Document 70JM5p35w00vYDYkGzdOL0Q6V

FILE NAME: Johnson & Johnson (JAJ) DATE: 2018 DOC#: JAJ075 DOCUMENT DESCRIPTION: Journal Article - Commentary on "Assessment of Health Risk From Historical Use of Cosmetic Talcum Power" < o m n r / i l tm tl ( Hilf u v 'r r . y Com m entary on " Assessm ent o f H ealth Risk F ro m H isto rica l Use of Cosm etic Talcum Pow der" N E W S O L U T IO N S : A Journal of Environmental and Occupational Health Policy 2018, Vol. 28(3) 400-409 The Author(s) 2018 Article reuse guidelines- D O l: 10 f 177/10 4 8 2 9 1f 18794166 lournais.sagepub.com/home/new SAGE David E g ilm a n 1 and Joan Steffen2 Abstract In response to recent litigation, Colgate Palmolive hired Exponent to determine if various samples of their cosmetic talc products contained asbestos. Anderson et al., Exponent employees, claim to report the findings of these analyses in their paper "Assessment of Health Risk from Historical Use of Cosmetic Talcum Powder." The microscopist who reviewed the samples found four anthophyllite fibers. O ne of the authors of Anderson et al., Patrick Sheehan, w ho is not a microscopist, directed the reviewing microscopist to alter the report and add the qualification that " . .this classification was inconclusive due to the small number counted." Deviations from the referenced analytical methods, however, would account for the small number of fibers counted relative to the limit of detection. Anderson et al., reported that "no asbestos fibers were detected in any of the eighteen samples analyzed" based on the report's altered conclusions. Keywords exponent, talc, baby powder, asbestos, litigation 'Warren Alpert Medical School, Brown University, Providence, MA, U SA 2Never Again Consulting, Attleboro, MA, U SA Corresponding Author: David Egilman, Warren Alpert Medical School, Brown University, 8 North Main Street, Suite 404, Attleboro, M A 02912, USA. Email degflman@egilman.com Egilman and Steffen 401 Com m entary For the past several years, users of Colgate Palmolive talc products who devcl oped mesothelioma have sued the company, alleging that asbestos in the tali caused their mesotheliomas. In response to the litigation, Colgate Palmolive hired Exponent to determine if various samples of their products contained asbestos. Anderson et al.' (all authors cite Exponent as their affiliated instiln tion) claim to report the findings of these analyses m their paper "Assessment <>l Health Risk from Historical Use of Cosmetic Talcum Powder." 1 Forcnsu Analytical Laboratories, the laboratory hired by Exponent to perform testiup. performed the analytical microscopy and their initial report of the microscopy stated that four anthophyllite asbestos fibers were present in three of eighteen talc samples; these results are quite different from those reported m Anderson et al.:1 No asbestos fibers were detected in any of the 18 samples analyzed. Of the 18 samples, two samples contained one fiber, and a third contained two fibers, which were initially reported as anthophyllite asbestos, noting that this classifica tion was inconclusive due to the small number counted. An e-mail from author Patrick Sheehan to Mark Floyd of Forensic Analytical Laboratories, released in litigation, revealed that Sheehan told the microscopist to change his findings based on Exponent's justification.3 Mark Floyd, the Forensic Analytical Laboratories microscopist performing the microscopic analysis classified the fibers as anthophyllite in his initial report. Sheehan, who is not a microscopist, directed Floyd to alter the report and add the quid ification that "...this classification was inconclusive due to the small numbei counted."1 Air sampling volumes for this study, however, fell well below tinamounts required by the referenced methods; this deviation would be expected to result in a lower number of asbestos fibers counted relative to the limit ol detection.2,3 In his initial report dated 21 June 2011, Floyd labeled two fibers from Sample S3-3-MR as "anthophyllite." Figure 1 shows the initial report for the lilx-i identified in grid opening 19.4 After receiving the above findings, in a 5 