What’s the harm in homeopathy?
A coronial inquest into the death of a woman from untreated bowel cancer has begun in Perth, WA.
Sadly, this is not the first time I have reported on deaths associated with the use of homeopathy. Recently there was the case of the untreated eczema death of toddler Gloria Sam, for which her parents were convicted of manslaughter.
Penelope Dingle died in 2005 from untreated bowel cancer aged 45 after being diagnosed in 2003. She first presented with bleeding from the bowel in 2001. Following a colonoscopy, she was advised by doctors to have surgery to remove the cancer. She declined conventional cancer treatment, instead deciding on following a regimen of alternative treatments including special diets, vitamins and homeopathy.
Her husband is Dr Peter Dingle, a prominent Professor of Environmental Toxicology at Murdoch University in Perth and a media personality and author. Modelling himself as a kind of Aussie Joseph Mercola, he has a flashy website and has written such titles as “Is your home making you sick?”, “Improve your memory, your thinking and your life” and “The six week healthy eating planner”, the latter co-written with a naturopath (read: not a doctor).
The inquest was conducted at the request of the family following Mrs Dingle’s death in 2005. According to evidence given at the inquest from friends of Mrs Dingle and from her diaries, she and her husband made a pact with homeopath Francine Scrayen to not take any conventional treatment including pain relief. Dr Dingle also planned to write a book about how to cure cancer with homeopathy and alternative treatments once his wife was cured. A friend of the couple testified they were “enthralled and entrapped” in the spell of Ms Scrayen.
A report from the West Australian newspaper described;
“….Pen had so much faith in Francine. She was totally in her control”.
The friend described how Mrs Dingle has called the homeopath “at least a dozen times a day” and would only consume homeopathic medicines prescribed by her.
She came to visit Mrs Dingle in 2003, and was shocked to see how emaciated she was, since she had been assured by the couple that Mrs Dingle was responding well to the treatment. When the friend spoke to the homeopath, who consulted exclusively by phone, her concerns were dismissed, with the homeopath saying Mrs Dingle’s pain “was in her head” and she merely had constipation. She would not allow Mrs Dingle to take any other forms of medicine.
The friend also described how Mrs Dingle moaned in pain every night she was there, and even a visiting nurse who rated her pain nine on scale of ten was unable to convince her to take pain relief. Eventually she did succumb, receiving morphine in hospital and emergency surgery. This was only after she was advised by doctors that she would vomit feacal matter and die an excrutiatingly painful death within 24 hrs if she did not. Her bowel was completely obstructed by the tumour at this stage and she had not had a movement for 12 days.
It was too late for Mrs Dingle by this stage as the cancer has metastasized after such a long period of neglect and she died in 2005.
The question now is will the homeopath be held accountable for contributing to the death? I am not familiar with the legislation in WA, but in NSW it is illegal to claim to be able to cure incurable diseases, in accordance with the Code of Conduct for Unregistered Practitioners, legislated by the HCCC. But technically, homeopaths are actually not unregistered practitioners since they do have a regulatory body, the Australian Homeopathic Association which has a code of conduct of their own.
It seems you don’t need to dig very deep to see where Mrs Scrayen has breached the code (mind you on looking through it, it is not particularly specific about harm or seeking conventional medical advice when necessary).
Section 1, part 1 under general principles of professional conduct, states that:
“the welfare of patients…..shall take precedence over a member’s self interest and the interests of employees and colleagues.”
Section 2, part 2 also states:
“Members shall not …cause undue harm to patients.”
The only other section that is relevant in this case is Section 2.4:
“Patients whose state of health is deteriorating shall not be attended indefinitely without the member in charge suggesting or insisting upon a consultation with at least one other practitioner to confirm the assessment and treatment.”
But by stating “at least one other practitioner” does suggest another homeopath, not like a proper doctor or anything, you know the ones who are qualified to treat cancer for example.
The HCCC Code of Conduct is not so ambiguous. Section 5 states:
“Health practitioners not claim to make claims to cure certain serious illnesses. (1) a health practitioner must not hold him or herself out as qualified, able or willing to cure cancer and other terminal illnesses.”
Now I don’t know if the homeopath claimed she could cure Mrs Dingle’s cancer – this information has not been revealed as far as I know. It might be the case that the couple made the decision to only use homeopathy and not conventional medicine. But even of this is true, the homeopath did apparently forbid Mrs Dingle from using conventional pain relief and surely this breaches either code of conduct for responsible behaviour.
