Cover-up of Talc Danger Finally Revealed; Johnson & Johnson Executives Should Go to Jail for Unnecessary Deaths

Johnson & Johnson is finally facing a reckoning for its deadly refusal to warn women about the use of talcum powder. Like the tobacco industry, Johnson & Johnson suppressed research about the danger and used its power to stop the U.S. Food and Drug Administration from taking action. The tale of this muscling the government is now out, thanks to the product liability lawyers suing the company, and the New York Times publishing the story based on its own investigation and the internal documents the lawyers forced the company to produce.

As I reported in several posts on this blog nearly three years ago, one of the leading researchers on ovarian cancer has estimated that 10% of all the cases--more than 2000 a year--are a result of talc powder use. In its response to petitions for warning labels,  the FDA acknowledged  that talc particles can enter a woman’s body via her vagina, and that such particles can cause ovarian cancer.  Nevertheless the agency refused, and continues to refuse,  to order a warning label because there is no “conclusive evidence.” 

Even the National Women's Health Network, usually a reliable advocate for women, refused to include a warning in its newsletter to women when I appealed to them to act in 2015. I'm a believer in the precautionary principle, a way of managing risk. When certainty is absent, but the risk is great, the prudent thing to do is give a warning. In the case of talc, advising people to stop using the product and switch to corn starch as a good substitute, is a no-brainer.

The Times story reveals that as early as 1971, a senior staff member at Johnson & Johnson warned the company that its talc could be contaminated with asbestos, a notorious carcinogen. 

Using Dr. Daniel Cramer's estimate of 10% of cases caused by talc use, that means that perhaps 100,000 women have suffered and most likely died unnecessarily since the company learned of the problem.

Johnson & Johnson is now facing nearly 12,000 ovarian cancer lawsuits, a fact that caused its stock to drop last Friday by 10 percent. 

Dropping stock prices and billion dollar injury verdicts are hardly sufficient penalty for Johnson & Johnson's callous disregard for women's safety. Those responsible should go to jail.##

10% of Ovarian Cancers Due to Talc Use Says Leading Researcher

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.

Talcum Powder Use May Cause Ovarian Cancer; FDA, Johnson & Johnson Reject Warning Labels

Not long ago my dear friend, Eileen, succumbed to ovarian cancer, discovered far too late for effective treatment. She had been a vigorous woman in her 70s, married to her childhood sweetheart. I can still see her striding into her living room in jeans and a shirt, blonde and pretty, with a big smile to greet me. She spent two months in the hospital hoping for a miracle, but none came. I miss her deeply.

When I first heard about her diagnosis I wondered if she had been a talcum powder user. Yes, innocent baby powder, sold in a pure white package, smooth and silky, just the thing after a shower to quickly dry your skin and make dressing easier.

But I had learned a long time ago that there was a possibility that fibers from this very soft mineral could enter a woman’s body via her vagina and sow the seed for deadly ovarian cancer. Some research quickly brought me up-to-date and revealed that women are now using the courts to try to force Johnson & Johnson to put a warning label on it’s baby powder and a grown-up version, Shower to Shower. Both class action lawsuits and individual lawsuits are in process.

In 2013, three doctors testified that they had found talc particles in cancerous tissue removed from the body of a South Dakota woman who had ovarian cancer. She had sued Johnson & Johnson, and a jury found that talc should carry a warning label.

Last year, women filed two class action suits against Johnson & Johnson charging that talc use can cause ovarian cancer. In the case filed on behalf of all women talc users in Missouri, the complaint said, "Despite the potential catastrophic health consequences, defendants do not tell consumers about the dangers associated with the talc-based Johnson's Baby Powder.”

In addition, women’s health advocates have twice filed citizen petitions with the U.S. Food and Drug Administration asking for a rule to require a warning that talc not be used in the genital area. The petitions were denied. (A spokeswoman for the FDA, Theresa Eisenman, would not explain the rejection. I have filed a Freedom of Information request to obtain the document denying the petitions.)

But my friend, like all but a few women in America, didn’t know any of this, and I was reluctant to upset her husband by asking him if she had used talc.

