MMR Settlement - too little, too late

Justice delayed is justice denied and for Robert Fletcher justice was denied for over seventeen years. He was 13 months old when he received his MMR vaccination. Ten days later he had a severe convulsion and went on to develop epilepsy and severe developmental delay. His mother, Jackie Fletcher told the Daily Mail,

‘Robert is nearly 19 but mentally he is like a 14-month-old toddler. He can’t stand unaided and he is doubly incontinent.
‘He can’t speak except to say “Hi, Mum” or “Hi, Daddy”.
‘We chop up his food and have to anticipate all his needs. He is prone to various illnesses and last week suffered around 40 severe epileptic seizures.

His case for compensation was dismissed in 1997 because it could not be proved beyond reasonable doubt that the vaccine caused his injury. This is in marked contrast to the system in the USA. The Court of Federal Claims, popularly referred to as the Vaccine Court, only requires that, on the balance of probabilities, it is more likely than not that the vaccine caused the injury. One attorney representing claimants in the Vaccine Court suggested that

“There is a difference between scientific proof and legal proof,” Conway said. “One is 95 percent certainty, and the other is . . . 50 percent and a feather.”

Finally, in 2010, an appeal has decided that, while it may not be beyond reasonable doubt, the MMR vaccination all those years ago probably triggered Robert’s epilepsy and awarded him £90,000 compensation.

The seizure occurred ten days after the vaccination. In our view, this cannot be put down to coincidence.
‘It is this temporal association that provides the link. It is this that has shown on the balance of probabilities that the vaccination triggered the epilepsy.
‘On this basis, we find that Robert is severely disabled as a result of vaccination and this is why we allowed the appeal.’

I support the vaccination programme. but this case concerns me for a number of reasons.

1. The delay in hearing this appeal is unacceptable. Roberts’ parents have spent his entire childhood battling with the authorities for compensation for an injury that occurred when he was thirteen months old.
2. The one day hearing was chaired by a barrister supported by two doctors. it was a tribunal rather than a court and no judge was involved.
3. £90,000 compensation for a lifetime of care is derisory.
4. It emerged that the government cannot say which vaccines are compensated. Nor does it record the injuries for which awards are made.

The Department for Work and Pensions, which administers the Vaccine Damage Payment Scheme, said: ‘We do not hold any information on how many awards have been MMR-related.
‘It is not a requirement when a case is being assessed for the medical adviser to state which vaccine the damage has been attributed to.
‘Nor is it a requirement to list the disabling condition that gave rise to the award.’

Again, the contrast with the USA could not be greater. Statistics about vaccine claims, verdicts and compensation paid are readily available on government websites. The UK government admitted to paying £3.5 million in compensation over the previous 8 years in 2005. The USA has paid out nearly $2 billion to 2,472 claimants over the past 21 years. They meet the legal costs of all claims whether upheld or not. The American Way seems to be to admit that vaccine injuries are a rare but unfortunate occurrence and to make the no fault compensation programme as transparent and user friendly as possible. By contrast the UK government is secretive, mean spirited and places obstacles in the path of potential claimants in a misguided attempt to bolster the vaccination programme. But insisting that vaccines are safe rather than being honest about the risks and benefits has not led to greater vaccine take up. On the contrary, whenever the government dismisses people’s fears instead of taking them seriously its “we know best” attitude merely reinforces people’s doubts. During the MMR scare vaccine take up slumped to less than 80 per cent and has still not completely recovered.

Of course the American system is open to abuse. Any lawyer who can make a half way plausible case for vaccine damage is going to be amply rewarded whether they win or lose. In 2010 54 failed cases still earned attorneys $2,922,678.87 in fees and costs. In 2009 the massive costs incurred by the autism omnibus proceedings inflated the figure for fees and costs for failed petitions to $9,914,919.36 shared between 58 payments to attorneys. In one case alone, attorneys claimed $2,180,885.29 and were granted an interim award of $1,452,806.11. Recent cases suggest that extravagant claims are now subject to closer scrutiny especially when they involve expert witnesses who are none too expert.

It could be argued that the American system of no fault compensation has encouraged the anti-vaccine movement by providing a focus for their claims in the Vaccine Court. Certainly the alleged link between autism and vaccines resulted in thousands of parents lodging claims. It also resulted in a lot of evidence being weighed in open court. The petitioners in the Autism Omnibus spent years commissioning research, recruiting experts and finally presenting their test cases in court. Every test case was lost and their general causation theory was left in tatters. To date all subsequent appeals by the petitioners have been lost as well.

Meanwhile the British Way has also encouraged an anti-vaccine movement. It was Robert Fletcher’s mother, Jackie who established the JABS website and made common cause with those parents who believed that MMR caused their child’s autism. For a long time she was the go-to person for quotes on any vaccine story in the news and the BBC News website always linked to JABS when it ran a vaccine story. Ironically the BBC report on the Robert’s appeal does not feature a link to JABS.

There is also a connection to the American situation. Dr Marcel Kinsbourne gave evidence on Robert’s behalf at his appeal. Dr Kinsbourne is also Michelle Cedillo’s doctor and gave evidence on her behalf that MMR caused her autism during the Autism Omnibus proceedings in the USA.

It is interesting to speculate on what might have happened if the doctor who first examined Robert under the compensation scheme in 1996 had not concluded that

he had suffered a ‘simple febrile convulsion with no long-lasting consequences’.

It was justice denied that prompted Jackie fletcher to set up JABS (Justice Advice and Basic Support), to give her support to Andrew Wakefield and to make common cause with vaccine autism activists on both sides of the Atlantic. Now that Robert has justice, albeit delayed, it is apparent that JABS will continue to campaign for the 2000 British parents who also believe that vaccines damaged their child. 15 years ago this settlement would have been quickly forgotten. Now, after Wakefield’s disgrace and the decision of the American courts should have buried the vaccine autism connection completely, this belatedly successful appeal has raised it again. Many of the vaccine activists like to imagine they are victims of an establishment conspiracy engineered by the government and the drug companies. All I can say is that it looks more like a cock up than conspiracy to me. Unless it is yet another example of the establishment conspiring to snatch defeat from the jaws of victory.

