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Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

20 May

The father-son team of Mark and David Geier have been charged with violations of medical practice. Mark Geier is a physician and his son, David, holds a bachelor of arts degree. Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine is the most recent post by Kathleen Seidel of Neurodiversity.com. This follows the suspension of Dr. Mark Geier (Maryland Medical Board Suspends Dr. Mark Geier’s License).

Ms. Seidel’s post follows her practice of a very thorough, well linked discussion of the topic. Here is her first paragraph (without links):

On Monday, May 16, 2011, the Maryland Board of Physicians charged Dr. Mark Geier with numerous violations of the Maryland Medical Practice Act, and charged his son, David Geier, with practicing medicine without a license. The charges come three weeks after the Board summarily suspended Dr. Geier’s license to practice medicine, in order to prevent harm to the many autistic children entrusted to his care. The suspension was upheld by a subsequent order issued by the Board on May 12, one day after a hearing at which Dr. Geier protested the suspension and submitted affidavits of support from the parents of seven of his patients. These included a statement from James B. Adams, Ph.D., a professor of engineering at Arizona State University who, like Dr. and Mr. Geier, has frequently exceeded the bounds of his academic specialty to conduct medical research premised on the discredited hypothesis that autism is a consequence of vaccine injury.

It is well worth the time to read the entire post: Maryland Authorities Charge “Lupron Protocol” Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine

Do we have to wait for someone to be injured to call a practice unsafe?

5 May

Mark Geier has had his license to practice medicine suspended in his home state of Maryland. The Chicago Tribune (which has discussed Mark Geier and his “lupron protocol”) has a story discussing this: Trib Update: Md. suspends autism doctor’s license.

These paragraphs stood out when I read them:

In some cases, the board found that Geier diagnosed the children with precocious puberty and prescribed Lupron and other hormone-disrupting drugs without examining them or conducting proper tests. Some of these children were within the normal age range for puberty, so they couldn’t have qualified for such a diagnosis, the board found.

Geier, who is not allowed to practice in Maryland while the case is pending, declined comment, instead referring questions to an attorney. The attorney, Joseph A. Schwartz III, said that at the root of the complaint was a “bona fide dispute over therapy” rather than a case of a doctor who is an immediate threat to patients.

“If you read the (complaint), you say, ‘Holy God, this is awful.’ But if it were so awful they should have an injured child, and they don’t. I would hope that the board would step back and say, ‘Maybe there’s a lot of controversy and he’s not in the mainstream.’ But let’s test these allegations in a fair hearing. It’s just like shadow-boxing with allegations that sound awful but when you delve into the facts of them you say, ‘What’s the big deal here?’” Schwartz said.

“But if it were so awful they should have an injured child”

Do we really have to wait for someone to be injured? Clearly, the answer is no. “An immediate threat” is different from “has already caused harm”.

Let’s address this question: “What’s the big deal here?” Let’s address it in short, easily digested statements, centering around the fact that this is a breach of ethics, not a question of treatment modalities.

Here are a few “big deals” which come to mind readily:

1) diagnosing children with a condition they do not have (precocious puberty)
2) not performing the follow through to see if children have brain tumors, which would be possible if the diagnosis were real.
3) doing (1) to justify a very serious medication for the disabled children
4) allowing an untrained/unlicensed person to perform examinations

Mr. Geier is very lucky that no one was injured. His original methodology included giving

Here is the paragraph on “use” for Lupron:

LUPRON DEPOT?PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg and 15 mg are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

One issue that came up was Mr. Geier’s lack of followup testing. Having diagnosed precocious puberty, he should have ordered tests to rule out brain tumors. These were not performed. This makes one question: did he actually believe the diagnoses himself or was he just negligent in calling for the brain scans?

Something caught my eye that I hadn’t seen before. Notice the pediatric dosage: 7.5, 11.25 and 15 mg. This is the same dosage that the Geiers note in their patent application: US20070254314A1: Methods of treating autism and autism spectrum disorders.

Check the dosages given to some children:

On Nov. 24, 2004, Child X was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

On Apr. 2, 2005, Child Y was given a single shot of LUPRON DEPOT® (leuprolide acetate, Takeda Pharmaceutical Company Limited, Osaka, Japan) in the amount of 22.5 mg.

Perhaps the pediatric doses were larger back then. I’d be very interested to know, as these children were given dosages above the maximum listed values.

In an interesting side note in this story. Mark Geier’s son, David, was appointed to a position on the Maryland state’s autism commission as a “diagnostician”. Apparently his position is being reviewed and he has been asked to resign:

Gov. Martin O’Malley appointed David Geier in 2009 to the state’s Commission on Autism as a “diagnostician,” a decision state officials are now reviewing. David Paulson, a spokesman for the state health department, said David Geier declined Wednesday to resign from the position.

Maryland Board of Phyicians: Mark Geier “endangers autistic children and exploits their parents”

4 May

Dr. Mark Geier is well known in the world of alternative medicine and autism. He, together with his son David, work a medical practice and publish papers. They are long-standing proponents of the vaccine-causation hypothesis, presenting pseudo-epidemiological studies as support. Dr. Geier has worked as a witness in the vaccine court, has has a long history of criticism for his work there.

One of the stranger notions Dr. Geier has put forth involves testosterone. In their model of autism, testosterone binds with mercury in the brain and makes it difficult to remove through chelation. For many, many reasons, this was just plain wrong. Based on their mistaken hypothesis, the Geiers have promoted a treatment for autism based on reducing testosterone in autistic children. In short, they put children on an injected drug: Lupron.

This idea has met with much criticism. Probably no one has studied the Geier’s and their actions more closely than Kathleen Seidel on her blog at Neurodiversity.com. Five years ago and more she exposed the “Lupron Protocol” in a sixteen partseries called

Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol.

Well, it isn’t just one of the best bloggers saying it anymore. The Maryland Board of Physicians has investigated Dr. Geier and Dr. Geier has now had his license suspended.

Here is part of the Order for Summary Suspension:

The Respondent misdiagnosed autistic children with precocious puberty and other genetic abnormalities and treated them with potent hormonal therapy (“Lupron Therapy” or “Lupron Protocol”), and in some instances, chelation therapy, both of which have a substantial risk of both short-term and long-term adverse side effects. The Respondent’s treatment exposed the children to needless risk of harm.

The introduction goes on.

The Respondent, in addition to being a physician, is certified as a genetic counselor. His assessment and treatment of autistic children, as described herein, however, far exceeds his qualifications and expertise. The extensive and expensive batteries of laboratory studies the Respondent initially orders, many of which he orders to be repeated on a monthly basis, are outside the standard of quality care for a work-up for an autistic patient or to determine the underlying cause of autism. The Respondent failed to conduct adequate physical examinations of any of the patients and in several instances, began his Lupron Protocol based merely on a telephone consultation with the child’s parent and the results of selected laboratory tests he ordered. The Respondent’s omission of a comprehensive physical examination constitutes a danger because his treatment is based on a diagnosis that requires documentation of sexual development beyond that expected for the age of the child. Moreover, his treatment may constitute more of a risk to a child with an underlying medical condition.
The Respondent failed to provide adequate informed consent to the parents of the autistic children he treated. In one (1) instance, he misrepresented that his treatment protocol had been approved by a federally approved IRB.
There are no evidence-based studies to support either the Respondent’s Lupron Protocol or his administration of chelation therapy to autistic children; he relies in large part on his own studies which have been wholly discredited by the Institute of Medicine and denounced by the American Academy of Pediatrics. The Respondent’s treatment of autistic children with his Lupron Protocol and chelation therapy is not limited to Maryland. Indeed, in a recent article in the Chicago Tribune, the Respondent stated his intent to open clinics all over the United States, H[w]e plan to open everywhere. I am going to treat as many as I can.