A year after her death, however, her daughter, who is keen to know why her mother died, asked him that very question.

Yes, he said, she had used talcum powder all her life. He had kept some, sometimes inhaling the scent because it reminds him of her. Such sad irony: the scent of the product that may have killed her brings her back to life for him.

It’s a disgrace and an outrage that talc is not labeled to warn women about the risk of ovarian cancer. In 2014, 14,270 women died from this disease. Dr. Samuel Epstein, who filed the petitions for labeling, calls the lack of action "criminal" in his book, Criminal Indifference of the FDA to Cancer Prevention. Johnson & Johnson, meanwhile, is keeping its head down, hoping word won't spread, a tactic that has served it well all these years. On it's website, there is no mention of the lawsuits, no explanation for the lack of warnings.  There's no public denial at all that I could find even in its latest Annual Report--except by lawyers in cases that have reached that point.

How many new mothers dust their baby girls’ genital area after baths and when diapering them? How many women freely dust their own genital area with talc or sprinkle it on sanitary napkins to mask odors, and even put it on diaphragms to make them easier to insert? Many older women, like my friend, have been doing this for not just years, but decades, never imagining that they might be putting themselves in mortal danger. After all, as the world’s softest mineral, talc makes skin feel silky smooth and dry. And talc already carries a warning label about not inhaling it because "it can cause breathing problems," and keeping it out of the eyes. You'd think that if there was other cause for concern, the label would say more, but it doesn't.

One of the doctors who examined the cancerous tissue from the South Dakota woman has been studying the relationship of talc and ovarian cancer for decades.  A Harvard Professor of Gynecology and Public Health, Dr. Daniel Cramer has this to say about risk factors for and against contracting ovarian cancer:

There are three events which increase risk for ovarian cancer that are associated with chronic inflammation affecting the lower or upper genital tract. These include: cosmetic talc powder use; repeated ovulation not interrupted by pregnancies, breastfeeding, or oral contraceptive use (incessant ovulation), and endometriosis. Besides pregnancies, breastfeeding, and oral contraceptive use that decrease ovulations, other factors that lower risk for ovarian cancer include childhood mumps, a tubal ligation, and an infection while breastfeeding (mastitis).

(I have included his assessment of how women can lower risk because women need to know that pregnancies and breastfeeding are beneficial. I am not in favor of oral contraceptive use, however, because of its role in increasing the risk of breast cancer.)

How much bigger might the risk be of using talc? According to charges filed in another class action lawsuit year, Stockton, California resident Mona Estrada cited studies suggesting a 33% increased risk from using talc-based powers on women’s genital area.

This and other studies, however, are not conclusive, no surprise since talc use occurs over decades, and cancer takes decades to develop. But studies that were mostly negative about the risks of talc use still reached conclusions that should lead to warning labels as a basic precaution.

For example, a study that tracked women whose histories of use or non-use of talc were known, and then looked at who and who didn’t develop ovarian cancer, concluded:

Our results provide little support for any substantial association between perineal talc use and ovarian cancer risk overall; however, perineal talc use may modestly increase the risk of invasive serious ovarian cancer.(Perineal is the term for the body part at the bottom of the pelvis.)

Given all the other precautions we take to avoid endangering our health, shouldn’t everyone be aware that using talc might be deadly?  The problem for Johnson & Johnson, of course, is that nobody has to use talcum powder. Cornstarch versions of dusting powder are widely available and don’t carry this risk.

I wish that women who feel so passionate about pink ribbon campaigns, who raise so much money to help women survivors of cancer and to support cancer detection like mammograms, would put their efforts behind true cancer prevention. Mammograms detect cancer after the fact. We need real prevention that reduces the risks before the fact, not after. When women have hysterectomies, gynecologists often advise them to have their ovaries removed to reduce the risk of ovarian cancer.

This, of course, is a drastic measure that has all kind of effects on a woman’s sex life and overall health. How many cases of ovarian cancer might be prevented by the simple requirement of warning labels on talc? Agitating for such labels might help prevent new generations of women from the suffering and death of ovarian cancer or giving up their sex organs to prevent it.