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But this morning I had reason to leap out of bed at the ungodly hour of 05:30 to hit the computer and report on some very good news.

Our government has gone done something good and given that this doesn’t happen very often, I reckon it’s worthy of a pre-dawn blog post.

The news, which was brought to my attention by Fuzztwin on Twitter, reports on changes to the current childhood immunisation schedule to include three new vaccines and increase the incentives for parents who complete the schedule, effective 2013.

From http://www.heraldsun.com.au/news/more-news/inject-children-or-lose-money/story-fn7x8me2-1226205382138

Chickenpox or varicella which as not previously been covered by the schedule (and hence was an out-of-pocket expense for parents wanting to vaccinate against chickenpox) will now be included.

Also new is vaccinations for meningococcal C and pneumococcal.

The new schedule brings the number of infectious diseases covered by the schedule to twelve.

Importantly, reports indicate that the number of shots kids will be required to get will actually be reduced however, since there will be new combination vaccines used.

According to a report in The Herald Sun a new combination vaccine will cover measles, mumps, rubella and chickenpox in one shot and will be administered at 18 months replacing the previous MMR given at 4 years. The number of visits will increase however, owing to the new scheduled shot at 18 months.

There are also changes to the incentive scheme for parents and this is where it gets interesting (well, for nerds of legislation like me).

Under the current maternity immunisation allowance scheme introduced in 1997, parents receive two one-off payments totalling $258 if they complete the vaccination schedule. This will be scrapped under the new system and replaced with three payments of $726 each, paid at one, three and five years. If kids are not fully vaccinated, then the $2100 will be withheld. (This is part of the current family tax benefit part A end-of-year supplement so it’s not an entirely new benefit).

From http://www.smh.com.au/national/tax-threat-to-parents-who-dont-have-their-children-immunised-20111124-1nwwx.html

Health Minister Nicola Roxon said: “We know that immunisation is fundamental to a child’s lifelong health and that’s why we want to make sure that children are immunised at the right time.

“We want all Australian kids to grow up healthy, and immunisation is essential to that.”

What is not mentioned in any of the news stories is whether this effects the current options for conscientious objectors. Under the current system, you can still get the maternity immunisation allowance even if you don’t vaccinate, if you identify as a conscientious objector (CO). Excerpt from the Centrelink website which administers the payment:

a recognised immunisation provider (e.g. your doctor) signs a letter or form saying that:

• they have told you about the benefits and risks of immunising your child and you have a conscientious objection to immunising your child (your provider should complete a Health Insurance Commission Immu-12 form),

• immunising your child with a particular vaccine is medically contraindicated (your provider should use the Health Insurance Commission Immu-11 form),

• the child has a natural immunity to the disease, or

• the vaccine is not available,

• you or your partner are a member of the Church of Christ, Scientist and you have a letter from an official of the Church advising that you are a practising member of the Church.

This is certainly going to be the bit the anti-vaxers are interested in. The news stories appeared overnight (at least one was published at 12:00) so we have yet to see a reaction from Meryl and her buddies. But you can expect some major *head asplosions* on this one, guaranteed. Particularly since Meryl had previously claimed she has some sort of influence when it comes to vaccination policy. It seems she might have missed this one.

This is not the only piece of good news in this story either. Reports also detail a new pertussis awareness campaign in the form of mail-outs to warn parents about the dangers of the current epidemic and advise on ways to protect their kids.

This is a direct response to campaigning by the McCaffery family who lost their baby Dana in 2009 at 4 weeks of age in the grips of a pertussis epidemic. The family was never warned about the risks of pertussis or that they needed, as parents and carers, to get boosters, since the effectiveness of the vaccines wanes over time.

From the Age:

Ms Roxon said the aim of the whooping cough campaign was to raise awareness, particularly among parents planning pregnancies and others to be aware of the dangers to infants and the need to have vaccinations at two months, four months and six months after birth.
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But the vaccinations do not provide lifelong protection from whooping cough and children should have booster shots at age four and then during teenage years, Ms Roxon said.

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”Whooping cough is not just a childhood disease, as adolescents and adults can account for half the cases in the community.”

Overall, this is a step in the right direction by the Australian Government and I applaud Nicola Roxon for (finally) taking action. The introduction of the chickenpox vaccine is also a welcome addition to the schedule, since it costs as much to get as the current maternity immunisation allowance (~$200) making the incentive seem moot.

It’s still early in Australia, and since this story only broke overnight, I wait with interest for the response of the anti-vaxers. I’ve also searched, but to no avail, for a government media release, as I’m keen to find out if any changes have been made to the CO conditions.

One suspects they will remain in place, at least in some form, since they are necessary for kids with genuine medical reasons for not vaccinating, but given that the maternity immunisation allowance scheme is to be scrapped, it appears they will at least need to be migrated, if not re-drafted.

I await with interest.

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Update: the government statement about changes can be found here

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I get emails. And recently I was reminded of one I got back in June which somehow slipped from my consciousness. With all the negative attention Nimrod has been receiving of late the response from some authorities has been, “we can’t respond unless someone reports him.” Indeed, last month, chair of the Chiropractic Board of Australia urged people to make a formal complaint against Mr Weiner after Australian Doctor posted audio of his two-hour public lecture on the dangers of vaccination.

So I went back through my emails and found a complaint from Dr John Cunningham, forwarded to me and submitted to AHPRA (then passed onto the Chiropractic Council of NSW) on April 4th, 2011. Dr Cunningham received the following response on May 31st, 2011 (my emphasis).

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Really? So it’s okay for a registered health professional to disseminate false, misleading and dangerous information under the guises of “it’s my opinion”? But what if the evidence says the opposite, which in this case it most certainly does.

If you take a look at the references Weiner uses in the 4 pages of anti-vax rhetoric posted on his website (which was the subject of Cunningham’s complaint), and his 2-hr long lecture on “18 reasons to not vaccinate” (pdf of references here) you’ll find a grab-bag of some of the most prominent anti-vaxers. He cites all my favourite loons including the AVN and their previous publication “Informed Choice”, Not-a-doctor Andrew Wakefield, Viera “parsnip box” Scheibner, Joseph Mercola, Whale.to and Vaccine Information Service Australia or VISA (amongst others).

There’s a glass and a half of crazy right there.

Weiner also drags out the some of the old favourite canards of the antivaxers. See the following paragraph as an example of vaccines cause everything;

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“Other conditions linked to vaccination include pervasive developmental disorder (PDD), Asperger’s syndrome, eczema, encephalitis, Guillain-Barre syndrome, convulsions, seizures, anaphylaxis, thrombocytopenia, optic neuritis, ocular palsies, retinitis, deafness, otitis media, ulcerative colitis, bowel disease, Crohn’s disease, headaches, dizziness, hearing and vision problems, arthritis, arthralgia, learning disorders, chronic fatigue, diabetes, multiple sclerosis and more.”

