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Thursday, December 10, 2015

Springer Link Ethics Journal Editors Do Something Unethical

Addendum 22 February 2016:  The journal Science and Engineering Ethics changes the formatting of their online articles during the publication process.  While the initial format of the Kern et al. (2015) review listed full author affiliations as they appeared in my first post, Conflicts of Interest are Bad, Just Not Our Own, the author affiliation are obscured now as they are in other online articles in Science and Engineering Ethics.  The author affiliations are apparent in the .pdf version.  For that Springer Link and their journal editors of Science and Engineering Ethics have my sincere apology.  However, I still stand fully behind my first post regarding this review article and given the massive undeclared conflicts of interest all the authors have and the self-serving nature of their review, this review should be retracted.

Springer Link's editors of Science and Engineering Ethics have pulled a sleight-of-hand since my last post about this spectacularly bad "review article" about conflicts of interest and transparency by a dodgy group of authors who didn't declare their own profound conflicts of interest.  Rather than retract this egregious example of dishonesty and peer-review failure, the editors simply and quietly removed the authors' affiliations.  The affiliations appear in my previous post but have been disappeared without explanation from the article. The description of Science and Engineering Ethics appears thusly:
Science and Engineering Ethics is a multi-disciplinary journal that explores ethical issues of direct concern to scientists and engineers. Coverage encompasses professional education, standards and ethics in research and practice, extending to the effects of innovation on society at large.

Recent controversies and instances of misconduct in science have attracted considerable media attention. In addition, the power of new technologies developed through science and engineering - especially as portrayed by the media - have inspired growing popular concern. Science and Engineering Ethics offers a forum for the examination and discussion of ethical issues arising in the practice of scientific research and engineering, and in the practical application of that work.

Although the focus of this publication is science and engineering, contributions from a broad range of disciplines are included.
Yet here the very editors of an ethics journal engage in a violation of ethics and commit misconduct by deleting author affiliations and allowing a completely dishonest Conflict of Interest statement remain.   As per Retraction Watch, the relevant research integrity office at the authors' institution should be contacted first.  That poses some difficulty here since most of the authors are employed by the same incestuous network of businesses and "charities" run by themselves.  I do know for a fact that the editors of Science and Engineering Ethics were contacted directly and the action that they have chosen flies in the face of publication ethics.  In any event they are:

SJ Bird: sjbird@mit.edu

RE Spier: r.spier@surrey.ac.uk

Institutional research compliance contacts for those authors who do have them are:
 
Helene Lake-Bullock
Research Compliance Officer, University of Kentucky
hlbullo@uky.edu

http://www.research.uky.edu/ori/staff.htm#HLB
Re: Boyd Haley

Gary S. Margules
Vice President, Office of Research and Technology Transfer, Nova Southeastern University
margules@nova.edu
http://www.nova.edu/rtt/staff.html
Re: Richard Deth

Danielle Beck
IRB Chair, IRB Simpson University
irb@simpsonu.edu
http://simpsonu.edu/Pages/Academics/Research/IRB/index.htm
Re: Brian Hooker

Systematic Assessment of Research on Autism Spectrum Disorder and Mercury Reveals Conflicts of Interest and the Need for Transparency in Autism Research is an egregious example of hypocrisy and should have been retracted but the editors doubled-down on publication misconduct by disappearing author affiliations which point to the plethora of conflicts of interest the authors have.  Shame on Springer Link.

My deep gratitude to capnkrunch who spotted this sleight-of-hand and brought it to my attention along with some contact information.

Thursday, October 29, 2015

Conflicts of Interest are Bad, Just Not Our Own

The Geiers, Hooker and Company have a new "Review" out which is hilariously titled,

"Systematic Assessment of Research on Autism Spectrum Disorder and Mercury Reveals Conflicts of Interest and the Need for Transparency in Autism Research"

Abstract

Historically, entities with a vested interest in a product that critics have suggested is harmful have consistently used research to back their claims that the product is safe. Prominent examples are: tobacco, lead, bisphenol A, and atrazine. Research literature indicates that about 80–90 % of studies with industry affiliation found no harm from the product, while only about 10–20 % of studies without industry affiliation found no harm. In parallel to other historical debates, recent studies examining a possible relationship between mercury (Hg) exposure and autism spectrum disorder (ASD) show a similar dichotomy. Studies sponsored and supported by industry or entities with an apparent conflict of interest have most often shown no evidence of harm or no “consistent” evidence of harm, while studies without such affiliations report positive evidence of a Hg/autism association. The potentially causal relationship between Hg exposure and ASD differs from other toxic products since there is a broad coalition of entities for whom a conflict of interest arises. These include influential governmental public health entities, the pharmaceutical industry, and even the coal burning industry. This review includes a systematic literature search of original studies on the potential relationship between Hg and ASD from 1999 to date, finding that of the studies with public health and/or industry affiliation, 86 % reported no relationship between Hg and ASD. However, among studies without public health and/or industry affiliation, only 19 % find no relationship between Hg and ASD. The discrepancy in these results suggests a bias indicative of a conflict of interest.