August 30th, 2010 Posted by Mike | MMR, vaccines | 11 comments

My response to the Interagency Autism Coordinating Committee

The InterAgency Autism Coordinating Committee is on the last day of its public consultation on the Strategic Plan for Autism, 2010. I just made the cut with my contribution after reading this opening to the Introduction to the Plan.

Two decades ago, autism was a little known, uncommon disorder. Today, with prevalence estimates increasing at an alarming pace, autism is emerging as a national health emergency. Autism is now recognized as a group of syndromes denoted as autism spectrum disorder (ASD). The most recent Centers for Disease Control and Prevention (CDC) prevalence estimates of ASD for children are 1 in 110 (CDC, 2009). These estimates, more than ten-fold higher than two decades ago, raise several urgent questions: Why has there been such an increase in prevalence? What can be done to reverse this alarming trend? How can we improve the outcomes of people already affected, including youth and adults?

This is my response.

As a UK resident may I offer an alternative perspective on autism to the one you present in your introduction? You suggest that there has been an alarming tenfold increase in prevalence since 1990, from 10 in 10000 to 110 in 10000, that constitutes a national health emergency.

Yet as far back as 1996, Lorna Wing[1], writing in the British Medical Journal offered a tentative estimate of 91 in 10000 based on epidemiological studies in Britain[2] and Sweden[3] carried out on children born before 1970 and 1985 respectively.

Wing suggests that broadening the criteria, increased awareness of ASD, particularly as it affects those without cognitive impairments and an increase in referrals for diagnosis may explain the apparent growth in prevalence. Until recently children in the UK with developmental delays were not usually referred for specialist diagnosis. Children were allocated to specialist provision on the basis of their IQ. Local Education Authorities made a virtue out of assessing individual educational need rather than applying labels. The needs of high functioning children in mainstream schools remained unrecognized and unmet. If, as a result, they became disruptive they were treated as maladjusted. In the USA autism has only been an officially notifiable diagnosis within the education system since the early 1990s. It is instructive that while the number of children diagnosed with autism has increased dramatically since 1998 the number of children served by IDEA in US schools has remained between 10 and 11 percent. [4]

This does not rule out the possibility of a real increase but it does suggest that any increase will be far more modest than the 10 fold increase that you suggest. It is unlikely that the USA is facing a massive growth of autism amongst young people sufficient to constitute a “national health emergency.”

The immense costs to society of ASD are often taken to include massive increases in demand for adult services as young people mature. But if there has not been a dramatic increase in numbers it is logical to assume that masses of undiagnosed adults are already amongst us. The first ever study of prevalence amongst adults in the UK [5] suggested that there are around one per cent living in the community. Most of them lacked educational qualifications, were single and not in receipt of services. A previous report by the National Autistic Society, “Ignored or Ineligible”[6] found that most autistic adults, whether high functioning or low functioning had needs that were not being met. Whatever the costs of autism, they are not being substantially borne by a society that ignores the reality for autistic adults. The costs are privatized as familial poverty and deprivation. When adults do take up services it is not to meet their needs as autistic individuals. Rather, they become a burden on psychiatric or custodial services because their autistic needs have not been met.

The need for an expansion of services for autistic adults need not be an economic burden. Again look to the UK. An Audit Commission report[7]) into services for autistic adults found the following.

• We explored the possible impacts of providing specialised health, social care and employment support for adults with high-functioning autism. Wider implementation of such services would require additional expenditure, for example an estimated £40 million per year by Primary Care Trusts and Local Authorities to provide specialised health and social care teams across the whole of England. Evidence from existing specialised services does however indicate that they can improve outcomes for service users, and our model suggests that the costs could over time be outweighed by overall public expenditure savings.
• A key factor would be the proportion of the local population with high-functioning autism identified by specialised services and given appropriate support, for example to live more independently or to obtain and retain employment. We estimate that if such services identified and supported around four per cent or more of the adults with high-functioning autism in their local area, they could become cost-neutral across public spending as a whole over time, as well as resulting in additional earnings and reduced expenses for individuals.
• Increasing the identification rate further could result in greater financial benefits over time. On a number of key assumptions, for example regarding housing settings and employment rates, some of them based on limited data, our model suggests that a six per cent identification rate could lead to potential savings of £38 million per year, and an eight per cent rate to savings of £67 million. Further work is needed to quantify the potential costs and benefits more precisely, and to explore in more detail the potential impacts of implementing such services.

I would suggest taking a step back from the rhetoric about a burgeoning epidemic with dire economic consequences. Instead you should embrace the benefits that accrue from acknowledging the true scale of ASDs in society. You should prioritize efforts to identify autistic adults across the life span and make provision to meet their needs. And, as the National Audit Office report from the UK shows, doing the right thing by autistic people is both fiscally and morally sound. Do the right thing, America.

References:

1. BMJ 1996;312:327-328 (10 February)
2. Wing L, Gould J. Severe impairments of social interaction and associated abnormalities in children: epidemiology and classification. J Autism Dev Disord 1979;9:11-29.
3. Ehlers S, Gillberg C. The epidemiology of Asperger syndrome. A total population study. J Child Psychol Psychiatry 1993;34:1327-50
4. http://www.autismstreet.org/weblog/?p=217#more-217
5. http://www.ic.nhs.uk/pubs/asdpsychiatricmorbidity07
6. http://www.autism.org.uk/en-gb/about-autism/autism-library/magazines-articles-and-reports/reports/our-reports/ignored-or-ineligible.aspx
7. http://www.nao.org.uk/publications/0809/autism.aspx

July 31st, 2010 Posted by Mike | Autism epidemiology, adults, autism advocacy | 6 comments

Deprivation of Liberty order against Steven Neary

This appalling story arrived in my inbox from a person I trust.

Please sign the petition to get Steven home and share his story with your networks.

The campaign to bring Steven back to his family home starts here.

