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Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic VI - Squalene Antibodies Revisited

by: SusanC

Mon Jun 29, 2009 at 20:05:25 PM EDT


Click on the links for

A newly published study appears to refute the connection between the presence of anti-squalene antibodies and Gulf War Syndrome, but is it convincing?

SusanC :: Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic VI - Squalene Antibodies Revisited
First, a quick recap.  The US government is stockpiling both antigens and adjuvants for the H1N1 vaccine, in anticipation of possible mass vaccinations in the fall.  Other governments (eg UK, Canada) have placed orders for adjuvanted flu vaccines for the current pandemic.  The use of adjuvants would mean a smaller amount of antigen required per dose, making it possible to vaccinate more people sooner.  Sounds good?  Except that these adjuvants are not yet licensed by the FDA, and their safety continues to be a cause for concern.  

One controversy that refuses to die has its origins in the discovery of antibodies against squalene by researchers in Tulane University in Gulf War veterans, recipients of the anthrax vaccine, and participants in NIH trials who received the squalene-containing adjuvant MF59, all of whom suffering chronic multisystem disorders loosely described as Gulf War Syndrome (GWS).  A recent exhaustive report from the Veterans Administration describes what happened next:

After its publication, the Asa/Tulane squalene antibody research was criticized by government scientists and panels. Critics questioned the idea that squalene, when injected, acted as an antigen, and whether the assay used had actually detected antibodies to squalene. Within months, however, investigators at Walter Reed Army Institute of Research (WRAIR) published research showing that squalene can act as an antigen and that antibodies could be detected in a model system.

Indeed, the DOD (Walter Reed) results show that squalene antibodies can be detected in a small percentage (7-15%) of normal population, comparable to the results from Tulane (5-16%), thus validating the Tulane tests.  What they did NOT do, however, was to test actual GWS sufferers.  Such an omission is particularly glaring, and the VA report remarked on it, in no uncertain terms:

Primary Gulf War squalene antibody question unanswered.

Eleven years after the squalene controversy was first publicly raised, studies have addressed several related questions....The observation from the Asa/Tulane studies that is most relevant to the health of Gulf War veterans, however, has not been further evaluated. Their initial study, reported in 2000, indicated that symptomatic Gulf War veterans had detectable levels of IgG antibodies to squalene, but that healthy veterans did not.This raised a testable hypothesis concerning an objective measure of an immunological abnormality that distinguished ill from healthy veterans. The Asa/Tulane studies may have correctly identified excess rates of squalene antibodies in ill veterans, whether or not they were caused by vaccines, by vaccine contamination, or by clandestine use of an unapproved adjuvant. It is important to determine whether the observed association between squalene antibodies and Gulf War illness is supported, or refuted, by more definitive research.

This story is important because, according to the VA report, GWS affects >25% of Gulf War veterans, and few have recovered.  If squalene-based adjuvants are somehow responsible for (or at least associated with) GWS, and if we vaccinate millions of people as quickly as we can with an adjuvanted pandemic vaccine, the consequences could make the 1976 swine flu vaccine fiasco look like a cakewalk.

Now, after 11 years, the DOD has finally done a study comparing squalene antibody levels in ill vs well military personnel.  The paper is available free at this link Antibodies to squalene in US Navy Persian GulfWar veterans with chronic multisymptom illness

ABSTRACT: Since the end of the 1991 Gulf War, there have been reports of unexplained, multisymptom illnesses afflicting veterans who consistently report more symptoms than do nondeployed veterans. One of the many possible exposures suspected of causing chronic multisymptom illnesses Gulf War veterans is squalene, thought to be present in anthrax vaccine. We examined the relationship between squalene antibodies and chronic symptoms reported by Navy construction workers (Seabees), n = 579. 30.2% were deployers, 7.4% were defined as ill, and 43.5% were positive for squalene antibodies. We found no association between squalene antibody status and chronic multisymptom illness (p = 0.465). The etiology of Gulf War syndrome remains unknown, but should not include squalene antibody status.

So they examined the serum of ill vs well veterans for squalene antibodies, and didn't find any difference between the two.  Case closed, right?  

Not so fast.  The lesson, as we have learned many times throughout this series, lies in detailed examination of their methodology.  This current study is based on serum collected during an earlier study Increased postwar symptoms and psychological morbidity among U.S. Navy Gulf War veterans, which surveyed active duty personnel among Seabees (Navy contruction workers), who were among the earliest groups complaining of symptoms.  

In late 1994 and early 1995, epidemiologic teams made three visits to each of the two Seabee Centers. Written informed consent was obtained from each participant. The study included an eight-page questionnaire, and the donation of clinical specimens (sera and whole blood) [3]. The questionnaire was introduced by research staff and self completed by the study subjects. Clinical specimens were preserved at - 70 C. The questionnaire collected information regarding prewar medical history, war exposures, and symptoms occurring for 1 or more months since July 1990.

Since this original survey was only conducted among active duty personnel, there is already some bias because the study excluded those who may have left service due to sickness since the end of the Gulf war in 1991.  That is the first bias.

The current study goes further than that.  It's common in studies to exclude certain subjects for reasons that are relevant to a particular study, but here, the exclusions defy comprehension or logic.  First of all, and most eggregiously,

Potential subjects were excluded if they reported bad reactions to immunizations or injections,

Look, this study was supposed to discover or refute any relationship between chronic multisystem illness and possible reaction to vaccines containing squalene.  The first thing they exclude is anybody who reacts to vaccines??  

There are other exclusions:

or reported cancer, tumors, lung disease, hepatitis, neurological problems, digestive disease, or psychiatric illness. Additional exclusions included self-report of leishmaniasis, HIV infection or AIDS, malaria, any psychological disorder, sleep apnea, narcolepsy, thyroid disorders, or mononucleosis that resulted in at least a 1-week loss from work or school since age 16. Females were also excluded due to the small numbers of participants

Hmm, I don't know.  This looks like a LONG list of exclusions to me (144 subjects were excluded).  Does it seem like they were keen on INCLUDING those who might actually be sick??   Let's see what they DO include:

Subjects who reported unusual fatigue and at least three of the additional 38 symptoms listed in Table 1 were defined in these analyses as "ill." Those without any reported symptoms were categorized as "well"

In other words, fatigue is a required symptom (more on the 38 later) in order to be considered as 'ill' in this study,  Here's the problem.  GWS covers a wide range of symptoms, of which fatigue is only ONE of several possible symptom domains, and by no means the most common one.  Many GWS sufferers have a variety of other symptoms but not necessarily 'unusual fatigue', as shown by this table from the VA report.

