Action For Autism

Thoughtful House after Wakefeld

There was a time when the names Wakefield and Krigsman were synonymous with Thoughtful House. Wakefield was director of research. Krigsman was director of the gastroenterology clinic.

Dr. Wakefield is one of the founders of Thoughtful House. He has been an integral part of the organization since its inception, particularly in the research program.

That is what it used to say on the Thoughtful House website. Now it says nothing at all. The press release containing that statement  has been removed, though it is still in Google’s cache. In fact all the press releases at Thoughtful House have been removed. That page is now “under construction.” So are the publications page and the page for research associates.

The links to conference presentations by Wakefield and Krigsman are broken. Krigsman you may recall left Thoughtful House around the same time as Wakefield. Krigsman’s biography and the gastroenterology FAQ at Thoughtful House are gone. If you Google them the link takes you to this one page website The announcement of Krigsman’s “new” research that is supposed to vindicate Wakefield is also gone from the website.

It is as if they are becoming non-persons, edited out of the record in a manner reminiscent of the old Soviet Union. So has there been a coup? I believe that Wakefield was forced out. After the GMC ruling his position was untenable. Krigsman’s departure was probably driven by business considerations to do with health insurance and billing procedures. But it does seem to have happened at an opportune moment for Thoughtful House

Their rising star is Bryan Jepson. His book is featured on the front page. He is the medical director at Thoughtful House. He has strong links to Defeat Autism Now. He seems to represent a return to traditional biomedical interventions for autism. These may be unproven but at least they are not disproven like the MMR hypothesis. Healing the gut and repairing the immune system via diet and supplements and normalizing behaviour via ABA may lack a sound evidence base but they are not yet discredited. Mainstream researchers continue to investigate them. Parents of autistic children who might be wary of anti-vaccine rhetoric and worried about invasive procedures and the dangers of chelation will consider other biomedical treatments.

That is not to say that Thoughtful House have rejected the anti-vaccine position completely. Laura Hewitson, their lead researcher now Wakefield has gone, is a plaintiff in the Omnibus Autism Proceedings. Her research appears tailored to prove her case before the vaccine court. But Thoughtful House is not going to be at the forefront of any anti-vaccine movement.

They will happily concede to parents beliefs in regard to vaccines while selling them diets, supplements and ABA programes. But the goalposts have been shifted away from vaccines to broader, vaguer environmental toxins within which vaccines are a special case affecting a minority of genetically susceptible children and not the driving force behind the so-called epidemic.

March 12th, 2010 Posted by Mike | Andrew Wakefield, MMR, Uncategorized, biomedical interventions | 3 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

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

NAS agrees, MMR does not cause autism

Even though the controversy about MMR and autism originated in the UK our National Autistic Society has always tried to steer clear of the controversy on the grounds that we are not a medical charity. This used to be our position. You can still find it in a forgotten corner of the NAS website.

National Autistic Society position statement
The National Autistic Society (NAS) is keenly aware of the understandable concerns of parents surrounding suggested links between autism and the MMR vaccine. The NAS urges continued efforts on the part of the Chief Medical Officer, supported by further authoritative research, to put these matters beyond doubt and allay any remaining public concern.
While there is still no conclusive evidence, it is crucial that health professionals listen to parents’ concerns and respect their views as the experts on their individual children. Some parents experience a lack of sympathy and understanding in the healthcare system on medical issues related to their child’s autism. This urgently needs to be addressed to ensure equal access to services.

But now the NAS has come off the fence. Our new statement begins:

The National Autistic Society (NAS) is keenly aware of the understandable concerns of parents surrounding suggested links between autism and the MMR vaccine. We recognise that the weight of epidemiological evidence indicates that there is no statistically significant link between the MMR vaccine and autism.

The statement could be stronger. To my knowledge there are no epidemiological studies showing a link between MMR and autism. As well as the epidemiology the clinical studies also stack up against the hypothesis. Hornig et al (2008) found

strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure.

Baird et al (2008) found

no evidence of a differential response to measles virus or the measles component of the MMR in children with ASD, with or without regression, and controls who had either one or two doses of MMR.

D’Souza et al (2006) found

no evidence of measles virus persistence in the peripheral blood mononuclear cells of children with autism spectrum disorder.

Afzal et al (2006)

failed to substantiate reports of the persistence of measles virus in autistic children with development regression.

I can understand why the NAS has taken so long to adopt its new stance. Within the NAS some of our members have been vocal in their support of Andrew Wakefeld and the MMR connection. Others have been equally vocal in opposing the idea. In the beginning I was undecided. The ham-fisted way in which the government went about reassuring us that MMR was safe was unconvincing and many of us, myself included, were inclined to give Wakefield the benefit of the doubt. See Mike Fitzpatrick’s article MMR: why government reassurances won’t work for one explanation of this widespread mistrust.

Support for Wakefield was more prevalent among parents of autistic children than it was among the general public. Our experience of government agencies in relation to diagnosis and provision for our autistic children was often fractious and confrontational. We bitterly referred to our own triad of impairments, meaning Health, Education and Social Services. The second issue of the NAS sponsored journal, Autism, in November 1997 examined the experience of 1200 families seeking diagnosis and the frustrations and dissatisfaction expressed by many parents.

Little wonder then, that if it was Wakefield versus the Government many of us were willing to give him the benefit of the doubt. The NAS was alert to our anger and was keen to bring us together to campaign for improvements in services. It had no desire to enter a divisive argument over MMR. So what has changed?

First and foremost the campaign strategy has been successful. Things are changing. We are putting autism on the statute books. The government is consulting with the NAS on a strategy for adults. The emphasis is on providing those adjustments and accommodations that will enable autistic people to lead a full and active life as contributing members of society. If some people decide to jump ship over MMR they are jumping from a successful ship.

By way of contrast, one of Wakefield’s staunchest allies is Polly Tommey. Her magazine, The Autism File promotes the MMR connection and a host of biomedical “remedies” that are supposed to reverse vaccine damage and cure autism. Yet her actions belie her words. Her latest project is to set up rural enclaves providing sheltered living and employment for autistic adults away from society.

Second, autistic adults are taking a leadership role in our campaign strategy. When it was just about the parents, as it largely was a decade ago, a diplomatic fudge made some sort of sense. But you cannot fudge the issues with an autistic person. If the science says there is no connection then why don’t we say there is no connection?