Keywords

Research Conflict of interest Transparency Autism Mercury Toxicants




Authors and Affiliations
  • Janet K. Kern: Institute of Chronic Illnesses, Inc., 14 Redgate Court, Silver Spring, MD 20905, USA
  •  David A. Geier: Institute of Chronic Illnesses, Inc., 14 Redgate Court, Silver Spring,   MD 20905, USA
  •  Richard C. Deth: Nova Southeastern University, Fort Lauderdale, FL, USA
  •  Lisa K. Sykes: CoMeD, Inc., Silver Spring, MD, USA
  •  Brian S. Hooker: Simpson University, Redding, CA, USA
  •  James M. Love: CoMeD, Inc., Silver Spring, MD, USA
  •  Geir Bjørklund: Council for Nutritional and Environmental Medicine, Mo i Rana,   Norway
  •  Carmen G. Chaigneau: CoMeD, Inc., Silver Spring, MD, USA
  •  Boyd E. Haley: University of Kentucky, Lexington, KY, USA
  •  Mark R. Geier: Institute of Chronic Illnesses, Inc., 14 Redgate Court, Silver Spring,    MD 20905, USA 

This study was supported by the non-profit 501(c)(3) Institute of Chronic Illnesses, Inc., and the non-profit 501(c)(3) CoMeD, Inc.

Conflict of interest

There are no competing financial interests. The authors have been involved in vaccine/biologic litigation.

Given who the authors are this review reads like a parody.  Let's take a look at their actual conflicts of interest and laugh at the sheer irony of them writing this.

The authors' COI statement of, “The authors have been involved in vaccine/biologic litigation.“ is both misleading and incomplete because it implies this litigation is in the past. Brian Hooker is currently a petitioner in the National Vaccine Injury Compensation Program on behalf of his son, Steven. Other authors, Geier, Haley and Kern are acting as expert witnesses for Dr. Hooker's case. James M. Love is providing some legal assistance. They all contend that the vaccine preservative thiomersal caused Steven Hooker's autism spectrum disorder (ASD). 
http://ia902504.us.archive.org/31/items/gov.uscourts.cofc.2340/gov.uscourts.cofc.2340.docket.html

Dr. Hooker also serves on the board of Focus for Health (https://www.focusforhealth.org/about-us/our-board/) (formerly Focus Autism) an anti-vaccine organization with the agenda to, “put an end to the needless harm of children by vaccination”.  One of their vision statements is "Investigate the relationship between thimerosal-containing vaccines and neurological dysfunction, such as tics, since CDC studies have confirmed a connection."  

The editorial staff of Translational Neurodegeneration has withdrawn Dr. Hooker's study: “Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data” stating: “The Editor and Publisher regretfully retract the article [1] as there were undeclared competing interests on the part of the author which compromised the peer review process. Furthermore, post-publication peer review raised concerns about the validity of the methods and statistical analysis, therefore the Editors no longer have confidence in the soundness of the findings. We apologise to all affected parties for the inconvenience caused.“  (Emphasis added)   http://www.translationalneurodegeneration.com/content/3/1/22

Dr. Mark Geier has a number of business interests which are all predicated upon the disproved hypothesis that the vaccine preservative thiomersal causes ASDs. The corporate headquarters of ASD Centers, LLC (http://www.autismtreatmentclinics.com/), CoMed (http://mercury-freedrugs.org/) and Institute of Chronic Illnesses, Inc. (http://www.faqs.org/tax-exempt/MD/Institute-Of-Chronic-Illnesses-Inc.html) are located at a home owned by Mark Geier. David Geier, Janet Kern, James M. Love, Carmen G. Chaigneau and Lisa Sykes all hold various positions in these businesses/charities.  Additionally, Janet Kern is on the Board of Directors of Geir Bjørklund's Council for Nutritional and Environmental Medicine (CONEM) which also has a strong focus on a mercury causation for autism. 

Mark Geier, David Geier, Janet Kern and Lisa Sykes are all involved with an elaborate grift to pay themselves for their own studies with monies from their own non-profit businesses as evidenced from their funding declaration for this study and several other studies along with three years of tax returns, 2011, 2012 and 2013 so far.  David Geier is conveniently president of the appropriately-named MedCon which pays him handsomely.  The Geier incestuous network of grifters includes appointing themselves to their own Institutional Review Board (IRB) which is supposed to oversee research and ensure ethics compliance via independent reviewers.  The Geiers and their business partners established a veritable fox-guarding-the-hen-house operation for themselves.   Kathleen Seidel meticulously catalogued the Geiers' et al.'s flouting of IRB regulations along with plagiarism, dodgy science and more egregious examples of failure to disclose conflicts of interest.  Incidentally, Ms. Seidel had to file an FOIA request to obtain the Geiers' IRB declaration.  I guess the Geiers et al. feel as though transparency is just for everyone else.

Dr. Mark Geier has had his license to practise medicine either revoked or suspended in all states where he used to hold licenses. These actions were based upon the serious charges initially investigated by the State of Maryland's Board of Physicians (https://www.mbp.state.md.us/bpqapp/Orders/D2425004.271.PDF): “The Board determined that the physician’s conduct constituted a substantial likelihood of a risk of serious harm to the public health, safety and welfare based on the physician’s experimental treatment of autistic children with Lupron.” Dr. Geier's son David Geier was charged with practising medicine without a license and fined $10,000 (http://articles.chicagotribune.com/2012-11-05/news/ct-met-autism-doctor-20121106_1_autism-doctor-david-geier-mark-geier). 

Dr. Richard Deth teaches pharmacology at Northeastern University. He was offered by the plaintiffs as an expert in the areas of physiology, neuropharmacology and the effects of thimerosal in the human brain. Dr. Deth is clearly qualified to testify as an expert witness in the areas of physiology and neuropharmacology. However, there is no recognized field of science in the third proposed area of expertise, namely "the effects of thimerosal in the human brain."

