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The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia.

24 Apr

A paper from researchers in Japan studies the questions of whether vaccines cause autism. In this study, The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia, the authors use a case-control method. The study is moderate in size, 189 autistics and 224 controls.

OBJECTIVE: The aim of this study was to investigate the relationship between autism spectrum disorder (ASD) and general vaccinations, including measles-mumps-rubella (MMR) vaccine, in Japanese subjects, a population with high genetic homogeneity.

PATIENTS AND METHODS: A case-control study was performed. Cases (n=189) were diagnosed with ASD, while controls (n=224) were volunteers from general schools, matched by sex and birth year to cases. Vaccination history and prenatal, perinatal, and neonatal factors from the Maternal and Child Health handbook, which was part of each subject’s file, were examined. To determine the relationship between potential risk factors and ASD, crude odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated, and the differences in mean values of the quantitative variables between cases and controls were analyzed using an unpaired t-test. Moreover, MMR vaccination and the effect of the number of vaccine injections were investigated using a conditional multiple regression model.

RESULTS: For MMR vaccination, the OR was 1.04 (95% CI, 0.65-1.68), and no significant differences were found for the other vaccines. For all of the prenatal, perinatal and neonatal factors, there were no significant differences between cases and controls. Furthermore, regarding the presence of ASD, MMR vaccination and the number of vaccine injections had ORs of 1.10 (95% CI, 0.64-1.90) and 1.10 (95% CI, 0.95-1.26), respectively, in the conditional multiple regression model; no significant differences were found.

CONCLUSIONS: In this study, there were not any convincing evidences that MMR vaccination and increasing the number of vaccine injections were associated with an increased risk of ASD in a genetically homogeneous population. Therefore, these findings indicate that there is no basis for avoiding vaccination out of concern for ASD.

The authors confirm multiple previous studies that the MMR vaccine does not increase the reisk of autism. They also present results that the number of vaccine injections also does not increase the risk of autism.

The authors also find that the number of injections is does not increase the risk of autism.

The MMR vaccine was used in Japan from 1984 to 1993, and the study includes children born from April 1984 to April 1992. Controls were selected according to these criteria:

One to two controls were selected for each case, matched by sex and year of birth and recruited as volunteers from general schools in the Kanto area, the same area where YPDC patients reside. Consent for participation in the present study was obtained from the parents (or legal guardians) of the students. Students who had previously been recognized as having developmental problems and were already receiving care were excluded, as were those whose records in the MCH handbook were missing or illegible and those with a history of vaccination in another country.

The team had a pool of 354 autistics to work from in this geographic region and time period. They were unable to obtain controls for all of these 354, so 189 autistics were randomly selected as cases.

Among the patients who initially consulted the clinic between April 1997 and March 2011, 1875 cases of ASD were identified. Of these, 89 cases were excluded because the MCH handbook was missing or the vaccination record in the handbook could not be read, and 3 were excluded because they had received MMR vaccination overseas. Of the remaining 1783 cases, 1429 were born before March 1984 or after May 1992, leaving 354 cases (males: n = 286, 80.8%) born between April 1984 and April 1992, the possible time period for MMR vaccination. The ASD group consisted of 280 subjects with Autistic disorder (79.1%), 27 subjects with Asperger disorder (7.6%), and 47 subjects with Pervasive developmental disorder not otherwise specified (13.3%).

MMR was not universally given in Japan during this time, and here are the vaccination rates for the cases and controls:

The vaccination rates in cases and controls were as follows: MMR, 24.9% of cases and 24.1% of controls; Measles, 66.7% and 62.9%; Mumps, 58.2% and 49.1%; Rubella, 57.1% and 53.6%; DPT, 97.9% and 97.8%; Polio, 97.4% and 98.7%; B-encephalitis, 88.4% and 92.0%, and BCG 96.3% and 97.3% (Table 1). The mean times of each vaccine injection in cases and controls were as follows: DPT, 3.8 times of cases and 3.7 times of controls; Polio, 1.9 times and 2.0 times; B-encephalitis, 1.7 times and 1.8 times (Table 2).

The authors note that this is the fourth case-control study on autism and the MMR, but that those studies relied upon more genetically heterogeneous populations:

The three previous case–control studies focused on the relationship between ASD and MMR. Specifically, the investigation of DeStefano et al. was based on the Metropolitan Atlanta Developmental Disabilities Surveillance Program [31]; Smeeth et al. used data from the UK General Practice Research Database [32]; and DeWilde et al. examined the association using the UK Doctors’ Independent Network Database [33].

As a side result, the authors tested whether maternal hypertension was associated with autism. They found an odds ratio of 2.4, but that this result was not statistically significant. This is in contrast to a recent study from the U.C. Davis MIND Institute.

Here is table 1 from the study, giving the odds ratios for MMR and other vaccines (click to enlarge):

Criticisms will include: the moderate size of the group, the selection criteria, the fact that the controls were volunteers and might therefore have some selection bias, the fact that not enough controls were recruited to include all the autistics, and the fact that most children who did not get the MMR received the measles, mumps and/or rubella vaccines as individual vaccines, the fact that vaccine uptake is high in Japan, the lack of a “vaccinated vs. unvaccinated” structure to the study and more.

Taken alone, yes, this would not be convincing evidence that the MMR vaccine doesn’t increase the risk of autism. This doesn’t mean this isn’t a good study. Further, it is well worth noting that this study does *not*stand alone. Multiple studies have shown that the MMR does not increase the risk of autism.

Also worth noting is that by looking at the total number of injections, this study in essence considers the question of whether “too many too soon” is a cause of autism. Based on these results, within the limitations of the study, the answer is no.

The Geier story on testosterone shifts again

19 Apr

When Mark and David Geier first proposed using Lupron on autistic children, it was supposedly to help remove mercury from the brain. Their theory was that mercury and testosterone bound together in the brain and that this prevented chelators from being able to remove the mercury. They first approached the Rev. Lisa Sykes, whose son was one of their patients, with the idea. You can hear her discuss that encounter here.

The blurb for that video was:

The Reverend Lisa Sykes is the mother of a recovering autistic boy (Wesley) and an ordained minister, currently serving as Pastor for the Christ United Methodist Church in Richmond, Virginia. In this interview, Rev. Sykes discusses how she came to having her son treated using the Geiers’ “lupron” protocol to more effectively remove heavy metals by first lowering Wesley’s abnormally high testosterone levels.

In the video, Rev. Sykes quotes David Geier (Mark Geier’s non-doctor son and partner in his clinic and research) in the video as saying:

“Do you know, we’ve figured something out!”

“We think we can get rid of the mercury by lowering the testosterone”

As the Geiers and the Rev. Sykes have been major proponents of the failed mercury causation idea, this is not surprising.

The science behind the idea was bad. To the point of laughable, if it weren’t for the danger posed to disabled children.

Mr. Geier has since had his license to practice medicine suspended, in large part due his “Lupron protocol” and the way he misdiagnosed children with “precocious puberty” in order to prescribe Lupron.

The Geiers and Rev. Sykes have a new paper out: “An evaluation of the role and treatment of elevated male hormones in autism spectrum disorders.”

The word “mercury” doesn’t appear in the main body of the paper at all. Just in a citation to one of the Geier team early papers. But they do conclude:

Anti-androgen therapy should be considered as an effective means to significantly help improve clinical features of patients diagnosed with an ASD.