Science can cut both ways. Autistic adults insist that they are not damaged or defective. They are different. They do not want research into the causes of autism if the agenda is prevention and cure. But most research into the causes of autism is carried out in order to facilitate prevention and cure.

We managed to fudge the vaccine question for years. That era is coming to an end. Now we face important debates about the nature of autism that cannot be fudged. Autistic adults are challenging the assumptions of scientists and posing their own questions. It is not altogether clear which is the most appropriate domain for these debates: science, ethics, moral philosophy? The three most important books on my shelves at the moment are:

Representing Autism - cultural criticism
Unstrange Minds; remapping the world of autism - anthropology
The Ethics of Autism - philosophy

I am sure that there are other, equally essential works and that they will likely transgress the boundaries of traditional autism disciplines like psychology and neurology. But there again, autistic people of my acquaintance are used to transgressing boundaries (and having their own boundaries transgressed). It is we neurotypicals who become defensive when we are taken out of our comfort zone.

We may be headed for uncomfortable times but I expect them to be far more productive and ultimately satisfying than the necessary but stultifying “autism wars” we have fought around the question of vaccines which should now be over.

September 19th, 2009 Posted by Mike | Andrew Wakefield, MMR, National Autistic Society, adults, science | 6 comments

Autism Omnibus: MMR - the evidence.

Throughout the entire Autism Omnibus Proceedings (OAP) the decision about whether or not vaccine strain measles virus had caused autism depended on a simple, verifiable fact. Could the petitioners show that vaccine strain measles virus had persisted in the bodies of autistic children? Special Master Hastings who heard the initial test case of Michelle Cedillo devotes 45 pages of his Decision to reviewing the evidence for this. (pages 40 -85)

Specifically, the petitioners’ primary expert concerning the causation of autism,  Dr. Marcel Kinsbourne, made it clear that his opinion in any individual case would depend upon the existence of a reliable laboratory finding of persisting vaccine-strain measles virus in the body of the individual in question. (Tr. 1180A, 1183A, 1196A.) Similarly, the petitioners’ primary expert concerning the causation of chronic gastrointestinal dysfunction, Dr. Arthur Krigsman, also specified that his opinion in any individual case would depend upon the existence of such a reliable laboratory finding of persisting vaccine-strain measles virus in the individual. (Tr. 531-33A, 538A.)

A Reliable Test for Persistent Measles Infection?

A logical consequence of this is that petitioners would have an interest in establishing the reliability and validity of the testing carried out by Professor O’Leary’s team at the Unigenetics Laboratory in Ireland on biological samples taken from Michelle Cedillo and other autistic chidren. Equally, the respondent would wish to challenge its reliability and validity. In addition to the testing carried out for the purpose of litigation the O’Leary lab had also carried out testing for research that was peer reviewed and published in academic journals. Of particular relevance was the paper by Uhlmann et al (2002) in which O’Leary’s team utilized the same PCR techniques that were used to test Michelle Cedillo’s sample.

In order to find measles RNA in the tissue samples they had to use a technique known as polymerase chain reaction (PCR). In PCR testing you use a primer that is known to react with your target material to amplify the target material, in this case measles RNA. But you have to perform additional tests to ensure that your primer is identifying measles RNA and only measles RNA. You have to determine that your primer is specific to the task and that there are no false positives.

When D’Souza et al (2006) tested autistic children’s blood for measles RNA using the same methodology as described in the Uhlmann paper they found lots of measles. They found it in the autistic children and the non-autistic controls. So they performed additional tests which filtered out most of the false positives. Then they carried out a “gold standard” test known as sequencing which eliminated all seven of the nine remaining samples which were able to be successfully sequenced. They concluded that none of their samples contained measles virus. They also concluded that the Uhlmann study was equally unlikely to have detected measles RNA because the primer was not specific enough to distinguish measles RNA from human DNA.

There is an obvious problem with applying the D’Souza findings to the Uhlmann study and by extension, to the reliability of the O’Leary lab in relation to Michelle Cedillo. De Souza found measles in nearly all their samples. If O’Leary was similarly unreliable why didn’t they find measles in their non-autistic control group?

Three expert witnesses for the respondent: Drs. Bustin, Rima and McDonald- offered a possible explanation. All agreed that procedures at O’Leary’s lab were error prone and liable to contamination and false positives. Dr. Bustin and Dr Rima also found evidence of alterations to laboratory records which, according to the testimony of Dr Bustin, were certainly improper and perhaps fraudulent. There were other problems.

For example, sometimes the guidelines of the testing equipment manufacturers were not followed, which could erroneously make negative results appear to be positive results and disregard for accepted procedures that seemed calculated to deliberately generate false findings of measles virus in some cases.

This led Special Master Hastings to note that

Dr. Bustin’s testimony suggested the possibility that the Unigenetics personnel might have been deliberately using incorrect settings on their testing machine, in order to generate “positive” results that might support the MMR/autism causation theory. (Tr. 2009-11A.)

Dr McDonald stopped short of alleging deliberate fraud but concluded that

I have had the opportunity to examine the majority of those so-called positive in cell-PCR slides and discovered worrying discrepancies between the methodologies reported in the Uhlmann et al paper and what was actually done in the lab. The technique is completely unreliable with an unacceptably high experimental failure rate, many of the control sections were destroyed during the processing, the wrong technical controls were being used, and the claims of positivity or negativity were subjective and spurious. In cell-PCR does not detect measles virus in the lymphoid tissue of children with autism.

In the face of detailed and damning testimony like this the assertions of the petitioners’ witnesses that they were satisfied with the reliability of the testing carried out at the O’Leary lab were not persuasive.

Shooting the messenger

Although the petitioners had failed to provide any evidence for persistent measles virus they still defended the hypothesis by criticizing those studies like D’Souza that called the hypothesis into question. This has been a common feature of both the Omnibus proceedings and the wider debate about vaccines and autism. The vaccine blamers seem to operate on the totally unscientific basis that once they have presented a plausible hypothesis it is up to their critics to provide proof positive that the hypothesis is false and any perceived flaws in these critics’ arguments are assumed to strengthen the hypothesis. I am sure there is a name for this sort of logical fallacy. The only thing that can strengthen a hypothesis is data.