The introduction ends with this paragraph:

The Respondent endangers autistic children and exploits their parents by administering to the children a treatment protocol that has a known substantial risk of serious harm and which is neither consistent with evidence-based medicine nor generally accepted in the relevant scientific community.

Pretty much sums it up. There are numerous counts and details listed in the full document. Below I’ll highlight some specific statements.

Patient A, a child whose mother stated aggression was not a problem, was reported as having aggression and self-injurious behaviors:

Notwithstanding Patient A’s mother’s report that aggression was not a problem with Patient A, the Respondent noted in the “Precious (sic) Puberty Evaluation” section of the form that Patient A, “bites and punches others; hits head with hands.”

As with many (if not all of the children) listed in the order, the diagnosis of precocious puberty was not considered valid:

45. The Respondent misdiagnosed Patient A with premature puberty. Significantly, Patient A did not meet the age criteria for premature puberty.
46. In addition, the results of Patient A’s laboratory studies do not support the Respondent’s diagnosis. The Respondent reported that Patient A’s testosterone metabolites were “significantly increased;” however, the results of Patient A’s luteinizing hormone (“LH”) were only marginally elevated, and his free testosterone and DHEA were within range for a ten (10) year old male.

One question that is often raised with alternative medical practitioners is the validity of their diagnoses. Quite often this involves diagnoses of “heavy metal toxicity” using non-standard tests. In the case of the Geier’s, there is also the validity of diagnoses of “precocious puberty”. There are standards for age, and for tests which should be performed. Reading the order, it is clear that age requirements were often ignored. Bone density tests were often not performed:

The Respondent failed to assess Patient B’s bone age, assess the child’s growth velocity or order a GnRH test to confirm the presumptive diagnosis of precocious puberty.

Also, the signs of precocious puberty could be due to a brain tumor. Yet brain scans were not performed. This from Patient E:

In addition, the Respondent failed to assess Patient E’s skeletal maturation by ordering an x-ray of her left wrist and he failed to order a scan of her brain in order to rule out a tumor.

Another question that often comes up with the Geier practice is what role David Geier plays. David Geier holds only a bachelor’s degree. He is not a physician. Patient C appears to have been examined by David Geier, with Dr. Mark Geier absent:

Patient C’s mother returned to the Respondent’s office on May 19, 2008 because of the worsening of Patient C’s aggressive behaviors. According to her complaint, the Respondent was not present during this office visit, She saw only his unlicensed son.

And, yet, the child was given “comprehensive” abdominal and thyroid ultrasounds at the visit:

The note of the visit indicates that “comprehensive” abdominal and thyroid ultrasounds were performed. Patient C’s physical appearance is described as suggesting “advancement from his chronological age” and that he appeared to be “potentially significantly physically aggressive to himself and/or others.”

and something akin to a diagnosis was rendered:

A portion of the “Psychological Examination” section of the note states, “It is apparent based upon examination of the DSM-IV criteria that [Patient Crs present symptoms are compatible with a diagnosis of pervasive developmental delay – not otherwise specific (sic).”

One problem with research performed by the Geier’s is the lack of an appropriate IRB–institutional review board. Dr. Geier placed himself, his wife and his son on the IRB. Not noted in the Order is the timing of the IRB. If memory serves correctly, there is evidence that the IRB was put into place after research began.

An IRB must consist of at least five (5) members. The ICI IRB’s members include the Respondent, his son and the Respondent’s wife. The ICI IRB is inconsistent with the requirement that a member should not have a conflict of interest in the research project.

The Order includes discussion that “The Respondent [Mark Geier] Misrepresented His Credentials”. When the investigative board interviewed him, here is how Dr. Geier described himself:

On November 6, 2007, in furtherance of the Board’s investigation, Board staff interviewed the Respondent. During the interview, the Respondent stated that he was a board-certified geneticist and a board-certified epidemiologist. The Respondent stated that he had been board-certified in epidemiology in 2007.

However, “board certified” and “geneticist” seem to be incorrect:

As to being a board-certified epidemiologist, this appears to be inaccurate:

166. By letter dated March 29, 2011, the Respondent, through counsel, submitted to the Board a “Fellowship Certificate” from the American College of Epidemiology (“ACE”). The ACE is a professional association whose policy on admission is “inclusiveness.” An ACE fellow is not required to have a degree in epidemiology, a degree in a “related field” is sufficient.
167. The Respondent knew, or reasonably should have known, that he was not board-certified in epidemiology.

As to being a “geneticist”, Dr. Geier is a “genetic counselor”, a different creature:

168. By letter dated March 29, 2011, the Respondent, through counsel, also submitted to the Board a certificate issued by the American Board of Medical Genetics on September 15, 1987 certifying the Respondent as a Genetic Counselor.
169. The term “genetic counselor” is not synonymous with “geneticist.” A geneticist, or medical geneticist, is a physician who evaluates a patient for genetic conditions, which may include performing a physical examination and ordering tests. A genetic counselor is an individual with a masters degree who helps to educate the patient and provides an assessment of the risk of the condition recur in the family.
170. The Respondent knew, or reasonably should have known, that he was not a board-certified geneticist.

Geneticist/genetic counselor and whether he is board certified in epidemiology or not are interesting but minor questions compared to the board findings of misconduct in treating disabled children. So it comes as no surprise that it is ordered:

Based on the foregoing, it is this 27th day of April , 2011, by a majority of the quorum of the Board:
ORDERED that pursuant to the authority vested by Md. State Gov’t Code Ann., § 1 0-226( c)(2), the Respondent’s license to practice medicine in the State of Maryland be and is hereby SUMMARILY SUSPENDED;

Mr. Mark Geier is at present unable to practice medicine in his home state of Maryland.

kathleen Seidel has already blogged this: Maryland Medical Board Suspends Dr. Mark Geier’s License

Lack of Correlation Between Metallic Elements Analyzed in Hair by ICP-MS and Autism

21 Apr

One of the theories behind the mecury-causes-autism hypothesis was that autistics are “poor excreters”. In other words, they can’t rid their bodies of mercury in the same way as other people. The idea has never had much scientific backing. One idea has been to measure hair for metals. I have read arguments that if there is more mercury in the hair than for an average person, that means that the individual is a poor excreter. I have also read that if their is less mercury in the hair, that means that the individual is a poor excreter. I have read that if the individual has the same amount of mercury, but that other metals meet some “counting rules” that means the individual is a poor excreter. In other words, no matter what data you get, someone will tell you that your kid has a problem excreting mercury.

The question has been studied. Hair has been analyzed. Fingernails have been analyzed. Toenails have been analyzed. In the recent study, hair has been analyzed, and the researchers did a meta-analysis of past studies. Result: there is no correlation between metal content in the hair and autism.

Lack of Correlation Between Metallic Elements Analyzed in Hair by ICP-MS and Autism.
De Palma G, Catalani S, Franco A, Brighenti M, Apostoli P.

Department of Experimental and Applied Medicine, Section of Occupational Health and Industrial Hygiene, University of Brescia, Piazzale Spedali Civili 1, 25123, Brescia, Italy, depalma@med.unibs.it.
Abstract

A cross-sectional case-control study was carried out to evaluate the concentrations of metallic elements in the hair of 44 children with diagnosis of autism and 61 age-balanced controls. Unadjusted comparisons showed higher concentrations of molybdenum, lithium and selenium in autistic children. Logistic regression analysis confirmed the role of risk factor for male gender and showed a slight association with molybdenum concentrations. Unconventional chelation and vitamin-mineral supplementation were ineffective on elemental hair concentrations. A meta-analysis including the present and previous similar studies excluded any association of autism with hair concentrations of mercury, cadmium, selenium, lithium and copper. A slight association was found for lead only, but it was very weak, as strictly dependent on the worst data from one study.

