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Huffington Post uses erroneous data to promote autism epidemic

26 Aug

correction:

As noted in the comments below, Mr. Kirby appears to be basing argument suggesting that the Hepatitis B vaccine could have caused autism on ADDM data, not on the NSCH dataset, as I assumed.

A recent blog post on the Huffington Post contains serious errors and should be edited or pulled.  At the very least a public acknowledgment of the error must be made.

Using data from the recently published 2007 National Survey of Children’s Health to estimate autism prevalence, a Huffington Post blogger (David Kirby) attempted to draw a connection between the Hepatitis B vaccine and an “explosion” of autism . Here is what he wrote:

If there is an environmental component to autism, hopefully scientists will want to know which exposures might have increased between, say, 1992 and 1996.

One possible answer is the Hepatitis B vaccine, (which also contained 25 micrograms of mercury containing thimerosal).

Introduced in 1991, it was the first vaccine ever given on a population basis to newborn babies (within the first three hours after delivery) in human history.

But according to the CDC’s National Immunization Survey (which also includes parental telephone interviews), only 8% of infant children received the Hep B vaccine in 1992, when that birth cohort showed an ASD rate of 60-per-10,000.

By 1994, the number of children receiving Hep B vaccine had reached just 27% — and the cohort showed an ASD rate of 66-per-10,000.

But the Hep B coverage rate had risen to 82% by 1996, when that cohort’s ASD rate exploded to around 100-per-10,000.

Correlation, obviously, does not equal causation. And no one is suggesting that Hepatitis B vaccine is the singular “cause” of autism. But the uptake rate of that particular immunization is at least one environmental factor that did demonstrably change during the period in question.

Emphasis is mine. I emphasized the data which  are the data that are incorrect.

The analysis is simple. Here are the actual results compared to what Mr. Kirby misreported:

1992 “birth cohort*”:
102 per 10,000 (not 60 per 10,000 as on HuffPo)

1994 “birth cohort*”:
113 per 10,000 (not 66 per 10,000 as on HuffPo)

1996 “birth cohort*”:
111 per 10,000 (close to the “around” 100 per 10,000 quoted).

Or, to put it very simply: Mr. Kirby’s statement that there was an “explosion” in the autism rates is incorrect. The evidence that the introduction of the Hepatitis B vaccine is somehow related to the increase in autism rates is false.

That entire statement isn’t even a misinterpretation–it is just simply, demonstrably, false.

Unfortunately, this isn’t Mr. Kirby’s first clear and serious error. He has a history of mistakes. Unfortunately, he doesn’t have a history of correcting his mistakes. Consider these examples:

In June 2008, epiwonk publish a blog post “David Kirby: HuffPost Report on CDC’s Vaccine Safety Datalink Uninformative and Completely Misleading“, demonstrating clear errors in Mr. Kirby’s post “CDC: Vaccine Study Design “Uninformative and Potentially Misleading“”.

The errors were serious enough that Mr. Kirby rewrote his blog post as CDC: Vaccine Study Used Flawed Methods. This included the following introduction:

NOTE: My original post on this topic mischaracterized the 2003 CDC vaccine investigation as an “Ecological Study,” which it was not. I am reposting this piece to reflect that information accurately, but also to point out that many of the weaknesses identified in the CDC’s data and methods apply to the published 2003 “retrospective cohort” study, as much as they do to any future “ecological” ones. I regret and apologize for the error.

Mr. Kirby “regrets” and “apologizes” for the error. Yet his original, erroneous blog post is still on the Huffington Post website. He never took it down. He didn’t even add an apology or correction note to the piece. Anyone following a link to it would have no idea that even the author acknowledges the serious flaws in that piece.

It is also worth noting that the “corrected” version of Mr. Kirby’s blog post was also in error. Again, as noted by epiwonk, this time in his piece “David Kirby HuffPost, Take 2: My Original Story was Flawed, So Here’s A Second (”Corrected”) Story That’s Still Flawed, But I Hope I Can Snow You Under Again This Time…”

Mr. Kirby compounded this error when he recreated it in his first “congressional briefing”, September 2008. Mr. Kirby misquoted a report by the National Institute of Enviornmental Health Sciences, and he was caught by a knowledgeable staffer.

Again, Mr. Kirbty has failed to correct his error.  He posted his power point presentation to his website, but without any acknowledgment of the error on page 6.  In the transcript for this talk, he only states, “NOTE: This statement omits important details of the CDC response” and sends you to other sites “For a more detailed explanation”. The “transcript” makes no reference to the exchange between Mr. Kirby and the congressional staffer, nor does it acknowledge that the omission was critical to the point being made. The transcript is noted as being a “Rush transcription by Nancy Hokkanen”. Being in a rush is not an excuse to leave important flaws unexplained.

