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Talc, Asbestos, and Epidemiology

Corporate Influence and Scientific Incognizance

Tran, Triet H.a; Steffen, Joan E.a; Clancy, Kate M.a,b; Bird, Tessa,c; Egilman, David S.a,d

doi: 10.1097/EDE.0000000000001091
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Open
ISEE

From the aNever Again Consulting, Attleboro, MA

bCollege of Engineering and Mines, University of Alaska - Fairbanks, Fairbanks, AK

cWesleyan University, Mellon Postdoctoral Fellow, Middletown, CT

dWarren Alpert Medical School, Department of Family Medicine, Brown University, Providence, RI.

Disclosure: T.H.T., J.E.S., K.M.C., and T.B. work for D.S.E., who serves as an expert witness in litigation at the request of people who claim injuries resulting from the use of talcum powders. T.H.T., J.E.S., K.M.C., and T.B. were not compensated by law firms for work on this article. This commentary was sponsored by the International Society of Environmental Epidemiology (ISEE). The contents are the sole responsibility of the author(s) and do not necessarily reflect the official views of the ISEE.

D.S.E. serves as an expert witness in litigation at the request of people who claim injuries resulting from the use of talcum powders. He has also served as an expert witness at the request of companies who have been sued for exposure to asbestos from their mines or products. He was not compensated for work on this commentary. No party to these litigations reviewed this commentary or had input into its content.

Publication of this commentary will advance D.S.E.’s credibility as an expert in this topic area and the commentary may be used in litigation, including advancing the arguments made in the commentary and as evidence of D.S.E.’s credibility. While they are not witnesses, this applies to the other authors as well.

Correspondence: Triet H. Tran, Never Again Consulting, 8 North Main St, Attleboro, MA 02703. E-mail: tranhaotriet@gmail.com.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

In the early 1970s, findings of asbestos in talc, and findings of talc colocated in ovarian tumor tissue, led to public controversy.1–5 For over 40 years, talc mining and manufacturing companies attempted to obfuscate the importance of these findings by keeping exposure information behind a corporate veil and otherwise influencing medical information concerning the health effects and asbestos content of talc used in cosmetics.6–9 Control over information is a recognized method by which industries maintain sales and avoid regulation and tort liability.10–16 There are many examples when companies have concealed the presence of hazardous components in products; failed to publish study results indicating that their products presented health risks; and manipulated studies to publish false results that encouraged product use or hid side effects.10–16 For example, in 1971, Henderson et al. found talc in an ovarian cancer tissue sample and raised concerns about the relation between talc use and ovarian cancer.17 Johnson & Johnson hired Arthur Langer, a mineralogist at Mount Sinai, to reexamine the tissue.9,17 Langer confirmed the presence of talc, and also found asbestos in ovarian cancer tissue. Evidence shows that Johnson & Johnson successfully dissuaded him from publishing these findings.9

Furthermore, the talc mining and manufacturing companies used their industry trade organization, the Cosmetic, Toiletry, and Fragrance Association, to influence national and international public health agencies to avoid regulation and defend themselves in toxic tort litigation.6–9,18,19 For example, in 1976, this association developed a specification for a new “product” and named it “cosmetic talc.”20 Through this specification, the association aimed to create a distinction between “cosmetic talc” and “industrial talc.” However, these two supposedly different talcs come from the same ores, in which asbestos was an accessory mineral, and the industries knew that the accessory asbestos could not be removed from the final product.1,2,21–23 The associations’ specification relied on an ineffective test method (J4-1) to test for the presence of asbestos.24 The J4-1 method had an insensitive level of detection above 0.5% for tremolite asbestos and did not test for either chrysotile asbestos or fibrous talc,24 despite company knowledge that these accessory minerals were present and had adverse health effects.25,26 Nonetheless, the association rushed to adopt the J4-1 as a voluntary standard to avoid the FDA’s ratification of more effective methods. The J4-1’s X-ray diffraction (XRD) is much less sensitive than transmission electron microscopy (TEM), which the talc mining and manufacturing companies described as “ultra-sensitive.”27 Moreover, the association’s consultants determined preconcentration before testing was “essential” for finding a “needle [asbestos] in a haystack [talc].”25,27,28 However, the J4-1 method did not specify the required preconcentration and confidential corporate documents released in the course of litigation indicate that, even using the J4-1 methodology, “cosmetic” talc powder formulations still contained considerable and detectable amounts of asbestos,29 an unavoidable consequence of mine geology.

From 1965 to 2003, Johnson & Johnson “cosmetic talc” came from a Vermont mine that contained 10%–20% fibrous talc and accessory tremolite-actinolite.23 The United States Occupational Safety and Health Administration has regulated fibrous talc as asbestos since 1972,26 and the International Agency for Research on Cancer (IARC) classifies fibrous talc as a carcinogen.23,30–33 Avon (a direct selling company in cosmetic category) found as high as 25% tremolite in its talc products.34 In 1976, the Cosmetic, Toiletry, and Fragrance Association misrepresented these concentrations to the United States Food and Drug Administration: “the summary will give you assurance as to the freedom from contamination by asbestos form materials of cosmetic talc products”.35 Steffen et al. reported that 686 of 1032 tests produced in litigation revealed the presence of asbestos in talcs used in cosmetics from 1948 to 2017.29,36 We know of no evidence that the talc mining and manufacturing companies tested products or mined talc for fibrous talc after 1970.

