Monday, August 24, 2015

"Vaccine Whistleblower": A Review of the Preface and Foreword

This book is being released today and is surely much anticipated by the anti-vaccine brigade which has desperately sought to get their "whistleblower" William Thompson heard by, well anyone in a position of authority or respected media.  Even the anti-vaxx-funded Rep. Bill Posey, R-FL couldn't raise any interest in the "CDC Whistleblower" manufactroversy when he made allegations against the CDC parroting William Thompson's uncorroborated claims.  Kent Heckenlively, a contributor to the autism-hating, anti-vaccine blog Age of Autism breathlessly proclaims:
"This is a slim, elegant book which can be read in a few hours and has the potential to change the minds of a lot of people."
It will, no doubt change the minds of a lot of people, it certainly changed mine but not in the way that Kent Heckenlively hopes.  It will only reinforce the true believers' minds but certainly illuminates the true colours and motives of those involved as well as show how desperate some are to think that so little is of such import as to have a congressional hearing over it.  This book is so bad that it's good, so good in the sense that it contains such demonstrably false information and a re-hash of previously debunked claims that I have chosen to review it in parts, the first being the Preface (Boyd Haley) and Foreword (Robert F. Kennedy, Jr. (RFK Jr.)), Introduction and then groups of chapters.

Preface by Boyd Haley, PhD

The Preface is written by Boyd Haley, PhD and formerly with the University of Kentucky Department of Chemistry.  Boyd Haley has been a long term steadfast proponent of the "autism is mercury poisoning" failed hypothesis.  He has referred to autism as "Mad Child Disease" and has created OSR #1 as an industrial sludge chelator but saw the financial opportunities and re-branded OSR #1 as a "supplement" for "treating autism". Fortunately the FDA forced Haley to remove OSR #1 from the market as a supplement but that hasn't stopped him from still attempting to take advantage of desperate parents; he's just doing what he should have done to begin with which is properly test and manufacture the product as a drug that needs approval.
I was exposed to the opinions of both autistic parents and the CDC on the involvement of vaccines, or components of vaccines, in the well-recognized epidemic of autism that started in approximately 1990. I came to this issue as a scientist. I am not the parent of a child with autism, nor, to my knowledge, are any of my relatives afflicted with this illness.
Thank you Boyd Haley for that time-saving tip.  Here I thought that autism prevalences were estimated via systematic collection and analyses of data but all we need to do is get the opinions of "autistic parents" [sic] and the CDC.  Haley's contempt of autistics is also noted.
I'm not sure what his significance is as a scientist is; he's a chemist and his only contribution to "autism research" has been some self-serving, dodgy letters and studies with the likes of the Geiers, Sykes and Blaxill.
The material herein, mostly presented by Dr. Thompson, a self-described whistleblower, details his experiences with inappropriate CDC handling of data used in peer reviewed journals to demonstrate vaccine safety. His statements are incredibly damaging to the reputation and credence of any work that the CDC supported that addresses the autism and vaccine safety issue.
There is indeed a disconnect with this claim by Haley as according to him and his confederates, the studies which cannot find any association between particular vaccines and vaccine constituents are never accepted by them but someone like William Thompson can make mere assertions and that's somehow damaging to the CDC and unravels all the vaccine safety studies they have conducted.  Haley like RFKJr. seem to think that the CDC is the sole arbiter of vaccine science everywhere in the world.
The inability of the CDC to identify the causes of Autism Spectrum Disorders, no matter the rate, is apparent. Perhaps the reluctance of its leaders to appropriately consider potential causes that they find unpleasant to accept is the reason.
Haley is erecting an absurd strawman here.  He somehow tasks the CDC with being the only agency responsible for identifying Autism Spectrum Disorders aetiology and when they don't, it must be vaccines and that is an inconvenient truth they don't wish to acknowledge.  It's really a shame that anti-vaxxers can't get better representation.
Vaccine safety goes well beyond autism as well. It is disturbing to think that the comparatively high infant mortality rate that the US has compared to its peer nations, many of which have schedules far less aggressive than the US’s schedule and many of which do not mandate vaccination, may be explained, at least in part, by the possible illness-inducing effects of our vaccine program. Would the lack of safety research be an explanation for the CDC’s claim of one in six children with neurodevelopmental issues in the United States?
Haley makes a very rookie mistake by invoking the vaccines-cause-infant-mortality canard.  There is no association and one of the biggest mistakes that people who believe this and disseminate this make is that the definition of infant mortality from country to country is static.  It is very disingenuous of Haley to perpetuate this myth; he claims he has the acumen to comprehend vaccinology but completely fails to apply any scrutiny to what amounts to be an urban, anti-vaxx myth.
However, with the recent success in the push by the vaccine industry supporters to demand all children be vaccinated, this series is as necessary for parents and pediatricians to read as it is for our congressional members to read and investigate thoroughly.
This is a case of "be careful what you wish for".  I know true believers like Boyd Haley think that this book is going to be the spark that finally gets their congressional hearing or somesuch but I suspect all it will do is fall by the wayside like their previous attempts to garner attention for #cdcwhistleblower.  If this is any indication of what the book contains then a bunch of unsupported statements and a few talking heads telling readers what they ought to believe is going to have a very disappointing outcome indeed.