We will wait and see. In the meantime, this is yet another sad case to add to the hundreds on the What’s the Harm website. It makes you wonder what exactly motivates people to shun science based medicine, and especially in this case, where the alternative was just water and the desire to pursue this line of treatment even after it became obvious the magic vibrating water was not helping.
Add to this, the fact that Dr Dingle has a PhD? None of it makes sense.
The AVN WA library lecture becomes a political bun fight where kids are the losers
Last night the State Library of Western Australia hosted the AVN on their premises, for the purposes of spreading bountiful misinformation about vaccines.
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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.
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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.
Callous, unethical and dishonest Wakefield finally gets struck off.
It may have come 12 years too late, but finally Andrew Wakefield, the doctor who sparked worldwide controversy about the safety of the measles mumps rubella (MMR) triple vaccine has been struck off the UK medical register.
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.
Dodgy devices to be regulated? I’m sceptical…
I just received this article from Australian Doctor via my mate the Jelly Bean Lady.
Dodgy devices to be regulated 25-May-2010 By Michael East
THE manufacturers of shonky devices used by alternative therapists to carry out what they claim are diagnostic tests will soon have to provide clinical evidence that they work under new Therapeutic Goods Administration regulations.
.The changes, which will be introduced in July, are in response to growing concerns about the number of in-vitro diagnostic devices employed by alternative therapists.
.Among the products advertised on the internet is the “Hemaview”, which, according to its manufacturer, uses one or two drops of blood projected onto a video screen to diagnose “nutritional deficiencies, organ dysfunction and certain biochemical imbalances”.
Director of the Alfred Hospital’s department of haematology Professor Hatem Salem said users of the device were “pulling the wool over people’s eyes”.
.“The notion that one can diagnose all sorts of ailments by examining a drop of blood on a video screen is both ridiculous and plain stupid.”
.Currently the TGA is only able to regulate diagnostic devices included on the Australian Register of Therapeutic Goods, including those that test for HIV and hepatitis C, as well as those used in the home.
.However, many of the in-vitro diagnostic devices used by alternative therapists have been exempt from scrutiny because they are not considered medical devices.
.From July the makers of all in-vitro diagnostic devices will then be required to show clinical evidence that their products work but will have four years to fulfil the new requirements. They will also have to make clear to the public the potential risks of the devices.
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I’m afraid I’m sceptical. Required to show clinical evidence? To whom? Unfortunately the TGA does not have a very good track record of policing things like this.
Remember the homeopath who made all sorts of outrageous claims about magic water as a substitute for vaccination? Fran Sheffield of Homeopathy Plus! simply didn’t agree with TGA findings that her claims were misleading, so chose to ignore a ruling to remove such material from her website. And in an example of laughing in the face of the law, the day after she was exposed on ABC1’s Lateline programme by Steve Cannane, she jumped the shark.
In a post entitled; “Lateline: Can homeopathy safely protect against epidemic and infectious diseases? Can homeopathy treat serious diseases such AIDS and cancer?” she went even further, claiming that water could safely treat AIDS and cancer.
So, whilst I applaud this legislation in principle, how does the TGA, or other relevant health authorities plan to police it?
I regularly attend the Mind Body Spirit/Wallet Festival in Sydney where there is a plethora of snake oil salesman using Hemaview and collecting money hand over fist from gullible clients. It’s a perfect set-up; let us diagnose you with some allergy or somesuch and then when I reach over here, I have a bucket of powder for the special price of way-too-much which will fix you right up!
In NSW in 2008, legislation was introduced to regulate unregistered health practitioners, that is, those who are not already represented by a regulatory body like doctors or dietitians. Section 17 of the Code of Conduct states that a health practitioner must display the code and a document that gives information about where clients can complain to the Health Care Complaints Commission (HCCC) if necessary.
I have dutifully trotted off to the MB$ four times now, will my code clutched tightly under my arm and as yet, I have not once seen the code displayed. It’s now become a bit of a joke between my friends and as such, we have nick-named our futile search “Code of Conduct Bingo”.
This “festival” had enough quackery and snake oil to start a factory. (As an aside, one also has to wonder how much of the takings are declared to the tax department at the end of the four day love in). Make no mistake, a large amount of cash is collected, when you count up the magic scalar energy infused Fusion Excel Pendants for $150-$200 (available from Alibaba.com for 6 bucks a pop) or the $45 for a 20 minute reading with a psychic (queues last week extended half way across the exhibition hall). Or the dangerous and useless ear candles, which you can buy wholesale for 20 cents a pop, or pay about 15 bucks for three at the MB$ (after you pay your 16 bucks to get in). Or how about a $60 Power Balance Bracelet (available from Alibaba.com for between 50 and 80 cents).