The paper was published in Acta Neurobiol Exp, a journal by the Neuroscience Society. The journal has an editor who is a proponent of the idea that vaccines cause autism and has a history of publishing low quality papers promoting the idea.

Frankly, I see this as an attempt by the Geiers to create a defense for their previous actions, those which resulted in Mark Geier’s license suspension. By distancing themselves from both the purported chelation idea and the precocious puberty idea they can create a justification for why they treated disabled children with a drug for which there was no clinically indicated need.

Suspension of Mark Geier is upheld

19 Apr

Mark Geier is a name well known in the autism world of alternative medicine as well as a major source of papers purporting to link autism to mercury. He had a medical practice, was licensed in multple states, presented repeatedly at autism parent alt-med conventions, and served as a witness for the vaccine court.

Mr. Geier’s license to practice medicine was suspended last year. Since then he has tried a few avenues to get his ability to practice reinstated, at least while he is pursuing appeals. The Maryland State Board of Physicians has denied his request and issued a (second) cease and desist order informing him to stop practicing medicine.

Mr. Geier and his son, David Geier, took a theory from Prof. Simon Baron-Cohen: the “extreme male brain” concept of autism. Where Prof. Baron-Cohen focused on the effects of fetal testosterone levels on brain development, the Geier team somehow arrived at the idea that autistics have mercury bound in to testosterone in their brains. One can read an analysis of this theory at A Photon in the Darkness, Miscellaneous Mercury Nonsense. As you can imagine from the title of that article, the autism/mercury/testosterone idea was an obviously bad idea from the start.

Unfortunately, the Geiers took this bad idea from theory to practice. They further hypothesized that these mercury/testosterone sheets prevented chelators from removing the mercury. So, they futher hypothesied, by reducing the amount of testosterone in the body, the mercury bound in these supposed mercury/testosterone sheets would be released allowing chelators to remove the mercury. Why lower levels of testosterone would lead to these supposed mercury/testosterone complexes breaking down is not well explained. Which is another way of saying it doesn’t make sense.

It is worth noting that these sheets, or matrices as the Geiers dubbed them, of mercury and testosterone do exist. In laboratories. After boiling mercury compounds in beakers of benzene. As Prometheus wrote back in 2006:

This is not a condition even remotely similar to anything found in living tissue – of any vertebrate species. In other words, it isn’t likely to happen in autistic children unless you dissolve them in hot benzene.

Basically every link in their logic chain was bad. But this did not stop the Geiers from applying Lupron as a treatment. The drugs for reducing testosterone production (such as Lupron) are expensive. Insurance doesn’t pay for Lupron to reduce testosterone levels in disabled children so that non-existent mercury/testosterone sheets will break down by some unexplained mechanism so that chelators can remove the mercury which is not really linked to autism. Probably because of the insurance angle, the Geier’s prescribed Lupron and similar drugs not for the supposed ability to help the chelating process, but to treat precocious puberty. Early onset of puberty.

According to the Maryland Board, based on records and testimony from patient’s parents, the Geiers failed to do the basic work involved in diagnosing precocious puberty and, in some cases, diagnosed precocious puberty in children who were old enough to be going through puberty.

Sound complicated? They were diagnosing precocious puberty without the proper tests in children who didn’t have it in order to prescribe drugs to reduce testosterone levels so that mercury/testosterone sheets which don’t exist in their brains will break down and allow a chelator to remove the mercury which doesn’t cause autism.

Lupron is not a mild drug. It reduces sex hormones and delays puberty. Children are supposed to go through puberty at a given time in their lives and delaying it comes at a cost. In addition the drug itself has side effects. From the recent decision upholding the suspension of Mr. Geier’s license:

Lupron treatment carries a very high risk of skin abscesses and infections, and it is contraindicated in patients with a history of seizures. Dr. Geier nevertheless prescribed it for Patient B, who had a history or uncontrolled seizures. Nor did Dr. Geier perform all of the necessary diagnostic procedures before prescribing Lupron. Nor did Dr. Geier physically examine Patient B until almost three years after he began prescribing for him. See Proposed Decision at 33, 37-38. This is only one example of the truly risky behavior that Dr. Geier engaged in with these patients.

Mr. Geier’s license to practice medicine was suspended last year by the Maryland Board of Medical Practice. He tried to defend himself in a series of actions since, with this action being the final word.

The Board “entirely agrees” with the a previous decision that allowing Mr. Geier to continue to practice medicine while awaiting the determination of formal charges raises the likelihood of serious harm to public health and safety:

The ALJ concluded that “allowing [Dr. Geier] to continue practicing medicine while formal charges are pending raises a substantial liltelihood of risk of serious harm to the public health, safety, or welfare.” The Board entirely agrees. For Dr. Geier to practice medicine at this time would constitute a danger to the patient community.(3)

The footnote (3) in the above statement was already quoted in this artice–look above to the paragraph on “Lupron treatment carries a very high risk…”

The Board repeated this position in their conclusion:

“I conclude that for all these reasons, the Patients’ health, safety or welfare was at risk of serious harm.. Further, the existence of all these problems throughout all the Records raises a substantial likelihood that the risk of serious harm to the Patients was also posed to many other children with autism treated by the Respondent. I find that this meets the necessary standard for summary suspension of the Respondent’s license: allowing him to continue practicing medicine while formal charges are pending raises a substantial likelihood of risk of serious harm to the public health, safety, or welfare,”

One very troubling argument made by Mr. Geier was that he was not required to have an Institutional Review Board for his research. One of the charges against Mr. Geier involved an IRB he instituted–where he, his son, his wife, a patient’s mother and other interested parties were members of the IRB. The Board did not address whether such a board was required, but did dismiss the charge based on the lack of evidence put forth by the State. More discussion on the IRB can be found at Neurodiversity.com in the article An Elusive Institute.

The Respondent argued both that he was not required by federal law to have an Internal Review Board and, that even if he was bound by such a requirement, the State failed to produce any evidence that his board operated in a flawed manner. The State did not dispute this argument in its response to the Motion. I agree with the Respondent that the State failed to produce sufficient evidence to survive a motion for judgment on the allegations related to an Internal Review Board. See COMAR 28.02.01.12E. C’ Md. Rule 2-519. I will recommend that this portion of the Motion be granted and further recommend that paragraphs 157 through 162 of the Order for Summary Suspension be dismissed.

The thought that somene (Mr. Geier in this case) believes that research could be performed on anyone, not just disabled children, without the protection of an IRB is frightening.

In what is to this reader the most ironic statement by Mr. Geier in this action:

Finally, Dr. Geier accuses the ALJ of establishing a new and unwarranted standard for the medical care of children with autism. Again, Dr. Geier fails to acknowledge that the ALJ relied to some extent on the testimony of his own expert witnesses, and on his own sworn statement, to make her findings regarding the standard of care and the deficiencies in Dr. Geier’s practice.

Yes. Dr. Geier accuses the ALJ of establishing a “new and unwarranted standard for the medical care of children with autism.” Mr. Geier, who while he may not have been the first to promote chelation for autism has been one of the primary proponents, Mr. Geier is part of the team who invented the idea of Lupron as a part of a chelation protocol. A “new and unwarranted standard for medical care of children with autism”.

In addition to this decision, and the cease and desist order, Mr. Geier’s licenses to practice have been suspended in California, New Jersey, Indiana, Florida, Ohio, Washington and Virgina.

