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Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic III - The Story of Fluad

by: SusanC

Wed Oct 17, 2007 at 12:47:02 PM EDT


( - promoted by SusanC)

Click on the links for

Reading the fine print, on the safety profile of adjuvanted flu vaccines.

The equivalent of "read the fine print" for a scientific paper is "read the data".  The interpretation of the data can be skewed by an author to support a larger agenda  Or an author can make mistakes.

Gary Matsumoto, Vaccine A, published by Basic Books 2004, p 134.

SusanC :: Adjuvants, Autoimmunity, and Vaccine Safety in a Pandemic III - The Story of Fluad

In reviewing this whole issue of safety around MF59 and the influenza vaccine, I've come to realize that the biggest challenge, and the commonest pattern that I've come across, is the difficulty of trying to pin down the truth.  In part II, I gave a few examples of statements made or written by scientists and authorities that, on closer scrutiny, do not always support the point they are trying to make, like here and here.

Because of this, I'm now going to focus on finding out whether and where any discrepancies or misrepresentations might lie, in all the 'evidence' that have been used to support the case that there is no cause for concern.
Maybe there isn't, but I believe we owe it to our children to exercise due diligence, and scrutinize this to the best of our ability. 

In this diary, I'm going to cover the adjuvanted influenza vaccines specifically, both the licensed seasonal flu one, and the pandemic vaccines under clinical trials.  Again because of the length, I will have to save the rest of the discussion for another diary!

FLUAD

  1. Fluad is the licensed MF59-adjuvanted vaccine for seasonal flu.  First some basic facts:

    • This vaccine was first licensed in 1997 in Italy.

    • In 2000 it was licensed in the rest of the EU via a European Mutual Recognition Approval mechanism, ie it did not have to go through more regulatory barriers in other countries once it was approved in Italy.

    • It is licensed for those aged 65 and over only.

    • The company claims variously that between 22 to 30 million doses of the vaccine have been 'distributed'.  That's not the same as the number of doses given, nor the number of people who have received it.  Still, suffice it to say that it's been given to millions by now.

  2. First let's look at the safety profile.  Yes, there is a series of clinical trials for subjects over 65, and the results generally show that the vaccine provides better immune response and protection.  The vaccine tends to cause more local reactions but generally these are considered mild and transient.

  3. As always, the devil is in the detail.  Let me just show one example.  This particular paper appears at first look to include a very large patient sample, which should give us a sense of comfort, right?
    Podda, The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine, Vaccine. 2001 Mar 21;19(17-19):2673-80.
    from the abstract:
    Data from a clinical database of over 10 000 elderly subjects immunised with this adjuvanted vaccine (FluadĀ®, Chiron Vaccines, Siena, Italy) demonstrate that, although common postimmunisation reactions are more frequent in recipients of the adjuvanted vaccine, this vaccine is well tolerated, also after re-immunisation in subsequent influenza seasons.

    How exactly was the safety profile determined? 
    All adverse events and specific post-immunisation reactions were recorded during the first 7 days, as well as the adverse events requiring physician consultation during days 7 through 28 post-immunisation.

    COMMENTS:

    • I think we can agree that if we are worried about autoimmune disorders, they may not manifest within this timeframe.

    • These disorders do not tend to have severe acute onset, but as generalized non-specific symptoms such as 'aching all over', which are so common in the elderly it is very likely they would not seek medical advice for them.

    • Whether one seeks physician consultation is also often dependent on socio-economic status as well, and the elderly is hardly the group that can afford to spend money except when absolutely necessary.

  4. But here's the killer phrase:
    There was no difference in the incidence of adverse events possibly related to vaccination occurring between day-0 and day-28.

    COMMENT:  It would appear that the investigators have exercised some pre-conceived judgment as to what might or might not be 'possibly related to vaccination'.
    Remember that such adjuvants are a completely different class of substance than vaccines.  We do NOT have extensive clinical experience on their effects in humans.  That being the case, would you not agree that the expecting the investigators to know what symptoms might possibly be related to vaccination is a bit like putting the cart before the horse?