September 2011 e-mail from Patrick Sheehan to Mark Floyd, Sheehan directed Floyd to change his report: "Please resend with anthophyllite replaced with transition17in the header."4 Floyd co m plied. The same results for the two fibers in Sample S3--3-MR appeared in (Inrevised report dated 28 October 2011, but with the heading changed to "transition fiber." After directing Floyd to remove "anthophyllite" I nun the fiber labels and before receiving the. second version of the report. Sluvlinn e-mailed Hoyd, "Please provide the lab report an il microgiaphs and sp ccti.d composition fm th e -I n iillio p h v llik lib e r identified isicj II y o n have .any law data N E W SO L U T IO N S: A Journal o f Environmental and Occupational Health Policy 28(3) Figure I. T h e initial re port fo r the fiber identified in grid op e n ing 19 Egilman and Steffen 403 sheets for these fibers. I would also like copies of these.'0 [Emphasis added]. The altered report for the fiber in grid opening 19 is shown in Figure 2 (see p. 69 in Deposition of Mark Floyd.. .6). Footnote 3 of Floyd's revised report to Exponent adopts Patrick Sheehan's rationale for reclassifying these fibers, "This classification was inconclusive due to the small number counted." In a related e-mail to Floyd, Sheehan wrote:7 Below are two proposed alternatives for footnote 3. The current classification statement is not sufficiently clear to me and appears unnecessary. I believe that the final statement may also be misleading as written and may not be necessary. Are either of the two alternatives acceptable or could they be modified to be acceptable7 Anthophyllite (AN) was the only amphibole or serpentine mineral type detected, and only in some samples. The classification of the anthophyllite fibers as asbestos is inconclusive due to the small number of fibers found at the specified analytical sensitivity which is approximately 5 fold below the applicable method detect limit for atmospheres free of interferences. Anthophyllite (AN) was the only amphibole or serpentine mineral type detected, and only in some samples. The classification of the anthophyllite fibers as asbestos is inconclusive due to the small number of fibers found based on the number of grid openings that were required for analysis to meet the specified analytical sensitivity of approximately 0.002 f/cm. [Emphasis added] After several e-mail exchanges, Mr. Floyd issued a new report which incorpo ra led not only the revised heading for Sample S3-3-MR (shown above) but also llie bolded sections suggested by Mr. Sheehan (see p. 69 and p. 95 in Deposition of Mark Floyd.. .6).8 Footnote 3 now read: "Anthophyllite (AN) was the only regulated asbestos type detected and only in some samples. This classification of lhe AN fibers as asbestos is inconclusive due to the small number counted." | Emphasis added] (see p. 95 in Deposition of Mark Floyd.. .6). Changing reports was not a standard practice for Floyd. At his deposition, he testified that his clients suggested language changes less than 1 percent of the laiic. Floyd stated that, had Sheehan not requested modifications, lie would have used the "boilerplate" language from his initial report. Despite the infor mation in the revised report, Floyd testified that, by his method, the fibers he lound were asbestos.8 Sheehan requested the changes so that the results could be used to support i lie ('igate Palmolive litigation defense Sheehan told Floyd:9 Sith|ccl S A M ) mu lo i'i.iplts N E W SO LUTIONS: A Journal o f Environmental and Occupational Health Policy 28(3) Sampl e L:iC- 5mmp' c I Gn<toos .; 4A3. Gnd 1 Grid opening l\> -u re 2. T h e altered re p ort fo r the fiber in g n d opening 19. gi/man and Steffen 405 Thanks for the reply Please remember that we need sufficient quality pictures to document the transitional nature of these three fibers as this report will be used in future litigation cases. Let me know if you are having trouble finding a scope and camera setup to use. [Emphasis added] As demonstrated here, Anderson et al.'s1explanation for the reclassification of the anthophyllite fibers was imposed post hoc. Floyd, the