Math errors are also not new to Mr. Kirby. In May 2008, Mr. Kirby wrote a piece analyzing data from Scotland. In doing so, Mr. Kirby misread a graph resulting in a factor of 10 error in a key piece of information (he misread a bar graph . After his error was blogged, Mr. Kirby corrected his Huffington Post piece. What he didn’t do, and he should have, was to note in the blog piece that he made the error and corrected it.

Mr. Kirby placed his Scotland data post in two sites: Huffington Post and the Age of Autism blog. In yet another odd move by Mr. Kirby, he left the original version of his post, complete with the factor of 10 error, on the Age of Autism blog (it still has 34,000 instead of 3,400). As noted above, Mr. Kirby obviously knows about the error, since he corrected it on the Huffington Post.

Since he clearly knew that his post on the Age of Autism blog had a big error, why didn’t he make a correction (with acknowledgment of the error) there?

Mr. Kirby had a bit of a problem with understanding the difference between Change.Org Change.Gov (the Obama transition team’s website) and Change.Org (a website that hosts blogs on important topics, including autism) (also noted here and here) He made a clear correction on the Huffington Post. However, his post on the Age of Autism blog just disappeared without a comment.

But let’s get back to the present. Mr. Kirby has blogged erroneous data and used this to show a false correlation between the Hepatitis B vaccine introduction and the rise in autism rates.

In case anyone is thinking, “are you sure you checked your own numbers, Sullivan?” The answer is yes. I double checked. I asked a frequent commenter on this blog, Dawn, to check my numbers. Another commenter independently collected and graphed the NCSH data as well. No evidence for an “explosion” of autism rates. Take a look at the graph. Mr. Kirby claimed that the 2007 survey data showed autism rates of about 60/10,000 for kids aged 13 and 15. There are no rates below 80 per 10,000 for the kids in those age ranges in that dataset.

So here we have a man with a history of errors, and with a history of failing to adequately correct his errors. He now has a new, big, obvious error. This error is likely the most serious of those listed here, in my opinion. Mr. Kirby has convinced people that the Hepatitis B vaccine could be causing autism. That was a serious accusation, and it was wrong. The question before us now is this: what will Mr. Kirby do now that he knows he made a mistake?

I’m very curious about that, so I’ve emailed Mr. Kirby and one of the editors at the Huffington Post with this information. I’ll let you all know what I hear back.

*note: the NSCH data are not given as “birth cohorts”. Instead, they are given by age. The survey was performed in 2007 and 2008. So, the 15 year old age group is roughly the “1992 birth cohort”. Likewise, 13 year olds are the 1994 “cohort” and 11 year olds are the 1996 “cohort”.

EDIT: Note that I too have a problem with keeping Change.Org and Change.Gov separate. This correction was made after the post was published.

Unscientific Americans

25 Aug

In Saturday’s Los Angeles Times, Lori Kozlowski talked to Chris Mooney in an article headed ‘Bringing science back into America’s sphere.’ The piece is about a book that Chris has co-authored with Sheril Kirshenbaum “Unscientific America: How Scientific Illiteracy Threatens Our Future.” It provoked such a lot of comments that they set up a blog so everyone could have their say.

Needless to say, as one of the book’s targets is the vaccine/autism camp and Chris mentions Age of Autism, that nest of anti-vaxers has dominated the comments with an orchestrated campaign. Here is my own attempt to stem the tide.

Those who have argued for a link between vaccines and autism adopt two contradictory positions. On the one hand we have those who point to the epidemiological studies as evidence of an autism epidemic whose growth is supposed to coincide with changes in the United States schedule for early childhood vaccinations. But when population studies fail to find a connection between vaccines and autism we get a different argument. Apparently there is a subset of genetically susceptible children that is too small to show up in population studies of vaccine safety. We have yet to hear a convincing explanation for this alleged genetic susceptibility to vaccine induced autism. But the parents who subscribe to this view are all convinced that, whatever it is, their child must have it.

It is difficult to see how this latter group could be persuaded to abandon their belief that that in their individual cases correlation does indeed equal causation. But I am at a loss to understand why they are willing to make common cause with the autism epidemicists, who are clearly and demonstrably wrong.

Regarding prevalence we have a very good idea why prevalence used to be 4 in 10000 and is now approaching 100 in 10000. In 1966 Victor Lotter carried out one of the earliest epidemiological studies in the county of Middlesex in the UK. He used a very narrow definition of autism in which only children who actively avoided human contact and engaged in elaborate repetitive behaviour qualified for diagnosis. When his students Lorna Wing and Judith Gould repeated the study in 1979 they found a similar rate of between 4 and 5 in 10000. However they also discovered a larger group who also engaged in repetitive behaviour but did not avoid human contact. However they did show difficulties in social communication and interaction. Wing and Gould defined ther problems within the triad of impairments, which also explained the aloof behaviour of the more typical Kanner type autistics. The newly identified members of the autistic spectrum numbered around 15 in 10000. Thus a simple broadening of the criteria lifted the numbers from 4 to 20 in 10000.

