One of the criticisms being leveled at the government for the recent adverse flu events is the question of how thoroughly the current 2010 seasonal flu triple antigen has been tested.

This year’s vaccine contains three viral components,
• A/California/7/2009 (NYMC X-181) (A/California/7/2009 (H1N1) – like) 7.5 µg haemagglutinin per dose
• A/Wisconsin/15/2009 (NYMC X-183) (A/Perth/16/2009 (H3N2) – like) 7.5 µg haemagglutinin per dose,
• B/Brisbane/60/2008 (B/Brisbane/60/2008 – like) 7.5 µg haemagglutinin per dose, a combination not used in Australia before.

Ian Barr, the deputy-director of the World Health Organization’s influenza centre in Melbourne, was interviewed for the World Today on ABC radio on Monday April 26th, about the question of whether the current seasonal flu combination has been tested in clinical trials.

IAN BARR: In Australia we don’t require that the influenza vaccine, the seasonal vaccine is tested for combinations but they have done that overseas, so they have tested in fact giving a full seasonal vaccine with the swine flu, so four vaccines at once if you like and there were no untoward effects there.

.

So I think there’s a high expectation that the combination of these three viruses will be no different from any other three viruses which we include every year without doing formal safety testing which takes quite a period of time and it is extremely expensive and time consuming.
.

CHARLOTTE GLENNIE: So in your opinion the fact that it is a combination vaccine would have nothing to do with this situation that we’ve got at the moment as far as you know now?
.

IAN BARR: I think that’s unlikely to be a factor. Certainly all viruses are slightly different but in terms of how they’re produced in the laboratory and tested in laboratory and then made in the commercial scale vaccine production areas, they’re all investigated individually for any particular differences in those viruses which might lead to some of these things we’re seeing currently, such as fever.

.

So I think that it’s unlikely but I guess we have to wait and see on analysis of these particular batches.

.

But subsequent tests by the TGA and other independent agencies have not identified a batch related problem. The Federal Government’s chief medical officer, Professor Jim Bishop, says there is no evidence to suggest that faulty batches of flu vaccine are to blame for adverse reactions in children, although further testing is yet to be completed.

Could old technology be to blame?

But rival vaccine manufacturers are questioning the manufacturing technique used by CSL Limited. Influenza Deeds of Agreement are in place with CSL Limited and Sanofi Pasteur for the supply of seasonal, pre-pandemic and pandemic influenza vaccines, but CSL is the primary supplier of AH1N1 vaccines to the Australian government.

CSL was once a division of  the Federal government. Known as the Commonwealth Serum Laboratories, it was established in Australia in 1916, then incorporated in 1991 and listed on the Australian Stock Exchange in 1994. But CSL continue to maintain a close relationship with the government much to the critique of their rivals.

Flinders University’s Professor Nikolai Petrovsky, the research director of rival vaccine manufacturer Vaxine, says CSL’s relationship with the Federal Government virtually guarantees it funding. So CSL has no interest in developing better vaccines with new technology such as genetically engineered proteins.

“They’re comfortable to really exploit the old technology which is highly profitable to sell each year to the Australian Government.”

CSL’s seasonal flu vaccine, Fluvax, is based on technology which involves growing the influenza virus in eggs – a technology which has been around for about 50 years. Professor Petrovsky says the CSL vaccine varies from batch to batch.

“That’s one of the consequences of using a 50-year-old technology, you get that variability,” he said.

He is calling for an independent inquiry into the Federal Government’s relationship with CSL.

A spike in vaccinations means a spike in reactions?

To date, there have been 57 reports of adverse reactions (including high fevers and convulsions) in WA, six in Victoria, four in NSW and Queensland, two in South Australia and one each in Tasmania and the ACT. One child died in QLD after receiving a flu injection. Initial findings from the coroner did not find the vaccine at fault but tests are ongoing.

Prof Bishop said some three million doses of the seasonal flu vaccine have gone out this year, with up to two-thirds sent to WA.

It could be a “partial explanation” as to why the western state has experienced a much higher rate of complications, normally expected in one out of every 1000 to 10,000 cases, Prof Bishop said.

WA provides the seasonal flu shot for free to children under five, whereas the rest of the country doesn’t.

The WA trials were started after the 2007 flu season, after 8 children across Australia under five years of age, died within 24 hours of developing mild and non-specific symptoms of respiratory infection. Although the cause of death has not been reported in many of these cases, these deaths appeared to be associated with influenza A.

In 2008, almost 65,000 children aged 5 and younger in Western Australia received free flu vaccinations made by CSL and Sanofi- Aventis SA as part of a trial that reduced hospitalizations by 88 percent, the state’s health department said in a statement last year.

Each year, CSL’s Fluvax vaccine contains fragments of three different types of influenza virus as recommended by the TGA and this depends on the strains of infectious flu in the environment. In addition, flu viruses mutate from season to season so vaccines become less effective and need to be modified to keep up with the current mutants.

The components have been tested individually but not in combination.

Although the current Fluvax® combination has not been tested in Australia, the individual components have.