There are other exclusions, including 371 deemed to be "not well, not ill", in addition to the 144 above, and another 151 for whom there was 'insufficient serum'.  

One telltale sign that this study group is NOT representative of GWS sufferers, is that they found only 7.4% of subjects fulfilling their criteria of being 'ill', whereas surveys by other researchers (with 1 exception) consistently show 25-30% excess illness in different study groups:

If you have read thus far, and have gotten thoroughly confused, it's time to start asking whether your confusion is accidental.  The point is, by

  1. artificially excluding vaccination-related issues eg history of reaction to vaccines, or
  2. symptoms commonly found in GWS eg gastrointestinal, neurological, or psychiatric conditions, and
  3. by restricting inclusion criteria to only those with 'unusual fatigue',
the authors have managed to remove a lot of possible cases where the detection of squalene antibodies may be significant.  

Also, the original authors of the 1994 study identified 22 commonest symptoms reported by 5% or more of study participants.  This current study, however, expanded the list of symptoms to 38, including nightmares, crying spells, abdominal pain, swollen glands, asthma, fever, suicidal thoughts, inflammation of the eyes etc.  This expansion of inclusion, of symptoms that were NOT commonly reported by the study subjects, increases the likelihood of subjects being included as 'ill' who are in fact not suffering from GWS but from the normal range of conditions that one would find in any military unit.

Next, we get to the squalene antibody test itself.  Despite ALL of the above, we can still see some associations.    


In the original 1994 survey, 30.2% of deployed and 1.4% of non-deployed personnel reported having received anthrax vaccination.  With the current study, ignoring the authors' grouping of 'ill' vs 'well', and just looking at the deployment status, you'll find that 52% (91 out of 175) of those who had been deployed to the Gulf tested positive for squalene antibodies, vs 39.8% (161 out of 404) of those not deployed.

Is that significant?  Is there a pattern here?  I don't know, I'm not a research scientist, but as a parent who may have to decide whether adjuvants are safe for my kids, I can only say that the way this study was performed, after 11 years of foot-dragging, leaves me with very little confidence that we are anywhere near getting to the truth of the squalene antibody issue.

Finally, in what may be the most significant omission of this whole fiasco, the authors made no attempt to correlate squalene antibody status vs whether the subject reported having received anthrax vaccine.  Since the original hypothesis was that these troops may have gotten sick from the vaccine, either because of contamination or because of illicit use of unlicensed adjuvants, wouldn't it be important to discover whether those who received the vaccine were more likely to test positive for squalene antibodies that those who did not?  And, to turn the question the other way round, IF the DOD has found there is NO correlation between someone receiving the anthrax vaccine and testing positive for squalene antibodies, don't you think it would be SO much more confidence-building, if they can PUBLISH such a finding?

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it seems to me these diaries on adjuvant safety
have taken on a life of their own.  When I first started writing about the subject, I never knew the whole thing would grow and grow as it has done.  Those of you who have followed this with me from the beginning, will remember how one question led to another.  Unfortunately, most of my/our questions still have not been answered.  

Since we are now in a pandemic, the question of adjuvant safety takes on another level of urgency.

This diary is the latest where I explore one particular aspect in detail.  Sometime in the future, hopefully soon, I'll probably try and summarize all the findings to date.  Until that happens, and even after that, I have a feeling that this subject will continue to be a work in progress.  Thanks for everyone's patience.



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


thank you
for taking the time to do this... it seems very much as if we are between a rock and a hard place on this one, as we know without a vaccine that we are in for a very bumpy ride, and it would seem that with one based on adjuvants , we are in for an equally bumpy ride , albeit of a different order. As a parent , it will be difficult, should it become apparent that this virus is becoming more virulent, to decide what risk is the risk to take.. I have an aunt that suffers from SLE and my own blood tests were equivocal following several miscarriages, so I know how devastating the disease can be.
As an aside, Susan, which current children's vaccines make use of adjuvants in the UK? I am sure I read that they are already being used, and given the bumper crop of vaccinations our young ones are exposed to already, any further use must be a major concern.

[ Parent ]
novel adjuvants in the UK
As an aside, Susan, which current children's vaccines make use of adjuvants in the UK? I am sure I read that they are already being used, and given the bumper crop of vaccinations our young ones are exposed to already, any further use must be a major concern.

Here's a list of UK immunisation schedule.  http://www.immunisation.nhs.uk...

A number of these vaccines are adjuvanted with alum (aluminium hydroxide).  Recently, Cervarix, a vaccine against HPV, was added to the list.  Cervarix (by GSK) contains a novel proprietary adjuvant AS04, which is a combined adjuvant containing alum as well as MPL, an oil-based adjuvant.  The UK government has signed contracts again with GSK for pandemic vaccine using another adjuvant AS03, "composed of squalene (10.68 milligrams), DL-alpha-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams) " (source)

Now, alum has been in use for decades.  The mainstream opinion is that alum is safe, although if you look carefully, the safety data is simply not there (ie there has not been any study done to demonstrate its safety)  The regulation and safety monitoring of drugs and vaccines is an evolving process, and alum, like many older substances that predated current regulations (thimerosal comes to mind), was simply 'grandfathered in'.  Experts have said that alum would probably not meet with regulatory approval today. http://biopharminternational.f... Indeed, recently, alum has been found to be associated with the development of a distinctive neuromuscular condition called macrophagic myofasciitis.  

Interestingly, the VA report on GWS (link in diary above) also commented on the potential adverse effects of alum-adjuvanted vaccines, of which the licensed anthrax vaccine is an example.  Another alum-adjuvanted vaccine that has caused some controversy is Gardasil, the HPV vaccine licensed in the US.  A recent report suggests that it is associated with many times more severe and fatal adverse event reports than Menactra, a meningococcal vaccine given to the same age group.  http://familylifenz.wordpress....

