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.

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.