Dr. Deth offered the opinion that exposure to mercury for thimerosal-containing vaccines causes autism, based on a molecular theory that he developed through his in vitro studies. Questions about the effect mercury has in the human brain necessarily come within the ambit of the field of toxicology. These questions, including any opinions about the absorption, distribution, metabolism, and the excretion of thimerosal or mercury all involve issues of toxicology.

Further, Dr. Deth is neither an epidemiologist, a neurologist nor a geneticist. That — vel non — would not operate to preclude his testimony. However, he has never taken any courses in epidemiology, has published no papers in any epidemiological journal, and is not a member of any epidemiological societies. He relies on an epidemiology paper published by Dr. Geier as support for his opinions. (20) Further, he relies on several papers about the neurology of autism. He is not a medical doctor and is not an expert in the field of pediatric neurology. Lastly, although he relies on various studies in the field of genetics, he does not have a degree in genetics nor is he a member of any professional genetics organizations or societies. Accordingly, in light of his expressed reliance on Dr. Geier's studies (that the Court has addressed at pp. 24-38 of this Opinion), this Court finds that he lacks a sufficient factual basis to support his testimony.
Boyd Haley is President and CEO of CTI Science (the website is non-existent now) and he licensed OSR#1 developed for chelating industrial mining sludge.  He re-branded OSR#1 as a "supplement" for chelating autistic children which made millions of dollars before the FDA sent him a warning letter to cease marketing of OSR#1 as a dietary supplement.  Boyd Haley continued to sell OSR#1 for a period of time after that enjoying a ridiculous mark up on it. He is currently attempting to resurrect OSR#1 with clinical trials operating under the business name EmeraMed and renaming OSR#1, Irminix. He has a vested financial interest in flogging the failed mercury-causation of autism.  He is also a member of Geir Bjørklund's fancifully-named Council for Nutritional and Environmental Medicine (CONEM).

Geir Bjørklund and Jim Love appear to be just another dodgy scientist and sleazy lawyer respectively getting in on the mercury grift that has successfully scared parents into buying shonky products to treat "heavy metal" toxicity in their autistic children and legal services for "mercury injuries".

To say that the authors' declared conflicts of interest is lacking is an understatement.  Every single one has a financial and personal stake in perpetuating the myth that thiomersal causes autism and/or mercury is responsible for mythical diseases.  And not one of these authors declared their actual conflicts of interest while writing about others' conflicts of interest.  Allowing a "review" such as this, by these authors to be published in an ethics journal is beyond the pale and even worse to let it remain in the public domain.

ETA 29.10.15: Thanks to comments by capnkrunch and Chris Preston who provided me with more accurate information on the study authors, I have made corrections within the body of the text.  I really appreciate the comments that keep this blog as accurate as possible.

ETA 1.11.15: Updated to include more information supplied to me by the excellent Kathleen Seidel and Matt Carey.  Thank you.

Update 12.14.17: Retraction Watch issued a post about the retraction and subsequent replacement of this study which includes some correction of material errors and a more accurate conflict of interest statement.  The retraction notice states:
Based on an assessment by the Editors, the Conflict of Interest statement of this article is inadequate because it fails to disclose conflicts of interest in addition to the declaration that “the authors have been involved in vaccine/biologic litigation.” In particular, Janet Kern is a board member of CONEM (Council for Nutritional and Environmental Medicine) and Geir Bjorklund is that organization’s founder and President. Mark Geier and David Geier do work under the auspices of the non-profit Institute for Chronic Illnesses, Inc. Lisa Sykes, Mark Geier and David Geier are officers of the Coalition for Mercury-free Drugs (CoMeD, Inc). Richard Deth is on the scientific advisory board of the National Autism Association. Brian Hooker is on the board of Focus for Health. James Love has been involved in amalgam litigation. Boyd Haley is involved in the development of a mercury-chelating agent. Some of the authors have a personal as well as a professional interest in autism. In addition, some authors are or have been involved in litigation related to vaccines and autism.
Furthermore, the article itself contains a number of errors, and mistakes of various types that raise concerns about the validity of the conclusion. As a result, this article is being retracted by the editors without the agreement of the authors. The online version of this article contains the full text of the retracted article as electronic supplementary material.

Tuesday, October 27, 2015

Atlanta Anti-Vaxx Rally Shifted Something...Just Not a Paradigm.


Please join us as we generate a new paradigm

I've slogged through the video of the entire rally supplied to me by an attendee, read the "educational" materials offered and perused photos of this event and it's about as paradigm-generating as the seasonal migration of Canada Geese.  I've transcribed many quotes and will mostly let them speak for themselves but nothing replaces listening to the entire talks by the few speakers I have selected.  But first, some literature that appeared at the great "new paradigm-generating" rally:





First up is Toni Bark, a "holistic" physician in an Illinois private practice offering a veritable cornucopia of bogus tests and "alternative" products.  Her entire speech is riddled with inflammatory rhetoric and outright fabrications but this gem at the end was particularly special (18:50):
"Don't kid yourself, if you don't take care of your body then you are contributing.  Every time you buy your prescriptions, you need a procedure, you need these meds to stay alive, you're contributing.  You have to vote with your money.  That means respecting your body, we need a health revolution and we need to tell 'Big Food' and 'Big Pharma' to eff off."
Huh, so all those people with insulin-dependent diabetes, people with raging bacterial infections and people with cancer don't respect their bodies are all just contributing to the problem when they buy their meds.  I guess Dr. Bark's dispensary must be filled with homeopathic nostrums and Bach's Flower Essences.  What a smug self-righteous cow.

