Saturday, March 28, 2015

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

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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.


Friday, January 9, 2015

A Feminist Reacts to Old Maid

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I just had to throw out the Old Maid.
The game was part of a package of four simple card games that I bought for my 5-year-old grandson for Christmas. Crazy 8s, Go Fish, War—and Old Maid. I took a hard look at the ugly photo of said Old Maid, and my immediate impulse was to throw the cards out. But I hesitated. Was I taking my feminism too seriously? Just a harmless children’s game, right?
I left the deck of cards in the box overnight.
By morning, my mind was made up: into the garbage it went.
My grandson will no doubt be exposed to the sexism that still pervades American culture. He’ll observe the obsession with women’s boobs everywhere from the sidelines of an NFL game to eye-candy ads for of all kinds of products marketed to men. He’ll see women trivialized and rescued over and over again in movies and on TV. He’ll hear coaches buck up their players with taunts of “Nancy” and other slurs that equate female with lack of courage, persistence and endurance.
But I won’t contribute to the brain washing. He won’t learn from me that being an unmarried older woman is to be a loser.
I buried the cards under the scraps from last night’s dinner.

Friday, December 12, 2014

Pope Francis Insults Grandmothers And the Media Stay Silent

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"We encounter a general impression of weariness and aging, of a Europe which is now a 'grandmother', no longer fertile and vibrant." Pope Francis, Address to the European Parliament,Nov. 25, 2014
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Today’s NY Times reported on the front page that Pope Francis had suggested that a dog could get into Paradise. This was considered newsworthy if not startling because Catholic doctrine has long maintained that animals don’t have souls and therefore can’t go to heaven.
But the Pope’s sexist comparison of a sclerotic Europe to grandmothers has gone without comment from The New York Times, on the front page or anywhere else in the paper, which did report on his speech and quoted his sexist remark.  Other media have similarly been silent to the extent that when I ask women I know what they thought of his comment, they have no idea he said it. How come? Is it because there's nothing new about the leader of the Catholic Church being demonstrably sexist?  Or is it because his insult runs counter to the now-entrenched media narrative that this Pope is different and liberal, even to the astonishing extent of suggesting that dogs might have souls?
I was baptized a Roman Catholic and attended Catholic elementary school. I might have gone into the religious life had the church not been so biased against women. The Church lost me in 8th grade when a priest came into my classroom and grandly announced that a basketball team was being formed—for the boys. This was big news because in those days Catholic schools  didn’t even have recess when we could run around, much less a gym or any organized sports.
But I’ve always loved sports, although at 5’3” basketball has never been anything but a frustration. Nevertheless, after the priest made his announcement, I stuck up my hand and asked whether there would be a team for girls as well.
This gave the priest pause, and then he said, “God has endowed boys with certain abilities that girls don’t have.” No, no team for the girls because we were not physically able! I was repulsed and hurt. Even though I had never at that time heard the word “sexist” I knew what it meant.
Of course, women’s subservient role in the Church was already obvious to me from the obsequious attitude of our teaching nuns to the priests, whose superficial homilies every Sunday—and yes, I attended every week—made me squirm even then.
Now I am a grandmother and a feminist who long ago realized that no woman in the world is secure while any woman anywhere must wear a burqa, is prohibited from driving a car, forced into a marriage she abhors, forced into sexual slavery, or kept from an education.  And this is only a partial list of the ways in which women all over the world are deprived of a full life.
It seems to me that the plight of women should merit the attention of a Pope truly focused on relieving suffering. But the Pope’s slur against Grandmothers shows that we should not expect this Pope to do anything to relieve women’s pain.
To those who say, well, isn’t it true that Grandmothers are no longer fertile? I say, yes, of course, and as a result Grandmothers are available to care for their grown children and their grandchildren. In fact, if it weren’t for Grandmothers, a vast number of American mothers would not be able to hold a job since providing good quality, affordable child care is still way down our lawmakers’ and corporate leaders’ lists of priorities.
Worse, the Pope blithely suggested that Grandmothers are not “vibrant,” not alive and involved. Really?  Consider 81-year old U.S. Senator Diane Feinstein, whose determination over a 5-year period forced into public view this week the torture and horrors inflicted by the CIA on prisoners following 9/11. Feinstein, whose accomplishments over her life are nothing short of amazing, is also grandmother to two girls.
One of the few people to comment on the Pope's sexist insult  was Joanna Moorhead in The Guardian, who noted that Pope Francis should know better, not only because of his own Grandmother, but also because of his witnessing the campaign by Argentine Grandmothers of the “disappeared” in that country.
Moorhead is apparently still a practicing Catholic, unlike me (I’ve found a home in the Unitarian Universalist faith.) She notes that older women are “the backbone” of the Church, the majority at Masses, the worker bees who keep the parishes running, and suggests he insults them "at his peril." Perhaps, if they knew he had done so--which they don't--but even if they did, their loyalty and faith would probably motivate them to let it pass.  
Moorhead concludes that Francis’s comment shows he is no different from the male sexists who have been running the Catholic Church for millennia.
I agree. And the lack of media attention to his slur against Grandmothers shows that the media are still controlled by sexists. Women beware.


