Blog of the Society for Menstrual Cycle Research

Yaz, Yasmin and Ortho Evra patch increase risk of blood clots

December 14th, 2011 by Laura Wershler

Blood clots are a serious, if rare, side-effect of hormonal contraceptives. If left untreated, clots can lead to debilitating, or fatal, strokes. The increased risk of blood clots in users of some hormonal birth control brands has been the subject of several recent news stories.

In early December, Health Canada asked Bayer Inc. to change the labels on Yaz and Yasmin, two of the most popular birth control pills, because use of the drugs is linked to higher rates of blood clots.

According to a November 2011 story at cbc.ca/news, health problems associated with these two drugs include stroke, deep vein thrombosis, pulmonary embolism and heart attack.

The concern surrounds the progestin – drospirenone –  used in Yaz and Yasmin. Although promoted as being associated with less bloating and clearer skin than other progestins, drospirenone is also associated with a “1.5-to-three fold increased risk of experiencing a clot compared to women using other birth control drugs.”

What this means in real terms varies from study to study, but one study led by Susan Jick of Boston University found the rate of non-fatal blood clots to be 30.8 per 100,000 among women taking Yaz or Yasmin (the only drugs containing drospirenone) compared to 12.5 per 100,00 among those taking pills containing the older, more common progestin levonorgestrel.

In related news this past week, advisers to the FDA recommended that Johnson and Johnson revise the label on its Ortho Evra birth control patch to better explain the risk of blood clots. Use of the patch has been associated with a higher rate of blood clots for several years. Publicity about the clot risk has no doubt contributed to a 50% decline in sales in the last five years. The formulary problem with the patch is its higher dose of estrogen compared to other pills.

The FDA advisers also recommended more detailed description of blood clot risks for Yaz and Yasmin.

What caught my eye in both stories were the take home messages from those requiring these label changes to women using these drugs.

Health Canada said women should talk with their doctors about the risks and benefits of taking drospirenone-containing oral contraceptives but did not urge women to stop using Yaz and Yasmin.

The FDA’s reproductive health advisers “voted 19-5 that the benefits of the weekly Ortho Evra patch outweigh its risks, including a potentially higher risk of dangerous blood clots that can cause heart attack, stroke and other life-threatening problems.”

I want to know why the five FDA panelists opposed to this decision think the benefits of the patch DO NOT outweigh the risks.

These news stories beg the question:  Should women be concerned enough about the increased blood clot risk associated with Yaz, Yasmin and the Ortho Evra patch to stop using these brands?  If you take these drugs, are you concerned?

If adverse publicity about blood clots resulted in a sharp decline in sales of the Ortho Evra patch, we should expect to see a similar decline in sales of Yaz and Yasmin.

The cbc.ca article reports that the family of a Toronto woman, who died of a large pulmonary embolism after taking Yasmin, has filed the first individual civil suit against Bayer Inc. in Canada. It also states that “more than 10,400 individual lawsuits related to the two pills have been filed in the U.S.”  Not to mention the class action suits related to these drugs currently in progress in both countries.

One thing is certain, the litany of stories about the adverse effects of hormonal contraceptives is not about to end anytime soon. Stay tuned.

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , , , , , , ,
Posted in Birth Control, Law/Legal, Menstruation, Pharmaceutical | 3 Comments »

Pfizer to pay $72 Million in Philadelphia PremPro Case

December 9th, 2011 by Chris Hitchcock

Three women who developed breast cancer after their use of combination hormone therapy have been initially awarded $72 million by a jury in Philadelphia, with further judgement about punitive damages still to come. The case concerns the use of PremPro, a combination of conjugated equine estrogen and medroxyprogesterone made by Wyeth. Wyeth has since been purchased by Pfizer. Women’s Health Initiative trial results released in 2002 found an increased risk of breast cancer in those randomized to estrogen + progestin compared with placebo. Earlier this year, Pfizer announced that it has set aside $772 million in its budget for settling PremPro lawsuits.

Prior to 2002, hormone replacement therapy was often recommended to otherwise healthy women as a health-enhancing preventative therapy. SMCR has long held that menopause is a natural stage in women’s lives, rather than a condition to be treated. Hormone therapy is no longer recommended for the prevention of disease in healthy women.

