Action For Autism

MMR Settlement - too little, too late

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

August 30th, 2010 Posted by Mike | MMR, vaccines | 9 comments

Mitochondrial disorder and autism

When Hannah Poling won her claim for an adverse vaccine reaction that triggered a pre-existing mitochondrial disorder and caused her to develop autistic symptoms it created quite a flurry in the autism world.

The strange thing was there were at least 5000 families in the Autism Omnibus Proceedings who believed that vaccines had caused their child’s autism. Their lawyers had spent years collecting medical evidence to support their claims. But when they presented their evidence in test cases before the Office of Special Masters of the U.S. Court of Federal Claims there was no mention of mitochondrial disorder. Hannah Poling was due to be one of those test cases before she withdrew from the Omnibus Proceedings because her mitochondrial disorder set her apart from the other petitioners.

The obvious conclusion remains that hers was a special case and her settlement has no bearing on the general causation theories of the Omnibus Proceedings. However publicists for the petitioners have tried to spin her story as follows.

They say vaccines do not cause autism. Here we have a case where vaccines do cause autism. Therefore why shouldn’t it cause autism in the rest of our cases?

Except that they were arguing for a completely different mechanism that did not involve mitochondrial disorders at all. This point was not lost on some of them. Take vaccine injury lawyer Robert Krakow, himself the parent of an autistic child. He was intimately connected with the Omnibus for many years. In fact his 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.

The vaccine-autism email lists were suddenly full of enquiries into “tests for mito.” Previously ignored research that had looked at links between mitochondrial disorder and autism was taken up by anti-vaccine bloggers as proof that these susceptible children were the real driving force behind the vaccine induced autism epidemic.

To do so they had to ignore a couple of inconvenient truths, in addition to the aforementioned failure of the petitioners’ legal teams and medical experts to uncover any link between autism and mitochondrial diseases.

1. Support groups for mitochondrial disorders and experts in the field were all agreed that vaccination was the best option for these children to protect them from the devastating consequences of exposure to full blown infection with vaccine preventable diseases.
2. Prior to the Hannah Poling case extensive research into mitochondrial disorders had not identified autism as a significant consequence. That is why the case took everybody by surprise.

The research findings could contradict previous concessions by the US Department of Health and Human Services that suggested a possibility that vaccination might have aggravated a child’s underlying mitochondrial disorder and caused her autism symptoms.

“After that ruling, there was some concern that vaccination may place some children with genetic disorders at increased risk for autism or other adverse effects,” said Nicola Klein, MD, Kaiser Permanente Vaccine Study Center, Oakland, California, on October 30. “But we found no increase in emergency room visits or serious side effects” among children with inborn errors of metabolism.

“Most of us who take care of kids with inborn errors of metabolism think vaccination is one of the best interventions we can offer them,” he said. “They are at increased risk for devastating complications, even death, from the diseases that the vaccines prevent.”

November 2nd, 2009 Posted by Mike | research, vaccines | 14 comments

Congratulations to Dr Offit

Liz Ditz at I speak of Dreams has just blogged the news that Paul Offit has been recognized with an award from the American Association of Pediatrics.

Congratulations to Paul Offit, M.D.

Paul Offit was one of the co-inventors of the rotavirus vaccine, Rotateq. He has written a number of books relating to vaccine issues, most recently Autism’s False Prophets. He has recently been interviewed in Wired: An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All. Offit is the dominant voice repeating the messages that vaccines are safe and effective. For his efforts:

The American Academy of Pediatrics (AAP) will present Paul Offit, MD, FAAP, with the President’s Certificate for Outstanding Service at the National Conference and Exhibition of the AAP. The award recognizes an individual’s outstanding service and long-term, personal dedication to the mission of the AAP and to the health, safety and well-being of children. Dr. Offit is a pediatrician, chief of infectious diseases and the director of the vaccine education center at the Children’s Hospital of Philadelphia. The AAP is honoring Dr. Offit in recognition of his ongoing commitment to promote immunization.

Congratulations, sir, for a well-deserved award.

I join Liz in offering my congratulations. If you want to send him a message of congratulations his contact details at the Childrens’ Hospital of Philadelphia are available on Paul Offit’s official website.

