Action For Autism

Polly Tommey and the Adult Autism Strategy.

Last year I wrote a couple of posts (here and here) criticizing Polly Tommey for pulling expensive publicity stunts that resulted in her meeting with Prime Minister Gordon Brown and his wife at Downing Street. She presented herself as just a mother speaking for thousands of other mothers. Her remarkable success was contrasted with the apparent failure of autism organizations to work together for the benefit of autistic people.

At the time I pointed out that many other organizations had come together to support the Autism Bill, soon to become an Act of Parliament and to to advise the government via the External Reference Group. Chaired by the NAS chief executive, Mark Lever, with an autistic vice chair, it included organizations of autistic adults as well as parents. The only significant absence from the campaign were representatives of the biomedical cure organizations, including Polly Tommey’s Autism Trust, which seemed intent on disregarding the rest of us in pursuit of its own agenda.

The result of all our campaigning and lobbying of government officials and politicians saw the government adopt the Autism Bill, guaranteeing its passage into law, and shaped the adult strategy for autism that was published this week. Then Polly Tommey appeared on GMTV to discuss the strategy. We learned that it was her poster campaign that galvanized the government. They had consulted with her on the strategy and the next step was to be a new poster campaign which presumably would drive the next phase of the project.

Then I turned to Age of Autism (AoA)which provided more details.

In 2009 Polly Tommey was approached by Gordon Brown to represent The Autism Trust within the External Reference Group (ERG).  This followed a meeting with the Prime Minister as a result of The Autism Trust’s “Dear Gordon Brown” charity billboard campaign.  Polly was part of the ERG that helped formulate “The strategy for adults with autism in England (2010).”

Actually, after months of patient negotiation in which various organizations learned to work together and gained the respect of government officials and ministers, I can think of nothing more disruptive to the process than for someone to be parachuted in on the strength of an advertizing campaign and lay claim to all the credit. AoA also suggests that she organized the public consultation on the strategy.

Last year, following the campaign, Polly announced on national television that everybody could take part in formulating this plan; no one was left out of the strategy. It was announced via a direct email address to the Department of Health so that everyone who wanted could get involved.

AoA does not mention the 14 other organizations led by the NAS that campaigned for the Autism Act and organized over a thousand responses from their members to the consultation process. It does not mention any of the other members of the ERG. It does not explain why the ERG report does not list Polly Tommey as a member or that it published its report before she is supposed to have been invited to join it. Nor, if she already has the ear of the prime minister, are we told why another poster campaign is needed. Perhaps it will be aimed at persuading the rest of the autism community that we are all wrong and we should be following her lead instead.

One thing is certain. Although Tommey continues to support Andrew Wakefield and his failed hypothesis you will not hear about that in her campaign to take credit for the success of a movement in which she was at best peripheral and at times a hindrance.

All these organizations supported the passage of the Autism Bill through Parliament. No mention of Polly Tommey’s Autism Trust.

This is the membership of the External Reference Group on Autism that published the Initial Report by the External Reference Group for the Adult Autism Strategy for England. No mention of Polly Tommey

External Reference Group Members

Chair Mark Lever, Chief Executive, The National Autistic Society

Vice Chair and Chair, Choice and Control Group Anya Ustaszewski, Member of the Autism Rights Movement and an adult with Asperger syndrome

Chair, Health Group Juli Crocombe, Consultant in Neurodevelopmental Psychiatry

Chair, Social Inclusion Group Eileen Hopkins, Director – International Development, Autism Speaks

Chair, Employment Group Carolyn Bailey, Chief Executive, Autism West Midlands

Chair, Training Group Clive Stobbs, Chief Executive, Autism Anglia

Members:

Wendy Atkinson Oldham County Council

Chris Austin Liverpool Asperger team

Amanda Batten Head of Policy and Campaigns The National Autistic Society

Richard Bremer Goldman Sachs

Maria Bremmers Autism London

John Dickenson Parent of an adult with ASD

Christina Earl Surrey County Council

Graham Enderby Carer of an adult with ASD

Ian Ensum Clinical Psychologist

Andrew Grainger Autism Initiatives

Ian Hall Royal College of Psychiatrists

Carolann Jackson Parent of an adult with ASD and chair of SAFE (Supporting Asperger

Families in Essex)

Sandra Knaggs Living Ambitions

Ann Le Couteur Professor of Child and Adolescent Psychiatry, University of Newcastle

Marie Lovell Skills for Care

Julie Lynes-Grainger Learning and Skills Council

Campbell Main Parent of an adult with ASD

Melissa McAuliffe East London NHS Foundation Trust

Andrew Merchant Priory

Richard Mills Research Director Research Autism

Chris Mitchell Adult with ASD

Thomas Moore Surrey County Council

Andrew Monaghan Hampshire Autistic Society

Liz Osman Secondee to Treehouse from Connexions

Fred Parsons NORSACA

David Perkins Prospects The National Autistic Society

Rebecca Rennison Policy Officer The National Autistic Society

Carole Rutherford Parent of an adult with ASD

Dinesh Sattee Adult with ASD

David Shamash Member of the London Autism Rights Movement and an adult with Asperger syndrome

Sarabjit Singh Adult with Asperger syndrome

Kobus Van Rensburg Northamptonshire Transition and Liaison Team

Adrian Whyatt Member of the London Autism Rights Movement and an adult with Asperger syndrome

March 5th, 2010 Posted by Mike | National Autistic Society, Uncategorized, adults, campaigns, government, politics | one comment

Autistic Adult Strategy published in the UK

The UK government have published their strategy for autistic adults, Fulfilling and rewarding lives: the strategy for adults with autism in England. This was welcomed by the National Autistic Society.

The National Autistic Society (NAS) is pleased to welcome the publication of the first ever strategy for improving the lives of adults with autism in England.
Last year, when we achieved the Autism Act 2009, we committed the Government to publishing an Adult Autism Strategy to transform services for adults with autism. The publication of this strategy meets this commitment.
The strategy sets out a number of key actions and recommendations for central Government as well as for local authorities, the NHS and Jobcentre Plus.
In particular, we welcome the following aspects of the strategy.
• Improved training of frontline professionals in autism.
• The recommendation to develop local autism teams.
• Actions for better planning and commissioning of services, including involving people with autism and their parents/carers in this process.
• Actions for improving access to diagnosis.
• Leadership structures at national, regional and local levels to support delivery.
• Proposals for reviewing the strategy to make sure that it is working.
We are particularly pleased that the strategy encourages the development of local teams and the development of local autism partnership boards.
These were key actions that we have been calling for throughout the development of the strategy.