–

He doesn’t provide a reference for these claims.

And as usual, Weiner beats the dead horse of vaccines = autism

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“After years of denying a link between vaccination and autism, on November 9, 2007 the US government in Court of Federal Claims admitted that vaccines can cause autism.”

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The reference Weiner cites for this claim is David Kirby writing for the Huffington Post in 2008. Kirby is also the author of “Evidence of Harm” a book detailing the personal stories of parents of children who have autism who went onto establish the advocacy group SafeMinds. So there may be a conflict of interest in what Kirby has to say.

There also *may* have been some advances on our understanding of the evidence against a link between vaccines and autism – which have occurred since 2008, both in the courts and in the lab.

But despite the fact that Weiner claims to base his information on the latest science, he uses outdated references, claims Wakefield’s work is “sound” and uses scary language that has no basis in science.

There’s more…

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Robert Mendelsohn, MD writes: “My suspicion, which is shared by others in my profession, is that the nearly 10,000 SIDS deaths that occur in the U.S. each year are related to one or more of the vaccines that are routinely given to children.”

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My suspicion? So you don’t have any evidence for that then? The reference for this statement is simply Mendelsohn. Ibid:250 which makes no sense to me. In any case, Mendelsohn is well known for his “unusual ideas”.

For example, he has opposed water fluoridation, immunization, coronary bypass surgery, licensing of nutritionists, and screening examinations to detect breast cancer. He has a listing on Quackwatch and whale.to.

The spurious claims about vax go on for 4 pages and at last check they were still there. (I’m actually surprised it is still up given the criticism Weiner has been under of late. Perhaps his cognitive dissonance is so strong that he thinks he is right. Sadly, I suspect this is the case).

But whether Weiner thinks he is right and that vaccines are bad “in his opinion” is irrelevant when it comes to his role a health care professional, especially when dealing with kids. Remember he’s a pediatric chiropractor dealing with kids as young as one-day-old.

And science is not formed via opinion, it’s based on evidence and there is no evidence for just about everything he claims (even chiropractic subluxations actually).

The fact that the CCNSW thinks it’s okay says a lot about their responsible approach to chiros under their jurisdiction and patients.

This story was covered in Australian Doctor today and rest assured, we have not seen the last of the Weiner files. More to come very soon.

The AVN was targeted in the statement in which AMA Vice President, Dr Steve Hambleton said that recent media reports outlining the views of the AVN show that this organisation has drawn the fire of the NSW Health Care Complaints Commission (HCCC).

“While we all value freedom of speech in our society, groups that promote what the NSW HCCC has described as misleading, inaccurate and deceptive information about immunisation, under the guise of ‘pro-information’ and ‘pro-choice’, are putting Australians at risk of diseases that can be prevented through vaccination” he said.

The AVN have previously been in legal strife with the AMA. Back in 2007 they published an advertisement on mandatory vaccination of healthcare workers in NSW which made some rather spurious claims about the AMA. The ad had been submitted to NSW Doctor magazine but was rejected upon the committee checking the AVN website and “finding out that we only had one medical practitioner listed amongst our Professional Members”.

So the AVN published it on their website, until the AMA’s lawyers got a gander at it. The AVN was forced to remove the ad and publish a retraction in its place which said (in part):

In particular it has been brought to the attention of the Australian Vaccination Network, the the Australian Vaccination Network accepts, that:

1- AMA (NSW) does not obtain any of its funding from pharmaceutical companies;

2- AMA (NSW) has not published any advertisement or advertorial for a pharmaceutical company in the NSW Doctor for a period of at least four years, and at no time has the advertising in NSW Doctor been almost exclusively that of pharmaceutical companies;

3- AMA (NSW) does not actively censor information made available to its members.

The Australian Vaccination Network unreservedly apologises for any offence or embarassment the publication may have caused AMA (NSW), its officers and employees.

Ads being rejected sight unseen by publishers is something the AVN are also familiar with. Remember when Sydney’s Child also rejected an ad from them back in April?

Today’s statement from the AMA is reproduced in full below. There is a link to the AMA story here.

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Misleading claims about vaccination putting Australian lives at risk

2 August 2010 – 2:15pm

Vice President, Dr Steve Hambleton, said today that the AMA is greatly concerned that groups that are promoting discredited theories about immunisation are exposing Australians to the devastating effects of preventable illnesses.

Dr Hambleton said that recent media reports outlining the views of the Australian Vaccination Network (AVN) show that this organisation has drawn the fire of the NSW Health Care Complaints Commission (HCCC).

“It is important for parents to have their children immunised. Immunisation saves lives,” Dr Hambleton said.

“While we all value freedom of speech in our society, groups that promote what the NSW HCCC has described as misleading, inaccurate and deceptive information about immunisation, under the guise of ‘pro-information’ and ‘pro-choice’, are putting Australians at risk of diseases that can be prevented through vaccination.

“We are now almost two generations away from deadly diseases such as tetanus, diphtheria and polio. Our grandparents will still remember how bad it was.

“Parents who choose not to immunise their children need to consider that they are putting not only their own children at risk, but they are also risking other children, with potentially fatal consequences.

“If immunisation rates fell because many parents relied on the efforts of other families to vaccinate their children, under the misapprehension that this would provide sufficient protection to the whole community, there would be new epidemics of old illnesses.

“The last outbreak of measles occurred in a school in an area with low immunisation rates. The outbreak was so severe that it interrupted the educational curriculum.

“The NSW HCCC’s findings and concerns regarding the AVN released last month are consistent with the views of the medical profession.

“It is critical that Governments promote the evidence and benefits of full immunisation and run an ongoing public education program that informs the public about the devastating effects of diseases that can be avoided through vaccination.

“The AMA welcomes the announcement last week that seasonal flu vaccination of young children can now be resumed, and commends the Commonwealth Chief Medical Officer for taking early action to investigate this matter and the latest advice, which means we can maintain confidence in our vaccination program,” Dr Hambleton said.
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Follow the AMA on Twitter.
Image screen capped from Vaccination Awareness and Information Service

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Dear Margaret Allen, If you do read this, please follow this link to see the nature of the AVN’s material. As a librarian of experience, I expect you have researched this group prior to agreeing to host them. If not, and I understand you are very busy, then it might be of interest.
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Well done to Margaret Allen, CEO of the library, who was apparently responsible for this lapse in judgement and now has the dubious honour of putting the health of WA children at further risk. I hope she is pleased with her decision to host a “controversial” group that is the AVN.

Message to Margaret Allen: there is nothing “controversial” about vaccines, except that which exists in the minds of the anti-vaxers.