The Maryland Board accepted James Adams (a materials scientist) as an expert on chelation, at the behest of Mr. Geier. The opinions offered by Mr. Adams differ from those of medical toxicologists (a group of physicians trained and in practice to treat poisoning):

The Respondent [Geier] testified in his sworn statement that he orders chelation therapy for hispatients on “various” schedules “every other day or a few days on and a few days off for a couple of months – three months.” State’s Ex, 8 at 34. Yet, the Respondent’s expert on chelation, Dr. Adams, testified credibly that patients need an even longer break between rounds of chelation: three days of chelation followed by eleven days off. Dr. Adams also testified that chelation therapy should only be initiated after a patient is given a short “challenge” dose of chelation to ensure that the patient actually needs the therapy. If administered to a patient who does not need it, chelation poses serious risks of injury to the brain and other organs. It is imperative, therefore, that a physician only administer chelation on a limited basis to the patients who actually need it. The Respondent not only skipped the challenge step necessary to ensure chelation was even necessary, but then went full force into chelation therapy on an intensive schedule (with an experimental drug.not FDA-approved for that purpose) without appropriate rest breaks. In several cases, moreover, the Respondent failed to regularly monitor the effects of chelation, and in two cases he prescribed it for patients that he knew he could not monitor.

The concept of a “challenge test” for diagnosing mercury intoxication is covered by the American College of Medical Toxicologists in American College of Medical Toxicology Position Statement on Post-Chelator Challenge Urinary Metal Testing. Who concluded:

“It is, therefore, the position of the American College of Medical Toxicology that post-challenge urinary metal testing has not been scientifically validated, has no demonstrated benefit, and may be harmful when applied in the assessment and treatment of patients in whom there is concern for metal poisoning.

I hope that the Maryland Board looks into this issue of challenge testing before ruling again on such issues.

Mr. Geier is scheduled to give a talk at a large annual autism-parent convention. Last year, after the first action suspending his license, he was reportedly given a standing ovation at this convention. This reader is at a loss to understand why.

Seafood Consumption and Blood Mercury Concentrations in Jamaican Children With and Without Autism Spectrum Disorders.

12 Apr

In yet another study on mercury and autism, a team from the University of Texas has investigated blood mercury levels in children with autism spectrum disorders (ASDs). In Seafood Consumption and Blood Mercury Concentrations in Jamaican Children With and Without Autism Spectrum Disorders they report that “After controlling for the child’s frequency of seafood consumption, maternal age, and parental education, we did not find a significant difference (P = 0.61) between blood mercury concentrations and ASDs. ”

“we did not find a significant difference between blood mercury concentrations and ASDs”

Here is the abstract:

Mercury is a toxic metal shown to have harmful effects on human health. Several studies have reported high blood mercury concentrations as a risk factor for autism spectrum disorders (ASDs), while other studies have reported no such association. The goal of this study was to investigate the association between blood mercury concentrations in children and ASDs. Moreover, we investigated the role of seafood consumption in relation to blood mercury concentrations in Jamaican children. Based on data for 65 sex- and age-matched pairs (2-8 years), we used a General Linear Model to test whether there is an association between blood mercury concentrations and ASDs. After controlling for the child’s frequency of seafood consumption, maternal age, and parental education, we did not find a significant difference (P = 0.61) between blood mercury concentrations and ASDs. However, in both cases and control groups, children who ate certain types of seafood (i.e., salt water fish, sardine, or mackerel fish) had significantly higher (all P < 0.05) geometric means blood mercury concentration which were about 3.5 times that of children living in the US or Canada. Our findings also indicate that Jamaican children with parents who both had education up to high school are at a higher risk of exposure to mercury compared to children with at least one parent who had education beyond high school. Based on our findings, we recommend additional education to Jamaican parents regarding potential hazards of elevated blood mercury concentrations, and its association with seafood consumption and type of seafood.

Members of this team have other work on autism in Jamaica. Last year they presented Paternal and Maternal Age Are Jointly Related to Autism Spectrum Disorders In Jamaican Children at IMFAR. which had goals of:

This study’s primary objectives were to investigate whether environmental exposures to mercury, lead, arsenic and cadmium play a role in autism. Additionally, we investigated other potential risk factors for autism, including maternal and paternal age

So we see that the recently released paper is part of the conclusion of that study, which was incomplete at the time of abstract submission for IMFAR. I believe this team is reporting again at IMFAR 2012.

Why bring this up? It’s a relatively small study on a topic that has been well covered in the past: autism risk and mercury exposure. Besides, do even supporters of the autism/mercury hypothesis think that blood levels of mercury are a good indicator to track? The answer is “yes” when blood levels might implicate mercury and “no” when blood levels do not (as is this case).

The mercury/autism hypothesis has a long history, but it is worth noting that there was a great deal of excitement a few years ago when a researcher claimed that by re-analyzing an existing dataset she could show a correlation between blood mercury levels and autism. Porf. DeSoto’s 2007 paper was Blood Levels of Mercury Are Related to Diagnosis of Autism: A Reanalysis of an Important Data Set. The re-analysis was criticized (e.g. Autism Street’s A Tale Of Two Tails and A Photon in the Darkness’ Winter Potpourri). As noted, the re-analysis was also welcomed in some circles, including an article by Age of Autism’s Mark Blaxill: When Smart Scientists Make Stupid Mistakes:

This is an important and unexpected finding. It supports one of the central hypotheses at the heart of the autism-mercury controversy and suggests that the excretion deficit in autistic children might persist longer than anyone had guessed.

The idea that correlations between blood levels in autistics could be “an important…finding” was downplayed a great deal a few years later after Prof. Hertz-Picciotto’s team at the U.C. Davis MIND Institute came out with a study, Blood mercury concentrations in CHARGE Study children with and without autism. The MIND team concluded, “After accounting for dietary and other differences in Hg exposures, total Hg in blood was neither elevated nor reduced in CHARGE Study preschoolers with AU/ASD compared with unaffected controls, and resembled those of nationally representative samples”. Key in that conclusion–“after accounting for dietary and other differences in Hg exposures”. This is something that was not done in the dataset that Prof. DeSoto re-analyzed.

Which led to a press release from Mr. Blaxill’s organization, SafeMinds: New California Study on Children’s Blood Mercury Levels Leaves Unanswered Questions About Mercury’s Role in Autism which downplayed any impact of the MIND study while somewhat ironically using DeSoto’s re-analysis for support. In other words, new research on blood-levels of mercury are not so important because we have older, uncontrolled, data which does say blood-levels are important.

More telling of the shift in support for blood mercury concentrations is this 2010 comment from Katie Wright at the Age of Autism:

Measuring random blood levels is a fruitless exercise, like testing ASD kids for grass allergies in the wintertime.

Don’t assume the door was closed on blood levels of mercury. In 2011 a paper was published, Theoretical aspects of autism: Causes—A review, which stated that there was evidence for a “metal metabolism disorder” in autistics and Supporting this relationship are reports documenting that heavy metals are increased in the blood and urine of autistic subjects”. This review was not surprisingly welcomed by groups promoting the idea that vaccines and/or mercury cause autism as well as criticized by many (for example)

So while, yes, these groups do welcome research indicating that blood levels of mercury are important in discussing autism research, they are also quite prepared to downplay using on blood-levels of mercury in studies which don’t support the mercury-causation idea.

Which is why one will not be surprised that research such as this new paper from Jamaica will have little impact on the mercury-causes-autism movement. Well, that and the fact that it is evidence against causation.