At least 32 epidemiologic studies have examined the relation between talcum powder usage and ovarian cancer.20,37–67 Twelve out of the 32 epidemiologic studies of talc and ovarian cancer incorporated the Cosmetic, Toiletry, and Fragrance Association’s claim that “cosmetic” talc has been free of asbestos since 1976.38–40,43,45,47,48,56,57,59,61,64 The association between asbestos inhalation and ovarian cancer was noted in 1949, again in 1960,68,69 and again in 1982.70,71 However, possibly as a result of the Cosmetic, Toiletry, and Fragrance Association’s claims, these researchers did not consider the role of asbestos exposures during talc use. Some authors, who recognized inhaled asbestos as an established ovarian carcinogen, rejected the causal association between talc powder use and ovarian cancer because of the lack of data on mechanism for so-called “asbestos-free” talc.43,56,57,64 Only Rosenblatt et al. considered confounding by occupational or other asbestos exposure.66

Deaths in infants from asphyxiation of talc during diapering and cases of consumer talcosis in adults both suggest high inhalation exposures from talc uses other than perineal application.70–73 Only 2 out of 32 epidemiologic studies of the association between perineal talc exposure and ovarian cancer considered the potential for exposure by nonperineal routes.51,66 The other published studies failed to include even obvious baby talcum powder uses, including diapering, which results in inhalation exposure and may also contribute to transvaginal talc dose in female infants.74 Had epidemiologists had access to company information regarding actual asbestos levels in cosmetic talc and airborne exposure measurements, their studies may have been designed to account for these other exposure routes. For instance, had they known that Johnson & Johnson noted that 100 million “baby bottoms” had been dusted with talc from 1930 to 1991, they likely would have considered inhalation talc and asbestos exposures to both parents and babies as routes of exposure.6 In addition, the epidemiologists did not indicate any awareness of the fibrous talc content of “cosmetic talc.” These unrecorded exposures resulted in misclassification and poor sensitivity (among those truly exposed, the proportion correctly classified as exposed is low), potentially contributing to the lack of dose-response relation observed in some studies, and likely driving the rate and odds ratios toward the null. The published literature underestimates exposures by routes other than perineal use partly because the researchers relied on talc mining and manufacturing company’s false representation that talc was asbestos-free after 1976.43,64

As importantly, the studies did not always adequately characterize the perineal talc exposures. Three of the investigations were planned as prospective cohort studies and talc exposure was only evaluated once; thus, the studies did not prospectively evaluate talc exposure over time.56,59,67 Also, given that the induction period and latency for ovarian cancer is between 25 and 40 years,67 none of the study cohorts had sufficient follow-up time.56,59,64,67 Gertig et al. (Nurses’ Health Study) stated that, “Our relatively short follow-up period may be inadequate to detect an association if the latency for development of ovarian cancer is more than 15 years.”56 Ten years later, Gates et al. updated the Nurses’ Health Study talc use results, comparing rates of ovarian cancer between two groups of talc users (>1 week to <1 week) and found a near null rate ratio of 1.06 (95% CI = 0.89, 1.28).64 The “Sister Study” follow-up had a median induction period and latency of 6.6 years.67 Further, a number of studies (including all three “prospective” cohort studies) conflated cornstarch and talc cosmetic powders, leading to additional exposure misclassification.56,59,64,67 Customer product false recognition and recall may have led to additional misclassification. For example, there are two different types of Johnson & Johnson powder products (talcum and cornstarch) and Johnson & Johnson has had the highest share of the total baby powder market.75 Customers are not likely to identify Johnson & Johnson talc baby powder since the bottle only lists talc as an ingredient in 6-point type on the back.76

Talc epidemiologists may therefore have overlooked vital exposure and induction period information. Nonetheless, 18 of the 32 studies reported an importantly elevated risk of ovarian cancer among talc users, compared with nonusers, prompting public health concerns and regulatory reviews of talc carcinogenicity. The Cosmetic, Toiletry, and Fragrance Association crafted and promoted an argument that would create doubt about the causal association of “cosmetic” talc and ovarian cancer to block the US National Toxicology Program and IARC from classifying their product as a carcinogen.77 They dubbed this the “fatal flaw” defense.78 The Association deemed the epidemiologic studies that found an elevated risk as “fatally flawed” because talc users in the studies were exposed to asbestos from talc products sold before 1976, which they argued caused an asbestos-related but not talc-related cancer excess.