Steven is a 20 year old man with autism. He loves music, swimming and Mr Bean.

Since December 2009, Steven has been incarcerated in a care home, against his and his family’s wishes. He went away for three days respite as his father was unwell and hasn’t been home since.

On 7th July, the London Borough of Hillingdon decided Steven would never be allowed to return to the family home as he is too great a risk.

Since being in the care home, occurrences of his challenging behaviour have risen by over 300%.

In April, Steven was served a “Deprivation of Liberty” order as he escaped from the home and removed a man’s glasses. No staff on duty noticed he was gone until he was out on the main road.

His clothes are repeatedly torn and he appears with bite marks on his arms and hands (not self inflicted).

He has tried to escape on several occasions.

He is repeatedly forced into a double bind situation where the managing authority create a situation that he finds difficult to understand and gets upset about. Steven reacts to the situation and then his reaction is used as evidence that he is too challenging.

In the last two weeks the London Borough of Hillingdon have cancelled Steven’s much look foward to holiday and his overnight stays at home.

He is 20 years old and could be facing the rest of his life in an institution

The Deprivation of Liberty Safeguards (DOLS) where only introduced after an autistic man successfully brought a case before the European Court of Human Rights. According to the Deprivation of Liberty Safeguards Code of Practise:

The deprivation of liberty safeguards were introduced to provide a legal
framework around the deprivation of liberty. Specifically, they were introduced
to prevent breaches of the European Convention on Human Rights (ECHR)
such as the one identified by the judgment of the European Court of Human
Rights (ECtHR) in the case of HL v the United Kingdom3 (commonly referred
to as the ‘Bournewood’ judgment). The case concerned an autistic man
(HL) with a learning disability, who lacked the capacity to decide whether he
should be admitted to hospital for specific treatment. He was admitted on
an informal basis under common law in his best interests, but this decision
was challenged by HL’s carers. In its judgment, the ECtHR held that this
admission constituted a deprivation of HL’s liberty and, further, that:

• the deprivation of liberty had not been in accordance with ‘a procedure prescribed by law’ and was, therefore, in breach of Article 5(1) of the ECHR, and
• there had been a contravention of Article 5(4) of the ECHR because HL had no means of applying quickly to a court to see if the deprivation of liberty was lawful.

To prevent further similar breaches of the ECHR, the Mental Capacity
Act 2005 has been amended to provide safeguards for people who lack
capacity specifically to consent to treatment or care in either a hospital
or a care home4 that, in their own best interests, can only be provided in
circumstances that amount to a deprivation of liberty, and where detention
under the Mental Health Act 1983 is not appropriate for the person at that
time. These safeguards are referred to in this Code of Practice as ‘deprivation
of liberty safeguards’.

The code of Practice is supposed to supplement and not replace the provisions of the Mental Capacity Act (2005). According to the government’s own strategy for adults with autism, Fulfilling and Rewarding Lives:

Mental Capacity Act (2005) – came into force in 2007 providing a clearer legal framework for people who lack capacity, for those caring for them and for the professionals who work with them by setting out key principles. It puts people who lack capacity at the heart of the decision-making process – this includes people with autism and those who may not find it easy to express their choice in words. The Act requires an assumption that people have capacity to make decisions for themselves unless there is evidence to the contrary.

Fulfilling and Rewarding Lives specifically instructs local authorities to take account of the views of autistic adults, their carers and their families when assessing need.

Such an assessment, carried out by trained practitioners and taking account of the communication needs of adults with autism, will be the key to unlocking care services throughout a person’s lifetime. It will provide a comprehensive view of the person’s condition and how it affects them – drawing on the experiences andviews of the person themselves, their family
and carers.

The DOLS Code of Practice is also clear about the need to take account of the person’s family. Too often in the past parents have felt excluded by adult services because legally they have no rights over their children once they become adults. Decision makers are obliged, under the Code of Practice to take account of

the views of the relevant person, their family or carers? Do any of them object to the measures?

They have a duty to minimize the likelihood of a Deprivation of Liberty Order

by minimising the restrictions imposed and ensuring the views of the relevant person, their family or carers. Do any of them object to the measures?(2.7 page 18)

Following a Deprivation of Liberty Order they are obliged to

Take proper steps to help the relevant person retain contact with
family, friends and carers.

Remember that Hillingdon Borough Council have stopped Steven’s home visits and decided he will never be allowed to return to the family home. His family feel so excluded from the decision making progress that they have resorted to an online petition in order to try and exert some influence on the Council.

It is unclear on the evidence so far whether or not these “safeguards” will be used primarily to protect the rights of people like Steven Neary or whether they will be used to protect local authorities who will continue to be able to breach the human rights of those in their care providing they can show that they have followed the letter if not the spirit of the law.

July 18th, 2010 Posted by Mike | adults, disability rights, services | 10 comments

Doctors Data sues QuackWatch

Andrew Wakefield has tried to silence Brian Deer with libel suits and press complaints.

Anti vaccine lawyer Cliff Shoemaker tried to subpoena Neurodiversity blogger Kathleen Seidel.

Homeopaths used the law of libel against Simon Singh.

A pill pusher tried to do the same to Ben Goldacre.

And now this dishonourable roll call of those who would use the courts to silence legitimate criticism of dubious medical practices is joined by Doctors Data. They are unhappy with Dr Barrett and his Quackwatch website because he points out that their testing services are being used to defraud patients.

Doctors Data tests urine samples for heavy metals.  But it does so after the patient has been given a chelating agent that will artificially increase the levels in their urine. It also tests after a six hour collection period rather 24 hours. As more metals will be excreted immediately after chelation this boosts the figures even more. Dr Barratt points out that even using a 24 hour collection period provoked tests are artificially high.

One experiment involved ten healthy people whose urine was examined before and after receiving a 1-hour infusion of calcium disodium EDTA. The infusion increased the excretion of lead about 6 times over the baseline level [2].
Another experiment tested workers who had industrial exposure to mercury. The researchers reported that provocation with DMSA raised the 24-hour average urine mercury level from 4.3 µg/g before chelation to 7.8 µg/g after chelation [3].