Michelle Ford, the event organiser and founder of yet another anti-vaxx "advocacy movement" VIAL (and likes to use the royal "we") perhaps sensed the paltry crowd's despondence over being a paltry crowd at such a "paradigm-shifting" event and offered up this awesome porky (1:31.15):
"I hear there's a big thing going on on Interstate 20 so we've got a few buses from Alabama that are stuck.  So anyway we're just going to have to be with them in spirit and generate that they can get here because man they moved mountains to be able to get themselves out here on those buses...12 buses.  That's right."
I don't know how "a few" is "twelve" but anti-vaxxers are rather innumerate and prone to exaggeration but I guess it must make sense to them. The U.S. South isn't exactly a hotbed of anti-vaxx activity and if this rally couldn't pull a dozen local buses into a large metropolitan city then how can they expect us to believe they got 12 busloads of anti-vaxxers from Ala-freakin-bama.  I guess this "big thing on I-20" is just part of the conspiracy.

I think my favourite speaker was Tony Muhammed, completely devoid of reality but an entertaining and charismatic speaker.  At the 7:20 mark of his talk he states:

"The honourable Elijah Muhammed in the 30's and 40's warned the members of the Nation of Islam that there are wicked people in high places who are coming up with experimental chemicals that could hurt the human family of the planet.  And we were always warned NOT to take certain vaccines.  And as a result, we have not suffered from the autism, from the measles, from the many viruses and sicknesses that's happening in our community."
On one hand Mr. Muhammed is saying that his people had the forethought to avoid vaccines and didn't "suffer from the autism", yet managed to avoid measles and presumably other vaccine-preventable diseases but on the other they are happening in his community.  I don't speak batshit crazy so perhaps someone would like to help out here.  At 8:03 he relays his boss' stunning ability to identify the exact contemporary event which was foretold millennia ago:
"The honourable Louis Farrakhan also said, 'this is prophesy, I need you to listen.' He said, 'When you go into the Book of Exodus there was a Pharaoh who saw in the Book of Exodus that the slaves was [sic] getting restless.  And the Pharaoh knew that it was time for a deliverer to bring them out from his control.  And Pharaoh made this statement, 'Come and let us deal wisely with them.' Then he said, 'Let's kill the male and spare the female.' Then Minister Farrakhan went to the New Testament. He said, 'Under Herod, Herod looked at the stars and he knew that it was time for a deliverer to come and lead the people to a new kingdom.  And Herod said, 'Let's kill all babies two and under.'  So it is no surprise that the vaccine makers have now increased the vaccine and are trying to get it to our boys before they are three years old. It's in prophesy."
Yup, the enslavement and slaughter of the Israelites is just like the completely concocted idea that two year-old, Black boys are preferentially given "the autism" from vaccines. Furthermore, it takes an ego of indescribable proportions draw this comparison.  I'm no Biblical scholar but how did the Pharaoh of the Exodus get a hold of the Book of Exodus which hadn't been written yet? 
"He then went to the book of Revelations as I close.  He said, 'In Revelations, there is a woman in Revelations who is pregnant with a child and then there's a dragon standing in front of the woman but the dragon wanted to devour the child before it was born.'  Now the big pharmaceutical companies, they have become the dragon of this whole planet and all of their products once you've injected them into you body or take it through your mouth it drags your mind down and you lose control."
Religion as an art form can mean anything you want it to mean and Tony Muhammed exploits that to it's fullest.  He then goes on to mock U.S. Congressman Elijah Cummings (D-MD) (19:06):
"And when I went to Congress, Elijah Cummings, I gotta tell you the truth.  Elijah Cummings is over the Oversight Committee and both Bobby Kennedy and myself went to this Negro and this Negro...excuse me I'm getting a little touched...I have him the information from the honourable Minister Louis Farrakhan and said, 'Brother Elijah we need you to look into this.' He said, 'Brother I'll look into that, we just had him [William Thompson] up here ten years ago.' And I said, 'Yeah Dr. Thompson lied to you.' He said, 'Well I'm going to look into this.' I said, 'If you look into this Brother we will stand behind you, the whole Nation will stand with you.'

Two days later, I did not know that in two days he learned how to moonwalk.  He called me back with a crackling sound in his voice.  He said, 'Brother Tony look I...I...I just want you to know I'm pro-vaccine.' I said, 'I don't care about you being pro-vaccine I asked you to call Dr. Thompson and subpoena him.'  'I don't know if I can do that...I just think you hooked up with some crazy people I think your information is wrong.' I said, 'Brother are you punking out?'  'I'm not a punk Brother I'm just telling you [unintelligible] I ain't got time to talk.' I said, 'That's okay, Minister Farrakhan likes bad news fast.'  And he hung up.  Guess who I called?  Minister Farrakhan.  He said, 'That's all right Brother.  I told you Pharaoh has some magicians.' He said, 'Not only have our Black politicians been bought but over 95% of our White politicians have been bought.'"
I can't be sure but calling a politician "Negro" and "punk" and "bought-off" may not be the kind of diplomacy that will get one any future consideration.  It's too bad that Tony Muhammed and Robert Kennedy didn't consider their involvement with crazy people and that their information is in fact wrong and not going to gain any traction with politicos, other than perhaps Rep. Bill Posey.