Lotter, Wing and Gould had all studied children excluded from mainstream education. In 1993 Stephan Ehlers and Christopher Gillberg went looking for children with the triad of impairments in mainstream education in the Swedish city of Gothenburg. They found a rate of 71 in 10000 for children with an IQ greater than 70. The children who were identified were known by their teachers to be having social and/or educational problems but the nature of their difficulties had not been recognised prior to the study.

So, as early as 1994, on the basis of epidemiological studies by Wing and Gould (1979) and Ehlers and Gillberg (1993) it was apparent that autism in all its manifestations including the classic Kanner type and the Asperger type affected at least 91 in 10000. The National Autistic Society in the UK issued a fact sheet to that effect. The modern version is available on our website.

In 15 years the figure for all autistic spectrum disorders in the UK has moved from 91 in 10000 to 116 in 10000 (Baird et al 2006). Thus it has remained flat at around 1 per cent for the whole period of the so-called autism epidemic. And that 1 percent represents the whole spectrum with perhaps a fifth to a quarter consisting of people with recognizable learning difficulties that are moderate or severe. The rest are more able.

I see no reason to doubt that the CDC estimate of 1 in 150 and the figures from recent studies that more closely approach the overall prevalence figures from the UK contain within them similar proportions of more and less able individuals. It is a shame that it has taken health and education services on both sides of the Atlantic so long to catch up with the true prevalence of autism amongst our children and begin to tailor services to meet their needs.

That still leaves those more able adults, often living a life less ordinary without the benefit of diagnosis and support, but still experiencing difficulties in their daily lives. The recent I Exist campaign by the National Autistic Society in the UK has influenced our government to take adult issues seriously

Comments are still open. Please visit and counter the collective lunacy of the anti-vaxers.

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Physician’s Warranty of Vaccine Safety

25 Aug

There is an amazing document to be found on the internet: the “Physicians Warranty of Vaccine Safety”.

My take on this? It isn’t a real method of communicating one’s possible concerns about vaccines with one’s doctor. Instead, it is appears to be intended to sway parents away from vaccinating their children. They read this and go “Oh No!” and probably never even show it to their pediatricians.

The document is long and asks doctors to provide huge amounts of information supporting the idea that vaccines are safe and effective. Again, my view is that the document is more about getting parents to question vaccines.

The “Warranty” includes a scary list of vaccine “fillers” including the ever not-present “antifreeze”. It brings up the SV40 scare, including the nonsensical statement, “I hereby warrant that the vaccines I employ in my practice do not contain SV 40 or any other live viruses.” I guess whoever wrote the “Physician’s Warranty of Vaccine Safety” never heard of he MMR vaccine, with its live viruses and all. How can a physician warrant that MMR doesn’t include “live viruses”?

In the end the objective of this document appears to be: give this to your doctor and when he/she refuses to sign it, take that as proof that vaccines are not safe.

To insure that this happens, the Physicians Warranty of Vaccine Safety includes a killer clause:

Regardless of the legal entity under which I normally practice medicine, I am issuing this statement in both my business and individual capacities and hereby waive any statutory, Common Law, Constitutional, UCC, international treaty, and any other legal immunities from liability lawsuits in the instant case. I issue this document of my own free will after consultation with competent legal counsel whose name is __________________________________________, an attorney admitted to the Bar in the State of ___________________________.
________________________(Name of Attending Physician)
________________________ L.S. (Signature of Attending Physician)

Yep. The doctor is supposed to waive all legal protection from liability. He/she is supposed to put his/her business and personal assets behind this.

Make a document that says, “I want a glass of water…oh, by the way, please waive all your legal rights before doing so”. See if your doctor will sign it.

I’ve toyed with creating a “Physicians Warranty of Autistic Child Safety”. It would require the physician to provide all the evidence that the alternative medical therapies have been tested and proven to be beneficial and safe.

Oh, yeah, the physician would have to waive his/her immunities from liability lawsuits.

I considered asking a number of the prominent alternative medical practitioners if they would consider taking my kid on as a patient, then asking them to sign the “Physicians Warranty of Autistic Child Safety”.

But why when I already know the answer will be no?

I guess it says something about the vaccine-rejectionists that they have to resort to such cheesy measures as the “Physicians Warranty of Vaccine Safety”.

Autism Speaks softens message on vaccines?