For those who claim that mercury testing should be done earlier–that testing autistic children is too late (“like testing ASD kids for grass allergies in the wintertime”) there is another study in process, one that was presented at IMFAR 2011. Prenatal and Neonatal Peripheral Blood Mercury Levels and Autism Spectrum Disorders which I don’t believe has been published yet. The conclusion from that study: “Levels of total mercury in serum collected from mothers during mid-pregnancy and in blood collected from infants at birth were not associated with risk of ASD.”

Mercury levels in pregnant women aren’t correlated to whether their children have autism. Mercury levels in newborns aren’t associated with autism risk. Blood levels in autistics are not correlated with their diagnosis. Add to this the fact that autism risk is not correlated to levels of mercury exposure from vaccines or immunoglobulins (e.g. Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism). And the fact that autism does not look like mercury intoxication. And that autism prevalence estimates continue to rise even after mercury was removed from vaccines. Why is there still support for this idea?

Why the next CDC autism rates spells bad news for the mercury hypothesis

22 Mar

A recent article on Disability Scoop discussed an upcoming CDC autism report. The MMWR’s(Morbidity and Mortality Weekly Reports) from the CDC have been one of the standards for autism prevalence for years. Each CDC prevalence estimate is calculated for a group of 8 year olds born in a certain year. For example, the last estimate was “Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, United States, 2006” for children born in 1998.

Every time a new CDC autism MMWR has come out, the prevalence estimates are higher. Every timer there are groups that point to the rising number of vaccines and mercury exposure from those vaccines. People point out that there is a correlation between mercury exposure (thimerosal) and the autism rates. The MMWR’s so far have been all for children born in the 1990’s, a period when the number of vaccines and the thimerosal exposure from those vaccines was increasing.

Here are the autism prevalence estimates from recent CDC reports:

2006 (birth year 1998) 9 per 1000
2004 (birth year 1996) 8 per 1000
2002 (birth year 1994) 6.6 per 1000
2000 (birth year 1992) 6.7 per 1000

Following this trend, the next report will be for children born in 2000, age 8 in 2008. From the perspective of testing the vaccine hypothesis, in particular the mercury/thimerosal hypothesis, this is the start of a new era. In 1999 the AAP recommended that thimerosal be removed from vaccines. By 2001, all infant vaccines with the exception of influenza were produced only in thimerosal-free versions. This means that children born in 2000, the cohort the CDC will likely report upon, received, on average, a lower exposure to thimersal than the previous groups.

If the mercury hypothesis were correct (and there already a great deal of evidence to say that it is *not* correct) the autism rate should go down. At the very least, it should stay the same as the group before–about 0.9%.

Of course we will hear claims like “but not all the thimerosal containing vaccines were gone for this group” and “but what about the influenza vaccine?” and more obvious excuses in case (at it seems likely) the prevalence goes up again.

All of these avoid the fact that the average thimerosal exposure will be much lower for this group than the previous (1998 birth year) group. The excuses amount to…well…how about a visual?

With thanks to Reuters for the image I am using.

Yes, goal posts will move. Nice idea putting them on wheels. Could save a lot of effort, but those promoting the mercury idea are already used to moving goalposts.

And what if the CDC also reports on birth year 2002 (they have reported two birth cohorts at the same time in the past)? Those goalposts might to have to move quite a bit.

Now consider a different perspective. Consider that each CDC report has been an undercount. They don’t do a “whole population” survey like was done in Korea recently. They don’t test all children, they rely upon records already in existance. The last CDC report found that about 23% of the children identified as autistic in the study did not have a diagnosis before the study. Clearly the United States has not been identifying all the autistics in the population. Given this, the rising autism prevalence estimates (and, yes, they are *estimates*) could be seen as an accomplishment. This is a position put forth by Prof. Richard Grinker. The rising prevalence estimates reflect a the U.S. getting better at identifying the autistic students in our schools.

COALITION FOR MERCURY-FREE DRUGS (COMED, INC.) v. SEBELIUS

15 Mar

The Coalition for Mercury Free Drugs (CoMeD) is an organization run by Mark and David Geiers. This is the father/son team which has promoted some of the most questionable research trying to link autism (and more) to mercury, especially in vaccines. They are also notorious for their “lupron protocol”, a therapy where a strong drug is used to reduce sex hormones in a bid to remove heavy metals from the body (if this doesn’t make sense to you, don’t worry about your understanding. It doesn’t make any sense).

CoMeD petitioned the secretary of health and human services (Kathleen Sebelius) to stop all use of thimerosal containing vaccines. The original petition was denied, and, now, Their appeal was dismissed.

We recognize plaintiffs’ genuine concern about thimerosal-preserved vaccines. But plaintiffs are not required to receive thimerosal-preserved vaccines; they can readily obtain thimerosal-free vaccines. They do not have standing to challenge FDA’s decision to allow other people to receive thimerosal-preserved vaccines. Plaintiffs may, of course, advocate that the Legislative and Executive Branches ban all thimerosal-preserved vaccines. But because plaintiffs are suffering no cognizable injury as a result of FDA’s decision to allow thimerosal-preserved vaccines, their lawsuit is not a proper subject for the Judiciary. We affirm the judgment of the District Court.

The decision ended simply: “We affirm the District Court’s judgment dismissing plaintiffs’ suit for lack of standing.”

Financials for Andrew Wakefield’s Strategic Autism Initiative

15 Mar

Non profit organizations in the United States have to file tax forms and those become part of the public record. After leaving Thoughtful House, Andrew Wakefield formed a non-profit called the “Strategic Autism Initiative” (SAI). That was in 2010. The tax forms (form 990) don’t become public right away, so the form for 2010 has been only recently made available, and is available here.

Since the SAI was formed in 2010, we don’t know how much of the year they were paying salaries (for example).

They pulled in $226,000. We know $100k was from Generation Rescue from their form 990.

Wakefield was paid $16,667. But we don’t know for how many months. SAI was formed in 2010, so it is a partial salary. He claims 30 hours/week.

Assume the $16,667 is one month’s salary. That works out to $200k/year at 30 hr/week. That’s the equivalent of nearly $270k for a full-time (40 hour per week) which was his salary at TH before he was let go.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota. They spent about $30k on this project, which is supposed to include prevalence studies in Somalia.

They had three research projects listed. Two seem to be the same–the “Somali project”. They have someone in the UK and someone in Minnesota working on this. They spent about $30k in each location on this project, which is supposed to include prevalence studies in Somalia.

As to the people involved with the SAI:

Andrew Wakefield is president
James Moody is VP
Terri Arranga is secretary
Mark Blaxill is treasurer
Polly Tommy is director
Phil Rawlins is director

Only Wakefield and Arranga are paid (Arranga was paid $2,400 in 2010, listed as putting in 15 hours/week)

They spent $5K in legal fees. $25k in advertising.

It will be interesting to read the 2011 form 990 when that is available. For one thing, this will give salary information for a full year. Also to see how well they do collecting donations. $250k is impressive for a first year. As already noted, $100k is from Generation Rescue. How much of the rest is really just a transfer from other vaccines-caused-an-autism-epidemic orgs is unknown.

What letter, Mr. Olmsted? Why this one, of course.