Nevertheless, Dr Hepner for the petitioners

stated that the failure of the Afzal and D’Souza studies to replicate the findings of the Uhlmann study was probably due to two factors. First, in those Afzal and D’Souza studies, the authors tested certain blood cells of the children, not intestinal tissue as did the authors of the Uhlmann article. Second, the Afzal and D’Souza studies tested autistic children, but not autistic children with gastrointestinal dysfunction as was the case with the Uhlmann testing. (Ex. 63, pp. 4-5; Tr. 629A-31A.)

I am not a scientist. But it seems self evident to me that if measles virus is persisting in the gut of autistic children and infecting their brains it would be remarkable if it was not also found in their blood. And D’Souza did carry out a further study on intestinal material with similar results. Furthermore the architect of the MMR/autism hypothesis, Andrew Wakefield, took part in a study that used PCR to detect measles RNA in the blood of autistic children.

Kawashima H, Mori T, Kashiwagi Y, et al. Detection and sequencing of measles virus from peripheral mononuclear cells from patients with inflammatory bowel disease and autism. Dig Dis Sci 2000;45:723–9.

The second criticism, that other researchers have not tested autistic children with GI dysfunction and this explains their failure to detect measles in the children, misses the point that D’Souza did find measles when he used the same techniques as the O’Leary team but these were false positives. Where is the data to support the petitioners’ case? It is not enough to query the studies that contradict your hypothesis. You need some positive evidence as well. The best that Dr Hepner could do, apart from defending the Uhlmann study, was to point to research of her own that has still not been published so we only have her word for it.

Finally, Dr. Hepner pointed to a study that is currently in progress, conducted by herself and several others, to which I will refer as the “Walker study.” She stated that the “preliminary data” from that study “present another step in support” of the proposition that the measles virus persists in the intestinal tissue of autistic children. (Ex. 63, p. 5; Tr. 634A-35A.)

Absence of Evidence

The petitioners not only failed to provide any reliable evidence for persistent measles infection. They also neglected to provide any evidence that the measles they thought they had detected was vaccine strain measles. This surprising omission drew this comment from Special Master Hastings.

The petitioners in this case, of course, need to demonstrate not only that Michelle Cedillo and other autistic children have persisting measles virus in their bodies, but that such persisting measles virus is vaccine-strain measles virus, i.e., derived from an MMR vaccination rather than from the natural, “wild” form of measles virus. The Uhlmann article, however, does not even purport to show that the measles virus, which was claimed to have been found in the children’s biopsies, was vaccine-strain measles virus. Similarly, the specific Unigenetics test of Michelle Cedillo’s tissue purported to identify only measles virus, not vaccine-strain measles virus.

The fact that the petitioners were unable to provide any evidence that vaccine strain measles virus had persisted in Michelle Cedillo or any other child for that matter left them trying to argue that the hypothetical possibility that MMR could cause autism was more probable than not. (The fifty percent plus a feather argument)

Hypothesis versus data

Case reports often suggest a hypothesis that has the power to explain novel situations. Autism emerged from case studies published contemporaneously but independently by Kanner in the USA and Asperger in Austria. But many hypotheses are generated in science and only those that are supported by data from systematic investigations will prosper. The MMR/autism hypothesis has been around for at least ten years since Wakefield’s paper in the Lancet. Unfortunately for the petitioners, most of the data has piled up against the hypothesis, as was evident from the proceedings in the Vaccine Court.

Vaccines have not always been with us and many parts of the world still do not have adequate supplies. So the obvious question is, “In the absence of vaccines does wild strain measles virus cause autism?” The answer is no. Measles virus can persist in the body and it has been known to infect the brain, often with fatal consequences. But there is no evidence that it has ever caused autism.

Perhaps the vaccine strain, because it is weaker than the wild strain, could cause autism instead of killing you. It could enter the brain, cause an inflammatory reaction and the resulting brain damage could cause autism. Perhaps. But the argument is very weak. Inflammation is associated with some cases of autism. Measles can cause inflammation. But it is quite a stretch to speculate on that basis that vaccine strain measles infection causes an inflammation that leads to autism. Special Master Hastings actually described the petitioners’ theory as speculative and dismissed it because of expert testimony like this on page 89 of Cedillo.

• This “is not biologically plausible.” - Dr Griffin.
• It would require a “new biology.” - Dr Ward.
• It “does not follow any [known] biologic model of a measles infection of the brain” - Dr Wiznitzer.
• “We understand especially what measles virus may or may not do within the nervous system,” and that knowledge is incompatible with the theory that the persisting measles virus would cause autism. - Dr Rust.

Rectifying an anomaly

And that is it really. A biologically implausible theory with no factual evidence to support it was allowed to drag on for seven years. The costs must run into millions of dollars. The real cost is in the damage this case has done to confidence in vaccines.  Vaccine preventable diieases are making a comeback and measles is leading the way.  There is also the cost to the families who believed this theory and, in addition to the legal expense that many will have incurred, there are the medical costs of  the remedies sold to them by the same quack doctors who promoted the theory in the first place.

I am also struck by a curious anomaly. The petitioners’ case has always stressed that it is persistent vaccine strain measles virus that is causing autism. Because they thought they were detecting measles RNA in children many years after their vaccination they argued that it was the persistence that led to autism. This suggests a chronic, debilitating effect rather than an acute episode leading to immediate regression. Yet the petitioners argued for just such an acute episode within days of the vaccination in the case of Michelle Cedillo.

If that was the case there was no need to prove the persistence of measles virus. It did not need to persist in order to have the stated effect within the time frame as described by Dr Kinsbourne. Readers may recall that for years prior to joining the Omnibus Proceedings, the Cedillo family and their principle expert witness, Dr Kinsbourne, believed that Michelle had suffered a table injury. That is, she had suffered a recognized injury as a result of MMR vaccination. It is quite feasible that such a claim would have been accepted and Michelle would have won a settlement.

I see no way to rectify this particular anomaly in Michelle’s favour. But I do hope that when they decide on costs, the special masters take into account the quality of legal work and the standard of the expert testimony offered and match the payments accordingly. My next post on the Omnibus will look at some of these so-called experts, notably Krigsman and Bradstreet, in more detail.

