illustration
Case 1
A previously healthy 31-year-old white man was activated from the Army Reserves for deployment to the Persian Gulf during Operation Desert Shield.  At that time, he received a series of immunizations: typhoid, influenza, and meningococcal vaccines, tetanus toxoid, and immune serum globulin. As per military protocol, all vaccines were given intramuscularly into the fight arm, whereas the immune globulin was administered intramuscularly into both gluteals.On the day after immunization, he developed a tender "grapefruit-sized" erythematous reaction in his fight deltoid muscle at the site of the typhoid injection. One week later, he had developed fight upper extremity paresthesia, which was followed by nearly complete loss of motor function in that arm. Over the next several weeks he developed recurrent left-sided pleurific chest pain with pleural effusion, triphasic Raynaud's phenomenon, polyarthritis of wrists, elbows, and ankles, recurrent irregular violaceous rashes over both upper extremities, and acral edema with "red" urine.

Musculoskeletal examination, performed 8 weeks after the immunizations were administered, showed bilateral wrist synovitis. His upper extremities showed Medical Research Council (MRC) (5) grade 3/5 strength of both proximal and distal muscle groups with associated atrophy. The lower extremity muscles showed MRC grade 4/5 strength.  Deep tendon reflexes were absent in the upper extremities and weakly present in the lower extremities.  Pinprick and vibratory sensations were diminished in both upper and lower extremities. Skin examination showed urticaria and livido reticularis of both upper extremities.

Pertinent laboratory findings included a white blood cell count of 3,100 cells/mm 3, hemoglobin 11.0 g/dL, and Westergren erythrocyte sedimentation rate of 80 mm/h. Urinalysis showed 300 mg/dL protein, 15 to 20 red blood cells per high-power field, and white blood cell and red blood cell casts.  Chemistry profile showed normal serum electrolytes and renal and liver functions. Antinuclear antibodies were present at 1:1,280 titer in a speckled pattern, SS-B at 1:4 titer, anti-double-stranded DNA at 1,890 IU/mL (normal, 100 IU/mL), and rheumatoid factor at 1:80 titer. C3 was 65 mg/dL (normal, 85 to 193 mg/dL), and C4 was 7 mg/dL (normal, 15 to 45 mg/dL). Cerebral spinal fluid indicated 4 red blood cells/mm 3, 2 white blood cells/mm 3, protein of 139 mg/dL, glucose of 52mg/dL, and immunoglobulin (Ig) G synthesis of 56.5 mg/24 hours (normal, <3.5 mg/24 hours); 5 oligoclonal bands were present.

Further evaluation showed bilateral pleural effusions by chest radiograph, a small pericardial effusion by echocardiogram, polyradiculoneuropathy by electromyography and nerve conduction velocities, immunoglobulin and complement staining at the dermal-epidermal junction by skin punch biopsy of rash, and diffuse proliferative glomerulonephritis by renal biopsy.

Seven years after diagnosis, despite initial therapy with high-dose corticosteroids and intravenous cyclophosphamide and ongoing treatment with hydroxychloroquine, azathioprine, and continued corticosteroids, he continues to suffer recurrent rashes, Raynaud's phenomenon, inflammatory arthritis, serositis, and cytopenias. He has residual neurological weakness, recurrent transient ischemic attacks, and chronic proteinuria. He has recently developed osteoporotic rib fractures.

 



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


another one
Case 2
A 23-year-old Hispanic woman, previously healthy and taking no medications, received a series of immunizations as a part of her Basic Training induction into the United States Army. By regulation, the following inoculations were performed: measles, mumps, rubella (MMR; given intramuscularly into the left arm), typhoid, influenza, and meningococcal vaccines and tetanus and diphtheria toxoids (given intramuscularly into the fight arm). Additionally, she received an oral polio vaccination.

Two days later, she complained of fever, nausea, vomiting, fatigue, and arthralgias that precipitated a 4-day hospitalization. No diagnosis was rendered at that time, and her symptoms waned. Two weeks after the immunizations, she developed another flu-like illness with a nonproductive cough, vomiting, diarrhea, fever, arthralgias, and a facial rash.

