One wonders if Meryl Dorey would have saved herself a lot of bad publicity had she just quietly posted the disclaimer as requested. As it turns out, there have now been two waves of bad publicity for the AVN. The first, after the HCCC report was released some two weeks ago and now the second wave with the refusal to post the disclaimer.

It seems the tide has definitely turned in the media with respect to the AVN. Previously the majority of the reporting was staunchly about “balance” never referring to the AVN as anti-vax and generally giving Meryl a pretty easy ride when it came to her avoiding the question of “you say you’re not anti-vax but which vaccines do you recommend?”.

And if you don’t believe me, listen to Steve Liebermann – who reckons the AVN should be shut down – tear shreds off the AVN on radio 2UE.

In the extensive coverage of the last few weeks, there has only been one example of television that I have seen the term “balanced” used and that was on the frothy morning show Sunrise (not known for hard hitting journalism). This morning the show interviewed both Meryl Dorey and Prof. Booy, who had both previously appeared on Radio ABC 702 Sydney. Even when Meryl got a pretty easy ride from the interviewer, there was no misunderstanding about the agenda of the AVN, as Prof Booy made it abundantly clear by referring to the AVN at least twice as the Anti-Vaccination Network.

You can watch the full story here.

And whilst there was a follow up story in today’s SMH, (following yesterdays front page criticism), interviewing Dorey and detailing her reasons for starting on her anti-vax crusade, it was juxtaposed with a series of rather loopy quotes from Dorey. In a column entitled “Dorey on vaccines” four quotations were published. Although they’re certainly not the most loopy I have seen from Meryl, they nonetheless do not make her look particularly “balanced” and “pro-information” (as she is still feebly clinging to BTW).

“I don’t see that the measles vaccine has done anything for Australia”

“Make no mistakes folks, this measles “outbreak” has been orchestrated for one reason and one reason only – to force the issue of compulsory vaccination.”

More conspiracy nonsense from Meryl, directly contradicting one of my favourite quotes from her;

“…we are already seen as rabid, idiotic fringe dwellers by so many in the mainstream, it does our cause no good at all to bring in conspiracy theories, which though we may subscribe to them, are unprovable.”

Thanks to the hard work of Steve Cannane who kicked this campaign off with the awesome report on Lateline some 2 weeks ago, the tone has been set in the media. Steve did a follow up story last night, this time covering the government’s seemingly disinterest in instigating the vaccination education campaign they have been promising for what seems like an eternity.

In the meantime the McCafferys (who have been extremely brave and stoic throughout this entire nightmare) have contributed to a website in collaboration with Professor Booy called Chain of Protection

Meanwhile Meryl continues unabated. She continues to bleat they are not anti-vax, that the HCCC does not have jurisdiction over them, that she is seeking legal advice etc etc. It’s like a broken record.

Pro-tip Meryl, saying it over and over again will not make it right. And because you arrogantly refused to put up the disclaimer, many more people now know just that.

Below is some of the coverage I have collected from the past few days. If you come across anything else, please leave a comment and I’ll add it here.

SMH Anti-vaccine Group a Threat

SMH Parents who lost baby stonewalled

SMH Still No Warning on Whooping Cough

The Medical News Anti-vaccination Group Declared Unsafe

Northern Star Warning Issued About AVN

ABC News Vaccine Group Needles Opponents
Anti-Vaccination Campaigners Slapped with Warning

New Scientist Anti-Vaccination Website Poses a Risk

International Business Times HCCC Warns Public on Anti-Vaccine Group

Medical Observer Public Warning Against Anti-Vaccination Website

2UE Steve Lieberman interviews Ken McLeod

The commission concluded that the AVN provide misleading information about vaccination and must post disclaimers on their website clearly stating they are anti-vaccination.

The report found evidence that the AVN misleads readers by using reliable and peer reviewed literature but selectively quotes from it, often in contradiction to the conclusions or findings of the studies. The AVN also gives non-peer reviewed and anecdotal material the same authority as peer-reviewed literature.

Ms Dorey responded to these accusations by saying:

“It is true that often times our information will contradict the conclusions of studies. This is because, as opposed to most doctors and government officials, we actually read the studies…that disconnect (between the data and conclusions) can be explained by the financial links between the study’s researchers and the companies whose products are being studied…This is not selective reporting, it is accurate reporting.”