March 11th, 2009 Posted by Mike | MMR, autism Omnibus, science, vaccines | 7 comments

RFK, Autism and the Vaccine Court

The Kennedy name still resonates with liberals and democrats around the world. So when Robert Kennedy weighed in on the vaccine-autism controversy with his article Deadly Immunity a lot of people took notice. Unfortunately for RFK some of them actually took the trouble to read the Simpsonwood transcript on which he based his tale of conspiracies and cover-ups and discovered that he had systematically distorted it in order to make it seem that it said the exact opposite of what it really said.

On that occasion he was promoting the idea that the miniscule amounts of mercury that used to be found in early childhood vaccines could cause autism. He is back again with another article promoting the vaccine autism connection. This time he has the US Court of Federal Claims (aka the Vaccine Court) in his sights.

RFK operates from a simple set of premises.

• The Vaccine Court exists to protect the vaccine program and vaccine makers.
  
• It employs a draconian armory of weapons deployable against plaintiffs intent on proving the causal connection between vaccines and autism.
• The standard of proof in the OAP is impossibly high.
• The CDC has actively, openly and systematically suppressed and defunded epidemiological studies that might establish a causal link. So the special masters in the vaccine court have to find for the government because of insufficient evidence.
  
• It’s Tobacco all over again only now it is the government and big pharma instead of the tobacco companies who are the villains. He even calls the studies that contradict his meanderings “tobacco science.”
  

Every one of his premises is wrong.  If it was just the case that  RFK does not know what he is talking about it would be a simple matter to educate him. But, just as with Simpsonwood, he has studied the evidence and twisted it to match his agenda.

RFK on the CDC

Let us start with his most outrageous accusations against the CDC, that they are actively suppressing research and funding junk science to protect the vaccine programme. He offers no evidence at all for this claim. He does not cite a single study that has been thwarted or quote from a single disgruntled whistleblower. The CDC funding comes from the federal budget and is subject to scrutiny and oversight by the Appropriations Committee. This year they are gently chided for spending so much time on autism research and reminded that cerebral palsy is in danger of being neglected.

The Committee is pleased with CDC’s progress in autism and developmental disabilities surveillance and is encouraged to learn of the launch of the largest ever epidemiologic study of potential causes of autism spectrum disorders. The Committee encourages CDC to build upon these successes and to also focus on the development of surveillance and research activities focused on cerebral palsy, another priority public health concern. (Page 110)

This will not please RFK. He wants vaccine studies not epidemiology. But that is being taken care of. The Appropriations Committee again.

ITEM
Autism and vaccines — The Committee continues to be aware of concerns about reports of a possible association between the measles component of the measles-mumps-rubella vaccine and a subset of autism termed autistic entercolitis. There have been presentations at medical meetings by researchers presenting data showing the presence of measles RNA in inflamed intestines of children with autism. The Committee continues its interest in this issue and encourages the interagency coordinating committee to continue to give serious attention to these reports. The Committee is aware that research is underway, supported by NIH, and encourages NIH to expedite this research. (Page 168-169)

RFK objects to epidemiological studies because they are supposed to be too crude to pick up the tiny numbers of vaccine susceptible figures. What we need instead are case control studies. Never mind that we are also supposed to believe that there is a vaccine induced autism epidemic affecting tens of thouands of children. Never mind that it was epidemiological studies that nailed tobacco as a cause of cancer and later nailed passive smoking while the tobacco industry relied on case control studies and dubious lab tests. So much for “tobacco science.”

Never mind. There was a case control study done recently. Two of the researchers had been witnesses for the families in the MMR litigation in the USA UK. The lead researcher, Mady Hornig had authored a study on mercury that was used by the petitioners in the Autism Omnibus. Another member of the research team Ian Lipkin explained how “the autism/parent advocacy community” had been involved in the design of the study to “ensure that all issues were being addressed.” The study was condemned by the autism/parent advocacy community when the results turned out to be

“inconsistent with a causal role for MMR vaccine as a trigger or exacerbator of either GI difficulties or autism [...] The work reported here eliminates the remaining support for the hypothesis that autism with GI complaints is related to MMR vaccine exposure. We found no relationship between the timing of MMR vaccine and the onset of either GI complaints or autism.”

Of course the fact that some of the funding and participants came from the CDC and the NIH was enough to invalidate the study in the eyes of true believers who judge research by its results, regardless of the merits of its methodology.

Vaccine Court

The same holds true of RFK’s opinion of the Vaccine Court. When Special Master Abell finds in favour of Bailey Banks it is “a remarkably clear and eloquent decision.” When three special masters find against the  test cases in the Autism Omnibus they are guilty of a “sweeping ruling.” Later he berates the special masters for placing undue reliance on medical records which are (allegedly) “often inaccurate.” But Bailey Banks won his case because in his“remarkably clear and eloquent decision.” Special Master Abell repeatedly cited Bailey’s medical records as corroborating his claim. RFK is not above citing medical records in evidence. Here for example.

Medical records associated with these proceedings clearly tell the tale. In perhaps hundreds of these cases, the children have all the classic symptoms of regressive autism;

Medical records, like case control studies it seems, are only inaccurate when they fail to confirm your prejudices. Unlike RFK who is consistently inaccurate.

• RFK: Although the vaccine court is mandated to fairly serve the victims of vaccine injuries, their primary purpose and raison d’etre is to protect the vaccine program and vaccine makers.
• FACT: The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims decides who will be paid.
• RFK: Damages are capped; awards for pain and suffering are strictly limited and punitive damages banned altogether.
  
• FACT: Awards to the estate in a vaccine-related death are limited to $250,000 plus attorney’s fees and costs. Awards to individuals with an injury judged to be vaccine-related have averaged $1,022,699. There is no limitation on the amount of an award in a vaccine-related injury. However, the law does contain certain restrictions. Eg a $250,000 cap on pain and suffering. And how can you have punitive damages in a no fault compensation scheme?
  
