In its response to petitions for putting warning labels on talc powder, The FDA has acknowledged that talc particles can enter a woman’s body via her vagina and that such particles can cause ovarian cancer. Nevertheless the agency has refused to order a warning label on talc powder because there is no “conclusive evidence.” I obtained the FDA response after filing a Freedom Of Information request.
I discussed the FDA’s response with Dr. Daniel Cramer, who has been treating women with ovarian cancer for three decades (he is 70) and conducting research on the link between talc use and this deadly cancer. Cramer is a Harvard Professor of not only obstetrics and gynecology, but also of epidemiology and public health. His research has convinced him that 10% of all ovarian cancer cases—(22,000 new cases were diagnosed in 2013)—or about 2,000, were due to talc use.
If a new drug trial cured 10% of ovarian cancer cases, that would be front-page news. But prevention, not treatment after the fact, goes largely unreported, especially if there is no “new” announcement from someone, a major problem in reporting on long-running battles for consumer safety. Besides, eliminating products and chemicals that cause cancer doesn’t make profits for the cancer treatment industry and manufacturers of dangerous products.
Here are some excerpts from my conversation with Dr. Cramer.
Question: The FDA says the evidence of a link is not conclusive. Do you think there is sufficient evidence already?
Answer: My studies show that 10%, maybe 2,000 cases in 2013, were caused by talc use. That is a lot that is entirely preventable. If you look at a package of talc, you will see a warning not to inhale it. That was the result of serious pulmonary (lung) problems in babies, and was based on case reports, not an epidemiological study. If they were willing to put a label based on case reports, why not on consistent epidemiological data? (Epidemiology is the study of patterns of disease development, origin and spread in a population.)
Question: The FDA says “a cogent biological mechanism by which talc might lead to ovarian cancer is lacking…” What do you think the mechanism is?
Answer: It’s pretty clear that talc is an immune disruptor that causes a potent inflammatory reaction. Inflammation is now believed to play a key role in cancer in general.
Question: Do you think contamination with asbestos fibers is the cause of problems with talc? (Studies from the 1970s found forms of asbestos fibers—asbestos is a known and deadly carcinogen--in talc products. The FDA notes in its petition response that “large deposits of high purity, asbestos-free talc do exist,” and that six years ago the agency tested 34 cosmetic products for asbestos fibers and found none.)
Answer: I continually see references on the Internet that manufacturers are required to remove asbestos. There never was such a law. Industry is supposed to monitor this themselves. But I believe there is an association of ovarian cancer and talc use regardless of whether there is contamination with asbestos. I believe that talc itself is a causal factor. (He so testified in the case of Deane Berg after examining tissue removed from her.)
Question: is there much research going on about this now?
Answer: I don't think so, and that's a shame. It's so frustrating because I see that there is clearly an association of talc and ovarian cancer that is causing women to die. For whatever reson, the agencies are doubting the association and treating it as a risk/benefit situation. Is there any real benefit to a cosmetic like talc?
Question: Are you continuing your work?
Answer: Yes. I never wanted to get involved in litigation, but it’s pretty clear this is the only way we are going to get movement on this issue. If I don’t get it done now, this whole thing is going to go away and the cosmetic companies will say, “We dodged a bullet.” I wish some big celebrity would say, “This pertains to me.” Someone needs to get angry.