Having said all that, the bigger problem IMO lies with the 'novel' adjuvants, such as MF59, AS04, or AS03, where quite simply there are too many unanswered questions.  Let's take Cervarix, for example.  If you look up the safety data for this vaccine, eg from reviews like this one, you will find that the clinical trials were done using alum or an alum-adjuvanted vaccine as controls.  In other words, there were no 'real' placebo-controlled studies (or at least I didn't find any) where you would use a totally inert substance like saline as placebo for comparison.  This practice of using another adjuvant as 'control' is alarmingly widespread, eg for Gardasil in the US.  So if/when you read studies that conclude there is no difference in adverse reaction between vaccinated subjects against controls, you have to be real careful and find out what kind of 'controls' were used.  

If that sounds remarkably similar to the creative selection of subjects in the squalene antibody study on the top diary, you're probably right.  The only advice I'd give would be, buyers beware.  Of course, that is easier said than done, since most people do not have the wherewithal to read scientific journals, and the information given out by governments are often less than useless, like this one about the HPV vaccine from the UK.  Check out that link.  It would be funny if it wasn't so serious....



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


[ Parent ]
Susan, I am looking forward to reading this diary in its
entity and will be back soon with questions or comments.  Obviously this is something that you have carefully studied and know a great deal about.  Thank you for taking the time to lay all this out for us.

GW


Who's minding the store?
How can our regulatory bodies deem this research to be adequate?  I keep thinking "3-card monte" or "sleight of hand" or "smoke and mirrors" and definitely have no feeling that our watchdogs are alert.  

The plan is to rush a vaccine and vaccinate everyone, and we just cross our fingers that nothing goes wrong?  We should remember that the corporations are protected from lawsuits now because this is an emergency (not sure of the wording, but it's a new law).  (Is the government itself protected?)  If the government approves a vaccine that later proves to ruin the health of x% of our children, whose fault will it be?

Being in a hurry to vaccinate as many as possible is understandable, but cutting corners and lying to ourselves about safety isn't what I'd call protective.  One question: how much protection would there be from one dose, even if the ideal is 2 shots?  Would it be better to give everyone a partial shield that's safe?

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


see comment directly below
by UK-bird... no one has said full speed ahead.

[ Parent ]
they haven't made the determination yet ;-)
How can our regulatory bodies deem this research to be adequate?

In fact, the FDA has been pretty cautious about the use of novel adjuvants.  Last December, they co-sponsored a meeting with the NIAID where the safety of adjuvants was explored over 2 days.  YOu can find the full transcripts of that meeting here.  In February of this year, Norman Baylor from the FDA gave a speech at the Phacilitate vaccine forum in Washington where he asked many of the questions that I/we have been asking here, eg are current mechanisms adequate for uncovering unusual or delayed adverse events?

Nothing is decided yet, and many people are looking at these issues.  The important thing is to remember that there are different branches of government and different agencies, each with their own responsibilities.  The squalene antibody issue is historical, but relevant to our understanding of how to evaluate the data around adjuvant safety.



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


[ Parent ]
Canada-U.S. may go different routes on pandemic vaccine production
http://www.google.com/hostedne...

Canada and the United States may go separate ways when deciding whether powerful boosting compounds called adjuvants should be added to swine flu vaccines, experts suggest.

Canada will likely use adjuvanted swine flu vaccine, says Dr. David Butler-Jones, head of the Public Health Agency of Canada.

But it is not a slam-dunk that regulatory authorities south of the border will clear adjuvanted flu vaccines for a U.S. mass vaccination campaign - if one takes place - this fall, some American experts say.

"The risk-benefit of using an adjuvant in a population in which you don't have a lot of data, i.e. younger people . . . has to be balanced against ... what's going on," says Dr. Anthony Fauci, head of the U.S. National Institute of Allergy and Infectious Diseases.

Cont.


this is a timely debate
"It (adjuvant) makes it a brand new vaccine," Fauci says.

He notes the FDA would have to decide whether it was satisfied by safety data generated in Europe, where one manufacturer, Novartis, has an adjuvanted flu vaccine licensed for use in seniors. "The FDA's going to have to look at it and say: Does this extrapolate to teenagers or people in their 20s or 30s?"

Precisely!

Particularly as Novartis's own data suggests that at least 34% of adverse events are reported by non-elderly adults, who probably make up a tiny fraction of vaccinees, since the vaccine is not licensed for anyone under age 65.  More here http://www.newfluwiki2.com/sho...



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


[ Parent ]
Antibodies to squalene in US Navy Persian Gulf War veterans with chronic multi-symptom illness
Below is a description of the above captioned study and its results and conclusions.  What follows afterward are some comments, analysis and suggestions for how a study like this could be conducted properly.

Grattan Woodson, MD

Abstract:
Since the end of the 1991 Gulf War, there have been reports of unexplained, multisymptom illnesses afflicting veterans who consistently report more symptoms than do nondeployed veterans. One of the many possible exposures suspected of causing chronic multisymptom illnesses Gulf War veterans is squalene, thought to be present in anthrax vaccine. We examined the relationship between squalene antibodies and chronic symptoms reported by Navy construction workers (Seabees), n = 579. 30.2% were deployers, 7.4% were defined as ill, and 43.5% were positive for squalene antibodies. We found no association between squalene antibody status and chronic multisymptom illness (p = 0.465). The etiology of Gulf War syndrome remains unknown, but should not include squalene antibody status.

Results:
1245: Screened for DOD GWS Study
666: Excluded from study
579: Included in study

From the tables presented by Susan above, here is a narrative describing the DOD study results: among the 175 deployed Seabees 29 or 16.6% had GWS symptoms with 55.2% of these being positive for squalene antibodies.  There were 146 deployed subjects described as well of which 51.4% of them were positive for squalene antibodies. Among the 404 non-deployed Seabees 14 or 3.5% reported GWS.  Of these, 35.7% tested positive for squalene antibodies. There were 390 non-deployed Seabees described as well in whom 40% tested positive for squalene antibodies.

Study Conclusion:
These results indicate that there was no significant differences in the percentage of vets with squalene antibodies between the groups deployed and non-deployed.  In those complaining of GWS, there was no difference in the percentage of squalene antibodies between those with and those without squalene antibodies.  This study shows that squalene antibodies are not related to symptoms of GWS.