• RFK Plaintiffs, in contrast, must fund the up front costs for experts on their own.
• FACT: If certain minimal requirements are met, the VICP will pay your lawyer’s fees and other legal costs related to your claim, whether or not you are paid for a vaccine injury or death. The VICP will not pay the fees of petitioners representing themselves, but will pay their legal costs, whether or not the claim is paid as long as certain minimal requirements are met. In effect, lawyers meet the up front costs of expert witnesses and bill the court at the end of the hearing.
• RFK: Worst of all — plaintiffs have no right to discovery either against the pharmaceutical industry or the government.
• FACT:
  (1) Scope in General. Unless otherwise limited by court order, the scope of discovery is as follows: Parties may obtain discovery regarding any nonprivileged matter that is relevant to any party’s claim or defense—including the existence, description, nature, custody, condition, and location of any documents or other tangible things and the identity and location of persons who know of any discoverable matter. For good cause, the court may order discovery of any matter relevant to the subject matter involved in the action. Relevant information need not be admissible at the trial if the discovery appears reasonably calculated to lead to the discovery of admissible evidence. All discovery is subject to the limitations imposed by RCFC 26(b)(2)(C).

Vaccine Safety Database

RFK complains that the government is restricting access to the Vaccine safety Database to the detriment of plaintiffs. And so it should. The VSD contains over 7 million medical records. They are held by major private care organizations who have a duty to protect patient confidentiality. The VSD is not and never should be a happy hunting ground for vaccine injury compensation lawyers. Bona fide researchers should have access to the VSD but the antics of a pair of “researchers” who make their living as expert witnesses in vaccine cases has not helped anybody in this respect. As Casewatch reports.

In summary, during the first visit the researchers conducted unapproved analysis on their datasets and on the second visit attempted to carry out unapproved analyses but did not complete this attempt. This analysis, had it been completed, could have increased the risk of a confidentiality breach. Before leaving, the researchers renamed files for removal which were not allowed to be removed. Had it gone undetected, this would have constituted a breach of the rules about confidentiality.

MMR or DTP?

RFK states that

since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many of these cases, the government paid out awards following a judicial finding that vaccine injury lead to the child’s autism spectrum disorder. In each of these cases, the plaintiffs’ attorneys made the same tactical decision made by Bailey Bank’s lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client’s autism.

The Omnibus was not established until 2002. So I doubt that many of these families opted out of its proceedings. As far as I know there are very few judicial findings that a vaccine injury led to an autism spectrum disorder. Kathleen Seidel found 9 cases which she reported on her Neurodiversity blog. If one looks at the statistics for the VICP it is apparent that there have been two spikes in petitions. The first occurred, reasonably enough in the first three years of the vaccine court and was overwhelmingly concerned with the old style DTP vaccine that was associated with encephalopathy and seizures. According to David Kirby the government sent CBS an email about these 1322 brain damaged children.

Slide 75

Email from HHS to CBS
Here are the numbers of compensable cases for encephalitis / encephalopathy and seizures in our database from October 1, 1988 to March 4, 2008.
Encephalitis/Encephalopathy    611
Seizure Disorders                     711
Total                                     1,322
There’s not much difference in the medical history and outcomes for children that were compensated for “encephalopathy” versus “seizures.”
Those compensated for encephalopathy often had seizures as part of their clinical picture, and vice versa.

How many of these were petitions for vaccine injury by the old DTP that had nothing to do with autism? It does not matter to RFK because he is trying to make the case that hundreds of autism claims have been settled that never mentioned the A word because to do so would bring down the wrath of the special masters upon you. He cites the unseen medical records as “evidence,” claiming that even though autism is not mentioned these records clearly show the pattern of regressive autism.

In fact autism has never been a barrier to claiming a vaccine injury. Bailey Banks attorney is quoted by RFK as saying that he decided not to go with the Omnibus because that would have made it harder to win. That is hardly surprising as in Bailey’s case a single incident of acute disseminated encephalomyelitis (ADEM) was alleged to have caused his problems. The omnibus was arguing for a persistent measles virus in the brain and never mentioned ADEM in any of the three test cases.

JFK’s other source is vaccine injury lawyer Robert Krakow.  But somehow, despite quoting him extensively, RFK never gets round to informing us that Krakow is himself the parent of an autistic child. He was intimately connected with the Omnibus for many years. In fact he was to be the replacement test case for Hannah Poling until he decided that the evidence for mercury causing autism was so weak that he jumped ship and is now pursuing his own claim for a vaccine induced mitochondrial disorder.

As to the alleged hostility of the special masters to autism claims, I am grateful to Anne who commented (no 5) on the Neurodiversity blog cited above as follows;

July 3, 2002 Autism General Order #1. There Chief Special Master Golkiewicz recounted how Cliff Shoemaker and other counsel for petitioners wanted to put the autism claims on hold pending scientific developments that they could use as proof of causation. Although the Special Master agreed to place the cases on hold, he forcefully reminded petitioners and their counsel that “[a]utism cases involving Table Injuries have been compensated under the Program,” and that cases like that should not be held up in the omnibus proceeding:

“One important caveat, however, is drawn to the attention of all petitioners and their counsel! There may be cases involving autistic-like disorders which manifested following an injury defined in the Vaccine Injury Table. That is, a vaccine may have suffered an episode involving a severe acute encephalopathy within 72 hours after a pertussis vaccination (DTP or DTaP), or 5 to 15 days after an MMR vaccination. If so, such an acute encephalopathy and any residual effects thereof would be presumed to be vaccine-caused pursuant to the Vaccine Injury Table. See 42 C.F.R. § 100.3(a) (10-1-97 version of CFR).5 However, this would apply only to cases falling within the current Vaccine Injury Table’s definition of “acute encephalopathy,” in which the vaccinee suffered a sudden, dramatic, and severe change in level of consciousness lasting at least 24 hours. 42 C.F.R. § 100.3(b)(2)(i)(A) and (D). The incident must have been “sufficiently severe so as to require hospitalization,” though actual hospitalization at the time need not have occurred. 42 C.F.R. § 100.3(b)(2)(i). Autism cases involving Table Injuries have been compensated under the Program. If in a particular case there exist medical records demonstrating that such a qualifying “acute encephalopathy” occurred within the appropriate time frame, petitioner or counsel should bring that to the assigned special master’s attention so that, if appropriate, the case can be processed without delay as a Table Injury.

Finally, petitioners should note that even after electing to have their case stayed pending the conclusion of the Omnibus Autism Proceeding, such election is not irrevocable. That is, if at a future time a petitioner determines that his own case should be separated from the Omnibus Autism Proceeding and processed separately, with the petitioner introducing case-specific proof of causation, such petitioner may request that a special master analyze his case. A special master will be assigned and the case will be processed as expeditiously as possible.”