I have just read the report and it is an important step forward. I do have a couple of concerns about the strategy. Michael Baron, who organized a conference on ageing and autism last year copied me into an email that points out that the needs of elderly autistics are largely ignored. This may be because care of the elderly, with or without autism, is low on the government’s list of priorities. Michael also suggests that there is little in the strategy for severely impaired individuals who are least able to offer themselves for employment.

The economic crisis means that there is little money for new initiatives and I am not encouraged by this passage from the strategy.

This not only reflects the current economic
situation, where every public sector
organisation is facing budget restrictions
and is required to do more with less, but is
also in line with the Government’s overall
policy direction of reducing statutory
requirements and encouraging frontline
staff to develop services and solutions
to meet local needs. While we recognise
that these factors make it a difficult time
for public services to respond to a new
strategy, we can no longer ignore the moral
imperative to address the unmet needs of
so many members of our society.

How do they propose to meet a moral imperative without additional financial resources? Part of the answer is in helping autistic people to find jobs.

Over the last few years, the Government
has made it clear that work is the best form
of welfare, the most effective route out of
poverty and a vital part of social inclusion.
However, adults with autism are currently
significantly under-represented in the
labour market. That is why chapter 5 looks
at how we will help adults with autism
into work. It explains changes underway
to the welfare system to better support
adults with autism, through effective work
preparation programmes and through
improvements to our benefits and tax
credit systems.

In the middle of a recession with mass unemployment this may not be realistic. There are lots of autistic adults who are quite able and willing to work right now. What we need is a programme for employers who may be doubtful of the wisdom of employing autistic people and a programme to support autistic people once they are in employment. The structural factors in the labour market that contribute to autistic unemployment are at least as important as the personal difficulties that some autistic people need help with.

Another part of the answer, suggested by the National Audit Commission report which helped to inform this strategy is that timely provision of services may be cost effective if it saves on long term provision and support for people in crisis. In the past this sort of intelligent financing has failed because there is no incentive say for social services to spend money that reduces future costs to the health service. Managers are concerned to defend departmental budgets and have no incentive to contribute to global savings. It will be interesting to see how this is actioned.

The real deal will come in December when the government publishes statutory guidance which will impose duties on agencies to act to meet the strategy. That was mandated by the Autism Act and is a legal requirement that will still be there after the general election, whichever party comes to office.

On balance this is a good start. But this is a long haul, not a quick fix. And as ever, as pointed out by Zoe Thompson on Facebook, it will depend on how well it is resourced and who is monitoring the outcomes.

March 5th, 2010 Posted by Mike | adults, campaigns, government, services | no comments

Is there a doctor in the (Thoughtful) House?

What are we to make of recent events at Thoughtful House, the integrated autism clinic and research centre that, until recently operated under the auspices of Dr Andrew Wakefield as director of research? First Wakefield resigned. Then the Times carried a story (now confirmed) suggesting that Arthur Krigsman was standing down as well.

Following the recent GMC hearings whose findings of fact confirmed a series of damning breaches of research ethics, dishonest reporting and callous disregard for the suffering of children it was no surprise that the Lancet finally retracted the paper that marked the start of the MMR scare in 1998. Then his latest paper, Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight, was withdrawn and removed from the Neurotoxicology website. Although they are refusing to comment, the editor at Neurotoxicology may have been influenced by the revelations at the GMC and the Lancet’s decision and taken another look at Wakefield’s study and decided that the faults identified by Prometheus Orac and others were too serious to be ignored.

All this was to be expected. Wakefield is isolated both as a doctor and a researcher. His links to the mainstream are damaged beyond repair. But he has managed to retain a loyal following of parents and until now Thoughtful House has provided him with a firm base in America and a source of income.

So Wakefield’s departure from Thoughtful House came as something of a shock as much for the manner of his leaving as anything else. Although the press release defending Wakefield that was issued after the GMC announced its findings is still on the website it is no longer featured on the home page. Stranger still, there is no press release concerning Wakefield’s resignation on the website even though his name has been removed from the staff list.

We do have this statement from Jane Johnson first posted on the Thoughtful House email list on Wednesday 17 February and widely repeated in all the press reports and blogs that this news has generated

The needs of the children we serve must always come first. All of us at
Thoughtful House are grateful to Dr. Wakefield for the valuable work he has done here. We fully support his decision to leave Thoughtful House in order to make sure that the controversy surrounding the recent findings of the General Medical Council does not interfere with the important work that our dedicated team of clinicians and researchers is doing on behalf of children with autism and their families. All of us at Thoughtful House continue to fight every day for the
recovery of children with developmental disorders. We will continue to do our
very best to accomplish our mission by combining the most up-to-date treatments and important clinical research that will help to shape the understanding of these conditions that are affecting an ever-increasing number of children worldwide.
Jane

The most favourable interpretation, and the one that Jane Johnson is promoting on the email list in response to the loyal parents who are upset by Wakefield’s departure is that

Dr. Wakefield feels he needs to pursue the GMC issue, and he’s concerned that the continued press coverage will hurt Thoughtful House. Those who know Dr. Wakefield will not find it implausible that he would step aside in order to protect an institution he helped found.

It is not implausible. Neither is it very convincing. Why has Wakefield remained totally silent? He has issued statements every step of the way during this long and sorry saga designed to make his supporters feel informed and happy. Why is there no official statement on the Thoughtful House Website? And if he really needed time off to concentrate on the GMC wouldn’t it have made more sense to do that during the hearing instead of  waiting until they they found against him?

And what of Jane Johnson’s role in all this? She has been a wealthy backer of Thoughtful House in the past. Her wealth derives from Johnson and Johnson, the pharmaceutical company. Now that is ironic. A constant jibe thrown at all Wakefield’s critics is that we are bought and paid for pharma shills. Now it turns out that Wakefield has his own links to Big Pharma.  Ms Johnson is described as the co-managing  director of the board of Thoughtful House. I gleaned this from the dust jacket of a book she co-authored with Bryan Jepson MD, who is described as Director of Medical Services at Thoughtful House. I tried to verify this but the current list of directors at Thoughtful House has been removed from their website. I can confirm that Ms Johnson is executive director of Defeat Autism Now.