Over 200 people attended the event, including the brave sceptics @podblack, @luminousmonkey and @danbuzzard who live tweeted and blogged the event. (They must have stronger stomachs than do I). If you want to follow the course of events as they unfolded you can search twitter for the hashtag #stopAVN.

The seminar itself featured a talk from PhD candidate Judy Wilyman from Murdoch University Perth and Meryl Dorey, media spokesperson (and immediate past president) for the AVN.

There is a history to this talk – it is the second time the AVN have scheduled a public lecture in Perth in recent weeks. The first time, their booking was cancelled at the eleventh hour owing to the Uniting Church in the City (responsibly) deeming that hosting the AVN was not within their charter and ethos and “..there may be a public perception that the Church does not support childhood vaccinations“.

Unfortunately for Meryl, she was informed of the decision as she was about to board a plane to Perth from the Gold Coast, and was forced to forfeit her airfare and return home with her tail between her legs. What a shame.

This time, the library assured Meryl they would not repeat such a cancellation. And so they kept their promise with Margaret Allen responding to emails of complaint with the same form response;

“The State Library of Western Australia provides facilities and services to the community of Western Australia as a whole; inevitably from time to time this may include interest groups with views that some may find controversial.
.

The State Library does not make any judgment about individuals, groups or organizations, unless there is a clear breach of law, policies or procedures, in which case we may act to exclude clients.”

I personally called the WA Dept of Health to ask them to explain themselves, but was informed that the matter had been passed to the Minister for the Arts and Culture since the majority of complaints pertaining to the event, were about the use of a state tax-payer funded facility.

So it was apparently out of their hands.

I think they should have made it their job to put a stop to this, and I informed them of such (I am not shy), but despite them agreeing with all my points about the AVN, they sat on their hands. They did however have a meeting with Meryl Dorey and Judy Wilyman the evening prior to the event, which I was told was a routine event offered to anyone requesting so. I imagine Meryl taught them much about vaccines.

I’m certain the head of the Immunisation Programme for WA Health, Dr Paul Effler can’t possibly know as much as someone touted as “Australia’s Leading Expert in Vaccination” whose qualifications are a “brain”.

Perhaps because of the current government departments sticking their fingers in their ears and yelling “TROLOLOLOLOL” the Shadow minister for Culture and the Arts, John Hyde got mad. I don’t know if he knows the AVN’s work, but he was quoted in a West Australian newspaper article entitled “Anti-vaccine forum causes row” saying the Barnett Government had opened the floodgates for any group to use the library’s facilities to push their agendas.

“Does this mean that the Liberal Party can hold a membership drive there, or for that matter the Ku Klux Klan or a bike gang?” Mr Hyde said.

“Why should a group that endangers the lives of WA children be allowed to speak and promote their cause at a taxpayer-funded venue dedicated to learning?” Mr Hyde said.

He also informed a colleague in a personal communication that he would be asking Ms Allen and the Minister to explain their policies with respect to allowing groups like the AVN free rein of State funded facilities in parliament today. I look forward to hearing their explanation.

Channel 7 news reported the story where Mr Hyde said:

“Our state library shouldn’t be subsidising or promoting propaganda that puts the lives of our children at risk.”

Professor Fiona Stanley was less polite, simply stating: “This misinformation will lead to the deaths of children.”

As for CEO Ms Allen, the resident sceptics last night reported that Channel 7 was forbidden from filming inside the venue and that this was at the request of Ms Allen, not the AVN. It seems strange to me that Ms Allen is happy to host “controversial” groups, but doesn’t want anyone to know what they say. Either way, she now has a lot of explaining to do.

Tweets such as this:
Hey @statelibrarywa good job on hosting an anti-vaxer and HIV/AIDS denier. Australia’s children thank you #stopAVN #FAIL

Very nice of AVN to talk about free choice, sorry, if your choice means a child dies, you don’t get to be free on that.

were appearing all over their twitter page last night as the seminar progressed.

Leading up to the event and because of the previous last minute cancellation,  Meryl was constantly screeching about “free speech” and democracy. Well, I want to be free to say “I HAVE A BOMB” on a plane, but for sake of public safety I wouldn’t, I can’t and I don’t. Much the same as yelling “FIRE!” in a crowded cinema when there is no fire.

Meanwhile a report which appeared in the West Australian last week claimed that more WA parents were opting out of vaccinating their children, with the number of youngsters not fully immunised in the national program doubling over the past five years.

But according to the Dept of Health this report was exaggerated. Medicare figures show WA has the lowest rate of childhood vaccinations in the country for children aged 12 to 15 months, but only by 0.2%.

The percentage of children 12-15 months of age (age calculated at 31 December 2009) assessed as fully immunised. Date of processing 31 March 2010.

ACT 92.8%, VIC 92.0, QLD 91.5%, SA 90.6%, WA 89.2%, TAS 93.0%, NT 89.4%, AUS 91.4%.

Similarly, the percentage of children 24-27 months of age (age calculated at 31 December 2009) assessed as fully immunised is lower by a difference of 2.3%.

ACT 93.9%, VIC 92.3, QLD 92.6%, SA 91.6%, WA 89.9%, TAS 93.5%, NT 92.0%, AUS 92.0%.

And according to Dr Paul Effler, the medical co-ordinator of the immunisation program in WA, the state is consistently lower than the rest of the country largely because the State had the fewest GPs, who give 63 per cent of immunisations, per capita.

I’ll bet you can’t guess where the lowest rates of immunisation nationally might fall. Go on, guess. And here’s a clue, the  AVN are based in Bangalow, an area know as the Northern Rivers.

From the most recent Medicare figures reporting the rankings for Divisions of General Practice in descending order based on immunisation coverage rates calculated from the General Practice Immunisation Incentives scheme. Rated for the May quarter 2010, from 1 (first) – (last) 113.

113. NORTHERN RIVERS GENERAL PRACTICE NETWORK 79.6%

Is it a coincidence that this is the region where the AVN are based?

Discuss.

Congratulations to Meryl Dorey and the AVN for campaigning hard and long, and succeeding in discouraging parents from vaccinating their children. First place in the lowest vax uptake in the country is nothing to be proud of.

And congratulations must also go to the WA government for allowing this dangerous group to spew their “controversial” BS all the way to Perth.

And what will be the prize? Mumps, whooping cough, pick your favourite communicable disease. They’re all in the running now.

Please see @podblack’s blog here for more information. Also a blog has been established for this event.

The Wakefield investigation was the longest in the history of the GMC, with the disciplinary panel sitting for a total of 148 days over a period of 2 and a half years at an estimated cost of one million pounds. The results of the investigation were revealed in a 143 page report on 28th January 2010, and found that Wakefield showed a “callous disregard” for childrens’ suffering and “abused his position of trust.”