In the two years I have been attending, I have not been aware of any representatives from relevant health bodies lurking around – this doesn’t mean they are not there of course. It would hardly make sense to walk around declaring your identity if you wanted to catch people in the act.
But certainly, I’ve been mistaken for such as person, at a Hemaview stand in fact. A colleague and I were asking for published evidence for the statement “clinically tested” which was splashed all over their stand, when the pamphlet he was holding was rapidly snatched out of his hand and the previously helpful assistant demanded, “are you Doctors?? Why do you want to know?…ARE YOU FROM THE TGA?”
Thou doth protesteth too much methinks.
It becomes very difficult not to lose your temper with these people, particularly when you know they are blowing it out their arse.
The first time I was exposed to a Hemaview/Live Blood Analysis person at the MB$, I was carefully shuffled away by my friend as my voice began to break and my ears to steam. It took him a good 10 mins to calm me down from the tidal wave of bullshit that had passed over me. You see, as a scientist I knew the terminology spewing from the representatives gob was real, but the deceit of peppering sciencey sounding words into a spiel about woo, to make it sound legitimate was too much for my science educated brain. She was right when she observed, just before I was escorted to the nearest corner, that I had been “affected by what she said”.
It’s just it was not in the way she presumed.
Another time at another Hemaview stand, I was with a nurse colleague when we were surreptitiously moved on with a nod the boss man. I guess he had twigged we were onto their profitable little scam.
It is interesting nonetheless, to observe the way woo-purveyors react to being challenged on their claims. After a fair bit of experience, I’ve come up with a theory. The ones who get angry and ask you to leave, are probably knowingly deceiving the punters. You might call them frauds or con men. The ones who genuinely try to answer your questions, even if their explanations are completely implausible and off with the fairies, are probably genuine, even if they are deluded.
It’s a bit like the psychics who spot you in the crowd, knowing who you are, and point out there are a lot of fake psychics here today.
I’M DEFINITELY NOT A FAKE, but look over there – he is!!!
So, personally, I am not confident this new legislation with have much of an impact of the alternative medicine industry. And it also seems odd that they are given four years to comply. Why so long? One thing is for certain though, the addition of legislation designed to clean up the industry will lend it unwarranted legitimacy. Imagine how happy snake oil purveyors will be to declare that their quantum energy box has been approved by the government.
The TGA is failing the Australian public. It’s a disgrace.
Statement from GMC regarding Wakefield
Wakefield has been struck off.
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.
UK doctors condemn homeopathy as witchcraft and demand ban
Following on from a parliamentary committee recommending all public funds be withdrawn from homeopathy in the UK, members of the British Medical Association have declared the alternative medicine to be “witchcraft” and demanded a ban.
Hundreds of members at the British Medical Association’s (BMA) annual conference of junior doctors have passed a motion attacking the alternative medicine and other remedies they claim have no scientific basis to support them.
Dr Tom Dolphin, deputy chairman of the BMA’s junior doctors committee in England, told the conference:
“Homeopathy is witchcraft. It is a disgrace that nestling between the National Hospital for Neurology and Great Ormond Street [in London] there is a homeopathic hospital paid for by the National Health Service (NHS)”.
The NHS is the equivalent of Medicare in Australia.
The announcement supports recommendations from the The House of Commons Science and Technology Committee after a parliamentary enquiry called an “evidence check”. In a 273 page report, summarising the evidence for the efficacy of homeopathy, the committee concluded that
* The NHS should cease funding homeopathy
* Recommend no further clinical trials of homeopathy.
* Evidence shows homeopathy doesn’t work.
* Explanations for why homeopathy works are “scientifically implausible.”
* Committee views homeopathy as placebo.
The report was tabled with evidence from hundreds of submissions from scientists.
From the report, the Committee wrote;
“In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos.”
The Committee concluded;
“Given that the existing scientific literature showed no good evidence of efficacy that further clinical trials of homeopathy could not be justified.”
“We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect..When doctors prescribe placebos, they risk damaging the trust that exists between them and their patients.”
Gordon Lehany, chairman of the BMA’s junior doctors committee in Scotland, said it was wrong that some junior doctors were spending part of their training rotations in homeopathic hospitals, learning principles that had no place in science.
He told the conference in London:
“At a time, when the NHS is struggling for cash, we should be focusing on treatments that have proven benefit. If people wish to pay for homeopathy that’s their choice, but it shouldn’t be paid for on the NHS until there is evidence that it works.”