These figures wrongly compared to the reference levels for adults in non-provoked tests even when the patients are children. Doctors Data claim that they are just offering a service. The interpretation of results s down to the patient’s doctor. So they are not responsible if a healthcare practitioner gives misleading advice based on their misleading lab results. This might just be plausible if they did not clearly indicate, as in this illustration, that they think their results show an excess. Any parent receiving this would be convinced that their child was poisoned regardless of the disclaimer at the bottom.

Even parents who believe in the vaccine autism myth are fed up with Doctors Data and have launched a petition because they want properly referenced tests.

Part of Doctors Data’s case is that they are unhappy because Dr Barrett reports on them to government and regulatory bodies. So they are claiming that Dr Barrett’s activities are damaging a perfectly legitimate operation because his actions might bring them under public scrutiny. If they are so legitimate what do they have to hide? And if they have got something to hide, taking Dr Barrett to court is not the wisest move. The roll of dishonour at the head of this blog were all litigants who thought they could use the law to browbeat their critics into silence. What happened instead was their activities were opened up to public scrutiny and they either lost or quit before it came to court because it was all a bluff. Are Doctors Data any different? I don’t think so. But just in case, Dr Barrett has a defence fund.

July 4th, 2010 Posted by Mike | Quackery | 7 comments

Help Close Down Judge Rotenberg Center.

June 30th, 2010 Posted by Mike | Judge Rotenberg Center, abuse, autism advocacy | one comment

Breakthrough in autism research … again.

Last week I wrote about press reports on a possible urine test for autism based on the limited findings of a pilot study that had a number of weaknesses. This week a rather more substantial piece of research has caught the attention of the media. Functional impact of global rare copy number variation in autism spectrum disorders by Pinto et al was published online by Nature on 9 June 2010. It is not an easy read for non-scientists like myself but there are some really helpful commentaries online. The NHS has a very readable guide on its NHS Choices site. PZ Myers has summarized the paper for a lay audience on his Science Blog, Pharyngula. Orac is another Science Blogger who offers his reflections on the study at Respectful Insolence. And the corresponding author for study, Stephen Scherer, answers questions from Kev Leitch over at LBRB.

Any one of these sources would have helped the reporters to write better articles. The Daily Mail and the Telegraph both persist with the theme from last week’s articles that a quick and easy test (Last week it was urine. Now it is a blood test.) will obviate the need for lengthy assessment and allow interventions to start much earlier. The Times also leads on the diagnostic possibilities of the new research.

I am reminded of the TEACCH seminars I attended many years ago with Professor Gary Mesibov from the University of North Carolina. Over three days he saved the lecture on diagnosis until last. His argument was that diagnosis is a relatively straightforward process that only tells us what people have in common. The really interesting stuff happens after diagnosis when you look at the person and assess their individual needs and discover what makes them unique.

Let us assume that The Mail is right and a blood test is developed that can reveal a child’s autism at 6 months. It will not reveal what they need in terms of speech therapy, occupational therapy, and educational provision. Specialists will still want to assess the child in order to prescribe programmes tailored to their personal requirements. If anything we want more follow up not less.

Actually, The Mail is emphatically wrong with its headline

Blood test to diagnose autism could be ready in three years

They attribute this claim to the research team from Oxford University who took part in the study.

A simple test that could revolutionise the diagnosis of autism could be available within just three years.
The kit would use a few drops of blood to help doctors decide if a child has the devastating condition, speeding up diagnosis and allowing life-altering treatment to start earlier.
The test, which Oxford University researchers believe could be in NHS clinics by 2013, would capitalise on the results of a landmark genetic study into the root causes of autism.

Which is strange. Because The Guardian reports that

Anthony Monaco, a geneticist at the University of Oxford, re-iterated Gallagher’s point by saying that the genetic picture of autism was too complex to make meaningful predictions [about genetic testing] right now.

And there is nothing in the press release from Oxford University to support The Mail’s claim. What is actually happening is that the Oxford University team in conjunction with researchers at Newcastle University, both of whom took part on the current research, are seeking funding for a pilot study to carry out further testing on 1000 autistic subjects to see if a diagnostic test is viable. We may get the results of the pilot study in three years. We most certainly will not have a readily available genetic test by then.

We should not be too surprised at the lack of accuracy in The Daily Mail. It is a long time supporter of Andrew Wakefield and purveyor of scare stories about vaccines and autism. The Daily Telegraph is a serious broadsheet newspaper. We expect better of it. But Richard Alleyne, the science correspondent, makes no attempt to reconcile his acceptance of this research with his equally enthusiastic response to last week’s reports that autistic children had a different metabolic profile, revealed in urine tests, that suggested that alteration to the flora in their intestines was the key to their autism.

PRESS RESPONSIBILITY

This goes to the heart of the problem with science reporting in the press and on TV. When scientists introduce new findings they have to frame them in the context of our previous knowledge. Journalists are under no such strictures even when reporting on developments that are contradictory.

The Guardian and The Independent were suitably cautious in their reporting and did not hype up the prospect of genetic tests. The Independent pointed out that

They believe that eventually it may be possible to devise genetic tests to determine a child’s predisposition to autism so they can be diagnosed before more obvious symptoms become apparent. Such tests are unlikely to be able to provide an unequivocal result – just a probability for the chances of developing autism.

Paradoxically, the more cautious reporting in the Guardian and the Independent did not refer to the National Autistic Society’s position. But the more enthusiastic Telegraph and Mail did carry a statement from Dr Gina Gomez de la Cuesta of the National Autistic Society that

“This study furthers our understanding of genetic variation in autism, however there is a great deal more research to be done.
“Genetic testing for autism is still a long way off, given that autism is so complex. Whilst it is very important that research continues, it is also crucial that those living with the condition have access to appropriate advice and information, as the right support at the right time can make an enormous difference to people’s lives.”