Fluvax® Jnr (2005/2006 batches) showed very good safety and efficacy profile in clinical trial.
.

Safety and efficacy of CSLs Fluvax® Jnr – seasonal flu vax (no thimerosal, no H1N1) This study was undertaken using the 2005-2006 flu vaccines, is designated the Paediatric study CSLCT-FLU-04-05 and was published in 2009.

The safety, tolerability and immunogenicity of Fluvax® vaccine was tested in 298 participants from a paediatric population (> 6 months to < 3 years and > 3 years to < 9 years).

.

Group A
Equal to or greater than 6 months to less than 3 years old
Biological: Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
.

Group B
Equal to or greater than 3 years to less than 9 years old
Biological: Influenza Virus Vaccine
2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
.
The total number of participants was 298 (Group A n=151; Group B n=147). There were no reports of serious adverse events related to Fluvax® vaccine during the vaccination period. Within 7 days after administration of Fluvax® vaccine, all adverse experiences reported with an incidence of 2% or greater. Unsolicited adverse events were collected for 30 days post-vaccination. Very common unsolicited events (< 1/10) reported were rhinitis, cough, teething and influenza-like illness.

.

Panvax® Jnr was tested in a 2009 trial and showed ~30% adverse effects in children under the age of 8.

.

Testing began on CSLs 2009 H1N1 Influenza Vaccine (CSL425) in July 2009, on 370 kids aged between 6 Months to 8 Years.
.
CSL Limited makes two AH1H1 vaccines, Panvax® and Panvax® Jnr (thimerosal free). The clinical trial is registered and published here.
.

Mild adverse effects were defined as adverse events easily tolerated by the participant, causing minimal discomfort and do not interfere with everyday activities (e.g., soreness at injection site)?.
Following the first vaccination:
.

• 16.3% had a mild fever (>37.5 degrees C < 38.5 degrees C) in the 15µg group
.

• 23% had mild fever in the 30 µg group
.

Combined mild adverse reactions, for 15 µg and 30 µg were 31.9% and 33.7%, respectively.

For moderate adverse reactions, 15 µg and 30 µg were 18.9% and 27.2%, respectively. This was defined as significantly discomforting, interferes with daily activity.

.

The clinical trial data was evaluated by the Therapeutic Goods Administration (TGA) and reviewed by the expert Advisory Committee on Prescription Medicines (ACPM). The evaluations found the vaccine, delivered in two doses not less than 28 days a part in children aged 6 months to 9 years, to be both safe and to offer good protection.

Panvax® was approved by the TGA on December 3, 2009 and the national immunisation program began on 30 September 2009.

The TGA has been closely monitoring any side effects from the use of the vaccine. To that date approximately 6 million doses of Panvax® had been distributed in Australia. As at 31 December 2009 a total of 1289 suspected side effects have been reported to the TGA following vaccination with Panvax® in Australia.

This is the current trial of the 2010 vaccine, containing A/California/7/2009 (NYMC X-181), (A/California/7/2009 (H1N1) – like)  A/Wisconsin/15/2009 (NYMC X-183), (A/Perth/16/2009 (H3N2) – like)  & B/Brisbane/60/2008 (B/Brisbane/60/2008 – like)
.

Current Influenza Vaccine Study in 6 month to 17 year olds
.

Australia is considering introducing the Influenza vaccine for all children under 5 years. At the same time, this study aims to improve our knowledge of the safety of Fluvax® in children aged from 6 months to 17 years old. Information from this study will help future decisions on how best to use Fluvax® in children.
.

What does the study involve? Each participant will be in the study for about 6 or 7 months. They will receive 1 or 2 doses of Fluvax®, depending on their age and how many doses of ‘flu vaccine they have had in the past. You will be asked to record certain reactions that might occur for 30 days following each vaccination.

.
This study has been approved by a human research ethics committee. In Perth the study is run by the research staff at the Vaccine Trials Group, Telethon Institute for Child Health Research in conjunction with Princess Margaret Hospital for Children and the University of Western Australia School of Paediatrics.

The latest information on the website says; “recruitment complete” which means they have enough people for the trial. I don’t know what stage they are at with respect to results. There is a brochure available here.

Parents call for calm.

Meanwhile, some parents are calling for calm and warning others not to shun vaccines completely.

Kellie Connolly writing for the Daily Telegraph on April 30th, recounts how her three year old contracted swine flu last year and was extremely ill for 2 months. He couldn’t keep food down for 13 days, lost a third of his body weight and he eventually developed pneumonia.

When she took him for his flu shot this year, around the time of the recent scare, he suffered an adverse reaction of high temperatures, vomiting and headaches.

Kellie says that of course she has concerns and she expects the authorities to thoroughly investigate them, but she was adamant;

“..As a mother of a child who’s had a terrible case of swine flu, and then witnessed an adverse reaction to a vaccine, I still say VACCINATE for everything else recommended by our health officials.”

Similarly,
Kylie Orr on the Essential Baby blog
says;

“Why would I question a free service provided by the government, which has been exhaustively researched and documented? I am not a scientist, medical practitioner or spokesperson for a pharmaceutical company.”