24 Aug

That is the message of a recent article by Mark Roth, Autism group softens stance on vaccines .

Autism Speaks, the nation’s largest autism advocacy group, recently made its clearest public statement yet that minimizes the link between vaccines and autism.

Mr. Roth discussed a recent statement from the Autism Speaks website by Dr. Gerri Dawson, Autism Speaks’ chief science officer. He quoted Dr. Dawson as stating:

“So … given what the scientific literature tells us today,” she says, “there is no evidence that thimerosal or the MMR vaccine cause autism” and “evidence does not support the theory that vaccines are causing an autism epidemic.”

It has been, well, interesting watching the reaction to Autism Speaks in the past few years. As recently as two years ago, the vaccines-cause-autism organizations were highly critical of Autism Speaks for ignoring the vaccine question. In fact, it seems like just this year that Autism Speaks “outed” itself as supporting the vaccines-cause-autism idea. This occurred when Alison Singer was forced to resign from Autism Speaks since she wouldn’t vote for vaccine-causation research in the IACC.

From my perspective, this “softened” stance by Autism Speaks is still a stronger message than they were sending a year ago.

This all begs the question: why did Autism Speaks soften their message?

I can speculate (and that is all this is, speculation). First, the vaccine question is highly charged. My guess is that Autism Speaks put off making a definite statement as long as possible. When Alison Singer resigned over her vote in the IACC (voting to remove vaccine research from the funded projects), Autism Speaks was forced to make their views public.

The departure of two key people, Alison Singer and Eric London over the vaccine question was not good publicity for Autism Speaks. Much more, the creation of the Autism Science Foundation gives potential donors a second viable option for an autism research charity that doesn’t fund vaccine-causation research (the first being the Simons Foundation).

What is odd about Dr. Dawson’s comments is this: If there is no evidence that thimerosal causes autism, why does Autism Speaks fund thimerosal research? Here are grants from 2008:

Differential Effects of Thimerosal on Cell Division and Apoptosis in Normal vs Autism Spectrum Disorder Cell Lines ($60,000 for one year)

and

Vulnerability phenotypes and susceptibility to environmental toxicants: from organism to mechanism ($330,000 over 3 years)

Specifically, thimerosal and other vaccine adjuvants will be studied.

(sidenote: Thimerosal isn’t an “adjuvant”)

and

Analysis of developmental interactions between Reelin haploinsufficiency, male sex, and mercury exposure ($324,340 over 3 years)

and

Etiology of Autism Risk Involving MET Gene and the Environment ($659,100 over 3 years)

The next line of experiments will examine the relationship in an even larger sample, and assess the functional effect of the MET gene polymorphism on immune cell activity, and to further examine the impact of environmental toxins (including ethyl mercury) on the gene expression-dependent function of maternal immune cells.

Is Autism Speaks softening their “message” or softening their “stance” on whether vaccines and/or mercury cause autism?

sound advice: pediatricians Answer vaccine questions

20 Aug

Below is a press release from the American Academy of Pediatrics. This isn’t really about autism. But, the autism parent community is one of the biggest sources of misinformation about vaccines. I don’t mind pitching in to help AAP get some quality information out.

CHICAGO — Parents who are doing their homework on their child’s vaccines can go directly to the experts for answers – without leaving home. The American Academy of Pediatrics (AAP) offers a series of audio interviews with pediatricians, researchers, advocates and other parents at http://www.cispimmunize.org/fam/soundadvice.html.

Interviews include a conversation with former First Lady Rosalynn Carter, who discusses her passionate crusade to ensure all children receive life-saving vaccinations. Dr. Richard Besser, the pediatrician who became the public face of the government’s swine flu response in spring 2009, offers advice to families preparing for a future epidemic. Dr. Ari Brown, author of the popular “Baby 411” guides, dispels common vaccine myths. And Dr. Harvey Karp, the pediatrician who has coached thousands of new parents through his “The Happiest Baby On The Block” book and DVD, explains in clear, easy-to-understand language why vaccines are not related to autism.

Parents can listen first-hand as experts address specific questions related to immunization:

Why is it important to vaccinate on time?

What vaccines do adolescents need?

Why should infants get the Hepatitis B vaccine?

Why do kids need the flu shot?

Are some children extra-sensitive to vaccines?

Why are vaccines required for school entry?

August is National Immunization Awareness Month, which is a perfect time to remind people of all ages to catch up on their vaccinations. On the AAP’s Sound Advice page, parents can hear personal stories of people who have been affected by vaccine-preventable diseases. Frankie Milley lost her only child, Ryan, at age 18 to meningitis; she went on to found an advocacy organization devoted to protecting other children from the disease that took her son’s life. Pediatrician Anna Lincoln tells how pneumococcal meningitis threatened the life of her previously healthy infant son, Wiley, before a vaccine was available to prevent the disease. Now she counsels parents in her practice on vaccines.