 

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , , ,
Posted in Law/Legal, Menopause | Comments Off

Menstruation, Prince Charles and The Biggest Hacking Scandal

August 29th, 2011 by David Linton

In light of the recent scandals over the phone and email hacking practices of Rupert Murdoch’s newspaper editors and reporters it is surprising that there has been so little mention of the fact that the most scandalous, damaging and far reaching hacking story associated with Murdoch centered on menstruation.  The only thorough review of the links between the current story and the earlier one appears in a detailed piece in The Sun-Herald from Sydney, Australia, July 31, 2011.

I have previously written about the incident here and elsewhere, but in light of the current coverage it deserves a fresh look.

In brief: in 1989, a time before either cell phones or email were commonly available (hard to believe there was such a time!), a phone hacker recorded a phone sex exchange between Prince Charles and his then-lover, Camilla Parker-Bowles in which erotic mention was made of tampons.  Three years later the full transcript of the conversation was published in an Australian women’s magazine, New Idea, and a world-wide scandal ensued.

Now, nearly 20 years after the story broke, it is about to come back into play as further investigations proceed into the illegal hacking activities of the Murdoch media empire.  Perhaps we will finally learn how much was paid for a menstrual story that humiliated the Royal Family, who the hackers were, and who authorized its purchase and publication.

And, from a Menstrual Studies point of view, its longevity reflects the deep fascination that the menstrual cycle continues to hold for the general public.

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , ,
Posted in Law/Legal, Media, Newspapers | Comments Off

Hymen Seek; or, Good Blood, Bad Blood

August 18th, 2011 by David Linton

The cultural taboo against male contact with menstrual blood can be traced all the way back to the Biblical book of Leviticus, and there have been various attempts to explain its origins, including the Freudian notion that male avoidance of menstrual blood stems from the fear that blood on the penis evokes fears of castration.

However, the contrary social value that prizes the presence of the hymen and, therefore, the evidence of its having been broken being blood on the penis, suggests a more complicated dynamic.*  James Joyce identified the conflict in the long stream of conscious ramble by Molly Bloom in Ulysses when she reflects on the connections she sees between the blood of her period and that produced by the broken hymen.

I bet the cat itself is better off than us have we too much blood up in us or what O patience above its pouring out of me like the sea anyhow he didn’t make me pregnant as big as he is I don’t want to ruin the clean sheets the clean linen I word brought it on too damn it damn it and they always want to see a stain on the bed to know youre a virgin for them all that’s troubling them theyre such fools too you could be a widow or divorced 40 times over a daub of red ink would do or blackberry juice no that’s too purply. . .

Today, rather than resorting to red ink or berry juice, as Molly Bloom suggests, women who can afford a surgical solution can purchase a hymen reconstruction operation.  But for those with fewer resources there are available fake hymen kits marketed under the name Joan of Arc Red.  Aside from the unfortunate image of poor Joan of Arc whose blood was shed at the burning stake rather than in a sexual encounter, these devices promise cheap and effective means of “passing” as a virgin.

When they first appeared, even the New York Times reported on the product, but not because of interest in quaint notions of virginity.  Rather, the focus was on the political ramifications.  The Times headline read, “Egyptian Lawmakers Want to Ban Fake Hymen.”  (10/5/2009) A member of the Muslim Brotherhood, Sheik Sayed Askar, was quoted as saying, “It will be a mark of shame on the ruling party if it allowed this product to enter the market.”  Other individuals interviewed for the article called for the exile of those who import the kits or some other forms of punishment.  The medical procedure that reconstructs a broken hymen by stitching is already illegal in Egypt.  It remains to be seen if the recent upheaval in Egyptian society will lead to changes in hymen values.

For more information on the story, a more detailed report is available at the Huffington Post.

*Editor’s note: For more on the just the anatomical eomplexity of this dynamic, see our December 8, 2009, post about the re-naming of the hymen as the vaginal corona.