Ultimately, I am a mum and if the experts tell me immunising my child is the best bet for keeping them safe from potentially deadly diseases, well that’s enough for me. If someone offers a counter argument, showing me figures and relevant links, backed up by science…..”

The vaccination programme for under fives remains suspended. You can report an adverse effect to vaccination, or other drugs at the TGA website.


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  • Nescio

    Oh please,
    .
    Apologies for taking so long to come back with this – real life intruded.
    .
    I have read through Blaylock’s article about the Simpsonwood CDC meeting in 2000. I started writing a long point by point refutation of his conclusions, but about half way through I wearied of it.
    .
    Much of Blaylock’s article is horrified outrage at what he imagines happened at the meeting, which I think he has misinterpreted. To me it looks as if the meeting participants took a long hard look at the slightest possibility of mercury damaging children. The cumulative dose of mercury given to children in vaccines was exceeding some of the EPA guidelines, depending on the length of time you looked at. The dose of mercury was also uncomfortably close to doses in pregnant women that had been associated with neurodevelopmental delay in their babies (Faroes and New Zealand studies)
    http://www.ncbi.nlm.nih.gov/pubmed/9392777
    http://www.ncbi.nlm.nih.gov/pubmed/9972579
    A more recent study in the Seychelles Islands found no effects of mercury at these levels of exposure.
    http://www.ncbi.nlm.nih.gov/pubmed/12767734
    It is worth pointing out that these were chronic exposures to methyl mercury, while vaccination with a thimerosal-containing vaccine is an acute exposure to the less-toxic ethyl mercury.
    .
    There are as number of areas where Blaylock seems to have misunderstood what was discussed at the meeting.
    .
    “On page 16, Dr. Johnson, an immunologist and pediatrician at the University of Colorado School of Medicine and the National Jewish Center for Immunology and Respiratory Medicine, notes that he would like to see the incorporation of wide margins of safety, that is 3 to 10-fold margins of safety to “account for data uncertainties.” What he means is that there are so many things we do not know about this toxin that we had better use very wide margins of safety. For most substances the FDA uses a 100-fold margin of safety.”
    .
    This is simply incorrect. What Dr. Johnston (Blaylock consistently misspells his name which is a problem because there was also a Dr. Johnson at the meeting) actually describes on page 16 of the transcript are the EXISTING margins of safety in the guidelines for mercury exposure, not what “he would like to see” at all. To quote Dr. Johnston, “Specialists in environmental health have extrapolated from those types of studies to establish safe exposure levels … on chronic, daily exposure to [m]ethylmercury that incorporate wide margins. That is three to ten fold to account for data uncertainties.” The ellipsis (…) is where I have omitted “and this is an important emphasis I would like to make”, to make it clearer.
    .
    These safe exposure levels for lifetime daily exposure, that incorporate 3 to 10 fold safety margins (actually I think they incorporate a 40 fold safety margin) are the same ones that Blaylock gets so excited about earlier because vaccination, acute exposure, at that time exceeded those safety levels for chronic exposure.
    .
    “In fact, in this study they excluded premature babies and low birth weight babies from the main study, some of which had the highest mercury levels, because they would be hard to study and because they had the most developmental problems, possibly related to the mercury.”
    .
    Not true. These babies were excluded because they were often not vaccinated at all, and yet had the highest levels of neurological and developmental disorders for reasons unconnected to vaccination, as is well understood. Page 32, “We know that premature children are not vaccinated in the same way as term babies. At the same time they are at higher risk for the outcomes.” Omitting these children was an attempt to exclude a very obvious confounding factor. Page 267 “When including all premature children, irrespective of their birth weight, we found a protective effect of thimerosal above the 25 µg level at 3 months, suggesting an avoidance of vaccination in the most severe group.”
    .
    In other words, premature babies are less likely to be vaccinated than full term babies, and more likely to have problems, giving rise to a correlation between not being vaccinated and these problems. Recognised problems associated with prematurity include, “Delayed growth and development, mental or physical disability or delay”. These are the “greatest risks” that Dr. Johnston was referring to, not risks from mercury in the vaccine.
    http://www.nlm.nih.gov/medlineplus/ency/article/001562.htm
    .
    Anyway, I think the best thing to do is to look at Blaylock’s conclusions. His words are in italics (I hope) as they are above.
    .
    “This top secret meeting was held to discuss a study done by Dr. Thomas Verstraeten and his co-workers using Vaccine Safety Datalink data as a project collaboration between the CDC’s National Immunization Program (NIP) and four HMOs. The study examined the records of 110,000 children. Within the limits of the data, they did a very thorough study and found the following:”
    .
    So far so good.
    .
    “Exposure to thimerosal-containing vaccines at one month was associated significantly with the misery and unhappiness disorder that was dose related. That is, the higher the child’s exposure to thimerosal the higher the incidence of the disorder. This disorder is characterized by a baby that cries uncontrollably and is fretful more so than that see in normal babies.”
    .
    This is true, but out of the 110,000 children examined, only 81 had this disorder, and these were children who had been given only 12.5µg mercury – none of the children exposed to more mercury than this had this disorder. It is hard to come to any conclusions based on this. Blaylock has cherrypicked the positive highest correlations out of this study, ignoring the negative correlations.
    Page 270 of transcript.
    .
    “Found a nearly significant increased risk of ADD with 12.5ug exposure at one month.”
    .
    Nearly significant? This sort of correlation could so easily be due to confounders – children whose parents take them to the doctor for their vaccinations may be more likely to be diagnosed with ADD, simply because of increased medical contact, for example. In fact the correlation is negative at 12.5 µg (rr=0.96), positive at >12.5 µg (rr=2.14 95% cl 0.99-4.62).
    .
    “With exposure at 3 months, they found an increasing risk of neurodevelopmental disorders with increasing exposure to thimerosal. This was statistically significant. This included speech disorders.”
    .
    Barely statistically significant, and again, confounders are very likely. It is also a little worrying that the baseline level of these disorders in those children who had received no vaccines is based on only 23 children. If there had been one or two more or fewer children in that group (maybe some children were missed, or included in that group by mistake), the relative risks would have changed hugely.
    Page 272 of transcript.
    .
    “It is important to remember that the control group was not children without thimerosal exposure, but rather those at 12.5ug exposure. This means that there is a significant likelihood that even more neurodevelopmental problems would have been seen had they used a real control population.”
    .
    Well that’s clearly untrue in some of the analyses, as you can see on the charts of relative risk and confidence limits for exposure at 3 months, which clearly show a control group with zero exposure to thimerosal for each disorder – page 275. There could not possibly have been “more neurodevelopmental problems” anyway, though lower levels in the control group would lead to a higher relative risk in the thimerosal exposed groups, not more cases.
    .
    “No one disagreed that these findings were significant and troubling.”
    .
    Again, not true. I can’t do better than Sceptico in refuting this claim, these are quotes he found:
    .
    “Part one, is there a causal association between ethylmercury and neurological effects noted in the Vaccine Study Datalink project? The answer is no. Why not? From a toxicologists (sic) viewpoint there is no dose response relationship” (Page 191)
    .
    “To me the increasing mercury levels in your population at one month… is so small that it would suggest to me that you have a confounder here. That this is not due to mercury.” (page 213)
    .
    “I gave it a value as 1. I think the strength of the associations are mostly weak and the weaker the associations, the more likely bias might explain some of this.” (Page 217)
    .
    “This is not designed as a study to look at the effects of these vaccines on the different outcomes, but it is using data collected for other reasons, so it is not a carefully controlled prospective cohort study to study. We are using data that was collected for other purposes.” (Page 218)
    .
    “Yet when the final study was published in the journal Pediatrics Dr. Verstraeten and co-workers reported no consistent associations were found between thimerosal-containing vaccine exposure and neurodevelopmental problems.”
    .
    I think that’s a pretty fair assessment of the study as presented in 2000, but Verstraeten had carried out further analysis of the results before publishing his final report, which can be found here:
    http://pediatrics.aappublications.org/cgi/content/full/112/5/1039
    .
    “In addition, he list himself as an employee of the CDC, not disclosing the fact that at the time the article was accepted, he worked for GlaxoSmithKline, a vaccine manufacturing company.
    So how did they do this bit of prestidigitation? They simply added another HMO to the data, the Harvard Pilgrimage. Congressman Dave Weldon noted in his letter to the CDC Director that this HMO had been in receivership by the state of Massachusetts because its records were in shambles. Yet, this study was able to make the embarrassing data from his previous study disappear. Attempts by Congressman Weldon to force the CDC to release the data to an independent researcher, Dr. Mark Geier, a researcher with impeccable credentials and widely published in peer-reviewed journals, have failed repeatedly.”