Autism is not mercury poisoning. It just isn’t. And here we have more money and more researcher time spent on a project that tells us what we already know. I’m glad to have researchers look at autism and I thank this team. But we’ve spent enough on that question, it is really time to move on.

Studies on the autism-vaccine hypothesis

15 Apr

Below is a collection of studies which the American Academy of Pediatrics put together on the autism/vaccine question. Why bring this up now? Because with the indictment of Poul Thorsen, I’ve read a number of comments where people are claiming that he worked on the study that debunked the connection. Hardly. Going through these quickly, I find 2 articles that Poul Thorsen worked on (the two Madsen studies). No one has made a credible claim that even the studies Mr. Thorsen worked on are tainted.

The comparison to Andrew Wakefield has already been made. Mr. Wakefield promoted the idea that the MMR vaccine caused autism, and was later was found guilty of a number of ethical lapses in his research efforts. The major difference between Wakefield and Thorsen is this: Wakefield was wrong. His assertion that the MMR was related to autism causation when he stated: “…but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines.” It was a statement not even supported by his own paper (even if it hadn’t been based on fraudulent research), much less has ever been supported by research by any other team. By contrast, the work that Mr. Thorsen worked on has been replicated.

Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study
Budzyn D, et al. The Pediatric Infectious Disease Journal. Vol. 29, No. 5, May 2010
Researchers in Poland compared vaccination history and autism diagnosis in 96 children with autism, ages 2 to 15, as well as 192 children in a control group. For children diagnosed before a diagnosis of autism, the autism risk was lower in children who received MMR vaccine than in nonvaccinated children. A similar result was achieved for the single-antigen measles vaccine.
AUTHOR CONCLUSION: The study provides evidence against the association of autism with either MMR or a single measles vaccine.
http://www.ncbi.nlm.nih.gov/pubmed/19952979

Lack of Association between Measles Virus Vaccine and Autism with Enteropathy: A Case-Control Study
Hornig M et al., PLoS ONE 2008, 3(9): e3140 doi:10.1371/journal.pone.0003140
Researchers looked for measles virus in the guts of 25 children with both autism and gastrointestinal disorders, and another 13 children with the same gastrointestinal disorders but no autism. The virus was detected in one child from each group.
AUTHOR CONCLUSION: This study provides strong evidence against association of autism with persistent measles virus RNA in the gastrointestinal tract or with measles, mumps and rubella (MMR) vaccine exposure.
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003140

Measles Vaccination and Antibody Response in Autism Spectrum Disorders
Baird G et al., Archives of Disease in Childhood 2008; 93(10):832-7
Case-control study of 98 vaccinated children aged 10-12 years in the UK with autism spectrum disorder (ASD) and two control groups of similar age: 52 children with special educational needs but no ASD and 90 children in the typically developing group. No difference was found between cases and controls for measles antibody response. There was no dose-response relationship between autism symptoms and antibody concentrations.
AUTHOR CONCLUSION: No association between measles vaccination and ASD was shown.
http://tinyurl.com/dn6yy8

MMR-Vaccine and Regression in Autism Spectrum Disorders: Negative Results Presented from Japan
Uchiyama T et al. Journal of Autism and Developmental Disorders, 2007; 37(2):210-7
Study of 904 patients with Autism Spectrum Disorders (ASD). During the period of measles, mumps and rubella vaccine (MMR) usage, no significant difference was found in the incidence of regression between MMR-vaccinated children and nonvaccinated children. Among the proportion and incidence of regression across the three MMR-program-related periods (before, during and after MMR usage), no significant difference was found between those who had received MMR and those who had not. Moreover, the incidence of regression did not change significantly across the three periods.
AUTHOR CONCLUSION: The data do not support an association between MMR and autism.
http://tinyurl.com/6c6o4r

No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells from Children with Autism Spectrum Disorder
D’Souza Y et al. Pediatrics 2006; 118(4):1664-75
Peripheral blood mononuclear cells were isolated from 54 children with Autism Spectrum Disorders (ASD) and 34 developmentally normal children, and up to 4 realtime polymerase chain reaction assays and 2 nested polymerase chain reaction assays were performed. No sample from either ASD or control groups was found to contain nucleic acids from any measles virus gene. In the nested polymerase chain reaction and in-house assays, none of the samples yielded positive results. Furthermore, there was no difference in anti-measles antibody titers between the autism and control groups.
AUTHOR CONCLUSION: There is no evidence of measles virus persistence in the peripheral blood mononuclear cells of children with ASD.
http://tinyurl.com/dcb79o

Immunizations and Autism: A Review of the Literature
Doja A, Roberts W. The Canadian Journal of Neurological Sciences 2006; 33(4):341-6
Literature review found very few studies supporting an association between vaccines and autism, with the overwhelming majority showing no causal association between the measles, mumps and rubella (MMR) vaccine and autism. The vaccine preservative thimerosal has alternatively been hypothesized to have a possible causal role in autism. No convincing evidence was found to support an association between the vaccine preservative thimerosal and autism, nor for the use of chelation therapy in autism.
AUTHOR CONCLUSION: With decreasing uptake of immunizations in children and the inevitable occurrence of measles outbreaks, it is important that clinicians be aware of the literature concerning vaccinations and autism so that they may have informed discussions with parents and caregivers.
http://tinyurl.com/ddnqq7

Pervasive Developmental Disorders in Montreal and Quebec, Canada: Prevalence and Links with Immunizations
Fombonne E et al. Pediatrics. 2006; 118(1):e139-50
Study of thimerosal and measles, mumps and rubella (MMR) vaccine uptake in 28,000 Canadian children born between 1987 and 1998, of whom 180 were identified with a pervasive developmental disorder.
AUTHOR CONCLUSION: The data rule out an association between pervasive developmental disorder and either high levels of ethyl mercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose MMR vaccinations.
http://tinyurl.com/5c27nu

Is there a ‘regressive phenotype’ of Autism Spectrum Disorder associated with the measles mumps-rubella vaccine? ACPEA Study
Richler et al. Journal of Autism and Developmental Disorders. 2006
A multi-site study of 351 children with Autism Spectrum Disorders (ASD) and 31 typically developing children used caregiver interviews to describe the children’s early acquisition and loss of social-communication milestones. For the majority of children with ASD who had experienced a regression, pre-loss development was clearly atypical.
AUTHOR CONCLUSION: No evidence that onset of autistic symptoms or of regression was related to measles, mumps and rubella vaccination.
http://tinyurl.com/66gtk2

Relationship between MMR Vaccine and Autism
Klein KC, Diehl EB. The Annals of Pharmacotherapy. 2004; 38(7-8):1297-300
Ten articles that specifically evaluated the possible relationship between the measles, mumps and rubella (MMR) vaccine and autism were identified. Review articles, commentaries, and evaluations of a link between gastrointestinal symptoms in autistic children and MMR immunization were excluded.
AUTHOR CONCLUSION: Based upon the current literature, it appears that there is no relationship between MMR vaccination and the development of autism.
http://tinyurl.com/chdjrk

Immunization Safety Review: Vaccines and Autism
Institute of Medicine, The National Academies Press: 2004
The IOM’s Committee on Immunization Safety Review was convened in the fall of 2000 to provide an independent review of increasingly prominent vaccine safety concerns. The 15 committee members with expertise in pediatrics, internal medicine, immunology, neurology, infectious diseases, epidemiology, biostatistics, public health, risk perception, decision analysis, nursing, genetics, ethics and health communications analyzed over 200 relevant studies.
AUTHOR CONCLUSION: The committee rejected a causal relationship between the MMR vaccine and autism as well as a causal relationship between thimerosal containing vaccines and autism.
http://books.nap.edu/catalog.php?record_id=10997#description