In 2000, “cosmetic” talc labeled as “not containing asbestos” was nominated to be included in the United States National Toxicology Program Report on Carcinogens. Two program scientific panels reviewed research on talc carcinogenicity and voted to list talc as a carcinogen.79,80 The Cosmetic, Toiletry, and Fragrance Association argued against the listing of talc in the report, asserting that the talc epidemiologic studies revealed increased rates of ovarian cancer due to the inclusion of patients who used asbestos-contaminated talcs manufactured before 1976.77,78,81,82 The Association argued that these results could not be applied to their “asbestos-free” talc, that the talc/ovarian cancer association was not causal because the summary risk ratio was below 2, and because many of the study results were not statistically significant.82 An alliance of chemical and tobacco companies successfully promoted these concepts under a campaign called “Sound Science” and “Good Epidemiologic Practices.”14 Epidemiologists and some courts have mistakenly adopted this tobacco pseudoscience.83,84 Greenland and others have repeatedly critiqued both of these arguments.84–88

Despite the Cosmetic, Toiletry, and Fragrance Association’s attempts to downplay the elevated risks of ovarian cancer associated with perineal talcum powder use reported in epidemiologic studies, both of the National Toxicology Program scientific panels voted to list talc “not containing asbestos” as a carcinogen.89 The Cosmetic, Toiletry, and Fragrance Association then threatened the United States National Institutes of Health and National Toxicology Program Report on Carcinogens budgets,90 and the National Toxicology Program management overruled the science panels.91,92 Talc was the only one of the 21 substances nominated for the Report on Carcinogens that the National Toxicology Program withdrew.93,94

The talc mining and manufacturing companies privately took credit for the National Toxicology Program decision and acknowledged that the epidemiologists had misinterpreted the studies:

“We [the talc industry] dodged a bullet in December based entirely on the confusion over the definition issue… Essentially, if the report were to be rewritten to state that the possibility of asbestos contamination of cosmetic talc prior to 1976 should simply be accounted for as an additional “confounding” factor in the epidemiology studies, a re-vote for “talc not containing asbestos fibers” would likely go the other way. …Time to come up with more confusion!” [Emphasis added].95

The Association also used the “fatal flaw” and asbestos-free arguments with the International Agency for Cancer Research when the agency reviewed talc carcinogenicity.96 An epidemiologist who had reviewed the relation between talc and ovarian cancer for the Association co-chaired the 2009 IARC 100 meeting section pertaining to talc.32,97 An academic consultant to the RT Vanderbilt talc mining company was a member of the IARC 93 working group on talc over the same period (2006–2010) that she testified in talc litigation.98,99 Neither disclosed these conflicts.98,99 IARC 93 accepted the Association’s misrepresentation on the asbestos content of talc, stating that “After 1976, these powders probably did not contain anthophyllite, chrysotile or tremolite.”32 IARC 100 listed talc as a probable ovarian carcinogen.32

Talc is one of the many examples of corporate influence on research and regulation. Tobacco and chemical companies also influenced epidemiologic methods for the determination of cause–effect relationships.11,14–16,100–103 There are several lessons to be learned for epidemiologists studying environmental, occupational, and consumer product hazards:

  1. Epidemiologists must work with toxicologists, industrial hygienists, and other professionals. In this case, occupational health physicians and industrial hygienists could have contributed to dose estimates and elucidated possible confounding asbestos exposures. Materials scientists could have tested the talcum powder for the presence of asbestos and other carcinogenic accessory minerals, like arsenic, that are permitted to be present in “cosmetic talc”. Hygienists could have discovered that at least four of the chemicals used in Johnson & Johnson perfumes are animal carcinogens.104,105
  2. It is important to question and verify assumptions and information provided by industries with material interests in research findings. Regulatory capture and the problem of “revolving door” regulators can sometimes undermine the effectiveness of government oversight.106–109 In this case, Dr. Eiermann, the head of the United States Food and Drug Administration’s regulation of cosmetics in the 1970s, worked for Johnson & Johnson in Brazil after WWII. His successor, John Bailey, led the cosmetics division in the 1990s, then in January 2002 became the Director of Cosmetic Chemistry for the Cosmetic, Toiletry, and Fragrance Association. While leading the cosmetics division, Bailey denied the first citizen’s petition to require the United States Food and Drug Administration to label talc a carcinogen in 1995 and after leaving the administration, he lobbied in 2009 on behalf of the Cosmetic, Toiletry, and Fragrance Association against granting a second citizen’s petition on talc warnings.110 In 2014, the Administration denied 1994 and 2008 citizen’s petitions on talc based on the Cosmetic, Toiletry, and Fragrance Association claim that “cosmetic” talc was asbestos free.111
  3. Researchers must be wary of scientific information gaps due to company ownership of knowledge and recognize litigation as a possible source of previously hidden scientific knowledge. Many of the documents we cite are publicly available as exhibits in court cases. There are several archives of documents and depositions produced in litigation that include important public health information, including unpublished studies.112–114 Over 900 medical publications have cited documents from the tobacco archives. Unfortunately, plaintiff lawyers and courts regularly permit companies to seal important public health information without forcing them to assert any claim of confidentiality. Few, if any, of these documents are trade secrets. Independent researchers can ask courts to unseal this information.
  4. The Cosmetic, Toiletry, and Fragrance Association assured the National Toxicology Program that fear of litigation ensured compliance with the J4-1 method.82 While litigation can be a powerful agent for public health, it is reactive, so can only affect change after injuries occur. Juries who see the evidence can make appropriate scientific inferences about causation and the need for warnings or withdrawal of a product with no discernible health benefits.115

In 1974, Johnson & Johnson told the FDA that, “…if the results of any scientific studies show any question of safety of talc, Johnson & Johnson will not hesitate to take it off the market.”7 In 1994, when it became aware of the question of ovarian cancer, Carter Wallace followed this community standard and stopped using talc on its condoms.116 Talc safety has certainly been questioned; we agree with Johnson & Johnson: it should not be sold.