“I welcome the questions,” Dr. Lincoln said. “I want parents to understand the vaccines, to understand why they’re important, to feel good and comfortable and confident in their decision to vaccinate their children. Although the diseases may seem low risk, they are not. We have to be diligent about continuing the schedule, because it can easily creep back to how it was before the vaccines, which was a time when children could be smiling one night, like Wiley, and the next morning, be fighting for their life in the intensive care unit.”

An interview with journalist Arthur Allen looks at how the media report on immunizations, and the resulting impact on public health. Ken Reibel, creator of the AutismNewsBeat blog, talks about his son’s diagnosis with autism. The audio interviews also include a message from actress Amanda Peet, who has partnered with the advocacy organization Every Child By Two to give parents the information they need about immunizations. Amy Pisani, executive director of Every Child By Two, and Mrs. Betty Bumpers, who co-founded the organization with Mrs. Carter, describe their personal reasons for promoting immunization.

Additional interviews feature pediatric infectious disease specialists Dr. Joseph Bocchini, Dr. Meg Fisher and Dr. Paul Offit; Dr. Judith Palfrey, president-elect of the AAP; Dr. Renee R. Jenkins, immediate past president of the AAP; and Dr. David T. Tayloe, Jr., president of the AAP.

“Parents are natural advocates for their children’s health,” Dr. Tayloe said, “and the AAP wants them to have the information they need about immunizations so they can make the right choices. The internet is peppered with inaccurate information about vaccines. We want parents to have a trusted place they can go for reliable advice. It’s important that immunization rates remain high or innocent children will become at risk for vaccine-preventable diseases.”

All the interviews can be downloaded to an mp3 player. Edited transcripts are posted.

The AAP has additional resources about immunization for parents and journalists:

Vaccine Studies: Examine the Evidence
o http://www.cispimmunize.org/Vaccine%20Studies.pdf

Facts for Parents About Vaccine Safety
o http://www.cispimmunize.org/fam/facts/VaccineSafety_English.doc

The Vaccine Schedule: Why is it Like That?
o http://www.cispimmunize.org/pro/pdf/Vaccineschedule.pdf

Questions and Answers About Vaccine Ingredients
o http://www.cispimmunize.org/pro/pdf/Vaccineingredients.pdf

Vaccines: What Every Parent Should Know
o http://www.aap.org/pressroom/aappr-features.htm

Jenny McCarthy: I’d like to see some action behind those words

18 Aug

Jenny McCarthy is on the cover of the latest Cookie Magazine. As part of her interview, she asserts that she is “pro safe vaccine”, not anti vaccine.

Now McCarthy, along with her boyfriend, actor Jim Carrey, serves on the board of directors of Generation Rescue, an advocacy and research organization that calls for eliminating toxins in vaccines and for delaying shot schedules.

Notice “delaying” shot schedules.

Another quote, talking about her own experiences:

Going over his medical history now, she sees a link between a series of ear infections, a severe case of eczema, and a hepatitis-B booster shot. “Looking back, I’d say, ‘God, if a kid is having more than seven ear infections in a year and he’s got eczema, there are some issues here—his immune system is obviously under attack, and we need to put him in the sensitive category. Let’s just delay some of his shots,’ ” she says. “Not eliminate, delay.”

Again, note the phrease “Not eliminate, delay”.

This isn’t exactly new. The Generation Rescue website page on vaccines tells parents to “consder delaying vaccines”. As near as I can tell, GR has had a statement like this since the vaccines page was first put up.

But here is where actions and words part company for both Jenny McCarthy and Generation Rescue. They have “recommended” vaccine schedules. Their “favorite” schedule, included in their paragraph on “consider delaying” vaccines, states flat out: no live virus vaccines. I.e. no Measles, Mumps, Rubella or Varicella (chicken pox).

That’s not “delay” that’s “eliminate”.

Let’s compare the GR alternative schedules to the CDC recommended schedule, shall we?

The childhood schedule includes vaccinations against 15 diseases:

Hepatitis B
Rotavirus
Diptheria
Tetanus
Pertussis
Haemophilus influenzae type b
Pneumococcal
Polio
Influenza
Measles
Mumps
Rubella
Varicella
Hepatitis A
Meningococcal

Now let’s check GR, Jenny McCarthy’s organization, and their recommended schedules:

First, GR’s “favorite” schedule only has protection against 4 diseases.

Pertussis
Diptheria
Tetanus
and, Polio

Again, that’s not “delay” that’s “eliminate”.