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , ,
Posted in anatomy, Law/Legal, Men, Sex, Virginity | Comments Off

Counterfeit EC in Circulation

July 29th, 2011 by Elizabeth Kissling

The U.S. Food and Drug Administration has issued a warning to consumers not to use the emergency birth control medicine labeled as Evital. The drug is not safe or effective in preventing pregnancy. The packaging label of the potentially ineffective and suspect counterfeit version says, “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet”, by “Fluter Domull”. It has not been approved for use in the United States, but may be in distribution in some U.S. Hispanic communities.

The FDA is asking that people who have seen this version of the drug contact them with information.  Approved versions of EC are available over-the-counter and by prescription to those 17 and older.

[via Feministing.com]

 

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , , ,
Posted in Birth Control, Law/Legal | Comments Off

Breaking News: Pfizer ordered to pay millions in PremPro cases

February 8th, 2011 by Elizabeth Kissling

Pfizer, which now owns Wyeth’s PremPro synthetic progestin-estrogen combination that was widely taken for relief of discomforts that sometimes accompany menopause, has been ordered to pay damages in two separate cases this week. The company must pay more than $10 million in damages to an Arkansas woman after an appeals court reinstated a jury verdict. And yesterday in Pennsylvania, an appeals court overturned a previous ruling that Pfizer’s Wyeth unit deserved a new trial in the case of a Philadelphia woman who had been awarded $1.5 million in compensatory damages and $8.6 million in punitive damages on her claim.


Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , ,
Posted in Law/Legal, Menopause, Pharmaceutical | Comments Off

Don’t Just Take Yaz, Be Yaz

November 17th, 2010 by Holly Grigg-Spall

yaz-tv-commercial-300x168Despite facing ever-rising numbers of lawsuits over their top-selling drug – birth control pill Yaz – the Bayer pharmaceutical company has released a rebranded version, with added vitamin B. Despite, or perhaps as a result of, the mounting claims for compensation made by those who believe Yaz, or more specifically the synthetic progesterone component of Yaz – drospirenone, caused their stroke, blood clot or heart attack or that of their now dead or disabled loved one, the company has seen fit to produce a modified alternative to improve on the risk of other, lesser known side effects.

Bayer suggests that Beyaz, with its added levomefolate calcium – a form of folic acid, which is a B vitamin – will alleviate the possibility of pregnancy complications and birth defects produced by the original Yaz pill. Yaz causes folate deficiency which creates problems if a woman falls pregnant whilst taking the drug, or soon after stopping. In the press release sent out by Bayer last week, the company stated that Beyaz would provide ‘folate supplementation’ – admitting in subtext that Yaz causes this deficiency and that the millions of women taking Yaz as the most popular birth control pill in the US and Europe have therefore experienced deficiency in a type of vitamin B seen as vital enough to necessitate the creation of a new drug.

Just as it seemed possible Yaz might be taken off the market, here is Yaz, new and improved. Except Beyaz still contains drospirenone, the claimed cause of not only serious physical side effects – but also a negative mental and emotional impact documented by women across the Internet.

Bayer is focusing on the effect of folate deficiency on pregnancy and the unborn. This choice suggests Bayer’s marketing department is aware that most women taking the Pill aren’t wanting to get pregnant, aren’t planning on getting pregnant soon and therefore will dismiss folate deficiency as nothing to worry over, yet. Although some women may be alarmed at their suggestion that you can get pregnant when on the Pill. A little research reveals folate supplementation has been linked in studies to a decrease in stroke and thrombosis risk – a subtext Bayer could not print without admitting blame and accepting the law suit claims.

The production of pharmaceuticals is a billion dollar industry and it is, unfortunately, necessary to assume moves are made for money and the market and not in the hope of improving the lives of women. The less sick, or deceased women, the less lawsuits, and the more money to be made for Bayer. The creation of Beyaz suggests Bayer cares, and has the interests of women at heart, but essentially it is a cynical ploy to win back the loyalty of the many women who have become suspicious of Yaz, and consequently the Pill as a whole, due on the controversies and, most importantly, their own experiences.