14 Mar

When Brian Deer wrote one of his 2009 article for the Sunday Times: Focus: Hidden records show MMR truth, he introduced the article with a discussion of the father of Child 11, the only American child in the Lancet 12:

ON a Monday morning in February 1997, a taxi left the Royal Free hospital, in Hampstead , northwest London. It turned out of the car park and headed to the renowned Institute of Cancer Research, six miles southwest in Fulham.

In the back of the cab sat a California businessman, whose commercial interests lay in electroplating, but whose personal crusade was autism. On his lap was a plastic pot, in which snips of human tissue floated in protective formalin.

The snips were biopsies taken from the gut of the man’s five-year-old son, then a patient on the hospital’s Malcolm ward. The boy, Child Eleven, as he is known to protect his privacy, had been enrolled in a programme to investigate alleged risks of the three-in-one measles, mumps and rubella (MMR) vaccine.

Mr. 11, as he is known, was the one parent who chose to confirm the results he was given by Mr. Wakefield’s team at the Royal Free. In particular, he wanted to confirm whether the tissue samples taken from his son really contained measles virus, as he was told. After taking samples to people outside Mr. Wakefield’s team at the Royal Free:

“It took a big fight to get the information,” said Mr Eleven. “They told me there was no measles virus. I had the tests repeated three times at different labs in the US, and they all came back negative.”

This comes as no surprise to readers today. Mr. Wakefield’s graduate student, Nicholas Chadwick, was telling him all along that the virology results were negative.

In a later report, How the case against the MMR vaccine was fixed, Mr. Deer also introduced the article with Mr. 11. He noted that Child 11 was listed in the Lancet article as having a first behavioral symptom of “Recurrent “viral pneumonia” for 8 weeks following MMR” as occurring 1 week after the administration of the MMR vaccine, a point critical to Mr. Wakefield’s claims. However, according to documents available to Mr. Wakefield, the child showed signs before the MMR. Per Mr. Deer:

But child 11’s case must have proved a disappointment. Records show his behavioural symptoms started too soon. “His developmental milestones were normal until 13 months of age,” notes the discharge summary. “In the period 13-18 months he developed slow speech patterns and repetitive hand movements. Over this period his parents remarked on his slow gradual deterioration.”

Enter Dan Olmsted, proprietor of the Age of Autism blog. Mr. Olmsted sought out Child 11’s father to corroborate Mr. Deer’s story. Such is the importance of contradicting Mr. Deer that he was willing to contradict Mr. Wakefield’s claim in the Lancet as well. Mr. Olmsted claims that Mr. 11 wrote him that rather than 13 months, “The onset of his autistic-like behaviors began around 18 months.”

The one thing that Dan Olmsted, Brian Deer and Mr. 11 apparently agree upon: the report in The Lancet is incorrect. Somehow I expect there is some convoluted explanation Mr. Olmsted would offer to avoid this problem, but lets move on. Unfortunately to a rather odd back-and-forth where neither party (Deer and Olmsted) communicating directly. To start, Mr. Olmsted would have us believe that Mr. 11 is annoyed? angry? with Mr. Deer’s reporting and thinks they “misrepresented the facts”.

Mr. Olmsted wrote:
[edit to add: Mr. Olmsted is quoting Andrew Wakefield’s defamation complaint here. I.e. these are Andrew Wakefield’s words]

Indeed, the child’s father has since written Deer and the BMJ to explain that Deer was misrepresenting facts about child 11, yet Deer and BMJ have printed no retraction, correction, or mention of this fact.

Mr. Deer noted this claim by Mr. Olmsted in his declaration:

Neither I nor (to my knowledge) the BMJ have received any letter from this father accusing me of “misrepresenting facts.” Nor have we received any request from this father asking for any retraction, correction, or for us to take any action at all. On the contrary, the father confirms the terms of the medical record (which he gave me at a meeting in California in September 2007), but disagrees with the accuracy of that record. The matter is thus purely a (very common) situation where parental recall and medical records do not coincide, and naturally parents believe their recollection to be right.

In a recent article, Mr. Olmsted wrote:

But the father told me: “Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration,” a clear contradiction that called for a prompt correction.

See what Mr. Olmsted did there? He cut short Mr. 11’s sentence and added his own ending. Which made me wonder, what was the full sentence and what was the full context.

If you are wondering that too, here is the full sentence from that email, in context:

Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication.

Is that an accusation of “misrepresenting facts” by Mr. Deer, as Mr. Olmsted asserts? Rather than call for a retraction or correction, as Mr. Olmsted claimed, Mr. 11 noted that “The Lancet article is a clear misrepresentation of my son’s history”, and that “the Lancet article is simply an outright fabrication.”

How do I know what is in the full email? Brian Deer entered it (redacted, of course) into the public record as an exhibit to his declaration. Given the way Mr. Olmsted was clearly cherry picking the email, I wanted to obtain the source for myself.

With apologies in advance for any transcription errors. But mostly with apologies to the young man who was Child 11 and to his father:

Daniel Olmstead
Brian Deer
Dear Mr. Olrnstead & Mr. Deer:
I have spoken with both of you regarding my son who may be one of the subjects in the Royal Free Hospital’s “research study” on autism summarized in the 1998 Lancet article.

The main reason I am contacting you now is to reiterate to Mr. Olmstead that we wish for our family to stay out of the public eye, and request that in any further discussions of this matter our privacy and the confidentiality of our son’s medical history be respected. We appreciate that in published work you, Mr. Deer, did that. My son has not consented to any disclosures regarding his medical history, and I hope that whatever information you disseminate will be shared in a manner that is not personally identifiable.

My second purpose in contacting both of you is to clear up some confusion, albeit generating additional questions which, as I explain below, I do not think are worth pursuing. Mr. Olmstead informed me that he believes that my son is Patient 1 I in the Lancet article, a conclusion he seems to have reached due to a violation of doctor patient confidentiality by Dr F. Given Dr. F’s distance, so far as I know, from these events, and his current state, it is hard to know what to make of this purported information. Mr. Deer’s article appears to assume that my son is Patient 11 as well, describing conversations with a father of “Patient 11 ” that appears to be me. However, we have no confirmation that Patient 11 is my son. When we got information during the Royal Free’s investigation, we were told he was Patient 13. Only 12 patients are reported in the Lancet article. I have no way of knowing how many subjects were excluded from the final report, or whether my son was one of them.

In any event, the description of Patient 11 in the Lancet article is not accurate if, in fact, it refers to my son. The Lancet article indicates that autistic symptoms started at 15 months, a week after the MMR, which is completely inaccurate; my son’s autistic behaviors started 2-1/2 to 3 months after the MMR, which was administered to him at 15 months. The Lancet article is a clear misrepresentation of my son’s history. Moreover, the Lancet article is not consistent with the Royal Free’s discharge summary regarding my son, and both the article and the discharge summary are inaccurate. One of the incorrect statements in my son’s discharge report was that autistic symptoms were seen from 13-18 months, while the vaccination was at 15 months. This is clearly inaccurate as his symptoms began several months after the MMR, as reflected in my initial correspondence to the Royal Free requesting my son be included in the research study. Based on the incorrect discharge summary I shared with him, Mr. Deer reasonably inferred that my son’s autistic symptom, predated his receipt of the MMR vaccination, which they did not. Mr. Deer’s
article makes me appear irrational for continuing to believe that the MMR caused difficulties which predated its administration, but until the incorrect dates in the discharge summary were pointed out to me this week, I failed to realize that thee discharge summary was inaccurate. While the inaccuracies in the Royal Free discharge summary may be chalked up to sloppy record keeping, if my son really is Patient 11 , then the Lancet article is simply an outright fabrication. My son’s autistic behaviors did NOT begin a week after administration of the vaccine, in fact they began several months afterwards, with several medical complications occurring in between.

