DCIS, female “viagra” and other disturbing women’s health news

Big news in women’s health this week. Good news? Depends on how you see it.

The NYTimes reports that surgery for early stage not-quite breast cancer is pretty much useless. Not shocking since NCI decided that DCIS shouldn’t even be called “cancer.

They say, for instance, that some premalignant conditions, like one that affects the breast called ductal carcinoma in situ, which many doctors agree is not cancer, should be renamed to exclude the word carcinoma so that patients are less frightened and less likely to seek what may be unneeded and potentially harmful treatments that can include the surgical removal of the breast.

Here’s what the editorial on the JAMA study says:

The original goal of mammographic screening was to identify invasive cancers at the earliest stage, because of the superior prognosis of stage I cancers. Prior to the advent of screening, ductal carcinoma in situ (DCIS) made up approximately 3% of breast cancers detected. As we pushed to find smaller and smaller cancers, and targeted calcifications instead of just masses, we began to identify DCIS more frequently. Now DCIS accounts for approximately 20% to 25% of screen-detected breast cancers. The cells that make up DCIS look like invasive cancer both pathologically and molecularly, and therefore the presumption was made that these lesions were the precursors of cancer and that early removal and treatment would reduce cancer incidence and mortality. However, long-term epidemiology studies have demonstrated that the removal of 50 000 to 60 000 DCIS lesions annually has not been accompanied by a reduction in the incidence of invasive breast cancers.1 This is in contrast to the experience with removal of colonic polyps and intraepithelial neoplasia lesions of the cervix, in which the removal of precursor lesions has led to a decrease in the incidence of colon and cervical cancer, respectively.2 We now know that breast cancer encompasses a range of behaviors, from aggressive to indolent; the latter are more likely to surface with screening.3 The analysis of Narod et al4 fuels a growing concern that we should rethink our strategy for the detection and treatment of DCIS.

In this video from Dana Farber, Dr. Eric Winer says doctors need to be clear with patients about the reality of DCIS. “What this is all about is conversations between doctors and patients.” Still, he describes surgery as the standard of care.  Will that change? Despite evidence the lumpectomy is as effective as mastectomy, many women still choose the latter.

Also, the FDA approved so called “female viagra” Here’s the benefit: women taking flibanserin reported between 0.5 and one more sexually satisfying event per month, compared with women taking a placebo.

Here’s what Boston-based  OBOS had to via a guest post on an FDA hearing.earlier this summer.index 

Liz Canner, a filmmaker who produced the documentary, “Orgasm, Inc.,” which examines the search for a female sexual enhancement drug, said the company had “deceived women into taking a drug that doesn’t work better than drinking a glass of wine or two, and could end up killing us.”

“To approve this drug would set the worst kind of precedent: that companies that spend enough money can force the FDA to approve useless and dangerous drugs,” said Dr. Adriane Fugh-Berman of Georgetown University.

More than 30 of those who testified — including health-care providers and a number of women who had participated in the trials — urged the panel to support the drug. One provider stood at the microphone in awkward silence to illustrate how little she has to offer her patients with low sexual desire.

“I want to want my husband, it is that simple,” Amanda Parrish, a mother of four from Nashville, told the panel. “For us, flibanserin is a relationship-saving and life-changing drug.”

Here’s another POV from North Shore psychology blogger Dr. Daniel Carlat;

Flibanserin (brand name Addyi) has just received a controversial and complicated FDA approval for the treatment of low sex drive in women. There’s a lot of outrage in the blogosphere, much of it centered on the lobbying of the FDA by disease advocacy groups.  I agree that this politicization of what should be a scientific process is embarrassing to both Sprout and its supporters. Nonetheless, I’m not nearly as hard on flibanserin as some of my colleagues.

However, the does agree with this statement:

Adriane Fugh Berman said it best as quoted by the New York Times: Flibanserin is a “mediocre aphrodisiac with scary side effects.”
 

Is female Viagra a scam? Boston women’s health group questions drug, supporters

indexThe non-profits pressuring the FDA to approve a drug billed as female Viagra do not quite make up a top ten list or women’s health advocacy organizations. This health writer has never heard of most of the groups cited in Sunday’s New York Times story.