No effect of MMR withdrawal on the incidence of autism: a total population study
Honda H et al, Journal of Child Psychology and Psychiatry 2005 June; 46(6):572-9
Study examined incidence of Autism Spectrum Disorders (ASD) to age 7 for children born between 1988 and 1996 in Yokohama, Japan. The measles, mumps and rubella (MMR) vaccination rate in Yokohama declined significantly in the birth cohorts of years 1988-92, and no MMR vaccines were administered in 1993 or thereafter. In contrast, cumulative incidence of ASD up to age 7 increased significantly in the birth cohorts of years 1988 through 1996 and most notably rose dramatically beginning with the birth cohort of 1993.
AUTHOR CONCLUSION: MMR vaccination is not likely to be a main cause of ASD, and cannot explain the rise over time in the incidence of ASD. Withdrawal of MMR in countries where it is still being used cannot be expected to lead to a reduction in the incidence of ASD.
http://tinyurl.com/d8f3lg

No evidence for links between autism, MMR and measles virus
Chen W et al, Psychological Medicine 2004 April;34(3):543-53
Study compared 2,407 persons with autism born between 1959 and 1993; to 4,640 Down syndrome subjects born between 1966 and 1993.
AUTHOR CONCLUSION: No increased risk of autism was found following exposures to wild measles and vaccinations with monovalent measles, and Urabe or Jeryl-Lynn variants of measles, mumps and rubella (MMR) vaccine.
http://tinyurl.com/5msou2

Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-Matched Control Subjects: A Population-Based Study in Metropolitan Atlanta
DeStefano F et al. Pediatrics 2004; 113(2): 259-66
Study compared ages at first measles, mumps and rubella (MMR) vaccination between children with autism and children who did not have autism in the total population and in selected subgroups, including children with regression in development.
AUTHOR CONCLUSION: Similar proportions of case and control children were vaccinated by the recommended age or shortly after (ie, before 18 months) and before the age by which atypical development is usually recognized in children with autism (ie, 24 months).
http://pediatrics.aappublications.org/cgi/content/abstract/113/2/259

MMR Vaccination and Pervasive Developmental Disorders: A Case-Control Study
Smeeth L et al. Lancet 2004; 364(9438):963-9
Matched case-control of 1,295 people born in 1973 or later who had first recorded diagnosis of pervasive developmental disorder while registered with a contributing general practice between 1987 and 2001. Controls (4,469) were matched on age, sex and general practice. 1,010 cases (78.1%) had measles, mumps and rubella (MMR) vaccination recorded before diagnosis, compared with 3,671 controls (82.1%) before the age at which their matched case was diagnosed,
AUTHOR CONCLUSION: Data suggest that MMR vaccination is not associated with an increased risk of pervasive developmental disorders.
http://tinyurl.com/8wlhfj

Prevalence of Autism and Parentally Reported Triggers in a North East London Population
Lingam R et al. Archives of Disease in Childhood. 2003; 88(8):666-70
Study of reported age of onset of Autism Spectrum Disorder (ASD) among 567 children in northeast London born between 1979 and 1998. The age at diagnosis of ASD was estimated to have decreased per five-year period since 1983, by 8.7% for childhood autism and by 11.0% for atypical autism.
AUTHOR CONCLUSION: The data suggest that a rise in autism prevalence was likely due to factors such as increased recognition, a greater willingness on the part of educators and families to accept the diagnostic label, and better recording systems. The proportion of parents attributing their child’s autism to MMR appears to have increased since August 1997.
http://adc.bmj.com/cgi/content/abstract/88/8/666

A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism
Madsen KM et al. New England Journal of Medicine. 2002; 347(19):1477-82
Compared relative risk of Autism Spectrum Disorder (ASD) in children vaccinated with measles, mumps and rubella (MMR) vaccine and unvaccinated children born in Denmark between 1991 and 1998. Of the 537,303 children in the cohort, 82% had received the MMR vaccine. Researchers identified 316 children with a diagnosis of autism and 422 with a diagnosis of other ASDs. There was no association between the age at the time of vaccination, the time since vaccination, or the date of vaccination and the development of autism.
AUTHOR CONCLUSION: This study provides strong evidence against the hypothesis that MMR vaccination causes autism.
http://tinyurl.com/5eob5k

Neurologic Disorders after Measles-Mumps-Rubella Vaccination
Makela A et al. Pediatrics. 2002; 110:957-63
Study of 535,544 1- to 7-year-old children who were vaccinated between November 1982 and June 1986 in Finland.
AUTHOR CONCLUSION: Data do not support an association between measles, mumps and rubella (MMR) vaccination and encephalitis, aseptic meningitis or autism.
http://tinyurl.com/6ybfjr

Relation of Childhood Gastrointestinal Disorders to Autism: Nested Case Control Study Using Data from the UK General Practice Research Database
Black C et al. British Medical Journal. 2002; 325:419-21
Nested case control study of 96 children diagnosed with autism and 449 controls. The estimated odds ratio for a history of gastrointestinal disorders among children with autism compared with children without autism was 1.0 (95% confidence interval 0.5 to 2.2).
AUTHOR CONCLUSION: No evidence was found that children with autism were more likely than children without autism to have had defined gastrointestinal disorders at any time before their diagnosis of autism.
http://tinyurl.com/csudoy

Measles, Mumps, and Rubella Vaccination and Bowel Problems or Developmental Regression in Children with Autism: Population Study
Taylor B et al. British Medical Journal. 2002; 324(7334):393-6
Population study of 278 children with core autism and 195 with atypical autism, born between 1979 and 1998. The proportion of children with developmental regression (25% overall) or bowel symptoms (17%) did not change significantly during the 20 years from 1979, a period which included the introduction of measles, mumps and rubella (MMR) vaccination in October 1988.
AUTHOR CONCLUSION: Data provide no support for an MMR associated “new variant” form of autism with developmental regression and bowel problems, and further evidence against involvement of MMR vaccine in the initiation of autism.
http://tinyurl.com/6oqsfc

No Evidence for a New Variant of Measles-Mumps-Rubella-Induced Autism
Fombonne E et al. Pediatrics. 2001;108(4):E58
Study compared 96 children with a pervasive developmental disorder (PDD) born between 1992 and 1995 and who had received the measles, mumps and rubella (MMR) vaccine, to PDD patients who did not receive MMR.
AUTHOR CONCLUSION: No evidence was found to support a distinct syndrome of MMR-induced autism or of “autistic enterocolitis.” These results add to the largescale epidemiologic studies that all failed to support an association between MMR and autism at population level. These findings do not argue for changes in current immunization programs and recommendations.
http://tinyurl.com/5adckj

Measles-Mumps-Rubella and Other Measles-Containing Vaccines Do Not Increase the Risk for Inflammatory Bowel Disease: A Case-Control Study from the Vaccine Safety Datalink Project
Davis RL et al. Archives of Pediatric and Adolescent Medicine. 2001;155(3):354-9
A case control study of 155 persons with inflammatory bowel disease with up to five controls each. Neither past vaccination nor age at vaccination with other MCV was associated with increased risk for Crohn’s disease, ulcerative colitis, or IBD. Risk for Crohn’s disease, ulcerative colitis, or IBD was not elevated in the time immediately following vaccination with either vaccine.
AUTHOR CONCLUSION: Vaccination with MMR or other MCV, or the timing of vaccination early in life, did not increase the risk for IBD.
http://archpedi.ama-assn.org/cgi/content/abstract/155/3/354

