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). 

Richard Deth sits on the Board of the National Autism Association which is a vaccine-causation group and heavily involved with bogus "biomedical treatments/cures" for autism.  He was more than "involved in vaccine/biologic litigation", he was a paid "expert" for the petitioners for the Omnibus Autism Proceeding and a really bad one at that.

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.