    .
    The good old Big Pharma shill gambit. If Verstraeten was really so biased, why would he have reported any correlations between thimerosal and health problems in children at all?
    .
    “It is obvious that a massive cover-up is in progress, as we have seen with so many other scandals – fluoride, food-based excitotoxins, pesticides, aluminum and now vaccines. I would caution those critical of the present vaccine policy not to put all their eggs in one basket, that is, with thimerosal as being the main culprit. There is no question that it plays a major role, but there are other factors that are also critical, including aluminum, fluoroaluminum complexes, and chronic immune activation of brain microglia.”
    .
    Blaylock shows his true colors here I think. It isn’t obvious to me that any sort of cover-up is in progress.
    .
    “In fact, excessive, chronic microglial activation can explain many of the effects of excessive vaccine exposure as I point out in two recently published articles.”
    .
    I don’t know if Blaylock’s theories about chronic microglial activation have any merit. They only seem to have been published in alternative medicine journals. The point is that this meeting did not find any convincing evidence of a link between vaccine exposure and any problems at all.
    .
    “In essence, too many vaccines are being given to children during the brain’s most rapid growth period. Known toxic metals are beings used in the vaccines that interfere with brain metabolism, antioxidant enzymes, damage DNA and DNA repair enzymes and trigger excitotoxicity. Removing the mercury will help but will not solve the problem because overactivation of the brain’s immune system will cause varying degrees of neurological damage to the highly-vulnerable developing brain.”
    .
    The brain’s most rapid growth period is not necessarily the time when it is most sensitive to interference with its development. The evidence suggests that the developing brain is at its most sensitive before birth. This is discussed in the meeting, page 23 for example.
    .
    I hope this explains why I think Blaylock is wrong in his assessments of the Simpsonwood meeting. Sorry it took such a long post to do so.