microscopist who examined the samples, originally identified the fibers as anthophyllite. Sheehan, not Floyd, directed both the change in fiber classification and the rationale for this revision. Anderson et al.1 collected and analyzed airborne samples according to NIOSH 7400 and 7402 analytical methods.1-3 A simple review of both NIOSH methods reveals that the minimum air sampling volume required to reach the limit of detection of\ the method is 400 L.2'3 The experimental design by Anderson et al.1used 48-min sampling with an air volume of 121 to 211 L.1By selecting a smaller sampling volume, the authors failed to follow the minimum requirements to reach the method's limit of detection, resulting in exposure underestimations. Since Floyd's original reports indicate the presence of asbestos in the bulk product used for exposure simulation, the small .sampling volume selected is the main reason why Anderson et al.1 could not detect a significant number of asbestos fibers. Finally, Anderson et al.1claim that their paper is an "Assessment of Health Risk from Historical Use of Cosmetic Talcum Powder." They did not report that Floyd had found anthophyllite asbestos in Johnson & Johnson Baby Powder in 2004.10In addition, Anderson et al.1restrict their analysis to the issue of asbestos content, ignoring other well-defined and accepted risks of talc-related medical problems among cosmetic users, like fatal aspiration and talcosis.11-44 Further, risks should not be isolated from benefits and reasonable alternatives. "Cosmetic laics" sold as dusting powders have no demonstrated health benefits. Moreover, there are safer substitutes that would eliminate both the asphyxiation and cancer risks. Roll-on talc powders are available for adult use and dustless baby powder is available for infants.45 Finally, corn starch has been used in cosmetic powders for decades. It is indisputable that com starch does not contain asbestos and, if applied with an applicator, will not result in fatal aspiration. Authors' Note I his commentary was originally submitted as a letter to the editor to Risk Analysis. Ilie imimal that published Anderson et al.1 The Risk Analysis Editor rejected the letter i.uilv because he did not consider depositions to be a valid reference source 406 N E W SC LU T IO N S: A Journal o f Environmental and Occupational Health Policy 28(3) Declaration of Conflicting Interests The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: David S. Egilman has been retained m asbestos and talc toxic tort litigation at the request of injured consumers and workers and at the request of asbestos product manufacturing companies defending similar cases; Joan Steffen works for Dr. Egilman as a research assistant. Dr Egilman was not an expert in the case Lon Konopka-Sauer and Richard Konopka vs. ColgatePalmolive Company; he was an expert m Gail Lucille Ingham et al. vs. Johnson & Johnson et al. Funding The author(s) received no financial support for the research, authorship, and/or publi cation of this article Notes a. The documents referenced in this article were released in litigation and are all in the public domain. The URL where each document may be accessed is included in the following references. The documents were obtained from plaintiffs counsel in Lori Konopka-Sauer and Richard Konopka vs. Colgate-Palmolive Company, Supreme Court of the State of New York, County of New York, Case No. 11-190070. The sole exception is Exhibit PLT-00002-0001, which was obtained from plaintiffs' counsel in Gail Lucille Ingham et al. vs. Johnson & Johnson et ah, in the Circuit Court of the City of St. Louis, State of Missouri, Cause No. 1522-CC10417-01. b. Transition fibers reflect the metamorphic (chemical but not structural) transition between fibrous anthophyllite or fibrous tremoiite and talc. The entire structure is fibrous. One end is chemically anthophyllite or tremoiite and the other is fibrous talc. IARC considers fibrous anthophyllite, fibrous tremoiite, and fibrous talc to be carcinogens.46 O R C ID ID David Egilman ' http://orcid.org/0000-0003-0280-163X References 1. Anderson EL, Sheehan PJ, Kalmes RM, et ah Assessment of health risk from his torical use of cosmetic talcum powder. Risk Anal 2017; 37: 918-929. 