Comment:
The fact that so many eligible vets were excluded from the study raises significant questions regarding the legitimacy of the data.  It suggests the protocol itself (study design bias) was biased against finding any relationship between vaccination and GWS.  Since the DOD did the study (institutional bias), this too represents a significant bias that can not be discounted and it alone could be grounds for discounting their findings since they are potentially liable for causing GWS in the vets they forced to be vaccinated, some against their will.

The DOD is not an objective organization.  The findings of all DOD studies conducted by DOD personnel or contractors are subject to both executive and military review.  Any "findings" developed that are not consistent with DOD policy can be changed by executive authority to make it consistent.

IMO, the question asked by the investigators is an important one but it can not be answered by this study due to the design bias (indicated by the exclusion of so many eligible subjects) and by institutional bias (the DOD is not capable of conducting an objective study of itself and its policies especially when one considers the severe political, career, and economic consequences of there being a causal link found between use of squalene and GWS)

This study should be repeated but not by the DOD.  A new protocol needs to be written that eliminates design bias that includes a new case definition for GWS that has been developed by an independent panel of experts. The study should be funded by the US Congress but conducted by an outside organization without any DOD relationships.  There were many hundreds of thousands of vets who severed in the first gulf war.  The best study design for this purpose is a retrospective case control study where there are two vets without GWS studied for every one vet with GWS.  This design will require a much larger number of study subjects than the number studied in the above DOD study.  

Grattan Woodson, MD


Thank you Susan for all this great info
All along I kept thinking "Well if it's used in Europe why aren't we using it here?"  Having now read everything I have to agree that caution is absolutely called for.  There are too many unanswered questions.  While my kids, dh and I are in the hardest hit age brakcets for illness/hospitalization/deaths, I don't think we will be first in line for a vax should the US go this route.  Right now the public isn't clamering for a vax yet (likely because they all assume "there will be a shot for that" - that's what the MSM keeps telling them eye roll).  But if cases spriral upwards then they will be shouting for something to be done, putting pressure on the already overtaxed FDA to do something quickly.  I don't see how they could possibly have a vax ready by fall AND have time to adequately test saftey and efficacy.  

the FDA is the most clued up
among regulatory agencies.  It's worse in Europe, where the EMEA operates a closed shop.  It's next to impossible to find out their workings.  I'm just finding out a lot about vaccine safety issues in the UK, and I must say the stuff I've read horrifies me.  I believe that is the first time I use that word, writing in public.

I'll post more info on the UK (and/or Canadian) situation as and when I can put together the relevant info.  



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


[ Parent ]
I would not have expected that.
Well, I would expect the FDA to be a bit more transparent than in Europe, but not that they had more/better info.  Despite it all, however, the FDA clearly does have too much on their plate and not enough qualified staff.  The last few years of recalls and other safety disasters have shown several serious flaws in the system.  Thanks to years of cuts while expanding their role (explain how that meakes sense?) safety is even more at risk.  Overtax them with pandemic pressures and they might explode before our very eyes.  

Please keep us posted - this is important stuff.  


[ Parent ]
this IS important stuff
Please keep us posted - this is important stuff.  

I'm spending almost all of my time on this, this past week.



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


[ Parent ]
a (small) number in Europe are following this


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

[ Parent ]
the thing about the FDA
is that their thinking (and approach) evolves over time.  The fact that they hosted the adjuvant meeting last December with the NIAID is to me very significant.  It brought out some of the most important debates on the science (or lack thereof) behind adjuvants.  It was a long hard slog for me to go through the transcripts, and there's still a lot I'm not clear about, but I would say that meeting was pivotal in changing/framing attitudes towards these novel adjuvants.



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


[ Parent ]
paranoid bumblings
I don't think that your examination of the methodology of this one study is well thought out.  You don't really provide reasons for your criticisms.  You rely on rhetorical devices to indicate that you have a problem with some of the methodology.

You mention some biases without examining the possible effect of those biases on the results of the study.  The fact that the study draws on people who were in active service in 1994 and may exclude some who may have already left active service, but you don't explain what the effect of this bias might be.  Is there any reason to think that people who had left active service by 1994 and who reported GWS might be more likely to be positive for squalene antibodies?

You say that some subjects were excluded in a manner that defies comprehension or logic, but you don't explain this statement.

The other exclusions seem pretty sensible: they're excluding people who are known to have other serious illnesses.  If you're going to question that as an exclusion, you should at least explain the objection.  It seems that they wanted to exclude people who had OTHER illnesses.

You mention that the study group is not representative of GWS sufferers, but your arguments is flawed (or just not well spelled out).  It seems like you're saying that normally 25 - 30% of Gulf War vets (not sure what you're saying) show GWS, but here only 7% of the study population had GWS.  That just means the study group wasn't representative of the Gulf War vet group.  (the confusion you refer to after that, IMO, is because you aren't making particularly coherent arguments).

When you talk about expansion of GWS symptoms, you need to realize that this is going to be a confounding factor in any study.  Not everyone agrees on what GWS is, whether it is an autoimmune disorder or a psychosomatic disorder or what.  I think that the main problem with your "dissection" is that it just implies the presence of flaws, without making good criticisms or discussing the strengths and weaknesses of the paper.  Your examination isn't balanced.

You then mention that less than 2% of non-deployed personnel reported having anthrax vaccination.  Look at the data in the table: about 40% of non-deployed Seabees had squalene antibodies.  So, if only 2% of non-deployed personnel received an anthrax vaccine, then obviously an anthrax vaccine could not cause squalene antibodies in 40% of non-deployed personnel.  I don't see how you could miss that.

I think that your examination of this article is totally unbalanced and even paranoid.


I think you misunderstood the purpose of this forum ;-)
To answer your last point first, I don't know what your definition of 'balanced' is.  If, as often happens in MSM, 'balanced' means always presenting 2 sides to the story as if both sides are fully equal and justified, then no, the purpose of this forum is not necessarily to hold being 'balanced' as the top priority, since there are times when one side of the argument is blatantly unjustified or at least much weaker than the other.  Not saying that is necessarily the case here, just saying...