  • http://thinkingisreal.blogspot.com AndyD

    Obviously I’m not a research scientist but I’d think almost any result – positive, negative or neutral – can indicate a poorly designed study. What matters, I assume, is repeatability of results across several studies. When only one study shows a significant result, different to all other studies, that one study will likely be called into question and its methodology be investigated.
    .
    Statistics, like chemistry, is another interesting area where “gut instinct” often brings the average person unstuck. For this reason, when one European lottery saw the very same numbers drawn two weeks in a row, people cried “foul” and an investigation was launched – but it really isn’t that remarkable that it happened.

  • oh please!

    Nescio thanks.
    .

    The 2 bits that stand out for me (haven’t got the time now to scroll thru the paper to give you page no & speaker) :
    1. One attendee discusses how his grandson(?) will be due for vaccination soon and he wants to make sure it doesn’t contain mercury. No one challenged him, it seemed that his opinion was that of the groups.
    and
    2. At some point towards the end they discuss a link between mercury and speech delay.
    .

    And a question_ I read once where negative correlations can indicate a poorly designed study – is this correct?

  • Nescio

    Hi oh please!
    I disagree. I think that Blaylock has used much the same ploy as Kennedy, I don’t think he gives an accurate picture of the discussions at that conference, and I don’t think the transcript shows that these people believed that mercury in vaccines was an issue. The participants were asked to rate the hypothesis that there is a link between mercury in vaccines and the neurological disorders discussed out of 6. All but one of them rated it as 1 or 2.
    .

    Verstraeten’s study, which is at the heart of Blaylock’s claims, showed some weak correlations between number of vaccines given and some neurological disorders. These correlations were likely due to chance, to bias or to other confounding factors – some of the correlations were negative – more mercury, lower rates of disorders.
    .

    Give me a couple of days and I will explain exactly where I think Blaylock has made several errors in his interpretations.

  • oh please!

    Nescio hi,
    Yes I was referred to Kennedy’s article earlier on. Although I didn’t read all of it the first part clearly demonstrated that he was being less than honest in what he was presenting.

    Blaylock has not, as far as I can tell used the same “out of context” ploy.
    He actually builds an accurate picture of discussions surrounding his selected texts.
    Of course the same event is experienced differently by different people. Maybe the same goes for reading.
    If you can show me some specific errors in Blaylock’s interpretation then I’ll have another look.
    I get that it was a meeting of professionals. They all came from various “arms” of the vaccine industry. I suspect that made the conversation a little more reserved and a bit harder for a reader to get the gist of it.
    Like if a bunch of Bank CEO’s got together to talk about why their interest rates have increased over the reserve rate. The conversation would be different if the Federal Finance Minister was also there, and different again if the media was there.

    In any case, my whole point was that collectively these people agreed to take no real action despite the fact that they believed that mercury in vaccines was an issue. It doesn’t help one to trust.

  • Nescio

    @oh please
    I read a large chunk of the transcript you posted a link to, when it all started seeming very familiar. It has obviously been transcribed by someone with little familiarity with medical terminology, by the way, and parts of it are hard to interpret (‘HIV’ instead of ‘HIB’, ‘parental’ instead of ‘parenteral’, ‘miolionization’ instead of ‘myelinization’, and birth ‘rates’ when they mean birth ‘weights’).
    .

    I quickly realized this was the very same meeting that R. F. Kennedy Jr claimed to prove that mercury in vaccines damages children and that this has been covered up, in an article some years ago in Rolling Stone magazine. I remember reading a takedown of RFK’s article, here: http://skeptico.blogs.com/skeptico/2005/06/robert_f_kenned.html I was shocked by his selective quote mining, and what appeared to be deliberate misunderstanding of what was discussed.
    .

    I also looked at what Blaylock has written about it, here: http://www.whale.to/a/blaylock.html I quickly realized he had used the same tactics.
    .

    I suggest you read Skeptico’s blog, which goes into detail about JFK Jr’s article. I think you will find it will put your mind at rest about the Simpsonwood meeting. To me it looks like a meeting of concerned professionals, looking at a potential problem with no preconceptions and examining the evidence with open minds before coming to the conclusion that there is no evidence that mercury in vaccines is a problem.

  • oh please!

    Andy, yes I get all that.
    I had to scroll back to remember what we were talking about, lol
    .

    OK – it was to support my point that there is a higher probability in the real world of an adverse reaction than in clinical trials.