It has been suggested that Thoughtful House has some major financial backers: wealthy parents of autistic children and corporate sponsors, who are unhappy with the publicity that Wakefield is attracting. Brian Deer has suggested that some may  be genuinely shocked by the revelations about his character and his research credentials.

Perhaps the most surprising feature of Wakefield’s departure is the total lack of comment by any of the bloggers who traditionally support him. Take Age of Autism. They have posted 36 articles supporting Andrew Wakefield since the GMC verdict on January 28th. The last one was on February 16th. In the five days following his resignation they have posted nothing about him at all.

It is plain that this has taken his supporters by surprise and not everyone is happy with it. One of the first objections came from an Italian organization, again taken from the Thoughtful House email list but repeated elsewhere.

Emergenzautismo (Italy) feels TH’s acceptance of Wakefield’s resignation
to be extremely detrimental to current science, our children and, not least,
Andrew Wakefield. Never has there been a more important time for a united front.
We are very confused and disappointed.

Ornella
administrator www.emergenzautismo.org

The feeling was compounded when it merged that Arthur Krigsman was also leaving Thoughtful House. This story broke in the Times but it was not until a concerned parent posted the LBRB version on the Thoughtful House email list and parents started to question what was happening that Jane Johnson again responded.

Dr. Krigsman’s decision to relocate his clinical practice to a facility outside
Thought House reflects his belief that the complexities inherent in a referral-based practice can be best addressed by his working independently. We will continue to refer patients for GI evaluations when appropriate, and we look forward to continuing to work with Dr. Krigsman on research projects. We are grateful to Dr. Krigsman for his dedication to Thoughtful House and for the work he does on behalf of the children we serve.

Just to be clear, this is official.
Jane

In my opinion the two events are not linked. If they were we would have seen a much more polished PR operation from Thoughtful House. Krigsman was probably already planning his move and will continue to see children at Thoughtful house until his new office in Austin is ready. His main clinic is in New York and he visits Thoughtful House for a few days once a fortnight. it looks like he is regularizing his business arrangements - a private practise that enjoys an association with Thoughtful House but is not part of it.

But the timing of the two events has caused a lot of parents to wonder just what is going on. Just as with the Autism Omnibus Proceedings they have been fed a line that everything is going well and the GMC is going to vindicate Wakefield. Now some of them must be wondering if they are being fed another line.

It would be tempting to think that Wakefield and Krigsman have been ousted in a power struggle that sees DAN doctor Jepson and DAN director Johnson firmly in control. But unless I see hard evidence to the contrary I will settle for the cock-up theory of history over the conspiracy theory.

As Oscar Wilde wrote in The Importance of Being Earnest

To lose one parent, Mr Worthing, may be regarded as a misfortune; to lose both looks like carelessness.

But if Bryan Jepson MD is the next to go I may have to revise my opinion and quote the words Ian Fleming gave to Goldfinger:

Once is happenstance. Twice is coincidence. The third time it’s enemy action!

While writing this post I have learned of a new article by Brian Deer exposing a failed attempt by Mark Blaxill of Safe Minds to employ Max Clifford to manage Wakefield’s PR disaster. Instead he is adding to it. Perhaps Jane Johnson’s do nothing approach was for the best. You can join the discussion on this latest development over at LBRB

UPDATE

Age of Autism has finally broken its silence with “an exclusive interview” with Andrew Wakefield. Four days after he was sacked by resigned from  Thoughtful House the announcement comes, not via a press release or a public announcement on the Thoughtful House website, not even an exclusive interview with Sally Beck or Melanie Phillips or another of his remaining friends in the mainstream media. No. He is reduced to talking to ex journalist and Generation Rescue PR hack Dan Olmsted on a fringe anti-vaccine website.

Wakefield claims to be looking forward to an

entirely new sort of opportunity that will allow me to continue my work on behalf of autism families.

Perhaps his friend Mark Blaxill will create a job for him at Safe Minds. Or maybe Jenny McCarthy’s Generation Rescue beckons. Either way it is a sad end to what could have been a distinguished career.

February 21st, 2010 Posted by Mike | Andrew Wakefield, MMR | 5 comments

Asperger boy is “too bright for services”

We the undersigned petition the Prime Minister to Better support, services, SEN assessments & statements for children with Aspergers in primary school.

Claire Parkinson has created this petition because

Today I become the voice of my 9 yr old son diagnosed with Aspergers. Since he was diagnosed over 1 year ago his primary school has refused any extra support, services or even a SEN assessment. Reason they say his to clever. Suffering with a social communication disorder with added sensory issues I feel help is needed. He has been excluded for not following instructions and once back he is excluded from lunch breaks as staff can’t handle him. I will have to collect and take him home everyday for 1 hr. Help! He has special educational needs and a statement is his only way forward in mainstream school. He is who he is and he should not be punished for this.

UK residents and British citizens are eligible to sign. Please  sign the petition

Claire’s dilemma illustrates the issues surrounding the proposal to merge Aspergers and Autism in a single Autistic spectrum Disorder in  DSM-V. Having a diagnosis of Aspergers is no use if it is used to deny access to services, as has happened in the case of Claire’s son.

Whatever the eventual outcome it is clear that, so long as authorities use diagnostic categories as one size fits all gateways to services, problems like this will always occur. Individual assessment and provision tailored to meet identified needs will always be required regardless of the presence or absence of any diagnostic label.

February 19th, 2010 Posted by Mike | DSM, aspergers, campaigns, services | 4 comments

Autism Insights cites Wakefield’s retracted paper

Autism Insights has published a new editorial addressing the question,

Is There a Relationship Between Autism and Gastrointestinal Disease?

They neglect to mention Tim Buie’s recent consensus report on gastrointestinal disorders and autism and autism published in Pediatrics. Nor, for that matter, do they refer to Arthur Krigsman’s study which they published last month. However, despite it being retracted by the Lancet, they manage to reference Wakefield’s discredited paper along with another of his studies twice.

10. Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 1998;351:637–41.

11. Wakefield AJ, Anthony A, Murch SH, et al. Enterocolitis in children with developmental disorders. Am J Gastroenterol. 2000;95:2285–95.

