Conflict Over Conflicts of Interest

“Let him who is without sin among you be the first to throw a stone … .”       John 8:7

In the recent issue of Carcinogenesis, Jonathan Samet attempts to defend the monograph and carcinogen identification process of the International Agency for Research on Cancer (IARC). Jonathan M. Samet, “The IARC monographs: critics and controversy,” 36 Carcinogenesis 707 (2015) [cited below as Samet]. The defense is largely redundant of a publication earlier this year, in which a gaggle (124) of scientists rallied around the IARC and its carcinogenicity assessments. Neil Pearce, et al., “IARC Monographs: 40 Years of Evaluating Carcinogenic Hazards to Humans,” 123 Envt’l Health Persp. 507 (2015) [cited below as Pearce].

Professor Samet’s editorial is remarkable in several respects. First, the editorial covers the same points and arguments as the opinion piece in the Environmental Health Perspectives. Samet was one of the gaggle of 124, and so his more recent editorial in Carcinogenesis is a redundant, duplicate publication.

Samet identifies recent criticisms of IARC as falling into four categories:

“(i) reliance on epidemiological evidence that may be limited;

(ii) limitations of the IARC process and reluctance to participate in it;

(iii) issues related to specific evaluations and

(iv) issues related to the composition of the Working Groups.”

Samet at 707. Samet’s defense consists largely in following the public health meme of attributing any dissent or disagreement to industry’s conflicts of interest. In his view, IARC used to have a problem with “not maintaining sufficient distance from industrial stakeholders and the associated potential for conflict of interest[1],” but the “industry” problem has now been remedied[2]. And so Samet reasons that any continued criticisms must be the result of the industrial critics’ conflicts of interest[3]. To be sure, industry conflicts of interest are given strict scrutiny. As we shall see, litigation and compensation industry credentials are welcomed at the IARC.

Samet’s defense, which is really an attack on the bona fides of the critics, has become a commonplace in the public health community, and has degraded debate into charges and counter-charges as to who has the greater conflict of interest. This defense ignores both the specific and the general criticisms of the IARC decision process.

As Professor Cornelia Baines has noted, the IARC “process,” carries the risk of group think and of ignoring substantive disagreement. “When experts in the field are chosen, some will come armed with their zealously-promoted and ferociously-defended versions of the ‘truth’, making predictable what they will recommend at the end of the review process.” Cornelia J. Baines, “Transparency at the International Agency for Research on Cancer (IARC),” 361 Lancet 781 (2003). This danger looms especially large when members of IARC working groups have already committed to the conclusion ultimately reached, or have written and published key studies the status of which will be enhanced or undermined by the outcome of the working group’s decision. Samet and the gaggle give no consideration to this potent source of conflicts of interest.

And Geoffrey Kabat, a senior epidemiologist at Albert Einstein School of Medicine, who was one of the gaggle’s “targets,” noted that the gaggle

“confine[] themselves to generalities and fail to come to grips with any specific criticisms on their merits. The EHP defense of IARC has all the subtlety of using an elephant gun to kill a gnat.”

Geoffrey Kabat, “How Many Scientists Does It Take To Squelch A Critic? Hint: 124,” Forbes (Mar. 10, 2015) (documenting how errant and mean-spirited the gaggle’s criticisms were).

Samet argues that the likelihood that other groups, such as the Environmental Protection Agency and the National Toxicology Program, walk in lockstep with IARC, suggests how “robust” the IARC system is. Using the IARC evaluation of formaldehyde as an example, Samet points to the “confirmation” of IARC’s judgments by EPA and NTP. Samet at 707. But this example and many others merely show that the IARC and the regulatory world are robust for group think. And yet the robust agreement is not always based upon robust evidence[4].

Like the gaggle’s editorial, Samet suggests that criticisms are good except that criticisms of the IARC, and especially his IARC working group, are “unfair and unconstructive.” Pearce at 514. Samet graciously acknowledges that “[w]ith regard to particular monographs, inevitably if evidence is lacking or mixed and at equipoise, any classification can be reasonably questioned.” Samet at 707. Like the gaggle, however, he never engages with Dr. Kabat’s procedural and substantive criticisms of Samet’s working group on electromagnetic radiation exposures.