The bottom line is that, if my son is indeed Patient 11, then the Lancet article made a false assertion that his symptoms set in immediately after the MMR; in service of some attorneys’ efforts to prove “causation” that, unbeknownst to me, apparently drove this research. If the sloppy mishandling of patient information and inaccuracies in my own son’s records is any indication of how that research was done, then I am very thankful that the Lancet article has been withdrawn and the “research study” discredited. That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases. I have been involved in and have supported serious research into the causes of and effective treatments for this illness. We know now that the study reported in the Lancet article was a huge and very costly distraction. I hope that you will join me in looking, with an open mind, at real explanations of the current situation, as well as in advocating for adequate medical care and educational services for the many people affected, so that outcomes can be positive, as they are now proving for my son. While some autism may be a natural part of the human condition, what is happening now requires explanation. We will not get it if we spend time rehashing old debates.

As for the confidentiality issues, I appreciate and rely on your courtesy and discretion

Mr. 11 asked for courtesy and discretion on confidentiality issues. I would put to Mr. Olmsted that when he published the first name of Child 11, he may not have been heeding Mr. 11’s wishes.

The father has made a few more statements about these events:

First, about the Age of Autism series: “Olmsted’s logic is twisted and emotional”.

About the research at the Royal Free: “We all make daily human errors, but I guess some people ( Royal Free ) do it for a lifetime !”

and

“What a HUGE embarrassment, and scientific fiasco ! “.

Mr. 11 asked “That brings me to my third reason for contacting you, which is to express my hope that we can all move on from this debacle and search for real causes of the current explosion in autism cases”

Whether one agrees with the “epidemic” or not, the idea of moving on from the “debacle” (which I read in context to refer to the story about Mr. Wakefield and the Lancet study) and focusing on research is a very wise suggestion. As Mr. Olmsted has shown, not only has Mr. Wakefield been a huge distraction, but his supporters have been as well.

A few details from Brian Deer’s declaration

13 Mar

Brian Deer’s declaration in the anti-SLAPP motion presents an interesting narrative of the history of the investigation into Andrew Wakefield’s MMR project. Of course much of it is not new for those who have followed the story, There’s the initial investigation for the Sunday Times. There’s the interaction with Richard Horton at The Lancet. There’s the slow unveiling of the “trickle truth” from Andrew Wakefield as he is faced with fact after inconvenient fact uncovered about his actions. There is Mr. Deer stating firmly and clearly that he is not in the pay of pharma interests. But there are also some points I don’t recall being made public.

Brian Deer got pulled in to the MMR story by the attention being drawn to a 2003 TV movie in the UK: “Hear the Silence“. This was a docu-drama about Andrew Wakefield. Sort of a small point in itself, but Mr. Deer also shared this detail:

For example, I interviewed John Walker-Smith, former professor of paediatric gastroenterology at the Royal Free, and the senior clinical author of the Lancet paper. Among other things, he told me that the TV docu-drama had been paid for by an American family involved in the research.

I don’t recall ever hearing or reading that “Hear the Silence” was financially backed by a family involved in the research.

As an aside, in reading up on “hear the silence” I found this news article which included this letter from a co-author of the 1998 Lancet paper:

Wakefield was not treated as a pariah by the hospital and the medical school. Indeed, it is interesting that the research team received lots of offers from distinguished researchers, who were willing to assist in the further development of the project along solid scientific lines. Although many members of the team welcomed those approaches, Dr Wakefield did not. Indeed he became increasingly insistent on meeting only those who were clearly ‘of the faith’. By so doing he made himself a pariah, since no self-respecting scientist would want to dispense with scientific rigour and objectivity.

That was in 2003. Just as Brian Deer was starting on the MMR project.

Back to Mr. Deer’s declaration. Another point I found interesting involves Mr. Wakefield’s credentials. Inflated credentials have been found all too often amongst those who promote the idea that vaccines cause autism. Consider Mr. Wakefield, now, as an example. In the past, Andrew Wakefield used his credentials: Dr Andrew Wakefield, MB, BS, FRCS, FRCPath.

MB, BS is for his degree: Bachelor of Medicine, Bachelor of Surgery.

FCRS stands for “Fellow of the Royal College of Surgeons”

FRCPath stands for “Fellow of the Royal College of Pathologists“.

When Mr. Wakefield filed his defamation case against the BMJ, Brian Deer and Fiona Godlee, he had already dropped the FRCPath. According to Mr. Deer’s declaration, Mr. Wakefield had been “expelled from the Royal College of Pathologists” in 2010.

This begs the question why the Royal College of Surgeons did not expel Mr Wakefield. Mr. Deer clarifies that: “the college has informed me that he was not in fact affiliated with the Royal College of Surgeons at any time in the last 15 years. Therefore, he
could not be expelled.”

Yes, Mr. Wakefield has apparently been using FRCS after his name without having the right to do so for 15 years. This includes in the documents he filed in the Texas courts for the defamation case.

What can one say: the top of page one of his petition includes an affiliation Mr. Wakefield apparently has no right to use. Perhaps a small point which will come as part of the many unwelcome surprises for his attorney.

Another odd fact was that Mr. Wakefield used a publicist as far back as 2003, when Mr. Deer first approached him. By Mr. Deer’s account, Mr. Wakefield is the only doctor he’s encountered with a publicist. Mr. Deer asked numerous times for interviews, but Mr. Wakefield has always declined. In one case, Mr. Wakefield allowed the Sunday Times to interview him, but only if Mr. Deer, the man doing the story, was not present.

Perhaps Mr. Deer has stated this somewhere, but he was attending the GMC hearings as a representative of Channel 4 (where he had done a documentary on Mr. Wakefield years earlier).

It is interesting to see just how many times Andrew Wakefield has sued or threatened suit against journalists.

Here is a quote from Mr. Wakefield’s business plan. This was drafted before the Lancet article was published and only obtained via a freedom of information act request. (Note that before the FOIA was enacted in the UK Mr. Wakefield’s hospital stonewalled attempts to obtain such documents). This isn’t really new information (it came out in the GMC hearing), but does have impact on the defamation claim:

It is estimated that the initial market for the diagnostic will be litigation driven testing of patients with AE [autistic enterocolitis] from both the UK and the USA. It is estimated that by year 3, income from this testing could be about £3,300,000 rising to about £28,000,000 as diagnostic testing in support of therapeutic regimes come on stream.

It is very hard to argue that claims that Mr. Wakefield had clear financial conflicts of interest in light of such documents. Or that he had interests above and beyond his part as a paid expert in keeping the MMR litigation going. Or that these conflicts were hidden from the public, as they only came to light through FOIA long after the Lancet paper was published.

Here is an example of the defamation Mr. Wakefield alleges stems from comments by Fiona Godlee:

For example, in an additional allegation of fraud against Dr. Wakefield, Dr. Godlee referred, in her lecture, to a comparison of the interval between MMR vaccine exposure and “symptoms” in children reported by Dr. Wakefield and his colleagues in two different versions of the Lancet Article, a draft prepared in August 1997 and the final published paper, the Lancet Paper. Dr. Godlee went on to use this allegation as her basis to conclude that Dr. Wakefield fraudulently manipulated the reduction of the time interval in order to create “a legally compelling case which would be a maximum of 14 days and in this case an average of 6.3 days.” She not only falsely suggested that Dr. Wakefield fraudulently misreported this medical data, but she imputed to him a malignant intent that he knowingly altered this data in an effort to influence vaccine injury litigation. Both allegations are false and defamatory.