Wow, talk about a disconnect. Firstly, it’s the old Big Pharma conspiracy theory again. When you got no evidence to support your claims, its time to roll out the Big Pharma Shill canard. *Yawn*

But this is interesting – she claims to have actually read the studies? This was not the impression Todd Sidwell gleaned when he analysed one of Meryl’s responses to the HCCC a few months back. Unless she intended to copy/paste mistakes, which were traced back to whale.to and other anti-vax conspiracy websites.

From Tom’s article: “At best she hasn’t read the papers she cites and includes them out of ignorance, and at worst she is being deliberately deceptive – and I spelled this out very clearly in the analyses I sent to the HCCC.”

See The Truth Behind the AVN Claims for the full details

—

The complaint, authored by Ken McLeod, included accusations such as:

• The AVN claims to support “informed choice” but only provides information designed to dissuade people from vaccinating

• State on their website that there are links between vaccination, autism, Crohn’s disease irritable bowel syndrome and shaken baby syndrome

• Cherry picking data to suggest that Gardasil has killed young women

• Bacterial meningitis has increased since the introduction of the meningococcal vaccines

• Autism is caused by mercury in vaccines

• Vaccination is unnecessary since homeopathy can be just as effective

• Misrepresenting the facts surrounding the death of Dana McCaffery and harrassing her parents

—–

The AVN are considered Health Care providers under the public health act

This case was somewhat of a test for the HCCC, since it was not immediately clear if the AVN even fell under the HCCC legislation. Initially the Commisssion had to establish if the AVN could be classified as “health care providers”.

Mrs Dorey had this to say;

“The complaint alleges that both the AVN and myself are “health service providers” because we are providing “health education services to the public” for the purposes of the health care complaints act 1993…Neither the AVN or Meryl Dorey are health care practitioners as the term is generally understood colloquially or have we ever claimed to be.”

Yet the commission disagreed with this, noting “the provision of health education was evident” on their website and also “Mrs Dorey participating in pregnancy discussion groups and in lecturing at universities” did indeed constitute health education.

Even more embarrassing for Dorey was her own constitution which stated the purposes of the AVN were “the advancement and promotion of education and learning amongst the public”.

Plus, the legislation is quite clear about the definition of a health care educators/provider, nothing “colloquial” about it. Yet, despite the Commission findings and the fact that she lectures at uni, Dorey still denies they are considered health educators. From the Lateline report;

“We do not agree that the HCCC has jurisdiction over us and we have been saying this from the very beginning and we are seeking legal advice over this issue.”

She now claims to be seeking legal advice on this caveat, despite the fact that she has already had 12 months to do so? Odd.

—-

The Commission focussed cheifly on the issues raised by Mr McLeod and Mr and Mrs McCaffery in relation to the AVN website. Here they examined the post “10 reasons why parents question vaccination” which consists of such statements as “vaccines have never been tested”, “vaccines contain toxic additives and heavy metals” and “vaccines do not necessarily protect against infectious diseases”. They asked Mrs Dorey to provide evidence for these claims.

The Commission analysed references provided by Mrs Dorey and noted many were not relevant to her claims, she was guilty of cherry picking or omitting data to support her claims and other information was demonstrably false.

Of note is her citation of an article about Gardasil from Natural News. com – yes that guy – where she omitted paragraphs to reinforce the claim that the vaccine had been linked to deaths in young women.

On other vaccines the report stated; “The AVN has selectively quoted information to suggest vaccination against meningococcal disease has been ineffective when there is no evidence of this”.

And “The AVN claims that vaccination is linked with a range of long term side effects however has provided no evidence to support this”. (My emphasis)

The AVN is anti-vax and must declare this on their website

The Commission has recommended that The Australian Vaccination Network include an appropriate statement in a prominent position on its website which states;

1. The Australian Vaccination Network’s purpose is to provide information against vaccination in order to balance what it believes is the substantial amount of pro-vaccination information available elsewhere
2. The information provided should not be read as medical advice
3. The decision about whether or not to vaccinate should be made in consultation with a health care provider

If the AVN fails to comply the commission will issue a public statement. Of course we had hoped the HCCC could have done more to limit the dissemination of false information by the AVN, but at least the resulting media coverage will shine some light on the true nature of the AVN.