The last speaker, presented as "our fearless leader" was Robert F. Kennedy, Jr.  His entire speech was filled with demonstrably false statements so I just picked some choice bits beginning at 3:45:


"The director of the Office of Research Integrity (ORI), who's the guy who's supposed to make sure we have honest science in all the agencies, he said the problems with the CDC and FDA were so intractable, that the science was so corrupt, that it could not be corrected.  And so he resigned his job.  So it's not just Robert Kennedy who says there's a problem at the CDC."
Yes it kind of is actually.  The Director of the ORI did resign but not even mention the CDC nor FDA.  Then at 5:08:
"So when I was a little boy I had to take three vaccines, my children had to take 69 vaccines.  Now why did that change?  It all changed in one year, 1989."
Children today don't even get 69 vaccines and his were born in 1984, 1988, 1994, 1995, 1997 and 2001The schedules have also changed such that if his children were vaccinated according to schedule they would have received some different vaccines but no where near 69 even into adolescence.  RFK, Jr. is a pandering fool and he continues to bring it on:
"It all changed in 1989...that all of these diseases that we never heard of when I was a boy, all of a sudden they started.  And we have today the sickest generation of children in the history of the world.  [Applause] All of these diseases, ADD, ADHD, we didn't know about these things when I was a kid."
Who knew that ADHD (ADD is really a sloppy use of ADHD) is a disease.  It has always struck me odd that proudly announcing one's ignorance of something and using it as proof that it is something entirely new when you've finally heard of it is not something you should be proudly announcing.  RFK, Jr. goes on to claim that there is a higher level of mercury in vaccines than coal.  Of course he also doesn't bother to make a distinction between the different species of mercury.  He then makes a rather odd announcement:
"And by the way my child was destroyed by them, by this mercury." 
WTF is that supposed to mean?  Did he just say that he has a "vaccine-injured" child?  All these years he's been caterwauling about thiomerosal and only just now he decides to announce this?  I'm sure his child would be thrilled to know his father thinks he was destroyed too.  RFK Jr. displays the typical mindset of the anti-vaxxer not only with what he just said but this:
"Anecdotes ultimately become science"
All these years that scientists have been conducting research to answer questions and all we really had to do was collect anecdotes.  I feel so silly wasting years and money on my education.  What would an anti-vaxx rally be without invoking a plot involving the Eeeveeel Dr. Offit (16:58):
"So let me give you an example, in 1989 Paul Offit was like the Lex Luthor of vaccines and he sits in a chair at the Children's Hospital of Philadelphia that is paid for by Merck, a 1.5 million dollar grant by Merck.  So he is already a toady of Merck's and he was allowed to sit on the committee that approved the rotavirus vaccine.  He owned the patent to the rotavirus vaccine.  He didn't recuse himself.  He voted to add that to the schedule.  Once it got on that schedule it was worth billions of dollars and he sold his patent for $182 million.  Do this was a little bit of a scandal and the Inspector General of HHS went to investigate it and what they found was this is horrible, this is catastrophic, it shouldn't be happening but guess what?  It's completely legal under CDC's rules."
Of course it's legal and a non-issue because non of this happened the way RFK, Jr. described.  Dr. Gorski explains how the Hilleman Chair works and it's not even CHOP's, it's the University of Pennsylvania's School of Medicine's.  The chair didn't even exist when Dr. Offit voted to put a competitor rotavirus vaccine, Rotashield on the ACIP schedule, not his own RotaTeq as the dunderhead RFK, Jr. stated.  Nor was this ever a scandal.  Dr. Offit didn't own the RotaTeq patent, CHOP did, sold it and Dr. Offit's share, along with two other inventors amounted to about $6 million.  But RFK, Jr. isn't going to let pesky facts get in the way of a perfectly good slanderous rant.  He closes with an inept "challenge" to Dr. Frank DeStefano of the CDC (29:50):
“Dr. Frank DeStefano, who runs the Vaccine Division [at the CDC] and orchestrated this corruption, Dr. DeStefano is a criminal and he committed scientific research fraud and he is guilty of ijuring all these people. I'm saying that and I am using his name. If what I'm saying is untrue it is an act of slander and I want him to sue me. If he didn't do I, he ought to sue me. He ought to file a suit this afternoon and enjoin me from ever saying that again. If someone said that about me I would sue them immediately. I'm saying to you Frank DeStefano, if you didn't poison these children, you need to sue me right now and shut me up because what I'm saying to you is damaging to your career. Let's see what he does on Monday”
Well it's now Tuesday and still no one gives a toss about RFK, Jr.'s petulant little rant.  No one sums it up better than Herr Doktor Bimler though:
"It would require the purportedly defamed individuals to show that Kennedy had enough credibility and standing in the community for the stupid spilling out from his mouth to injure their reputations."
Brian Hooker was scheduled to speak but didn't show up and no one mentioned him even though he was an architect of the "CDC Whistleblower" nonsense and of course only author of his incompetent/fraudulent "re-analysis" of DeStefano et al. (2004) .  It struck me as odd that given his role, no credit was given to him nor any utterance of remorse that he couldn't make it there.

