A couple of weeks ago, the Wall Street Journal ran an editorial that complained that FDA Commissioner Makary had touted dodgy evidence about the potential harms of talcum powder in food and medications,[1] and called an improper public meeting to discuss his concerns. The editorial noted the procedural irregularity of convening a meeting to review evidence of the supposed harms of talc in food and drugs, without proper notice and public comment.[2] The panel met just four days after the FDA’s press release.[3]
The FDA’s announcement of the irregular meeting cited last year’s IARC classification of talc in its group 2A, “probably carcinogenic” to humans, and an article in a new journal, the Journal of the Academy of Public Health, on the editorial board of which, Martin Makary sits.
The irregularity of this FDA meeting becomes even more obvious upon closer inspection. Much could be said about the irregularity of IARC classifications. The IARC defines “probably” in its 2A “probably carcinogenic” classification in a distinctly unscientific way when it reveals, in its Preamble, that its use of probably has no quantitative meaning. In attaching a 2A label to talc, the IARC rejected a conclusion that there was sufficient evidence of human carcinogenicity for talc; indeed, it found the human epidemiology on point to be “limited,” in other words, insufficient. Furthermore, the IARC’s limited conclusion was based upon a claimed association between perineal talc exposure and ovarian cancer.[4]
The irregularities abound. The FDA announced that it was convening an “independent panel of scientific experts” to explore the issue of talc in food and in drugs. And yet, one of the panelists, Daniel Cramer, has served as an expert witness for the talc lawsuit industry on multiple occasions, against Johnson & Johnson.[5] How irregular that no defense expert witness was invited to participate in the panel.
The irregularity of Daniel Cramer’s participation may be Trumped by the irregularity of the entire enterprise. Commissioner Makary works for Secretary Robert F. Kennedy, Jr., who has spent much of his adult life advancing litigations for the lawsuit industry. Kennedy’s son, Conor, is a lawyer at Wisner Baum, a lawsuit industry firm that has cases against Johnson & Johnson. The day of the FDA meeting, but before the panel convened, Commissioner Makary barged into another Advisory Committee meeting, convened to discuss the licensing of an unrelated anti-cancer therapeutic, and ranted about how talc was causing cancer.
Earlier this week, Commissioner Makary replied to the Wall Street Journal editorial, but failed to make his case on the science.[6] He cited IARC, but failed to disclose the meaning of the IARC classification, and to what it applied. Makary cited a 2019 Taiwanese study (Chang) that he described as having reported an association between the oral intake of talc and gastrointestinal cancer.[7] What was most irregular for a scientist who has responsibility for the FDA, however, was Makary’s failure to describe the Chang study accurately.
Chang set out to study stomach cancer, not all of gastrointestinal cancers, by looking at stomach cancer incidence in users a talc, used as a Chinese herbal, in high, medium, and low levels. The study was a typical insurance claims database study, which is interesting but which can yield only limited information. Chang and colleagues had no information about lifestyle variables such as smoking, diet, or obesity. The authors note that in Taiwan, talc is used as an antipyretic and diuretic agent, but they fail to discuss why study participants would have used an herbal remedy with such an indication for any significant length of time. To their credit, the authors excluded patients with peptic ulcer disease or Helicobacter pylori infection prior to the inclusion date. Gastritis and infection with h. pylori are potent causes of stomach cancer. Unfortunately, the information on participants’ infection status, for exclusion, was made before 1997, and so the authors had no information whether the participants who had stomach cancer actually had h. pylori infections at or near the time that they were diagnosed with stomach cancer. Helicobacter pylori infections have an attributable risk for stomach cancer of about 75%.[8] Similarly, the authors lacked information on other risk factors, such as high salt intake, pernicious anemia, EBV infection, alcohol, family predisposition, and socioeconomic status.
Using the low-exposure group as their control, the Chang study reported an adjusted stomach cancer hazard ratio of 1.58 (95% CI, 0.79 – 3.17; p = 0.19), for participants with high exposure, and an adjusted hazard ratio of 2.30 (95% CI, 1.48 – 3.57; p < 0.001) among persons with medium exposure. The authors claimed these data showed an association, but they acknowledged that the lack of a dose-response relationship made the association less likely to be causal. The association, such as it was, however, came unraveled after they excluded participants whose herbal talc use was less than five years. The exclusion, which is biologically important given that latency and induction periods for carcinogenesis are likely longer than five years, vitiated the statistically significant correlation between talc ingestion and the incidence of stomach cancer. The authors’ conclusion was thus pretty tame: “[d]espite the absence of dose-response effect, there might be a link between stomach cancer and talc.” And then again, there might not be.
Makary was not content to argue from weak and equivocal evidence. He offered a sop to the lawsuit industry and his boss, Robert F. Kennedy, Jr., by asking rhetorically whether the plaintiffs’ bar might be correct on talc. According to Makary, “They [lawsuit industry firm] were [correct] with OxyContin, Vioxx and Makena. Perhaps they will be with talc.” Well, even the blind squirrel sometimes finds a nut. OxyContin litigation turned on a marketing issue, and Makena (hydroxyprogesterone caproate), a progestin injection was withdrawn because of lack of efficacy. Even Vioxx, which had an unlabeled potential harm for a limited subgroup of users, spawn a litigation in which the lawsuit industry tried to make every user, even those who may have licked a pill for one day, a winner in the lawsuit lottery.
[1] Editorial Board, “The FDA Takes a Trial-Lawyer Turn,” Wall St. J. (May 21, 2025).
[2] FDA News Release, “FDA to Host Inaugural, Independent, Scientific Expert Panel Open to Public,” FDA (May 16, 2025).
[3] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025). The participants were FDA Commissioner Martin A. Makary, FDA Deputy Commissioner Sara Brenner, and a group of scientists, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer.
[4] IARC Press Release no. 352, “IARC Monographs evaluate the carcinogenicity of talc and acrylonitrile” (July 5, 2024).
[5] See Berg v. Johnson & Johnson Consumer Co., 983 F.Supp.2d 1151, 1154 (D.S.D. 2013); Carl v. Johnson & Johnson, 464 N.J. Super. 446, 237 A.3d 308, 310 (N.J. App. Div. 2020).
[6] Makary, “The FDA Presents Its Case for Targeting Talc,” Wall St. J. (June 2, 2025).
[7] Che-Jui Chang, Yao-Hsu Yang, Pau-Chung Chen, Hsin-Yi Peng, Yi-Chia, Sheng-Rong Song & Hsiao-Yu Yang, “Stomach Cancer and Exposure to Talc Powder without Asbestos via Chinese Herbal Medicine: A Population-Based Cohort Study,” 16 Internat’l J. Envt’l Res. Public Health 717 (2019).
[8] Raghav Sundar, Izuma Nakayama, Sheraz R Markar, Kohei Shitara, Hanneke W M van Laarhoven, Yelena Y. Janjigian & Elizabeth C. Smyth, “Gastric cancer,” 405 Lancet 2087, 2089 (2025).
