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Tag Archives: Vaccines

Finally in the series of extracts from my IAS Charity complaint, I give a brief look at the impact of anti-vaccine information in New Zealand. I also bring together information from other parts of the complaint that have not been covered in the extracts so far.

Impact of Anti-Vaccinationist Misinformation in New Zealand

Maintaining a high level of vaccine coverage is important for reducing the probability of disease outbreaks and to limit the spread of disease in the community. Diseases (often) spread due to contact between infected and uninfected individuals. If the uninfected individual has partial protection from the disease due to immunisation then the disease will spread with more difficulty. This is often referred to as “Herd Immunity”.

Herd immunity does rest on several assumptions, one of which is that immunised individuals are spread evenly throughout the population. If pockets of unvaccinated individuals develop then diseases can gain a foothold in that part of the population and spread outward – even to vaccinated individuals. If parents in a community are convinced by the IAS information not to vaccinate their children then an in-road for disease is created and outbreaks can occur. As such this would constitute a detriment to both children and the wider community – in direct contradiction to the IAS stated charitable aims.

New Zealand has struggled to reach recommended vaccination levels in the past with the coverage rate in 2005 being only 77% at two years of age1. With such low rates of vaccine uptake in the population there is a risk of vaccine preventable disease outbreaks occurring in the population and putting children’s lives at risk. In fact this is happening now with the measles outbreak in Auckland. Health officials have linked this outbreak to lowered vaccine uptake attributable to anti-vaccine misinformation2.

Vaccine coverage for a disease such as measles needs to be at approximately 90% or greater in infant populations to prevent epidemics3. Despite a focus on increasing coverage since earlier this century and improving coverage since the 2005 survey New Zealand still only sees an average of 85% vaccination coverage in this age group, with some areas dropping as low as 75%4.

In 2004, just prior to the Vaccine Coverage survey, a study was performed to see what reasons parents gave for not vaccinating their children5. The results of the study found that many of the parents interviewed made a decision not to vaccinate based on perceived risk of the vaccines. The risks cited were common anti-vaccinationist misunderstandings, including linking vaccines to autism and the belief that children’s immune systems are weakened by immunisations.

While almost all of the study participants consulted their GP for vaccination information, this source was seen as biased. In fact many of the “Pro-vaccine” sources were considered biased and parents expressed interest in information provided by groups outside the “medical establishment” indicating distrust of medical advice on this topic in general. The Immunisation Awareness Society was explicitly listed as a source of information by 76% of survey respondents, along with Naturopaths and Homeopaths (43% and 48% of respondents respectively).

The Immunisation Advisory Centre is sufficiently concerned about misleading anti-vaccination claims that they have included a page dedicated to rebutting this information on their website6.

Conclusion

The IAS dispute that they are “anti-vaccine” both in their Charity “Rules” (3. Beliefs, subsection C7 and through comments on their website. This claim rings hollow though when the actual content of their writings is examined. Therefore it is important to look at the effective output of the ideologies, philosophies and stance of the charity rather than their explicit statements.

In regard to IAS staff and members, belief that they are acting in the public interest, belief that their materials constitute an educational resource and belief that they are in fact doing the right thing are not enough. I have no doubt that the founding members, the officers and members of IAS sincerely think that they are provide a public service and that their interpretation of the scientific facts is the correct one. This however only affords them the right to be respected as individuals and for their views to be given fair hearing, it does not constitute a right to charitable status and does not exempt their views from criticism.

The IAS has shown through their materials that, despite protestations to the contrary, their views are anti-vaccine. This entails that their views are factually and scientifically incorrect, that they have an agenda to reduce or stop vaccinations being performed and that through this their actions may translate into serious harm for individuals, the community and the public at large. The IAS currently enjoys charitable status, as such they are exempt from taxation on their income. This amounts to a government subsidy of anti-scientific and potentially harmful views.

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One last point, I am pretty clear to paint the IAS as anti-vaccine. They themselves deny this label, as mentioned above. But then I have a bias don’t I? Well, heres a link to a website that has the opposite bias, they list the IAS as on of their “100+ Great Anti-Vaccination Information Links“, I’d say that;s telling.