For their second option, GR claims you can “turn back the clock” and use the 1983 schedule. I don’t know how anyone could think that is supposed to be a “delay” in shots. Here’s the count (6 diseases covered):

Diptheria
Tetanus
Pertussis
Polio
Measles
Mumps
Rubella

As the third option, Jenny McCarthy’s organization suggests you “go Danish” and use the Denmark schedule (7 diseases):

Diptheria
Tetanus
Pertussis
Haemophilus influenzae type b
Polio
Measles
Mumps
Rubella

Jenny McCarthy *says* she is promoting “delaying” vaccines. Her actions speak much louder than her words.

If you want to say you are for “delaying” vaccines, then change your website. Pretty simple.

Of course, when you do, I’d love to see the science showing that the delayed schedule you pick is safer than the current one.

Chelation challenge testing: not scientific, not beneficial, may be harmful

13 Aug

Who knows about the toxic effects of mercury? Toxicologists. The premier toxicology group in the U.S, the American College of Medical Toxicologists, represents the doctors who test and treat people suffering from real heavy metal poisoning.

By contrast, many doctors have added chelation to their treatment options due to the false theory that autism is caused by heavy metal poisoning (specifically, mercury). These alternative-medicine practitioners usually depend on non-standard test to “prove” heavy metal poisoning. The favorite seems to be the “challenge” chelation test. In this test, a chelator is given to a person before a urine test. Chelators are chemicals which bind to metals in the body and allow them to be excreted more easily. Thus, if you give a chelator to a person, you expect their urine to show higher levels of heavy metals.

This has been discussed on this blog and elsewhere for a long time.

And now the American College of Medical Toxicologists has come out with an official position statement.

The practice is not scientific. There are no reference values for post-challenge urine metal testing. There is no correlation between actual metal exposure and post-challenge test results.

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.

It’s time for post challenge urine testing to end. It is time for chelation as a “treatment” for autism to end. It is time for those who promoted the “autism is mercury poisoning” theory to step forward and admit their mistakes.

Autism Omnibus: Snyder appeal denied

12 Aug

The appeals for the MMR phase of the Omnibus are now concluded: all three were denied.

The Autism Omnibus Proceeding is the way the “Vaccine Court” has taken on the task of deciding the merit of the theory that autism is a vaccine injury. The petitioners had two basic theories: (a) the MMR vaccine can cause autism and (b) the vaccine preservative thimerosal can cause autism.

Three hearings were heard for each theory. In each hearing a single individual took the role of a “test case”. So, each hearing not only represented the case of a single child, but also presented “general causation” evidence as to whether MMR or thimerosal could cause autism.

The six test cases (three MMR and three thimerosal) have been heard. The MMR cases were ruled upon, and all three were denied. All three were appealed. And, now, all three appeals have been denied.

Here is the conclusion of the appeal for the last of the MMR test cases, that of Colten Snyder:

As the special master’s decision makes clear, Colten, and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitioners’ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitioners’ motion for review. Pursuant to Vaccine Rule 30(a), the clerk is directed to enter judgment in accordance with this decision.

Very solid decision. The appeal was denied.

Looking back through the document one finds that the Judge noted that the case for MMR causing an injury was clearly not supported, and that the Special Master did not make an error in her decision:

The court finds no error in the special master’s findings. The special master’s conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitioners’ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. See id. at *87-93 (petitioners’ theory),
116-35 (Unigenetics’ reliability). Next, the special master’s conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record.

In a statement reminiscent of the Cedillo hearing (first MMR test case) the Judge noted that the medical records show that the “onset of symptoms” did not occur when the petitioners thought:

She [the special master] found that based on the medical records, the onset of Colten’s symptoms did not occur at the time suggested by petitioners.

It is worth reading or skimming the decision. It is a good summary of the case and the evidence presented. I don’t want to quote much more of the document here, with this exception.

Petitioners’ charge–that the special master feared a public backlash against vaccines if she ruled in their favor–is preposterous. There is not a shred of evidence to support petitioners’ claim;70 it rests solely on petitioners’ speculation. Merely because the special master found that petitioners did not carry their burden of proof does not diminish her integrity or render her decision unsupported. Claims of error by a losing party against a decision maker are hardly unusual, but should be grounded in reality.

One thing that bothered me greatly was the implication in the appeals that the Special Masters were acting improperly out of some hidden motive such as trying to protect the vaccine program or fear of public backlash. Sometimes it is difficult for a lay person like myself to understand whether such arguments are expected and “just part of the game” or whether they are attempts to impugn the integrity of the Special Master. I have read enough comments on other blogs to see that many readers are willing to accept that members of the judiciary could act to deny children due process.

I’m glad the Judge in this appeal took the time to respond to these false allegations.