This was the first time I watched back to back talks by anti-vaxxers and it was educational.  They all present competing ideas of autism-causation via vaccines be it thiomersal, toxins, MMR, too-many-too-soon or even any.  But no one questions them nor do they question each other.  They just keep talking past one another and all nod in agreement (and they call us sheeple).  But when you're unencumbered by facts, your own reality is just a hand-wave away.

Thursday, September 24, 2015

When Pro-Vaccine Goes Wrong

Every blogger gets emails to flog someone's materials and are either ignored or dealt with more creatively.  Mostly we ignore them but yesterday Just the Vax received a solicitous email asking us to promote a "new lifestyle movement" that couldn't be ignored:

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FOR IMMEDIATE RELEASE


PARENTS FOR VACCINATIONS LAUNCHES LIFESTYLE MOVEMENT
Brand Wristband Promotes Pro-Vaccination Choice

August 24, 2015, Los Angeles, CA – Los Angeles based mom, Trisha Gum, today has launched a new website to promote vaccinations for children called Parents for Vaccinations.  The website was created to generate a pro-vaccination lifestyle and make it easy for that lifestyle choice to be instantly recognizable.

Years ago parents could depend on herd immunity to protect young children and people of all ages who suffer from health conditions leading to immunodeficiency.  With the increasing number of parents who choose to delay vaccinating their children, or skip vaccination altogether, that general reliability is no longer the case. 
“As a mom of two small children, I knew all the typical safety questions parents ask whenever their kids meet up for a play-date or visit an unfamiliar home: Is there a pool, and is it fenced or covered? Do you smoke? Do you have a dog?” states Gum. “Recently it dawned on me there was a new safety question to ask; and with this wristband, the question is easily answered.”

Approaching this important vaccination question is made easier, in fact, even eliminated with the Parents for Vaccinations lifestyle wristband.  The bright orange silicone wristband on children’s wrists alerts everyone that the child’s parents believe in vaccinations.  The wristbands are available in six sizes from toddler – adult and are $3.95 with family-pack discounts available. 

Like herd immunity, the vaccination process is a numbers game. The goal of Parents for Vaccinations is to band together and change the conversation across the country. The brand is launching the hashtag #raiseyourwrist to be used on Facebook, Instagram, and Twitter to create a sense of community for the movement.

A portion of the Parents for Vaccinations wristband proceeds will benefit nonprofit organizations that provide education and outreach for vaccinations nationwide.  For more information on Parents for Vaccinations, please visit www.parentsforvaccinations.com.


About Parents for Vaccinations
Parents for Vaccinations believes that parents have a responsibility to make sure they are prepared for whatever risks their kids may encounter. With several credible news reports regarding outbreaks of long-dormant childhood diseases, Parents for Vaccination families have chosen to trust their pediatrician and make what they believe is the only responsible choice. The brand’s bright orange silicone wristband promotes this choice via a simple, visual announcement. Parents for Vaccinations love vaccinations. They love that those vaccinations protect their kids and make their family, their neighborhood, and their hometown a little safer. To join the movement and share this message, please visit www.parentsforvaccinations.com and socially via @parentsforvaccinations on Facebook and Instagram, and @ParentsForVax on Twitter. 


Media Contact
White Handed PR
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At best, this is not a well-thought-out campaign and at worst, carpet-bagging on the increased awareness of the anti-vaccine movement.  First, this "campaign" promotes identifying the nice, little vaccinated children to play with each other with a wristband to the exclusion of everyone else very much like...
Secondly, who's to say that an unvaccinated family can't buy these wristbands to make a point in order to let their unvaccinated children be able to play with the "identifiable" vaccinated children?  It's pitting children against children and punishing children for their parents' decisions while claiming the high ground and celebrating sanctimonious self-righteousness.  It's just plain wrong and won't do anything to promote increased vaccination uptake.  On the contrary, it will turn people off, even those of us who promote vaccination and work (on our own time and own dime) countless hours to counter anti-vaccine propaganda.

Lastly, at the time of this writing Parents for Vaccinations did not list the "non-profit organizations" they intend to donate the proceeds for the sale of the wristbands to nor the percentage of each sale that would be donated (it's certainly something I consider before making a purchase).  They also haven't declared (and provided proof) that these wristbands were manufactured in a facility that doesn't use child and/or forced labour.

While perhaps well-intentioned, this campaign is seriously misguided.  I hope that Ms. Gum will re-direct this campaign to make this a conversation between parents and not use children as vehicles to distinguish the "good" parents from the "bad" parents.  Much of what perturbs me about this campaign is that it feeds into the "Mompetition" style of parenting that we can do without.  Parenting isn't an Olympic competition.

Thursday, September 3, 2015

Kidnapping...Now a Vaccine Adverse Event.

A bizarre story of kidnapping has emerged in California which has been (tastelessly) dubbed, the "Gone Girl" kidnapping.  It was initially believed by the Vallejo Police that kidnap victim, Denise Huskins and her boyfriend Aaron Quinn perpetrated a hoax.  That was not the case as Matthew Muller, a former Marine and disbarred attorney was arrested for the kidnapping of Ms. Huskins.
The man charged in a California kidnapping that police initially dismissed as a hoax said he acted alone, and that mental illness and a side effect from a vaccine contributed to his behavior, the FBI said in a court filing.