  5. Let's get back to the "10,000 patient" sample question. 
    A large phase IV trial was not included in the safety meta-analysis because the safety follow-up did not include the assessment of common post-immunisation reactions, but only that of adverse events leading to a physician visit within 7 days of immunisation.

    So how many people were ACTUALLY included for "the assessment of common post-immunisation reactions" on days 0-7?  2112 for first immunization, 492 for second, 150 for the third immunization.  Now, I don't know how exactly these numbers work, but I can't see how someone can take part in the 2nd and 3rd immunizations without having been in the first.
    Which means this study evaluated about 2000 patients for the immediate period after vaccination.  Which is still a fairly large number, but hardly the 10,000 shown in the abstract.

  6. So what EXACTLY were the rest of the patients assessed for?  The rest of the 9171-2112=7059 subjects were only assessed for (see above) adverse events leading to a physician visit within 7 days of immunisation.

    In other words, unless you are desperately ill within the first week of vaccination, AND your symptoms pass the test of whether they are 'possibly due to vaccination', any other reaction would not be counted! 
    Is this enough to make you feel comfortable about giving such adjuvanted vaccine to your child?  I don't know.  Suffice it to say that autoimmune conditions as well as other syndromes such as GWS or chronic fatigue don't tend to have acute onset, but they can be just as crippling as many other severe illnesses.

  7. Studies in non-elderly subjects.  In comparison, the data on non-elderly subjects is even more scarce, irrespective of how they try to portray the issue.

    The most important one is the one on Fluad, the seasonal vaccine:

    Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults, Frey S, Poland G, Percell S, Podda A. Vaccine. 2003 Oct 1;21(27-30):4234-7.
    Abstract
    The adjuvanted influenza vaccine FLUAD is composed of subunit influenza antigens combined with the MF59-adjuvant emulsion. The vaccine was developed primarily for use in elderly populations, but non-elderly individuals might also benefit. To evaluate this hypothesis, 301 healthy adults were assigned randomly to receive two intramuscular injections of either FLUAD (150 subjects) or a non-adjuvanted vaccine, Fluzone (151 subjects), in two trials conducted at a 1-year interval. Injections consisted of 15 micrograms per 0.5 ml dose. Vaccine composition was A/Texas/36/91 (H1N1), A/Johannesburg/33/94 (H3N2), and B/Harbin/7/94 for the first injection and A/Texas/36/91 (H1N1), A/Nanchang/933/95 (H3N2), and B/Harbin/7/94 for the second injection. Immunogenicity was evaluated at 28 and 180 days post-immunization. FLUAD was generally well tolerated in healthy adults when compared with Fluzone. FLUAD was associated with increased pain at the injection site after immunization. A statistically significant increase in the incidence of injection-site warmth, chills, myalgia, and analgesic/antipyretic use occurred in the FLUAD group after the first injection but not after the second injection. In both groups, most of these local and systemic reactions were classified as mild. FLUAD was more immunogenic than Fluzone following both injections. After the first injection, statistically significant differences were found in the percentage of subjects with four-fold rises in hemagglutinin inhibition (HI) titers at 28 days post-immunization for the B antigen. After the second injection, the FLUAD group had significantly higher HI titers, a significantly higher percentage with a four-fold increase in titer, and a significantly greater percentage of subjects with titers >/=160 for the H3N2 antigen at 28 days. Only minor immunogenicity differences between the two groups were seen at 180 days. Compared with Fluzone, FLUAD was associated with increased immunogenicity and mild post-immunization reactions in healthy adults. The magnitude of increased immunogenicity in healthy adults was less than that seen in elderly populations.

    This looks pretty straight forward, they injected 150 people aged 18-64 with the regular flu vaccine, and 150 people with the adjuvanted one, fluad.  Fluad appears to cause more mild reactions but also more immunogenic, but this increased immunogenicity is not as marked as in the elderly group, and not sustained at 180 days.  In this and the rest of the studies quoted here, the subjects were followed up in similar ways as the studies on elderly subjects described above, so I'm not going to repeat myself.