But familiar women’s health groups, like Boston’s Our Bodies, Ourselves, are siding with the FDA on this one. From their response to an earlier review of the drug.

imagesWomen taking the drug had less than one additional “sexually satisfying event” (orgasm not required) than women taking a placebo. And in the meantime, the drug caused dizziness, nausea and fatigue, particularly with long-term daily use, in some women — hardly the recipe for sexual excitement.

The FDA also considered whether the drug had increased women’s desire — a crucial element of the HSDD diagnosis, which involves low or no sexual interest to the point of distress in people who are physically healthy and not depressed — and found that the drug failed in this area.

The FDA takes another look — and offers  a live webcast of the deliberations —  on Thursday.

In it’s report on the 2010 FDA rejection of the drug, the OBOS  website notes another Bay State-based critic of the drug:

According to Julia Johnson, the panel’s chairwoman and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School, the impact of the drug flibanserin … was “not robust enough to justify the risks.”

More here from another independent, feminist women’s health group, The National Women’s Health Network:

Members of the campaign called “Even the Score” are challenging the FDA on what they claim is a perpetuation of a gender bias by virtue of the claim that the FDA is holding drugs that treat women’s sexual problem to a higher standard than those for erectile dysfunction.  Even the Score has engaged prominent women’s rights organizations, health care providers, the media and members of Congress in a public relations misinformation campaign to criticize the FDA.  There are Female Sexual Dysfunction drugs currently under FDA review, and Even the Score is attempting to move the discussion away from the safety and effectiveness of these drugs and towards controversy about gender bias. 

The reality is that no amount of public relations or slick marketing can get around the fact that the drugs currently being proposed for Female Sexual Dysfunction simply don’t work and may be quite dangerous. Poor efficacy, a strong placebo effect, and valid safety concerns have plagued all of the drugs that have been tested so far. There are many reasons why the proposed drugs may not have been effective in increasing women’s sexual enjoyment; chief among them is the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives will continue to drum up hype over the possibility of a “pink Viagra” because the profit market for this type of drug is estimated to be over $2 billion a year.

Note that neither of these groups accept funding from the pharmaceutical industry. Even the score supporter include Sprout, the company seeking approval for the drug and Trimel Pharmaceuticals, a company testing a nasal testosterone gel for “female orgasmic disorder.”

Where to put health stories in the paper and why it matters

The Boston Globe has taken to playing stories on medical research findings — like today’s digital mammography report —  on Page 2. For the writer, good play, but not great. To the reader, this suggest important, but not front page important.  This is commendable – often stories about complicated or incremental developments make  the front page,  giving readers the false impression that they need to stop eating eat this food or start taking that drug.

photo (3)A front page story on a research paper suggests a major development. (Good health writers try not to use the hyperbolic word “breakthrough.”)  So, the 1A Vertex story on a new CF drug rates as both a business and medical story. It could be life changing for people with cystic fibrosis and for the company’s bottom line, which is suffering from the arrival of new Hep C drugs. What we don’t like about the CF story – it could use a comment from someone not involved in the research. It’s a business story, so they seek out an analyst,  but he gushes. And his agenda is investing, not health.  It needs a CF scientist or clinician not involved in the study. Still, we get how hard it is to pull these stories together on deadline.

The Page 2 story on digital mammography offers such a comment. The JAMA article was accompanied by an editorial from Dr. Etta Pisano, a breast imaging radiologist at the Medical University of South Carolina who has done a lot of work in this area. Could have been a bit higher in the story but it works:

“There’s a debate about the harms of screening and overdiagnosis of breast cancers from mammograms and to me, this doesn’t resolve that,” she said.

Want to see how it shouldn’t be done? Check out the Health News Review. The list of stories that resorted to sensational language – breakthrough, game-changer, best way of detection, any woman should have this, lifesaver – was long.”

What’s the Boston play online? By late morning, neither story was high on the home page. At least you can click on the Business section from the home page. Health? Still no home on the home page. Click on “News” to find the link.