2. NIOSH. Method 7400, issue 2: asbestos and other fibers by PCM, https://www.cdc. gov/niosh/docs/2003-154/pdfs/7400.pdf (994, accessed 30 July 2018). 3 NIOSH Method 7402, issue 2: asbestos by TEM, https://www.cdc.gov/niosh/docs/ 2003- 154/pdfs/7402.pdf (1994, accessed 30 July 2018) Egilman and Steffen A 4 Deposition of Mark Floyd Exhibit 42: email from Patrick Sheehan to Mark H<> dated May 1, 2012. New York City Asbestos Litigation, http://asbestosandlalc.oii Response%20to%20Anderson%20et%20a!/Mark%20Floyd%20-%20Forcnsic"n 20Analyst-42.PDF (2012, accessed 30 July 2018). 5. Deposition of Mark Floyd Exhibit 35: email from Patrick Sheehan to Mark l-lo- dated August 11, 2011. New York City Asbestos Litigation, http://asbestos;mdi.i com/Response%20to%20Anderson%20et%20a!/Mark%20Floyd%20-% 20Forensic%20Analyst-35.PDF (2012, accessed 30 July 2018). 6. Deposition of Mark Floyd Exhibit 2: exposure simulation for historical (aim powder report, May 2012. New York City Asbestos Litigation, http://asbe.slo-.ai talc.com/Response%20to%20Anderson %20et%20al/Mark%20Floyd%20-% 20Forensic%20Analyst-2.pdf (2012, accessed 30 July 2018). 7. Deposition of Mark Floyd Exhibit 34: email from Patrick Sheehan to Mark FI<-. dated August 2, 2011. 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Gould SR and Bamardo DE. Respiratory distress after talc inhalation. Br J Dis Chest 1972; 66: 230-233. 34 Jenkins MQ. Poisoning of the month. Dusting powder inhalation. J S C Med Assoc 1963; 59: 62. 35. Lawson R. Acute talc inhalation. Nursing 2012; 42: 72. 36. Lund JS and Feldt-Rasmussen M. Accidental aspiration o f talc. Report of a case in a two-year-old child. Acta Paediatr Scand 1969; 58: 295-296. 37. Matina F, Collura M, Maggio MC, et al. inhaled surfactant in the treatment of accidental talc powder inhalation: a new case report. Ital J Pediatr 2011; 37: 47. 38. McCormick MA, Lacouture PG, Gaudreault P, et al. Hazards associated with diaper changing. JAMA 1982; 248: 2159-2160. 39. Moon MC, Park JD, Choi BS, et al. Risk assessment of baby powder exposure through inhalation. Toxicol Res 2011; 27: 137-141. 40. Moss MH. Dangers from talcum powder. Pediatrics 1969; 43: 1058. 4L Motomatsu K, Adachi H and Uno T. Two infant deaths after inhaling baby powder. Chest 1979; ~5. 448-450. Egilman and Steffen 409 42. Pfenninger J and D 'Apuzzo V. Powder aspiration in children. Report of two ca.si-. Arch Dis Child 1977; 52: 157-159. 43. Russell RS, Merz RD, Sherman WT, et al. The determination of respirable parlicli-i in talcum powder. Food Cosmet Toxicol 1979; 17: 117-122. 44. Panarelio G, Occhipinti G, Piazza M, et al. Severe acute respiratory failure due to inhalation of baby powder and successfully treated with venous-venous extracoipn real membrane oxygenation. A Case Rep 2015; 5: 228-230. 45. Song J, Koch J and Squier M. Patty Cake, Inc., assignee. Dustless baby powdei United States patent US 5,747,007, 5 May 1998. 46. IARC Talc. Silica and some silicates, IARC monographs on the evaluation o f carci/io genic risks to humans. Lyon, France: International .Agency for Research on Cancel, 1987, Vol. 42, pp. 185-224. Author Biographies David Egilman, MD, MPH, is a clinical professor in the Department of Innnh Medicine at Brown University. Egilman is President of the Board, (loh.il Health Through Education Training and Service, a nonprofit that helps develop community-oriented primary care medical and nursing schools in developing countries. His research interests include health-related capitalist externalities, corporate creation of "doubt science," medical epistemology, and warninr. and risk communication. loan Steffen, BA, is a researcher for Egilman. She studied medical anthropology and women, gender, and sexuality studies at Washington University in St. Louis. Her research interests include health-related capitalist externalities, coiporate creation of "doubt science," research misconduct, the marketing of lo w pharmaceuticals and medical devices, and the impact of corporate influence on public health.