Overall, the press did a better job on this story than on last week’s tale of urine tests. But that is only because this was a much better piece of science with lots of experts involved who were willing to talk to the press. There has been a lot of criticism of the standard of science reporting and the media have taken a lot of the flak for perpetuating controversies like the MMR Hoax because they did not understand the science. But journalists can only understand what scientists (or their press officers) tell them.

Moreover journalists are unwilling to challenge, or critically evaluate the claims made by scientists. There is a sort of deference reminiscent of political reporting in the UK in the 1950s when a television interview consisted of a journalist asking a senior politician what he wanted to say and maintaining a respectful silence before thanking him at the end. This all changed with Robin Day who was one of the first to ask really probing questions of world leaders.

I am not suggesting that journalists should raise technical questions at the level of peer review. But when research institutions issue press releases and encourage the publication of stories about their activities in the lay media they should expect to be challenged on questions of legitimate concern to the rest of us.

MISSING QUESTIONS

None of the journalists challenged the researchers’ use of the word “disease” in relation to autism even though it is a common source of contention within the autism community.

Money was not discussed apart from a reference to the $4 million dollars put up by one of the funding partners in the research. Although the cost of DNA profiling will inevitably become cheaper with time it is still expensive and if the prospects for a putative genetic test for autism are a long way off, an affordable test is even more distant.

MISSING ANSWERS

When spokespersons stated that this research would make a difference to the lives of autistic people and their families they were not asked to explain how. Tony Monaco of Oxford University did suggest that knowing there was a genetic cause might stop families from blaming themselves and help them to move on. This is potentially the most useful result of research in the short term. The Guardian acknowledged that

Discovery of a major genetic underpinning for autism will help further allay parents’ fears of a sinister environmental cause, such as the link that was proposed by Andrew Wakefield in a paper in the Lancet in 1998. The General Medical Council recently struck him off the medical register over his research ethics. But some parents of autistic children continue to believe he has been the scapegoat for a vaccine scandal, in spite of the absence of scientific evidence for his claims.

The same point was much more forcefully made at the above mentioned Pharyngula blog.

One fact is so obvious that it’s unfortunate I have to mention it: no external agent, such as a vaccine, can generate a consistent pattern of duplication and deletions in an affected individual’s cells. These data say it’s an error to chase down transient environmental agents given relatively late in life to people.

Orac, also cited above makes a similar point.

Almost as important as the candidate pathways implicated by this study that clearly need further study to validate whether they are truly involved in the pathogenesis of ASDs or not are the pathways that were not implicated. One of the major claims of the “autism biomed” movement, the group of quacks who claim that they can treat autism with all manner of woo ranging from chelation therapy to various antioxidants and supplements, is that there are significant defects in pathways involved in countering the effects of oxidative stress, particularly pathways that result in glutathione production. (Glutathione is one of the major scavengers of reactive oxygen species–a.k.a. free radicals–in the cell.) Such claims were prominently featured by the lawyers for the complainants in the Autism Omnibus. Treatments allegedly targeting “detoxification” pathways involving “Glutathione, Cystathionine, Homocysteine, Methionine” figure prominently on the website of many a quack and are a favorite among the “vaccines cause autism” crowd. Don’t ask me how “vaccine injury” somehow causes oxidative stress sufficient to “cause autism.” Anti-vaccine “scientists” have long and convoluted pseudoscientific explanations that are implausible and unconvincing.

None of these “detoxification” pathways showed up in the analysis of Pinto et al.

Exactly. While the study’s authors and the journalists speculate at length about the future benefits of this research it is left to bloggers like Orac and PZ Myers to point out the incontrovertible lessons that we we can draw from this research in the here and now. While a bewildering number of individual genetic variations have been discovered, the significant ones affect a fairly small number of key processes in neurological development that occur in the developing embryo and early infancy. The process is so subtle and pervasive that it is nonsense to think in terms of a simple genetic predisposition and a single environmental trigger that might occur in early childhood, be it a vaccine or some other hypothetical toxin.

Having dismissed these environmental causes, it would be equally mistaken to argue that the biomedical nostrums of Defeat Autism Now and its imitators are going to do anything to fundamentally alter the architecture of the brain.

QUACKERY DISMISSED BUT NOT THE QUACKS

Which is why it was disappointing that, when the Independent went to Polly Tommey for a “human interest” sidebar to its coverage of the study, it did not ask her the obvious questions about her continuing support for Andrew Wakefield or her husband’s “clinic” that is selling these unproven remedies for autism. Will any journalists attend Polly Tommey’s Audience with Andrew Wakefield on June 17th. and ask him to justify his theories in the face of this contrary genetic evidence?

MISSING VOICES

The most glaring omission in the coverage was the total lack of comments from autistic people. They have been saying for years that they are differently wired. Here we have some research which suggests that it has identified some of the genes responsible for that different wiring and identified the processes involved. The Guardian had Charlotte Moore, a parent. the Independent had Grace Boyle, a sibling. Both provided excellent, thought provoking opinions on the research. But why did nobody ask an autistic person what they thought of this research?

June 13th, 2010 Posted by Mike | genetic research, genetic testing, journalism | 4 comments

Urine Test for Autism

WHAT THE PAPERS SAY

I had hoped that the press would have learned from their experience with Andrew Wakefield and the Great MMR Hoax. Perhaps now they would be more circumspect in reporting “breakthroughs” in the science of autism. But on the evidence of recent reports in the Mail, the Express and the Telegraph it seems my hopes were misplaced. All three papers carried reports on recently published research into Urinary Metabolic Phenotyping and Autism.

The Express story was the shortest and its headline was suitably cautious.

NEW TEST MAY SPOT AUTISM IN CHILDREN

It has all the essentials.

The Mail also maintains a note of caution in its headline

Revolutionary urine test for autism could soon diagnose children with the condition

Its story contains the same elements as the Express but adds that

• The diagnostic process is not only lengthy but also traumatic for young children.
• It is proven that autistic children have different microbes in their gut.
• The test should be available in 5 years time.

Both papers seem to have taken their story direct from the press release issued by Imperial College London. Both make much of the lengthy diagnostic procedures and suggest that a simpler biomedical test could replace these procedures. In this they misunderstand the nature of autism and the problems we face in getting a diagnosis.