(7/3/02 Autism General Order #1, pp. 6-8.)

So the special masters were inviting plaintiffs to submit claims for table injuries and bypass the Omnibus because they did not want children to suffer unnecessary delay in obtaining compensation, not because they were trying to cover up the alleged vaccine autism connection. Perhaps they remembered the previous spike in vaccine claimants when according to one attorney who spoke to Arthur Allen over a third of all claims had nothing to do with DTP. The government set the evidence barrier low and it was exploited. Predictably the government reacted and removed most of the injuries from DTP from the list that receieved automatic awards - the list of table injuries. And just to show how unworthy is RFK’s appraisal of the special masters as tools of the government here is another quote from Arthur Allen’s book. This time it is the senior special master, Gary Golkiewicz, commenting on the removal of DTP injuries from the table who told Arthur that the government had

“altered the game so that it is clearly in their favor. This group has a vested interest in vaccines being good. It does not take a mental giant to see the unfairness in this.”

So much for special masters as government stooges. I have had enough of RFK. I empathize with the commenter on his article who wrote that he never expected this to be the last piece he ever read by Robert Kennedy. I hope it is the last piece I ever have to read as well.

March 1st, 2009 Posted by Mike | MMR, autism Omnibus, journalism, vaccines | 7 comments

Autism Omnibus - Cedillo family loses

The Verdict

Ten years after first petitioning the United States Court of Federal Claims, aka the Vaccine Court, the Cedillo family have their answer.

After studying the extensive evidence in this case for many months, I am convinced that the reports and advice given to the Cedillos by Dr. Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment. Nevertheless, I can understand why the Cedillos found such reports and advice to be believable under the circumstances. I conclude that the Cedillos filed this Program claim in good faith.

Thus, I feel deep sympathy and admiration for the Cedillo family. And I have no doubt that the families of countless other autistic children, families that cope every day with the tremendous challenges of caring for autistic children, are similarly deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. Congress designed the Program to compensate only the families of those individuals whose injuries or deaths can be linked causally, either by a Table Injury presumption or by a preponderance of causation-in-­fact evidence, to a listed vaccination. In this case the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude that the petitioners in this case are not entitled to a Program award on Michelle’s behalf.

(Office of Special Masters 98-916V (henceforth Cedillo 2009) pages 173-174)

This is what I feared would happen back in June 2007 when the case finally came to court. I wrote a post entitled Autism Omnibus - a disaster for the parents which ended thus:

The family have my complete sympathy. I do not blame the parents for believing their lawyers’ arguments and accepting the claims of these so-called experts. But if those lawyers and their expert witnesses are laughed out of court what will happen to the Cedillo family and all the other families relying on their case? Do the anti vax campaigners have their own Anti-Vaccine Injury Compensation Fund to help the families left high and dry in the wake of their failed agenda?

I have just finished reading all 174 pages of the judgement by Special Master George L. Hastings Jnr. in the case of Michelle Cedillo and it is a damning judgement on the expert reports and testimony presented by the  Cedillos’ legal team. It also offers many useful insights into the background to the omnibus proceeedings and the conduct of all the parties concerned. Unless otherwise indicated all references are to Cedillo 2009.

The Cedillo family

Michelle Cedillo was born August 30th, 1994. She received her MMR vaccination on December 20th, 1995. Within a week she had a high fever that subsided and then returned, necessitating a visit to the doctors. Three months later her doctor noted that since this illness she was talking less.  In July 1997 she was diagnosed with severe autism and profound metal retardation. Michelle has also suffered from gastrointestinal symptoms including constipation, diarrhea and reflux, as well as arthritis, uveitis, pancreatitis and epilepsy.

Michelle’s family suspected vaccine damage and entered their claim in December 1998. The initial expert reports, filed in 2001, were for a table injury. Table injuries are recognized side effects of vaccines. If a parent can demonstrate that a table injury occurred within the specified timescale following vaccination they will usually be compensated. It is not necessary to prove that the vaccine actually caused the injury, only that it is plausible. In looking at the balance of probabilities this requirement has been described as 50 per cent plus a feather. The burden of proof is much less onerous than in a civil court.

Then, in January 2002 the family were persuaded to change their claim from one of table injury to one of causation-in-fact. To win a claim like this one has to demonstrate that an injury that is not included in the table of injuries was, nevertheless, vaccine induced. The burden of proof is greater than in a simple case of a table injury. But the standard of proof remains “50 per cent plus a feather.”

I do not know the basis for the Cedillos’ original table injury claim. According to the National Vaccine Injury Program Factsheet it could have been any of the following consequences of MMR:

Encephalopathy, Chronic Arthritis, Thrombocytopenic purpura,
Vaccine-strain measles viral infection in an immunodeficient receipt.

But not autism. I wonder if the Cedillo family know that the arthritis reaction to the Rubella component of the MMR was first established as a table injury by Special Master George L. Hastings, who presided over the Cedillo case, following an omnibus proceeding in 1993. The Petitioners Steering Committee certainly did because they cited it as a model for the Autism Omnibus. (Cedillo 2009, page 16)

Special Master George L. Hastings’ expresses a high opinion of the Cedillo family. It was reasonable for them to believe their daughter’s ill health was a result of vaccine damage. It was reasonable for them to seek legal advice and to be guided by the health care professionals provided to them. Unfortunately their legal/medical team seem bereft of reason. It is plausible that a table injury claim would have been successful. Instead her family were persuaded that Michelle was a poster child for the vaccines-cause-autism hypothesis and now they are left with nothing.

The Process

Michelle Cedillo’s claim was first lodged in December 1998.

During the first two years after the filing of the petition, petitioners’ counsel were primarily engaged in the tasks of (1) assembling and filing the voluminous medical records pertaining to Michelle’s illness, and (2) searching for one or more expert witnesses who could opine that Michelle’s illness was vaccine-caused. On October 31, 2000, the petitioners filed the expert report of Dr. Cindy Schneider, and on May 8, 2001, they filed the expert report of Dr. Marcel Kinsbourne, both reports contending that Michelle suffered a “Table Injury.” Respondent then filed an opposing expert report, of Dr. Max Wiznitzer, on July 11, 2001. (Cedillo 2009, page 17)

Then, in 2002 the table injury petition was altered to one of causation-in-fact and the Cedillo case joined the Omnibus Autism Proceedings (OAP). The OAP were meant to speed up the process as first hundreds and then thousands of parents lodged their petitions claiming that vaccine caused their child’s autism. Under the arrangements agreed by all parties the Petitioner Steering Committee (PSC) would gather the evidence for a general causation theory which would be presented at a hearing in 2004.