It’s time for David Kirby to disavow the autism epidemic

3 Aug

The idea that mercury caused an epidemic of autism is both wrong and very damaging to the autism communities. Many contributed to this damaging notion., but David Kirby without a doubt carries a good quantity of the blame for his book “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” and efforts since.

Mr. Kirby often tries to hide behind the notion that he is just “trying to spark a national debate”. Sorry, but that is nonsense. He actively promotes the idea that vaccines cause autism. It is unclear to this reader whether Mr. Kirby is currently being paid for his efforts. In the past he cherry picked information and packaged it in seemingly self-consistent packages to convince people that an epidemic did occur.

He has now moved to a tag-team approach for presentations to the US congress. He presents information to support the idea that vaccines could cause autism. He then let’s Mr. Mark Blaxill take over to promote the epidemic with the old, tired arguments.

It’s like Mr. Kirby still wants to be able to say, “I never really said there was an epidemic. I was just sparking a discussion.” It’s Mark Blaxill that is actually calling it an epidemic.

Nonsense.

This has been bothering me for some time. It came up again strong when Mr. Kirby commented on a blog piece. David Kirby doesn’t generally participate in the online discussions-even to the point of not answering comments on his own blog pieces. He broke that tradition recently in a blog piece on the Mother Jones website: Breaking: Vaccines still don’t cause autism

My response to Mr. Kirby incorporated much of what I was considering for a future blog post. So, rather than paraphrase what I wrote, here it is in full:

Mr. Kirby,

I see your usual arguments above. I see, also, the usual gaps in your discussion. Over the years, you have gone from promoting the “vaccines caused an epidemic of autism” to dancing around the subject of the false “epidemic”, neither stating that there was an epidemic, nor admitting your mistake. Could you comment somewhere, on the record: was there an “epidemic” of autism caused by mercury? You seem to leave that to your colleague, Mr. Blaxill, giving yourself some form of plausible deniability. It is irresponsible.

You rely heavily now on the NVAC recommendations. Why do you leave out so many comments by NVAC?

The NVAC is assured by the many epidemiological studies of the effects of mercury exposure done in a variety of populations, which have demonstrated that thimerosal in vaccines is not associated with autism spectrum disorders in the general population.

Are you prepared to agree with NVAC that the data are in and that there has been no epidemic of mercury caused autism? It would be the honest thing to do.

You rely heavily on the idea that mitochondrial disorders are related to autism. You pushed heavily on your blog the idea that mitochondrial disorders are caused by mercury, without substantiation. In fact, this idea is strongly rejected by the very experts you rely upon.

Further, you leave it implied that children with mitochondrial disorders and autism indicate a link to autism as a vaccine injury. This is clearly not the case.

Why do you leave out the fact that most children with mitochondrial disorders and autism do not show regression. Without regression, it is clear that vaccine injury is not causing autism in these individuals?

Why do you leave out the fact that in the one study of children with mitochondrial disorders and autism, it is clear that vaccines are not causal in the vast majority of cases, and could be questionable in the one case cited so far?

You cite that there could be a sizable population of autistics who have a mitochondrial dysfunction. Yet you leave out the public statements by one of the very doctors who supported the Hannah Poling case in vaccine court that any such injuries are rare. This from the few doctors who support the idea of mitochondrial disorder as a vaccine injury. Other specialists have stated that it is far to early to draw a conclusion that mitochondrial disorders caused by vaccination is even “rare”.

Why have you not removed your blog piece that was so erroneous that you were forced to rewrite it within a day, with an admission that you seriously erred? Isn’t that a form of dishonesty?

Are you prepared to join Rick Rollens, one of the strongest proponents of the vaccines-cause-autism notion, in stating that the idea that MMR causes autism has been tested and MMR is no longer suspect?

I will ask again, if you are going to cite NVAC, are you willing to join them and state that mercury did not cause an “epidemic” of autism?

Would you at least be willing to include quotes from NVAC that are, shall we say inconvenient, to the notion of a vaccine induced “epidemic” of autism? Quotes such as:

Vaccination almost certainly does not account for the recent rise in ASD diagnoses; however, public concern regarding vaccines and autism coupled with the prevalence and severity of ASD warrant additional study in well defined subpopulations.

This quote makes it clear that
a) NVAC does not support the idea of an autism “epidemic” caused by vaccines
b) NVAC is not calling for studies of vaccines and autism due to evidence presented so far, but, instead, by public concern.

Mr. Kirby, your half truths and misleading arguments cause great harm to the autism communities, as well as to public health. You personally are responsible for much of the public’s misconception that mercury caused an “epidemic” of autism. Don’t you agree that you personally should publicly refute your previous stance?

Being wishy-washy on the epidemic question and letting your colleague Mark Blaxill push the idea in your tag-team briefings is just dishonest. Either you still believe in the mercury-caused-epidemic (and you are wrong) or you should be clear that it was a mistake.