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ABOUT THE AUTHORS

TRIET TRAN received his Bachelor of Science in Statistics and Quantitative Econometrics at Brown University. DAVID EGILMAN is a clinical professor of Family Medicine at the Alpert School of Medicine at Brown University. He does research on warnings and risk communication and corporate corruption of science. He is president of Global Health through Education Training and Service (GHETS.ORG), which funds the development of community oriented primary care curriculum in developing countries through South-South exchanges. TESS BIRD was trained in medical anthropology at the University of Oxford, and writing at the University of Connecticut. She is currently a Mellon Postdoctoral Fellow in Writing for the Social Sciences at Wesleyan University. JOAN STEFFEN is a student at Harvard Law School. She received her Bachelor of Arts in medical anthropology and women, gender, and sexuality studies at Washington University in St. Louis. KATE CLANCY is a senior at the University of Alaska Fairbanks studying Geological Engineering.

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REFERENCES

1. The US Food and Drug Administration (FDA). Memorandum of a Symposium Asbestos and Talc Lung Cancer at Levels Below Occupational Exposure. 1971. Available at: https://repository.library.brown.edu/studio/item/bdr:841478/.
2. Schaffner R. Letter to Romer from the Department of Health, Education, and Welfare. 1975. Available at: https://repository.library.brown.edu/studio/item/bdr:841473/.
3. Cralley LJ, Key MM, Groth DH, Lainhart WS, Ligo RM. Fibrous and mineral content of cosmetic talcum products. Am Ind Hyg Assoc J. 1968;29:350–354.
4. Gross P, de Treville RT, Cralley LJ, Davis JM. Pulmonary ferruginous bodies. Development in response to filamentous dusts and a method of isolation and concentration. Arch Pathol. 1968;85:539–546.
5. Lichtenstein G. High levels of asbestos found in 3 paints and 2 talcums here. 1972. New York Times. Available at: https://search.proquest.com/docview/119556279?accountid=9758.
6. Ashton W, Memo to Leebaw J. Re: Johnson’s Baby Powder Use, JNJ 000312709. 1991. Available at: https://repository.library.brown.edu/studio/item/bdr:841456/.
7. Hildick-Smith G, Nashed W. Memo: Johnson & Johnson Meeting with the Commisioner: Substantial Asbestos Can be Allowed Safely in a Baby Powder JNJ 000307413. 1974. Available at: https://repository.library.brown.edu/studio/item/bdr:841462/.
8. Pier J. 2004. Email to Robert Pier Re: OOPS. Available at: https://repository.library.brown.edu/studio/item/bdr:841469/.
9. Hildick-Smith G. Letter to Langer. 1971. Available at: https://repository.library.brown.edu/studio/item/bdr:841461/.
10. Cosgrove L, Vannoy S, Mintzes B, Shaughnessy AF. Under the influence: the interplay among industry, publishing, and drug regulation. Account Res. 2016;23:257–279.
11. Michaels D. Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health. 2008.Oxford: Oxford University Press.
12. Egilman D, Bird T, Lee C. MetLife and its corporate allies: dust diseases and the manipulation of science. IJOEH. 2013;19:287–303.
13. Egilman D, Bird T, Lee C. Dust diseases and the legacy of corporate manipulation of science and law. Int J Occup Environ Health. 2014;20:115–125.
14. Ong EK, Glantz SA. Constructing “sound science” and “good epidemiology”: tobacco, lawyers, and public relations firms. Am J Public Health. 2001;91:1749–1757.
15. Egilman DS, Bagley S, Biklen M, Golub AS, Bohme SR. The beryllium “double standard” standard. Int J Health Serv. 2003;33:769–812.
16. Egilman DS, Bohme SR. Over a barrel: corporate corruption of science and its effects on workers and the environment. Int J Occup Environ Health. 2005;11:331–337.
17. Henderson WJ, Joslin CA, Turnbull AC, Griffiths K. Talc and carcinoma of the ovary and cervix. J Obstet Gynaecol Br Commonw. 1971;78:266–272.
18. Sandland G. Minutes - CTFA Subcommittee of SAC on Asbestos in Talc, October 11, 1973. The Cosmetic, Toiletry and Fragrance Association, Inc. Available at: https://repository.library.brown.edu/studio/item/bdr:841488/.
19. Sandland G. Letter to FDA Hearing Clerk Re: Proposed Order Method for Asbestos in Talc Published in the Federal Register (38 P.R., No. 188, pgs. 27076–27081) September 28, 1973 Report of CTFA Talc Subcommittee on Method to Detect Chrysotile and Tremolite in Talcs. 1973. Available at: https://repository.library.brown.edu/studio/item/bdr:841489/.
