Undisclosed Conflicts of Interest in Vaccine Research

Conflicts of interest (COIs) are very important considerations in research. The most obvious COIs are financial; the researcher may receive financial gain for one result versus another, or they will at least avoid losing current or future income if they get a specific result. But COIs could also be non-financial. Perhaps they have family or close friends that would prefer one outcome versus another. Or they might hold a volunteer position of authority in the sponsor's organization. Whatever form they take, COIs may not necessarily invalidate a study, they hold the potential to influence scientists' behavior during a study, their analysis of the data, and the conclusions they draw from their research. Sometimes, the researcher may not even be fully aware of the influence of their COIs on their work. Blinding can help reduce the influence of conflicts of interest, but any COIs must be disclosed so that anyone who reads the study can think about how they may have influenced the study design, the methods, the analysis, and the conclusions.

When it comes to published research, most journals require authors to disclose both financial and personal relationships with other organizations or people that could bias their study. Failure to disclose COIs can be grounds for refusal of a manuscript or retraction of a paper that has already been published. It can really damage the researcher's reputation, but it can also harm the reputation of the journal.

This all brings us to a study that was originally published as an uncorrected proof in the journal Vaccine, and later withdrawn by the journal: Behavioral abnormalities in young female mice following administration of aluminum adjuvants and the human papillomavirus  (HPV) vaccine Gardasil, by Rotem Inbar, Ronen Weiss, Lucija Tomljenovic, Maria-Teresa Arango, Yael Deri, Christopher A. Shaw, Joab Chapman, Miri Blank, and Yehuda Shoenfeld.

A Snapshot of the Deep Pockets of the Anti-Vaccine Movement

Research is expensive. Lab techs, study coordinators, grad students and post-docs have their salaries (often a pittance compared to the importance of their work and the skills required); primary investigators (PIs) have theirs. Then there are the costs for materials - drugs or other substances under investigation, reagents, etc., as needed. Statisticians, equipment. The expenditures add up.

And PIs spend a considerable amount of their time just seeking out grants to support their research. Many rely heavily on government entities like the National Institutes of Health, one of the largest funders of research in the United States. Some research funds come from industry sources, the results of which need somewhat greater levels of attention to suss out the valid results from the bias. Others find support from private donors and foundations.

This latter source is the bread and butter of cranks and pseudoscientists (well, with the addition of the NIH's National Center for Complementary and Alternative Medicine, but that's a whole other post). For example, Mark Geier (who has had his various medical licenses stripped for unethical conduct) and his son, David (who has no medical licenses and was found by the Maryland Board of Physicians to have practiced medicine without a license), essentially fund themselves through their non-profit corporations CoMeD, Inc. and Institute of Chronic Illnesses, Inc. Other anti-vaccine researchers, perhaps lacking their own wealth, rely on other individuals and families devoted to the "vaccines cause autism" myth who happen to have significant assets to fund their dubious research.

Such is the case with a new study by Christopher Shaw and Lucija Tomljenovic, titled Administration of aluminium to neonatal mice in vaccine-relevant amounts is associated with adverse long term neurological outcomes (back in December 2011, Orac pointed out the flaws of the study [Edited to add February 5, 2015: the study Orac discussed formed the basis for the 2013 study I discuss here.]). This study received significant funding from The Dwoskin Family Foundation and the Katlyn Fox Foundation, both of which have funded previous studies by one or both of this duo.