October 24th, 2009 Posted by Mike | Paul Offit, vaccines | 5 comments

Patent Nonsense

Last month Dr Paul Offit, the chief of Infectious Diseases and the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, was invited to throw out the first ball at a major league baseball game between the Philadelphia Phillies and the Arizona Diamond Backs. Moreover, he was invited as a representative of the Immunization Coalitions of South Eastern Pennsylvania. The Philllies were honouring Dr Offit and lending themselves to the promotion of the vaccine program.

Dr Offit is with Phillie Phanatic, the team mascot. Perhaps this is what Jenny McCarthy meant with her “Green Our Vaccines” campaign. Dr Offit brought along his own mascot, Bee Diddy, from the Bucks County Immunization Coalition. Bee is no stranger to Citizens Bank Park, the home of the Phillies. Here s/he is last year promoting adult vaccination awareness at one of their games.

It is good to know that there are organizations actively promoting immunization in the US and that they have the support of mainstream society. The anti-vaccine groups that make so much noise in and around the autism community are very much in the minority. They ought to be an insignificant minority. After all there is plenty of evidence supporting the safety and efficacy of vaccines and the science points against any connection between vaccines and autism. Even the vaccine court, which is predisposed to support claims for vaccine injury, has thrown out recent test cases for an autism vaccine connection because the evidence was overwhelmingly against it. One special master even said that the parents had been seriously misled by their physicians.

However, with the help of some well placed political representatives, celebrity endorsements and cheerleaders in the media, they have been an effective lobby. They persuaded government that they had legitmate concerns and millions of research dollars where diverted into investigating the putative link between vaccines and autism. Their representatives have been invited to participate in governmernt committees and to contribute to the design of part of the research program.

This means that their pronouncements are often widely disseminated. Take a recent press release from the grandly named National Autism Alliance. It was distributed by the PRNewswire service and was taken up by Reuters.

Bizarrely entitled, Offit’s Failure To Disclose Financial Interests on Dateline Jeopardizes Swine Flu Vaccine, its thinly diguised message is that anyone with a connection to the vaccine industry has to be a pharma shill and hence cannot be trusted. These people are outraged because Dr Offit is one of their fiercest critics. The author of Autism’s False Prophets, a doctor who has devoted his life to the welfare of childen and speaking up for the safety and efficacy of vaccines committed the ultimate sin in their eyes. Not only does he defend vaccines, he invented a vaccine against the rotavirus and received a substantial financial reward when the Children’s hospital of Pennsylvania sold the patent rights for 182 million dollars.

NAA believes that Dr Offit’s share was between 29 and 50 million dollars and that this somehow compromises his independence. Seriously, if I had even one million dollars that would not compromise my independence. IT WOULD GUARANTEE MY INDEPENDENCE. And how does Dr Offit use his financial independence? He does what he always does and turns up for work at the Children’s Hospital of Philadelphia every day. He was not in it for money when he went into medicine. He was not in it for the money when he spent 20 years developing a vaccine. He is not in it for the money now. He is in it for the children and I say he deserves every penny he gets.

As it happens, Dr Offit made around 5 million dollars for his 20 years of work on the Rotateq vaccine. Not that it is anybody’s business but his own. But the ridiculous amounts cited by the anti-vaccine lobby were beginning to take on the power of an urban myth.

Meanwhile back to baseball. Even at five million dollars Dr Offit is not the most expensive pitcher to step out for the Phillies. Starting pitcher Cole Hamels started his 2009 season by signing a 3-year, $20.5 million deal with the Phillies.

Blog reactions to NAA’s press release.

Left Brain Right Brain
Autism News Beat
Confutata
Countering Age of Autism

September 15th, 2009 Posted by Mike | vaccines | 16 comments

A Broken Trust: Lessons from the Vaccine–Autism War

11 years after Andrew Wakefield launched the MMR/Autism Hoax at a press conference to publicize his paper in the Lancet vaccination rates in the UK have yet to recover and measles is once more endemic in the UK. We had 1348 cases last year compared to 56 cases in 1998. In the USA MMR coverage remains high but measles is making a comeback courtesy of anti-vaccine enclaves amongst the “worried well” who regard autism as a more serious threat than the infectious diseases that, thanks to vaccines, they have never experienced. In the USA 25 percent of adults believe there is a connection between vaccines and autism. They are more likely to blame thimerosal, a mercury based preservative that used to be widely used in childhood vaccines, (but was never in the MMR triple vaccine) and other alleged pollutants that exercise Green Our Vaccines campaigners.