12. Wakefield AJ, et al. Enterocolitis in children with developmental disorders. Am J Gastroenterol. 2000;95(9):2285–95.

13. Wakefield AJ, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 1998;351:637.

The authors present an analysis of the complete medical history records of the Autistic Genetic Resource Exchange (AGRE). They compare parental reports of Gastrointestinal disease in autistic subjects and their non-autistic siblings. The data is interesting, if inconclusive. The only significant differences were the greater frequency of constipation and diarrhoea in autistic subjects. But no reasons were offered as to why this might be the case.

The most striking feature was the complete absence of inflammatory bowel disease (IBD). I was surprised that the authors did not pick up on this during the discussion as they highlighted the controversy surrounding IBD and autism in their introduction.

To return to the question, “Is there a relationship between autism and gastrointestinal disease?” the answer is we do not know. We are still waiting for some definitive data. On the evidence so far I do not expect to find it any time soon in Autism Insights.

February 15th, 2010 Posted by Mike | Andrew Wakefield, Autism Insights, GI disorders | 10 comments

Andrew Wakefield, the never ending story

If you watch a lot of cop shows you soon come to recognize the basic plot lines. Perhaps the villain is obvious from the start but is able to elude justice until a dogged investigator uncovers the evidence that will put him away. Or else all the evidence points in one direction but a lone detective refuses to buy it and unearths the secret that saves an innocent man from a miscarriage of justice. Sometimes the guilty are protected by their friends in high places. Then along comes the brave maverick policeman who overcomes all obstacles to expose the corruption and justice prevails at the end.

I was reminded of this by responses to the recent judgement against Wakefield by the GMC and the subsequent retraction of his 1998 Lancet paper. Wakefield’s defenders still see him as the brave maverick. Vaccines are the villain and so far they have evaded justice thanks to the corruption at the heart of the medical/research establishment. We have reached that stage in the plot where everything seems hopeless. Our hero has been all but destroyed. The conspirators are congratulating themselves. Evil has triumphed. Or has it?

Now, when they least expect it, our hero strikes. They have no answer to his new and devastating evidence. They realize their mistake and try to silence him. Too late! The truth will out and Justice shall prevail. Of course real life is not like the movies. But that fact is lost on many of Wakefield’s supporters. They clutch at the flimsiest of straws to convince themselves that we are about to enter the final reel when all will be revealed.

One such straw is Arthur Krigsman’s long awaited paper which supports Wakefield’s premise that gastro-intestinal disease and autism are connected. In fact it is so faithful to the master’s original that Krigsman even replicates Wakefield’s breaches of medical ethics. We are promised more studies and devastating proof that Wakefield was right along. This proof is so devastating that it could not be used in his defence at the GMC and had to be held in reserve until after his public humiliation and the destruction of his professional reputation (aka “the witch hunt,” “kangaroo court,” “censorship,” “conspiracy,” etc., etc.,)

At this point in the script I should be saying that the plot thickens. But sadly for Wakefield et al it seems that the plot is unravelling instead. His most recent paper, an attempt to diversify into mercury and vaccines has been withdrawn by the editor. no reason was given. It may the undisclosed conflict of interest from lead author Laura Hewitson or simply the fact that it is an atrocious piece of work. Meanwhile his fan base are doing their best with a number of gambits.

No parent ever complained to the GMC.

The GMC brought the complaint after it was made aware of Brian Deer’s allegations. As Deer points out in this comment on LBRB Wakefield’s parent supporters may have packed the public gallery and joined protests outside the hearing but the only parent to give evidence appeared for the prosecution not the defence.

Not only could Wakefield have called anybody he wanted (and he called nobody whatsoever, and didn’t even ask questions of the government’s vaccine supremo), but a parent of one of the 12 kids – Rochelle Poulter – DID give evidence. She appeared in August 2007 for the prosecution, and gave them a mass of documents which were devastating to Wakefield’s case. One of the letters was to Walker-Smith where she says that he’d told her that the research might not help her child, but might help other children. Devastating stuff.

There was an estabishment conspiracy to silence Wakefield.

All I can say is they did not do a very good job. Two of the most pro establishment newspapers in Britain, the Mail and the Telegraph, regularly carry pro Wakefield stories. The BBC still gives the pro Wakefield website, JABS, web address alongside every MMR story it runs. The Spectator, unofficial house magazine of the Conservative Party, continues to carry pro Wakefield stories from Melanie Phillips. Fiona Phillips (no relation) is still writing paeans to Wakefield in the pro-Labour Daily Mirror. Even the Guardian Group succumbed with a terrible front page article in the Observer that had to be withdrawn and a fawning two page spread by sports writer turned health editor. Meanwhile science that refutes Wakefield has been virtually ignored by the mainstream media outlets.

Government witnesses lied to the GMC

This potentially libellous accusation from Ron Moody made a brief flurry but seems to have faltered along with an open letter to the GMC from a retired sex therapist and the We Support Dr Andrew Wakefield petition against Times Newspapers. Claiming to represent “multitudes of citizens worldwide” they have collected around 2000 signatures so far. But with names like Seymour Butz, Fivepounds Forkidsblood and Al Coholic, not every signatory is taking it seriously.

Good Cop or Bad Cop?

To return to my original theme, I think that they are all watching the wrong movie. What about the story where the cop goes after the bad guy and finds out that he is innocent? But he is so convinced of his guilt that he goes after him for something else. And when the evidence fails again he decides to fake it. The bad guy has to be guilty. No way is he going to escape on a technicality like lack of evidence.

Wakefield is a surgeon with a research interest in gastroenterology. He was supposed to be investigating the causes of Crohns Disease. He thought a potential cause was measles virus, possibly measles vaccine virus. But his research was flawed and when others failed to replicate his results the theory was forgotten.

At this point if his prime purpose was to research  Crohns he would have dropped the failed measles hypothesis and explored other venues. But Wakefield had a prime suspect - MMR. If he could not tie it to Crohns he would get it for something else. Why not autism?

But what if the bad guy was innocent all along? What if the cop let his obsession cloud his judgement, leading him to ignore the real evidence and fabricate his own so-called proof. We all know how that movie ends.

Sadly for us as well, real life is not like the movies. While Wakefield’s  career as a serious medical researcher may be over he appears to have made good his escape and seems set to enjoy his ill-gotten gains in his Texan hideaway for some time yet.