Secondly, this is a discussion forum, a public place for conversations.  It's where we share thoughts and ideas, and let others wade in with theirs.  So, thanks for wading in.  

BTW, I was at a FDA meeting yesterday, and met someone from GSK who stated, in response to a comment from a member of the committee, something to the effect that they are very willing to share as much safety data with the public as possible, how they fully understand the need for transparency etc.  I thought that was such an encouraging sign, that I gave him my card and suggested to him to read the discussions here.  Of course, most people post anonymously here, and you're very welcome to do that too, but I'm kinda curious whether this is just a coincidence, that 2 diaries on adjuvants suddenly received such interest from a new member of this forum!!  

Anyway, if you are from GSK, welcome to FW!  And if you are not from GSK, welcome to FW as well!!  LOL!

OK, back to this diary.  ;-) I thought my comments were pretty clear - that this was supposed to be a study to rebut or disprove the original hypothesis, that somehow people who had received the anthrax vaccine AND who became ill (not everyone who received that vaccine did become ill, at least I never came across any suggestion of that kind) with some multi-system illnesses (including some autoimmune ocnditions as originally described in the Asa studies), may have tested positive for squalene antibodies.  And so, one of the questions that I had, when I read this paper, was whether they made a good faith effort, in INCLUDING people who were sick, and in INCLUDING people who had reported having vaccine reactions.

As I said right upfront, I'm not a research scientist, so I don't profess to having the expertise on the more esoteric aspects of  'confounding factors' etc that you seem to suggest you have.  Which of course you certainly would have, if you do work for GSK.

But I am asking a very simple question: how is it that after so many years, that the DOD would publish a study that deliberately EXCLUDE the very people who are most relevant to the question of squalene antibodies found in military personnel, ie those who reported having had vaccination reactions, and/or those who had all sorts of illnesses as originally reported in the Tulane studies?

Here's what the first study from Tulane said:

Nevertheless, all patients reported here meet the case definition recently established (Fukuda et al., 1998). In agreement with a prior study (Grady et al., 1998), some of these GWS patients also had abnormal laboratory values, including positive antinuclear antibodies (ANA;17%), anti-dsDNA (14%), autoimlow C3 and C4 (14%), anemia (14%), anti-thyroid microsomal antibodies (14%), and elevated ESR and/or CRP(22%). A minority of symptomatic patients met diagnostic criteria for classical autoimmune diseases, including Sjochogren's syndrome (8%), multiple sclerosis (3%), ALS (8%), and systemic lupus erythematosus (17%).

It looked to me there were some seriously sick people in there, and I'm sure I'm not the only one who would like to see whether those in the DOD database who were similarly sick, including those with neurological conditions like ALS, that the paper EXCLUDED - whether those people tested positive for squalene antibodies.  To find that they were not even INCLUDED in the study cohort, after ELEVEN YEARS, is disconcerting if not entirely surprising.  

Yes, of course the researchers are entitled to exclude whatever they want to exclude, to generate the data that THEY are interested in.  I just find it disappointing, that they did not address the issues that I (and probably many others) are interested in, which would at the very least involv a replication of the Tulane study, or, as Dr Woodson said above, an independent study:

This study should be repeated but not by the DOD.  A new protocol needs to be written that eliminates design bias that includes a new case definition for GWS that has been developed by an independent panel of experts. The study should be funded by the US Congress but conducted by an outside organization without any DOD relationships.  There were many hundreds of thousands of vets who severed in the first gulf war.  The best study design for this purpose is a retrospective case control study where there are two vets without GWS studied for every one vet with GWS.  This design will require a much larger number of study subjects than the number studied in the above DOD study.

I think Dr Woodson shares my/our disquiet, about conflicts of interest.  




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


[ Parent ]
btw the GSK guy today stated categorically that
the effect of adjuvants are limited to the local area and lymph nodes, and that there is no biological possibility that adjuvants can activate autoimmune diseases.

Of course, it's always difficult to prove a negative.  How does one prove NO BIOLOGICAL POSSIBILITY?  I wonder...  

It would have been SO much more convincing if he had said, as many of his coleagues would say, that there is no evidence that adjuvants triggers autoimmune diseases, even though as we know absence of evidence is not the same as evidence of absence.  There are also others who admit to 'theoretical risks', so as far as I can tell, that level of certainty, of 'no biological possibility', appears not to be shared by his industry colleagues.

It certainly is NOT shared, by the NIH scientists who made presentations at the FDA/NIAID meeting on adjuvants, like the eminent immunologist Dr Ethan Shevach, nor Jesse Goodman, who seem clearly troubled by the lack of appropriate models to use, to determine the immunotoxicity of adjuvants, as I quoted here http://www.newfluwiki2.com/sho...



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


[ Parent ]
make that THREE !! ;-D
BTW, I was at a FDA meeting yesterday, and met someone from GSK who stated, in response to a comment from a member of the committee, something to the effect that they are very willing to share as much safety data with the public as possible, how they fully understand the need for transparency etc.  I thought that was such an encouraging sign, that I gave him my card and suggested to him to read the discussions here.  Of course, most people post anonymously here, and you're very welcome to do that too, but I'm kinda curious whether this is just a coincidence, that 2 diaries on adjuvants suddenly received such interest from a new member of this forum!!  

More here http://www.newfluwiki2.com/sho...

Seems like the adjuvant safety issue is receiving a LOT of attention.  

Good!



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


[ Parent ]
nope
No, I don't work for GSK.  I'm a (currently unemployed) biochemist who came across your wiki because it is being used as a source of information by others, so I just happen to be someone who was pointed in this direction.

I'm sorry for being so harsh and I hope I didn't insult you.  I am a scientist and we tend to have thick skins because a lot of our profession involves criticizing our peers, who often happen to be our friends (or being criticized by people we respect).  I often tend to play the "devil's advocate" and try to represent the point of view that is under-represented so if you'd been arguing that adjuvants were safe, I'd probably be criticizing from a different point of view.  Playing the Devil's Advocate just comes naturally with me.

What I will do, when I have time, is try offering you the best feedback that I possibly can.


[ Parent ]
Sure, that will be great. ;-)
What I will do, when I have time, is try offering you the best feedback that I possibly can.

There's lots to talk about.  Also, why don't you write some of your own ideas, and not just give feedback?  I'm sure we can learn a lot from that.  