Matthew Muller made the comments to a television news reporter during a jailhouse interview in July, FBI Special Agent Wesley Drone said in an affidavit in support of a search warrant. The reporter was not allowed to record the interview and had been asked by Muller not to reveal his comments about acting alone and the vaccine. She did report that Muller said he felt bad for the kidnapping victim and thought the victim deserved an apology.
This sounds like just the type of story that Robert F. Kennedy, Jr. can throw his weight behind and use on his "U.S. tour" as an example of how dangerous vaccines are.

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 Thimerosal...in 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...

Monday, June 1, 2015

Once Again No, Vaccines Did Not Harm Children in Mexico


A couple of weeks ago the autism-hating, anti-vaccine blog Age of Autism ran a story of vaccines killing and hospitalising several infants in Chiapas, Mexico during a routine immunisation programme.  As of this writing only one commenter linked to a news story of possible bacterial contamination and the author of the blog post hasn't even bothered to issue a correction.

However, Orac in his usual Respectful Insolence style correctly urged patience for the investigation to conclude and that bacterial contamination was a more likely explanation.  Well that investigation has concluded and it was a bacterial source but not from the vaccines themselves but rather externally during handling and administration:
  • Although no hypothesis is not rejected, the only vaccine given in common to all children affected was that of Hepatitis B, so the research focused on the biological.
  • The batch of the vaccine was properly certified.
  • No adverse events were recorded after 100,000 doses were administered in various parts of the country since Oct. 2014.
  • Results of blood cultures at that time showed the presence of the local external contamination, outside the biological vaccine, in particular bacteria, which was consistent with the clinical pictures of hospitalized children. Microbiology studies conducted on children reported the finding of Staphylococcus hominis, a type of bacterium commonly found in the skin of people. These findings rule out other bacteria, such as those found in the gastrointestinal tract and airways. Molecular studies demonstrated that isolated Staphylococcus hominis in different patients was the same, namely that the bacteria came from a single source of contamination.
  • In conclusion, the Federal Commission for Protection Against Health Risks (COFEPRIS) analysis found that the vaccine was not defective and remained in temperature. Therefore, bacterial contamination occurred during the procedure of handling and application of the vaccine.  
While the conclusion that the vaccines were manufactured and stored properly can help establish confidence in vaccine programmes, two infants are dead and dozens were hospitalised due to improper handling of the vaccines.  This tragic result emphasises the need for more rigorous training of personnel administering any medications.  This was an avoidable error and the focus should be on that, not vaccinesdidit.

Thursday, May 14, 2015

In Remembrance of Lilady


A friend and fellow skeptic known as "Lilady" has passed away leaving a huge hole in our hearts and on the internet.   She was an omnipresent voice on numerous blogs and articles regarding vaccines and autism and will be sorely missed.

Lilady had a severely developmentally and medically disabled son whom she cared for with the deepest love and commitment I have ever known.  She became a fierce opponent of state mental institutions that cruelly warehoused special needs people and fought tirelessly for their closure.  She was the original Mother Warrior.  Through her trials and tribulations along with other parents of special needs children, she "adopted" the son of a friend whom she helped care for until Lilady passed away.

Lilady's advocacy extended to the internet where she was a prolific commenter on vaccine and autism articles.  She fearlessly questioned dubious stories, provided sound evidence to support her claims and was never intimidated by anyone.  Her decades-long expertise as a public health nurse along with her experience with special needs children and adults and fierce passion made her a formidable foe of anti-science purveyors.

Our thoughts are with her and her family and hope they know how appreciated, respected and missed their Lilady will always be.

Monday, February 23, 2015

18 month old, unvaccinated, previously healthy toddler dies of measles in Berlin outbreak

Berlin, Germany's capital, has seen a very large measles outbreak on the past months. Since October 2014, 574 measles cases had been reported.

Today, the Berlin health senator confirmed that on 18 February 2015, an 18 month old toddler, who had not been vaccinated against measles, and did not have any chronic disease, died after having been treated for measles infection in the Charité hospital for 5 days. While the child was vaccinated against some diseases, according to the German media, he had not received the recommended MMR. In Germany, the first MMR is usually given between 11 and 14 months and the second is recommended between 15 and 24 months.

Over the past couple of years, discussions about mandatory vaccination had come up in Germany, some child care centers had begun to only accept vaccinated children, and discussions are unlikely to subside now. The question is whether parents, who are already afraid/suspect of the government could be convinced by a mandate - suggestions are welcome how to reach them better.

Meanwhile, our heartfelt thoughts go to the boy's family and everyone whose lives he touched. Another preventable measles death too many.

Tuesday, February 17, 2015

The Measles Vaccines (MMR and MMRV) Protect Against Measles


Photo: http://imgbuddy.com/measles-virus-picture.asp


A new anti-vaxx myth has surfaced which seems to have been developed as a result of my recent blogpost Disneyland Measles Outbreak is Due to Measles which discussed the measles genotype responsible (hint: it wasn't the vaccine strain).  Some, with no knowledge of virology nor immunology are spreading the myth that since the measles strain in the MMR vaccine is genotype A that it couldn't possibly protect against measles genotype B3 which is the genotype responsible for the latest U.S. outbreak and has spread to Mexico and Canada.  I will discuss how and why MMR vaccines are cross-protective for wild-type measles strains.

First there is some terminology which must be understood to follow along:
Serotype: Microorganisms of the same species can be further divided into serotypes, serovars or sub-groups based upon their surface antigens.