Surprisingly, in her own response to the Commission, Meryl Dorey in fact admitted to being anti-vaccination, stating there is a need to provide an alternative to mainstream vaccination information.

According to the final report:

“In her response to the commission Ms Dorey conceded that provides anti-vaccination information. Ms Dorey stated there is a need to provide information about vaccination, alternative to that disseminated by the government.”

No longer can Ms Dorey hide behind “we are not anti-vax we are pro choice” which has always been her public persona.

Meryl has already issued a press release stating that the report constitutes an “outrageous attack”; “the threat to freedom of speech and the implications regarding loss of medical choice inherent in this decision make this an issue that cannot go unchallenged”. Interestingly, all references to skeptics with a capital “S” (thereby inferring Australian Skeptics) have been removed and replaced with Stop the AVN and their supporters.

The story has also been reported on 6 minutes here which contains a link to the full article as a pdf.

There is already a comment from Age of Autism UK editor John Stone, the same website who recently referred to the action as “fascist“.

—-

UPDATE #1

Apologies for any errors in the initial post, I am currently at TAM8, and am suffering from severe sleep deprivation! Plus, the post was written between the hours of 2 am and 5 am Las Vegas time (yawn).

Since then, I have had 4 hrs sleep and made some changes, plus others have now blogged the story.

See the story on YouTube
Podblack has a report here
ABC news has a related story here
Orac chimes in
Adelaide Now
Northern Star
Mia Freedman’s Mamamia
Immunisation – getting the right advice audio on 2UE
The World Today Top doctor backs disclaimer for anti-vaccination site
AAP story from Danny Rose

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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.
—

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.

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.

.

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.

—

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.

According to the Church there were concerns raised by a number of people, including prominent church members who are experts in the field of ethics and public health, that the message promoted by the Australian Vaccination Network is not in line with the ethos and values of the Uniting Church in Australia.

No Uniting Church in the City venue is being made available to the AVN for tomorrow night’s meeting (update AEST 20:42, please see below; it has been cancelled with plans to reschedule in the next four weeks).

The AVN organised the seminar following the recent spate of adverse reactions to the seasonal flu vaccine in children under five years of age.

Australia wide, over 400 reactions have been reported, in five states, the majority of which occurred in Western Australia. Authorities are still investigating the cause of high fevers and febrile convulsions. Most children recovered, but one child in Queensland died 12 hrs after receiving the vaccine. The coroner found no evidence to implicate the vaccine.

The AVN seminar, “Flu Vaccines and Informed Choice” was described in an e-newsletter;

“This talk examines the risk of flu to children, the effectiveness of the vaccine and the additional risks to children’s health of adding another vaccine to the childhood schedule.”

Both media spokesperson and immediate past-president, Meryl Dorey and Murdoch University PhD candidate Judy Wilyman were scheduled to talk.

“To date, more than 300 serious reactions to the current seasonal flu shot have been reported in children under the age of 5 with one child known to have died within hours of being vaccinated. All the indications are that this figure grossly underestimates the actual number of reactions. In her talk, Meryl Dorey will discuss how vaccines are intended to work and why it is that they often don’t. She will talk about the known side effects of childhood and adult shots and reveal that according to the Australian government, as few as 1% of vaccine reactions ever get reported, leading to a belief that they are perfectly safe.”

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This is not the first time the AVN has been refused access to a venue after having organised, booked and advertised a seminar. In 2009, they were forced to find another venue at short notice after a school in Mt Barker, South Australia declined their appearance, following notification of the nature of their material.

In a blog post entitled “AVN Under attack” Meryl Dorey described how those opposed to her ideas “…have tried to get venues where I am scheduled to present vaccination seminars to cancel and have harassed those who sponsor such events.”

Whilst publicly claiming to be the “pro-choice”, the AVN preaches a clear anti-vaccination message, designed to scare parents into shunning vaccinations for their children.