This situation persists despite the fact that Wakefield’s hypothesis is thoroughly discredited. The overwhelming opinion among scientists and doctors, backed by numerous scientific studies, is that there is no evidence of a connection between MMR and autism. A similar situation pertains with regard to thimerosal containing vaccines (TCVs). Moreover it is now 7 years since all routine childhood vaccines in the USA became thimerosal free. The growth of autism has not abated. This alone suggests that vaccines are not responsible.

Liza Gross discusses the reasons for this in an article published today by PLoS Biology, an open access journal, freely available online. In the article, entitled “A Broken Trust: Lessons from the Vaccine–Autism Wars,” Gross draws on the work of medical anthropologist Sharon Kaufman in an effort to understand

how the idea of a vaccine–autism link continued to gain cultural currency even as science dismissed it.

It is interesting to note both the similarities and the differences between the British and American responses. In the USA the authorities invoked the precautionary principle to remove thimerosal from childhood vaccines. The American Association of Pediatrics (AAP) issued a statement to reassure the public that

This merely served to convince a section of the public that there must be something wrong based upon the nostrum that there is no smoke without fire. In the UK health officials took an opposite stance in relation to MMR, refusing Wakefield’s call for the MMR vaccine to be split into separate shots because there was no evidence to support his claims. Rather than reassure the public, this tough stance was presented as evidence of yet further government intransigence in the face of a potential health disaster and is best understood in the context of the contemporaneous controversy over mad cow disease and the threat posed to humans from contaminated beef.

Kaufman argues that the hold which these narratives exert on the public consciousness goes a long way to explaining why the subsequent efforts by authorities both in the UK and the USA to marshal and present a wealth of scientific evidence has failed to seriously dent public perceptions. 

Gross talked to Paul Offit, who correctly pointed out the need to bridge the gap between public and scientific perceptions of risk. But public understanding has always lagged behind science. The difference today is that public trust in science has been eroded. And the technological revolution that is the World Wide Web means that anyone can go online and find competing voices that are just as “sciency” as the experts we used to rely on. But these online health gurus make their living by being persuasive, not necessarily by being right.
What they have is a story with more narrative power than the strictly factual accounts of their scientific gainsayers. Offit understands this. It is why he has turned down requests to appear on any show with Jenny McCarthy, who uses her celebrity status to promote the anti-vaccine message.

‘‘Every story has a hero, victim, and villain,’’ he explains. ‘‘McCarthy is the hero, her child is the victim—and that leaves one role for you.’’

Gross ends with Rachel Casiday, a medical anthropologist in the UK who believes that the answer is for scientists to counter attack with narratives of their own.

Casiday suggests providing an alternative, science-based explanation or relating emotionally compelling tales about counter-risk—such as helplessly watching a young child die of a vaccine-preventable disease—in the same narrative format.

My only criticism of this article is that it can be seen as perpetuating a myth, a narrative if you like, about science being beyond most people. We rely, not upon our understanding, but upon the expert status of others in order to guide our actions. When experts are competing for our attention it is those with the most compelling narratives who prevail. Therefore the real experts need to beef up their image and their presentation skills and beat the self-styled experts and lifestyle gurus at their own game. 

There is another story that needs to be told. The anti-vaccine movement did not emerge without challenge. The real experts may have missed the signs and failed to counter the contrarians until it was almost too late. But a number of parents of autistic children together with autistic self advocates have been meeting the challenge of the anti-vaccine movement online on email lists, in newsgroups, blogs and the latest social networking sites.

We do not think of autism in terms of epidemics and public health disasters. We want help to deal with the consequences of autism rather than its alleged causes. We believe that social models of disabilty have at least as much to say about autism as medical models. We need to celebrate and encourage autistic strengths while acknowledging the very real difficulties that face autistic people and their families. 