 

Wednesday, December 3, 2014

No Joke: Standup Seating Could Be Real

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I thought I was just fantasizing about passengers standing during airline flights, strapped in like people held against the sides of a spinning amusement park ride. But I’m way behind the profit maximizers at the airlines.  Standup seating or something close to it could become real as long as people are willing to save money by standing up. This isn’t hard to imagine at all. Standing in line is routine shopper behavior these days, covered as important news and evidence of the health of our economy.
So what if getting that bargain on Black Friday, for example,  comes at a price to your feet and body? It's the bargain that matters.
The airline industry would be happy to oblige with a new low-price opportunity. There are logistics to work out like compartments for baggage, potty breaks, etc. But creative minds motivated by profit usually find a way.
The only thing that may be holding the airlines back is that there is actually a federal seat standard. It’s a performance safety standard, meaning it measures the effect of a standard on a safety outcome—in this case, whether the airline cabin can be evacuated in 90 seconds or less with half the exits blocked.
Really? This is not information that I’ve ever known before. In all the times I’ve flown, while I have imagined emergencies, I never gave much thought to how exactly everyone would evacuate and how long it would take.
Now that I have, I don’t believe the seating that’s common now can meet this 90-second standard. Maybe it could be done by a planeload of passengers who’d had a proper evacuation process explained to them, and maybe rehearsed it.
The routine safety instructions I’ve heard on every flight refer to evacuation only in an offhand way. The flight attendant asks that you locate the exit nearest to you should you have to leave the plane, and most passengers aren't even paying attention.
Seems to me there’s a lot more to be said. Like don’t all rush into the aisles at once and, leave your stuff behind!
The airlines, in fact, do conduct mock evacuations to prove they can meet the standard. But they do this with a planeload of people on the ground who have been brought in specifically to evacuate, and they know it. In a real emergency, panicked passengers might very well rush the aisles and try to grab their possessions, despite instructions they might be getting at that moment.
But let’s get real about the fact that Americans are growing in size while the seat sizes are shrinking. Women with big busts, natural or enhanced; men with big chests and shoulders, from fat or gym mania or both; and tall people. Then there are overweight people, with big bellies and big butts.
Flyers with these body types struggle to maneuver their bodies into the rows that contain their seats. And that’s with the seat sizes common today. A full plane with its share of over-sized people in the newer, smaller seats, evacuated in 90 seconds, unrehearsed? Hard to believe it could be done.
All that said, there’s little doubt that the trend is to seats as small as the airlines can get away with.  I learned from an article in the Los AngelesTimes that a major airline, name unknown, is “considering” offering a lower fare if you are willing to give up some legroom. They are rumored to be considering an “Economy Minus” special fare with legroom of around 30 inches.
Actually, it’s chest room you’d be giving up: that’s the way the airlines measure the space between rows. They call it “pitch” and define it as the distance between the back of your seat and the back of the set in front of you. So it was reduced pitch that I noticed on my recent flight to Chicago on American Airlines (link to previous blog). For comfortable reading, I needed to get my book another inch away from my eyes. I had never had this problem before. Reduced pitch also reduces legroom, of course.
Why stop at 30 inches? The L.A. Times article says Spirit Airlines already has seats with a pitch of 28 inches. Meanwhile, Flyersrights.org,  a non-profit that represents airline passengers,   would like to see a federal seating standard of 35 inches minimum pitch, and an 18-inch minimum width.
I have no doubt the industry would strenuously oppose any standard beyond the existing safety standard and would trumpet the mantra of consumer choice as a cover for their goal of maximizing profits.
But someone in Congress or the Transportation Department ought to be asking about the consequences of setting a new bottom fare price based on willingness to endure discomfort. Right now, people who play astronomical prices for First Class, who comprise 21% of the people on a typical plane, occupy 40% of all the space. Will that become the only option for  bosomy woman and big-chested gym rats? How much will it cost if you just want enough space to read a book? ##

Monday, October 13, 2014

Scared of Ebola? Consider The Flue Pandemic of 1918-1919

I'm in the midst of reading Dennis Lahane's excellent novel, Any Given Day. It gives a harrowing account of what happened in Boston after American troops came home from World War I carrying the flu virus with them.

He describes the health care system in Boston as so overwhelmed, that they could do nothing beyond picking up the dead bodies. It sounds exactly like what is happening in West Africa today.

Lahane did the historical research, of course, that makes a novel like this more than just a good story--which it most certainly is. According to the U.S. Public Health Service, 675,000 people, out of a population at the time of 105 million, died from the flu in just a few months. Hundreds of thousands of others were left orphaned or widowed. And, workers in those days, when they were trying to organize, had no health insurance and no pensions, so those widows and orphans were impoverished beyond our imaginations. Lahane, in this 2008 novel, offers a good look at those working conditions as well.

So, scary as Ebola is, let's take a deep breath and put this in perspective as people living in a country with a highly-developed health care system. And that goes in spades for the media outlets, both broadcast and in print, that are scaring people silly both for profit and to try to pin the outbreak of this disease on President Obama. ##