Footnotes:
1. NZ Vaccine coverage survey 2005
http://www.moh.govt.nz/moh.nsf/pagesmh/6028/$File/national-childhood-immunisation-coverage-survey2005.pdf
found on:
http://www.moh.govt.nz/moh.nsf/indexmh/national-childhood-immunisation-survey-2005

2. Stories covering the Aucland Measles outbreak:
http://www.stuff.co.nz/marlborough-express/news/5220199/Immunisation-rate-of-refusal-growing
http://www.nzherald.co.nz/immunisations/news/article.cfm?c_id=461&objectid=10553617
http://www.stuff.co.nz/national/health/5222511/Measles-outbreak-likely-to-spread

3. Predictive model for Measles Outbreaks. Coverage at 15months should be >90%
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810912/pdf/10813154.pdf

4. Immunisation Coverage report 2010:
http://www.immune.org.nz/site_resources/Professionals/Research/2010_Immunisation_coverage_report.pdf
Found Here:
http://www.immune.org.nz/?t=603

5. Study looking at reasons NZ parents give for not vaccinating:
http://www.nzma.org.nz/journal/117-1189/768/

6. IMAC website with anti-vaccination rebuttals:
http://www.immune.org.nz/?T=938

7. Charities Register page for IAS:
http://www.register.charities.govt.nz/CharitiesRegister/CharitySummary.aspx?id=17c102eb-e79c-de11-9604-0015c5f3da29

Next up in our voyage of crank discovery, via extracts from my IAS charity complaint, is a breakdown of simplistic reasoning around vaccine ingredients. Again, I have reproduced elements of the original article here for your convenience.

The following example was posted as a look at vaccine ingredients in two parts. I will not be so lenient – Both in one for you.

Vaccine Ingredients – Part 1
posted May 6, 2011

This post contains a number of misunderstandings and falsehoods both explicitly stated and implied. The post lists the type of cell culture lines that viruses are cultivated in in order to create vaccines and then implies that the cells from these cultures are still found in the final vaccine product that is injected, including the emotive claim that we are injecting aborted foetal tissue into our children with the vaccine.

[Quote]
“I bought Sue Claridge’s fantastic book “Investigate Before You Vaccinate,” and turned to page 44 which states: “The cell cultures used to grow the viruses and bacteria include monkey kidney (vero cells), foetal calf serum, chick embryo fluid, yeast and human diploid cells (cells from aborted human foetuses). WHAT?! You mean to tell me that we are injecting aborted human fetal cells into our babies?!”

This is incorrect.

While it is true that there are some cell lines used to culture viruses used in vaccines, it is inaccurate to say that we are injecting these cells into children. Once again precision in language is important, there are currently existing cell lines that were originally cultured using aborted foetal tissue. These cell lines used originated in the 1960s1, meaning that the cultures used now many cell replication generations removed from the original tissue and are now are simply cells grown for medical use – not foetuses.

The only vaccine in the New Zealand schedule to be developed using cell lines derived in this fashion is the MMR vaccine, due to the inability to grow Rubella virus in any other type of cell line2. Vaccines must also be purified before use in order to remove these cells prior to injection3,4. Following purification the cells of the original culture are no longer present.

The article then proceeds to give a laundry list of possible vaccine ingredients, with the implication that the levels of these compounds are harmful at the doses provided in the vaccine.

[Quote]
“…formaldehyde (an embalming fluid). SERIOUSLY?! Oh, it gets better!!! Some vaccines also contain mercury, aluminium, preservatives, stabilisers, lactose, sorbitol, sodium chloride, sucrose, sodium borate, magnesium chloride, sodium phosphate, hydrolised gelatine, neomycin, gentimicin, streptomycin and human albumin…”

This dose insensitivity of the anti-vaccine rhetoric is recurrent and important. All chemicals have a threshold above which they can have detrimental effects on human physiology, the question is whether this threshold is exceeded by vaccine ingredients. The medical community is in agreement that the answer to this question is “no”. At this point the anti-vaccine community does not need to provide proof that the levels of compounds found in vaccines are harmful, the only goal is to raise questions about safety.

The United States CDC website has a page dedicated to vaccine ingredients and countering anti-vaccine questions about them5. The IAS article highlights that formaldehyde is used in vaccines and points out that this is used as an embalming fluid. The CDC website answers this question and it is telling that the IAS article does not mention that formaldehyde is also made in the body during normal metabolism. In fact it is calculated that a baby (depending on size) would have more than 50 times the amount of formaldehyde in its body naturally than it would get from a vaccine dose.

Most of the rest of the ingredients listed are stabilisers and preservatives of the vaccine components. Several such as sodium chloride (table salt) and sucrose (sugar) would not be considered harmful by most reasonable people. As such I will point out a small selection that would seem to be concerning and give the actual facts behind their use.