The GMC “..determined that Dr Wakefield’s name should be erased from the medical register…”.

The decision follows an investigation into Wakefield’s behaviour surrounding the 1998 publication of a scientific paper in The Lancet journal, linking the triple MMR vaccine with gastrointestinal disorders and autism. Although the study itself did not demonstrate the MMR vaccine caused autism, Dr Wakefield urged caution and advised parents to get single injections against measles, mumps and rubella at a subsequent press conference.

Wakefield’s statements resonated world wide, scaring many parents away from vaccinating their children and firmly cementing the anti-vaccination movement. The resulting drop in vaccine compliance, spurred on by a complicit media, continues to contribute to outbreaks of vaccine preventable diseases such as measles, mumps and whooping cough.

Wakefield was found to have brought the medical profession “into disrepute” after he took blood samples for the study from children attending his son’s birthday party in return for 5 pounds “reward”. He later laughed and joked at a conference about the children fainting and vomiting.

(It’s unbelievable that Wakefield would expect this method of collecting samples for a study to be ethical and above board. He is either completely clueless when it comes to the strict procedures instructed by ethics committees or he’s a completely incompetent researcher. Or perhaps his ego got in the way).

In addition Wakefield conducted unnecessary, painful and intrusive diagnostic treatments on children, including colonoscopies and spinal taps, procedures for which he did not have ethics approval to undertake.

In further investigations, Sunday Times journalist Brian Deer revealed that Wakefield did not disclose serious financial conflicts of interest. Deer provided evidence that Wakefield was paid thousands of pounds by lawyers seeking a link between the MMR vaccine and autism. Wakefield also had a patent pending on his own single measles vaccine, similar to the one he urged parents to seek out at the press conference following the publishing of the paper.

In 2004, ten of the thirteen authors on the Lancet paper withdrew their names from the publication stating; “We wish to make it clear that in this paper no causal link established between MMR vaccine and autism as the data were insufficient. However the possibility of such a link was raised and consequent events have had major implications for public health.”

It took a further six years before the editor of the Lancet, Richard Horton, retracted the paper, which effectively means it is now scratched from the scientific record. Another Wakefield paper which was accepted for publication in the journal NeuroToxicology was also subsequently withdrawn.  This study attempted to show a link between thimerosal and impaired neurological development and was nick-named “14 monkeys”.

Wakefield relocated to the US in 2005, where he established and was director of the alternative medicine clinic for children with autism spectrum disorders, known as Thoughtful House. The clinic has come under fire for using questionable treatments such a chelation, a scientifically unproven therapy for autism. He was pressured into resigning his position following the GMC findings in January. (Interestingly, the “Founders” tab on their website is broken, and there is no mention of Wakefield anywhere that I can find. Wakefield has been effectively erased from their records).

Despite recent events, the anti-vaccination movement continue to rally around their “poster boy”. Wakefields’ supporters called the findings “unjust”, a “smear campaign” and “a sad day for our children.” Generation Rescue, a zealous anti-vaccination group in the US, (publicly represented by Jenny McCarthy), issued a statement of support following the GMC findings in January;

“Dr. Andrew Wakefield is perhaps this debate’s greatest hero. He’s a doctor who has held onto the truth, unbowed, through pressure that would break most mortals. Dr. Wakefield’s influence in saving other children from the fate that befell so many children is incalculable.”

Comments left on the Age of Autism website were supporting calls for Wakefield to be knighted. How people can support such a fraudulent and discredited man is completely beyond me.

So let’s summarise the chain of events that led to Wakefield getting struck off

• Wakefield was getting paid by lawyers putting together a class action suit against the manufacturers of MMR for 2 years prior to the publication of the Lancet paper.

• He called for parents to seek out a single vaccine for measles – he had a patent on his own single measles virus.

• The PCR data was found to have come from contaminated samples and could not be independently confirmed.

• Pathology results were fabricated

• No conflicts of interest were declared when the paper was submitted.

• He did not have ethics approval for some of the studies on children.

For such a small study (12 children) that did not even examine a vaccines/autism link, it is incredible to think that it had such a large impact on public health. But of course the blame does not solely lie with Wakefield. The media were highly complicit in spreading the fear about the MMR vaccine. And the result of their misinformation was MMR vaccination rates in the UK fell from over 90% to below 80%. And although the anti-vaccine movement  was well and truly active at this stage, it must be acknowledged that this boosted their cause.

Even after 10 of the 12 authors removed their names from the paper in 2004 for “public health” reasons, Brian Deer exposed the conflicts of interest and fraudulent practices, the Lancet retracted the paper completely in 2010, rapidly followed by NeuroToxicology doing the same, the GMC called Wakefield dishonest and irresponsible, he got shafted from the woo-fest that is Thoughtful House, he was stripped of his license, people continue to rally around him.

No respectable medical journals are gonna touch him again. Although he is on the editorial board of the quack-fest that is Medical Veritas, The Journal of Medical Truth, along with other prestigious anti-vaxers such as Veira Shreibner. Actually itr seems quite a shame really. If you search PubMed for AJ Wakefield, you get 15 reviews and 112 other papers. He was a prolific publisher, especially for a clinician, but it matters not anymore.

Recently he sat down to be interviewed by Mercola in a five part series on YouTube.

Although clearly Wakefield knew what was coming – I mean he wrote it in his book, which was published weeks ago, and entitled “Callous disregard”, that he lost his medical license. Harriet Hall has had the stomach to read the book, you can read her blog about it here.

Speaking prior to the GMC hearing on May 24, Wakefield told the BBC he was not responsible for the resurgence in measles. He has also said he categorically denies suggestions that he had acted dishonestly, or against the best interests of children.

He did not attend the GMC hearing in London, rather choosing to appear on the Today Show in New York City where he was interviewed by Matt Lauer. The interview is a clear illustration of him now believing the rheteoric, as he repeatedly insists that his Lancet findings been repeated in five different countries and that there is a link between vaccines and autism. He also tells Lauer the GMC decision is a PR exercise designed to ruin him.

Despite a flurry of research spurred on by Wakefield’s 1998 study, no link between vaccines and autism has been found and Wakefield’s original findings have not been reliably replicated.

Speaking at an anti-vaccine rally in Washington on Wednesday, Wakefield said he plans to set up a virtual university where he will design studies and recruit researchers to carry out the work.

Wakefield’s colleague, Professor Walker Smith, a senior author on the study has also been struck off the UK medical register. The other doctor under investigation, Professor Simon Murch was found not guilty of professional misconduct.

Smith and Wakefield have 28 days to appeal the decision. Wakefield has indicated that he planned to do so.

Apologies for not blogging this properly. I have just written an article for someone else, and can’t post the same text here. I will endeavour to do so in the next few days.