Time Trends in Autism and in MMR Immunization Coverage in California
Dales L et al. Journal of the American Medical Association. 2001; 285(9):1183-5
Scientists looked for correlation between increases in the rate of autism diagnoses and increases in the rate of measles, mumps and rubella (MMR) vaccination in children born between 1980 and 1994.
AUTHOR CONCLUSION: These data do not suggest an association between MMR immunization among young children and an increase in autism occurrence.
http://jama.ama-assn.org/cgi/content/abstract/285/9/1183

MMR and autism: further evidence against a causal association
Farrington CP, et al. Vaccine. 2001; Jun 14; 19(27):3632-5
Data from an earlier measles, mumps and rubella (MMR) vaccine study (Taylor et al, 2000) were reanalyzed to test a second hypothesis.
AUTHOR CONCLUSION: Results provide further evidence against a causal association between MMR vaccination and autism.
http://tinyurl.com/5lb3w7

Mumps, Measles, and Rubella Vaccine and the Incidence of Autism Recorded by General Practitioners: A Time Trend Analysis
Kaye JA et al. British Medical Journal. 2001; 322:460-63
Study compared prevalence of measles, mumps and rubella (MMR) vaccination among children in the United Kingdom to rising prevalence of autism diagnoses for children.
AUTHOR CONCLUSION: The data provide evidence that no correlation exists between the prevalence of MMR vaccination and the rapid increase in the risk of autism over time.
http://www.bmj.com/cgi/content/full/322/7284/460

Further Evidence of the Absence of Measles Virus Genome Sequence in Full Thickness Intestinal Specimens from Patients with Crohn’s Disease
Afzal MA, et al. Journal of Medical Virology. 2000; 62(3):377-82
Study of specimens of macroscopically inflamed and normal intestine along with mesenteric lymph nodes from patients with Crohn’s disease. None of the samples examined gave any evidence of the persistence of measles virus in the intestine of Crohn’s disease patients.
AUTHOR CONCLUSION: The study supports previous findings produced by this laboratory and others using highly sensitive measles virus specific PCR diagnostic technology.
http://tinyurl.com/aoec5b

Absence of Detectable Measles Virus Genome Sequence in Inflammatory Bowel Disease Tissues and Peripheral Blood Lymphocytes
Afzal MA et al. Journal of Medical Virology. 1998; 55(3):243-9
Study looked for measles virus in 93 colonoscopic biopsies and 31 peripheral blood lymphocyte preparations, examined and obtained from patients with inflammatory bowel disease (IBD) and noninflammatory controls.
AUTHOR CONCLUSION: Measles virus was not detected using this method.
http://www.ncbi.nlm.nih.gov/pubmed/9624614

Autism and Measles, Mumps, and Rubella Vaccine: No Epidemiological Evidence for a Causal Association
Taylor B et al. Lancet. 1999;353 (9169):2026-9
Researchers looked for a change in trend in incidence or age at diagnosis associated with the introduction of measles, mumps and rubella (MMR) vaccination to the United Kingdom in 1988. The study identified 498 cases of autism (261 of core autism, 166 of atypical autism, and 71 of Asperger syndrome) in children born in the UK since 1979. There was a steady increase in cases by year of birth with no sudden “step-up” or change in the trend line after the introduction of MMR vaccination. There was no difference in age at diagnosis between the cases vaccinated before or after 18 months of age and those never vaccinated. There was no temporal association between onset of autism within 1 or 2 years after vaccination with MMR. Developmental regression was not clustered in the months after vaccination.
AUTHOR CONCLUSION: Data do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in this large regional sample.
http://tinyurl.com/5bgvwg

No Evidence for Measles, Mumps, and Rubella Vaccine-Associated Inflammatory Bowel Disease or Autism in a 14-year Prospective Study
Peltola H et al. Lancet. 1998; 351:1327-8
Prospective study of 3 million adverse events in temporal relation to MMR vaccine. A form was filled and posted to the data collectors, followed by another form with further information 2-3 weeks later. Researchers traced subjects who developed gastrointestinal symptoms or signs lasting 24 hours or more at any time after MMR vaccination (apart from within the first hour). Researchers also checked hospital and health center records or interviewed the local public-health nurses.
AUTHOR CONCLUSION: Over a decade’s effort to detect all severe adverse events associated with MMR vaccine could find no data supporting the hypothesis that it would cause pervasive developmental disorder or inflammatory bowel disease.
http://www.freenetpages.co.uk/hp/gingernut/lancet/Finland%20May%201998.pdf

Exposure to Measles in Utero and Crohn’s Disease: Danish Register Study
Nielsen LL et al. British Medical Journal. 1998; 316(7126):196-7
Investigators identified 472 women aged 15 to 43 years who had been admitted with measles between 1915 and 1966. Thirty-three were pregnant: 11 developed measles during the first trimester, 9 during the second, 6 during the third, and 9 had exanthema less than 14 days after delivery. Of the 26 offspring identified (including one set of twins), four died, one in infancy. The diagnoses of the other three, who died as adults, did not suggest inflammatory bowel disease. Among individuals still alive (median age 51.4 (36-79) years) none were registered as having Crohn’s disease or inflammatory bowel disease.
AUTHOR CONCLUSION: Exposure to measles in utero does not seem to be strongly associated with the development of Crohn’s disease later in life.
http://www.bmj.com/cgi/content/short/316/7126/196

U.S. Court of Federal Claims decision in Omnibus Autism Proceeding
On Feb. 12, 2009, the “vaccine court” ruled in three test cases on the theory that MMR vaccine and the vaccine preservative thimerosal are linked to autism. The court found the scientific evidence is overwhelmingly contrary to this theory.
http://www.uscfc.uscourts.gov/node/5026

Studies looking at thimerosal:

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism
Price C et al., Pediatrics. Vol. 126 No. 4 October 2010, pp. 656-664
Researchers reviewed managed care organization records and conducted interviews with the parents of 256 children who were verified to have ASD according to a standardized personal evaluation. Children with ASD were further categorized as having autistic disorder or ASD with regression. Another 752 children without autism, matched to the ASD children by birth year, gender and managed care organization, were also studied. For none of the autism outcomes was prenatal or early life receipt of thimerosal-containing vaccines and immunoglobulins significantly greater among children with ASD than among children without ASD.
AUTHOR CONCLUSION: These results add to the evidence that thimerosal containing vaccines do not increase the risk of autism.
http://pediatrics.aappublications.org/cgi/content/full/126/4/656

Continuing increases in autism reported to California’s developmental services system: mercury in retrograde
Schechter and Grether, 2008, Archives of General Psychiatry. 65(1):19-24
Study analyzed autism client data from the California Department of Developmental Services between 1995 and 2007. Even though thimerosal was absent from scheduled childhood vaccines after 2002, cases of autism continued to climb quarter by quarter.
AUTHOR CONCLUSION: The California DDS data do not show any recent decrease in autism in California despite the exclusion of more than trace levels of thimerosal from nearly all childhood vaccines. The data do not support the hypothesis that exposure to thimerosal during childhood is a primary cause of autism.
http://www.ncbi.nlm.nih.gov/pubmed/18180424

Mercury Levels in Newborns and Infants After Receipt of Thimerosal-Containing Vaccines
Pichichero, et al., Pediatrics. Vol. 121 No. 2, 2008, pp. e208-e214
Study assessed blood mercury levels of 216 healthy children prior to immunization with thimerosal-containing vaccines, and 12 hours to 30 days after. The blood mercury half-life was calculated to be 3.7 days and returned to prevaccination levels by day 30.
AUTHOR CONCLUSION: The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines in infants is substantially shorter than that of oral methyl mercury in adults. Increased mercury levels were detected in stools after vaccination, suggesting that the gastrointestinal tract is involved in ethyl mercury elimination. Because of the differing pharmacokinetics of ethyl and methyl mercury, exposure guidelines based on oral methyl mercury in adults may not be accurate for risk assessments in children who receive thimerosal-containing vaccines.
http://pediatrics.aappublications.org/cgi/content/full/121/2/e208

Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years
Thompson, et al. 2007, New England Journal of Medicine. 357:1281-1292
Study compared early exposure to thimerosal-containing vaccines to 42 neuropsychological outcomes in 1,047 children between the ages of 7 and 10 years. Exposure to mercury from thimerosal was determined from computerized immunization records, medical records, personal immunization records and parent interviews.
AUTHOR CONCLUSION: The study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.
http://tinyurl.com/5ndvpe

Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations
Fombonne, et al., Pediatrics. Vol. 118 No. 1, 2006, pp. e139-e150
Quantified thimerosal and measles, mumps rubella (MMR) vaccine uptake in 28,000 Canadian children born between 1987 and 1998, of whom180 were identified with a pervasive developmental disorder.
AUTHOR CONCLUSION: The data rule out an association between pervasive developmental disorder and either high levels of ethyl mercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measlesmumps-rubella vaccinations.
http://tinyurl.com/5c27nu

Immunization Safety Review: Vaccines and Autism
Institute of Medicine, The National Academies Press: 2004
The IOM’s Committee on Immunization Safety Review was convened in the fall of 2000 to provide an independent review of increasingly prominent vaccine safety concerns. The 15 committee members with expertise in pediatrics, internal medicine, immunology, neurology, infectious diseases, epidemiology, biostatistics, public health, risk perception, decision analysis, nursing, genetics, ethics and health communications analyzed over 200 relevant studies.
AUTHOR CONCLUSION: The committee rejected a causal relationship between the MMR vaccine and autism as well as a causal relationship between thimerosal containing vaccines and autism.
http://books.nap.edu/catalog.php?record_id=10997#description

Thimerosal Exposure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Andrews N et al., Pediatrics. Vol. 114 No. 3, 2004, pp. 584-591
Study analyzed thimerosal exposure and possible development delays in 109,863 children born in the United Kingdom from 1988-97. Exposure was defined according to the number of DTP/DT doses received by 3 and 4 months of age and also the cumulative age-specific DTP/DT exposure by 6 months.
AUTHOR CONCLUSION: With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.
http://tinyurl.com/7rvj6m

Autism and thimerosal-containing vaccines: Lack of consistent evidence for an association
Stehr-Green P et al., American Journal of Preventive Medicine. 2003; 25(2):101-6
Study compared the prevalence/incidence of autism in California, Sweden and Denmark from the mid-80s to the late 90s with average exposures to thimerosal containing vaccines. In all three countries, the incidence and prevalence of Autism Spectrum Disorders began to rise in the 1985-1989 period, and the rate of increase accelerated in the early 1990s.
AUTHOR CONCLUSION: The data is not consistent with the hypothesis that increased exposure to thimerosal-containing vaccines is responsible for the apparent increase in the rates of autism in young children being observed worldwide.
http://www.ncbi.nlm.nih.gov/pubmed/12880876

Thimerosal and the Occurrence of Autism: Negative Ecological Evidence From Danish Population-Based Data
Madsen et al., Pediatrics; Vol. 112 No. 3, 2003, pp. 604-606
Analyzed data from the Danish Psychiatric Central Research Register recording all psychiatric admissions since 1971, and all outpatient contacts in psychiatric departments in Denmark since 1995. There was no trend toward an increase in the incidence of autism during that period when thimerosal was used in Denmark, up through 1990. From 1991 until 2000 the incidence increased and continued to rise after the removal of thimerosal from vaccines, including increases among children born after the discontinuation of thimerosal.
AUTHOR CONCLUSION: The discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. The data do not support a correlation between thimerosal-containing vaccines and the incidence of autism.
http://tinyurl.com/5omq4u

Association Between Thimerosal-Containing Vaccine and Autism
Hviid et al., Journal of the American Medical Association, 2003; 290(13):1763-6
Study of 467,000 children born in Denmark between 1990 and 1996 compared children who were vaccinated with a thimerosal-containing vaccine to children who received a thimerosal-free formulation of the same vaccine. The risk of autism and other autism spectrum disorders did not differ significantly between children vaccinated with thimerosal-containing vaccine and children vaccinated with thimerosal-free vaccine.
AUTHOR CONCLUSION: The results do not support a causal relationship between childhood vaccination with thimerosal-containing vaccines and development of autistic-spectrum disorders.
http://tinyurl.com/5rtzjd


Thimerosal Exposure in Infants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Support a Causal Association
Heron et al., Pediatrics. Vol. 114 No. 3, 2004, pp. 577-583
The researchers monitored the thimerosal exposure of more than 14,000 children born in the UK between 1991 and 1992. The age at which doses of thimerosal-containing vaccines were administered was recorded, and measures of mercury exposure by 3, 4 and 6 months of age were calculated and compared with measures of childhood cognitive and behavioral development covering from 6 to 91 months of age.
AUTHOR CONCLUSION: No convincing evidence was found that early exposure to thimerosal had any deleterious effect on neurologic or psychological outcome.
http://pediatrics.aappublications.org/cgi/content/abstract/114/3/577

Additional studies looking at vaccine safety:

On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes
Smith M and Woods C, Pediatrics. Vol. 125 No. 6 June 2010, pp. 1134-1141

The study of data on more than 1,000 children born between 1993 and 1997 looked at their vaccination schedules up to 1 year of age, and studied their performance 7 to 10 years later on 42 different neuropsychological outcomes. Timely vaccination was associated with better performance on numerous outcomes. The less-vaccinated children did not do significantly better on any of the outcomes.
AUTHOR CONCLUSION: This comparison of children vaccinated on time with children whose vaccinations were delayed or incomplete found no benefit in delaying immunizations during the first year of life. For parents who are concerned that children receive too many vaccines too soon, these data may provide reassurance that timely vaccination during infancy has no adverse effect on long-term neuropsychological outcomes.
http://pediatrics.aappublications.org/cgi/content/abstract/125/6/1134

Poul Thorsen indicted

14 Apr

Poul Thorsen, a Danish scientist who worked on many subjects including autism prevalence, was indicted in the United States today, the Atlanta Business Chronical reports. The article, Dane indicted for defrauding CDC, notes:

A Danish man was indicted Wednesday on charges of wire fraud and money laundering for allegedly concocting a scheme to steal more than $1 million in autism research money from the Atlanta-based Centers for Disease Control and Prevention.

Poul Thorsen started his association with the CDC as a visiting researcher. Later he moved to Denmark and Aarhus University.

According to the news article, Mr. Thorsen was using his position to create fraudulent invoices, and got his university to pay funds into his personal accounts in the US.

Mr. Thorsen worked on many projects. Most pertinent to this blog are his group’s efforts on autism epidemiology. These include works on MMR vaccines and thimerosal (e.g. A population-based study of measles, mumps, and rubella vaccination and autism and Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data )

No charge has been made about the quality of these research projects or the conclusions drawn. However vaccine-causation advocates have been promoting the Thorsen case as part of their efforts.

Make no mistake: if guilty Poul Thorsen has committed very serious crimes. As a taxpayer, of course I am upset that this man might have stolen taxpayer money. As an autism parent, I can say without reservation that if found guilty Mr. Thorsen should be sentenced to the maximum sentence. The damage to the reputation of the research community which has sought to answer the questions of vaccine causation. A million dollars is a lot of money, but it is small change compared to the potential damage that might be caused .