The first that would seem worrying is amorphous aluminum hydroxyphosphate sulfate. The approximate amount of this compound used in vaccines is 225 μg. Used as an adjuvant (a vaccine additive that modifies its effects) this ingredient actually makes the vaccine more potent by enhancing the body’s immune response to the vaccine. As such it has an 80 year track record of safety in vaccines6. Also, dietary sources of aluminium are not insignificant, estimated at 1.6-13 mg per day7 or 7-60 times that in the vaccine, even though bioavailability of chemicals is affected by the method of introduction to the body (oral vs injection) it’s hard to see how this minuscule amount would make any difference.

Another potentially scary sounding chemical in vaccines is sodium borate, the approximate dose per injection of vaccine is 35 μg. This is used to balance the pH. The LD50 (a measure of toxicity) for this compound is 2-3 g/kg in mammals8 and as such is actually slightly less toxic than table salt (~3 g/kg9), the 35 μg in the vaccine if given to a 50kg individual equals a 0.7 μg/kg dose, this isn’t even close to a dose high enough to cause even a minor problem.

The article goes on to make a specious assertion that we were “created perfect as we are” and that we shouldn’t need to inject “formaldehyde and monkey cells” into our bodies to make our immune systems work, if we did we would be “born with it”.

[Quote]
“Weren’t we created perfect as we are? Do we really need to be “fixed” or “made better” by injecting these substances into our bodies? If we were meant to have formaldehyde and monkey cells in our bodies in order for our immune systems to work, wouldn’t we have been born with it?”

Aside from the unintended irony that we actually were born with formaldehyde in our bodies this claim is poor reasoning. By this criteria some of us would have also been “born with” glasses or contact lenses or hearing aids. This article also would appear to refute the utility of acquired immunity – if we needed foreign bodies in our system to make our immune systems work then we would have been born with them.

Finally the question is asked “If we’re all suddenly going to get sick or die if we don’t get these vaccines, then how did we survive for tens of thousands of years without these ingredients inside us?” ignoring for the moment that it is not the vaccine ingredients themselves that we need but rather the antigens in the vaccine that the rest of the ingredients stabilise and preserve, the simple answer to this question is “millions of us didn’t survive”.

Vaccine Ingredients – Part 2
Posted May 9 2011

This post appears to be one long argument attempting to cast doubt on the level of knowledge we have regarding the operation of our immune system. By quoting from an anatomy and physiology text book10 and emphasising tentative sounding words such as “appears”, “may” and “apparently” the author is attempting to show that the entire field on immunology is in doubt.

[Quote]
“On page 778, after talking about T cell maturation, it mentions that “less is known about the factors that control B cell maturation in humans” i.e. they haven’t quite figured out how B cells mature in our bodies yet. Another classic is on page 792, when they try to explain why the immune cells sometimes attack foreign human cells when a patient has received a graft. Their explanation is that “apparently, [emphasis mine] the cytotoxic T cells sometimes ‘see’ the foreign class I MHC antigens as a combination of self class I MHC protein bound to foreign antigen” i.e. they don’t actually [emphasis mine] know how it works, but this is their best guess.”

The fact that the text is dealing with minutia of the immune system down to the level of cell generation and activity seems to not persuade the author that in fact there is a great deal currently known about immunity and how our immune system works. To the point that it is considered feasible (by the author) that future text books will recall the use of vaccines and their “toxic ingredients” as complete folly.

The level of argument here is such that similar reasoning could be used to show that since the fluid dynamics at the edges of aircraft wing tips is not completely worked out, in the future we may discover that airplanes cannot fly after all. The point of this parody is to show that the author is confusing knowledge of mechanism with knowledge of efficacy. We know vaccines work, study upon study of new and old vaccines verify this fact every day. The inability of science to answer every minute facet of why they work does not invalidate this data. Once again the only goal here is to plant a seed of doubt about the safety and effectiveness of vaccine in the minds of the public. As such the IAS once again demonstrates the education is not the desired outcome of their operation.