In the meantime, here are the findings on Wakefield from the GMC.

SPOILER ALERT:

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

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The effect of the foregoing direction is that, unless Dr Wakefield exercises his right of appeal, his name will be erased from the Medical Register 28 days from when formal notice has been deemed to be served upon him by letter to his registered address.

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Date: 24 May 2010

Dr Andrew Jeremy WAKEFIELD

Determination on Serious Professional Misconduct (SPM) and sanction:

The Panel has already given its findings on the facts and its reasons for determining that the facts as found proved could amount to serious professional misconduct.

It then went on to consider and determine whether, under Rule 29(1) of the General Medical Council Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules Order of Council 1988, the facts as admitted or found proved do amount to serious professional misconduct and if so, what, if any sanction it should impose. It has accepted the Legal Assessor’s advice in full as to the approach to be taken in this case, and has looked at each doctors’ case separately but, when considering whether Dr Wakefield is guilty of serious professional misconduct, has looked at the heads of charge found proved against him as a whole. It has not confined its consideration to the heads of charge; it has also had regard to the evidence that has been adduced and the submissions made by Ms Smith on behalf of the General Medical Council. On behalf of Dr Wakefield, no evidence has been adduced and no arguments or pleas in mitigation have been addressed to the Panel at this stage of the proceedings. In fact Mr Coonan specifically submitted:

“……we call no evidence and we make no substantive submissions on behalf of Dr Wakefield at this stage.” “…I am instructed to make no further observations in this case”.

Nevertheless, the Panel considered the totality of the evidence in Dr Wakefield’s case including the reference dated 27 October 1995, from Professor Leon Fine, the then Head of the Department of Medicine at the Royal Free Hospital, when reaching its decision at this stage, having been asked to consider that as part of Mr Coonan’s submissions at Stage 1.

Serious professional misconduct has no specific definition but in Roylance v General Medical Council [1999] Lloyd’s Rep. Med. 139 at 149 Lord Clyde, in giving the reasons of the Privy Council, said:

“Misconduct is a word of general effect, involving some act or omission which falls short of what would be proper in the circumstances. The standard of propriety may often be found by reference to the rules and standards ordinarily required by a medical practitioner in the particular circumstances…”

Lord Clyde went on to say:

“The misconduct is qualified in two respects. First, it is qualified by the word ‘professional’ which links the misconduct to the profession of medicine. Secondly, the misconduct is qualified by the word ‘serious’. It is not any professional misconduct which will qualify. The professional misconduct must be serious.”

The Panel has acted as an independent and impartial tribunal and exercised its own judgement on these matters. It has borne in mind the relevant GMC guidance at the time, namely the 1995 Good Medical Practice and, in so far as the findings relate to events after 1998, the 1998 Good Medical Practice. It has considered what has been adduced and submitted on behalf of the doctors about the standards and procedures which were prevalent at that time.

In considering Dr Wakefield’s case, the Panel has also taken into account the passage of time before these matters were brought before it and the length of time this case has taken. It noted that the multiple sittings were for a variety of reasons including professional commitments of the Panel and requests from Counsel for reasons such as illnesses, accidents, unavailability of witnesses and preparation time.

The Panel has noted Dr Wakefield’s previous good character and taken into account everything it has heard including his qualifications, experience and standing within the profession, with patients and the parents of patients.

The Panel considered the conduct of Dr Wakefield whilst he was registered as a medical practitioner and employed by the Royal Free Hospital Medical School in 1996 and 1997, initially as a Senior Lecturer in the Departments of Medicine and Histopathology. Later, from 1 May 1997 he was a Reader in Experimental Gastroenterology and an Honorary Consultant in Experimental Gastroenterology at the Royal Free Hospital.

The Panel has already found proved that Dr Wakefield’s Honorary Consultant appointment was subject to a stipulation that he would not have any involvement in the clinical management of patients. On five occasions (child 2, 4, 5, 12 and 7) he ordered investigations on children, when he had no paediatric qualifications, and in contravention of the limitations on his appointment. The Panel considered this alone constituted a breach of trust of patients and employers alike.

In February 1996 Dr Wakefield agreed to act as an expert in respect of MMR litigation. In relation to the Legal Aid Board (LAB), the Panel found that Dr Wakefield accepted monies totalling £50,000 procured through Mr Barr, the Claimants’ solicitor to pursue research. A costing proposal had been submitted by Mr Barr to the LAB containing detailed information provided by Dr Wakefield, and Dr Wakefield ought to have realised that Mr Barr would submit it to the LAB.

The costing proposal set out costs in respect of the investigation of five children. It covered each child’s four-night stay in hospital with colonoscopy, MRI and evoked potential studies. Dr Wakefield admitted that the funding subsequently provided by the Legal Aid Board had not been needed for these items because these costs were borne by the National Health Service as the patients were being admitted as NHS patients.

The Panel found that Dr Wakefield had a duty to disclose this information to the Legal Aid Board via Mr Barr. It was dishonest and misleading of him not to have done so. The Panel concluded that his intention to mislead the Legal Aid Board was sufficient on its own to amount to serious professional misconduct.

The Panel also found that in respect of £25,000 of LAB monies, Dr Wakefield caused or permitted it to be used for purposes other than those for which he said it was needed and for which it had been granted. In doing so he was in breach of his duties in relation to the managing of, and accounting for, funds.

In September 1996 Dr Wakefield made an application to the Ethical Practices Sub-Committee of the Royal Free Hospital (Ethics Committee) seeking approval for a research project involving 25 children. This was approved by the sub-Committee as Project 172-96. He named himself as one of the three Responsible Consultants, thereby taking on the shared responsibility for the information given in support of his application; for ensuring that only children meeting the inclusion criteria would be admitted to the study; that conditions attached to the Ethics Committee approval would be complied with; and that children would be treated in accordance with the terms of the approval given.

In respect of Research and Ethics Committee approval, the Panel had regard to the particular ethical guiding principles with regard to conducting research on children. It rejected Dr Wakefield’s overall contention that Project 172-96 was never undertaken; that all the investigations carried out on the children were clinically indicated and that the research elements of the project were covered by another Ethics Committee approval.

The Panel concluded that the programme of investigations that these children were subjected to was part of Project 172-96. It further determined that the conditions for approval and the inclusion criteria for that project were not complied with. The Ethics Committee’s reliance on the probity of Dr Wakefield as a Responsible Consultant was not met.

