Testimony of Dr. James Lyons-Weiler (PhD) Re: Dr. Kelly Sutton’s Case Relevant Experience: Dr. Lyons-Weiler has 20+ years research in biomedical sciences (basic, translational, clinical). He has been a teacher of research study design courses to graduate students and medical residents. He led the design and analysis on over 100 basic, translation and clinical research studies at The University of Pittsburgh. He taught the design and analysis of health outcome-related designs of studies to residents and physicians at the University of Pittsburgh Cancer Institute; He is a world-renowned expert in molecular diagnostics and treatment prognostics using mixed data (biomarkers, clinical & demographic data) and has an extensive recent record of research in vaccine safety science, including studies on the toxicity of aluminum dosing in pediatric vaccines, comparisons of alternative vaccine schedules, and a recent vaccinated vs. unvaccinated study. He has published a peer-reviewed study on the likelihood of disease caused by proteins included in COVID19 vaccines, and he has provided peer-review for studies on the development of COVID19 vaccines. Re: The Case of Dr. Kelly Sutton When physicians are confronted with differences among patients in their ability to tolerate medicine in cancer treatments, it is widely understood and appreciated that underlying, unseen biological differences may exist among patients with respect to their ability to tolerate and indeed survive specific treatment regimens. No one expects that all patients will respond equally well (or poorly) to all prescription drugs; physicians often attempt a particular route of treatment, only to discover it is either ineffective or that the patient is intolerant of the initial treatment, and alternative therapies are sought. With vaccines, the presumption of the population-wide approach to vaccination is that the vaccines are sufficiently safe (i.e., tolerable by a sufficient percentage of patients) such that the specific approach for any given vaccine should be to vaccinate as many people as possible, with as few exceptions as possible. I wish I could say that the science on vaccine safety supported the notion that vaccine adverse events are rare. Instead, I am sorry to have to report that the field of vaccine safety science is rife with studies that smack of tobacco science, including all of the following flaws in the design of the study, or its analysis: - Over-reliance on observational studies, which fall short of providing sufficient evidence for, or against, causality assessment adverse events; - Insufficient statistical power to detect serious adverse events (small sample numbers); - Non-representativeness of the population studied; - Testing irrelevant and unrelated hypotheses; - Adjustment of the study design after peeking at the results; 1 - Repeated rounds of data analysis in search of a result that fits a pre-supposed outcome favoring vaccine safety; - Non-reporting of clear evidence of association of adverse events with exposure to vaccines; - Manipulation of study group composition to obtain the desired analysis outcome - Reliance on causal non-determination inferences by physicians of new conditions that present during the course of clinical trials for new vaccines in search of adverse events that might be caused by the vaccine; - Failure to use an inert placebo for the control group exposure, favoring instead either an active adjuvant (like aluminum oxyhydroxide) or another vaccine - Direct influence of funding source personnel on the design of studies or reviews, representing a direct and overt serious conflict of interest (Delong, 2012) These and other flaws have been reviewed by myself carefully (see IPAK Report (Lyons-Weiler, 2018)), and by others (e.g., Hooker et al., 2014). Physicians like Dr. Sutton are confronted with patients presenting with symptoms or sets of symptoms following vaccination for which the consensus holds that the vaccines did not cause the adverse health outcomes, they are faced with either accepting the consensus opinion (which emits primarily from the Advisory Committee on Immunization Practices, or ACIP), or from directives from the US Centers for Disease Control and Prevention. This has motivated scientific research in my research program. Both ACIP and the CDC fall under the administration of the US Department of Health and Human Services (US HHS). US HSS is the defendant in the National Vaccine Injury Compensation Program (NVICP), which it also administers, a clear breach of the separation of powers clause. My research on vaccine safety science began in an innocuous manner. I was writing a book, and had decided to add a chapter on vaccines to celebrate their successes. Given my expertise and experience in the design of clinical research - and in the development of algorithm to predict patient health outcomes using biomarkers in cancer and other diseases - I had expected that vaccine safety science would be top-notch, with