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Footnotes:
1. Cell lines

http://www.viromed.com/services/product/wi38.htmhttp://www.viromed.com/services/product/mrc5.htm

2. Vaccine Manufacture

http://www.immunizationinfo.org/issues/vaccine-components/human-fetal-links-some-vaccines

3. Vaccine Purification:

http://www.cuno.com/healthcare/pdfs/application_briefs/vaccine_production.pdf

4. Vaccine requirements(Section III, sub section B.5. paragraph 2):

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074801.htm

5. CDC Vaccine ingredients page:

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm

6. Aluminium track record:

http://www.webmd.com/parenting/news/20040129/aluminum-in-vaccines-poses-no-harm

&

http://www.chop.edu/service/vaccine-education-center/hot-topics/aluminum.html

7. Dietary aluminium:

http://www.efsa.europa.eu/en/efsajournal/pub/754.htm

8. Sodium Borate MSDS:

http://www.anachemia.com/msds/english/f880%28vcr%29.pdf

9. Safety sheet for NaCl

http://msds.chem.ox.ac.uk/SO/sodium_chloride.html

10. The Text book that appears to be written about:

http://www.campusbooks.ac.nz/product/21980-HumanAnatomyandPhysiology-9780321584199

As promised here is the first of the articles that I deal with in the formal complaint I made to the Charities Commission regarding the misinformation spread by the anti-vaccine charity IAS.  So, with out further ado (what is ado anyway?) here is the link to the offending piece and my rebuttal:

Thimerosal in your Vaccine?
Posted September 13, 2010

This post on the IAS website (made up of basically an uninformed question about the harmfulness of ethyl mercury and a video) insinuates that Ethyl Mercury (also known under the trade name Thimerosal)1 is both harmful in the amount contained in vaccines and, by extension, that New Zealand vaccines contain this substance and should therefore be viewed with suspicion.

The first thing to note is that the Thimerosal post is irrelevant to New Zealand populations as Thimerosal is not present in any of the vaccines used in New Zealand2. Bringing up this issue in the context of New Zealand vaccines (implied as this is a New Zealand organisation geared towards New Zealand residents) is at best ignorant and at worse disingenuous scaremongering. Even so it is useful to deconstruct the post anyway as it is indicative of the faulty reasoning and scientifically inaccurate content of the IAS website.

The post includes a link to the Material Safety Data Sheet (MSDS) for Ethyl Mercury as support for this claim3. The relevant part of the MSDS has been reproduced below to give an indication of what the post considers concerning about the use of Thimerosal in vaccines.

Quoting from the MSDS:

“Effects of Overexposure: Topical allergic dermatitis has been reported. Thimerosal contains mercury. Mercury poisoning may occur and topical hypersensitivity reactions may be seen. Early signs of mercury poisoning in adults are nervous system effects, including narrowing of the visual field and numbness in the extremities. Exposure to mercury in utero and in children may cause mild to severe mental retardation and mild to severe motor coordination impairment.”

This is used in conjunction with a video link on the page4 to advance the hypothesis that Thimerosal in vaccines causes  autism, despite the fact that the symptoms listed are explicitly due to overexposure, not the trace exposure that  constitutes the vaccine dose. This type of “any level is harmful” approach to medicine neglects the dose response  relationship of drugs and other chemicals in the body. This hypothesis also ignores scientific research into
mechanisms of autism, the epidemiology of the increase in autism reports and the failure of the hypothesis to account for the continued rise of autism cases after Thimerosal was removed from the majority of vaccines.

The web-based resource Science Based Medicine has a reference page containing summaries of and links to the various studies showing no link between Thimerosal in vaccines and development of autism or autism spectrum disorder (ASD)5. The studies in aggregate looked at the claim of a link between Thimerosal and autism in a number of ways. Several looked at large groups of individuals and attempted to find any sort of correlation between childhood exposure to Thimerosal and development of autism symptoms. All together these studies combed through the data of over 750,000 individuals in several different countries and found no evidence to support a link.

Continuing to disseminate information that implies a link between Thimerosal and autism is to be either wilfully ignorant of the current state of research, in which case claims to educational content are not accurate, or to be dismissive of the current research as being an inaccurate reflection of the facts. This second option depends on there being some sort of conspiracy within the scientific/medical community to hide the truth. No such conspiracy can be substantiated.
As an side, the MMR vaccine has also been linked to development of autism in the minds of anti-vaccine campaigners since Andrew Wakefield’s now discredited and retracted paper in the Lancet6. A Cochrane review of the evidence shows

“No credible evidence of an involvement of MMR with either autism or Crohn’s disease was found.”

and

“Exposure to MMR was unlikely to be associated with Crohn’s disease, ulcerative colitis, autism or aseptic meningitis…”7