Foreword by Robert F. Kennedy, Jr.

RFKJr. begins with the obligatory, "I have always been fiercely pro-vaccine." but then predictably degrades into the usual anti-vaccine rhetoric.  RFKJr. bemoans the "continued presence of vaccines..." implying that Thimerosal is still in vaccines; it isn't.  It's only present in some multi-dose influenza vaccines and not paediatric vaccines nor those recommended for pregnant women.  He makes a claim that displays his ignorance and/or dishonesty regarding influenza vaccines:
Thimerosal is still present in four American vaccines, including giant “bolus” doses in fifty million flu vaccines administered each year to American adults, pregnant women, and infants.
What exactly are "giant bolus doses"?  RFKJr. would like us to believe that somehow larger-than-recommended doses of influenza vaccines are administered just because they contain thimerosal.  But let's look at some actual numbers.  Thimerosal-free influenza vaccines comprise the bulk of the supply, 66-68% to be exact or 116-118 million out of a total of 171-179 million manufactured.  The uptake for pregnant women and infants and young children is about 50% which is an order of magnitude below the availability of thimerosal-free influenza vaccines which are what is recommended for pregnant women and children less than three years old.   RFKJr. can't even qualify his statements with any evidence that these populations are receiving thimerosal-containing influenza vaccines.  In my opinion, his statement is intentionally inflammatory rhetoric and is relying upon those reading to just take his word based upon his namesake.

RFKJr. proclaims that because he published a book (my friend's ten year-old son published a book too) that he is some kind of expert in thimerosal.  He goes on to make lofty and completely unsupported claims that thimerosal is responsible for a litany of disorders and diseases.  Amusingly, other self-appointed "vaccine experts" jockeying for notoriety amongst the anti-vaxx brigade all have their own pet claims that aluminium, GMOs and foetal DNA are responsible for the same disorders and diseases that RFKJr. says thimerosal is responsible for.  RFKJr. even goes on to repeat the same hoary old trope that a broken multi-dose vial of influenza vaccine in a physician's office requires evacuation and environmental hazmat clean-up:
Thimerosal is so toxic that when a doctor carelessly shatters a multidose flu vial, state laws require evacuation of the building and clean-up by trained hazmat crews wearing protective boots, gloves, and respirators. Common sense should tell us that it’s not a good idea to inject this poison into infants or expectant mothers.
No, no and no; this is patently false and as an environmental activist or at least know someone at the EPA who could have helped him out with this one, RFKJr. should know better; I suspect he does but the reality doesn't make for whipping up indignation.  Multi-dose influenza vials contain ten doses or 5mL total volume.  There is 25μg ethylmercury per dose or 250 μg total in a full vial of a thimerosal-containing influenza multi-dose vial.  Let's compare this to a compact fluorescent bulb or CFL which contains 4-5 mg of elemental and highly volatilised mercury and what is required for cleanup and disposal.
Ventilate the room, clean it up and dispose of in a proper hazmat container.  But RFKJr. is perpetuating the myth that a full multi-dose vial with about 20 times less mercury (and a less toxic form) than a CFL somehow requires full hazmat cleanup.