At present the problem is not so much the length of the assessment  itself but the time spent waiting between appointments. First you need a referral, usually from a GP. When you finally get to see the diagnostic team there is not a uniform procedure. Then you wait for the report. Then, armed with your diagnosis the real work begins of identifying and accessing whatever services are available in your area. It would be better if everyone got to see a consultant paediatrician or child psychologist along with assessments for speech and language therapy, occupational therapy and a full medical work-up that led seamlessly from diagnosis to appropriate services tailored to the child’s individual needs.

If a urine test can be developed it will be more in the nature of a screening tool. It might conceivably expedite the initial referral but it will not replace the need for a detailed follow up.

THE HYPE

The Telegraph is rather more forthcoming in its headline.

Autism test could make the condition ‘preventable’

This goes way beyond what was claimed in the press release and is based on this quote from one of the researchers, Professor Nicholson.

“Children with autism have very unusual gut microbes which we can test for before the full blown symptoms of the disease come through.
“If that is the case then it might become a preventable disease.”

Professor Nicholson is an eminent and well respected scientist in the field of biological chemistry. But nobody on the research team has a primary qualification or research interest in autism. Dr Yap is a member of the National Autistic Society. Dr Angley is a pharmacist who has turned to autism research and published papers on biomedical interventions for autism. But they appear to have been ill-advised on the present state of academic research into autism, particularly in regard to the gastro-intestinal tract. This may be down to the fact that they offer

thanks also to Dr. D. Granpeesheh (C.A.R.D, Los
Angeles, Ca.) for helpful discussions on the manuscript and
related data.

Doreen Granpeesheh has been a long time colleague and supporter of Andrew Wakefield and her C.A.R.D. organization continues to provide educational services to parents who attend Thoughtful House, the Texas clinic that Wakefield established after his departure from the UK. This may explain the uncritical acceptance of papers by Wakefield and others on the fringe of autism research that informs this paper’s position on a unique disturbance of microbes in the gut of autistic people. LBRB and Countering Age of Autism both discuss the questionable nature of these sources.

Even so, Professor Nicholson is going far beyond the study’s findings with these speculations. He is suggesting that the alleged abnormal microbial environment in the gut is what causes autism. The journalist, Telegraph Science Correspondent, Richard Alleyne extrapolates from this to suggest that

Eventually the link between the learning difficulties and the gut microbes could be established and that could lead to “probiotic” treatments or cures.

It is not always clear to this reader whether Alleyne is expressing his views or paraphrasing Professor Nicholson. Either way, the entire piece displays intense ignorance about autism.

We are told that early intervention can prevent permanent psychological damage. Diagnosis presently occurs after the damage has been done. Early intervention is delayed because it is currently difficult to establish a firm diagnosis until children begin speaking.

But even if we had a reliable urine test at 6 months of age what sort of intervention is envisaged at that age? Glenn Doman’s quackery?

THE PRESS RELEASE

I do not understand why Imperial College issued a press release about this. It is a pilot study. The results are interesting but will not be significant until they are replicated on a larger scale. The study itself is very honest about its limitations and the need for more work. If there is to be a simple test for autism it is still years away.

It is easy to criticize the media for misleading coverage of scientific affairs.But in this case the media seem to have been misled by ICL. The press release begins thus:

Children with autism have a different chemical fingerprint in their urine than non-autistic children, according to new research published tomorrow in the print edition of the Journal of Proteome Research.

No matter how much they qualify this opening statement, that is the headline for any news editor. But is it true? To answer that we have to look at the study itself.

WHAT THE PAPER SAYS

I have read the paper in question. It is not an easy read and I do not pretend to understand all of it, especially the technical discussion of methodology and the statistical analysis of results. But, having read a lot of autism research in recent years, a number of questions occur to me.

Recruitment

Normally studies like this go into some detail about how the subjects were recruited. This is because so many details can confound a study. Are subjects matched for age, gender and socio-economic status? As we are looking at biomedical markers in urine at what time of day was it collected? Were all subjects controlled for diet, supplements and medication? We are not told. Bizarrely, part of the control group was recruited in Switzerland. all the rest were Australian. Why? We are not told.

Results

The “unique fingerprint” claim suggests to a lay audience (and the claim was made in a press release aimed at a lay audience) that they tested the urine and the results showed three distinct results - autistics, siblings of autistics and controls. However, the way they tested showed so many variations between individuals that autism specific variations were not  that obvious. They had to run the results through a sophisticated statistical analysis to identify any significant differences. Different methods of analysis revealed different results.

Visually, allowing for the interindividual variability, the urinary spectra were very similar, but the autistic individuals showed subtle differences in urinary succinate, N-methyl nicotinic acid (NMNA) and N-methyl nicotinamide (NMND) compared to the controls, as evidenced from the median spectra shown in Figure 1.
Multivariate Statistical Analysis of the NMR Spectral

To further explore the metabolic differences between the three groups of participants, multivariate statistical analyses were employed on the full resolution NMR data set consisting of 34 controls, 28 siblings and 39 autistic urine samples to extract useful metabolic information. PCA was carried out on UV-scaled data to identify any inherent differences within the data set. The resulting scores plot of PC1 versus PC2 (Figure 2A) showed no clear differences between the three groups, all pairwise combinations of PCs down to PC3 were examined, which showed no discrimination indicating that the major source of variation in the data was not related to autism, but was rather dominated by interperson variability.

However by utilizing group information in PLS-DA analysis, systematic differences could be observed between the three groups (Q2 ) 15%; R2 (goodness of fit) ) 65.7%). The corresponding crossvalidated PLS-DA scores plot (Figure 2B) showed clear separation between autistic individuals and the controls and partial separation between siblings and the controls.

I take that to mean that when looking at the data for each individual there was not a single feature, a chemical fingerprint, that identified all the autistic individuals. But when they looked at each chemical in turn and checked its prevalence in each of the three groups they did find a statistically significant difference between groups. They may have identified potential fingerprints but they have no reliable way, as yet, of using them to identify autistic subjects.