Physical examination at that time indicated a temperature of 102°F, malar rash, occipital alopecia, oral ulcers, and decreased breath sounds at the left lung base. Laboratory studies included a white blood cell count of 2,700 cells/ mm 3 with 26% lymphocytes, hemoglobin 9.7 g/dL, and a Westergren erythrocyte sedimentation rate of 52 rnm/h. Antinuclear antibodies were present in a titer of 1:640. Also present were antibodies to SS-A, RNR and Sm antigens. Antibodies to doublestranded DNA were measured at 13 IU/mL (normal, < 10 IU/mL). C3 was 29 mg/dL (normal, 86 to 184 mg/dL), and C4 was <8 mg/dL (normal, 15 to 45 rng/dL). Chest radiograph showed a left pleural effusion.

Treatment with oral corticosteroids produced an incomplete clinical response. Shortly after discharge from the hospital, she was lost to follow-up.  Her current condition is unknown.



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


This is generally the response
that I have to the annular flu vax.  Which is why I don't get it anymore.  I'm asthmatic, so flu mist isn't an option.

Be kind, for everyone you meet is engaged in a great struggle.--Philo of Alexandria

[ Parent ]
this is different
This is something a lot more than a transient response.  This is a woman who was subsequently found to fulfill the diagnostic criteria for lupus.  Notice she had pleural effusion, the classic lupus malar rash, fever, etc 2 weeks after vaccination, which marked the onset of a long term severe life-threatening illness.



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


[ Parent ]
The Reveres
Did you read EM today? It has an article about GSK`s new adjuvant;

  The big pandemic flu vaccine news of the moment has to be The Lancet report that vaccine maker GlaxoSmithKline has been able to get excellent antibody production against H5N1 with a new adjuvanted preparation that contains remarkably little viral antigen. This is important because the currently the only FDA approved pre-pandemic H5N1 vaccine uses more than 20 times as much (90 micrograms versus 3.8 micrograms) in an unadjuvanted preparation with much worse antibody response.

In today's Lancet, Isabel Leroux-Roels and colleagues report safety and immunogenicity data from a phase-1 dose-sparing study of egg-derived inactivated split A/Vietnam/1194/2004, a clade 1 vaccine adjuvanted with a proprietary adjuvant, ASO3, an oil-in-water-based emulsion containing DL-alpha-tocopherol squalene, and non-ionic detergent polysorbate 80.

  Sorry,I don`t know how to do links here.
  Anyways,I was under the impression that squalene was a not good at all thing. Am I wrong?

There is no pleasure in having nothing to do; the fun is in having lots to do and not doing it." -Mary Wilson Little


squalene
is a component of MF59.  Did you read this whole thread?  If you haven't, I would suggest that you take your time and read everything that I've written on this subject.



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


[ Parent ]
Link
http://scienceblogs....

In today's Lancet, Isabel Leroux-Roels and colleagues report safety and immunogenicity data from a phase-1 dose-sparing study of egg-derived inactivated split A/Vietnam/1194/2004, a clade 1 vaccine adjuvanted with a proprietary adjuvant, ASO3, an oil-in-water-based emulsion containing DL-alpha-tocopherol squalene, and non-ionic detergent polysorbate 80.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
What's different between MF59 and ASO3?
What's common between them - squalene. Is squalene the culprit in MF59? If so, does that make ASO3 suspect, or least a warning statement should have been attached?

I am confused by the code names. What sounds like a completely new break through may not be such a break through after all. It is just an adaptation with a new name.


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
these are proprietary formulations
they use code names so you don't know what they are. 



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


[ Parent ]
ASO3: My OMG.
I just realized this ASO3 with squalene and some unknown detergent is made by GSK.

GSK has a huge and powerful presence in Canada.  The manufacturing plant in a Toronto suburb was officiated by our then Prime Minister Jean Chretian.  Since then, GSK bought a vaccine plant in Quebec.

The U.S. won't have the President officiating the opening of a pharmaceutical plant. This should tell you something.

Talking about presence:

http://www.gsk.ca/en...

That means I will one day be offered this made in Canada 'silver bullet'.

OMG, OMG, OMG.



You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
what do you mean?
The U.S. won't have the President officiating the opening of a pharmaceutical plant. This should tell you something.

link?



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


[ Parent ]
GSK is leading seasonal vaccine manufacturer in Canada.
We are proud of their presence in Canada.  So proud that the 'new' head office opening (over 10 years ago, can't find it in the news any more) was attended by our then Prime Minister Jean Chretien. The head office and main plant in a Toronto suburb:

http://gsk.ca/englis...