    However, given that the purpose of this study is to evaluate safety as well as efficacy in a younger age group, the single most important piece of information missing from the data is the mean or median age of the subjects!  I mean 18-64 is a pretty wide range.  For example, there is a big difference if the mean age is 28 or 58!  But apart from stating this is a study for those aged 18-64, the only other mention of age in the whole paper is this one single sentence:

    The mean age and sex distribution were similar in the two groups.

  8. Other studies on non-elderly subjects that I can find include the following.  I'm including the ages given and the number of people vaccinated, to give you an idea for comparison.  The safety follow-up is pretty similar.

    Safety and Immunogenicity of Nonadjuvanted and MF59-Adjuvanted Influenza A/H9N2 Vaccine Preparations
    age 18-34, total 96 subjects, 48 each group.
    MF59-adjuvanted influenza vaccine confers superior immunogenicity in adult subjects (18-60 years of age) with chronic diseases who are at risk of post-influenza complications
    Mean age 51, 120 given subunit vax with MF59, 118 subunit vax only.
    Safety and antigenicity of non-adjuvanted and MF59-adjuvanted influenza A/Duck/Singapore/97 (H5N3) vaccine: a randomised trial of two potential vaccines against H5N1 influenza
    Mean age around 28 years.  32 MF59, non-adjuvanted 33.

The rest of this series can be found via these links here part I, part  II, part IV, and part V.

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so how much experience
is there for the use of MF59 adjuvanted flu vaccine in non-elderly subjects?  Remember that even though Fluad is licensed only for the elderly, there may have been times when physicians have used it 'off label' for non-elderly people as well.  Trouble is, we don't know how many, and certainly we don't have any safety data for those.

Anybody else who can find other studies on MF59 adjuvanted influenza (not other vaccines) vaccine human trials, please post them.

Thanks!



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


A few basic Questions:
Anyone who has ever taken a basic science class in College would find fault in all of the testing.

-1- Why is there no data on all subject(s) general health prior to test? i.e. BP, temp, well being, blood test, etc.

-2-  Why is there no data on all subject(s) age, sex, race, location, immediate health concerns/problems, etc.  prior to test.

-3-  Were tests a blind, or double blind study? 

-4-  Did the subject(s) know what they were getting?  Mental concerns about flu shots can cause illness just prior/after injections.  I know because I get stomach pains every year I get the flu shot.  "MENTAL" 

A few concerns from basic science....  did they follow basic scientific and medical testing procedures....?

---------------------------------------------------------

What I'm talking about is:

Were the test done in a scientific and proper manner?

Will the results be usable by the medical community?

------------------------------------------------------------

A scientific test:  It is a test that can be repeated time and time again and you will get the same results each time.

My point is maybe the authors of the papers did some editing prior to publishing......

Sorry SusanC I had to ask..... RICH

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


good questions ;-)
Some of these issues are addressed in some of the studies, and I'm not going to quote all of them, cos there's just lots.  I'm only highlighting the pertinent issues.  Where there are very obvious points of concern that are not addressed, like the age issue, both for the non-elderly, as I wrote above, but also for the elderly as well.  This study for example, was conducted with institutionalized elderly subjects.  2 points to note:

  1. The mean age of the subjects was 83.3.

  2. Let me quote the paper on how they determine vaccine safety in this instance.  Note that in a lot of other studies, the subjects are at least asked to keep a 7 day diary.  Well, I guess it didn't work in this case, cos the subjects were too senile, maybe?
    Post-immunisation reactions were recorded by means of a questionaire at the end of the first week after immunisation concerning local reactions (induration, redness, soreness and swelling) and systemic reactions (headache, malaise, myalgia, shivering, fever).

Here's my question: how many 83 year-old institutionalized people are capable of remembering what they had for dinner the night before, let alone whether they had any of these symptoms for 7 days prior?  What do you think gets recorded if the subject is uncertain or unable to communicate?