  • http://thinkingisreal.blogspot.com AndyD

    @oh please… I understand that “flu-like symptoms” are listed as potential side effects from flu vaccines. I know that seems counter-intuitive (it bamboozled me for years) but I guess the point is that you are far less likely to suffer severe consequences, like death, from the vaccine than from the real thing.
    .
    The symptoms we see from viral infection are the result of the immune system kicking in and doing its job (as I understand it in simple terms). Since vaccination also activates the immune system, it’s hardly surprising to see similar symptoms. The difference is that the vaccine is dead while the real virus isn’t and so the real thing can essentially fight back (multiply, etc) and lead to longer-lasting or more severe symptoms.
    .
    Around 40,000 people a year die from flu in the US every year. I guess that means around 4000 must succumb in Australia. You father in-law isn’t one of them.

  • oh please!

    Thanks Maggie,
    if someone can show me I’m wrong I’ll be happier than you think

  • http://scepticsbook.com Maggie

    @ohplease, except that’s not what happened. I do not have the references in front of me – I can chase it up after work.

  • oh please!

    Dr Blaylock:
    Firstly the fluoridation thing: don’t really want to get into that except to ask -how much fluoride is the correct dosage for a person to ingest to ensure healthy teeth, and by what mechanism does this happen?
    .

    I’m going to ignore all the “shoot the messenger” remarks because if I don’t, I haven’t got the luxury of deleting my own comments.
    .

    This is the paper in question that Blaylock discusses.
    http://www.nationalautismassociation.org/pdf/simpsonwood.pdf
    I have read, as well as Blaylock’s article, a few sections of this report.
    As yet I can’t see any other conclusion:
    51 scientists & physicians got together 10 years ago and decided not to tell the public about what their data showed: that mercury in vaccines causes adverse effects on brain development.
    They did little more than sit on their hands.
    End of story.

  • oh please!

    Hello!
    All I can tell you it was flu like symptoms – ha had a fever for a few days and felt unwell for a few weeks.
    I know! It was not necessarily the flu shot – just extremely coincidental.
    I wasn’t really aware of the adverse reaction reporting back then so it wasn’t reported.

  • http://scepticsbook.com Maggie

    @ohplease, out of interest what was he sick with?

  • oh please!

    Andy
    My father inlaw, last year, was convinced by sister in law to have the flu jabs.
    He suffers from a few things: he’s had a “frozen shoulder” for a few years, he is on some sort of medication for indigestion, and has been on medication for high blood pressure for a few years.
    He is 75 yo.
    If he had applied for the clinical trials I’d guess that he would be rejected (tho I’m not sure). The very fact that “healthy people” are asked for would deter many people from even applying.
    .

    Anyway he got the flu shot and was sick as a dog for 2 weeks.
    .

    There’s an anecdotal example of how “real world” v “clinical” statistics would be different.
    Andy I’m not suggesting any conspiracy theory here, and no I don’t have any data to support what I’m saying. To me it’s just logical: the average person used in a clinical trial is healthier than the average person receiving a vaccine in the real world.
    I don’t have any problem with this.
    The initial point I made was that given the high rate of adverse reactions in the clinical trial that it’s not surprising that there seems to have been a lot of adverse reactions in the real world.
    .

    Dr. Blaylock – I’ll have a look at that nos

  • Chris

    Dr. Blaylock has been retired for several years. He was a neurosurgeon, and has no real training and expertise in toxicology, immunology, autism and any real medical research conducted for the last twenty years.
    .

    Seriously, the man spends his retirement writing conspiracy ridden articles and selling supplements (his special “brain repair formula”). Truly, he can be ignored.

  • http://thinkingisreal.blogspot.com AndyD

    Some of the things on that list look like they’d be excluded because they could confound the data rather than present patient risks. Some others would, I suspect, be included on things doctors should be on the lookout for – no point giving a jab to someone who is clearly allergic to vaccines.
    .
    But again it appears you’re crusading for perfection before action. You seem to expect the medical community to answer all possible questions before implementing any strategy that might carry some risk to some people. And again I admit that I’d like that too. I’d also like to be able to fly by flapping my arms a few times. Maybe one day both will be possible.
    .
    Come on Andy, it’s not a huge point, naturally these vaccines will have a higher adverse reaction rate in the real world.
    .
    Do you have the supporting data or do I have to just trust your instinct on that? In fact, do you even have the data of how many kids were vaccinated this year and how many suffered adverse reactions? Any percentages?
    .
    Based on our previous conversations regarding providing clean water to the third world, you might be interested to know that Dr Blaylock also opposes fluoridation. It appears he thinks it’s as toxic as mercury and is only put in our water because Alcoa needed to get rid of waste fluoride so they convinced governments it would prevent tooth decay. [cue theme tune from Twighlight Zone]

  • http://scepticsbook.com Maggie

    @ohplease

    a few things I have missed.
    .

    I also have an issue in determining the the “validity” (not sure what the correct term is) of studies sometimes.

    .

    The best place to start is on PubMed. This is the largest database of peer reviewed biological papers and journals. If a journal is indexed on PubMed, this is a good indication that it is a reasonably good journal.
    .
    But in addition, journals are ranked by a number called an impact factor.
    The higher the number the better the journal.
    .