There is, of course, a serious danger of placing so much emphasis on conflicts of interest as a proxy for truth and validity. One could be hoisted with his own conflict-of-interest petard. Samet, for instance, in his Carcinogenesis editorial declares no conflict of interest, and yet he was the Chairman of the IARC working group on radiofrequency electromagnetic radiation exposure[5] that was the subject of Dr. Kabat’s and others’ scathing criticisms.

Carcinogenesis has the following policy on conflicts:

“Carcinogenesis policy requires that each author reveal any financial interests or connections , direct or indirect, or other situations that might raise the question of bias in the work reported or the conclusions, implications, or opinions stated – including pertinent commercial or other sources of funding for the individual author(s) or for the associated department(s) or organization(s), personal relationships, or direct academic competition.”

Carcinogenesis CONFLICT OF INTEREST FORM <accessed July 10, 2015>.

In addition to Samet’s personal role in the criticized IARC determination, several of the gaggle have been regular testifiers for litigation-compensation industry[6]. There are no disclosures of litigation conflicts of interest in the gaggle’s editorial. Pearce.

Samet himself has been at the center of other conflict-of-interest controversies. In 2011, two tobacco companies sued the United States Food and Drug Administration (FDA) to challenge how the agency staffed its Tobacco Products Scientific Advisory Committee (“TPSAC”), which was charged with investigating the public health implications of using menthol in cigarettes.   The companies alleged that the FDA failed to comply with the Federal Advisory Committee Act (“FACA”). The TPSAC, formed after the enactment of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) reported that menthol in cigarettes adversely affected public health, and that menthol should be removed to promote public health.

The basis of the suit was that three members of the TPSAC had served, or continued to serve, as paid expert witnesses for plaintiffs in litigation against tobacco companies. The companies claim was that the these TPSAC members, including Dr. Samet, created a partial, interested, imbalanced committee that was unfairly predisposed to view menthol in cigarettes as harmful. In 2012, a federal district court refused the FDA’s motion to dismiss[7], and last year, the court granted the tobacco companies substantially the relief they sought[8].

The FDA appealed Judge Leon’s ruling, but in March 2015, the agency announced that four members of the TPSAC were removed, including Dr. Samet. Ironically, the American Thoracic Society (ATS) submitted an amicus brief, despite having an obvious conflict of interest. Dr. Samet is a member of the ATS’s Tobacco Action Committee, through which he organizes and coordinates the ATS’s anti-tobacco activities. The ATS and Dr. Samet’s anti-tobacco activism may be laudable, but that activism, along with Dr. Samet’s engagement as a litigation expert witness for plaintiffs against tobacco companies, surely constitute a conflict of interest, if anything is.

[1] Editorial, “Transparency at IARC,” 361 Lancet 189 (2003).

[2] citing Herbert Needleman & James Huff, “The International Agency for Research on Cancer and obligate transparency,” 6 Lancet Oncol. 920 (2005)

[3] citing those who would be manufacturers of faux certainty, Naomi Oreskes & Erik Conway, Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (N.Y. 2010); David Michaels, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health (N.Y. 2008).

[4] See, e.g., C. Bosetti, Joseph K. McLaughlin, Robert E. Tarone, E. Pira & Carlo La Vecchia, “Formaldehyde and cancer risk: a quantitative review of cohort studies through 2006,” 19 Ann. Oncol. 29 (2008).

[5] IARC Press Release N° 208, “IARC Classifies Radiofrequency Electromagnetic Fields as Possibly Carcinogenic to Humans” (31 May 2011).

[6] Including Martyn T. Smith, whose testimony has been the subject of several judicial exclusions for lack of validity.

[7] Lorillard, Inc. v. United States Food and Drug Admin., Civ. No. 11-440 (RJL), 2012 WL 3542228 (Aug. 1, 2012).

[8] Lorillard, Inc. v. United States Food and Drug Admin., 56 F. Supp. 3d 37 (D.D.C. 2014) (Leon, J.). Judge Leon’s decision is discussed in “Conflict of Interest Regulations Apply Symmetrically” (July 25, 2015). The case is currently on appeal to the Court of Appeals for the District of Columbia Circuit.

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