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


[ Parent ]
Playing the Devil's Advocate:
Why were subjects excluded if they reported bad reactions to immunizations and injections?

Since the study is looking to explore a potential link between what may be an autoimmune disorder caused by a squalene containing anthrax vaccine used during the Gulf War, they want to exclude subjects who might be succeptible to problems from injections and immunizations in the first place.  Had they included subjects who react poorly to immunizations or injections in general, then this might cause false positives.

144 subjects were excluded on this basis.  Results were obtained for total of 579 subjects.

Table 4 is where the heart of the conclusion lies and where the effects of those excluded would have an effect.  Would all 144 excluded subjects be "ill" and squalene antibody positive?  If so, that would mean 165 (88%) antibody positive ill subjects and 22 antibody negative ill subjects (12%) - which would indicate a correlation.

We don't know how many were excluded due to reporting bad reactions to immunizations or injections, cancer, lung disease, hepatitis, etc.  I think it would be a stretch to imagine that all of them were excluded because of bad reactions to immunizations.

I would certainly like to know the authors' rationale for excluding those subjects.  I wonder if they looked at the data or not and whether or not they would release it if asked (you could e-mail them and ask them what's up with their exclusion criteria).    


[ Parent ]
I'm sorry, I find that totally unconvincing
Since the study is looking to explore a potential link between what may be an autoimmune disorder caused by a squalene containing anthrax vaccine used during the Gulf War, they want to exclude subjects who might be succeptible to problems from injections and immunizations in the first place.  

Since the study is looking to explore a potential link between something that may have been CAUSED (or at least triggered) by a particular vaccination, I don't see the rationale for excluding the VERY people who may have been susceptible to developing problems with the vaccine.  Sure these same people may (or may not) have a general tendency to have reactions to vaccines.  But if we find these people do test positive, then the next step would be to do bigger cohort studies, to tease out whether the squalene antibody was more closely related to vaccination reactions in general, or specifically to anthrax vaccines.  Getting rid of them from the study cohort right from the get-go, smacks to me of "we don't really want to know what's the problem with these people!"

Had they included subjects who react poorly to immunizations or injections in general, then this might cause false positives.

Um, "Those who react poorly to immunizations" - what exactly does that mean anyway? People who do not develop an immune response?  Or people who develop excessive or adverse responses?  Please be specific, you're the scientist here!

More importantly, false positive for what?  For squalene antibodies? Why would including people who reacted to vaccinations create false positives?  If they are positive, why would that be 'false'?  

It would be 'false' only if you hypothesize 2 things:

1) that people who react to vaccines are more likely to be positive for squalene antibodies (which btw supports Tulane's hypothesis)
2) and it is NOT the intention of this study to find such subjects.  

Like I said, you're the scientist here, what do I know??  But it seems to me that if somebody tested positive, they tested positive. This is the FIRST study that the DOD did, on their veterans of whom, I might remind you, >25% are affected by GWS, and, according to the VA report "few have recovered"  If they had any 'positive' finding in this paper, instead of their current conclusion, this study would have been just the BEGINNING of researching the ramifications and implications of those positive tests.

Of course, by excluding them and/or by suggesting such positives as 'false' positives, it would ensure we will NEVER find out whether there is any significance with the squalene antibody finding.

144 subjects were excluded on this basis.  Results were obtained for total of 579 subjects.

May I remind you (and readers) that in fact, another 371 were excluded for being 'not well, not sick', according to the authors' criteria.  BTW, where did those criteria come from?  The study did not give a rationale for their exclusions, nor any reference for case definition (btw, in comparison, the Tulane study clearly used and referenced a highly credible case definition, by Fukuda et al)  Is there a case definition for GWS somewhere that says "unusual fatigue and at least three of the additional 38 symptoms listed in Table 1"?  What kind of case definition is that anyway, like what exactly counts as 'unusual'?   What is the justification for selecting those 38 symptoms?

I think it would be a stretch to imagine that all of them were excluded because of bad reactions to immunizations.

No, I didn't suggest that.  Please do not put words in my mouth.  Thank you.



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


[ Parent ]
Emailing the authors is a good suggestion though n/t


[ Parent ]
not my thing
I'm just using their peer-reviewed paper to make a point, not to create more work for myself!!.  

The point is made.  As always, others may or may not agree,
and I'm fine with that.  There are plenty more immediately important things for me to work on, than to beat a dead horse....  If it took them 11 years and umpteenth committee hearings just to do ONE study, I don't believe I have enough lifetimes to get any coherent answers out of them!

Of course, anyone else who feels like it is of course welcome to email the authors....



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


[ Parent ]
not to mention that biggest bias
of conflicts of interest, that Grattan Woodson raised, that the DOD is not a neutral party to this.  If there is any correlation between the vaccines they gave to military personnel and their sickness, the DOD is potentially liable.  It would not be in their interest to find any correlation, would there?  



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


[ Parent ]
I sent CJ Phillips an email
I've sent CJ Phillips, the corresponding author, asking if he could explain the basis for excluding subjects with poor reactions to injections and immunizations and/or release the number of subjects excluded on that basis.

[ Parent ]
oh good, thank you !! n/t




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


[ Parent ]
exclusion of bad reactions
I've been away for a while, but I got a response from CJ Philips.  He referred to figure 1 and pointed out that 144 people, only about 1.3% were excluded based on the criteria listed.  

He said that often negative reactions to vaccines develop and resolve rapidly and are often due to allergic reactions from egg proteins.


[ Parent ]
cont
"I don't see the rationale for excluding the VERY people who may have been susceptible to developing problems with the vaccine"

Again, I'm playing the Devil's Advocate.
I'm thinking that it might be on the basis that those reporting problems to vaccines would be susceptible to all vaccines and the question is about this vaccine.
If you look at autoimmune disorders and vaccines, adjuvants are known to cause antibodies to appear at higher levels in animals models (I can provide references if you like), but when it comes to autoimmune disorders, it's generally thought that microbial antibodies are a necessary cause (this is from research that isn't necessarily done on adjuvants).  
That is, there's a risk of autoimmune disorders from vaccines and they have something to do with an increase in antibodies appearing.  If Gulf War Syndrome (GWS) is an autoimmune disorder then you might want to exclude subjects who are already susceptible to autoimmune disorders because they may have developed autoimmune problems in the first place.
Of course, if the number of people excluded on this basis was far higher than would normally be expected, then this is hard to justify.

