TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Quackers & Cheese – Trump Picks Kennedy to Study Vaccine Safety

January 11th, 2017

Science necessarily involves a willingness to follow evidence to whatever conclusions are warranted, if conclusions properly can be had. When it comes to vaccination conspiracies, Democrats have it in their political DNA to distrust pharmaceutical companies that research, develop, and manufacture vaccines. The current Republican party, which has been commandeered by theocrats and populists, see vaccination as federal government aggrandizement, and resist vaccination policy as contrary to God’s will. Science is often the loser in the cross-fire.

And so we now have the public spectacle of watching the left and the right join in similar scientific apostasies. Consider how both McCain and Obama both suggested that vaccines and autism were related in the 2008 election. (Although both candidates were to some extent slippery in their suggestions, which might have been appropriate given how little they knew about the controversies.) And consider Michelle Bachmann was converted to a similar view about the HPV vaccine on the basis of a woman’s anecdote about her child. And then on the far left, you have the uplifting story of Robert F. Kennedy Jr, and his brief on how thimerosal supposedly causes autism.

So it should be no surprise that Donald Trump, a Birther, a Mirther, a mid-night Twitterer, should embrace the anti-vaccination movement. Trump has made it clear that he rejects evidence-based policy, and so no one should expect him to embrace a scientific policy that is driven by high-quality scientific evidence. According to Kennedy, Trump wants Kennedy to head up a “commission on vaccine safety and scientific integrity.” Michael D. Shear, Maggie Haberman & Pam Belluckjan, “Anti-Vaccine Activist Says Trump Wants Him to Lead Panel on Immunization Safety,” N.Y. Times (Jan. 10, 2017); Domenico Montanaro, “Despite The Facts, Trump Once Again Embraces Vaccine Skeptics,” National Public Radio (Jan. 10, 2017).

Who needs the National Academy of Medicine when you can put a yutzball lawyer in charge of a “commission”?

Some of the media refer to Robert F. Kennedy Jr. as a vaccine skeptic, but their terminology is grossly inaccurate and misleading. Kennedy is a vaccine denier; he has engaged in a vitriolic campaign against the safety and efficacy of vaccines. He has aligned himself with the most extreme deniers of science, medicine, and public safety, including the likes of Andrew Wakefield and Jenny McCarthy. Kennedy has not merely engaged hyperbolic rhetoric against vaccines, he has used his radio show on the lawsuit industry’s Ring of Fire, to advance his campaign against public health as well as to shill for the lawsuit industry on other issues. SeeRFK, Jr.: Science Shows That Autism — Mercury Link Exists – PT. ½,” Ring of Fire (Mar 8, 2011).

Kennedy should not be characterized as a skeptic, when he is a shrill ideologue, for whom science has no method that he is bound to respect. Back in July 2005, Kennedy published an article, “Deadly Immunity,” in both Rolling Stone and on Slate’s website. The article was a hateful screed against Big Pharma and government health agencies for an alleged conspiracy to hide the autism risks of thimerosal preservatives in vaccines. Several years later, on January 16, 2011, Salon retracted the article. Seehttps://en.wikipedia.org/wiki/Deadly_Immunity” entry in Wikipedia. See also Phil Plait, “Robert F. Kennedy Jr.: Anti-Vaxxer,” Slate (June 5 2013) (describing Kennedy as a full-blown anti-vaccination conspiracy theorist); Rahul K. Parikh, M.D., “Inside the vaccine-and-autism scare: A pediatrician traces the rise of the anti-vaccine movement that falsely linked thimerosal with autism and turned parents away from the most lifesaving medicine in history,” Salon (Sept. 22, 2008); Keith Kloor,Is Robert F. Kennedy Jr. Anti-Science?” Discover Magazine (June 1, 2013); Steven Novella, “RFK Jr.s Autism Conspiracy Theory,” (Jun 20 2007).

Back in 2008, President Obama apparently considered Robert Kennedy for a cabinet-level position, but on sober reflection, thought better of it. See Steven Novella, “Politics and Science – The RFK Jr. Test,” (Nov. 07 2008). The Wall Street Journal, joined by many others, are now urging Trump to think harder and better about the issue, perhaps with some evidence as well. See Alex Berezow & Hank Campbell, “Ignore Anti-Vaccine Hysteria, Mr. Trump: Robert F. Kennedy Jr.’s conspiracy theories have no place in the White House,” Wall Street J. (Jan. 10, 2017).

Credible Incredulity

May 19th, 2016

Has skepticism become a victim of political correctness and adversarial zeal?

In the last century, philosopher Bertrand Russell advanced intelligent skepticism against myriad enthusiams and mindless beliefs, political, religious, and pseudo-scientific. Russell saw unwarranted certainty as a serious intellectual offense:

“The fundamental cause of the trouble is that in the modern world the stupid are cocksure while the intelligent are full of doubt.”

Bertrand Russell, “The Triumph of Stupidity” (1933), Mortals and Others: Bertrand Russell’s American Essays, 1931-1935 , at 28 (1998).  When many American intellectuals were still in their love swoon over Stalin, Russell chastised the Soviet dictator for his betrayal of ideals and his enslavement of Eastern European. Stalinism’s certainty about politics and science was not a virtue, but a grave sin.  Or, in Russell’s words:

“One of the painful things about our time is that those who feel certainty are stupid, and those with any imagination and understanding are filled with doubt and indecision.”