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Footnotes:
1. Thimerosal clarification of chemistry:
The chemical IUPAC name of Thimerosal is actually
Ethyl(2-mercaptobenzoato-(2-)-O,S)mercurate(1-) sodium.
This breaks down to Ethyl Mercury in the body.
http://en.wikipedia.org/wiki/Thiomersal

2. Vaccine ingredients:
a. Childhood vaccine Schedule:
http://www.moh.govt.nz/moh.nsf/indexmh/immunisation-schedule-html
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/wycpreve/$File/wycpreve.pdf
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/gwcinfih/$File/gwcinfih.pdf
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/gwcinfiv/$File/gwcinfiv.pdf
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/gwchibrx/File/gwchibrx.pdf
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/gwcbostv/$File/gwcbostv.pdf
http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/cscgarda/$File/cscgarda.pdf

b. Influenza Vaccines:
http://www.moh.govt.nz/moh.nsf/indexmh/influenza-a-h1n1-2010-faqsseasonal#safety
http://www.moh.govt.nz/moh.nsf/Files/swineflu/$file/vaxigrip.pdf
http://www.moh.govt.nz/moh.nsf/Files/swineflu/$file/Fluvax.pdf
http://www.moh.govt.nz/moh.nsf/Files/swineflu/$file/Influvac.pdf

3. MSDS cited on the IAS website:
http://www.vaccine-tlc.org/docs/Thimerosal%20Material%20Safety%20Data%20Sheet.pdf

4. Misleading video posted under the heading “Thimerosal in your Vaccine?”:

5. The Science-Based Medicine resource page on Vaccines and Autism:
http://www.sciencebasedmedicine.org/reference/?p=1

6. Andrew Wakefield:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960175-4/fulltext
http://www.bmj.com/content/342/bmj.c7452.fullhttp://www.nature.com/ajg/journal/v105/n5/full/ajg2010149a.html

7. Cochrane review:
http://www2.cochrane.org/reviews/en/ab004407.html

I haven’t really been writing much lately, for this blog at least. Much that is due to simple procrastination but earlier this year my free time was spent doing something equally stimulating.

Back in July I submitted a complaint to the New Zealand Charities Commission, which they (allegedly) are currently investigating, about the Immunisation Awareness Society (IAS). This is a charitable organisation that disseminates anti-vaccine information, while at the same time denying that they are anti-vaccine.

Grant has recently done an excellent post on some of the nonsense put out by IAS representatives, go have a read if you’ve not seen it yet.

My complaint focuses on the fact that to be a registered charity an organisation must fulfil a charitable purpose (makes sense). The particular legislation outlines these purposes as:

“the relief of poverty, the advancement of education or religion, or any other matter beneficial to the community.”

In my complaint I detail how the advancement of education is not met by the IAS, that they are anti-vaccine and that they therefore do not constitute a benefit to the public. As they do not relieve poverty nor advance religion this effectively should remove them from the arena of “Charity”.

To answer the question posed in the title, theoretically – yes there is quality control over charities. Part of the mandate of the Charities Commission is to:

“promote public trust and confidence in the charitable sector”,

“monitor charitable entities and their activities to ensure that entities that are registered as charitable entities continue to be qualified for registration as charitable entities”

and

“inquire into charitable entities and into persons who have engaged in, or are engaging in, conduct that constitutes, or may constitute, a breach of this Act or serious  wrongdoing in connection with a charitable entity”

In large part my compliant is based on this previous post about the IAS, cleaned of snark and updated with a few references. In addition I dismantle a few of the “Educational” posts on their website to show how the information they promote is factually incorrect and geared towards convincing parents not to vaccinate their children.

In particular I look at This post that attempts to link NZ vaccines with Thimerosal and thereby to Autism even though both links in this chain are fictitious. Next I go over This post which is a copy of a submission to an FDA committee by Roberta Boyce founder of the anti-Gardasil website truthaboutgardasil.org, predicably criticising the Gardasil vaccine for being some sort of secret plot to make people sick and sterile. Okay maybe you couldn’t have predicted that. Finally I take apart yet more claims about the “Toxic” ingredients of vaccines, similar to another of my previous posts. Then I cover potential and actual damage caused by anti-vaccine sentiment (like the Auckland Measles outbreak).

I have no doubt that the IAS will rail against this complaint claiming that I’m trying to suppress free speech (nothing of the kind, they can continue their activities without being a charity) or that I’m attempting to smear them (no need, their output speaks for itself) or that I’m a henchman for the Immunisation Advisory Centre (no affiliation, but if they want to throw some money my way…;-)).