I completely agree that I don't understand why people with poor reactions to immunizations were excluded from this study.  I think I'll just email the authors and ask them.

We still don't know how many people were excluded on this basis, either.  That's a key issue.  If it's only two or three people then it wouldn't have an impact.

I'm not entirely sure what they mean by poor reactions to immunizations.  Their earlier study doesn't seem to include the questionaire (the huge Seabee study).  It might have been as simple as that on the questionaire and left to the soldiers to interpret (eg "Do you respond poorly to immunizations?").  I would suppose that they're referring to adverse responses but the authors aren't specific (I know I'm the scientist here, but I can only go based on what the authors tell me - their phrasing is vague and I'm not exactly sure what it means - it could be totally open to interpretation or it could have been specific).

"More importantly, false positive for what?  For squalene antibodies?"

False positive probably isn't the right phrase.  What I mean is that since autoimmune problems are thought to have something to do with higher than usual (?) levels of antibodies and autoantibodies, then those likely to develop autoimmune disorders even without adjuvants may show elevated antibodies anyway.

"Like I said, you're the scientist here, what do I know??"

Your questions are perfectly reasonable.  I just think your original dissection gave a critical impression that was based more on rhetorical questions than on balanced evaluation and discussion of the questions you've raised.  I think the question about the exculsion criteria of this study is the most important question, because it's potential effect on the study is huge.  My speculation on the methodology of the study is just that: speculation.  I do think that the exclusion criteria is really strange, I'm just trying to provoke discussion.

"May I remind you (and readers) that in fact, another 371 were excluded for being 'not well, not sick', according to the authors' criteria.  BTW, where did those criteria come from?"

I have seen some dispute as to whether GWS is one single illness or is a cluster of illnesses.  I think this is just a way of avoiding confusion.  Those with few symptoms might be "ill" but maybe they don't have GWS.  Part of the problem is obviously going to be in the definition of GWS.  The authors have categorized as those having MCI (multisymptom chronic illness) as those with a larger number of symptoms.  Presumably, those with more signs of illness would have a higher likelihood of testing positive for squalene antibodies if that's involved in the development of the illness.

I think the definition of GWS they used, if I recall correctly, came from their previous Seabee study.  I'm not entirely sure what the definition of GWS is considered to be, but it seems to me that the authors listed those as "ill" as being those with three or more symptoms, those as 'well' as those with no symptoms and excluded the middle.  I think they're trying to sample from both extremes with the hope of being more likely to find a correlation.

"What is the justification for selecting those 38 symptoms?"

I think that came from their large study (Gray et al., 2002).

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM.  (2002)  Self-reported Symptoms and Medical Conditions among 11,868 Gulf War-era Veterans:  The Seabee Health Study.  Am J Epidemiol.  155: 1033 - 1044.

"No, I didn't suggest that.  Please do not put words in my mouth. "

Since I pointed out the effect on table 4 that 144 ill and squalene positive subjects would have, I had to point out out that it would be a stretch to imagine that all 144 subjects were excluded on that basis.  I wasn't trying to imply that you said that.


[ Parent ]
I agree that GWS is probably a collection
of syndromes with a variety of causations.  One thing I want to emphasize again, which I said in earlier parts of this series that you might have missed, it that GWS is not the focus of my attention.  Specifically, in thie context, whether there might be a safety signal, and some relevant lessons for us to tease out.

In other words, all I'm doing, is trying to determine whether the original concerns expressed by the Tulane researchers, that antibodies to squalene might be associated with chronic multi-system disorders, including a variety of autoimmune diseases, can be put to rest with the new data.  

I just think your original dissection gave a critical impression that was based more on rhetorical questions than on balanced evaluation and discussion of the questions you've raised.

This is an internet discussion forum for the general public, not a peer-reviewed journal or something like that.  Nobody is trying to pretend this is the last word or the best explanation of the issues.  In fact, in case you haven't noticed, I'm not even trying to answer the questions I've raised.  You know why?  Cos I DON'T have the answers.  And because I/we here DON'T have access to the data, the full picture of what happened to those soldiers.  

And, again I said this in earlier parts of this series, this is a work in progress.  I'm writing about these issues because they are important and relevant to concerns about the possible use of adjuvanted vaccines on healthy young people - a concern which I might add is shared by many - and not because I believe I know the answers.  I have stated, over and over again, that people need to make up their own minds and not take anyone else's word for it, mine included.

But, reading between the lines of what you are saying, about 'balanced evaluation' etc, if having a full understanding of the issues sufficient to pass your 'test' of 'balanced evaluation' is a pre-requisite for posting on this forum, then we might as well shut up shop right now, cos we'd be back to the same old patriachal condescending world, where the public is told, "trust me, we know what we are doing, and if I say it's safe, don't worry your pretty head about it."

Is that what we want?  I'd say not!!



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


[ Parent ]
more
"all I'm doing, is trying to determine whether the original concerns expressed by the Tulane researchers, that antibodies to squalene might be associated with chronic multi-system disorders, including a variety of autoimmune diseases, can be put to rest with the new data"

I would say that no, the paper being discussed here (2009 Vaccine article), doesn't put the concerns to rest.  I do agree that the methodology leaves questions to be answered.

"if having a full understanding of the issues sufficient to pass your 'test' of 'balanced evaluation' is a pre-requisite for posting on this forum,"

I'm not trying to say that.  I think a balanced discussion needs to examine both sides.

"I'm not even trying to answer the questions I've raised"

That's why it seemed to me that your questions were meant to have a rhetorical effect.

I'm not trying to get into a verbal fist-fight.  I'd very much like to stick to the topic and just discuss the issues you've raised.


[ Parent ]
by way of clarification
"I'm not even trying to answer the questions I've raised"

That's why it seemed to me that your questions were meant to have a rhetorical effect.

I believe in informing and empowering the public, so if I do know something for sure, or with sufficient clarity, I don't have a problem saying it.    Just so you know.  ;-)



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


[ Parent ]
not POOR reaction to immunization
I'm not entirely sure what they mean by poor reactions to immunizations.