February 15th, 2010 Posted by Mike | Andrew Wakefield, MMR, Uncategorized | 2 comments

Krigsman, Wakefield and Research Ethics

Arthur Krigsman has finally published a paper which is supposed to provide independent verification of Wakefield’s premise that gastro-intestinal disease and autism are connected. It is published in Autism Insights, an open access journal. There is nothing wrong with this except that Andrew Wakefield is on the editorial board of Autism Insights alongside one of Krigsman’s co-authors, Carol Stott. Like Krigsman, Stott works for Andrew Wakefield’s Thoughtful House. In fact the Editorial Board is dominated by Wakefield’s allies and associates. The editor in chief, Anthony J Russo has only two autism related papers listed on PubMed and one of those was co-authored with Krigsman, Wakefield and Bryan Jepson, medical director at Thoughtful House and also a member of the Autism Insights editorial board. Autism Insights has only published two articles since its inception in September 2009. I suspect that it has been set up with the sole purpose of publishing papers by biomed supporters that cannot find a reputable journal that will publish them. This would make it no better than the bogus journals that Elsevier set up to publish infomercials for drug companies posing as bona fide research.

I can understand why other journals might be wary of Krigsman. He lists his main academic affiliation as Assistant Professor of Pediatrics, New York University School of Medicine. However, under cross examination as an expert witness in the Autism Omnibus proceedings it emerged that although he was on the staff at NYU he had never taught a class there and had never been paid a salary.

RICCIARDELLA: Doctor, your C.V. states that you’re a clinical assistant professor at New York University. Is that correct?

KRIGSMAN: Correct.

RICCIARDELLA: Are you currently on staff there?

KRIGSMAN: Correct.

RICCIARDELLA: When was the last time you taught a class at NYU?

KRIGSMAN: I haven’t taught there.

RICCIARDELLA: You’ve never taught a class at NYU.

KRIGSMAN: I’m on staff there.

RICCIARDELLA: Are you salaried?

KRIGSMAN: From NYU?

RICCIARDELLA: Yes.

KRIGSMAN: No.

RICCIARDELLA: Have you ever been salaried at NYU?

KRIGSMAN: No.

One of the co-authors, Marvin Boris, also boasts an NYU affiliation, Associate Clinical Professor of Pediatrics, New York University School of Medicine. But NYU had nothing to do with this research. Krigsman used to work at Lenox Hill Hospital in New York but left under a cloud in 2004. Their IRB had turned down his research proposals on three occasions in 2001/2002 because they were concerned for patient safety and concerned that he might be performing invasive procedures for research purposes on patients for whom there was no clinical indication. Krigsman went ahead anyway and even announced his research when he testified before the United States House of Representatives Committee on Government Reform on ‘The Status of Research into Vaccine Safety and Autism.’ (June 19th 2002)

To check whether he was in fact carrying out research without IRB approval the Lenox Hill Medical Board asked to see the records of ten patients selected at random. Krigsman refused. [source] He even tried to sue the hospital and when his suit was dismissed, his resignation brought all inquiries into his conduct to an end. [source] Krigsman presented his research as a slide show at IMFAR 2004 Two years later there was a poster presentation at IMFAR 2006 which listed Krigsman as co-author. This time he claimed to have discovered measles virus in his samples. He also claimed to have IRB support for his research. There is no mention of measles virus in the current paper. But there is IRB approval from the Copernicus Group who provide independent oversight and scrutiny to researchers at institutions that do not have an IRB.

I do not know how rigorous Copernicus are. Perhaps it is just bad luck that  as well as Krigsman they also gave IRB approval to the Geiers for a paper which had already been published using a fake IRB packed with business associates and family members of the researchers. Now they have approved research that was refused IRB approval at the hospital where Krigsman worked when he took the specimens from autistic children who underwent colonoscopies at Lenox Hill Hospital. Remember that Krigsman was turned down three times for IRB approval by Lenox Hill IRB. He first applied in January 2001 and

This proposal was rejected by the Hospital’s IRB on February 21, 2001, due to concerns that the procedure’s risks would outweigh its anticipated benefits.

This is a clear indication that he was refused permission to carry out colonoscopies or take biopsies for research purposes. A revised proposal was submitted in June to retrospectively analyse the results from 50 children who had already had colonoscopies that, according to Krigsman, were clinically indicated. A decision was deferred pending revision of the proposal. This revision of the revision was finally refused permission in December 2002 on the grounds that

Dr. Krigsman had not obtained informed consent from the subjects or their legal representatives.

Perhaps that explains the delay in publication because now, eight years after the event, he does claim that

Informed consent was obtained for each child included in the study.

Meanwhile, way back then, there were concerns about the 200 autistic children that Krigsman had already subjected to colonoscopies. Where these all clinically necessary procedures or was Krigsman using these children for research purposes without IRB approval?

On January 23, 2003, Dr. Jerome Waye, the Chief of Endoscopy; Dr. Armando Grassi, the Chairman of the Deparment of Pediatrics; Dr. Hary Ioachim, the Chairman of the IRB; and, Ms. Debora Marsden, Lenox Hill’ s Compliance Officer, met to discuss Dr. Krigsman predicament. In light of the IRB’ s concerns, Dr. Krigsman was advised that Dr. Waye s approval was required before he could perform any endoscopic procedures at the Hospital.

Dr. Grassi instituted a corrective action procedure, which is employed to review the situation whenever a hospital’s staff member’s activities are called into question. Here, there were concerns that Dr. Krigsman may have been conducting research without approval and that he may have performed invasive endoscopic procedures as well as tissue biopsies on autistic children without medical necessity.

Pursuant to the Hospital’s by-laws, a Deparmental Ad Hoc Review Committee was appointed to investigate. Two hundred of Dr. Krigsman s cases were reviewed and discussions were held with pediatric gastroenterologists. Concerns about the medical necessity of the endoscopic procedures persisted. The Ad Hoc Review Commttee recommended that Dr. Krigsman’s patients’ hospital charts be reviewed and that he be advised not to use information gathered from past patients without the IRB’ s permission. Following review of Dr. Krigsman’ s patients ‘ hospital records, the Hospital’s Medical Board still questioned the necessity for medical procedures performed by him. Since Dr. Krgsman had informed the Ad Hoc Review Commttee that his patients had undergone a complete work-up in his office prior to their hospitalizations, the Hospital’s Medical Board recommended that the Ad Hoc Review Committee randomly review ten of Dr. Krigsman s patients’ office records in an attempt to further evaluate the need for the procedures in question. Dr. Krigsman refused this request on June 2 2003. [source]

Krigsman then decided to sue the hospital. His suit was dismissed in April 2004 and Krigsman elected not to seek renewal of his contract of employment when it expired at the end of that year. As he was no longer employed by Lenox Hill this ended the Office for Human Research Protections‘ investigation into his conduct there.