I’m hopeful that this complaint will at least get the Charities Commission to pay attention to the IAS and it’s output. Like I said I’m not interested in shutting them down, upholding free speech means defending those you don’t agree with (or something, I’m hazy on the details. People tell me it’s good). The issue I have is that these guys are essentially receiving a government subsidy (in the form of tax exemptions) for spouting inaccuracies.

Finally I have to give enormous thanks to Simon Clendon who kicked me into action after my post on the IAS philosophies and took on the task of editing the brain dump that resulted. He also made a bridge to the nice people at the IMAC who provided some extra info (still no affiliation just a few emails).

For those who want more on how I deal with the IAS misinformation I will repackage the various sections of the complaint as follow-up posts (tagged “IAS complaint”). Plus, I went to all that work, might as well eh?

If you want to read the full complaint in all it’s damning detail and mind numbing depth you can find it in PDF form Here, I’ve also got a snappy snip url: http://snipurl.com/iascomplaint. Go on, you know you want to. Tell your friends.

There are also a few supporting documents at that address as well, just to make finding them easier. If this inspires you to make your own complaints then go for it, the more the merrier, probably. I’m sure you needn’t go to as much trouble as I did (though if you want to, it’s fun. Plus by now the IAS has continued to march ahead with new misinformation).

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I just read this story about an independent review of science reporting from the BBC (via RD.net). It covers the release of a report on the coverage of science by the BBC, while the report is mostly favourable there are a few things that could be addressed and done better.

The obvious one is the general media habit of false balance. This is the practice of inserting contrary views for the sake of it and in doing so providing a false sense of the actual sate of affairs. Examples given in the report are AGW, the MMR vaccine/Autism brouhaha and GM crops. For other markets I’d throw in the creationism/evolution “debate”, clashes between so-called Complementary and Alternative Medicine (CAM, or now “Intergrative Medicine”) and other issues where the science strongly favours one view point.

This is a significant problem in the media where the pressure must be great to both appear “impartial” and to take advantage of “manufactroversies” to drive consumers up-take of content. Care must be taken when presenting stories to give due weight to each view point in order to convey the correct interpretation to the target audience if stories are to be presented correctly. Too often fringe views are given disproportionate air time in order to the provide “balance”, but this has the effect of giving these views more credence in the public consciousness than they deserve.

A great parody/analogy used in the report by the reviewer was “mathematician discovers that 2 + 2 = 4; spokesperson for Duodecimal Liberation Front insists that 2 + 2 = 5, presenter sums up that “2 + 2 = something like 4.5 but the debate goes on”.

That’s it in a nutshell.

A great video of comedian Dara O’Briain covers the same point. (I know it’s been posted before but it’s hilarious)

I have not yet had a chance to look at the entire report (it’s over 100 pages) but hopefully I can wade through it at some point ad pull out a few more interesting points.

Last week I presented the safety study for the Gardasil qHPV vaccine, after this a reader remarked that it was a relief to see as she was concerned by a story she had read. It revolved around the unfortunate case of a UK school girl who died shortly after receiving a vaccine. As the full story does not yet seem to have been covered adequately by local news I thought I would cover the salient points here.

Firstly there are two competing HPV vaccines in the world market, Gardasil produced by Merk and Cervarix made by GalaxoSmithKline (GSK).  Here in New Zealand we have opted for the Merk version of the vaccine while the UK uses GSK’s product. Cervarix immunizes against the HPV strains 16 and 18 which are implicated in development of cervical cancer while Gardasil also covers strains 6 and 11 which cause genital warts.

Thus the first point to be made in relation to New Zealand readers is that the vaccine this young girl was exposed to is not the same one that is being given to our population.

To summarize the facts about this case, as reported by TimesOnline on the 29th of September, 14 year old Natalie Morton died in hospital on the afternoon of the 28 of September. Preceding her death by several hours was her injection of the GSK HPV vaccine Cervarix, this proximity in time is the only evidence that linked the vaccine to the girl’s death.

Late on the 29th the news that Natalie had a “serious underlying medical condition” was reported in the Guardian. At this point it was still unclear (to the public) whether the vaccine was in any way related to Natalie’s death. Health officials were however preparing to continue the vaccinations that had been put on hold following Natalie’s perceived complications.