Some of us have a professional as well as a personal involvement in autism. But most of us do not. That has not stopped us from grappling with the science in order to marry the narrative of our lives or our children’s lives to the scientific evidence in order to create new stories. If the professionals would take heed of our stories they would be better placed to challenge the pity party mentality of those who would demonize both science and autism to the detriment of both. And, who knows, perhaps together we can create positive outcomes for our narratives. 

May 26th, 2009 Posted by Mike | journalism, science, vaccines | 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

Singer resigns from Autism Speaks

Alison Tepper Singer has resigned from Autism Speaks over the question of vaccines and autism. Singer apparently accepts the scientific consensus that there is no evidence of a link between vaccines and autism, unlike her ex-employer, Bob Wright.

The Interagency Autism Coordinating Committee (IACC) was meeting this week to vote on a draft of the Strategic Plan for Autism Research. It contained two proposals for further research  into vaccines. Alone among the six public members of IACC, Singer voted with the federal members of the committee to remove these proposals from the plan so they could be examined by the National Vaccine Advisory Committee.

The decision was condemned by Autism Speaks in a press release because the proposal to refer these proposals back was not communicated to the public members prior to the meeting. According to Wright because of this “last minute deviation” the plan “is tainted and cannot be supported by the autism community.” This is curious because the press release also tells us that:

Autism Speaks Executive Vice President Alison Tepper Singer was the sole public member to cast a vote in support. The evening prior to the vote, Singer submitted her resignation to Autism Speaks – which was accepted – based on her intention to vote on certain Strategic Plan vaccine safety matters in a way that diverged from Autism Speaks’ position on this issue.

So Singer knew about the proposal the night before and presumably so did Autism Speaks when she told them why she was resigning. So what is Autism Speaks up to? I have written previously about the tension within Autism Speaks between Wright’s agenda and the way he runs Autism Speaks like a private corporation and the scientific agenda he is funding. I think that this latest posturing by Wright over the alleged “last minute deviation” is an attempt to express his support for the vaccine hypothesis. But by dressing it up in procedural rhetoric he is also attempting to keep his scientists onside.

Will any scientists follow Singer and resign from Autism Speaks? And where will she lead? Obama is planning a massive injection of funds into scientific research as part of his recovery plan. If the life sciences get their share it will be interesting to observe the changing landscape as private funding is squeezed by the recession (how many celebrity donors were burned by Madoff for example?) while Obama introduces a New Deal for publicly funded science.

Singer has shown herself to be more than capable in her role at Autism Speaks. She has made mistakes in the past, most notorious being her comments in the film Autism Everyday. But her espousal of scientific evidence may lead to advancement within the Obama administration. Such a prospect may reinforce the commitment to scientific principle among more of the staff at Autism Speaks and prompt more resignations.

Sullivan has posted the full text of Singer’s own press release and the one from Autism Speaks with a commentary on Left Brain Right Brain

January 16th, 2009 Posted by Mike | Autism Speaks, interagency autism coordinating committee, vaccines | 7 comments

Measles: a non-trivial disease.

Thanks to the Gutenberg Project I have recently discovered a very old report on measles, by W. C. Rucker, Assistant Surgeon General, United States Public Health Service, 1913. It begins starkly enough with the grim statistic that 11,000 children in the USA died of measles in 1910. For those who have no memory of measles I offer this description from Rucker.

Frequently a child will go to a party and engage in innocent games in
which children are brought in close contact with one another. Perhaps
among the guests there is one with reddened, watery, eyes, which are
sensitive to light. The eyelids are perhaps a little puffy, and the guest
has a hard, high-pitched cough. The other children pay no attention to
this, and the games go on uninterruptedly. In this way a single child in
the beginning stages of measles may easily affect 15 or 20 others. This is
frequently the case when kissing games are played.

