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Epidemiology Studies of Talc Users. There have been published cases of mesothelioma in cosmetic talc users There have been no large scale studies anywhere in the world of cosmetic talc users and mesothelioma. DEFENDANTS NEVER STUDIED IT.
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Epidemiology Studies of Talc Users • There have been published cases of mesothelioma in cosmetic talc users • There have been no large scale studies anywhere in the world of cosmetic talc users and mesothelioma
DEFENDANTS NEVER STUDIED IT WE DON’T KNOW HOW MANY JOHNSONS BABY POWDER USERS HAVE MESOTHELIOMA
Mesothelioma is an extremely rare cancer • 13 per million • 1 per every 75,000 • Italy: 1800 • Vermont: 400
Epidemiology Study of Vermont Talc Miners • The National Institute of Occupational Safety and Health published a Mortality Study of Vermont Talc Miners in 1979 • The study included 392 workers employed a minimum of 1 year between 1940 and 1969 • There were 7 deaths from Respiratory Cancer compared to 3.1 expected among Vermont men • Observed Deaths/Expected Deaths = 2.25 (95% Confidence Interval 0.9-4.6)
Epidemiology Study of Vermont Talc Workers DOES NOT Inform Us about Mesothelioma Risk to Cosmetic Talc Users • <400 workers • Latency • Asbestos diseases among Vermont Talc Workers
Doctors advise against talc for use on babies • 1959: • “About 1/3 of the doctors are presently advising against the use of baby talc, inasmuch as starches and oils have greater purity and there is no dangerous dust to inhale.”
J&J AND RUBINO • 1. Paid for the study. • 2. Paid middleman to “monitor” • 3. Approved the protocol • 4. “Controlled” the study • 5. “Instructed” Rubino what to say • 6. Dictated the conclusions • 7. Wrote entire sections • 8. Edited the work • 9. Added references • 10. Had it rewritten by a ghostwriter
Rubino - Italy Published Mortality - March 1976 Mortality Speech – May 1976
Rubino - Italy Published Mortality - March 1976 Mortality Speech – May 1976 All Cancers – 111 (31) Lung Cancers – 11 (2) Oesophagus Cancer – 8 (14) Acute Resp. Diseases – 40 (15) Chronic Resp Diseases – 12 (13) • All Cancers – 142 • Lung Cancers – 13 • Oesophagus Cancer – 22 • Acute Resp. Diseases – 55 • Chronic Resp. Diseases – 25 BY REDEFINING THE REFERENT GROUP REPORTED 59 FEWER DEATHS
Rubino/Coggiola - Italy Published Mortality - Rubino Published Mortality - Coggiola
Rubino/Coggiola - Italy Published Mortality - Rubino Published Mortality - Coggiola Oesophagus Cancer – 10 (12) Stomach Cancer – 31 (4) Intestine Cancer – 13 (5) Liver Cancer – 10 (5) • Oesophagus Cancer – 22 • Stomach Cancer - 35 • Intestine Cancer – 18 • Liver Cancer - 15 BY REDEFING THE COHORT REPORTED 26 FEWER CANCER DEATHS
Coggiola - 2017 • Excluded anyone >85 yo • Excluded all women • Excluded all cancers during the last 4.5 years • Excluded 1921-45 workers • 84% had <40 year latency • >40% of cohort still alive
Coggiola - 2017 Mirabelli - 2017 Coggiola - 2017
Coggiola - 2017 Mirabelli - 2017 Coggiola - 2017 Inclusion Criteria: >1 month employment after January 1, 1946 Male < 85 years old • “In 2007, after the mortality follow-up by Coggiola et al. (2003) had been completed, we registered a case of pleural mesothelioma (a man, aged 79) who reported to have been employed as a maintenance worker from 1947 to 1957 at the Talco and Grafite mill.”
Epidemiology • Given the size of the groups of workers from the mines that supplied J&J talc (1972-2003), just as likely to find no mesotheliomas as it would be to find one.
CONCLUSION Epidemiology Studies of Miners and Millers DO NOTInform on Mesothelioma Risk of IndividualsWho Have Used Cosmetic Talc Products For Personal Hygiene.
Epidemiology Studies of Users of Asbestos-Contaminated Talc ARE NOT NECESSARY to Ascribe Causation of Mesothelioma