With regard to nine of the eleven children (2,1, 3, 4, 6, 9, 5,12 and considered by the Panel, it determined that Dr Wakefield caused research to be undertaken on them without Ethics Committee approval and thus without the ethical constraints that safeguard research. Ethical constraints are there for the protection both of research subjects and for the reassurance of the public and are crucial to public trust in research medicine. It was in the context of this research project that the Panel found that Dr Wakefield caused three of these young and vulnerable children, (nos. 3, 9 and 12) to undergo the invasive procedure of lumbar puncture when such investigation was for research purposes and was not clinically indicated. This action was contrary to his representation to the Ethics Committee that all the procedures were clinically indicated. In nine of the eleven children (2,1, 3, 4, 9, 5,12, 8 and 7) the Panel has found that Dr Wakefield acted contrary to the clinical interests of each child. The Panel is profoundly concerned that Dr Wakefield repeatedly breached fundamental principles of research medicine. It concluded that his actions in this area alone were sufficient to amount to serious professional misconduct.

The results of the research project were written up as an early report in the Lancet in February 1998. Dr Wakefield as a senior author undertook the drafting of the Lancet paper and wrote its final version. The reporting in that paper of a temporal link between gastrointestinal disease, developmental regression and the MMR vaccination had major public health implications and Dr Wakefield admitted that he knew it would attract intense public and media interest. The potential implications were therefore clear to him, as demonstrated in his correspondence with the Chief Medical Officer of Health and reports which had already appeared in the medical press. In the circumstances, Dr Wakefield had a clear and compelling duty to ensure that the factual information contained in the paper was true and accurate and he failed in this duty.

The children described in the Lancet paper were admitted for research purposes under a programme of investigations for Project 172-96 and the purpose of the project was to investigate the postulated new syndrome following vaccination. In the paper, Dr Wakefield failed to state that this was the case and the Panel concluded that this was dishonest, in that his failure was intentional and that it was irresponsible. His conduct resulted in a misleading description of the patient population. This was a matter which was fundamental to the understanding of the study and the terms under which it was conducted.

In addition to the failure to state that the children were part of a project to investigate the new syndrome, the Lancet paper also stated that the children had been consecutively referred to the Department of Paediatric Gastroenterology with a history of a pervasive developmental disorder and intestinal symptoms. This description implied that the children had been referred to the gastroenterology department with gastrointestinal symptoms and that the investigators had played no active part in that referral process. In fact, the Panel has found that some of the children were not routine referrals to the gastroenterology department in that either they lacked a reported history of gastrointestinal symptoms and/or that Dr Wakefield had been actively involved in the process of referral. In those circumstances the Panel concluded that the description of the referral process was irresponsible, misleading and in breach of Dr Wakefield’s duty as a senior author.

The statement in the Lancet paper that investigations reported in it were approved by the Royal Free Hospital Ethics Committee when they were not, was irresponsible.

Subsequent to the paper’s publication, Dr Wakefield had two occasions on which he could have corrected the content of the Lancet paper yet both times he compounded his misconduct.

First, in a published letter in response to correspondents who had suggested that there had been biased selection of the Lancet children, Dr Wakefield stated that the children had been referred through the normal channels, a response which was dishonest and irresponsible. He provided an inaccurate statement which omitted relevant information when he knew that the description of the population in the study was being questioned by the scientific community.

Second, at a meeting of the Medical Research Council, the Chair, Professor Sir John Pattison referred to the seriousness and importance of the implications of Dr Wakefield’s research and its major public health implications. At that meeting and on the issue of bias in generating the series of cases, Dr Wakefield stated that the children had come by “the standard route”, a response which was dishonest and irresponsible.

Regarding the issues of conflicts of interest, Dr Wakefield did not disclose matters which could legitimately give rise to a perception of a conflict of interest. He failed to disclose to the Ethics Committee and to the Editor of the Lancet his involvement in the MMR litigation and his receipt of funding from the Legal Aid Board. He also failed to disclose to the Editor of the Lancet his involvement as the inventor of a patent relating to a new vaccine for the elimination of the measles virus (Transfer Factor) which he also claimed in the patent application, would be a treatment for inflammatory bowel disease (IBD).

Even before the publication of the Lancet Paper, eminent professionals had expressed concerns about the LAB funding to Dr Wakefield and potential conflicts of interest. Dr Wakefield rejected these views. With regard to non-disclosure to the Ethics Committee, Dr Wakefield did in evidence accept that the Legal Aid Board funding should have been disclosed, but said that his involvement in the litigation need not, especially because of his interpretation of the questions in the application form. He said no question was asked which related to that matter and therefore felt no need to disclose. In evidence to the panel he stated:

“The form is set out expecting certain answers to specific questions and no such question exists. Therefore, since it was not asked, it was not answered.”

However, given the importance of an Ethics Committee’s reliance on the probity of an applicant, the Panel determined that this was a failure by Dr Wakefield and his actions amounted to serious professional misconduct.

With regard to the non-disclosure to the Lancet the Panel accepted evidence from the Editor of the Lancet, as to the importance of this issue. The Lancet published clear guidance in relation to the conflict of interest test that the applicant should apply and the need to discuss any issues arising from it with the Editor. The Lancet test was: “Is there anything that would embarrass you if it were to emerge after publication and you had not declared it?” Dr Wakefield chose not to declare or discuss any conflict of interest with the Editor. He stated that he was able to reconcile his position, was not embarrassed by it, and was quite proud of the position he had taken on behalf of the Lancet children.

Dr Wakefield was insistent that his involvement with the new patent had not given rise to any prior need to disclose. Despite the clear terms of the patent, he did not accept that the invention was envisaged as an alternative vaccine to MMR. He acknowledged that he had envisaged the use of transfer factor for at least a proportion of the population and that he had a financial and career interest in its success, but he said that it did not cross his mind to disclose it, and even with hindsight he insisted that there was a reasonable argument, as he put it, for non-disclosure. The Panel considered that his actions and his persistent lack of insight as to the gravity of his conduct amounted to serious professional misconduct.

In relation to the administration of Transfer Factor to Child 10, the Panel noted the admitted background of Dr Wakefield’s involvement in a company set up with Child 10’s father as Managing Director, to produce and sell Transfer Factor. Around the same time, Dr Wakefield inappropriately caused Child 10 to be administered transfer factor. The Panel accepted that information as to its safety had been obtained and that the approval to administer Transfer Factor to one child was granted in the form of “Chairman’s approval”, “on a named patient basis” in a letter from Dr Geoffrey Lloyd, Chairman of the Medical Advisory Committee at the Royal Free Hospital. Nonetheless the Panel found that Dr Wakefield was at fault because the substance was given for experimental reasons, he did not cause the details to be recorded in the child’s records, or cause the general practitioner to be informed, and he did not have the requisite paediatric qualifications.

Dr Wakefield’s actions were contrary to the clinical interests of Child 10 and an abuse of his position of trust as a medical practitioner. The Panel considered these to be serious departures from the standards of a registered medical practitioner and concluded that these amounted individually and collectively to serious professional misconduct.