I was just saying I don't expect a U.S. President to officiate the opening of a manufacturing plant or corporate head quarters. I think HHS Secretary attended a tour of a new vaccine plant but that was expected as it was clearly his mandate to do so.

Such is the clout of a big company, even a good one, with a small country like Canada, population 33 million. We have to offer a friendly environment to investors.

I can be convinced, but I don't see any other vaccine manufacturer supplying 'me' with the pandemic flu shot.

Now some one please make a squalene antidote.

Or some one makes something so good and compelling that my government decides to risk 3000 'good' jobs. Better yet, GSK buys this 'someone'.



You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
well, it's early days yet
AS03 still has a bit of ways to go.  And other competitors are getting in the game. 



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


[ Parent ]
In a severe pandemic...
I might well take the risk of developing lupus or other autoimmune disorders from a vaccine adjuvant.  And I say that as someone who already has chronic possibly auto-immune things wrong with her and is therefore probably particularly prone to suffering such side effects.

I don't like that this is the possible result of adjuvants, and I especially don't like that they seem to be hiding it and not looking for safer alternatives, but when it comes right down to it, it's a risk/benefit calculation. 

If the CFR were even at 1918 levels, let alone anything close to the current CFR, then while I'd be frightened by the possibility of (another) debilitating lifelong illness, I'd have to weigh that against the risk of dying horribly and painfully and immediately.  Not to mention all the after effects of severe flu - isn't there a Korean man who a year after his bout with H5N1 was still essentially paralyzed? 

There would be many factors, of course; how well my preps were sustaining us, how high the CFR was, etc.  If it looked like I could just SIP long enough, I would.  But for the vast majority of Americans who haven't prepped at all, I can see the cost/benefit math coming down strongly in favor of taking the risk.

I just wish they'd disclose that math.  They could prevent a recurrence of the swine flu fiasco (where the statistical evidence apparently wasn't even very robust) by being frank with the public.  They could say, look, you might stand a 1 in 100 (or whatever) chance of longterm illness from this vaccine, but you stand a far greater chance of dying in the next year if you don't get it.  We could vaccinate x number of people if we didn't use adjuvant; we can vaccinate 5x or 10x people if we do, and save many more lives.

People who could get it would still get the vaccine, and there'd be no scandal (though plenty of tragedy) later.


the issue is not just whether you should take it
but whether the government is ignoring other alternatives that do not require adjuvants.  Like the recombinant HA protein vaccine, from Protein Sciences.  I wrote about it on this diary (Option 2).  Since then, I have not found anything that changes my mind about how this is the best option.  But llast I heard, they may not even be able to go on to human trials for the H5 version because small companies find it very hard to get the funding support that big companies get from the federal government. 

I intend to write a literature review on the recombinant protein, probably sometime in the next couple of weeks.  Look out for that.



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


[ Parent ]
Thanks for the link
I saw that diary, but I'd forgotten about it.  I'll keep an eye out for that upcoming post.

Man, large corporate interests just seem to rule and ruin everything the government does, don't they?  *sigh*


[ Parent ]
personally, I don't have a problem
with corporate interests per se.  I believe that commercial markets have a healthy and important role in providing services, alongside government entities.

For me, what is under question here is not the role of the corporate interests, but the role of government, whether it is doing sufficient due diligence.

In the case of a whole new class of biological product like adjuvants, and particularly in the context of a pandemic vaccine where you are likely to vaccinate millions of people in a short space of time, we need to examine whether current regulatory and oversight processes are robust enough to cover such a new class of substances for such an eventuality.

Right now I'm not sure they are.

The questions being raised from the stories and papers I quoted contain too many disturbing pieces each of which may not amount to anything much (and therefore is enough for tptb to sweep under the carpet), but taken as a whole really begs the question: are current FDA rules sufficient to protect against this TYPE of adverse effects, ie chronic debilitating and/or life-threatening conditions that do not manifest soon enough to be easily 'proven', until we have vaccinated enough people to create a big enough group of 'test subjects'.

At which point, depending on severity of the outcome, it may all be a bit too late.



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


[ Parent ]
my concern is
in our enthusiasm to save lives, we may inadvertently lose our focus on the balance between risk and benefit.

In anticipation of the very likely scenario of a EUA being authorized, what is the bar that we have in place right now, to guard against catastrophic eventualities?