RFKJr. introduces the thrust of the book and the players involved, namely Brian S. Hooker and William Thompson by immediately inflating their credentials and work to make them seem more relevant and knowledgeable than they actually are.  To whit:
Barry built his book upon four legally taped conversations between CDC senior vaccine safety scientist Dr. William Thompson and Simpson College professor and epidemiologist, Dr. Brian Hooker.
"Legally taped conversations" is arguable since William Thompson stated he didn't know he was being recorded and Brian Hooker lives in a state which requires knowledge and permission of both parties being recorded.  William Thompson isn't nor ever has been a "senior vaccine safety scientist".  He's a psychologist and worked briefly in the CDC's National Center for Immunizations and Respiratory Diseases, Influenza Division and also the National Immunisation Program.  Thompson also used to work for Merck but I guess that's only cause to discount someone if they are pro-vaccine.  Brian Hooker is a biochemical engineer, he has no epidemiology education nor experience as evidenced by his retracted Translational Neurodegeneration study in which he attempted a "re-analysis" of the 2004 DeStefano et al. MMR study and failed miserably.  Brian Hooker works in a second tier, private Christian liberal arts college with an undergraduate enrolment the same size as my child's elementary school.
He [Thompson] is also coauthor of the CDC’s seminal 2004 study known as DeStefano 2004, which dismissed the link between the MMR vaccine and autism. That study has been cited in ninety-one subsequent published studies and is one of the principal cornerstones for claims by the CDC and the vaccine industry that vaccines do not cause autism.
Another easily falsifiable claim by RFKJr.  DeStefano et al. (2004) is not a "seminal" study about MMR and autism.  Hell, reviews of MMR-Autism studies were being conducted prior to 2004 and DeStefano et al. (2004) is only one in a long list of studies from all over the world which cannot find any association between MMR vaccination or Thimerosal and autism.  RFKJr. goes on ad nauseam about (completely unsupported) statements William Thompson has made about rampant corruption within the CDC's Immunisation Safety Office.  RFKJr. also reiterates Thompson's claims of details about the "CDC's tricks for executing the fraud" but is nothing but hearsay from a person who hasn't even conducted statistical analyses for the studies he claims are fraudulent nor does he even have any expertise.  Thompson via RFKJr. claims:
That’s the gimmick the CDC has perfected, in order to preserve the illusion of Thimerosal safety. In the 2007 study, CDC scientists removed the low IQ individuals and individuals with autism or other neurological diagnosis from the pool before even beginning their study on Thimerosal exposure.
This is about as dishonest as someone can get since "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years" wasn't even inclusive of autism per the own authors' parameters who include William Thompson.
Since the CDC is conducting a separate case–control study of autism in relation to mercury exposure, a measure of autism was not included in the test battery.
That is because a separate study examining Thimerosal exposure and autism was in the works and subsequently published as "Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism".  This study is remarkably absent from discussion for some very (not really) strange reason i.e. people like RFKJr. are confounded by the results:
In the covariate adjusted models, we found that an increase in ethylmercury exposure in 2 of the 4 exposure time periods evaluated was associated with decreased risk of each of the 3 ASD outcomes.
More on this later.  Going back to the Thompson et al. (2007) study, RFKJr. confidently proclaims that:
Despite those crooked presentations, scientists still found a persistent signal for tics, a family of grave neurological injuries, including Tourette’s syndrome that are associated with autism. Thompson now says that his bosses at the CDC pressured him to also alter the results of that study in order to conceal Thimerosal’s risks. Thompson says that the CDC’s Developmental Disabilities branch chief, Frank DeStefano, and his superiors at the CDC pressured him to manipulate the study’s findings and to bury the truth. In response to this pressure, the published version downplayed data showing that Thimerosal causes “tics.”
These are very serious allegations, allegations that would result in possible criminal penalties.  But glaringly absent is how?  Thompson didn't conduct the statistical analyses but being the lead author, he would have access to them and the raw data so should be able to provide definitive and conclusive evidence as to how the study's findings were manipulated but there is none.  Thompson et al. (2007) assessed 42 neuropsychological outcomes, tics being just one.  Thompson via RFKJr.   claims that "the published version downplayed data showing that Thimerosal causes "tics." yet the study results state:
Among boys, higher exposure to mercury from birth to 7 months was associated with significantly better performance on letter and word identification on the Woodcock–Johnson test, third edition (WJ-III), poorer performance on the parental rating of behavioral regulation on the Behavior Rating Inventory of Executive Function, and a higher likelihood of motor and phonic tics, as reported by the children's evaluators.
That is an accurate reporting of what they found and they can't say that "Thimerosal causes tics" because they also found significant positive associations:
We found no consistent pattern between increasing mercury exposure from birth to 7 months and performance on neuropsychological tests. Among girls, the only significant findings were two associations with better test performance. Among boys, there was a beneficial association between mercury exposure and identification of letters and words on the WJ-III and a detrimental association with behavioral regulation and motor and phonic tics according to the ratings of evaluators. An association with tics was also found in one HMO in the screening analysis of the CDC's Vaccine Safety Datalink4 and an analysis of the General Practice Research Database.21 The replication of the findings regarding tics suggests the potential need for further studies.