A key finding of the Lancet article was that 8 of 12 families blamed the MMR as the “apparent precipitating event” in causing their child’s autism. The time between MMR and onset of symptoms was 14 days. However, Mr. Deer has pointed out that more than the 8 reported families blamed the MMR. When those children were removed from the pool, the average time from MMR to onset of autism symptoms narrowed considerably (a point Mr. Deer has made repeatedly). What I hadn’t absorbed before was that Mr. Wakefield had admitted at one point that some of the parents’ recollections were omitted from his claim. From Mr. Wakefield’s press complaints commission submission:

Parents of 8 of the 12 children made the link between MMR vaccination and onset of symptoms contemporaneously. Other parents made the link retrospectively, that is, some years later. We reported on those 8 who made the link at the time of their child’s deterioration and excluded those who made the link later in order to remove any bias associated with recall that may have been prompted by, for example, media coverage.

If true, this would have been an important point to have made in the paper–or anytime in the 10 years after it’s publication. Not in a PCC complaint. That said, Mr. Deer points out where even Mr. Wakefield’s late admission is apparently false:

But this story cannot be reconciled with the children’s records as a whole. There were numerous notes of parents making the association later, whose testimonies he not only included in the paper, but adopted them as fact in his temporal calculations. For example, in the case of child 1, the GP writing to the Royal Free more than two years after the boy was vaccinated, described the parents’ association with MMR as their “most recent concern” as to the possible cause of his autism.

While on the subject of the PCC. What happened to Mr. Wakefield’s complaint? Turns out the PCC put it on hold until after the GMC hearings concluded. Mr. Wakefield never re-activated the complaint. He does refer to it (here’s an example from early 2011). Mr. Deer makes the case that the PCC complaint is an example of Mr. Wakefield using the complaints process (lawsuits, PCC, etc.) as debate tools. A point which if made would go to the argument that the defamation suit was filed frivolously.

As a related point– Mr. Wakefield *did* initiate an appeal of the GMC decision. He dropped it.

There is the (somewhat obvious, but I didn’t connect the dots as to the importance for the defamation case) fact that many of the details put forth in Mr. Wakefield’s “Secrets” series with the BMJ were first put forth in the lay press as MMR Doctor Fixed Data on Autism and Focus: Hidden records show MMR truth. Why is this important? Because Mr. Wakefield had 1 year from the data of first publication of statements to claim defamation, and these newspaper articles are from 2009, three years before the defamation claim. One wonders if this fact was made clear to Mr. Wakefield’s attorney in advance of filing the claim.

The following is more an observation of my own that something from the Brian Deer declaration. But, since Mr. Deer makes passing note of the recent “Health Freedom Expo” in Long Beach, California, I was reminded of this. Mr. Wakefield, together with a number of other members of the “vaccine epidemic” community. One thing I noticed when their talks were announced was the fact that speakers paid to give their talks. Under “register to speak” on the Health Freedom Expo website is listed “speaker fees”: $250 per 45-minute time slot. What I didn’t see before was this statement: You MUST be an Expo exhibitor to be a speaker. How much does it cost to be an exhibitor? Well, for the upcoming expo in Chicago, a standard booth costs $995. Did Mr. Wakefield (and his colleagues who spoke) pay $1245, plus travel expenses to attend? Plus the cost for a ballroom to host a fundraiser?

All these are tiny oddities in a long saga filled with much greater stories.

BMJ, Brian Deer file anti-SLAPP motion against Andrew Wakefield

11 Mar

About 2 months ago Andrew Wakefield filed a defamation lawsuit against the British Medical Journal, Brian Deer and Fiona Godlee for the series of three articles “The Secrets of the MMR Scare” and public comments made since. In particular, Mr. Wakefield took issue with statements about his research being fraudulent (and variations on that term like “fraudster”, “bullshit” etc.). Mr. Wakefield claimed that the facts presented by the BMJ articles were incorrect and based on information not available to him at the time he wrote his Lancet article.

Mr. Wakefield chose to file his defamation suit in Texas (his home state). This presented him immediately with two hurdles. First he has to show that the court has jurisdiction over primarily UK entities. Second he faced the possibility of an anti-SLAPP motion. SLAPP stands for “Strategic lawsuit against public participation“. Per Wikipedia:

A strategic lawsuit against public participation (SLAPP) is a lawsuit that is intended to censor, intimidate, and silence critics by burdening them with the cost of a legal defense until they abandon their criticism or opposition.

The typical SLAPP plaintiff does not normally expect to win the lawsuit. The plaintiff’s goals are accomplished if the defendant succumbs to fear, intimidation, mounting legal costs or simple exhaustion and abandons the criticism. A SLAPP may also intimidate others from participating in the debate. A SLAPP is often preceded by a legal threat. The difficulty, of course, is that plaintiffs do not present themselves to the Court admitting that their intent is to censor, intimidate or silence their critics. Hence, the difficulty in drafting SLAPP legislation, and in applying it, is to craft an approach which affords an early termination to invalid abusive suits, without denying a legitimate day in court to valid good faith claims.

Many states in the U.S. have enacted anti-SLAPP legislation. Texas enacted a law fairly recently and this motion could be the first major test of that law. I say “could” because of the first hurdle: jurisdiction. As Popehat has already noted, the plaintiffs in the anti-SLAPP motion “specially appear”. I.e. they keep the right to fight on jurisdictional grounds.

The motion and Mr. Deer’s supporting declaration can be found on Mr. Deer’s website. Mr. Deer’s declaration goes through the full history of his involvement with Mr. Wakefield’s research.

As Popehat notes, the motion appears quite strong. As is the case with legal motions, it covers multiple arguments. For example, they not only argue that the statements on their own are permissible speech, but they argue that the statements themselves are accurate.

Here is a section of the table-of-contents for the motion:

V. TEXAS’S NEW ANTI-SLAPP STATUTE APPLIES TO DR. WAKEFIELD’S CLAIMS.

VI. DR. WAKEFIELD’S CLAIMS FAIL BECAUSE HE CANNOT SHOW THAT THE CHALLENGED STATEMENTS ARE FALSE

A. Dr. Wakefield Must Prove that Defendants’ Statements Are Not Substantially True.
B. Dr. Wakefield Is Precluded from Re-litigating the GMC’s Findings, Which Establish the Substantial Truth of the Challenged Statements.
C. The Undisputed Evidence Also Establishes the Substantial Truth of the Challenged Statements.

1. Dr. Wakefield’s Misreporting and Falsification Permeated His Research.

2. Dr. Wakefield’s Undisclosed Conflicts of Interest.
3. Dr. Wakefield’s Review of the GP Records

VII DEFENDANTS’ STATEMENTS OF OPINION AND RHETORICAL HYPERBOLE ARE NOT ACTIONABLE.
A. Several of Defendants’ Statements, Including that Dr. Wakefield’s Research Must Have Been “Fraud,” Are Nonactionable Expressions of Opinion.
B. Defendants’ Expressions of Rhetorical Hyperbole and Colorful Language Are Not Actionable.