20. The Cosmetics Fragrance and Toiletry Association (CTFA). The Cosmetics, Fragrance and Toiletry Association (CTFA) Specifications - Talc & Cosmetic Talc. 1976. Available at: https://repository.library.brown.edu/studio/item/bdr:841476/.
21. Walther B, Leedom W, Crisera J. Johnson & Johnson and Johnson & Johnson Consumer Inc.’S Supplemental Answer To Interrogatory No. 3 Of Plaintiff’s First Set Of Interrogatories In Ratcliff Vs. American Honda et al. Superior Court Of Washington For King County, Case No. 16-2-18128-7 Seattle Washington. 2017. Available at: https://repository.library.brown.edu/studio/item/bdr:841453/.
22. Miller R. Testimony of Roger Miller Testimony of Roger Miller Jan 16, 2007 Superior Court Of The State Of California County Of San Francisco Lopez, et al., v Acands, Inc., et. al.,pg 83. 2007. Available at: https://repository.library.brown.edu/studio/item/bdr:841467/.
23. Ashton W. Geology and Ore Reserves. Geological Audit Windsor Minerals File #124. 1970. Available at: https://repository.library.brown.edu/studio/item/bdr:841455/.
24. The Cosmetics Fragrance and Toiletry Association (CTFA). The Cosmetics Fragrance and Toiletry Association (CTFA) Method J4-1: Asbestiform Amphibole Minerals in Cosmetic Talc. 1976; QE-CPC00001142 - QE-CPC00001151. Available at: https://repository.library.brown.edu/studio/item/bdr:841475/.
25. The Cosmetics Fragrance and Toiletry Association (CTFA). Minutes: The Cosmetics Fragrance and Toiletry Association (CTFA) Task Force on Round Robin Testing of Consumer Talcim [sic] Products for Asbestiform Amphibole Minerals. 1977. Available at: https://repository.library.brown.edu/studio/item/bdr:841477/.
26. Occupational Safety and Health Administration (OSHA). Federal Register, Vol 37, No. 202-Wednesday, October 18, 1972 Pg. 22142. 1972.
27. Sandland G. Meeting Notes of CTFA Talc Subcommittee. 1974. Available at: https://repository.library.brown.edu/studio/item/bdr:841472/.
28. Ponder H, Krause J, Link G. Procedure to Examine Talc for the Presence of Chrysotile and Tremolite–Actinolite Fibers Prepared for Johnson & Johnson. 1973. Available at: https://repository.library.brown.edu/studio/item/bdr:841470/.
29. Steffen JE, Tran T, Fassler EA, Egilman DS. Presence of Asbestos in Consumer Talc Products: Evaluating a “Zero Tolerance” Policy. 2017.APHA.
30. International Agency for Research on Cancer (IARC). IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans - Silica and Some Silicates. 1987;42.
31. International Agency for Research on Cancer (IARC). Carbon black, titanium dioxide, and talc. IARC Monogr Eval Carcinog Risks Hum. 2010;93:1–413.
32. International Agency for Research on Cancer (IARC). Arsenic, Metals, Fibres, And Dusts. IARC Monogr Eval Carcinog Risks Hum. 2012;100(Pt C):11–465.
33. Smith WL. Studies of the Physical Properties of Talc, Their Measurement, and Comparison to Johnson And Johnson. 1957. Available at: https://repository.library.brown.edu/studio/item/bdr:841474/.
34. Rowland C. Tremolite in Talc Program. 1972. Available at: https://repository.library.brown.edu/studio/item/bdr:841471/.
35. Estrin N. Letter to Eiermann of the FDA. 1976. Available at: https://repository.library.brown.edu/studio/item/bdr:841459/.
36. Bicks P., Ratcliff V. Johnson & Johnson: Summary Judgment Hearing. 2018. Available at: https://repository.library.brown.edu/studio/item/bdr:841458/.
37. Booth M, Beral V, Smith P. Risk factors for ovarian cancer: a case-control study. Br J Cancer. 1989;60:592–598.
38. Chang S, Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer. 1997;79:2396–2401.
39. Cook LS, Kamb ML, Weiss NS. Perineal powder exposure and the risk of ovarian cancer. Am J Epidemiol. 1997;145:459–465.
40. Cramer DW, Vitonis AF, Terry KL, Welch WR, Titus LJ. The association between talc use and ovarian cancer: a retrospective case-control study in two US States. Epidemiology. 2016;27:334–346.
41. Cramer DW, Welch WR, Scully RE, Wojciechowski CA. Ovarian cancer and talc: a case-control study. Cancer. 1982;50:372–376.
42. Cramer DW, Xu H. Epidemiologic evidence for uterine growth factors in the pathogenesis of ovarian cancer. Ann Epidemiol. 1995;5:310–314.