Thompson can say anything he likes but without evidence, they are just baseless charges.  Thompson too appears to be very dishonest by claiming causality.  If he is such a good investigator he should know that an epidemiological study cannot establish causality.  RFKJr. then veers the crazy train back to the MMR-causation claim:
The damage isn’t isolated to mercury-triggered neurological injuries. When Thompson discovered that the MMR vaccine was causing dramatic rises in autism in African American boys, his CDC bosses ordered him to keep his mouth shut. Thompson coauthored a seminal 2004 study on the MMR subsequently published in Pediatrics. He now admits that, under pressure from his superiors, his team fraudulently withheld data demonstrating a 340 percent higher risk of autism in African American boys who received that vaccine on time compared to boys who delayed the vaccine.
There is that claim of "seminal 2004 study" again; it's not and makes me wonder if RFKJr. knows what the word means.  DeStefano et al. (2004) did not find a "340 percent higher risk of autism in African American boys...", that was Brian S. Hooker and his incompetent "re-analysis" that apparently William Thompson helped him with.  Again I ask, if there were manipulation of the data in the DeStefano et al. study, how and why didn't Thompson give the missing data to Hooker?
When Thompson sent a letter complaining about the fraud to CDC director Julie Gerberding, her lackey, Robert Chen, chief at the Immunization Safety branch, stalked Thompson into the CDC’s parking lot to menace and threaten him. Thompson would be fired, Chen explained pointedly, if his complaints persisted.
Where is this letter?  In all of the "more than 100,000 documents" that Thompson allegedly gave Rep. Bill Posey and many to Brian Hooker, none are this letter?  Julie Gerberding has not been director of the CDC since 2009, just one of now countless facts RFKJr. can't seem to nail down.  More importantly, Thompson makes another serious allegation which is possibly a criminal activity and that is being menaced and threatened by a very accomplished and respected CDC scientist with more than 30 years of employ with the agency.  How very odd that such a blatant display of harassment could take place but Thompson is the only one to have experienced this.
Because of that study, doctors and public health officials continue to give that vaccine to children, even though its links to autism are proven in this and many other studies. On the basis of all the population data and the CDC’s most recent autism incidence estimates, at least 100,000 African American male children could have been spared debilitating neurological injury if the CDC scientists had told the truth when Thompson and his team first discovered the increased risk in 2001.
It truly boggles the mind that RFKJr. can make this leap; there are no other studies that "prove" MMR is "linked" to autism and again, even removing the DeStefano et al. (2004) study from the literature, there still exists dozens more powerful studies which cannot find any association.  It's pure race-baiting.  RFKJr. goes on to use Thompson's completely unsubstantiated hearsay to "verify" the "well-documented corruption at the CDC's Immunization Safety Office."  This appears to be the only somewhat supported allegation that RFKJr. has been able to make but has nothing to do with Thompson as he wants us to believe.  RFKJr. cites some reports such as Conflicts of Interest in Vaccine Policy Making (2000) which certainly exposes some problematic practices and it's also 15 years old, much has happened since then.  He also cites CDC Off Center (2007) in which then Senator Tom Coburn didn't agree with some spending that the CDC engaged in and even blamed the CDC when they got ripped off by employees and grantees, not much there.  Levinson (2008) found a substantial percentage of Special Government Employees within the CDC were not completing financial and conflicts of interest disclosures.  RFKJr. also invokes David Wright's scathing exit from the Office of Research Integrity but the CDC is not mentioned contrary to what RFKJr. claims.  None of this is any evidence of fraudulent behaviour by CDC scientists which is the crux of this book.
Thompson and his attorney have handed over thousands of damning CDC documents to Congressman Bill Posey of Florida in the hope that Congress will subpoena him to testify under oath.
So where are they?  If anti-vaxxers like RFKJr. and Brian Hooker want action then why is this the best they have to offer?  Rep. Bill Posey read a statement allegedly from William Thompson on the House floor in July:
At the bottom of Table 7 it also shows that for the non-birth certificate sample, the adjusted race effect statistical significance was huge. All the authors and I met and decided sometime between August and September ’02 not to report any race effects for the paper. Sometime soon after the meeting, we decided to exclude reporting any race effects, the co-authors scheduled a meeting to destroy documents related to the study. The remaining four co-authors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can. However, because I assumed it was illegal and would violate both FOIA and DOJ requests, I kept hard copies of all documents in my office and I retained all associated computer files. I believe we intentionally withheld controversial findings from the final draft of the Pediatrics paper. 
If this is from Thompson, he has yet to acknowledge it although I don't doubt the veracity of the statement; it's just curious that this appears to be what Thompson wanted but is silent on the matter.  Thompson states that they decided to exclude reporting race effects but yet the final study does report race effects.  If Thompson can be this confused about such an easily verifiable fact in his own study, what does that say about his actual expertise and integrity?  His allegation that documents were illegally destroyed is very suspect and contrary to standard procedure for document dumps after electronic records are established.  Thompson so much as admits he reviewed the documents and thought they should be discarded but in the same breath accuses his co-authors of illegal document destruction.  Anti-vaxxers are putting their faith in yet again, another very suspicious person.

To be continued...