Clinical Trials and Epidemiologic Studies Biased by False and Misleading Data From Research Participants

Many legal commentators erroneously refer to epidemiologic studies as “admitted” into evidence.[1] These expressions are sloppy, and unfortunate, because they obscure the tenuousness of study validity, and the many hearsay levels that are represented by an epidemiologic study. Rule 702 permits expert witness opinion that has an epistemic basis, and Rule 703 allows expert witnesses to rely upon otherwise inadmissible facts and data, as long as real experts in the field would reasonably rely upon such facts and data. Nothing in Rule 702 or 703 make an epidemiologic study itself admissible. And the general inadmissibility of the studies themselves is a good thing, given that they will be meaningless to the trier of fact without the endorsements, qualifications, and explanations of an expert witness, and given that many studies are inaccurate, invalid, and lack data integrity to boot.

Dr. Frank Woodside was kind enough to call my attention to an interesting editorial piece in the current issue of the New England Journal of Medicine, which reinforced the importance of recognizing that epidemiologic studies and clinical trials are inadmissible in themselves. The editorial, by scientists from the National Institute of Environmental Health Studies and the National Institute on Drug Abuse, calls out the problem of study participants who lie, falsify, fail to disclose, and exaggerate important aspects of their medical histories as well as their data. See David B. Resnik & David J. McCann, “Deception by Research Participants,” 373 New Engl. J. Med. 1192 (2015). The editorial is an important caveat for those who would glibly describe epidemiologic studies and clinical trials as “admissible.”

As a reminder of the autonomy of those who participate in clinical trials and studies, we now refer to individuals in a study as “participants,” and not “subjects.” Resnik and McCann remind us, however, that notwithstanding their importance, study participants can bias a study in important ways. Citing other recent papers,[2] the editorialists note that clinical trials offer financial incentives to participants, which may lead to exaggeration of symptoms to ensure enrollment, to failure to disclose exclusionary medical conditions and information, and to withholding of embarrassing or inculpatory information. Although fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators, the participants’ misconduct can seriously bias and undermine the validity and integrity of a study.

Resnik and McCann’s concerns about the accuracy and truthfulness of clinical trial participant medical data and information can mushroom exponentially in the context of observational studies that involve high-stakes claims for compensation and vindication on medical causation issues. Here are a couple of high-stakes examples.

The Brinton Study in Silicone Gel Breast Implant Litigation

In the silicone gel breast implant litigation, claimants looked forward to a study by one of their champions, Dr. Louis Brinton, of the National Cancer Institute (NCI). Brinton had obtained intramural funding to conduct a study of women who had had silicone gel breast implants and their health outcomes. To their consternation, the defendants in that litigation learned of Dr. Brinton’s close ties with plaintiffs’ counsel, plaintiffs’ support groups, and other advocates. Further investigation, including Freedom of Information Act requests to the NCI led to some disturbing and startling revelations.

In October 1996, a leading epidemiologist wrote a “concerned citizen” letter to Dr. Joseph Fraumeni, who was then the director of Epidemiology and Genetics at the NCI. The correspondent wrote to call Dr. Fraumeni’s attention to severe bias problems in Dr. Brinton’s pending study of disease and symptom outcomes among women who had had silicone breast implants. Dr. Brinton had written to an Oregon attorney (Michael Williams) to enlist him to encourage his clients to participate in Brinton’s NCI study.   Dr. Brinton had also written to a Philadelphia attorney (Steven Sheller) to seek permission to link potential study subjects to the global settlement database of information on women participating in the settlement. Perhaps most egregiously, Dr. Brinton and others had prepared a study Question & Answer sheet, from the National Institutes of Health, which ended with a ringing solicitation of “The study provides an opportunity for women who may be suffering as a result of implants to be heard. Now is your chance to make a major contribution to women’s health by supporting this essential research.” Dr. Brinton apparently had not thought of appealing to women with implants who did not have health problems.

Dr. Brinton’s methodology doomed her study from the start. Without access to the background materials, such as the principal investigator’s correspondence file, or the recruitment documents used to solicit participation of ill women in the study, the scientific community, and the silicone litigation defendants would not have had the important insights into serious bias and flaws of Brinton’s study.

The Racette-Scruggs’ Study in Welding Fume Litigation

The welding fume litigation saw its version of a study corrupted by the participation of litigants and potential litigants. Richard (Dickie) Scruggs and colleagues funded some neurological researchers to travel to Alabama and Mississippi to “screen” plaintiffs and potential plaintiffs in litigation for over claims of neurological injury and disease from welding fume exposure. The plaintiffs’ lawyers rounded up the research subjects (a.k.a. clients and potential clients), talked to them before the medical evaluations, and administered the study questionnaires. Clearly the study subjects were aware of Scruggs’ “research” hypothesis. The plaintiffs’ lawyers then invited researchers who saw the welding tradesmen, using a novel videotaping methodology, to evaluate the workers for parkinsonism.

After their sojourn, at Scruggs’ expense to Alabama and Mississippi, the researchers wrote up their results, with little or no detail of the circumstances of how they had acquired their research “participants,” or those participants’ motives to give accurate or inaccurate medical and employment history information. See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006) (a largely duplicative report of the Alabama welders study).

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette’s Alabama study on welding and parkinsonism). After the defense had the opportunity to obtain and analyze the underlying data in the Scruggs-Racette study, the welding plaintiffs largely retreated from their epidemiologic case. The Racette Alabama study faded into the background of the trials.

Both the Brinton and the Racette studies are painful reminders of the importance of assessing the motives of the study participants in observational epidemiologic studies, and the participants’ ability to undermine data integrity. If the financial motives identified by Resnik and McCann are sufficient to lead participants to give false information, or to fail to disclose correct information, we can only imagine how powerful are the motives created by the American tort litigation system among actual and potential claimants when they participate in epidemiologic studies. Resnik and McCann may be correct that fabrication or falsification of medical history and data by research participants is not research misconduct by the investigators themselves, but investigators who turn a blind eye to the knowledge, intent, and motives of their research participants may be conducting studies that are doomed from the outset.

[1] Michael D. Green, D. Michal Freedman, Leon Gordis, “Reference Guide on Epidemiology 549, 551,” in Reference Manual on Scientific Evidence (3d ed. 2011) ( “Epidemiologic studies have been well received by courts deciding cases involving toxic substances. *** Well-conducted studies are uniformly admitted.) (citing David L. Faigman et al. eds., 3 Modern Scientific Evidence: The Law and Science of Expert Testimony § 23.1, at 187 (2007–08)).

[2] Eric Devine, Megan Waters, Megan Putnam, et al., “Concealment and fabrication by experienced research subjects,” 20 Clin. Trials 935 (2013); Rebecca Dresser, “Subversive subjects: rule-breaking and deception in clinical trials,” 41 J. Law Med. Ethics 829 (2013).

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