43. Gates MA, Tworoger SS, Terry KL, et al. Talc use, variants of the GSTM1, GSTT1, and NAT2 genes, and risk of epithelial ovarian cancer. Cancer Epidemiol Biomarkers Prev. 2008;17:2436–2444.
44. Godard B, Foulkes WD, Provencher D, et al. Risk factors for familial and sporadic ovarian cancer among French Canadians: a case-control study. Am J Obstet Gynecol. 1998;179:403–410.
45. Harlow BL, Cramer DW, Bell DA, Welch WR. Perineal exposure to talc and ovarian cancer risk. Obstet Gynecol. 1992;80:19–26.
46. Kurta ML, Moysich KB, Weissfeld JL, et al. Use of fertility drugs and risk of ovarian cancer: results from a U.S.-based case-control study. Cancer Epidemiol Biomarkers Prev. 2012;21:1282–1292.
47. Merritt MA, Green AC, Nagle CM, Webb PM; Australian Cancer Study (Ovarian Cancer); Australian Ovarian Cancer Study Group. Talcum powder, chronic pelvic inflammation and NSAIDs in relation to risk of epithelial ovarian cancer. Int J Cancer. 2008;122:170–176.
48. Mills PK, Riordan DG, Cress RD, Young HA. Perineal talc exposure and epithelial ovarian cancer risk in the Central Valley of California. Int J Cancer. 2004;112:458–464.
49. Ness RB, Grisso JA, Cottreau C, et al. Factors related to inflammation of the ovarian epithelium and risk of ovarian cancer. Epidemiology. 2000;11:111–117.
50. Purdie D, Green A, Bain C, et al. Reproductive and other factors and risk of epithelial ovarian cancer: an Australian case-control study. Survey of Women’s Health Study Group. Int J Cancer. 1995;62:678–684.
51. Terry KL, Karageorgi S, Shvetsov YB, et al; Australian Cancer Study (Ovarian Cancer); Australian Ovarian Cancer Study Group; Ovarian Cancer Association Consortium. Genital powder use and risk of ovarian cancer: a pooled analysis of 8,525 cases and 9,859 controls. Cancer Prev Res (Phila). 2013;6:811–821.
52. Vitonis AF, Titus-Ernstoff L, Cramer DW. Assessing ovarian cancer risk when considering elective oophorectomy at the time of hysterectomy. Obstet Gynecol. 2011;117:1042–1050.
53. Wu AH, Pearce CL, Tseng CC, Pike MC. African americans and hispanics remain at lower risk of ovarian cancer than non-hispanic whites after considering nongenetic risk factors and oophorectomy rates. Cancer Epidemiol Biomarkers Prev. 2015;24:1094–1100.
54. Pike MC, Pearce CL, Peters R, Cozen W, Wan P, Wu AH. Hormonal factors and the risk of invasive ovarian cancer: a population-based case-control study. Fertil Steril. 2004;82:186–195.
55. Chen Y, Wu PC, Lang JH, Ge WJ, Hartge P, Brinton LA. Risk factors for epithelial ovarian cancer in Beijing, China. Int J Epidemiol. 1992;21:23–29.
56. Gertig DM, Hunter DJ, Cramer DW, et al. Prospective study of talc use and ovarian cancer. J Natl Cancer Inst. 2000;92:249–252.
57. Harlow BL, Weiss NS. A case-control study of borderline ovarian tumors: the influence of perineal exposure to talc. Am J Epidemiol. 1989;130:390–394.
58. Hartge P, Hoover R, Lesher LP, McGowan L. Talc and ovarian cancer. JAMA. 1983;250:1844.
59. Houghton SC, Reeves KW, Hankinson SE, et al. Perineal powder use and risk of ovarian cancer. J Natl Cancer Inst. 2014;106:dju208.
60. Moorman PG, Palmieri RT, Akushevich L, Berchuck A, Schildkraut JM. Ovarian cancer risk factors in African-American and white women. Am J Epidemiol. 2009;170:598–606.
61. Rosenblatt KA, Weiss NS, Cushing-Haugen KL, Wicklund KG, Rossing MA. Genital powder exposure and the risk of epithelial ovarian cancer. Cancer Causes Control. 2011;22:737–742.
62. Tzonou A, Polychronopoulou A, Hsieh CC, Rebelakos A, Karakatsani A, Trichopoulos D. Hair dyes, analgesics, tranquilizers and perineal talc application as risk factors for ovarian cancer. Int J Cancer. 1993;55:408–410.
63. Whittemore AS, Wu ML, Paffenbarger RS Jr, et al. Personal and environmental characteristics related to epithelial ovarian cancer. II. Exposures to talcum powder, tobacco, alcohol, and coffee. Am J Epidemiol. 1988;128:1228–1240.
64. Gates MA, Rosner BA, Hecht JL, Tworoger SS. Risk factors for epithelial ovarian cancer by histologic subtype. Am J Epidemiol. 2010;171:45–53.
65. Wong C, Hempling RE, Piver MS, Natarajan N, Mettlin CJ. Perineal talc exposure and subsequent epithelial ovarian cancer: a case-control study. Obstet Gynecol. 1999;93:372–376.
66. Rosenblatt KA, Szklo M, Rosenshein NB. Mineral fiber exposure and the development of ovarian cancer. Gynecol Oncol. 1992;45:20–25.