Bertrand Russell, New Hopes for a Changing World at 4-5 (1951).

In the 21st century, ideologues of various stripes have tried to silence healthy skepticism and doubt by claiming that their critics have “manufactured doubt.”[1] This aggression against skepticism and doubt, joined with a biased conception of conflicts of interest, have become part of a concerted campaign to privilege tendentious scientific claims from critical scrutiny.

Philosopher Susan Haack, who has aligned herself on occasion with these politicized acolytes of certainty,[2] recently has pushed back, with a reminder that credulity for unwarranted claims, in all walks of life, is unethical.[3]  Haack’s essay is a delightful effort to clarify what credulity is, and to explore why credulity is an epistemologic vice and a social hazard, as well as the implications for citizens and scientists of living in an evidence-based, not a faith-based world.

Drawing inspiration from the the English mathematician and philosopher, William Kingdon Clifford, Haack has adopted one of Clifford’s bon mots as her motto:

“The credulous man is father to the liar and the cheat.”[4]

Indeed! And credulous judges and juries are the parents to specious claims and shyster lawyers.

Clifford’s essay should be required reading for politicians, judges, regulators, and legislators who evaluate the claims of scientist advocates.  Spurning ethical relativism, Clifford identified the key intellectual “sin” in an evidence-based world:

 “It is wrong always, everywhere, and for anyone, to believe anything upon insufficient evidence.”

William K. Clifford, “The Ethics of Belief,” 29 Contemporary Rev. 289, 295 (1877).

Professor Haack should be commended for her fulsome irony for publishing in a journal of one of the world’s more credulous institutions, and for reminding us that credulity is an intellectual vice.


[1] See, e.g., David Michaels, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health (2008); Naomi Oreskes and Erik M. Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (2010).

[2] See, e.g.,Bendectin, Diclegis & The Philosophy of Science” (Oct. 26, 2013).

[3] Susan Haack, “Credulity and Circumspection: Epistemological Character and the Ethics of Belief,” 88 Proc. Am. Catholic Philosophical Assn 27 (2015).

[4] citing and quoting William K. Clifford, “The Ethics of Belief ” (1877), in Leslie Stephen and Sir Frederick Pollock, eds., The Ethics of Belief and Other Essays 70, 77 (London 1947).

The IARC Process is Broken

May 4th, 2016

Last spring, the International Agency for Research on Cancer (IARC) convened a working group that voted to classify the herbicide glyphosate as “probably carcinogenic to humans.” The vote was followed by IARC’s Press Release, a summary in The Lancet,[1] and the publication of a “monograph,” volume 112 in the IARC series.

IARC classifications of a chemical as “probably” carcinogenic to humans are actually fairly meaningless exercises in semantics, not science. A close reading of the IARC Preamble definition of probable reveals that probable does not mean greater than 50%:

“The terms probably carcinogenic and possibly carcinogenic have no quantitative significance and are used simply as descriptors of different levels of evidence of human carcinogenicity, with probably carcinogenic signifying a higher level of evidence than possibly carcinogenic.”

Despite the vacuity of the IARC’s “probability” determinations, IARC decisions have serious real-world consequences in the realm of regulation and litigation. Monsanto, the manufacturer of glyphosate herbicide, reacted strongly, expressing “outrage” and claiming that the IARC had cherry picked data to reach its conclusion. Jack Kaskey, “Monsanto ‘Outraged’ by Assessment That Roundup Probably Causes Cancer,” 43 Product Safety & Liability Reporter 416 (Mar. 30, 2015).

In the wake of the IARC classification, in the fall of 2015, the United States Environmental Protection Agency (EPA) reviewed the evidence for, and against, glysophate’s carcinogenicity. The EPA found that the IARC had deliberately failed to consider studies that did not find associations, and that the complete scientific record did not support a conclusion of human carcinogenicity. EPA Report of the Cancer Assessment Review Committee on Glyphosate (Oct. 1, 2015).

For undisclosed reasons, however, the EPA’s report was never made public until a couple of weeks ago, when it showed up briefly on the agency’s website, only to be pulled down after a day or so. See David Schultz, “EPA Panel Finds Glyphosate Not Likely to Cause Cancer,” Product Safety & Liability Reporter (May 03, 2016). No doubt the present Administration viewed a conflict between EPA and IARC, and disparaging comments about the IARC’s “process” to be national security issues.  At the very least, the Administration would not want to undermine the litigation industry’s reliance upon the IARC cherry-picked report.

All joking aside, the incident highlights the problematic nature of the IARC decision process, and the reliance of regulatory agencies on the apparent authority of IARC determinations. The IARC process is toxic and should be remediated.


[1] Kathryn Z Guyton, Dana Loomis, Yann Grosse, Fatiha El Ghissassi, Lamia Benbrahim-Tallaa, Neela Guha, Chiara Scoccianti, Heidi Mattock, Kurt Straif, on behalf of the International Agency for Research on Cancer Monograph Working Group, IARC, Lyon, France, “Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate,” 16 The Lancet Oncology 490 (2015).

 

 

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

October 2nd, 2015

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).