Were the test done in a scientific and proper manner?

Will the results be usable by the medical community?

Well, Richard, these results are published in peer-reviewed journals.  I'm no scientist nor academic, I'm sure I'm not qualified to make a judgment as to the veracity of claims in such publications..



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


[ Parent ]
Thanks SusanC
I remember POLIO vaccine when it came out.  It was the end to all ends for people inflicted with polio. 

I also remember that people were infected from the first vaccine because they used it too soon, having not being properly tested. It took another 2 years before it was ready for general use. Today there is no polio, except in labs!

The point is not enough testing was done, and production was started long before it should have; people were hurt because of it.

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


[ Parent ]
Paranoid Questioning tells us little
You imply that the phrase "possible related to vaccination" means that the investigators restricted the possible adverse events attributable to the vaccine.  While this is true, the investigators would have pre-conceived ideas about what kind of adverse events might possibly be related to the vaccine, you need to acknowledge that the adverse event reporting may have included more adverse events than actually were caused by the vaccine.  Your implication is obviously that the investigators restricted the adverse events considered, but quoting that single sentence doesn't tell us if this is the case.  When looking at 'unsolicited' adverse events, one thing to keep in mind is that people are very apt to jump to the conclusion that some symptom they're experiencing is because of a drug they took before (the logical fallacy of "after, therefor because of").  Raising an issue with the "killer phrase" may be valid, but you really just speculate on its meaning.

I don't mind questioning these studies, but it seems silly to me that you're questioning the science of a study with rhetoric.

I suggest trying to criticize a study that is open access so at least we can read the study in full.  I can't make much of criticisms that quote a few sentences in a paper.


Again, thank you for making my point!!
I suggest trying to criticize a study that is open access so at least we can read the study in full.

that important information are hidden in subscription journals, or, worse, only in special interest conferences that you have to pay $$$$ to access.  Which ensures that the public will NEVER become aware of these goings on.

I can't make much of criticisms that quote a few sentences in a paper.

Oh, but then SURELY you know that if I quote more than snippets I'd then be accused of copyright violations, right?

btw, thank you for giving us another view of the limitations of adverse event reporting:

you need to acknowledge that the adverse event reporting may have included more adverse events than actually were caused by the vaccine.

As a newbie, you probably are not aware that such issues have been covered elsewhere on this forum - that correlation is not the same as causation, etc etc.  I'm sorry, I don't believe anyone here is capable of or interested in making every post comprehensive.  And, who wants to READ such stuff anyway??

Yeah, again I apologize. Maybe I should have added a disclaimer - in addition to the usual ones such as information not to be construed as medical advice etc - that nothing should be construed as comprehensive coverage of any issue.  But then again those who are used to blogging already know that, and one of the thing that bloggers hate most, is when people talk condescendingly to them.  They can smell condescension, like they can spot a troll, from a mile off.

At least that is my experience.  Yours may differ.



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


[ Parent ]
for everyone else
here's a good overview of the usefulness and limitations of vaccine adverse event reporting.    It covers passive surveillance, which of course is not the same as active surveillance.  OTOH, since anyone can report to VAERS including patients, through the official VAERS site AEs are less likely to be filtered out by doctors, officials, and vaccine companies.  

Contrast that with the UK system of 'yellow cards' (sorry, no link!!) where only medical professionals can report, and where the public cannot access the raw data, but instead only gets to read a summary compiled by government, that classifies reported AEs into categories as determined by the government.

Like this one on Cervarix the HPV vaccine made by GSK.  Notice how 1155 events from 442 reports were classified as 'psychogenic', as opposed to:

  • injection site reactions 752 events, 547 reports
  • allergic reactions 397 events, 231 reports
  • 'other recognized' reactions 1644 events, 901 reports
  • suspected adverse events not currently recognized - 534 events, 303 reports

Take 'syncope' for example (which btw is a fancy way of saying 'fainting').  2 reports of syncope are classified as allergic reactions, 164 are classified as psychogenic, (with an additional 13 'presyncope' in the same category) and 14 classified as suspected adverse events not currently recognized.  