To summarize

• Krigsman carried out research without IRB approval and without informed consent.
• Krigsman carried out invasive procedures whose clinical necessity has been questioned.
• Krigsman obstructed investigations into his questionable conduct and sued his employers in an attempt to circumvent due process by artful pleading.
• When this ploy failed he left the hospital rather than face a proper investigation.
• Now he has published his research, in breach of advice not to use information gathered from past patients without the IRB’ s permission.

February 14th, 2010 Posted by Mike | Andrew Wakefield, MMR | 14 comments

Andrew Wakefield: The Honorary Consultant

There is a mighty blog storm surrounding the announcement last week of the General Medical Council’s “finding of fact” in relation to the Fitness To Practice hearing regarding Andrew Wakefield, John Walker Smith and Simon Murch.

Liz Ditz is collating blog responses to the decision here:

Andrew Wakefield: Dishonesty, Misleading Conduct, and Serious Professional Misconduct: Blog Posts Approving of Verdict; Blog Posts Critical of Verdict

Kathleen Seidel has posted the entire ruling and for those who may not have the time or the inclination to read all 143 pages she has posted the edited highlights on her blog:

U.K. General Medical Council Rules Wakefield & Co. “Dishonest,” “Irresponsible”.

And of course Brian Deer has reported on the findings for the Sunday Times in a story headlined ‘Callous, unethical and dishonest:’ Dr Andrew Wakefield.

Among Wakefield’s supporters the reaction to the GMC’s verdict is one of disbelief.

The One Click group has been supporting for Wakefield during the GMC hearings. In April 2008 they were confident of victory.

The Defence presentation has demonstrated that the position always maintained by Dr Wakefield of there being no conflict of interest, no issues relating to funding, that the investigations of these children were clinically justified and that the research was ethically approved has been very clearly established.

Now that “clearly established” case has been dismissed we are told this is a kangaroo court and a show trial.  Government witnesses are supposed to have lied. The GMC “moved the goal posts.” According to Cry Shame

The Panel has chosen the facts it wants, and rejected those it doesn’t want, to find the doctors guilty on fact – facts that go back 16 years.

An Honorary Consultant

Wakefield has never treated a child for autism. I do not know if he has ever treated a child for anything. In the UK senior hospital doctors or consultants have responsibility for patient care. Wakefield never made the rank of consultant. He was a lecturer and a researcher whose contract specifically excluded him from treating patients.

Dr Andrew Wakefield was a Senior Lecturer in the Departments of Medicine and Histopathology at the Royal Free Hospital and from 1st May 1997 a Reader in Experimental Gastroenterology. He was an Honorary Consultant in Experimental Gastroenterology with a stipulation in his contract that he had no involvement in the clinical management of patients.

Yet it was Wakefield who signed the orders for medical investigations into children, despite the clause in his contract and despite having no paediatric qualifications. The medical investigations he sanctioned were not clinically indicated but carried out purely for reasons of research. This breached medical ethics and was not in the interest of the child.

Follow the Money

Wakefield was initially paid £50000 to cover the cost of investigations into children for solicitor, Richard Barr. The money came from the Legal Aid Board (ie taxpayers’ money). However, because the children were admitted to the Royal Free as National Health Service patients, the NHS (taxpayers’ money again) picked up half the bill. Wakefield should have returned the extra £25000. Instead he used it in part to fund salaries for researchers.

Conflict of Interest

The research proposal submitted to the LAB in June 1996 for funding was judged by the Panel to be essentially the same as the project submitted to the Royal Free for ethical approval in September of that year. But the ethics committee were not informed of any involvement with MMR litigation. Nor did Wakefield inform them of the LAB funding.

Ethical Conditions

Part of the ethics committee conditions were that approval only covered children enrolled after 18 December 1996. Yet seven of the twelve children in the study had been enrolled, admitted to hospital and subjected to invasive tests before that date.

All patients had to show signs of intestinal disease or dysfunction and all procedures had to be clinically indicated - ie intended to investigate or treat the intestinal disease or dysfunction. But these procedures were not always clinically indicated even where the child did show evidence of intestinal disease or dysfunction.

Child 1 for example

Professor Walker-Smith, after his assessment of Child 1 on 19 June 1996, concluded in his letter to Dr Barrow that Child 1 had the features of “toddler’s diarrhoea” and planned to see Child 1 again in three months’ time. However, Child 1 was admitted to hospital one month later. There were no apparent clinical reasons for this change in plan. Child 1 underwent a colonoscopy, MRI scan of his brain, an EEG and a variety of blood and urine tests. These were some of the investigations listed in the programme of the project. He was further admitted on 23 October 1996 for further investigations regarding the “etiology of the autism”, again for no obvious clinical gastro-intestinal reasons.

During this admission, Child 1 underwent a barium meal and follow-through and a lumbar puncture. These were also the investigations listed in the programme of the project. The Panel has concluded that Child 1 underwent a programme of investigations for research purposes and for which there was no Ethics Committee approval.

Children enrolled in the study had to have “manifested disintegrative disorder.” I find this a bizarre construction. Childhood Disintegrative Disorder is a very rare manifestation of PDD, first identified as Heller’s Syndrome a century ago. Its diagnostic validity and its place on the autistic spectrum have both been questioned. Why not refer to regressive autism instead?

Most bizarre of all, given the consequences, MMR was not even mentioned! A condition of admission to the programme was that all children were to have  been vaccinated with the measles or measles/rubella vaccine. Thus every child in the study breached its own guidelines!

So we have an investigation into a new form of autism that manifests itself after MMR vaccination in which neither autism nor MMR are mentioned in the protocol. Were Wakefield and his team guilty of sloppy thinking and using ill defined terms or was this a deliberate attempt to mislead?