What if, when it is all over, and a lot of lives are ruined, and it turns out in subsequent investigations that those 5 service personnel with 'post-vaccination' lupus, had all been given adjuvanted vaccines, can we live to face ourselves knowing we never pressed tptb sufficiently for answers to these questions?

Are those in charge of pandemic policies empowered with sufficient authorities to ask those questions that involve possibly secret DOD activities?  If for whatever reason it is not possible to find answers to those questions, should we not consider adjuvants more as last resort?  It certainly is not being portrayed that way, right now, by the various people in government who have spoken about it.



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


[ Parent ]
Adjuvants are being characterized as the savior
to help us overcome lack of manufacturing capacities ("promising", according to Adm Agwunobie, "though preliminary"  which is a "plausible deniability").

Although I think there is a need for a "last resort" solution, describing adjuvants as "promising" is as far away from the "last resort" reality that they are.

This is way over "inform without inflame".  This is "misinform without precaution".

I accept the reality that vaccine makers will promote their product benefits, but I think the government should not become big pharma's mouthpiece. The government's job is to regulate and set standards for safety, not lower the standard in order to make a product acceptable.

I cannot believe that Admiral Agwunobie, Dr. Bruce Gellin, Secretary Leavitt, etc. know less than us about the risks of adjuvants. Material information is omitted from public communication, and even if there is immunity according to the letter of the law, if it can be proved that they knew about this risk of oil based adjuvants, then they will be held to account.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
Unless the small company got bought by the big company,
the small will be ignored no matter how good the product is.


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.

[ Parent ]
I don't care who buys who out
I just want the best product that we can get onto market soonest in largest quantities.

Right now, I'm concerned that tptb might have concluded adjuvants is the way to go, and therefore no longer try hard enough to find other, better alternatives.  But I must emphasize this is my concern, not that I know any information about whether that is the line of thinking.  Just to be clear.



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


[ Parent ]
Perhaps its time for a reality check in tin-foil-hat land..?
I think its time for abit of a reality check here tin-foil-folks...

Any vaccine has an adverse reaction rate, as do the majority of medicines..
Tamiflu is no different from anti-depressants in that regard. (and anti-depressants have been linked to an increased risk of teen suicide), Tamifu has been linked to adverse psychiatric reactions.

The same can be true for many "safe" vaccines - there is a very small but real risk of adverse reactions from vaccines that protect people against diseases with very large risks  of death...Speak to anyone who's worked in the 3rd world where these diseases are rife and you will understand just what a blessing vaccines have been world-wide...
Its only in our closeted first world existance that people can elect to opt-out, as they have the choice as those diseases are no longer common here...

As an extreeme example - the much talked of Swine flu vacine caused 8.6 per million vaccinees cases of Guillain-Barré syndrome in the misguidedly rushed vacination program prior to a pandemic being proven....
Contrast that in the case of a [real] pandemic to 50,000 deaths per unvaccinated population (in the case of a 5% lethal pandemic)..and its not hard to pick one's choices...

I hope no-one is arguing that various adjudents are totally safe, (or that any vaccine is totally safe!) the risks of ANY of them are currently far from proven,
verses the very real risks from the various diseases they are trying to treat...

i.e.
Thermistol - various peer reviewed research for the MMR have failed to demonstrate _any_ causal link to autism....

Aluminium - please read the current alzheimers research...aside from the fact that we _all_ get large environmental exposure to alumium through the modern environment the current indications are that while the _total_ removal of alumium might prevent some forms of alzheimers from developing - this is not practical for the general population, and allumium is in fact at best one of the trigger factors in some forms of dementia (as only a small percentage of those exposed to it get dimentia),
and it is the genetic triggers that is primary for causing brain plaques to form. That does'nt mean there might not be aluminium based therapies, but that does mean that even living in in a plastic bubble you will only prevent some forms of Alzheimers...

So while I agree we should try to make vaccines as safe as possible, this obviously is'nt going to be possible in the case of a flu pandemic. 

Ask someone who actually works (as opposes to living in tin-foil-land..) in the vaccine industry about the time-lines involved, and you will be in for a rude-shock...

From virus discovery it takes 3-6 months to come up with a target vaccine (whatever the technology employed, and new vaccine technology is a long, long way from production...),
a figure that everyone is working to reduce of course...
- then weeks to months to test it in a crash-program...
Then you start mass production....
(assuming your vaccine production lines are even tooled up to make these new forms of vaccines - which most are not).
Adding re-testing with adjuvants and you are looking at months, add the suggested long-term testing with adjuvants,
and you are looking at years....