gold-standard, double-blinded, inert placebo studies being used to determine the causality of any adverse health outcomes. The general concept at the time (2015) was that vaccines were effective, had saved millions of lives, and were, for the most part, safe, save the rare bad luck of a “hot lot” of vaccines. We have since learned that vaccine lots are distributed geographically at random to prevent communities from learning about hot lots. By that time, mercury (ethylmercury, specifically) had been removed from pediatric vaccines out of an abundance of caution, and it had been determined (so we were told) that vaccines do not cause autism. In my personal experience with vaccines, I had decided 2 to space my own children’s’ vaccines out, in an abundance of caution. Importantly, no pediatrician ever expressed any concern over the decision to space out vaccines for my two sons. When I tried to write the chapter on vaccines, I found that I could not in good faith report that vaccine safety science was rigorous and robust, and therefore I could not report that vaccines were safe & effective. What I reported instead were some of that mentioned in the list above on the flaws and shortcomings of vaccine safety science. When the chapter was complete, I knew that the chapter itself would kill the popularity of my book, but I felt obligated to report what I had found. The most damning evidence of scientific wrongdoing came in the form of the interviews between Dr. Brian Hooker and Dr. William Thompson of the CDC. Dr. Thompson had been put on administrative leave for bringing concerns over his co-authors’ plan to exclude certain results from a report of the Institutes of Medicine (IOM), an arm of the National Academy of Sciences that was changed by Congress to conduct regular reviews of the safety of pediatric vaccines. Time and again the IOM had determined that there was insufficient evidence to rule in or rule vaccines as a contributing cause of autism (See NAS, 2012). Dr. Thompson provided Dr. Hooker, as well as Congressman Dan Burton (FL) with evidence that the CDC willfully altered the study design of a study of on-time vs. delayed Measles, Mumps & Rubella (MMR) to bring about a different result than had been found via the initial analysis. The hacked study was eventually published infamously as Destefano et al., (2014). I immediately recognized this as a flaw known as “analysis-to-result” (aka “p-hacking”), in which a scientific investigator might wish to find a particular relationship or result in a collection of data that favored their pet hypothesis, but, upon conducting their experiment or study, found the “wrong” result. After looking at the initial result, either by changing the study design or the design of analysis, investigators can “find” the result that fits their pet hypothesis, assuring publication and grants. This type of activity is universally recognized as posing a serious threat to the validity of any scientific study (e.g., Head et al., 2015; Bruns and Ioannidis, 2016; Bin Abd Razak et al., 2016; Raj, 2018; Pedroni et al., 2019). Dr. Thompson’s revelations to Dr. Hooker were a stunning indictment not only of the scientific validity of that single study (which was eventually published as Destefano et al., 2008), but also of the way CDC handled the actual doing of science, and also of the integrity of the investigators and CDC leadership itself. Instead of seeking to resolve the issue raised by Dr. Thompson’s appropriate, earnest and forthright expression of concern, Dr. Julie Gerberding saw fit to put Dr. Thompson (through an intermediary) on leave so Dr. Frank Destefano could present the results instead. Dr. Frank Destefano, the lead author, admitted to news journalist Sharyl Attkisson that their decisions to change the study design were arbitrary and unable to rule out a causal link between vaccines and autism (Appendix 2; Transcript of the Interview between Dr. Frank Destefano, CDC and Sharyl Attkisson, Journalist). As egregious and disturbing as these 3 revelations were, the most disturbing revelation to me was the reveal from Dr. Thompson that CDC had a “sanitation” committee to which all manuscripts for all vaccine-related studies had to be submitted for review prior to submission to a research journal so any negative inferences about vaccines could be modulated (minimized) via language change. Upon listening to those recordings, reading the transcripts, and eventually reading Dr. Thompsons’ admission issued via his lawyer, I decided to embark on a path in my career from which I knew there could be no reward - and from which there could be no return. I read and evaluated all of the studies that CDC had cited that claimed to show that vaccines were not related to autism (see IPAK report (Lyons-Weiler, 2018). I found them deeply disturbing. I found, first of all, that not all vaccines had even been studied for association with autism, and that some studies exist that have, in fact, reported association (Fig.