Like it not, the MMR and Autism debate is once again about to explode into the public arena. Dr Crippen does not like it for, eventhough I cannot fault the wishes of the medical profession and a number of others to call Andrew Wakefield to account, the process is going to give yet another airing to his unsustainable and discredited views.

The problem with Andrew Wakefield is that he is not mad.

It would much easier if he were. And he is not unqualified. It is easy to lampoon the likes of Patrick Holford, who founded the "Institute for Optimum Nutrition" and then awarded himself the Diploma of the Institute for Optimum Nutrition.

Andrew Wakefield is a qualified doctor, a Fellow of the Royal College of Surgeons and a Fellow of the Royal College of Pathologists.

What did he do wrong?

Along with colleagues who should have known better, he submitted a "scientific" article to the Lancet. The editor of the Lancet, who should have know better, published it. Scientific articles in learned journals such as the Lancet are normally evaluated by experts (peer review) before publication.

Wakefield's article was not properly peer evaluated.

To the layman - and in this case the layman is often a distraught parent desperate to find a reason for their child's autism - the article is plausible.
Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children
A J Wakefield, S H Murch, A Anthony, J Linnell, D M Casson, M Malik, M Berelowitz, A P Dhillon Sounds good, doesn't it? Read it in full here. It describes some complicated science which someone without medical qualifications would find hard to understand. And it contains a little bombshell, all the more powerful for being understated.

The original Watson and Crick article on the structure of DNA concludes with their now famous modest understatement,
"It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material."
Andrew Wakefield slipped in his now infamous "modest understatement."
We have identified a chronic enterocolitis in children that may be correlation to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunisation.Both these "modest statements" reverberated around the world. One was utterly bogus. Even if it were accepted that the data upon which Wakefield based his paper was correct - and it was not - the conclusions he reached are unsustainable. Irresponsible and unsustainable. The fallacy of the incorrect syllogism. Temporal relationships do not prove causal relationships.

• I ate an apple and the next day it rained.
• I gave my child an immunisation and the next day he grazed his knee.
  
• I gave my child the MMR immunisation and the following month he was diagnosed as autistic.

Trisha Greenhalgh is a well-respected family doctor and academic, who writes regularly in the BMJ. Her particular interest is communication, clarity of expression and scientific honesty. If you read only one article on Wakefield, read this one (in full here)
In conclusion, the Wakefield study was scientifically flawed on numerous counts. I am surprised that neither the editor nor the reviewers spotted these flaws when the paper was submitted. Had they done so, the public would have been saved the confusion and anxiety caused by false credibility conveyed by publication of the study in this prestigious journal.

Professor Trisha Greenhalgh OBE MD FRCP FRCGP
It gets worse.

There is a background suggestive of moral and financial corruption which has been extensively described by Brain Deer, the investigative journalist. Full details here.

It is this background, more than the incorrect conclusions, that has finally brought Andrew Wakefiled in front of the GMC. The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.

The charges Andrew Wakefield and colleagues face are about honesty and include:

• undertook research during the period 1996-98 without proper ethical approval
• failed to conduct the research in accordance with the application submitted to the ethics committee
• failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee.
• permitted a programme of investigations to be carried out on many children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.
• acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper.
• allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield's conduct in relation to research funds obtained from the Legal Aid Board ("LAB") was dishonest and misleading.
• allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.
• allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement. (see here)
  

The GMC hearing is due to start next week on 16th July. Full details of the hearing and the charges are currently available on the GMC site here.

Andrew Wakefield drew his "conclusions" from a study of 13 children. I prefer a more authoritative paper which studied 27,749 children.
METHODS. We surveyed 27 749 children born from 1987 to 1998 attending 55 schools from the largest Anglophone school board. Children with pervasive developmental disorders were identified by a special needs team. The cumulative exposure by age 2 years to thimerosal was calculated for 1987-1998 birth cohorts. Ethylmercury exposure ranged from medium (100-125 g) from 1987 to 1991 to high (200-225 g) from 1992 to 1995 to nil from 1996 onwards when thimerosal was entirely discontinued. Measles-mumps-rubella coverage for each birth cohort was estimated through surveys of vaccination rates. The immunization schedule included a measles-mumps-rubella single dose at 12 months of age up to 1995, and a second measles-mumps-rubella dose at 18 months of age was added on after 1996.They found no correlation between MMR and autism.

They found no correlation between mercury and autism.

And this was not a small study of thirteen children, or of a handful of children bribed to give blood samples at a birthday party. It was a study 27, 749 children born over an eleven year period.

The full paper can be read here.

I can understand, but not support, the angry parents who are desperate for something to "blame" for their child's autism. I cannot understand, and I condemn, the sections of the media that continue to give Andrew Wakefield a supportive and sympathetic hearing.

Andrew Wakefield is mobilising his resources (considerable - see Brian Deer here) and his lawyers and will use the GMC hearing as a public forum to air his views. Even if he is struck off the medical register, to a number of people he will be a martyr.

And once again, I fear, the uptake of MMR will drop off and once again we will start seeing cases of measles and its occasional serious neuro-pathological sequelae.

Measles

Sub-acute sclerosing pan encephalitis

There will be more deaths. Avoidable deaths.

What more can I say?

I could say that I have four teenage children and they have all had the MMR immunisation. Twice.

It would have helped if Tony and Cherie Blair had been able to say the same about young Leo, wouldn't it?

But life is not like that.Labels: Andrew Wakefield, autism, fraud, GMC, MMR, patents. Posted by: Dr John Crippen    Source

---