    Journals are ranked by Thomas Reuters on Journal Citation Reports®.
    .

    .

    .

    Unfortunately you can only access it with a subscription. I have screen shotted the top ones for you above (click for better resolution). If you want to find the impact factor of a specific journal you can try Googling it – this will usually find the IF.
    .

    In some of the lower ranked journals (ie less than 5) you then need to look at the study to be absolutely sure that the study is sound. This requires scientific knowledge, but even if you don’t have advanced science quals., I encourage you to read some papers anyway. It will at least allow you to familiarise yourself with convention. Start by reading the abstract, the results and the conclusions. See if you can spot inconsistencies. This is a very good exercise in critical analysis, even if you don’t completely understand the terminology.
    .
    How old is the paper? Anything older than 5 years may have been superseded – depending on the findings. For example, the Bradford Assay (a protein assay) was developed in the 60s and has been improved upon but is still relevant. It is appropriate to cite this.
    .
    1) is the journal MEDLINE/PubMed or Web of Science indexed?
    2) does the journal have a good impact factor? >2
    3) Do the authors have conflicts of interest which might impair unbiased reporting? (There should be a section entitled “conflicts of interest” – check it out. Find a free access paper on PubMed and read the Financial Disclosures. Makes for interesting reading).
    .
    [FYI, the first author is usually the person who did all the experiments and wrote the paper, the last is usually the person in charge of the project and also helped in writing the paper i.e., the boss of the lab. Anyone in between has contributed somehow, either by doing some experiments, processing statistics, etc. You will come across papers where there are hundreds of authors, this means that it was a HUGE project, requiring collaboration from many sources. These are often the papers that get published in VERY high ranking journals].
    .

    4) Check the publication record of the first & last author of a paper on PubMed or Google their name on Google Scholar (you usually need their surname and two initials to do this successfully).
    5) Read the paper not just the abstract
    6) Have the authors been linked to any unscientific publications/conspiracy websites?
    7) is the data sound and statistically valid?
    .

    Dr. Blaylock serves on the editorial staff of the Journal of American Physicians and Surgeons, official journal of the Association of American Physicians and Surgeons.
    .
    Journal of American Physicians and Surgeons in not MEDLINE/PubMed or Web of Science indexed. It also contains some pretty weird and conspiracy-like ideas. It is not respected in the scientific community.
    .

    These are some rules of thumb. But you need to take each paper on its merits.

    .
    Note: for a scientific paper to get published requires a huge amount of work. And the higher ranking the journal, the more work required. My recent submission took 2 years, and it has not been accepted yet. The peer review process is incredibly tough. The description of this process also requires another post on its own.
    .
    Some basics of clinical trials and why these exclusion criteria are enforced are here. It will take me an entire new post to explain it to you in detail. If you are interested, this is a good place to start.

  • oh please!

    well maybe not:
    Do doctors exclude 65+yo from getting the flu vaccine for the following reasons:
    Exclusion Criteria:

    1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
    2. Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
    3. Known history of Guillain-Barré Syndrome;
    4. Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
    5. Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
    6. History of seizures;
    7. Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
    8. Clinically significant history of malignancy
    9. Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
    10. Current immunosuppressive or immunomodulative therapy;
    11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
    12. Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
    13. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
    14. Current treatment with warfarin or other anticoagulants;
    15. Major congenital defects;
    16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
    17. Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
    18. History of psychiatric disorders;
    19. Resident of long term care facility.
    (see: http://www.clinicaltrials.gov/ct2/show/NCT00735475?term=CSL&recr=Open&rank=3)
    .

    And why do they always ask for “health volunteers” for these trials?
    http://www.csl.com.au/s1/cs/auhq/1196562649386/content/1196562648402/content.htm
    .

    I don’t remember seeing any ads suggesting that the “flu vaccine is now available for healthy people”
    .

    Come on Andy, it’s not a huge point, naturally these vaccines will have a higher adverse reaction rate in the real world.

  • oh please!

    sigh, ok

  • http://thinkingisreal.blogspot.com/ AndyD

    Exclusion Criteria:

    * Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

    .
    In my experience “are you allergic to anything?” is a pretty standard question before a doctor issues medication. So if the allergies are “known” the same exclusions would apply in the real world. If they are “unknown” then I assume they’d be accepted into the clinical trial – thus achieving balance between the two “worlds”.

  • oh please!

    Although I’ve never been part of a clinical study it appears that “healthy” subjects are usually required,
    ie: http://www.clinicaltrials.gov/ct2/show/NCT00940108?term=csl&rank=1
    I guess it’s not until one fills out the application form that you would find out what conditions might exclude you from the study.
    So yes for clinical trials healthy is a relative term.

    .

    I don’t think that children “in the real world” are put through that sort of screening. Although if the doctor is doing the correct thing he should be screening his patients.
    .

    I assume (because I know it to be a fact with the swine flu vac for adults) that many children may have been offered the vaccination while visiting their doctor for an unrelated issue.

    .

    I guess my point is that “in the real world” there is a greater chance of a child with a compromised immune system receiving the vaccine – therefore having a higher chance of an adverse reaction.
    .