They were also recently refused paid advertising in The Child Group magazines, distributed free Australia wide and targeted specifically to parents, for similar reasons.

In South Australia, the AVN was able to secure a new venue at the last minute.

A recent tweet from the AVN (@nocompulsoryvac) published at 12:31 AEST, May 13th said; “Flying out to Perth, WA for our seminar tomorrow nite on flu vax. If you haven’t booked yet, extra chairs have been put in-call 1800 007 468 about 5 hours ago via HootSuite”.

At the time of writing, it is not known if Mrs Dorey is aware of the venue cancellation.

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UPDATE:

Meryl has just sent an e-newsletter about this. The text is reproduced below. Please write to the Uniting Church to thank them for taking a responsible stance here. Or call them on (08) 9321 9711.

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“UNITING CHURCH CANCELS AVN SEMINAR AT THE 11TH HOUR

At about 12:45 this afternoon, I was standing on line, waiting to board a plane that would take me to Perth. I had packed, arranged rides for my children, caught up on my office work for the next few days and was ready to just sit back, relax and enjoy the flight (while going over my powerpoint slides for the 20th time!)

As I was waiting my turn to give my ticket to the hostess, my mobile phone rang. I almost didn’t answer but seeing that it was a Western Australian number, I thought I’d better.

Little did I know…

On the other end of the phone was a Mr Andy Corkill who is the Mission Development Officer for the Uniting Church of Perth.

He was calling to inform me that the Church Council had received calls from the WA Dept of Health and from some of their own congregants including a senior academic from a university in Perth. All these people were urging the church to cancel our seminar which was taking place on Friday night.

Mr Corkill informed me that the Council had met the night before and decided that they would cancel the event and that there was really nothing he could do to change this because it was a decision made by the Council – not by him.

When I told him that we had over 100 people booked in to attend and that I was about to board a flight from QLD to Perth specifically for this event, he suggested that we find another venue. He was quite helpful and said they would be happy to post a sign at the Uniting Church to let people know the location of the new venue – hah!

I asked him where he thought I would be able to find a venue for over 100 people in just over 24 hours and he replied that he couldn’t help with that but I couldn’t have any Uniting Church venues.

So – off to the counter I go and ask them to pull my bags off the plane – down the $750 we paid to the Church for the venue and the almost $700 for the plane fares.

Don’t be downhearted!
A person could really be forgiven for feeling more than a little bit downhearted by these events. After all, there are children all across Australia who have died or been seriously injured by the flu vaccine in recent weeks. There is a little girl in PMH right now who was in a coma for some time and now faces a difficult and uncertain future because of this shot. And yet, the Department of Health and certain academics have decided that Australian parents need to be treated like mushrooms and kept away from any information that might call into doubt the safety of shots.

Unfortunately for them however, this action is going to backfire and backfire badly. This backlash is already starting!

The media in WA is now asking the following questions:

1- Who at the department of health chose to put pressure on the Church to force them to cancel our seminar? Why would a small event, attended by only 100 people, be of concern to the government?
2- Who was the senior academic who used his status as a member of the Uniting Church congregation and a supposed expert on this issue to state that the AVN should not be allowed to speak at a Church venue?
3- By trying to suppress this information, is the government trying to pretend that these reactions never took place? Are they stepping on our right to freedom of communication – a right that has been upheld by the High Court of Australia?

In the meantime, we contacted everyone who was booked into the seminar tomorrow to let them know it’s been cancelled. Several of these people have excellent contacts with larger and better venues in Perth and we are hoping to reschedule this talk for sometime within the next 4 weeks.

Of course, we will let you know as soon as we have rescheduled.

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UPDATE#2 16/05/10

The Church has now issued a press release stating their reasons for cancelling the AVN seminar. To read the pdf, click on the hyperlink “Cancellation of Australian Vaccination Network Event” on this page.

To read some of the emails apparently sent to the Church from AVN supporters, go here.

But investigations are being hampered somewhat, due to a software glitch which has prevented optimum recording of doses on the Australian Childhood Immunisation Register (ACIR).

A spokesperson for Medicare Australia, which administers ACIR, said they were aware that software had affected the transmission of data from some practices, and were advising all providers to review products.