Which means 91% of post-vaccination syncope from Cervarix is deemed by the UK government as psychogenic.  Is that an accurate reflection of the nature of those AEs?  I have no idea, since none of us have access to the original reports to make a determination for ourselves.

To put this in context, syncope is particularly interesting since the FDA very recently 'approved' a new label for Gardasil, the HPV vaccine made by Merck and marketed in the US, so now they are required to include syncope in 'the Warnings and Precautions section'.  Without making a determination that such reactions are 'psychogenic', the FDA deemed it necessary to warn that

Syncope (fainting) has been in Gardasil's labeling for both the healthcare provider and the patient since October 2007; however, FDA and the Centers for Disease Control and Prevention (CDC) continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil.  Some who fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider's office, and other fainting episodes resulted in motor vehicle accidents.

Which is why personlly I find the US approach much more informative, simply because of the transparency, something that, btw, GSK appears to aspire to.  I say, good for them!!



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


[ Parent ]
Just to let you know
the appalling restrictions of the Yellow Card system in England went west some years ago. Anyone can now report an adverse drug reaction (although it's still called the YC system) http://www.mhra.gov.uk/Safetyi...

[ Parent ]
oh good, thank you !!
I couldn't find it!  Shows how GREAT this forum is!

This is certainly an improvement, although I would really prefer to be able to access raw data rather than pre-disgested reports from the government.



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


[ Parent ]
I have to disagree somewhat
there are loads of places on the net you can read about people moaning about side-effects (eg, http://www.askapatient.com/vie... )

I would rather have an independent body reviewing the data on my behalf, than have to take these patients' word for it. People's recall is generally pretty poor and apt to make an unjustified correlations.

Fortunately in the UK we still have a lot independent academics examining safety and cost-effectiveness. As the NHS picks up the tab for over-prescribing, contraindications and unexpected adverse reactions, it is not in their interest to prescribe unnecessarily.


[ Parent ]
it depends, I guess
on how keen one is to examine data.  I believe the solution in principle should be to do both.  Again, VAERS is an example.  The data is there for anyone to search, but researchers, including from the CDC, also do their analyses and publish them.  

The point is, without access to real data, there is no way for independent verification in the spirit of accountability and transparency, in an industry intimately related to people's wellbeing but where data is already so difficult to find, cos so much is deemed 'proprietary' information.  Which means the public, the consumer AND taxpayer, just has to take their word for it.

Along those lines, an interesting question was raised in the FDA meeting yesterday, about the rapid sharing of any early signals on safety, efficacy, whatever.  The answer from the feds was that research by NIH is funded by taxpayers and the information will all be in the public domain, but they have limited leeway with information from commercial entities.  At that point, a member of the committee reminded everyone that any trials done by vaccine companies are ALSO paid for by taxpayers, too.  

I thought that was a good point, but no one had anything to say in response to that.  At least none that I heard!



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


[ Parent ]
wait, that site says drug safety
does that include vaccine adverse reactions?  I did a google vaccine site:http://yellowcard.mhra.gov.uk/  and got ZERO results.

Does anyone know?



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


[ Parent ]
Yes, the MHRA has responsibility for licensing vaccines
The results of their investigations are reported eg Fluvirin: http://www.mhra.gov.uk/home/gr...

You wouldn't be able to read the text of individual complaints.


[ Parent ]
This section might be useful
"The MHRA continually monitors both the safety and quality of the medicines, including vaccines, available on the UK market. The information and links in this section are intended as a source of information for parents, health professionals and others interested in vaccine safety. The MHRA position and conclusions of the Committee on Safety of Medicines (CSM) on a number of key vaccine topics are included as well as several sources of general information on vaccines and vaccine safety."

http://www.mhra.gov.uk/Safetyi...


[ Parent ]
thanks for your help n/t




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


[ Parent ]
ok this is really confusing
I tried "vaccine site:mhra.gov.uk/" which gave me 800+ results including this page monitoring vaccine safety, which included a link that said monitoring the safety and quality of vaccines and medicines but the link led to a page that says medicines safety monitoring.