So your challenge as a politician in charge of medicine and public-health will be as follows...do we :-
A) Only give out [say] 10M doses of the vaccine that we can realistically produce this year with a non-adjuvant based vaccine?
Lets say this vaccine is 100% protective, and the H5N1 mortality rate is 5% (a fair assumption) - then you've just saved 500,000 lives.

OR do you :-

B) Use a semi-tested adjuvant that the researchers say _should_ be relativly safe, but that has'nt been longitudinally tested with that specific vacine...
Use an adjuvants that x10 the amount of vaccines...
and save 10x (5,000,000) lives instead, but risk the chance that several thousand people might get sick - and possibly die from adverse side-effects...

It seems like simple maths to me....

I think we can all agree that more adjuvants should be tested, and tested more in-depth, but to pretend that any crash vaccine program (let alone one with adjuvants) wont be a crap-shoot in terms of unanticipated side-effects is to live in a dream-world...

Those people wanting a totally safe medical procedures should avoid any drugs, operations or vacccines...
ALL of which can and do regularly have lethal side-effects...

I also find it very hard to believe that either governments or industry will be "held to account" in the case of a pandemic vaccine...

With people dropping like flies in street, people would happily agree to a government indenmity for any possible vaccine side-effects when its materially obvious that it protects one from the very side-effect of not taking it..
i.e. death...
(or look to the increasing possability that the encephalitis lethargica epedemic of the 20s&30s was a side-effect of an earlier 1918 severe influenza infection).

So the choices might be like this...
5%+ chance of death in the primary pandemic,
0.5% chance of death/perminant coma from 'encephalitis lethargica' in the next 10 years...
Or a 0.01% chance of getting some undefined possible future side-effect...

The alternative will be going to the back of the queue and waiting for longitudinal studies to be completed many months (actually years) later...

...after which time the pandemic will likely have played its course in several waves - so you've either survided (or not) the pandemic....

So I dont really see the logic in much of the above....

What I DO think we should be pushing is towards more research into various adjuvants - and probably government subsidise the research AND make it 100% clear to manufacturers that as long as they are totally open with their research findings that there will be no legal consequences in the case of a pandemic...

To ask yourself why vaccine companies are'nt developing any new adjuvants - you just need to look at the whole MMR fiasco..after probably a decade + of research you launch an adjuvant, there is a later (unproven) scare, with no proven links; so after investing probably millions your product is now rejected by the public...
Ask what company in their right mind would risk such a problem again...??

Mark (ex Chemical Engineer)

Others Ive spoken with on related issues:-
1. A lead research into Alzheimers.
2. A researcher into vaccine crash-production...
(neither fields I must add I am expert in of course,
but I trust that these people know what they are talking about...)
3. Please read recent commentairy by Oliver Sax (of "Awakenings") for the influenza pandemic link...and others...


[ Parent ]
Funny you should ask.
Perhaps its time for a reality check in tin-foil-hat land..?

I was wondering why a serious subject with cases listed through out did not interest regular users of tin-foil

http://www.newfluwik...

Then I realized Flublogia is actually full of vaccine promoters. What they do is to drum up the fear in the herd (which they call cats), exaggerate the likelihood of a high CFR, insist that the government will use excessive emergency powers, suggest that one has to prep for 3 months to 18 months (which means prepping never becomes government recommendation to the public and if no one preps the only option is vaccine no matter how unsafe or untested it is), push for more funding of whatever pandemic inspired research, secure government guarantees for revenue stream before product manufacturing, secure government waiver of liability, discourage regulation and call it a reality that people must accept, promote the notion that the real enemy is the WHO or the China syndrome so there is a fall guy ready to pick up the blame when pandemic hits.

Of course you already found your fall guy if whatever adjuvant you encourage people to accept turns out detrimental:

(or look to the increasing possability that the encephalitis lethargica epedemic of the 20s&30s was a side-effect of an earlier 1918 severe influenza infection).

You would want people to believe that any side effect is not from adjuvant but from your 'simple reality' of a pandemic flu.

The only problem is you have not supplied one piece or data of study to suggest that adjuvants are safe, and evidence that more arms-length safety studies of adjuvants are unnecessary.