Patents and Single Vaccines

One thing I never understood about Wakefield advising parents to use single vaccines was this. If it was the measles component of MMR that did the damage why would giving it in isolation be less damaging? Of course it wouldn’t. But if the doctor who discovered the danger was able to develop a safer single vaccine it would make sense. And quel surprise! Even before he began his research, Wakefield had taken out a patent for a single vaccine that protected against measles and treated the Inflammatory Bowel Disease and Regressive Bowel Disease allegedly caused by the old vaccine. RBD refers to the autistic enterocolitis that he had not discovered yet. IBD was a reference to his previous theory that Crohns disease was caused by measles virus. This too was without foundation and may explain why he switched is attention to autism.

Wakefield began treating one of the study children, Child 10, with this transfer factor in 1997 and set up a company with the child’s father to exploit the invention. After the Lancet paper was published he applied for permission to run a clinical trial on autistic children. So he had a vested interest in damaging the reputation of the MMR vaccine and was prepared to try out his experimental treatment on Child 10 for research purposes.

Brian Deer summarized this Transfer Factor in his investigation

Recipe for madness?: Wakefield’s claims for a measles vaccine, and treatments for bowel disease and autism, were bizarre. The technology involved is of so-called “transfer factors”, a now largely abandoned fringe conjecture based on a theory that special substances can be harvested from white blood cells. The Royal Free’s recipe advised injecting mice with measles, extracting and processing white cells, injecting the result into pregnant goats, milking them after kid-birth and turning the product into capsules.

The Birthday Party

Buying blood samples from children at his son’s birthday party; this is probably the one element of the whole affair that did most to turn public opinion against Wakefield. The amazing thing is not that he did it but that he felt able to joke about it to an audience of parents who did not find it repellent.  This goes some way to explain the hubris of a man who surrounds himself with admirers who believe he can do no wrong. The GMC was more level headed in its verdict

You showed a callous disregard for the distress and pain that you knew or ought to have known the children involved might suffer,

Found proved

in the circumstances you abused your position of trust as a medical practitioner,

Found proved on the basis of the above findings.

Your conduct set out in paragraph 42.b. was such as to bring the medical profession into disrepute;’

Found proved on the basis of the above findings.

The Honorary Consultant dishonoured

The science behind Wakefield’s theory was always tentative and has been thoroughly repudiated by subsequent research. This has not always been reflected in media coverage. Journalists and the public they serve often stumble over the science. But everyone can understand dishonesty, callous disregard for the suffering of children, unethical conduct. I just find it terribly sad that Wakefield had to be discredited as a person in order for people to reject his bad science. The quacks who play by the rules and do not attract the attention of investigative journalists and professional oversight committees continue to prosper at the expense of a public who have a poor understanding of what science based medicine means. The GMC hearings have done nothing to alter that fact.

February 3rd, 2010 Posted by Mike | Andrew Wakefield, MMR | 9 comments

Polly Tommey and the Autism File

Polly Tommey is feeling the pressure. According to an article she wrote for The Age of Autism leading autism organizations in the UK, academics and celebrities are telling her that her continuing support for Andrew Wakefield is a liability. Even her advertisers are threatening to pull out.

Specifically, I have been “warned” not to print any more articles written by Dr. Andrew Wakefield (he wrote for the first time in the last issue); I was also warned not to invite him to speak at our conference. Separately, some organizations have warned me that they will not have anything to do with me if I continue to support and publish papers by him. Some advertisers tell me they have to stop working with us as they are “under pressure” to pull out, and a number of celebrities, high earning individuals, journalists, scientists, practitioners, and people who want to contribute to the magazine or to our campaigns say that it’s more than their job’s worth to be associated with the work of this man more than their job’s worth to even listen to what he has to say. All of them say that they can’t support The Autism File if The Autism File appears to support Dr. Wakefield.

Tommey presents this as a threat to her editorial integrity. “They” are trying to silence her. The pressure is all “political.” Even people who might want to work with her or write for the Autism File are afraid to because Andrew Wakefield has been discredited and if they identify themselves with his most stalwart supporter in the UK they too could be discredited and marginalized. Academics are afraid of losing their government funding.

Tommey offers no real evidence to support these claims. She describes a meeting with a senior representative of a leading autism organization,

The message I was very clearly given at this meeting was that if The Autism File magazine continued to publish Dr. Wakefield’s work, if I continued to support him publicly, and if I allowed him to speak at our conferences, then they could not work with either me or The Autism File. He also reminded me, very pointedly, that they worked closely with the Department of Health and were the decision makers regarding many important issues relating to autism . . . .

At some unspecified time in the past, some time ago, an unnamed eminent academic was invited to join the scientific advisory board of the Autism File

He was keen but stated he could only do so if certain existing members – specifically including Andrew Wakefield – were removed from it. He then bluntly warned me that if The Autism File continued to support Dr. Wakefield it would be “shut down.” Despite his standing and expertise, his concern was such that ultimately he chose not to even write for our magazine because, he said, “it is too controversial,” and, given that he is funded by the government, he felt that if he did, then his funding would be at risk.

Finally, she tells of the time when she was appearing on a popular daytime TV show, The Wright Stuff.

Before going on air, the host Matthew Wright joined us in the “green room” and said that he had been told by the show’s lawyers that if Dr. Wakefield’s name was mentioned, he had to say that Wakefield was “discredited.” We questioned why, but Matthew said that he had no choice these were his lawyers’ instructions . . . .
When I was on GMTV they said pretty much the same thing, and we have all read the same in many newspapers.

That is the sum total of her evidence, or at least the evidence that she chooses to present to support her claim that

a number of people and organizations have evidently decided that they should be determining the editorial policy of our magazine

But Polly Tommey is unbowed. She sets out to refute all claims that Wakefield has been discredited and restates her commitment to publish reports and stories that are sympathetic to Wakefield and his theories.

Part of Tommey’s problem is that she is a victim of her own success. The Autism File is a professionally produced, attractive read. It’s basic premise is that autism is a medical disorder that responds to biomedical interventions associated with alternative therapists - diet, supplements, chelation etc. Tommey’s husband, Jonathon runs an Autism Clinic which is promoted by The Autism File and offers

Dietary Modifications
Nutritional Supplementation
Immunological Regulation/ Modulation
Homoeopathy
Gastrointestinal Treatments
Liver Support & Enhanced Detoxification (methylation and transulfation)
Glandular Support (adrenals, thyroid and pancreas)
Heavy Metal Clathration(sic) Therapy
Physical Therapies - exercise, massage, reflexology, kinesiology, lymphatic drainage, yoga, breathing and relaxation techniques, etc.