So why did it take until 2007 for the first test case to be heard and 2009 before a judgement was reached? One might be forgiven for thinking that the respondent for the government, the Dept of Health and Human Services (HHS), had been dragging its heels.

In fact it was the PSC that constantly returned to the court seeking more delays. They did not have a viable case in 2002. But they did believe that the government and the drug companies were conspiring to hide the evidence. By the end of 2006 they had requested and received 214,000 pages of documents from government files.

A lot of the science that they were to rely on in court did not exist in 2002. To take an example, the evidence for thiomersal damaging the immune system relied upon research by Goth et al (2006) and (Agrawal et al (2007). The evidence for a “mercury reflux disorder” or the theory that some children were poor excretors of mercury depended inter alia on research by Holmes et al.(2003), Bradstreet et al. (2003) and Adams and Romdalvik (2007).

Regarding their central idea, that vaccine strain measles could enter the brain and cause autism, Special Master Hastings expressed surprise that the PSC offered so little evidence. Two of their expert witnesses, Hepner and Krigsman, were involved in a study of measles virus persisting in the gut of autistic children but it has yet to be published.

So many of the delays are down to the PSC seeking to buy time while they looked for evidence that might bolster their claim. Finally they proposed a change to the OAP. Instead of a general causation hearing they wanted to present three general causation theories:  thiomersal/MMR together, thiomersal acting along, MMR acting alone and they wanted to introduce a test case - Michelle Cedillo. This is in contrast to the process Special Master Hastings describes in relation to the aforementioned Rubella/arthritis hearing over which he presided.

For example, I myself presided over an “omnibus proceeding” concerning the “general causation” issue of whether the rubella vaccine can cause chronic arthropathy. I met with counsel representing petitioners whose cases involved that “general causation” issue, and respondent’s counsel. Those counsel developed evidence concerning the general causation issue, filed expert reports and medical literature, and then presented oral testimony from the experts at an evidentiary hearing. Based upon that evidence, I filed a published opinion concluding that the rubella vaccine can cause chronic arthropathy under certain circumstances, if a case meets certain criteria. In re Ahern, No. 90- 1435V, 1993 WL 179430 (Fed. Cl. Spec. Mstr. Jan. 11, 1993). Based on that opinion, most of the pending or later-filed cases involving that general causation issue then resolved without the need for an individual, case-specific trial. For example, in 70 such cases the parties reached a settlement affording compensation to the petitioner, based upon the similarity of those petitioners’ situations to the criteria outlined in the Ahern opinion. In 52 other cases, the petitioner either voluntarily dismissed the petition or abandoned prosecution, apparently in light of the fact that the petitioner’s case did not fit within the stated criteria. In only 31 cases was I required to make a formal ruling concerning whether the petitioner was entitled to an award, and even those cases involved either no trial or a limited trial, because the “general causation” evidence from the omnibus proceeding was available for application to those individual cases. (Ten of those 31 cases were resolved in favor of a petitioner,(Cedillo 2009, page 16)

I suspect that the PSC, realizing the weakness of their position and running out of reasons to delay even further, wanted a test case around Michelle Cedillo because they hoped that her obvious physical ill health would persuade the special master that she deserved an award for her injuries and the merits of her case would ease the passage of the general causation hypothesis.

It was not to be. Special Master Hastings was quite clear that the primary purpose of the hearing was to adjudicate the evidence for general causation.  Only then would he apply the evidence to the particulars of the Cedillo case. By opting for a test case the PSC undertook first to prove that MMR could cause autism and then, and only then, could they argue that in this particular case MMR did cause autism. The office of the special masters (OSM) agreed to the test case procedure but asked for three test cases for each causation theory. You have to read the docket for the OAP to appreciate just how hard this was for the PSC. They really struggled to find enough parents who would come forward as test cases.

You would think that after five years of activity and around 5000 families signed up for the OAP they would have no problem identifying test cases. But they kept missing deadlines. As late as April 2007 they still had not found a second test case for the thiomersal/MMR theory even though the first test case was due to start in June. When they did find a family like the Polings who were willing to step up to the mark for the thiomersal causation theory, it turned out that their case was so atypical that they were able to settle with HHS without going to court. Then the family chosen to replace them dropped out as well.

In following this for so long I got an impression of the PSC as something that talked a good fight but backed down every time it was challenged. Then it finally had to take its case to court and it very soon became apparent that the PSC had no case at all.

The year long delay between the hearings and the judgement tempted some to speculate that it was a very close decision. The Poling decision was erroneously regarded as de facto recognition by HHS that vaccines cause autism.  But Special Master Hastings offers a more realistic reason.

Finally, I note that much time has passed since the conclusion of the evidentiary hearing in this case in June of 2007. However, two major factors should be recognized.

First, the completion of the three-week evidentiary hearing in this Cedillo case in June of 2007 did not mark the end of the presentations by the parties relevant to this case. Additional “general causation” expert testimony, much of it relevant to this Cedillo case, was presented during the evidentiary hearings in the Hazlehurst and Snyder cases in the fall of 2007, with the Snyder hearing not concluding until November 9, 2007. Then, the parties’ process of briefing this Cedillo case extended into May of 2008. Finally, even at that point the petitioners in this case were still keeping alive their option to submit additional “general causation” evidence that they hoped to obtain from a British litigation file. It was not until July of 2008 that the Petitioners’ Steering Committee in the OAP concluded that they would not attempt to obtain further evidence from that British litigation. (See discussion at p. 83 below.) Thus, it was only at that time that I could, as I did on July 30, 2008, file an Order declaring that the evidentiary record in this case was closed.
Second, it should be recognized that the evidentiary record, based upon which I have decided this case, is massive. This record dwarfs, by far, any evidentiary record in any prior Program case. A few statistics may give a flavor of the amount of material involved. The record contains about 7,700 pages of Michelle Cedillo’s medical records alone. The parties filed a total of 23 expert reports in this Cedillo case alone, and a total of 50 expert reports including the Hazlehurst and Snyder cases. During the evidentiary hearings, 16 expert witnesses testified in Cedillo, four in Hazlehurst, and eight in Snyder. The hearing transcripts totaled 2,917 pages in Cedillo, 1,049 pages in Snyder, and 570 pages in Hazlehurst. The parties filed six post-hearing briefs in this Cedillo case alone, totaling 462 pages.