The UK currently had four NHS funded homeopathic hospitals, in Liverpool, Bristol, Glasgow and London. A fifth hospital in Kent closed in 2009 when NHS funding was withdrawn. Latest figures show 54,000 patients are treated each year at four NHS homeopathic hospitals at an estimated cost of £4 million.
Homeopathy was invented 200 years ago by the German physician, Dr. Samuel Hahnemann, and is based on a ‘like-treats-like’ concept: that the symptoms of an illness can be treated by minute quantities of the same substance that caused it. But remedies are diluted to such a degree, there is virtually no chance of the active ingredient existing in the final product.
The concept of “Homeopathy, there’s nothing in it” made headlines around the world last year when mass homeopathic overdoses were conducted outside of pharmacies across the globe. The campaign was organised in protest at the highly respected Boots chain of pharmacies in the UK selling their own range of homeopathic “remedies”.
During the parliamentary evidence check, the professional standards director for the Boots high street pharmacy chain, Paul Bennett admitted to selling homeopathic remedies because they are popular, not because they work. In a statement, which has since been referred to as a huge foot-in-mouth, he said;
“There is certainly a consumer demand for these products,” but “I have no evidence to suggest they are efficacious”.
Homeopathy also publicly funded in Australia
In Australia, homeopathic consultations are not directly covered by Medicare, but GPs can bill for any consultation deemed “by the majority of professional peers as clinically relevant”, a Medicare spokesperson said.
Dr Ken Harvey, of the school of public health at La Trobe University, objects to the use of public money on placebo;
“I don’t believe there’s an evidence base to homeopathy, and I don’t think it should be financed by public money,”
“If a doctor wants to offer homeopathic consultations then it should be done separately…at the patient’s own expense.”
Dr Harvey referred to a New South Wales GP who offers homeopathy consultations as being fully reimbursed by Medicare. The GP, Dr Michael Cleary was adamant;
“The people who are using [homeopathy] are [also] taxpayers,” he said.
“If I was a person who wasn’t allowed to get a Medicare rebate from seeing my [homeopathic] doctor, I’d be wondering why I’m paying the levy.
Professor Mike Daube, president of the Public Health Association of Australia, also called on the TGA and Department of Health to conduct a review of homeopathy.
“There’s a long history to homeopathic practice, but we need to know whether it’s appropriate in the light of 21st-century science,” he said.
Another venue pulls the plug on the AVN
The Uniting Church in the City has withdrawn access to their venue for a scheduled AVN seminar, due to be held in Perth tomorrow night.
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.
Wakefield’s paper vindicated “again”? Not likely.
Andrew Wakefield is in disgrace.
Earlier this year, he was forced to resign from the US-located autism clinic Thoughtful House, which he established after leaving the UK in 2005. In the longest investigation in the history of the General Medical Council, surrounding his behaviour during research for his notorious “Lancet” paper he was found to be unethical, callous and irresponsible.
Following this, The Lancet made a complete retraction of the paper, six years after the majority of the authors had already disassociated themselves from it in 2004. Another paper, accepted and due to be published in NeuroToxicology, showing that thimerosal caused impaired neurological development in baby macaques, was withdrawn.
These days he can be seen hanging out with the likes of Dr. Joseph Mercola, the anti-vaxer, anti-pharmaceuticals and lover of all things woo.
Yet, because of the publicity at the time (and subsequently) surrounding the Lancet paper, it is often forgotten that what Wakefield and colleagues actually claimed was not MMR causes autism, but that autism was linked to a new form of gut pathology, dubbed “autistic enterocolitis” (essentially ulceritive colitis in autistic children).
But like much of the data in the now retracted paper, it appears the pathology results purporting to demonstrate this are under suspicion. According to a recent feature in the British Medical Journal from investigative journalist, Brian Deer;
“Two years before the paper was published he (Wakefield) was hired by a solicitor to help launch a speculative lawsuit against drug companies that manufactured MMR vaccine. And the instrument of their attack was to find what he called at the time “a new syndrome” of bowel and brain disease caused by vaccines.”
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Notably, Wakefield was also paid in excess of four hundred thousand pounds of legal aid money by the lawyers to find this link. Some pretty hefty vested interests involved there.
But, despite Wakefield being completely disgraced, his believers have clung on even tighter to his findings in the face of consistently damning evidence.
The comments on the piece from Brian Deer already contain claims that other papers have “vindicated” Wakefield’s 1998 study. What they mean is that the findings of ulceritive colitis in autistic children has since been repeated.