About 10 days later the children who have exposed themselves to the
disease begin to sicken. They, too, have red, watery, sensitive eyes and
puffy eyelids. In fact, in rather severe cases the whole face has a rather
swollen, puffed appearance. The throat feels parched and a dry, irritating
cough increases the discomfort. The child is apt to come home from school
feeling drowsy and irritable, not infrequently complains of chilly
sensations, and may even have a chill. At night the irritation increases,
the child is feverish, the whites of the eyeballs show little red lines
upon them, and the little sufferer has the appearance of being just ready
to cry.

If the anxious mother takes the child to the window in the morning, raises
the curtain, and examines the little one’s throat she will see that the
hard palate and back of the throat are a dull, angry red. Perhaps there
are a few little red spots on the hard palate, and if the mother will look
closely at the lining membrane of the cheek she will see some small
white-tipped, reddish spots. These are called “Koplik’s” spots, and are
one of the signs of measles.

The child is kept from school that day, and that night his fever is higher
than it was the night before. He rolls and tosses about the bed and wakes
up his mother a good many times to ask for a drink of water. This sort of
thing continues for 3 or 4 days; then, one morning when the child is
having its bath the mother sees some little dusky red spots along the hair
line. They look a good deal like flea bites. Within 24 hours this rash is
spread over the body and the child looks very much bespeckled and swollen.
In from 5 to 7 days the rash begins to fade, and within 3 or 4 days
thereafter is entirely gone away, leaving behind a faint mottling of the
skin. This is followed by a peeling off of the outer layer of the skin in
little bran-like pieces. This process is called desquamation, and lasts
about a week or 10 days.

In the meantime the fever has gone away, and as soon as the child has
finished scaling he is permitted to go out and play with the other
children, and before long is back at school. The foregoing is a
description of a mild case.

Yes, that was a mild case. He follows with a more serious case.

If measles assume a malignant type, as it sometimes does among the
nonrobust, it may be ushered in by convulsions, very high fever, and an
excessive development of all the ordinary symptoms, or the rash when it
appears, instead of being a good healthy-looking red, may be a
bluish-black discoloration which looks like a recent bruise.
Broncho-pneumonia, the most common and the most fatal of all the
complications of measles, is very apt to occur. The cough is very painful,
and death quickly relieves the sufferer.

Broncho-pneumonia is treatable nowadays but that is no reason to wish it on a child. Yet a recent comment on an article in the Times suggests precisely that. The article was a reasonable piece on the rise in measles cases (over a thousand this year so far) in the UK because of declining vaccination rates. One commenter replied:

1,000 measles cases? Trivial ! And the disease is easily treated. Your kids are more likely to be struck by lightning than to risk dying from measles, mumps and rubella. So stuff the dependency culture. And note that GPs are seriously overpaid for giving jabs.

If more people read W. C. Rucker we would see less comments like that. Do we have to wait until more people become personally acquainted with the reality of measles before we get a change in attitudes? All those people who claim that the “immuno-compromised” and those with a “genetic predisposition” are at risk from the MMR jab should consider what a full blown measles epidemic would do. Rucker again:

Measles, then, is a serious disease, sparing practically no exposed person
who has not had it. In 1846 it attacked the Faroe Islands, and the record
of that visitation is both remarkable and instructive. The island had been
free from the disease for 65 years, when a Danish cabinetmaker returned
from Copenhagen to Thorshavn with the disease. He infected two friends,
and the epidemic increased by leaps and bounds, until within a very short
time over 6,000 persons out of a population of 7,782 were attacked. Almost
every house on the island became a hospital, and the only persons who
passed through the visitation unscathed were old inhabitants who had had
the disease as children 65 years before. Not a single old person who was
not protected by a previous attack and who was exposed to the infection
failed to contract the disease.

One good thing about the Times article was that it was following a recent trend for the media to discuss vaccines and disease without mentioning autism. The MMR-autism connection seems to be thoroughly discredited with all but a few die-hards in the media nowadays. But the damage has been done and a significant number of people are now suspicious of vaccines for no good reason. The press could make some amends for its role in bringing about this state of affairs by reprinting articles like Rucker’s and reminding people of the real damage that real diseases are capable of instead of promoting unfounded fears.

December 3rd, 2008 Posted by Mike | MMR, journalism, vaccines | 5 comments