This is the secret of its success. It has a core readership amongst those parents who believe autism has environmental causes that are treatable. These beliefs are never challenged. According to Tommey

The Autism File exists to provide help and support to parents, professionals, and caregivers in understanding autism better by bringing informed articles and opinions on the condition from all over the world and enabling them to then make up their minds about whether this advice will help their families and their children. We have done this for over 10 years and our readers’ feedback supports our continuing to do this.

But the Autism File does this by offering positive endorsements to a number of approaches including non-biomedical aspects of autism like behavioural therapies, educational therapies and services for adults. It does not publish critical views of any of these therapies. Though it may publish opinion pieces about why conventional research that does critique these therapies is flawed. Unlike its American counterparts that sneer at neurodiversity it acknowledges some of the concerns of autistic adults. It is supporting Gary McKinnon’s campaign against extradition to the USA. It boasts Temple Grandin on its editorial board and publishes articles on education by Stephen Shore. These are two autistic individuals, prominent speakers and authors who distinguish themselves by either endorsing biomedical cures (Grandin) or displaying a benign agnosticism (Shore).

The Autism File has been a commercial success. The international edition is on sale in over 2000 bookshops in the USA and Canada, there is a Spanish language edition and the UK magazine is available from W.H. Smiths, Sainsbury’s, Borders, and selected Tesco stores. Tommey has used this success to promote herself as an autism advocate. I have referred in the past to her successful PR campaigns that have resulted in meetings with the Prime Minister and his wife and invitations to speak at seminars.

But all this limelight has brought her support for Andrew Wakefield into focus. This did not matter when the Autism File was a subscription only house magazine for the Andy Wakefield Fan Club. But now the magazine and its proprietor are bidding to go mainstream they are meeting with widespread suspicion and hostility for their support of Wakefield.

In her defence of Wakefield Tommey seems to think that this is all the fault of a couple of journalists; Horton at the Lancet and Deer at the Sunday Times. She fondly imagines that their campaign to discredit Wakefield will all come unstuck when the GMC delivers its verdict on Wakefield this year after a lengthy investigation into accusations of professional misconduct and breaches of research ethics. I do not know what the outcome will be. If the GMC runs true to form it will probably deliver a fudge that satisfies nobody.

Never mind. In one sense the hearings are irrelevant. Wakefield is already discredited because his ideas have been proved wrong. The NAS fudged the vaccine question for years. Now they have come out against a link between MMR and autism because the science overwhelmingly says so. The MMR hypothesis has been tried in the US courts and found wanting.

Tommey poses some of the bigger questions.

• Why is it so important that Dr. Wakefield is seen to be discredited?
• Whom is it important to?
• Who stands to gain from this?
• Who will lose out if the truth is revealed?
• What is it that people are so frightened of?
• What is it they don’t want us to know?

Given the overwhelming nature of the evidence against Wakefield’s theories one could equally ask similar questions of the Autism File itself and its continuing support for Wakefield and anti-vaccine quackery.

January 8th, 2010 Posted by Mike | Andrew Wakefield, MMR, Quackery, journalism | 31 comments

Gary McKinnon - campaign update

Gary McKinnon is an autistic adult and a UK citizen with an obsessive interest in UFOs. This led him to hack into US military computer networks looking for evidence of a cover up. As a result of his actions the US government is seeking his extradition. There is an account of the whole affair on Wikipedia

I believe that Gary McKinnon should be tried in the UK and serve his sentence here. It is up to the judge to decide whether or not his Asperger’s Syndrome is a mitigating factor when passing sentence.

I share concerns that if he is extradited to the USA and treated as a terror suspect his mental health will suffer. His autism ill befits him to cope and there are professional concernss that he may become suicidal if the extradition goes ahead. Therefore I am supporting the campaign outlined below and urge you all to do the same.

The campaign website carries more information.

The National Autistic Society is also supporting Gary McKinnon’s campaign against extradition.

For immediate release ………………………………….. Wednesday 6 January 2010

Online Campaigners Show Support for Gary McKinnon
Text GARY to 65000 to join petition

Two major online campaigns - a text petition and the “Chicago” song download - are being launched this week demonstrating continued, and widespread, public opposition to the extradition of Gary McKinnon.

For further information, please contact:
Melanie Riley, Bell Yard Communications +44 (0) 20 7936 2021
melanie@bell-yard.com +44 (0) 7775 591244

The reference to “imbalanced extradition arrangements” refers to the most recent treaty (2003) between the UK and US governments. This treaty does not apply in Gary’s case. If it did he would already have been extradited with no option to challenge the decision in the UK courts. I added this comment in an earlier post on the subject.

The extradition treaty between the USA and the UK that has been ratified by both countries dates from 2003. Under its provisions either the UK or the USA can request extradition if an offense has been committed that is punishable in both countries by a minimum sentence of 1 year in prison. The lack of reciprocity resides in the fact that the UK is obliged to deport subjects who are suspected of an offense in the USA. Unlike the UK, Americans are not subjects of the crown butcitizens of their state and enjoy the protection of its constitution. One of the provisions of that constitution is that citizens can only be deported if prima facie evidence is presented before the US courts.

Prior to 2003 UK subjects also had this protection. The USA had to show their evidence to a UK court before a deportation order could be made. That is why Gary McKinnon is still in this country. His offense was committed before 2003 and so he has been able to challenge the deportation order through the UK courts.

As the treaty does not apply to Gary I am not convinced that tying his case to a campaign for a fairer treaty will help him. As I see it Gary’s problems do not arise from failings in the law but in the aversion of the UK authorities for any form of public disagreement with the USA over questions of security and anti-terrorism activities.  This is mirrored by the increasing restrictions on civil liberties being enacted in UK law. I agree with Henry Porter that 2009 was a bad year for civil liberties and like him I hope that in this election year we will have the opportunity to Vote for liberty and rights in 2010.

January 7th, 2010 Posted by Mike | Law and Order, campaigns, politics | 11 comments