 

Are potentially toxic chemicals in CapeCod drinking water a health risk? A public meeting

The scientists at Silent Spring Institute in Newton took on a very difficult job — Look at the links between the environment and the Cape Cod breast cancer cluster.

imagesScientists have challenged the relevance of cancer clusters. And, critics of environmentalists like to dismiss this kind of research as the work of  so-called “chemophobes.”

So, if it doesn’t concern you that a Silent Spring study concluded that  “pharmaceuticals, consumer product chemicals, and other emerging contaminants can be found in the majority of public drinking water wells tested on Cape Cod, MA,” go ahead, skip this post and drink up.

If it does, check out the group’s work, including the recent, peer-reviewed  study on chemicals in Cape water. Or head out to Hyannis for meeting on “How can we protect cape drinking water? New research motivates innovative wastewater plans.” Here’s a report from WCAI radio and here’s the pitch, straight from the SSI press release.

DATE: Wednesday, October 2, 2013
WHERE: 12:00–1:30 p.m.
Barnstable Town Hall, 2nd Floor Hearing Room, 367 Main Street, Hyannis
(Lunch will be served)
WHO: Laurel Schaider, PhD, Research Scientist, Silent Spring Institute
Ann Maguirefirst president and co-founder of Massachusetts Breast Cancer Coalition and co-founder of Silent Spring Institute
John K. Erban, MD, Clinical Director, Tufts Medical Center Cancer Center; and Silent Spring Institute Board of Directors
For Immediate Release

Silent Spring Institute Research Update

How can we protect cape drinking water? 
New research motivates innovative wastewater plans

Progress in breast cancer prevention research

DATE: Wednesday, October 2, 2013
WHERE: 12:00–1:30 p.m.
Barnstable Town Hall, 2nd Floor Hearing Room, 367 Main Street, Hyannis
(Lunch will be served)
WHO: Laurel Schaider, PhD, Research Scientist, Silent Spring Institute
Ann Maguirefirst president and co-founder of Massachusetts Breast Cancer Coalition and co-founder of Silent Spring Institute
John K. Erban, MD, Clinical Director, Tufts Medical Center Cancer Center; and Silent Spring Institute Board of Directors

Recent findings and next steps for Silent Spring Institute study of contaminants of emerging concern in Cape Cod groundwater

Previous studies by Silent Spring Institute have shown pharmaceuticals, consumer product chemicals, and other contaminants of emerging concern in Cape Cod drinking water and groundwater. With funding from the Commonwealth of Massachusetts, Institute researchers recently completed a study that synthesized existing information about contaminants of emerging concern in septic system discharges and used these results to estimate contaminant inputs into watersheds and areas that recharge drinking water wells on Cape Cod. Starting this fall, Silent Spring Institute will be conducting a new study of contaminants of emerging concern in eco-toilets, a sustainable, low-cost approach being considered to treat wastewater and address nutrient pollution on the Cape. These studies are especially important now because Cape Cod is debating wastewater management options to address nutrient pollution i nto sensitive ecosystems, and these decisions have long-term implications for protection of drinking water quality.

 

 

BPA linked to infertility? Until we know more, how to reduce exposure

cans

From Boston.com

A growing body of evidence suggests that women who have high urine levels of bisphenol-A—a chemical used in some hard plastics and to coat metal cans—are more likely to suffer from infertility, and now researchers have found a possible reason why. BPA may disrupt eggs from maturing properly, according to a study from Brigham and Women’s Hospital researchers.

“As many as 20 percent of infertile couples have unexplained infertility, and this might just shed a glimmer of light on a contributing factor that plays a role,” said study co-author Catherine Racowsky, director of the hospital’s assisted reproductive technologies laboratory.

So, what to do to reduce you BPA levels? The Silent Spring Institute, a Newton research program looking a the links between breast cancer and the environment,  did a study looking at just that in 2011. They found that by families that were willing to give up canned food, food packaged in plastic, and restaurant meals for three days. “When study families switched to the fresh food diet, their levels of the hormone disruptors BPA and DEHP dropped by half.”


More here from the FDA. 