67. Gonzalez NL. Douching, talc use, and risk of ovarian cancer. Epidemiology 2016;27:797–802.
68. Wyers H. Asbestosis. Postgrad Med J. 1949;25:631–638, illust.
69. Keal EE. Asbestosis and abdominal neoplasms. Lancet. 1960;2:1211–1216.
70. Nam K, Gracey DR. Pulmonary talcosis from cosmetic talcum powder. JAMA. 1972;221:492–493.
71. Weiss B, Boettner EA. Commercial talc and talcosis. Arch Environ Health. 1967;14:304–308.
72. Lee G. Memo: Talc/Powder Safety Studies Grave concern about TEM. 1974. Available at: https://repository.library.brown.edu/studio/item/bdr:841465/.
73. Motomatsu K, Adachi H, Uno T. Two infant deaths after inhaling baby powder. Chest. 1979;75:448–450.
74. Sjösten AC, Ellis H, Edelstam GA. Retrograde migration of glove powder in the human female genital tract. Hum Reprod. 2004;19:991–995.
75. Johnson and Johnson. Johnson’s Baby Powder Market Share Projection. 1978. Available at: https://repository.library.brown.edu/studio/item/bdr:841454/.
76. Johnson and Johnson. Copy and Graphics Specification. 2010. Available at: https://repository.library.brown.edu/studio/item/bdr:841463/.
77. Zazenski R. Email to Michael Chudkowski, Re: Winning Hand. 2000. Available at: https://repository.library.brown.edu/studio/item/bdr:841482/.
78. Zazenski R. Email to James Coughlin, Re: Winning Argument. 2000. Available at: https://repository.library.brown.edu/studio/item/bdr:841481/.
79. Zazenski R. Imerys History of the 10th Roc Reviews of Talc Not Containing Asbestiform Fibers. 2005. Available at: https://repository.library.brown.edu/studio/item/bdr:841484/.
80. National Toxicology Program (NTP). Draft Report on Carcinogens: Background Document for Talc - Asbestiform and Non-Asbestiform. Meeting of the NTP Board of Scientific Counselors - Report on Carcinogens Subcommittee. 2000. Available at: https://repository.library.brown.edu/studio/item/bdr:841468/.
81. McEwen G. Letter to K. Olden, NTP RE: Review of Cosmetic Talc for Listing in the Report on Carcinogens, Twelfth Edition (69 Federal Register 28940). 2004. Available at: https://repository.library.brown.edu/studio/item/bdr:841487/.
82. McEwen G. Letter to Dr. C.W. Jameson, NTP RE: Call for Public Comments on 21 Substances, Mixtures and Exposure Circumstances Proposed for Listing in the Report on Carcinogens, Twelfth Edition (69 Federal Register 28940): Cosmetic Talc. 2004. Available at: https://repository.library.brown.edu/studio/item/bdr:841466/.
83. Egilman D, Kim J, Biklen M. Proving causation: the use and abuse of medical and scientific evidence inside the courtroom–an epidemiologist’s critique of the judicial interpretation of the Daubert ruling. Food Drug Law J. 2003;58:223–250.
84. Greenland S. Relation of probability of causation to relative risk and doubling dose: a methodologic error that has become a social problem. Am J Public Health. 1999;89:1166–1169.
85. Greenland S. Null misinterpretation in statistical testing and its impact on health risk assessment. Prev Med. 2011;53:225–228.
86. Greenland S. The need for critical appraisal of expert witnesses in epidemiology and statistics. Wake Forest Law Rev. 2004;39:20.
87. Greenland S. Nonsignificance plus high power does not imply support for the null over the alternative. Ann Epidemiol. 2012;22:364–368.
88. Carruth R, Goldstein B. Relative risk greater than two in proof of causation in toxic tort litigation. Jurimetrics. 2001;41:195–209.
89. National Toxicology Program. NTP Archived Talc Materials. Available at: https://ntp.niehs.nih.gov/pubhealth/roc/zarchive/othernoms/t/talc/archive/index.html.
90. Zazenski R. Email to S. Mann (Johnson & Johnson) Re: OMB Letter 2005. Available at: https://repository.library.brown.edu/studio/item/bdr:841485/.
91. Graham J. Letter to Elias Zerhouni Re: Concern about RoC Process Under the Information Quality Act. 2004. Available at: https://repository.library.brown.edu/studio/item/bdr:841460/.
92. Kelley W. Letter to Kerry Weems Principal Deputy Assistant Secretary for Budget - Technology and Finance, Re: Eliminating RoC. 2004. Available at: https://repository.library.brown.edu/studio/item/bdr:841464/.
93. National Institutes of Health (NIH). National Toxicology Program (NTP); Report on Carcinogens; Status of Nominations to the 12th Report on Carcinogens (RoC): Request for Comments and Nominations of Scientific Experts. Available at: https://www.federalregister.gov/documents/2005/10/18/05-20729/national-toxicology-program-ntp-report-on-carcinogens-status-of-nominations-to-the-12th-report-on.