The Western Australian Department of Health issued a letter to providers on May 6th;

“One of the major deficiencies in interpreting the data is the lack of reliable information on numbers of children vaccinated, including the brand and batch of vaccine used. This has arisen because of problems with the transfer of influenza vaccination data from practice software systems to the ACIR.”
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“Better data on total numbers of children vaccinated and the brands/batches used will allow calculation of rates of adverse events, and a clearer determination as to whether the risk is truly elevated compared to expectation (e.g. relative to the 2008 and 2009 WA programs and international experience), and whether any increase is specific to a particular vaccine brand or batch used.”

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They are also asking for providers to supply them with the numbers of children having received the vaccine manually.

“Because uncertainty remains as to how effective the ACIR upload approach may be, WA DoH would be very grateful if you could also complete the attached form, indicating numbers of children vaccinated with a trivalent influenza vaccine between the dates of 8 March and 23 April 2010, by age group, vaccine brand and batch. This information will also help to clarify how well influenza vaccination data entered in practice software systems is being transferred to ACIR.”

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The latest figures indicate 400 cases of fever and 77 convulsions in five states. Those reports led the Chief Medical Officer to suspend flu vaccination in all children younger than five years.

Associate Professor Richmond, a consultant at Princess Margaret hospital, (where most of the cases have appeared), and head of the WA influenza vaccine trial, said the adverse events this year appeared excessive compared to last year when 60,000 children – around half of the eligible cohort – received free influenza vaccine funded by the West Australian Government.

“The original whole flu virus seemed to be associated with more fevers, but now the virus gets split. So that will be something people will be looking at – is there more or less flu virus in this year’s vaccine which could be causing problems.”

However, some children who presented at hospital with high fever had gone on to have a second dose of vaccine without incident, he said.

In Australia the flu season is rapidly approaching, resulting in a rush on the vaccine for those still eligible and a subsequent exhaustion of supplies.

Those most vulnerable to such flu complications are adults over 65, especially those in nursing homes and kids under 2. Kids under 5 have been at higher risk of swine flu complications.

In Australia in 2009 there 47, 736 cases of laboratory confirmed influenza and so far in 2010 there have been 488.

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.

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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.

Australian parents urged to get the real facts on vaccination

Businessman, aviator, and explorer, Dick Smith, has funded an Australian Skeptics’ advertisement to urge parents to access factual information on vaccination, in the wake of the country’s largest Whooping Cough epidemic.

The advertisement warns people to avoid advice from groups such as the Australian Vaccination Network (AVN), which state that they are ‘pro-choice’ but are opposed to vaccination and spread misinformation about the safety and effectiveness of vaccines.

“Dick Smith Foods has funded this advertisement in the public interest, to ensure parents access unbiased, accurate advice from reputable medical sources. The Australian Vaccination Network is no such source,” said Mr Smith.

The advertisement – placed in the Thursday, August 6 edition of The Australian newspaper – warns parents that the AVN is spreading false claims including that vaccines contain toxic quantities of mercury, aluminium, and formaldehyde; that vaccines cause conditions such as autism, and that the AVN is providing incorrect information about the risks of childhood illnesses.

Following the tragic death of three babies to Whooping Cough, Australian Skeptics has established an information page with information on the myths and realities of vaccines and links to reputable sources.

The parents of four-week-old Dana McCaffery, who died from Whooping Cough in March, have welcomed the Skeptics’ actions.

“We implore parents to access reputable sources for information about vaccination. We thank the Australian Skeptics for presenting this information, which informs parents about the risks of preventable illnesses, addresses fears of vaccines with proven evidence, and debunks common myths. It is vital all Australian governments act now and implement comprehensive education campaigns to fully inform parents about the importance of vaccination,” said Toni and David McCaffery.

Eran Segev, president of Australian Skeptics Inc, said: “Australian Skeptics believes strongly that the public should have access to full and factual information so that they can form their opinions and choices in life, not half-truths, mistruths and fantasies.”

The Australian Skeptics has several thousand members across Australia, and investigates paranormal and pseudo-scientific claims from a responsible scientific viewpoint.

Further information: Australian Skeptics

Media contact: Tim Mendham, 0432 713 195