(Interestingly, one piece of supporting evidence they are citing is an abstract which was presented at a conference as a poster on Sunday, May 2, 2010. It’s not indicated if it has been published in the conference proceedings).
I haven’t read the studies cited in the comments, which apparently prove Wakefield was right after all, as there are many. But I have no immediate reason to doubt their validity. As a body of work, they may indeed support the hypothesis that ulceritive colitis exists in autistic children.
But why bring in the discredited and retracted (= scratched from the scientific record) Wakefield study into the mix? Why not let the new work stand on it’s own? Particularly when the pathology slides from the Wakefield study are now lost and the conclusions under suspicion.
From Brian Deer:
“The biopsy slides are no longer available, according to one of the paper’s authors, Professor Amar Dhillon, but the GMC obtained all but one of the hospital pathology reports, and for the missing case I obtained the discharge summary. I passed the summary and reports to specialists for their reaction. They concluded that most of the 11 children reported as having non-specific colitis in the Lancet paper had been reported by the Royal Free as having normal pathology.”
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So how was the diagnosis of non-specific colitis obtained in the paper if the pathology slides were normal? Well it’s not entirely clear but it is known that Wakefield apparently wrote them into the paper.
And recall;
“Two years before the paper was published he (Wakefield) was hired by a solicitor to help launch a speculative lawsuit against drug companies that manufactured MMR vaccine. And the instrument of their attack was to find what he called at the time “a new syndrome” of bowel and brain disease caused by vaccines.”
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Even the editor of the Lancet, Richard Horton, who withdrew the paper, was circumspect about the condition;
“I do believe there was, and remains, validity to the connection between bowel disease and autism, which does need further investigation,” Richard Horton told the BBC in February 2004.
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Wakefield has fallen, hoisted by his own petard. He will not be published in scientific journals again. His latest work is “Callous Disregard“, an account of the GMC enquiry in his own words, with a forward by the poster child of anti-vax, Jenny McCarthy. Any one not wanting to tarnish their reputation or their science, would be advised to stay well away.
Software glitch hampering adverse reactions reporting
Authorities are no closer to determining what caused hundreds of adverse reactions in the under 5s receiving the 2010 trivalent influenza vaccine.
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.”
.“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.
Flu vax reactions; bad batch ruled out, the search for the cause continues.
One of the criticisms being leveled at the government for the recent adverse flu events is the question of how thoroughly the current 2010 seasonal flu triple antigen has been tested.
This year’s vaccine contains three viral components,
• A/California/7/2009 (NYMC X-181) (A/California/7/2009 (H1N1) – like) 7.5 µg haemagglutinin per dose
• A/Wisconsin/15/2009 (NYMC X-183) (A/Perth/16/2009 (H3N2) – like) 7.5 µg haemagglutinin per dose,
• B/Brisbane/60/2008 (B/Brisbane/60/2008 – like) 7.5 µg haemagglutinin per dose, a combination not used in Australia before.
Ian Barr, the deputy-director of the World Health Organization’s influenza centre in Melbourne, was interviewed for the World Today on ABC radio on Monday April 26th, about the question of whether the current seasonal flu combination has been tested in clinical trials.
IAN BARR: In Australia we don’t require that the influenza vaccine, the seasonal vaccine is tested for combinations but they have done that overseas, so they have tested in fact giving a full seasonal vaccine with the swine flu, so four vaccines at once if you like and there were no untoward effects there.
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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.
.CHARLOTTE GLENNIE: So in your opinion the fact that it is a combination vaccine would have nothing to do with this situation that we’ve got at the moment as far as you know now?
.IAN BARR: I think that’s unlikely to be a factor. Certainly all viruses are slightly different but in terms of how they’re produced in the laboratory and tested in laboratory and then made in the commercial scale vaccine production areas, they’re all investigated individually for any particular differences in those viruses which might lead to some of these things we’re seeing currently, such as fever.
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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
.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.
.Mild adverse effects were defined as adverse events easily tolerated by the participant, causing minimal discomfort and do not interfere with everyday activities (e.g., soreness at injection site)?.
Following the first vaccination:
.• 16.3% had a mild fever (>37.5 degrees C < 38.5 degrees C) in the 15µg group
.• 23% had mild fever in the 30 µg group
.Combined mild adverse reactions, for 15 µg and 30 µg were 31.9% and 33.7%, respectively.
For moderate adverse reactions, 15 µg and 30 µg were 18.9% and 27.2%, respectively. This was defined as significantly discomforting, interferes with daily activity.
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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.
.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.