Dr Wakefield caused blood to be taken from a group of children for research purposes at a birthday party, which the Panel found to be an inappropriate social setting. He behaved unethically in failing to seek Ethics Committee approval; he showed callous disregard for any distress or pain the children might suffer, and he paid the children £5 reward for giving their blood. He then described the episode in humorous terms at a public presentation and expressed an intention to repeat his conduct. When giving evidence to the Panel, Dr Wakefield expressed some regret regarding his remarks. The Panel was concerned at Dr Wakefield’s apparent lack of serious consideration to the relevant ethical issues and the abuse of his position of trust as a medical practitioner with regard to his conduct in causing the blood to be taken. The Panel concluded that his conduct brought the medical profession into disrepute.

Dr Wakefield defended the ethical basis for the taking of blood at a birthday party contrary to the experts who gave evidence to the Panel and who strongly condemned this action. The Panel determined that his conduct fell seriously short of the standards expected of a doctor and was a breach of the trust which the public is entitled to have in members of the medical profession. It concluded that this behaviour amounted to serious professional misconduct.

The Panel has borne in mind the principles guiding a doctor as set out in the relevant paragraphs of 1995 Good Medical Practice which relate to providing a good standard of practice and care, good clinical care, keeping up-to-date, abuse of professional position, probity in professional practice, financial and commercial dealings, and the general principles of conflict of interest, followed by particular provisions as to the way in which research must be conducted. The 1998 Good Medical Practice, relevant to Dr Wakefield’s conduct at the birthday party, lists the duties of a doctor in providing a good standard of practice and care, keeping up-to-date and the issue of research and the absolute duty to conduct all research with honesty and integrity.

In all the circumstances and taking into account the standard which might be expected of a doctor practising in the same field of medicine in similar circumstances in or around 1996-1998, the Panel concluded that Dr Wakefield’s misconduct not only collectively amounts to serious professional misconduct, over a timeframe from 1996 to 1999, but also, when considered individually, constitutes multiple separate instances of serious professional misconduct.

Accordingly the Panel finds Dr Wakefield guilty of serious professional misconduct.

In considering what, if any, sanction to apply, the Panel was mindful at all times of the need for proportionality and the public interest which includes not only the protection of patients and the public at large, but also setting and maintaining standards within the medical profession, as well as safeguarding its reputation and maintaining public confidence in the profession. It bore in mind that the purpose of sanctions is not punitive, although that might be their effect.

The Panel noted the submissions of GMC Counsel that the appropriate and proportionate sanction would be erasure in light of his serious and wide-ranging misconduct. However the Panel accepted the Legal Assessor’s advice that this was only a submission on behalf of the GMC and it was for the Panel to make up its own mind. Dr Wakefield’s counsel did not make any substantive submissions on his behalf.

The Panel went on to consider whether it should, pursuant to Rule 30(1), postpone the case. It received no submissions in this regard and so went on to determine whether it was sufficient to conclude the case without making a direction or with an admonition.

The Panel made findings of transgressions in many aspects of Dr Wakefield’s research. It made findings of dishonesty in regard to his writing of a scientific paper that had major implications for public health, and with regard to his subsequent representations to a scientific body and to colleagues. He was dishonest in respect of the LAB funds secured for research as well as being misleading. Furthermore he was in breach of his duty to manage finances as well as to account for funds that he did not need to the donor of those funds. In causing blood samples to be taken from children at a birthday party, he callously disregarded the pain and distress young children might suffer and behaved in a way which brought the profession into disrepute.

In view of the nature, number and seriousness of the findings the Panel concluded it would be wholly inappropriate to conclude the case without making a direction or

with a reprimand.

It next considered under rule 31 whether it was sufficient to direct that the registration of Dr Wakefield be conditional on his compliance during a period not exceeding three years with such requirements as the (Panel) may think fit to impose for the protection of members of the public or in his interests. Conditions have to be practicable, workable, measurable and verifiable and directed at the particular shortcomings identified. The Panel concluded that Dr Wakefield’s shortcomings and the aggravating factors in this case including in broad terms the wide-ranging transgressions relating to every aspect of his research; his disregard for the clinical interests of vulnerable patients; his failure to heed the warnings he received in relation to the potential conflicts of interest associated with his Legal Aid Board funding; his failure to disclose the patent; his dishonesty and the compounding of that dishonesty in relation to the drafting of the Lancet paper; and his subsequent representations about it, all played out against a background of research involving such major public health implications, could not be addressed by any conditions on his registration. In addition, the Panel considered that his actions relating to the taking of blood at the party exemplifies a fundamental failure in the ethical standards expected of a medical practitioner. It concluded that conditional registration would not mark the seriousness of such fundamental failings in his duty as a doctor.

The Panel next went on to consider whether it would be sufficient to suspend Dr Wakefield’s registration for a period not exceeding twelve months. Dr Wakefield has demonstrated a persistent lack of insight and has insisted in many instances on his ethical propriety: in the context of the referral process and the treatment of the children in the research project in which he was engaged; in the context of the funding of the project; with regard to the terminology of the Lancet paper; with regard to his non-declaration of interests; with regard to not acting in the best clinical interests of the Lancet children and with regard to obtaining blood from children at a birthday party.

The Panel noted that the sanction of suspension may be appropriate for conduct that falls short of being fundamentally incompatible with continued registration; where there is no evidence of harmful deep-seated or attitudinal problems; and where there is insight and no significant risk of repeating behaviour. Although these points have been set out in the GMC’s Indicative Sanctions Guidance which was published subsequent to these events, the Panel considered that the guidance outlines the type of sanction appropriate to the gravity of misconduct and that the same principles are applicable to Dr Wakefield’s actions at the material times. The Panel considers that Dr Wakefield’s conduct in relation to the facts found falls seriously short of the relevant standards and that suspension would not be sufficient or appropriate against a background of several aggravating factors and in the absence of any mitigating submissions made on his behalf. Dr Wakefield’s continued lack of insight as to his misconduct serve only to satisfy the Panel that suspension is not sufficient and that his actions are incompatible with his continued registration as a medical practitioner.

Accordingly the Panel has determined that Dr Wakefield’s name should be erased from the medical register. The Panel concluded that it is the only sanction that is appropriate to protect patients and is in the wider public interest, including the maintenance of public trust and confidence in the profession and is proportionate to the serious and wide-ranging findings made against him.

The effect of the foregoing direction is that, unless Dr Wakefield exercises his right of appeal, his name will be erased from the Medical Register 28 days from when formal notice has been deemed to be served upon him by letter to his registered address.