Now if you are not a regular user of tin-foil, then you may very well be one of those big pharma lobbyists that we so loathe. It is not inconceivable that your back ground in "a research into vaccine crash-production" aligns with the business interests of certain pharma companies or consortium.

Welcome to the Fluwiki.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
Need a premium quality tin-foil hat for a fashion statement?
The trendiest is the one with OXIDE.

Yeah, made from surplus Aluminum Oxide that were at one time intended for adjuvants, now replaced by the squalene oil based MF59 or ASO3.


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


[ Parent ]
thanks for your comments
As you so eloquently pointed out, a pandemic is a unique situation when people are 'dropping like flies' and where the usual cost/benefit equations may need to be adjusted.  No one is suggesting that we should preclude the use of semi-tested countermeasure of any kind in such situations.

However, let me point out the following:

  1. We are NOT in a pandemic right now.  THIS is precisely the time for us to work at identifying the most serious adverse effects of any potential agent we are going to use in such emergency situations for millions of people.  No one is suggesting we should give up adjuvants, but rather that we need MORE research into them! 

  2. For the purpose of saving lives in a pandemic, particularly if it were to happen soon, we may have to take a risk and use vaccines that are not well tested.  Personally I am not against the idea of using MF59 or similar adjuvants, but only if better/safer alternatives are not available.  Right now, there ARE better alternatives, and I'm pleased to say that the government appears to have seen the light.

  3. Adjuvants are not vaccines, vaccine preservatives nor indeed any other class of pharmacological agents.  It is a whole new class of biological agents in itself.  My concern specifically, and correct me if I'm wrong, is that we are tinkering with the immune system in a unique way that has ALMOST NO longitudinal studies data available, at least not for people under age 65, where the effects may be subtle and/or delayed but still cause severe life-threatening and life-long diseases.  Do we want the first major use of such agents to be in emergency use situations for millions of young people?

  4. Not only do we not have the data before the use of such adjuvanted vaccines, we do not even have the established protocols as part of regulatory requirements that would automatically seek out such conditions in vaccinees!  To the extent that this novel technique is INTENDED to stimulate the immune system BEYOND what traditional vaccines (for which we have ample experience) can do, I would suggest with respect that regulatory agencies need to come up with NEW AND ADDITIONAL ways of screening for such adverse effects.  Until the mechanism is in place to routinely screen for such conditions as autoimmune disorders post-vaccination, I would suggest that we need to proceed with extreme caution before vaccinating millions of young people in one go!

  5. In addition, most vaccine and adjuvant research is conducted by vaccine/pharmaceutical companies, albeit sometimes with government grants and in collaboration with academic institutions.  Under these conditions, and correct me if I'm wrong, there is hardly the incentive to go look for adverse reactions other than those that are currently 'on the books'.  (See my comments towards the end of the top diary.)  For example, is anyone in the industry repeating and reviewing those animal studies that show such oil adjuvants to consistently cause induction of autoantibodies?  In particular, are they testing their OWN proprietary adjuvants, or making them available for independent researchers to test, for such effects?  If you know of any, I would appreciate you posting such information.  It IS a matter of public interest, IMO.

  6. Has anyone done any follow-up investigation of those 5 service personnel with post-vaccination lupus?  Has there been any expanded research into finding such cases, either in service personnel or in the general population?  Have there been studies into the incidence of autoimmune diseases in service personnel and veterans who have received vaccinations in the last 20 years, as compared to the normal population?  If the answer is no to all these questions, and until these issues have been much more thoroughly investigated and resolved, then I would submit with all respect that the scientific community, vaccine companies, together with the government (including more specifically the DOD and VA) have not shown the standard of due diligence needed to justify emergency use of such substances on millions of young people.

  7. I agree with you on how difficult it is to get companies to invest in vaccine technology after the MMR stuff particularly.  However, the difficulty of getting investment should not be the reason for lowering the standards of vigilance that we should demand of our leaders.  Rather, the solution should lie in more public funding of research, particularly targeting the most promising technologies and products and giving them more assistance in the process of development, with I believe is the part of the intention of the new draft BARDA strategic plan.



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


[ Parent ]
sorry - was this followed on? not meaning SusanC should do it, REALLY NOT!


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

[ Parent ]
no, you didn't mean me ;-)
of course.  I'm only volunteering.  But it's gone so far down my to-do list I have to search for it....