By the 2nd of October the full story was clear, as covered in Medical News Today, Natalie’s death was revealed to have been caused by a previously undiagnosed and apparently asymptomatic malignant tumour in her chest. The tumour was described as having heavily infiltrated her heart and gone into her left lung. The HPV vaccine was officially cleared of any causitive agency in her death, in fact according to Dr Caron Grainger, Joint Director of Public Health for NHS Coventry and Coventry City Council, it could have happened at any point.

This story, if the end had been less definitive, could have been a very powerful anecdote against the use of HPV vaccines, as comments both within and about the early news stories reveal. Some with a vested interest of discrediting vaccines will undoubtedly still try to use it as such, already there are attempts to label the cause of death as fiction.  This shows a deeply unsettling conspiracy mindset as well as disrespect to Natalie and her family in trying to use her tragic tale to further their own agenda.

Last month the Post-licensure safety study for Gardasil (the HPV vaccine) was released. The study focused on the reports of adverse events as reported to the VAERS database by the manufacturer, doctors and patients or caregivers. Much has been made by detractors of the vaccine about the serious alleged side effects that have struck young women given the course of injections. These allegations have been supported by referring to the VAERS database itself so if they are valid they should be upheld by this study.

Of the 12,424 reports that VAERS received in the 2.5 year period following implementation of the vaccine, 772 (6.2%) were classified as “serious”, the total number of vaccine doses distributed in this period was 23 million. The category of “serious” was defined according to the FDA regulatory definition of an adverse event that “is life threatening; results in death, permanent disability, congenital anomaly, hospitalization, or prolonged hospitalization; or necessitates medical or surgical intervention to preclude one of these outcomes”.

It must be noted at this point that the VAERS database cannot determine causality, the events reported merely have to occur after vaccination takes place. Therefore anything that happens to a patient in this time frame that someone thinks might be related to the vaccine may be entered. I point this out only to remind that while we may be looking at vaccine safety life does go on, accidents happen and co-incidences occur. The point of a study such as this is to determine if these events are occuring at a frequency higher than what we would expect in the normal population. In other words, is there really a correlation between these events and the vaccine or is is simply a statistical fluke.

The study looked into each type of adverse report in detail and attempted to answer the above question, does the rate of reporting exceed that which would be expected in the general population? In almost all cases the answer appears to be “No”, the exceptions to this were reports of syncope (fainting) and venous thromboembolic events (blood clots), this finding will certainly be followed up in future studies. Curiously one of he more prominent adverse effects that has been concerning many on both sides of the debate, Guillain-Barre´ Syndrome was not found to occur more than expected.

Guillain-Barre´ Syndrome is an auto-immune condition that can be brought on by vaccines but also by normal infections. The syndrome is caused when the immune system is stimulated by an antigen but then starts to target the body’s own nervous system, it usually exhibits as an ascending paralysis noted by weakness in the legs that spreads to the upper limbs and the face along with complete loss of deep tendon reflexes. As vaccines are made to induce an immune reaction the link between vaccines and the syndrome is biologically plausible and not controversial in the medical community.

The study concludes favourably but cautiously, as scientific studies are wont to do:

Vaccination with qHPV has the potential to decrease the global morbidity and
mortality of HPV-associated diseases, including cervical cancer. After hepatitis B vaccine, which can prevent liver cancer, qHPV is only the second vaccine licensed with an indication to prevent cancer. The postlicensure safety profile presented here is broadly consistent with safety data from prelicensure trials. Because VAERS data must be interpreted cautiously and cannot generally be used to infer causal associations between vaccines and AEFIs, postlicensure monitoring will continue, and identified signals may be
evaluated using epidemiologic observational studies.

The full study can be found here, a summary of the study here and a comprehensive discussion of the study here.

My two regular readers are probably sick to death from hearing about a certain HPV vaccine by now but I thought I’d put up a quick comparison of VAERS data for those that are interested.

The raw VAERS data is quite popular among those who wish to cast aspersions on the safety of the vaccine so I thought I would query the database myself to see what the results would be and compare the Gardasil figures against less controversial vaccines. I decided to compare the data for all reported adverse events between the time 2006-2009 for not only the HPV quadrivalent vaccine but also the flu vaccine and the MMR vaccine. If Gardasil is so dangerous the figures should be significantly higher for this vaccine than the others shouldn’t they?