Meanwhile, from the bottom of that page, it says To submit a Yellow Card please visit our Reporting suspected adverse drug reactions page.  This last said page is titled Reporting suspected adverse drug reactions and there is NO mention of vaccine on that page either.

I believe from looking through these pages that on balance, probably one CAN make a vaccine adverse reaction report there, although it probably won't get the top prize for being user friendly and helpful for the general public...



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


[ Parent ]
There is a link
under the big yellow box it says "Go to the online reporting site for the Yellow Card Scheme (opens in a new window)". Then you have to register in order to submit a report.  

[ Parent ]
OOH! How exciting!
You can get to the raw data!

If you go to the first page of the Yellow Card Scheme here: http://www.mhra.gov.uk/Safetyi...

on the left there is a box that says Patient Reporting. If you click on that it takes you to a page explaining about side effects. Toward the bottom there is a section headed "
"Downloading data collected through the Yellow Card Scheme on suspected side effects" - Complete listings of the suspected adverse drug reactions (ADRs) reported to the MHRA through the Yellow Card Scheme by health professionals and patients are provided in drug analysis prints.  Drug analysis prints can be accessed at this link:

(How do I embed a link???)


[ Parent ]
here's the link
http://www.mhra.gov.uk/Safetyi...

To see what raw data looks like in VAERS, go to the VAERS page , click on the link at the bottom to agree to their conditions, which takes you to the database.  You can also search VAERS here .



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


[ Parent ]
actually those are still not raw data
they are compilations of all reports.  Here's a better link, where it's easier to find actual reports in VAERS

Here's a test search I did, for lupus and lupus-related events, for all vaccines in a 2 year period.  http://www.medalerts.org/vaers...

Note that 60% of all lupus-related reports were made for the HPV vaccine.  Scroll down to read details of individual reports.  Now, again, this is raw data, people reporting something that happened that they thought might be vaccine-related but that may or may not be related at all.  And I'm not going to discuss Gardasil cos that is not the focus of this forum.  I'm just using this to show the kind of information you would get, from reading the raw data.



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


[ Parent ]
I know, I saw that, thanks.
what I'm trying to say is, as you navigate, very quickly you lose any reference to vaccines, causing some uncertainty as to whether you are on the right page, or whether you are 'allowed' to report there.  It's a minor quibble, just a little confusing IMO.



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


[ Parent ]
The site
is for both data collection and reporting. I don't think you need to drill down into the topics in order to make a report - the YC scheme is a separate section.  

[ Parent ]
Basic science classes
"Anyone who has ever taken a basic science class in College would find fault in all of the testing."

Anyone who has ever taken a basic science class would want to read the study.
You're appealing to emotions in your assertion and anyone who has taken a basic science class would (hopefully) ignore this logical fallacy and ask for you to point out the faults in the testing instead of just saying that reasonable people would agree.

Re: your points.

#1 - Is this a rhetorical question that's supposed to serve as a comment?  Whether or not every subject had all of the physiological parameters measured is not a meaningful basis for finding fault in the testing.  What's important are what the data made available by the tests indicate.

#2 - Again, is this supposed to be a rhetorical question serving as a comment?  The lack of data that you point to just means that less information is available upon which hypotheses can be drawn.  Just because the data you list are not available does not mean that the testing was faulty, just that the conclusions that can be postulated are limited.

#3 - DID YOU READ THE PAPER?  I don't know.  I thought you were pointing out faults in the testing, not asking questions about methodology.

#4 - The subjects may have been told that they would either get an influenza vaccine or a placebo and then would not which they received.


here's a suggestion
If you want to comment on or reply to a specific post, it's better to click on the 'reply' button, so that your reply will end up right under the original comment, in this case from Richard.  Otherwise, nobody can make any sense of what you are trying to say, or who you are trying to compliment or insult, you know...

Hope this is useful.



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


[ Parent ]
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