Bayer has created a product that will solve a problem caused by one of its products, and make money from this. Even more ludicrous than that, it is ‘solving’ a problem by making an addition to a Pill that is causing the problem, in the hope the negative impact on the body will be balanced out. Bayer could have told its customers that they need to take a folic acid supplement when using Yaz, or eat foods rich in folic acid, instead of creating Beyaz.  Continue reading...

Tags: , , , , , , , , ,
Posted in Birth Control, Communication, Health Care, Law/Legal, Media, Menstruation | 4 Comments »

Problems with YAZ making news again

November 5th, 2010 by Elizabeth Kissling

An Oklahoma City news program prepared this investigation about health risks of Bayer’s best-selling birth control pill, YAZ, with dramatic personal stories. The video cannot be embedded here, but you can watch it and read the news story here.

Previous commentary and reporting about YAZ at re:Cycling: The Next YAZ, What’s Up with YAZ?, and The Future of YAZ. For more about YAZ, see the reporting of our friend, Holly Grigg-Spall, at Sweetening the Pill.


Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , ,
Posted in Birth Control, Health Care, Law/Legal, Pharmaceutical | Comments Off

For Now, Your Genes Belong to You

April 6th, 2010 by Elizabeth Kissling

Guest Post by Barbara A. Brenner Executive Director, Breast Cancer Action

One of the saddest aspects of capitalism is that companies think they can and should own anything they get their hands on. Some time ago, they started obtaining patents on human genes, including two genes implicated in breast cancer: BRCA1 and BRCA2.

The company that obtained the patents on these genes is called Myriad Genetics. With the patents, Myriad controls both the tests given to women to see if they carry mutations on these genes that may predisposed them to breast and ovarian cancer, as well as all the research related to the genes.

How can anyone own our genes? Up until now, no court has been asked that question. But last week, in a ground breaking decision, a federal judge in New York declared that Myriad’s patents on the breast cancer genes are invalid because they patent a part of nature.

That may seem like an obvious thing to most of us, but the research community is up in arms about how their inability to patent genes will inhibit their ability to innovate new treatments. Sounds plausible, but don’t be fooled. These patents are more about making money than they are about taking care of people who are sick.

Breast Cancer Action, an education and advocacy organization that carries the voices of people affected by breast cancer, was a plaintiff in the lawsuit brought by the American Civil Liberties Union against Myriad over the patents. Because — unlike almost all other breast cancer organizations — we don’t accept funding from Myriad or other companies that profit from breast cancer, we could stand up for  the interests of patients who either couldn’t afford the very expensive test, or who couldn’t learn what their “ambiguous” test results meant because the research wasn’t being done to find out.

Ambiguous gene test results are not uncommon, and they are most often found in women who are not white. So, once again, the worst impact of health policy – in this case, the policy to allow genes to be patented – fell on the people who were most likely to have the worst breast cancer outcomes.

Thanks to the ACLU, the Public Patent Foundation and a federal judge, the patents on the breast cancer genes are now invalid. That means that, once the decision becomes final, new tests will be on the market, and researchers will be able to pursue a greater understanding of what mutations on the genes mean.

Myriad will appeal. The case will probably eventually end up in the US Supreme Court. Myriad might get a stay of the trial court ruling pending that appeal. If they do, we’ll have to wait for our genes to be returned once again to their rightful owners – us.

Reprinted with permission.

Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , , , , ,
Posted in Law/Legal, Philosophy | 1 Comment »

Today in Unnecessary Inventions

February 17th, 2010 by Elizabeth Kissling

Device for reducing duration of menstrual flow (Patent Pending)An Israeli inventor has applied for a patent for a device to shorten the duration of menstrual flow. Apparently it works by insertion into the vagina and “delivering pressure oscillations and/or acoustic waves and/or shock waves to the vagina and cervix to change the flow properties of menses fluid”, which causes the rate of blood flow to increase so that total time of bleeding decreases. Also, “the device also includes an absorbent member attached to the pressure oscillations generating unit for absorbing menstrual secretions.” In other words, there’s a built-in tampon to catch the increased flow.

For my money, that little device looks and sounds a lot more uncomfortable than wearing pads or tampons.



Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: , ,
Posted in FemCare, Law/Legal, Menstruation, Objects | 4 Comments »

When Mirena Meets Mommybloggers

February 9th, 2010 by Elizabeth Kissling

Guest Post from Evil Slutopia

There are Tupperware parties, Passion Parties, Pampered Chef parties, and…Mirena IUD parties? Yes, apparently these events popped up early last year and were a joint effort from Bayer Pharmaceuticals and the mom marketing site Mom Central.

Here’s one mom blogger’s description of the Mirena party that she hosted:

Then tonight I hosted a party at my house with Mom Central. Mom Central had found me through this blog and asked me if I would be interested in hosting an event sponsored by Mirena. As I welcome any opportunity to sit down with some girlfriends with some free food and drink, I was happy to accept. Before the party started, I walked around nervously, terrified that only a couple of people would show up. We’re all so busy, and I worried that people would end up skipping a strange commercial-sounding event. But one by one, they rolled in and I began to relax.

We had an amazing evening, talking about sex, fashion, and living a simpler life. I realized that we don’t actually spend a lot of time talking about sex and relationships. We laughed a lot but also went home with some great tips.

If you’re thinking that “strange commercial-sounding event” sounds like an accurate description for a party like this, you won’t be surprised by what comes next. What this mom didn’t mention, possibly because she wasn’t aware, was the fact that the script used at these parties didn’t comply with FDA implementing regulations or the Federal Food, Drug, and Cosmetic Act, prompting the FDA to send a warning letter to Bayer at the end of last year. (Bayer is no stranger to FDA warnings – they recently had to “correct” ads for their Yaz/Yasmin birth control pills, which are also the subject of several lawsuits, after the FDA said they were unclear and misleading.)

Before I get into the specifics of the FDA violations in this case, let’s take a look at some more details about these events. First, let’s look at Mom Central. The main Mom Central site has forums, blogs, parenting tips, a product testing panel, giveaways, and so on, but it’s the Mom Central Consulting site that we’re really interested in. Here are some quotes from the site about what they do:

  • Companies eager to tap the powerful, abundant, dominant women’s market are often challenged to target and reach Moms simply through their own internal “experts.” We at Mom Central Consulting are Mom Experts currently engaged in crafting messaging, marketing to mothers and reaching millions of Moms nationwide every month.
  • TODAY’S MOMS REQUIRE TARGETED, HOLISTIC MARKETING APPROACHES that reach them where they are in their lives today. At Mom Central Consulting we create customer loyalty and word of mouth programs that: foster credibility, drive evangelism and engage Moms in irresistible brand experiences that drive sales and fuel profits.

    Our two-pronged targeted approach connects clients with our vast proprietary network of leading Mom Experts and Opinion Leaders and then activates Moms to become trusting, loyal advocates and consumers of your brand, product or service, making us experts at marketing to women.

  • CORPORATE SPOKESPERSON BUREAU: We can draw from our pool of hundreds of talented media savvy spokespeople to create a customized corporate press campaign featuring credible experts within your product category.

So maybe the goal of the hosts and attendees at these parties was to have a fun night eating free food and talking about sex and relationships, but it’s important to keep in mind that that’s not the main goal of Mom Central or the product that they’ve been hired to represent. What they want to do is “activate” some Mirena evangelists.  Continue reading...

Tags: , , , , , , , ,
Posted in Advertising, Birth Control, Law/Legal, Pharmaceutical | 3 Comments »

“Abortion is a matter of survival for women”

January 22nd, 2010 by Elizabeth Kissling

It was 37 years ago today that the U.S. Supreme Court decided Roe v. Wade, in which the Court held that a woman’s right to an abortion fell within the right to privacy protected by the Fourteenth Amendment.

In commemoration of that decision and women’s right to autonomy over personal reproductive decisions, I’m posting some of the newly released video of the late Dr. George Tiller talking about why he performed abortions.


Thank you, Dr. Tiller, for trusting women.


Post to Twitter Post to Plurk Post to Yahoo Buzz Post to Delicious Post to Digg Post to Facebook Post to MySpace Post to Reddit Post to StumbleUpon

Tags: ,
Posted in Activism, Health Care, Law/Legal | 1 Comment »

« Older Entries
Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.