94. HBW Insight. Talc Removed from 12th RoC. Available at: https://rose.pharmaintelligence.informa.com/RS013458/Talc-removed-from-12th-RoC. Accessed December 3, 2017.
95. Zazenski R. Email to Eric Turner, Robert Bernstein, Re; Summary of CRE Meeting, Time To Come Up With More Confusion. 2001. Available at: https://repository.library.brown.edu/studio/item/bdr:841483/.
96. Zazenski R. Email to Timothty McCarthy, Re: IARC Talc Monograph. 2008. Available at: https://repository.library.brown.edu/studio/item/bdr:841486/.
97. The Cosmetics Fragrance and Toiletry Association (CTFA). Letter to Mary S. Wolfe Executive Secretary National Toxicology Program, RE: Review of Nominations for Listing in the 10th Report on Carcinogens (65 Federal Register 65352): Non-Asbestiform Talc. 2000. Available at: https://repository.library.brown.edu/studio/item/bdr:841452/.
98. Straif K, Benbrahim-Tallaa L, Baan R, et al; WHO International Agency for Research on Cancer Monograph Working Group. A review of human carcinogens—Part C: metals, arsenic, dusts, and fibres. Lancet Oncol. 2009;10:453–454.
99. Wylie A. Deposition in Estate of Flora Franklin Vs General Motors Corp., et al., Anderson Circuit Court, Anderson Kentucky. 2007. Available at: https://repository.library.brown.edu/studio/item/bdr:841480/.
100. Bohme SR, Zorabedian J, Egilman DS. Maximizing profit and endangering health: corporate strategies to avoid litigation and regulation. Int J Occup Environ Health. 2005;11:338–348.
101. Egilman D, Fehnel C, Bohme SR. Exposing the “myth” of ABC, “anything but chrysotile”: a critique of the Canadian asbestos mining industry and McGill University chrysotile studies. Am J Ind Med. 2003;44:540–557.
102. Egilman D, Scout, Kol L, Hegg LA, Bohme SR. Manipulated data in Shell’s benzene historical exposure study. Int J Occup Environ Health. 2007;13:222–232.
103. Ong EK, Glantz SA. Tobacco industry efforts subverting International Agency for Research on Cancer’s second-hand smoke study. Lancet. 2000;355:1253–1259.
104. Waddell WJ. Analysis of thresholds for carcinogenicity. Toxicol Lett. 2004;149:415–419.
105. Johnson & Johnson. Fragrance Ingredients. Safety and Care Committment Website. 2018. Available at: https://www.safetyandcarecommitment.com/Ingredients/Fragrances.
106. Piller C. Is FDA’s revolving door open too wide? Science. 2018;361:21.
107. Egilman DS, Presler AH, Valentin CS. Avoiding the regulatory capture of the Food and Drug Administration. Arch Intern Med. 2007;167:732–733.
108. Carboni M. The Finacial Impact of Political Connections. 2017.Cham Switzerland: Palgrave Macmillan.
109. O’Connor A. Study Warns of Diet Supplement Dangers Kept Quiet by F.D.A. 2015. New York Times. Available at: https://well.blogs.nytimes.com/2015/04/07/study-warns-of-diet-supplement-dangers-kept-quiet-by-f-d-a/.
110. Bailey J. Telephonic Oral Deposition of John E. Bailey, Jr., Ph.D. 2015. Winkel vs. Calaveras Asbestos, LTD, et al., Available at: https://repository.library.brown.edu/studio/item/bdr:841457/.
111. Musser S. Letter to Samuel Epstein Re: Docket Numbers 94P-0420 and FDA-2008-P-0309-0001/CP. 2014. Available at: http://www.judicialhellholes.org/wp-content/uploads/2017/03/2014-Denial-of-CPCs-Citizens-Petitions-1.pdf.
112. Anderson SJ, McCandless PM, Klausner K, Taketa R, Yerger VB. Tobacco documents research methodology. Tob Control. 2011;20(suppl 2):ii8–i11.
113. Davis RM, Douglas CE, Beasley JK. The Tobacco Deposition and Trial Testimony Archive (DATTA) project: origins, aims, and methods. Tob Control. 2006;15(suppl 4):iv4–iv8.
114. Freudenberg N. ToxicDocs: a new resource for assessing the impact of corporate practices on health. J Public Health Policy. 2018;39:30–33.
115. Rockoff J, Randazzo S. Johnson & Johnson Hit With $4.7 Billion Jury Verdict in Baby Powder Suit. WSJ. 2018. Available at: https://www.wsj.com/articles/j-j-hit-with-550-million-jury-verdict-in-baby-powder-suit-1531435569?mod=searchresults&page=1&pos=2.
116. Tracy JA. Imerys Call Report to Carter Wallace. 1993. Available at: https://repository.library.brown.edu/studio/item/bdr:841479/.
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