VIII DR. WAKEFIELD’S CLAIMS BASED ON BRIAN DEER’S WEBSITE PUBLICATIONS ARE BARRED BY THE STATUTE OF LIMITATIONS.
DR. WAKEFIELD IS A PUBLIC FIGURE, AND HE CANNOT SHOW ACTUAL MALICE.
A. Dr. Wakefield Is a Public Figure.
1. The “MMR Scare” Is a Public Controversy.
2. Dr. Wakefield Had More than a Trivial or Tangential Role in the
Scare.
3. Dr. Wakefield’s Claims Are Germane to His Participation in the
Controversy.
B. Defendants Did Not Act with Actual Malice.

1. Actual Malice Is an Exceedingly Difficult Standard to Satisfy.
2. The Evidence Here Precludes a Finding of Actual Malice.

Mr. Wakefield faces a number of burdens to overcome this motion. He must show that the statements made were more damaging that the truth. He must show that the statements are false–not just minor wording differences but that the “gist” of the truth is missing from the statements made. He must show that either he is not a public figure (very difficult for a doctor who has had a publicist for at least 10 years and has certainly put himself into the public sphere). He must show that Brian Deer, Fiona Godlee and the BMJ acted with actual malice.

He must present substantive evidence for each of these before he can go to trial. If he fails, he faces not only payment of reasonable legal fees and costs, but also the possibility of a penalty to deter future frivolous lawsuits. In that regard, the motion puts forth the history of Mr. Wakefield’s previous legal threats and lawsuits.

The most famous instance of Mr. Wakefield’s litigious history is his lawsuit against Brian Deer in 2004. Justice Eady made very clear statements on that:

[Dr. Wakefield] wished to use the existence of libel proceedings for public relations purposes, and to deter critics, while at the same time isolating himself from the ‘downside’ of such litigation, in having to answer a substantial defence of justification.

To put this in perspective–such a statement by the judge in Texas would almost certainly be followed by not only a dismissal of the case, but a financial judgement in favor of Mr. Deer, Ms. Godlee and the BMJ.

The motion makes it clear that Mr. Wakefield has faced negative commentary on his work and his character from many quarters in the past few years. From their introduction:

Two months ago, Dr. Andrew Wakefield was named by Time magazine as one of the “Great Science Frauds” of modern history. Last April, the New York Times described him as “one of the most reviled doctors of his generation.” In 2009, a Special Master presiding over vaccine litigation in the United States Court of Federal Claims recognized that Wakefield’s 1998 paper in The Lancet medical journal, which suggested a possible link between the lifesaving Measles, Mumps, and Rubella (“MMR”) vaccine and the development of autism in children, was considered a “scientific fraud.”

The Lancet has now fully retracted Wakefield’s paper, and its editor has state publicly that the paper was “utterly false” and that Wakefield “deceived the journal.” Wakefield’s home country’s medical board, the United Kingdom’s General Medical Council (“GMC”), convicted him in 2010 of multiple charges of “serious professional misconduct,” including “dishonesty” and “unethical conduct.” It further held that his misconduct had been so severe and extensive that the only punishment that would adequately protect the public from him was the permanent revocation of his medical license. As the New York Daily News put it, “Hippocrates would puke.”

As to specific instances of calling Mr. Wakefield’s work fraudulent, they quote multiple instances of the term being used. As noted above, one of the Special Masters in the Omnibus Autism Proceeding (vaccine court) called the work “scientific fraud”. Probably the most damaging instance for Mr. Wakefield are quotes from his own attorney in the General Medical Council (GMC) hearings who stated that some of the charges, if found proved, would amount to charges of fraud. Those charges were found proved.

There is definitely a movement amongst Mr. Wakefield’s supporters to recast his defamation suit as a retrial of not only his Fitness to Practice hearing before the GMC, but as a legal test of the validity of his MMR/autism hypothesis. Even just within the past couple of days Jenny McCarthy re-emerged in her role as a vocal Wakefield supporter with this (and other) erroneous arguments.

Courts are well aware of attempts for people to use defamation cases as a proxy for fighting other arguments. For example, readers might recall a recent defamation case where Barbara Loe Fisher (of the self-named National Vaccine Information Center) sued Dr. Paul Offit, writer Amy Wallace and Conde Nast publications for two words in an article: “she lies”. In the decision dismissing the defamation suit the judge noted:

Not only does Plaintiff’s claim of the statement’s falsity invite an open ended inquiry into Plaintiff’s veracity, it also threatens to ensnare the Court in the thorny and extremely contentious debate over the perceived risks of certain vaccines….and, at the bottom, which side has the truth on its side. This is hardly the sort of issue which would be subject to verification based on a core of “objective evidence”

and

Courts have a justifiable reticence about venturing into a thicket of scientific debate, especially in the defamation context

However, one must note that Mr. Wakefield’s defamation suit does *not* involve the issues of his research conclusions/findings (or non-findings as they have been retracted from the public sphere). The question put forth by Mr. Wakefield was whether statements such as “fraud”, “fraudster”, “determined cheat” are actionable defamation and whether these are based on allegedly misrepresented details from the research–such as diagnoses of the children and when symptoms appeared. Mr. Deer shows in his declaration that the facts presented in the BMJ studies are accurate.

On the “weight of evidence” front, consider this: Mr. Wakefield submitted a 17 page defamation claim. The defendants have responded with a 53 page anti-SLAPP motion and 5 declarations. The declarations include one from Mr. Deer with 101 pages and 104 exhibits. Where Mr. Wakefield is using a neighbor as his attorney, one who is not a specialist in health, media or defamation cases, the BMJ team are using a top Texas law firm and a total of seven attorneys. The lead attorney is listed as having experience with healthcare and publishers:

Tom has a wide range of experience in state and federal appeals and trials. His experience includes commercial, intellectual property, and healthcare litigation, and class actions. He has represented publishers and broadcasters in all aspects of media litigation throughout his career.

the second attorney listed has direct experience on defamation:

Marc’s practice focuses on media and privacy law, class actions, and general commercial litigation. His media law experience includes representing publishers in litigation involving claims for defamation, invasion of privacy, misappropriation, copyright, and related causes of action. In addition, he has defended companies in consumer class actions across the country relating to advertising and digital privacy. He regularly provides advice regarding website terms of service, arbitration agreements, and privacy law.

According to the BMJ’s motion, ” To avoid dismissal, the plaintiff [Mr. Wakefield] must submit “clear and specific evidence” to support each essential element of his claims.”

I suspect that Mr. Wakefield will have a meeting with his attorney very soon to discuss strategy. They are outclassed on the facts of the case, on the manpower and expertise of the attorneys and the credibility of the witnesses. They will discuss “each essential element of his claims” and how they stack up against the evidence presented. One might suspect that Mr. Wakefield’s attorney was unaware of how shaky their position was at the start, getting his facts from Mr. Wakefield. They now know, through hundreds of pages of arguments and evidence, how the defense can answer the “essential claims”.

If they can dismiss before the jurisdiction question is addressed and avoid the anti-SLAPP motion, they might be well advised to do so. The “reasonable costs” the BMJ are incurring are sure to be sizable. And the litigious history of Mr. Wakefield will surely play into a determination of whether to impose penalties on top of those.

From where I sit, Mr. Wakefield just doesn’t have the facts on his side. Nor does he have the law on his side. The jurisdiction question may be a blessing in disguise for Mr. Wakefield: giving him the opportunity to bow out before the anti-SLAPP motion goes into effect.

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