Robert F. Kennedy Jr. not holding a press conference on Monday

9 Apr

My guess is that you are reading this thinking: this is news? Doesn’t pretty much every day go by without Robert F. Kennedy holding a press conference? Well, yes. But there was a press conference planned for Monday. Yes, the man who brought you “Deadly Immunity” (an article promoting the mercury/autism link that was so flawed that it was retracted by Salon.com and quietly removed from the Rolling Stone website) has something so new and important that he wants to tell the world about it from in front of the White House.

The subject? A study purportedly showing that many autistic kids have been compensated over the years by the National Vaccine Injury Compensation Program (a fact that has been public knowledge for 9 years or more). The article, under review by his University’s law journal, appears to be the one which was touted as ongoing a few years ago (I recall this being on a piece by David Kirby on the Huffington Post before he focused on his new project of food safety).

That press conference, from what I’ve heard, has been put off until after the paper is actually accepted and published.

Here’s the background history:

1) The US adopts a National Vaccine Injury Compensation Program in the mid-late 1980’s.

2) Autistic kids are amongst those compensated.

3) The concept of a vaccine-induced autism epidemic gains momentum in the late 1990’s.

4) Enough cases are submitted to the Program that an Omnibus proceeding is started to cover all the cases.

5) The first item added to the docket, Autism General Order #1, tells attorneys to be aware that autistics with table injuries should be handled outside the Omnibus for faster processing. (year 2002)

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.

and

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.

6) The government concedes Hannah Poling’s case as a table injury (late 2007) and the Hannah Poling concession was leaked while still in process. (Feb. 2008).

7) Given the news focus generated, then Chief Special Master Gary Golkiewicz was quoted:

“Years ago, actually, I had a case, before we understood or knew the implications of autism, that the vaccine injured the child’s brain caused an encephalopathy,” he said. And the symptoms that come with that “fall within the broad rubric of autism.”

And there are other somewhat similar cases, Golkiewicz says, that were decided before autism and its symptoms were more clearly defined.

8) Kathleen Siedel found a number of cases which were in the public record involving vaccine injury cases compensated. This list then appeared in many places, including a journal paper.

9) it was signaled that a new study was in the works where the prevalence of autism was notably higher amongst people compensated in the vaccine-injury program.

10) The autism prevalence estimate in the US was increased to 1 in 100, up from 1 in 150. Whether this had an impact on the apparent delay of (9) I can’t say.

Short form: we’ve been waiting for years for the study which will show us that the fraction of kids compensated by the Court is higher than expected. Now it appears that the study is in process and in a law journal. And that Robert F. Kennedy wanted to tell us all about it on Monday. But that won’t happen now, apparently. Apparently even law journals have embargoes.

Even though the press conference seems to be canceled for now, I guess that sometime in the near future Robert F. Kennedy will confirm what is and has been public knowledge. This will be followed by a blog storm acting as though this is news. Perhaps I’ll be surprised and something new will be in the announcement.

So far, the fraction of children with ASD diagnoses who have been compensated by the Autism Omnibus Proceeding is 1 in 838. This isn’t a fair estimate of what the final fraction will be, as many of those cases dismissed are for procedural issues like failure to prosecute and timeliness of filing. For that one compensated case, there is the note:

*May include case(s) that were originally filed and processed as an OAP cases but in which the final adjudication does not include a finding of vaccine-related autism.

**HHS has never concluded in any case that autism was caused by vaccination.

Reconsidering the Nature of Autism

8 Apr

Todd Drezner has a new piece up on the Huffington Post: Reconsidering the Nature of Autism. He starts out by quoting the forward to one of Jenny McCarthy’s books. The forward is by alternative medical practitioner Jerry Kartzinel.

Here is what Mr. Drezner wrote in his introduction:

“Autism … steals the soul from a child; then, if allowed, relentlessly sucks life’s marrow out of the family members, one by one.” So wrote Dr. Jerry Kartzinel in the introduction to Jenny McCarthy’s bestselling “Louder Than Words.” No wonder, then, that the concept of neurodiversity– the idea that we should understand and accept autistic people as a group that thinks differently from the majority — has proven to be so controversial.

The quote takes me back. Back to when I was starting to look online for information about autism. I remember when Jenny McCarthy hit the scene. Kev responded here with his blogging. The blog might have been kevleitch.co.uk then, not LeftBrainRightBrain. I remember that Kev’s blog went down: the traffic was so high that he hit his bandwidth quota. I remember that he responded to the forward from Jerry Kartzinel. He responded with words and, a little later, with video:

I don’t bring this up just for some sort of nostalgia. But this reminds me of two major themes. First: words hurt. What Dr. Kartzinel wrote, and Jenny McCarthy published, hurt. It hurt a lot of people. It added to the stigma of autism and disability. Second: words can be powerful. Kev fought back, as did many others. How or if this was an influence on Todd Drezner, I can’t say. It influenced me as I still remember it.

We can’t sit back and let people stigmatize others, for whatever reason they may have. Kim Wombles shows that almost every day with her blog Countering. Bev did it with a humor and keen perspective on Asperger Square 8. Corina Becker is taking up the task with No Stereotypes Here. And this is just a few of the many voices, autistic and non, out there.

Having said this, I will bring up one message that I’ve felt needed to be countered for some time. Here is a screenshot of a page from the book “the Age of Autism” by Dan Olmsted and Mark Blaxill. Both write for the Age of Autism Blog (Dan Olmsted appears to be the proprietor). Mark Blaxill is a member of the organization SafeMinds. Both promote the idea of autism as vaccine injury and, more specifically, the failed mercury hypothesis. (click to enlarge)

To pull but one disturbing quote: “As one of the first parents to observe an autistic child, Muncie learned how well autism targets ‘those functions distinctly human’ “. Yes, I have spent quite a lot of time fighting bad science like the first part in that sentence: the idea that autism is new/the kids in Kanner’s study were the first autistics ever. But what about the second part: that autistics are missing or have impaired “distinctly human” functions? Yes, I’ve also responded to that sentiment in the past and I plan to continue to do so. And that is much more important than the fight against bad science.

Words hurt. Jerry Kartzinel’s words hurt. Dan Olmsted and Mark Blaxill’s words hurt. They hurt and they are wrong. Plain and simple.

Another phrase from the above paragraph: “autism brutally restricts the interests of the affected”. So say the team that has one interest: pushing mercury in vaccines as a cause of autism. A little ironic?

Reading their writing, I am reminded of one of Bev’s amazing videos:

Back to the paragraph from “The Age of Autism”. Dan, Mark: You don’t think autistics made tools, explored the globe, invented new technologies? The sad thing is, it seems like you don’t.

Yeah, a lot of kids, kids like mine, aren’t in the world explorer/inventor categories. And even kids like mine are still as human as you or I. They are not missing anything “distinctly human”.

The Autism-Vaccine Debate: Why It Won’t Go Away

11 Feb

Who said it was? Backstory: “The Autism-Vaccine Debate: Why It Won’t Go Away” is a recent blog post by David Kirby at the Huffington Post. Yes, he’s come back to talk about autism and vaccines.

I say again: who says the debate is going away? The scientific debate on the main issues: thimerosal and the MMR is over. That scientific debate has been over for some time. The rising autism “rate” wasn’t caused by mercury. It wasn’t caused by MMR. Autism isn’t a “novel” form of mercury poisoning. These facts don’t stop activist groups and online discussions, or the debate elsewhere for that matter.

The debate isn’t going away, but is is morphing. From the piece by David Kirby:

There is clearly no single cause of autism, and we are not going to find answers looking only at genes, or for that matter, only at thimerosal or MMR.