Dr Wakefield is presently not subject to any interim order on his registration. The Panel will hear submissions on whether an immediate order of suspension should be imposed upon him pending the outcome of any appeal, first from Ms Smith on behalf of the General Medical Council and then from Mr Coonan on behalf of the doctor but will do that at the conclusion of the reading of all three determinations.

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.

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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.
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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?
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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.

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

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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.
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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).

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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
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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
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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.

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

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Testing began on CSLs 2009 H1N1 Influenza Vaccine (CSL425) in July 2009, on 370 kids aged between 6 Months to 8 Years.
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CSL Limited makes two AH1H1 vaccines, Panvax® and Panvax® Jnr (thimerosal free). The clinical trial is registered and published here.
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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:
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• 16.3% had a mild fever (>37.5 degrees C < 38.5 degrees C) in the 15µg group
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• 23% had mild fever in the 30 µg group
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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.

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

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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.

In Western Australia, 55 children suffered convulsions after having the vaccination, and almost 200 others suffered fevers and vomiting, chief health officer Dr Tarun Weeramanthri said.

The vaccination programme was suspended last week when adverse reactions began to appear.

Health authorities are undertaking urgent tests in an effort to understand why the reactions took place. Most of the adverse reactions took place in WA, but reports are now trickling in from SA, QLD and NSW.

In NSW, one child with a fever and rash and one child with a febrile convulsion have been reported to NSW Health. Both children have now fully recovered.

Earlier this month, a child aged 2 from Queensland died 12 hrs after receiving a seasonal flu vaccination, but it is not yet known if the vaccine was implicated. The coroner is investigating.

State authorities are currently working together to compile the spread of the reactions to better characterise the problem.

The Commonwealth’s chief medical officer, Professor Jim Bishop told ABC radio;

“We’ve got to keep this in perspective. We’re looking at an increase in fever causing convulsions in a state and we’ve got to work out if that’s above the baseline.”

Initial speculation was the vaccines may have been a bad batch but this has since been ruled this out, since multiple batches were used. CSL, the manufacturers of Fluvax, said three rival vaccines are available nationwide and that investigators have yet to discover which vaccine was given to the affected children.

Professor Bishop said this year’s batch includes swine flu vaccine, which was subject to thorough testing last year, and two strains of seasonal flu that were only minutely different to previous vaccines to combat slight genetic changes in the virus.

Dr Barr, the deputy director of the World Health Organisation’s influenza centre in Melbourne, said he thought it unlikely that the combination of the different strains in the vaccine would have triggered the reactions.

Dr Barr told ABC Radio that viruses produced and tested in a laboratory, then made into vaccines on a commercial scale, were ”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”.

The TGA is currently testing samples of the vaccines used in Western Australia where most of the reactions have occurred.

—-
UPDATE: from the Brisbane Times

An initial autopsy into the death of a Brisbane toddler has found no sign the seasonal flu vaccine was to blame, the state’s chief medical officer has said.

Dr Jeannette Young said a series of further tests would be necessary.

During a press conference this afternoon, Dr Young defended Queensland Health’s handling of the toddler’s case and blamed the private general practitioner who administered the vaccine to the girl for not reporting it, as is required under law.

She has referred the Mt Gravatt doctor to the Medical Tribunal Board.

The AVN president Meryl Dorey has just advised her subscribers that three domains have been suspended following a ‘legal complaint’ to their American host.

In an e-newsletter titled “AVN under attack” Dorey says the following;

“I came home this afternoon after doing our week’s grocery shopping, to find that all 3 of our domains have been suspended by our American server. When I contacted them, they told me that the reason for the suspension was a ‘legal’ complaint they had received. They would not give me any other information about the complaint so I have to wait to speak with their legal department next week.”

But then she says something very interesting;

“As soon as I hung up the phone with the web hosting company, I received a phone call from a friend who works in the Australian media. This person warned me that a media smear campaign against the AVN is about to start. They said that this campaign has been planned for some time and that it will involve trying to link the AVN with pornographic material.”

Okay, bizarre. And a little bit crazy. A smear campaign designed to link the AVN to porn? Sounds strange and a little bit pointless to tell you the truth. I’m not sure what this is designed to achieve. I hope Meryl knows and trusts her media source, cause this sounds a little too outlandish to be true.

Yet, the AVN has had a rough 12 months, so perhaps Meryl is inclined to believe anything at the moment. There are numerous complaints pending about the organisation, including an ongoing investigation by the Health Care Complaints Commission for spreading bad health advice and one with the Office of Liquor Gaming and Racing for alledegly trading as a charity without a valid license for more than 2 years.

Meryl describes the last 12 months in a slightly more hysterical fashion;

1- The spurious complaint against the AVN and myself with the HCCC.
2- Harassment of our advertisers.
3- Harassment of our professional members.
4- Death threats by email and telephone.
5- Establishment of websites and blogs specifically intended to stop the AVN.
6- Ridiculous accusations which state that the AVN supports conspiracy theories including the Illuminati and alien body-snatchers.
7- Harassment of the families of AVN supporters which, among other things, includes the posting of personal and business details on the internet.
8- Complaints filed with the Department of Fair Trading.
9- Complaints filed with the Office of Liquor, Gaming and Racing.
10- Complaints filed with ASIC.
11- Attempts to stop AVN-hosted seminars.
12- Hacking of the AVN website and email server.
13- Accusations that AVN supporters are child murders.
14- Threats to file defamation lawsuits.
15- Legal complaints which have shut down our website and email server.
16- Harassment of people who have donated to the AVN including tampering with their websites.

But the facts are pretty straight forward in this case. The AVN disseminates dangerous and inaccurate information about vaccines to vulnerable parents, who are then frightened into not vaccinating. Children are getting sick, some are dying.

It is therefore not such a bad thing that this information is removed from the public domain for a few days at least. It could save some kids’ lives.

Read the full text of the e-newsletter here.

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UPDATE: Ms Dorey’s suggestion that a smear campaign is about to commence linking her to porn may be a little late off the mark. There exists an adult website called AVN.com for Adult Video Network, which has been in existence for a very long time. Is this what her ‘anonymous media caller’ was referring to? Hat tip to TAG for making this connection.
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UPDATE#2: It seems most likely that the website being suspended is a mix up in a complaint against the adult site AVN. There has been mention of child pornography allegations, making it most likely that the American service provider banned the AVN.org not AVN.com

Steve Novella blogged about this before and if you want a more detailed explanation of the case I recommend you buzz on over to Neurologica. He also gives commentary in this story from Inside Edition about Desiree’s seemingly amazing “recovery”.

So is it a hoax? Take a look.

* although the report above says it was the “seasonal flu” just about every news story I heard, flip-flopped between the H1N1 and the seasonal flu vaccine, and sometimes even within the same report. Media FAIL.

Tip o’the hat to Scooter