Antigen: A structural protein on the surface of a pathogen that is able to recognise cell receptors on the surface of a host cell.  The antigen is also the part of the pathogen which provokes the host adaptive immune response that generates antibodies.

Epitope: The very specific part of the antigen which antibodies attach to.

Genotype: The nucleotide sequence of certain regions of a viral genome which classifies differences.

The measles virus has only one serotype and causes measles unlike Human Papillomavirus which has dozens of serotypes and can cause different diseases.  This is why we see multiple serotypes included in the HPV vaccine and only one strain in each of the available measles vaccines which are all genotype A.
Many of the attenuated strains in use are derived from the Edmonston strain isolated in 1954, including the Schwartz, the Edmonston-Zagreb, and the Moraten strains. Other strains which are not derived from Edmonston strain include the CAM-70, TD 97, Leningrad-16, and Shanghai 191 (Ji-191) strains.
Measles virus genotypes are based upon their nucleotide sequences at the least conserved regions of the viral genome:
Wild-type measles viruses have been divided into distinct genetic groups, referred to as genotypes, based on the nucleotide sequences of their hemagglutinin (H) and nucleoprotein (N) genes, which are the most variable genes on the viral genome.
The 450 nucleotides encoding the carboxy-terminal 150 amino acids of the nucleoprotein has up to 12% nucleotide variation between genotypes. The 450 nucleotides that encode the carboxy-terminal region of the nucleoprotein (N–450) are required for determination of the genotype. The measles genotyping protocol is available from CDC.

Photo: http://download.thelancet.com/images/journalimages/0140-6736/PIIS0140673610623525.gr3.lrg.jpg

What this means is that whenever a measles case occurs, a sample (throat or nasal swab) is taken from the patient, submitted to RT-PCR (reverse transcription-polymerase chain reaction) and PCR (polymerase chain reaction) which are molecular techniques to essentially isolate amplify the number of DNA copies so that they can be sequenced.  DNA sequencing determines the nucleotide sequences of specific genome regions and then compared to other isolates to see where the measles virus came from and also mutations that may have accumulated.

Recovered measles viruses are constantly monitored, tested and characterised to identify areas of the genome which may antigenically-drift.  Circulating measles viruses have also been tested against vaccine-derived antibodies to ensure vaccines will cross-protect against the numerous genotypes that are imported.  This is achieved through virus neutralisation assays for example.  This is a test that combines measles genotypes with serum samples of people either vaccinated or previously infected with wild-type measles to determine if antibody binding occurs.  A fluorescent tag is added and then the antibody-antigen complex is measured. Results of various assays demonstrate that vaccine-derived antibodies protect against many different measles genotypes:
The serum samples from recently vaccinated persons neutralized both the Moraten and Chicago-I viruses equally well (table 1): There was a less than 2-fold difference in neutralization titers. In contrast, serum samples from persons with a recent wild type infection were able to detect antigenic differences between the viruses. Sera in this set had neutralization titers against Chicago-l that were 4-8 times higher (average, 5.1) than the titers against the vaccine strain.
Very specific antibodies called monoclonal antibodies (MAbs) are also developed and tested against measles viruses including the vaccine strains to monitor vaccine efficacy and antigenic drift of measles genotypes:
Overall, the antigenic data indicated that some epitopes have been conserved between the vaccine strain and the recent wild type viruses, while others are unique to the recent wild type virus. The H and F proteins are responsible for the induction of a neutralizing antibody response to measles virus. Therefore, the antigenic differences were most likely due to variation in these surface glycoproteins. 

Protection against the current circulation measles genotype, B3 has been elucidated.  In other words, studies have been and are conducted to test antibodies derived from vaccination against numerous wild-type measles viruses.  Measles genotype B3 which is the currently circulating strain in the U.S., is neutralised by vaccine-derived antibodies.  That, in turn, means that the virus can't bind to host (human) cell receptors and cause disease.
On the basis of the sequences of their N and H genes, MeVs can be assigned to 1 of 23 genotypes and 1 provisional genotype [11, 12]. All vaccine strains and their wild-type progenitors are assigned to genotype A. Experiments with monoclonal antibodies have defined antigenic differences between the H proteins of genotype A vaccines and the H proteins of wild-type viruses grouped in other genotypes [62, 188, 189]. However, there is only 1 serotype for measles, and serum samples from vaccinees neutralize viruses from a wide range of genotypes, albeit with different neutralization titers [188, 190] More importantly, despite the presence of different endemic genotypes, vaccination programs with standard measles vaccines have been successful in every country where they were performed adequately [191193]. Suboptimal seroconversion after vaccination is likely the result of inadequate coverage; improper administration, transport, or storage of vaccine; or age of the vaccine recipients [194196].
It's a bit of a complex issue to digest but some key points are that measles vaccines induce many different antibodies against measles antigens.  There is some antigenic drift that renders a single antibody insufficient binding to a single antigen from some wild-type measles viruses but over all, vaccines protect us from many different genotypes including the currently circulating B3 genotype. The epidemiology of the measles outbreak also demonstrates the effectiveness of the MMR vaccine.  To date there have been 141 cases confirmed (dozens more reported) by the CDC. Measles is one of the most infectious diseases known and this interactive graphic demonstrates how measles can spread in variable susceptible populations.  If the vaccine did not proffer cross-protection, there would be tens of thousands of cases to date.  Obviously this is not the case as the majority of cases are unvaccinated.

A more easily-digestible version of this has been posted at The Scientific Parent.