The paper says

Potential subjects were excluded if they reported BAD reactions to immunizations or injections

Big difference!!  With all respect.



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


[ Parent ]
I can read
Whatever.  I know it said "bad" and I used the word "poor."  I don't consider it that big a difference.  Next time, I'll use the word "bad."  

[ Parent ]
sorry, just that I've encountered
too many people who use words very cleverly to get away from issues.  Didn't know you weren't one of them.



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


[ Parent ]
actually with my limited knowledge
If you look at autoimmune disorders and vaccines, adjuvants are known to cause antibodies to appear at higher levels in animals models (I can provide references if you like), but when it comes to autoimmune disorders, it's generally thought that microbial antibodies are a necessary cause (this is from research that isn't necessarily done on adjuvants).

I'd say, I don't know whether it is a NECESSARY (ie 100% required) part of the equation, but it would seem that both adjuvants and specific antigens (which may not have to be specific to the autoimmune problems triggered) may both be required to trigger actual disease.  So, yeah, I think you are probably right.



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


[ Parent ]
and if you have references for that
they would be really helpful too!  



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


[ Parent ]
adjuvants and autoimmune disease
The following are some articles about autoimmune disorder either caused by vaccines, illness or adjuvants.  They are open-access so you should be able to find them for free (try PubMed or I suppose googling their titles).

Billiau A, Matthys P.  (2001)  Modes of action of Freund's adjuvants in experimental models of autoimmune diseases.  J Leukoc Biol.  70: 849 - 860.

Kuroda Y, Akaogi J, Nacionales DC, Wasdo SC, Szabo NJ, Reeves WH, Satoh M.  (2004)  Distinctive patterns of autoimmune response induced by different types of mineral oil.  Toxicol Sci.  78: 222 - 228.

Offit PA, Hackett CJ.  (2003)  Addressing parents' concerns: do vaccines cause allergic or autoimmune diseases?  Pediatrics.  111: 653 - 659.

Carlson BC, Jansson AM, Larsson A, Bucht A, Lorentzen JC.  (2000)  The endogenous adjuvant squalene can induce a chronic T-cell-mediated arthritis in rats.  Am J Pathol.  156: 2057 - 2065.

Vial T, Descotes J.  (2004)  Autoimmune diseases and vaccinations.  Eur J Dermatol.  14: 86 - 90.

Fujinami RS, von Herrath MG, Christen U, Whitton JL.  (2006)  Molecular Mimicry, Bystander Activation, or Viral Persistence: Infections and Autoimmune Disease.  Clin Microbiol Rev.  19: 80 - 94.

The basic idea of it is:
"The concept of molecular mimicry holds that the antigenic determinants of vaccines or residues contain a sequence of amino acids sufficiently similar to a self-antigen to produce cross-reactivity with the formation of autoantibodies and/or activation of specific T
cells."
(Vial and Descotes, 2004)

Lets chill.  I think you've raised really good points.  Lets try not to agitate each other.  I know I can come off as a know it all but believe it or not I am able to admit when I'm wrong.  I'm trying to learn too.  If I'm doing something that annoys you, feel free to point it out, but if we get angry with each other we'll get distracted from the issues.


[ Parent ]
thanks, much appreciated
and yes, about the chilll part,  ;-)



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


[ Parent ]
devil's advocate
From my own perspective, playing the devil's advocate is good, but obviously not enough. ;-)

Thanks for keeping the interest alive.  This IS, and will be, an important subject.

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


[ Parent ]
Autoimmune disorders, anti-bodies and gender
In the posts above, Susan C provides data on the prevalence of various autoimmune antibodies in veterans of the 1st Gulf war from the Tulane study.  

   

Nevertheless, all patients reported here meet the case definition recently established (Fukuda et al., 1998). In agreement with a prior study (Grady et al., 1998), some of these GWS patients also had abnormal laboratory values, including positive antinuclear antibodies (ANA;17%), anti-dsDNA (14%), autoimlow C3 and C4 (14%), anemia (14%), anti-thyroid microsomal antibodies (14%), and elevated ESR and/or CRP(22%). A minority of symptomatic patients met diagnostic criteria for classical autoimmune diseases, including Sjochogren's syndrome (8%), multiple sclerosis (3%), ALS (8%), and systemic lupus erythematosus (17%).

I was shocked to see these values!  Why, well why no gender was given for these vets in this quote and there are many women in the US military, the vast majority of these people with these anti-bodies were almost certainly male.

So, what is the beef?  Specifically, it is well known that women have a higher prevalence of auto-antibodies than men.  We do not know why this is but it is undoubtedly true.  However, the rates of auto-antibody prevalence seen in this mixed gender group clearly exceeds that found in women generally and much higher than that seen in men.

Since the majority of those within this group with these auto-antibodies are almost certainly men given the demographics, this degree of auto-antibody prevalence then is a very important anomaly meaning it is a totally unexpected result that is currently unexplained.

Here are a few questions that come to mind; 1) what is the prevalence of these auto-antibodies, most of which are associated with auto-immune disease among a random sample of these vets compared to an age and sex matched prevalence of other US citizens? 2) what is the rate of GWS in US vets who served anywhere within the military with these auto-antibodies compared to US vets serving anywhere within the military without the auto-antibodies?  

To do this study would require a defined and appropriate definition of what exactly GWS is.  Once this is developed, then those with GWS can be identified and compared with those without this condition.  

Grattan Woodson, MD


good questions, Grattan!
The original paper by Asa et al didn't give the exact gender distribution but it did say that this was a predominant male population, as you said, and also made similar observations about how unusual it is to find such a lot of autoimmune conditions in a predominantly male, previously healthy (how else did they get into the military?) young population.  

I am again reminded of what I wrote about before, 5 cases of 'post-vaccination lupus' in military personnel, of whom 2 were male.  In that paper, the author just reported the cases, and didn't comment on the most glaring commonality of these cases: that they were ALL in military personnel!

As you said, what's the beef?



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


[ Parent ]
Times
The times in which we live are too complicated. Drugs whose names did not pronounce on the disease, which they do not understand. Basically there are few things really safe for children. Squalene antibody seems to be an issue still unresolved.

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