T
ips from SSI on how to limit exposure to BPA

While scientists continue to study the health effects of these chemicals, here
are  simple steps to play it safe and reduce your exposure:

Fresh is best 
BPA and phthalates can migrate from the linings of cans and plastic 
packaging into food and drinks. While it’s not practical to avoid food 
packaging altogether, opt for fresh or frozen instead of canned food as 
much as possible.

Eat in
Studies have shown that people who eat more meals prepared outside 
the home have higher levels of BPA. To reduce your exposure, consider 
cooking more meals at home with fresh ingredients. When you do eat 
out, choose restaurants that use fresh ingredients.

Store it safe
Food and drinks stored in plastic can collect chemicals from the
containers, especially if the foods are fatty or acidic. Next time, try 
storing your leftovers in glass or stainless steel instead of plastic.
While scientists continue to study the health effects of these chemicals, here 

Don’t microwave in plastic
Warmer temperatures increase the rate of chemicals leaching into food and drinks. So use heat-resistant glass or ceramic containers when you microwave, or heat your food on the stove. The label “microwave safe” means safety for the container, not your health. 

Brew the old-fashioned way
Automatic coffee makers may have BPA and phthalates in their plastic containers and tubing. 
When you brew your coffee, consider using a French press to get your buzz without the BPA.

Did news reports miss the message on IOM breast cancer/environment study?

Earlier this week, we cast this IOM study as offering little new news.  But, as Julia Brody of  The Silent Spring Institute points out, that’s not quite true.  From the environmental Health News website:

…(M)ost of the news media missed the significance of the assessment on environmental chemicals. The real news is that the report is an authoritative statement that a cascade of scientific evidence plausibly links consumer product chemicals and pollutants with biological activity suggesting breast cancer risk.

Instead of saying what is in the report, glass-empty stories said that the IOM “failed” to “definitely” link any chemicals to breast cancer or find “clear” environmental links. Some incorrectly said the report tells women to stop worrying about consumer product risks. These stories ignore the report’s important explanation that definitive evidence is not attainable and lack of human evidence of harm doesn’t mean something is safe.

From original NYTimes story on the report:

The report, 364 pages long and two years in the making, was issued on Wednesday by the Institute of Medicine, an independent group that is part of the National Academy of Sciences and advises the government and public. The work was done by a committee of 15 outside experts, mostly from universities, and nine institute staff members. The sole sponsor was a breast cancer advocacy group, Susan G. Komen for the Cure, which requested the report and spent $1 million on it.

For women who were hoping for definitive safety information about the huge number of chemicals to which people are exposed — from air pollution and cosmetics to cleaning products, food and drinking water — the report may come as a disappointment. It is based largely on a review of existing research, and its limited advice reflects the lack of solid scientific information in many areas of concern to the public.

Women should take note on Cape Cod, where the breast cancer rate is higher than average.  The Silent Spring Institute, one of the few groups doing research on environmental links to breast cancer, recently reporting finding 27 chemicals in well water on the Cape.

The 27 contaminants detected included 12 pharmaceuticals (the most common being one antibiotic and one epilepsy drug); five perfluorinated chemicals (found in non-stick and stain-resistant household products); four flame retardants; two hormones; one skin care product; one artificial sweetener; one insect repellent; and one plastics additive. Health-based guideline values were available for only four detected chemicals (PFOS, PFBS, DEET, carbamazepine), and no samples approached or exceeded these values. The most frequently detected chemical was acesulfame, an artificial sweetener, which was found in 85 percent of wells, and perfluorinated chemicals were detected in 70 percent of wells.

“While the levels of pharmaceuticals, flame retardants, and other emerging contaminants in drinking water are not currently regulated, we still think that it is prudent to find ways to prevent discharges from septic systems and wastewater treatment plants from impacting drinking water supplies, as we don’t fully understand the potential health impacts,” lead investigator Laurel Schaider said.

For more on health and the Massachusetts environment see  SSI or the Massachusetts Environmental Public Health Tracking (MA EPHT) Program Website

This website is designed to provide you with access to current and accurate health and environmental information available for Massachusetts. You can use Massachusetts Environmental Public Health Tracking (MA EPHT) information to learn about the health of your community and access information about your environment.

 

 

 

 

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