Saturday, March 28, 2015

Roundup “Probable Cause of Cancer;” Science Dispute Similar to Talc Findings

Officials at the International Agency for Research on Cancer just concluded that Roundup, the most widely used herbicide in the world, “probably” causes cancer. But way back in 1991, the Environmental Protection Agency dismissed studies leading to that conclusion.
Monsanto, the chemical behemoth whose smart marketers came up with such a cute name for poison, responded angrily to the conclusion of the international group which consists of 17 reviewers from around the world. The company said the reviewers were “cherry picking” the data to support their case.
The current situation with talc echoes the opposing views on Roundup. While the FDA has denied petitions to warn women that talc use may increase the risk of ovarian cancer, the international agency concluded in 2007 that talc is “possibly” carcinogenic, a lower level of concern than “probably.”
The international agency also did something in regard to Roundup that the U.S. Food and Drug Administration failed to do with talc: They looked at the raw data of a study of glyphosate (the chemical name for Roundup) and interpreted its results themselves. This lead to a finding of evidence of causing cancer, while the original authors of the study found the opposite.
One of the studies on which the FDA relied in rejecting the labeling petitions was done in 2003 by supposedly impartial researchers from a consulting company, Meta-Analysis Research Group. This group analyzed the results of 16 earlier studies.
The study first concludes that talc is responsible for a 33% increased risk of ovarian cancer for women who uses talc, and then in the next breath, dismisses the finding as caused by “selection bias and/or uncontrolled confounding.”
The FDA quoted these words exactly in its response to the petitions for warning labels.
The lead author of that study was Michael Huncharek, the scientific director of Meta-Analysis Research Group. This firm’s website  boasts of a client list including, yes, the baby-powder maker Johnson & Johnson.  Meta-Analysis's list of accomplishments hints at more, saying it:
Provided litigation support to a major environmental law firm representing a consumer products company centering on alleged health risks associated with the use of consumer grade talc…and
Successfully represented a major consumer products company before the US FDA in response to a Citizens Petition seeking a cancer warning label on their personal hygiene products.
So it seems we have Dr. Huncharek, to thank for helping to persuade the FDA that no warnings are needed. He is a practicing radiation oncologist, a doctor who administers radiation to cancer victims.
Huncharek’s firm did not respond to an email asking if Johnson & Johnson had paid for the talc study.
So how valid are the conclusions he reached after his analysis?  Dr. Daniel Cramer, the researcher who has been studying the link between ovarian cancer and talc for decades, said Huncharek’s group “always concluded the way the sponsor wanted.”
This dispute might have been aired if the FDA had agreed to a hearing on the risks of talc. But when it denied the petition for labeling, it also denied the need for a hearing.
So what’s next? Time, I think, for women to make themselves heard directly. On-line petition anyone?

Thursday, March 19, 2015

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.

Monday, March 2, 2015

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.