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


[ Parent ]
the task of searching down your own to-do list is just not posible, i know :-)


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

[ Parent ]
IMO, I believe TPTB should do
at least 3 things:

  1. Urgently fund a series of independent (of manufacturers) animal studies to verify whether these oil adjuvants especially squalene do indeed stimulate autoantibodies, as the studies I quoted suggest.  ie repeat those and similar studies to see if the results are reproducible by other labs.

  2. Ask the DOD/VA for full disclosure of the vaccination history of those 5 personnel, and specifically ask whether any of them have been given formulations that are different from FDA approved commercial versions.

  3. Fund a larger scale review of Army and VA medical center records to find a) any other post-vaccination severe illnesses among service personnel, and b) the incidence of lupus among service personnel.

The problem is right now, as far as I can tell, all the research on MF59 is done by researchers connected to vaccine companies, albeit sometimes in collaboration with other entities.  I understand there are IP issues that may make that necessary, I just don't know whether the regulators are sufficiently alert to ask the right questions!



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


Australia: Sugar finding could help fight flu
http://www.abc.net.a...

Research has shown that a component of the natural sugars in plants could make flu vaccines up to 100 times more effective.

[snip]

The hospital is looking for people to trial a vaccine containing the substance.

"It could potentially be available within a year or two," Professor Petrovsky said.


You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


OT: Asbestos lobby - a slow death similarity
I googled "asbestos lobby"

http://www.google.ca...

to try to understand how lobbies work, and to my dismay I found an example in my own backyard (Canada):

http://www.canada.co...

selling asbestos to Indonesia;

and this article:

http://www.btinterne...

In his presentation, Mr. Vojakovic spoke of the effectiveness of the Australian asbestos industry's defensive strategy including its manipulation of medical and scientific research to forestall legislative action and prevent victims' compensation claims from succeeding. The misuse of science by asbestos stakeholders was the subject of Dr. Arthur Frank's contribution Science for Sale. The commercial use of corrupt science and industry-commissioned scientists by vested interests has been on-going for some considerable time. The tobacco industry began honing the use of public relations (PR) companies and disinformation campaigns to confuse smokers and mislead government agencies over the health effects of smoking in the 1950s. The infamous PR company Hill and Knowlton (H&K) which represented big tobacco also represented Johns Manville, the biggest asbestos group in the U.S., and the Asbestos Information Centre, the UK's asbestos trade association. With the involvement of H&K, asbestos stakeholders went on the offensive; whereas formerly their efforts had primarily been on hiding information and suppressing detrimental research findings, H&K coordinated a disinformation campaign with slogans such as: "Where would we be without asbestos," and "Asbestos - it's a natural." The objective of the coordinated PR onslaught was to influence worker protection legislation, the outcome of legal cases and Congressional and Parliamentary action which could affect profit margins. Eventually, however, the truth emerged and asbestos litigation began to take its toll, bankrupting major U.S. asbestos producers and users: U.S asbestos liabilities now stand at over $100 billion.

The propaganda which was spread shortly after the attacks on the World Trade Center on September 11 is a classic example of the use of disinformation to muddy the waters. Within days of the attacks, a "so-called" expert was claiming that the reason the buildings collapsed was their lack of asbestos fireproofing! Dr. Frank was confident that, despite the ongoing propaganda campaign on behalf of this moribund industry, progress is being made: 40 countries have banned asbestos, action is being taken on the transborder movement of asbestos-contaminated ships (the Clemenceau), the World Trade Organization upheld a country's right to ban asbestos and the ILO has recently passed a pro-ban resolution. Concluding his talk on an upbeat message, Dr. Frank urged delegates to work together to counter the damage being done to workers and the public by the globalization of capital.

You want perspective. I want perspective. Let's talk. We don't have to agree on every thing. If we do, one of us is redundant.


Uniklinikum Bonn under Flu Attack
As per the latest news Professor MD Michael Lentze - head of Bonn University Cynics died today due to Swine Flu.

Coral Quiet


Dr. Lentze reported on a woman's death, according to this article.
BONN, Germany  German medical authorities are reporting the country's first swine flu death in a person with no other known health problems.

Bonn's university hospital announced the death Friday of a 48-year-old woman. Michael Lentze, medical director at the Bonn hospital, said the woman had been healthy until being infected suddenly with swine flu.[snip]
http://www.metronews.ca/ottawa...

I'll post this in today's news.  Thank you for the information!

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


[ Parent ]
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