David Kirby’s main contribution to the discussion was his book: Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical Controversy. Mr. Kirby has been a major proponent of the mercury hypothesis since he started on that book, fed by research garnered by SafeMinds founder Lyn Redwood. The book wasn’t about “vaccines” and the autism epidemic, or “environmental causes of an autism epidemic”, it was about “mercury in vaccines and the autism epidemic”.

The debate isn’t going away, but it is getting weaker. And it’s just moving a few goalposts: Let’s play down mercury. Let’s play down MMR. It’s the “Autism-vaccine” debate, not “Mercury in vaccines and the autism epidemic”.

Mr. Kirby does in this blog post what he has done so well for the past few years. He puts the current talking points out there, nicely packaged. Here’s a good example, where he even manages to include a plug for the latest pseudo-research. It’s amazing, really:

That’s because evidence of a vaccine-autism link did not come to them via a 12-year-old study published in a British medical journal, nor from Hollywood celebrities: Not very many had heard of Wakefield until recently.

Some of these parents actually keep up with the science, including a new review of autism studies in the Journal of Immunotoxicology which concludes: “Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis following vaccination.”

Simply amazing. People haven’t heard of Wakefield, but they know about a paper that just came out yesterday in a relatively obscure medical journal? It’s product placement. Very slick. Mr. Kirby plugs this paper as though it is as natural as all the judges on “American Idol” drinking from great big red Coca Cola cups.

He also gets in the “the discussion isn’t all about Wakefield” theme that is in the current responses to the disclosure of fraud in Mr. Wakefield’s research. “Not many people had heard of Wakefield until recently.” As a side note, the obscure Mr. Wakefield appears on 30 pages of Mr. Kirby’s book, Evidence of Harm.

Let’s check whether people have heard about Mr. Wakefield. According to a recent Harris poll (one that Mr. Kirby cites, by the way):

In the new Harris Interactive/HealthDay poll, 69 percent of respondents said they had heard about the autism-vaccination theory — but only half (47 percent) knew that the original Lancet study had been retracted, and that some of that research is now alleged to be fraudulent.

The question “Are you aware that the medical journal that published the paper linking vaccines to autism has now withdrawn the paper, and a published account describes the research as fraudulent?” 47% of people asked said yes.

That’s a pretty big number of people who not only (a) knew about Mr. Wakefield’s paper but also (b) knew it had been retracted and described as fraudulent. What other research paper would the public know about in such great numbers, 12 years after publication?

To state the obvious, yes, Mr. Wakefield and his research was known. Well known. It has been a big piece of the vaccines-cause-autism debate.

Here’s the table from that Harris poll question, showing that 47% of people had heard about the retraction and fraud. Even more important, take note of the fact that people who are informed about the retraction and the fraud are much less likely to believe that vaccines cause autism (click image to make big):

Yep, 65% of people who have heard about the retraction and fraud say that the vaccines-cause-autism idea is “not true”. Mr. Wakefield’s work was known and important to the vaccines-cause-autism cause.

Mr. Kirby then goes into the standard talking points of the day: only two vaccines (MMR) and one ingredient (thimerosal) have been explored for relationship to autism, followed closely by a denial that any of those studies were of any value because they are performed by people who have a “vested interest”.

Of course, “vested interests” in those promoting the vaccine hypothesis, both professional and financial (of which Andrew Wakefield is only the most prominent example) are ignored. As we quickly see as Mr. Kirby warns us that the expected SafeMinds response is on the way to the recent paper showing no link between thimerosal exposure and autism.

Mr. Kirby finishes with “The CDC estimates that there are about 760,000 Americans under 21 with an ASD. Even if just 1 percent of those cases was linked to vaccines (though I believe it is higher), that would mean 7,600 young Americans with a vaccine-associated ASD. ”

Yes, Mr. Kirby is adapting. Adapting in much the way that I have said the vaccine-causation community needs to adapt in order to stay alive. They need to abandon the “epidemic” rhetoric. Claim that if there are people with vaccine-induced autism, the number is very small, too small to be picked up by epidemiology.

Rather than really adapt, Mr. Kirby wants to play both sides of this. He wants to say, “what if the number is really small” and say that the data available show that the rise in autism prevalence is correlated with vaccines.

At the risk of being accused of “product placement” myself, I can’t help but bring up an incident discussed in the book “The Panic Virus“. I don’t have the book handy, so I apologize if I get this not 100% accurate. Seth Mnookin tells of talking to Dr. Jon Poling, father of Hannah Poling, during an AutismOne conference. While Dr. Poling is telling Mr. Mnookin that, yes, the concession in the vaccine court isn’t about causation, David Kirby is giving his talk saying exactly the opposite.

One question I know I will face soon is: why do I bring up David Kirby again? Why not move on from the vaccine debate. In the end it is because of statements like this:

In my opinion, many children with autism are toxic.

After over five years as a self-described member of the autism community, David Kirby still uses damaging language. Children are not “toxic”. Even children who have demonstrated heavy metal poisoning (which autism is not) are not “toxic”. If you touch them, you don’t get poisoned. They are “intoxicated”. But, that doesn’t read well, does it? I’ll say it again, autism is not a form of mercury poisoning. I really don’t need my kid labeled “toxic”.

I don’t know if David Kirby is “anti vaccine” or not. If you notice, I rarely use the term. I don’t care if David Kirby is anti vaccine. It isn’t the label “anti-vaccine” that matters. David Kirby is intellectually dishonest and his actions are irresponsible. On a more personal note, he puts forth an image of autism that is damaging to my kid.

Sloppy science – a perfect example of how the anti-vaccine crowd will listen to anything

11 Feb

Both Age of Autism and David Kirby have recently reported on a new review paper with Age of Autism describing it as ‘pretty interesting’ and David repeating a part of the abstract:

Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis following vaccination.

So, should we all in the skeptic camp be reaching for our humble pie and our knife and fork? Not exactly. Lets take a look at the contents of this paper. Lets start here:

The vaccine organism itself could be a culprit. For example, one hypothesis of the cause of autism is that the pertussis toxin in the DPT vaccine causes a separation of the G-alpha protein from retinoid receptors in genetically at-risk children (Farfel et al., 1999; Megson, 2000). The pertussis toxin creates a chronic autoimmune monocytic infiltration of the gut mucosa lamina propia and may disconnect the G-alpha protein pathways, leaving some G-alphamodulated pathways unopposed. In turn, the non-specific branch of the immune system is turned on and, without retinoid switching, cannot be down regulated.

Wow, blinded with the cool science yet? No, me neither. Go back to line one where it says ‘one hypothesis’. All that follows from that point is mere opinion. There’s no science to back it up.

Another organism of suspect is the live measles virus…

Yeah except its really not. The issues with the Wakefield hypothesis are so many and so thoroughly debunked, it really isn;t worth my time or yours going through them again and again.

There is evidence that Thimerosal (which is 49% ethyl mercury) is indeed harmful. Since the 1930s, Thimerosal has been extensively used as an antibacterial agent in vaccines (Geier et al., 2007). Thimerosal has been implicated as a cause of autism. Not only is every major symptom of autism documented in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of mercury poisoning itself (Bernard et al., 2001)

Oh dear. Reliance on more thoroughly debunked rubbish in the form of well, anything by the Geier’s and the ridiculous Bernard ‘paper’. I’m happy to go through why these are rubbish but I think I’d be preaching to the converted.

The rest of the paper is a rogues gallery of debunked and fringe science. Helen Ratajczak cites the Geier’s numerous times, DeSoto and Hitlan, Nataf and Rossignol to name but a few. This isn’t a paper so much as an advert for the sort of poor science that was examined in the Autism Omnibus proceedings and roundly rejected by the Special Masters. For goodness sake, she even cites David Ayoub of the Black Helicopter infamy.

When it comes to this paper – handle with extreme caution. Its toxic rubbish.

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