Interpretation

There is a lot of discussion of how the results may be indicative of metabolic dysregulation that fits with certain hypotheses about possible metabolic pathways in autism, always with the caveat that further studies are required. I feel that this discussion is premature. All the weaknesses above - the over hyping of results and the attempts to present a preliminary study as supporting a hypothesis about the gut and autism that is much disputed and lacking in hard evidence - all this finds its basis in similar overreaching assumptions in the paper itself. Something is going on here in addition to the science that threatens to subtract from any merit the study might have.

And the study is not without merit. It would indeed be a step forward if we could establish biological markers for autism. But any follow up will have to address the waeakneses identified in this excellent commentary from NHS Choices

The research has several limitations:

The researchers point out that, as it is not possible to tell whether these differences indicate a cause or consequence of the disease, further research is needed in a larger group of children over time.
Different statistical analyses had different results, some showing differences in certain chemical levels in autistic children, while others did not.

The researchers did not assess the medications the children with autism were taking for their condition or the diet they were following. Both would affect the chemicals they found in the children’s urine samples.

Finally, these children had already been diagnosed with autism, and the study design was cross-sectional, looking at their urine samples from only one point in time. It is not possible to say whether there would be any differences in the chemicals found in the urine in younger children prior to standard diagnosis, and whether it could be used as a diagnostic tool.

This is encouraging research, but it is too early to say whether this research would be of benefit in terms of providing an additional diagnostic tool for autism in children.

June 6th, 2010 Posted by Mike | journalism, research, science | 8 comments

Andrew Wakefield’s Farewell

Today should see the end of the saga of Andrew Wakefield at the GMC. Following the Finding of Fact hearing earlier this year in which Wakefield’s research methods were described as callous, dishonest and unethical by the GMC panel, you do not have to be an investigative journalist of Brian Deer’s stature to predict that Wakefield will be struck off.

Will that be the end of the affair? I would like to think so but the answer is probably, “No.” Throughout the hearing, which stretched over three years, the common complaint from Wakefield’s supporters was that none of the parents whose children featured in the original Lancet paper had complained. All were backing Wakefield. Why wouldn’t the tribunal listen to them? Well, it could probably hear their noisy protests outside the tribunal. But it was unable to listen to them inside the tribunal for the simple reason that Wakefield did not call one parent in his defence. They blogged and twittered and facebooked and organized demonstrations and petitions. But none where asked to give evidence on his behalf.

They will be there again today, their loyalty undimmed, even though their hero has chosen to stay in America. According to Age of Autism

Matt Lauer will be interviewing Dr. Andrew Wakefield, the doctor whose controversial paper ignited a media firestorm about autism, GI disease and the MMR vaccine, on NBC’s The Today Show between 8:00am and 8:30pm EDT this Monday, May 24th.

Join us for a rally of support Monday morning at 30 Rockefeller Plaza in Manhattan. We suggest you arrive early! NBC is just steps away from Grand Central Station and a short cab ride from Penn Station. Make signs, and wear your Age of Autism T-shirt!

After the disastrous verdict at the earlier hearing Wakefield suggested that he had the evidence that would vindicate him. He even tried to spin his enforced departure from Thoughtful House as an opportunity to concentrate on the GMC and clear his name. It might have helped if he had turned up to defend himself. But no. He was too busy writing a book, “Callous Disregard,” which goes on sale today.

So there you have it. Before the GMC panel Wakefield was happy to let his lawyers do the talking. (One reason the hearing took so long was the number of procedural objections and arguments over points of law.) But he was unwilling to call witnesses on his own behalf, perhaps for fear of exposing them to cross examination which might have revealed even more damaging information. After the panel he promised a bombshell that would vindicate him. Now we have it - an interview on NBC to promote a book containing all the evidence that he chose not to present at the tribunal, presumably for the same reason he chose not to call any witnesses - he knows it would not stand up in court.

While his supporters in the UK continue to keep the faith Wakefield is too busy pursuing fresh career opportunities in the USA to bother with them. It is so blatant it takes my breath away. Wakefield’s message is this.

OK, I’m busted. I have got nothing that will stand up to public scrutiny in a tribunal. So I have to spin it to win it. I will use the media to the fullest extent to complain about how I am being silenced and hope the public will buy it. It probably will not play so well in Britain any more. I can only hope that the American public proves just as gullible.

May 23rd, 2010 Posted by Mike | Andrew Wakefield, MMR | 10 comments

Diet and autism: fresh evidence

Gluten free and Casein free (GF/CF) diets have been suggested for autism for many years. A survey of parent members of the National Autistic Society in 2005 found that even though only 7.5% cited gastro-intestinal (GI) difficulties as an issue for their child around half had used special diets of one sort or another. Between 10 and 20 percent reported improvements following the diet and around 10 percent wanted more research into diets and other biomedical interventions. Although most of the GI issues were reported in children with autistic disorder parents of children with Aspergers Syndrome supported the use of special diets in comparable numbers. In line with Paul Shattock’s oft quoted remark that nobody ever died of a gluten deficiency parents have often regard the GF/CF diet as essentially benign. It may be expensive and time consuming to implement but it cannot do any harm and may help with behaviour. So where is the harm in trying it?

The most obvious source of harm is the nutritional effect of limiting the type of foods offered to a growing child. Foods that contain gluten and casein also contain essential nutrients that may not be present in the GF/CF alternatives. Two years ago the National Institutes of Health reported on problems with bone density in autistic boys

The researchers believe that boys with autism and ASD are at risk for poor bone development for a number of reasons. These factors are lack of exercise, a reluctance to eat a varied diet, lack of vitamin D, digestive problems, and diets that exclude casein, a protein found in milk and milk products. Dairy products provide a significant source of calcium and vitamin D. Casein-free diets are a controversial treatment thought by some to lessen the symptoms of autism.

A recent study due to be presented at IMFAR this year went to great lengths to ensure that children on the GF/CF diet did not miss out on essential nutrients.