In addition, the amount of medical literature filed into the records of the three cases was staggering. In the Cedillo case alone, the parties filed a total of 658 medical journal articles, medical textbook excerpts, or other items of medical literature. Many more such documents were filed into the Hazlehurst and Snyder cases, so that a total of 939 different items of medical literature were filed into the three case files (even after excluding from the count those documents that were filed in more than one case). Some of those items were extremely lengthy. (E.g., Ex. JJ, 163 pages; Ex. L, Att. 1, 617 pages; Ex. BB, Att. 94, 306 pages.) I have not attempted to calculate the total number of pages of those 939 documents, but clearly the total runs well into the tens of thousands of pages. And most of those documents are densely packed with difficult, technical information, so that studying even a medical journal article that is only a few pages long can require a lengthy time period.
Further, the complexity of the material involved here is daunting as well. The medical records, expert testimony, and medical literature involve many different subspecialties of biology and medicine, including neurology, gastroenterology, virology, immunology, molecular biology, toxicology, genetics, and epidemiology.

In sum, the massive nature of the evidentiary record, along with the complexity and variety of the scientific issues involved, necessitated the lengthy time period spent in preparing this Decision. (Cedillo 2009, pages 18-19)

To my mind the situation prior to the decision was this.

• A speculative claim for vaccine damage as a cause of autism was entered with the court.
• Petitioners were given lots of time in order to substantiate their claims.
• Petitioners were allowed to determine the format of the hearings.
• Petitioners were given every assistance by the court in order to assemble their evidence.
• Petitioners were given every assistance in discoverng potentially damning material held by the government.
• The initial test case was presided over by a special master who had previously ruled in favour of general causation for a vaccine injury in an omnibus hearing concerning the rubella vaccine. He subsequently decided in favour of the majority of cases in that omnibus proceeding.
• The Special Master examined every possible reason for finding in favour of the PSC.

And still they lost. The hypothesis was found wanting.

The Hypothesis

Michelle Cedillo became the first of three test cases for the hypothesis that the mercury in a vaccine preservative called thiomersal [thimerosal in the USA] weakened the immune system in susceptible children and subsequently enabled live measles virus from the MMR vaccine to persist in the body, particularly in the gut where it caused gastrointestinal dysfunction, and in the brain, where it caused autism. Although Special Master Hastings dealt at length with the argument that thiomersal weakened the immune system he was also clear that this was essentially a sideshow.

I find the first part of the petitioners’ theory of this case–i.e., their contention that thimerosal-containing vaccines damaged Michelle’s immune system, thereby making it possible for the vaccine-strain measles virus to persist within Michelle’s body–to be essentially unnecessary to the rest of their causation argument. That is, if petitioners were able to persuade me that the vaccine-strain measles virus did likely persist in Michelle’s body and cause damage to either (or both) her brain or gut, I would compensate such damage. It would not matter why the measles vaccine-strain virus was able to persist; whether that persistence was the result of thimerosal-containing vaccines or for some other reason would be irrelevant. (Cedillo 2009, page 21)

The PSC have announced that they will no longer be presenting a third set of cases to test the hypothesis that MMR alone causes autism as they feel that the evidence presented in the three test cases for the thiomersal/MMR hypothesis made the case sufficiently for MMR alone as a cause of autism. In effect they are agreeing with Special Master Hastings that the evidence on thiomersal that they presented in the Cedillo case was unnecessary and irrelevant. This did not stop Special Master Hastings from carefully considering the evidence for thiomersal harming the immune system before rejecting it in its entirety. All the arguments are set out in Cedillo 2009, pages 22 - 40.

The single biggest problem with attempting to connect thiomersal with MMR is this. If Michelle Cedillo had a compromised immune system as a result of vaccine damage in the first months of life why did it not show itself at the time? She did not have adverse reactions to her early vaccinations. In fact tests show that her immune system responded appropriately to the vaccines, creating antibodies and strengthening her immune system. Her medical records show no signs of an abnormal immune system in the first year of life. When the petitioner’s expert witness, Dr Byers, attempted to use test results that showed abnormalities the respondent’s witness, Dr McCusker pointed to a fundamental error. Dr Byers was comparing Michelle’s results to values for adults. If you compared them to age adjusted values for children the results were normal. Even using adult values Michelle only deviated slightly.

Dr. Gupta himself, after doing the 1997 testing in question, described Michelle as having “almost normal immune functions.” (Cedillo 2009 page 38)

Confusion

rather than Conclusion seems to sum up proceedings thus far. At three years old, after receiving all her vaccines and being diagnosed with autism, Michelle Cedillo had a normal immune system. She had other health problems and a year later her parents entered a petition for a table injury with the vaccine court. Three years later in 2001 an expert report was entered in support of the petition by Dr Marcel Kinsbourne.

Then, somehow by 2002, Michelle’s parents had been persuaded that she did have an abnormal immune system. Moreover she had had it for most of her life as a result of receiving thiomersal containing vaccines. Her dysfunctioning immune system had allowed the measles component of her MMR jab to persist in her body and enter her brain, causing her autism. The table injury was replaced by a causation-in-fact claim. And when it finally came to court in 2007 it seems that Dr Marcel Kinsbourne had been similarly persuaded because he was the main witness for the contention that MMR had caused Michelle’s autism.

The most bizarre revelation in the record so far (Cedillo 2009 page 42) is that the Cedillos decided to alter their claim two weeks before their doctor took a biopsy from Michelle and two months before they got the results back confirming (erroneously as it turned out) that measles virus had persisted in Michelle’s gut. Someone was very persuasive indeed.

But, in the absence of hard evidence, they could not persuade the special masters. In my next post on the Omnibus I will look more closely at the standard of evidence in support of the MMR hypothesis and  role of Dr Krigsman

February 22nd, 2009 Posted by Mike | MMR, autism Omnibus, science, vaccines | 18 comments