It was a mistake. Earn some respect. Admit it.

Autism Omnibus: Hazelhurst appeal denied

29 Jul

The Autism Omnibus Proceedings is, for better or worse, one of the big stories in the world of autism news. Hearings have been held, using the best science and arguments that could be brought to bear. The two theories were (1) does MMR cause autism and (2) does thimerosal cause autism.

Each theory was tested using three “test cases”. Essentially, three trials for each theory, each discussing an individual child plus arguments on “general causation”.

So far, the decisions are only in on the MMR question. The answers were clear and decisive: “this is not a close case”.

The Omnibus decisions are not the end of the vaccine/autism lawsuits. Not by a longshot. The first step was an appeal, and the first appeal has been decided.

Here is the conclusion of the Judge who heard the appeal for the Hazelhurst case:

In hearing this appeal, the court is not without sympathy for Yates, the Hazlehursts, and the other children and families dealing with autism and autism spectrum disorders. And this court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is AFFIRMED.

I.e. the appeal failed. The decision stands. The Court holds that MMR does not cause autism.

The judge’s decision in the appeal gives a good summary of the original case. If you want to read about the Hazelhurst case, it would be the first place I would send you.

From the appeals judge’s ruling, here are the two “cardinal” flaws in the petitioner’s case:

1) First, the special master explained that petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus rather than on the characteristics of vaccine-strain measles, despite the fact that the measles vaccine is distinguishable from the wild-type measles virus in several key respects.

2) Second, the special master observed that petitioners’ experts further based their opinions on studies (detecting the presence of the measles virus in the gut tissue of autistic children) that the special master found to be unreliable.

The special master considered the presence of the measles virus in the gut to be the “linchpin” of the petitioner’s case. In other words, they needed to show reliable data or studies demonstrating that the virus was still in the tissues of the children long after the vaccination.
The two studies they had to rely on were (a) that by Dr. Wakefield’s team and (b) an unpublished study by Dr. Stephen Walker, presented as a poster at the 2006 IMFAR conference. Well, the Wakefield study was pretty well discredited, and the Walker study was never published.

In the appeal, the Hazelhurst’s lawyer argued that the testimony of Dr. Stephen Bustin should not have been considered. Amongst the arguments were that some of the information was submitted at the last minute.

No arguments were made that Dr. Bustin was wrong in his analysis of the O’Leary laboratory. That was one of those strange moments in law–no one challenged Dr. Bustin on being right. The judge hearing the appeal noted that the rules for the Vaccine Court are different from a typical court of law. Specifially, the rules are designed specifically to allow more information in to inform the Special Master. The judge further noted that under the typical rules of evidence, the Walker study would never be admitted anyway.

If you haven’t read about Dr. Bustin’s testimony, you should consider it now. Dr. Bustin basically discredited the entire “persistent measles in the gut” idea by showing that the O’Leary laboratory that made tests had serious methodological flaws and, basically, couldn’t make the tests at all.

The Hazelhurst’s lawyer then argued that the Special Master failed to include all the relevant evidence., In specific, that the Walker study wasn’t given due weight.

Again, one of those strange moments in law. The laywers moved directly from trying to get the Special Master to exclude evidence that was clearly relevant, to claiming that the Special Master had to include all relevant evidence. I guess that’s why I am not a lawyer. I couldn’t pull that off with a straight face.

As it turns out, even the witness for the Hazelhurts’ side stated that the Walker study wasn’t reliable:

Respondent additionally notes that Dr. Hepner herself acknowledged that the preliminary data from the study was “not useful at this time” (Cedillo Tr. at 682), declined to draw any conclusions about the biological significance of the Walker group’s findings (Cedillo Tr. at 682), and identified what respondent describes as several significant drawbacks to the study, including that the experiments had not been “blinded”28 and had lacked negative controls.

So, it is rather moot as to whether the Walker study was considered, since it doesn’t really provide substantial evidence to support the MMR theory.

The third main argument used in the appeal was that the Special Master failed to decide on a “critical issue”. Namely, whether regressive autism exists as a separate phenotype.

The Special Master wrote in his decision, and the appeals judge agreed: since the decision held that MMR doesn’t cause autism, there was no point in deciding on the question of regressive autism as a separate phenotype.

Given that the expert testimony was against this idea, it is probably better for the petetioners that this question was left unanswered.

The main result is, of course, the original decision was upheld. Looking forward, it doesn’t look good for the MMR theory to win in civil litigation from my perspective. The Bustin testimony is very damning to the little evidence there is, and that will be allowed in a civil case. The Walker study, however, will almost certainly not be allowed as it is unpublished and has severe limitation

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