    Given that about 1 in 6 kids in the clinical trial had a reaction that interfered with their daily routine (we don’t know how badly it interfered) then it shouldn’t be surprising that a higher rate was achieved in the real world.

  • http://thinkingisreal.blogspot.com/ AndyD

    I’d suggest that, in general, vaccinations are given to “healthy” kids in the real world, with the caveat that “healthy” is a relative term. Is there some suggestion that the issues we’ve seen are all related to unhealthy kids?

  • oh please

    Yes you’re right we don’t know what number of kids in the trial had severe reactions. But given that these were healthy kids (in the trial) the real world experience was always going to be “worse”.
    I wonder if the raw data is accessible?

  • http://thinkingisreal.blogspot.com AndyD

    I probably know as much about reading scientific papers as you do but to me “significantly discomforting, interferes with daily activity” does not equate with “fell ill”. And I’m assuming that “moderate” is worse tan “mild”.
    .
    In “the real world” we’re talking febrile convulsions and possibly death, not “Mummy I’ve got a headache and my arm hurts”. What were the percentages of serious afflictions in the trials and does the real world experience match or differ?

  • oh please!

    So for the 2008PanVax Junior:
    Combined mild adverse reactions, for 15 µg and 30 µg were 31.9% and 33.7%, respectively.
    .

    For moderate adverse reactions, 15 µg and 30 µg were 18.9% and 27.2%, respectively. This was defined as significantly discomforting, interferes with daily activity
    .

    So for all adverse reactions in this trial it was roughly 50%
    I think I’ve read that right.
    .

    Now given that there is a criteria for participants in these trials (basically they must be fairly healthy) why did it come as such a surprise that so many children fell ill in the real world?
    .

    And Maggie the 88% thing, was that from the page linked? I remember reading it a few days ago and now it’s not there (unless I read it elsewhere. The page was last modified a while ago?

  • oh please!

    Andy,
    I think I’ve got it figured why I drift from calm to annoyed. The last page (Flu Vax…suspended…) and this page are interesting enough to engage me but then at some point thru the posts the avn or Meryl enters the conversation.
    .

    As you may suspect I have a healthy distrust of big pharma & vaccines and therefore found myself becoming annoyed at the constant “swiping” at the avn.
    I have no real opinion on the avn (I’ve only really tuned in recently to what they’re upto).
    I think I explained in some of my original posts my thought on health. My position on vaccination is an extension of my position on big pharma – it is an industry, like any other that has corruption and is primarily motivated by profit.
    And I think many people are paying the price.
    .

    So from here on in I’ll try to ignore any comments regarding meryl or the avn & discuss the real issues.
    cheers

  • http://thinkingisreal.blogspot.com AndyD

    Thanks for this mammoth effort Maggie… but where’s the illuminati?
    .
    I was particularly interested in this from the WA trial statement…
    .
    The paediatric influenza vaccination program in WA was part of an assessment into whether flu vaccine should be funded for all Australian children aged between six months and five years.
    .
    So it appears the “trial” Dorey was scare-mongering about was just a trial of “free” versus “not free”. Gosh, I hope parents WERE warned they wouldn’t have to pay. I’d hate to be find that out too late.
    .
    @oh please – I still can’t figure you out. One minute you drift toward calm and reasonable and ask some interesting questions – then you swing right back into “it’s all a massive conspiracy to make our kids sick for profit!!!”. Bizarre.
    .
    On that note, care to elaborate on what “vested interested” you insist Kylie Orr must have? Is it not possible for someone to support vaccination without having any “vested interest” beyond the health of their child? What a strange, strange world you appear to live in. (oh, and if you follow the link you’ll see exactly what she said next).

  • oh please!

    Maggie, good article, sometimes it’s more interesting what’s not said than what’s said.
    .

    Some comments & questions:
    Parents call for calm?
    “Meanwhile, some parents are calling for calm and warning others not to shun vaccines completely.”
    .

    What about: some parents have now become distrustful of how important their child’s health really is to big pharma (and the TGA for that matter).
    .

    Kelly Orr – wow – she’s happy to accept a free service (which has been exhaustively rsearched! – doesn’t she listen to the news?) because it’s free and an expert (who her gp?) told her it’s good.
    But – get this – if someone came to her with a counter argument showing figures and relevant links, backed up by science…and here I’ll assume she says she’d consider not vaccinating?
    .

    Please don’t try and tell me this person has no vested interest.
    .

    The W.A. govt leaflet says:
    There was a 50 per cent decrease in the number of confirmed flu cases in the under-five age group last year compared to 2007, despite equivalent flu seasons
    .

    Does anyone know how to access the data that they based these quotes on? It’s not that I don’t trust them it’s just that I don’t trust them.
    .

    more tomorrow
    and
    .

    a trial that reduced hospitalizations by 88 percent, the state’s health department said in a statement last year.
    .

    The 88% thing – I remember reading that a few days ago but when I go to that page I cant find it?
    In any case I’m guessing they mean 88% reduction in flu related hospitalizations.

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