The researchers took on the difficult yet crucial task of ensuring participants received needed nutrients, as children on gluten-free, casein-free diets may eat inadequate amounts of vitamin D, calcium, iron and high quality protein.

They also tried to control for the effects of different treatments and therapies that might confound the results of a dietary trial by ensuring that all the subjects received the same early intensive behavioural intervention during the trial. Twenty two children aged between thirty and sixtysix months were enrolled in the trial but only fourteen completed it. One withdrew after proving positive for celiac disease. Another had an iron deficiency and the rest were unable to adhere to all the study requirements.

The trial lasted for eighteen weeks. A month into the trial each child received a cleverly disguised snack containing either gluten, casein, a combination of both or neither and went on to receive three of each type of snack in random order at one week intervals. The snacks were disguised so that neither the researchers, the children, their parents nor their teachers could identify them. The result was that there was no difference to sleep patterns, bowel movements, language or behaviour in any of the children.

The authors acknowledge the obvious weaknesses in this study. it had a small sample size and did not include children with GI disorders. However it was very well designed and provides a model for future studies. Another study, Absence of urinary opioid peptides in children with autism (Cass et al 2008) found no evidence of increased urinary peptides i autistic children compared to non-autistic controls. This is in line with Hunter et al (2003).

All this suggests that unless your child has an obvious GI disorder you should not even consider a GF/CF diet. Even if there are GI problems it is highly unlikely that urinary peptides are to blame. And if the peptides are not there why use the diet? The commercial labs that claim to routinely detect these peptides in samples from autistic children stand in marked contrast to the university and hospital labs that have failed to detect these peptides even when using very sensitive testing procedures. The study by Cass et al found evidence that suggested the presence of peptides in 25 out of 68 samples from children with an ASD. However that was not the whole story.

By HPLC analysis alone, 25 urine samples from the autism/Asperger group were selected as showing peaks in approximately the correct locations to be opioid peptides. For all 25, MALDI-TOF MS analysis of the relevant fraction found no instances of ions of m/z corresponding to opioid peptides. These results indicate that the peaks observed on the HPLC trace were not opioid peptides.

Then we have the evidence from America. Ibrahim et al 2009 found no evidence of increased GI disease in autistic subjects. A recent review published by the American Association of Pediatrics found no evidence base for an increase in GI disorders or for the effectiveness of dietary interventions in autism.

This does not mean that there is no connection between autism and GI disorders. Ibrahim et al conclude that

As constipation and feeding issues/food selectivity often have a behavioral etiology, data suggest that a neurobehavioral rather than a primary organic gastrointestinal etiology may account for the higher incidence of these gastrointestinal symptoms in children with autism.

And the AAP review stressed that some so-called autistic behaviours may be indicative of gastro-intestinal distress and these children should not have these behavioural symptoms disregarded because they are autistic. As I wrote in my very first blog post

The first thing we have to be clear about is that the child’s symptoms are real. Some parents have had their worries dismissed because it is assumed that autistic children will have poor sleep patterns, scream a lot and be difficult to feed anyway. [...]

The second point is that some of these symptoms may be connected to a child’s autism. But we do not know how. If you are non-verbal and you have constant earache, you will head-bang. That does not mean that your earache caused your autism. Nor does it mean that alleviating your distress will cure your autism. It means you are autistic and you have an earache.

Anyone with an autism diagnosis should be given a full medical work up in case there are any other conditions that need treatment. Too often the diagnostic process stops when autism is identified. There are autistic children who have other conditions that may respond to safe, targeted biomedical interventions.

I would only add that “biomedical” in this context refers to evidence based medicine delivered by qualified professionals in a proper medical facility and not to the store front clinics of the alternative therapy business.

May 20th, 2010 Posted by Mike | Uncategorized, biomedical interventions | 6 comments

Let’s Talk Autism - next live Prime Ministerial Debate

I just received this message from Carole Rutherford at Autism in Mind and ask all UK readers to join us in trying to get autism discussed at the final televised debate between the party leaders.

The final Prime Ministerial debate takes place on Thursday night. The final debate is about the economy. It is estimated that there are at least half a million children and adults who have a diagnosis of autism. There are many more who have the condition without the diagnosis. There could be as many as 6 million families in the UK alone who are living with autism.

Autism-In-Mind and Asperger Syndrome Action by Parents want the leaders to talk about autism on Thursday night and we need your help now. We want you to submit the following question onto the BBC ‘Election Question’ form. The question is wrapped around the economy and how the money that is being spent on autism every year is being spent. It is important that we all ask the same question. We want 1000,s of people to ask this question by Thursday Night and if we can achieve this then maybe someone will listen to us and will talk about autism.

Question to submit to the BBC

A recent study by researchers at King’s College London estimated that autism costs the UK economy around £28.2 billion per year, and yet thousands of autistic/Asperger syndrome children and adults do not meet the criteria for any provision or services. Autism/Asperger syndrome requires services from the cradle to the grave. The only money attached to the newly published Autism Strategy will be half a million pounds for increasing awareness and understanding of autism among frontline professionals with nothing for service provision.

In the first debate there seemed to be recognition from all three parties that there is a huge social care agenda to be addressed in the future, but will it include autistic/Asperger syndrome and disabled people and what guarantee can you give that it will include them? How are you going to make sure that EVERY autistic child and adult is not left until crisis point before they are given the provision that they need? Many of us would like to know how much of the £28.2 billion is being spent on crisis management.<?b>

Here is where you post the question – you do have to give your name and where you live. You do not have to add a telephone number if you do not want to. If you do want to add this number 07960875526 this phone will be deactivated after Thursday night.

http://news.bbc.co.uk/1/hi/uk_politics/election_2010/8589502.stm

Here are some facts and figures produced about Autism last year by the National Audit Office – This might help you to understand how important it is for the Leaders to ‘Talk about Autism’ on Thursday night.
http://www.youtube.com/watch?v=eEKMsO9t0pU

April 26th, 2010 Posted by Mike | campaigns, politics | one comment