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My last post on Gardasil has garnered quite a bit of interest so I thought I would follow it up with a look at some of the other claims about this vaccine that are also geared towards warning women away from it. The focus of this entry is, as the title implies, the ingredients of the vaccine and their alleged toxicity. Now I would first like to make clear that I am not trying to argue that these compounds are not at all toxic, that would be an untenable position almost anything is toxic at the right (or wrong) dose. This brings up the heart of the issue though, the dose is key here, the claims by detractors of the vaccine imply that the amounts of the chemicals in the vaccine are above the toxic threshold. I, along with the medical community so I feel I’m in good company, consider this to be an incorrect conclusion.

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(Edit: For those interested in the toxic components of the vaccine please look here.)

Recently I  read a letter in a New Zealand paper decrying the widespread acceptance of the new HPV vaccine Gardasil. The letter contained references to suitably scary statistics from a impressive sounding report, in it it was claimed that Gardasil had contributed to the deaths of 18 people and had over 8000 reports of harm due to the administering of the vaccine. The letter ended with the sentence “This vaccine is essentially a large-scale, public health experiment. With doubt about its safety and efficacy, my daughters will not be getting it.”  I thought it might be useful to provide some information that casts a little more light on the situation, the statistics used in the letter and information on efficacy.

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Science and pseudoscience, what’s the difference? It’s not a trick question, as you approach the cutting edge of science, where the known becomes the unknown and theories become wild and speculative the line between the two can be quite fuzzy. String Theory anyone? But in general the difference lies in that where science starts with facts and observations and arrives at conclusions pseudoscience starts with a conclusion and twists fact and observation to fit. The two most common avenues to pseudoscience appear to me to be: First, when a hypothesis is retained long after dis-confirming evidence should have rendered it obsolete. Adherents of the “Vaccines cause Autism” movement would fall into this category. Second would be those who attempt to prove their own pet ideology by either conducting flawed research or by willfully misinterpreting the work of others. Creationists and Intelligent Design proponents might fall into this category.

Correctly discerning pseudoscience can be difficult, especially if it appeals to our own biases. Some things to consider are: Arguments from authority, real science shouldn’t be decided by a chosen few, rather it is the sum total of a multitude of efforts and advancements are evaluated by the scientific community as a whole and finally a consensus is reached. Insufficiently detailed references to supporting data, it is important to be able to find the primary sources that are being used to support a position so that you can read it yourself and determine if it has been correctly interpreted. Reliance on testimony, look at the quality of the references used, if they come mainly from personal experience they may not be reliable.

Finally, you may want to look at a larger sampling of the scientific community and see what they have to say about the topic or person you are interested in. There are bound to be many sides to the issue but you may pick up on the general flavour of scientific opinion. Good luck and happy investigations.

Resources

Parents have a tough job. That’s a fact. However this job is made tougher by two things, 1. Fear for their children’s safety, 2. False information in the media. The first is completely natural and even necessary. The second unfortunately is also natural and is something that arises because of peoples fear.

Part of the reason is that when you are talking about someone’s child then any risk is too much. That is understood and absolutely forgivable, this leads to trouble though when that fear is misinformed and the public does not have the knowledge to decipher the facts for themselves. An inability to rationally weigh the risks also leads to making decisions that can be detrimental to health long term.

The trouble with the current concern over vaccines causing autism is that this is primarily a case of parents being overwhelmed by media coverage that is intended to produce ratings not provide accurate information. It is a recurring theme that the controversial stories are hyped and the factual follow ups are down played or overlooked altogether.

Multiple studies have shown that the putative link between the MMR vaccine and autism does not hold up, some of these are listed below. In addition the rise in autism diagnoses that anti-vaccination groups point to is widely regarded by the scientific community to be an artifact of the inclusion of a wider variety of disorders under the umbrella term of “Autism” in recent decades. Autism is defined by a certain constellation of symptoms being present and their severity. In recent years less severe examples of these symptoms have been added to the diagnosis of the autism spectrum. This allows for a greater number of diagnoses than in the past.

This is a very complex and emotional debate and I have only touched on it briefly here, I recommend reading up on the subject through the resources listed below.

Resources

http://www.cdc.gov/od/science/iso/mmr_autism.htm

http://www.theness.com/articles.asp?id=74

http://www.theness.com/neurologicablog/?p=37http://www.immunize.org/mmrautism/

http://www.immunize.org/catg.d/p2065.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=26561

http://www.bmj.com/cgi/content/full/330/7483/112-d

http://www.bmj.com/cgi/content/full/324/7334/393

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