Blog of the Society for Menstrual Cycle Research

“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

April 18th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.

Is this additional text in an insert enough? Cynthia Pearson of the National Women’s Health Network has given an unqualified no as her response to the decision.  If no is the answer, then what needs to happen next? At this time I’ve seen no coverage outside of news reports that has shown the response of the wider feminist, or just female, community.

Menstrual Suppression for Military Women

January 13th, 2011 by Elizabeth Kissling

One of the arguments for using hormonal contraception to suppress the menstrual cycle is that it mitigates the logistical challenges menstruation can present in high-stress occupations in harsh settings — such as military service in a combat theatre. Given how  compelling the argument is, it’s surprising that birth control pills/patches aren’t used in these settings more frequently.

A new study in Women’s Health Issues indicates that although service women are eager to learn more about the option of menstrual suppression, education about it is lacking. A survey of U.S. women serving in Iraq, Afghanistan, and other combat operations indicates that the number of lost duty days due to menstrual pain would likely decrease with better education about suppression options and compliance regimens.

How the Pill Gave Birth to the Women’s Health Movement

May 25th, 2010 by Elizabeth Kissling
Photo from http://www.flickr.com/photos/blmurch/486046904/  // CC BY 2.0

Photo from http://www.flickr.com/photos/blmurch/486046904/ // CC BY 2.0

Only a latter-day Rip Van Winkle could avoid knowing that this month marks the 50th anniversary of the FDA’s approval of Enovid, the world’s first birth control pill. Hundreds of newspaper and magazine articles have marked this anniversary.

Many incorrectly credit the pill with giving birth to feminism. As Elaine Tyler May notes in the current issue of Ms., the pill didn’t start the feminist movement but was in the right place at the right time:

The timing could not have been better. The feminist movement gained momentum just as the Pill became available. With the ability to control their fertility, women could take full advantage of new opportunities for education, careers and participation in public life.

But in the midst of all this celebrating, we’ve neglected another anniversary: 2010 marks the 40th anniversary of U.S.  Senator Gaylord Nelson’s congressional hearings about the pill’s safety profile, which arguably did launch the women’s health movement.

That launch received a giant shove from Barbara Seaman, a magazine writer who published a book called The Doctor’s Case Against the Pill in 1969, and Alice Wolfson, a then-student and feminist activist. Seaman’s book documented medical risks of the pill–such as blood clots, decreased sex drive, mood disorders and certain cancers, and she alleged that the pharmaceutical industry had suppressed such information. Sen. Nelson was investigating other allegations against the pharmaceutical industry and read Seaman’s book, which motivated him to take on the pill as well.

At the time of the hearings, Wolfson was part of an activist collective known as D.C. Women’s Liberation. In discussing whether or not to attend the hearings, Wolfson and several other members discovered they all had experienced negative side effects of the pill, which their physicians had not warned them about. That revelation led to something bigger. As Wolfson later wrote in her memoir, “We went to the Hill to get information. We left having started a social movement.”

At the Nelson pill hearings, as they soon became known, medical experts delivered testimony about the known risks of synthetic estrogen, one of the main ingredients in birth control pills. No pill users were on the agenda. The only woman who testified was Dr. Elizabeth Connell, who expressed the fear that if dangers of the pill were publicized, women would give up birth control entirely. Connell said she worried that would lead to an explosion of unwanted pregnancies, or “Nelson babies.”

Alice Wolfson says she doesn’t remember the exact tipping point in the hearings that prompted her to speak up, but I like to think it was the moment when a medical researcher testified, “Estrogen is to cancer what fertilizer is to wheat.” Wolfson and other women raised their hands politely to comment, but when Sen. Gaylord refused to recognize them, they began shouting their questions.

Why weren’t we told about side effects?

Why aren’t any women testifying?

What happened to the women in the Puerto Rico study?

Why are you using women as guinea pigs?

Why are you letting the drug companies murder us for their profit and convenience?

The feminists immediately had the attention of reporters, and a movement was born. Seaman and Wolfson met during one of the breaks in testimony, and eventually worked together to create the National Women’s Health Network – still a vibrant and vital advocacy organization for women’s health.

The Nelson pill hearings eventually led to lower doses of estrogen in the pill (today’s oral contraceptives are about 1/10th the strength of Enovid) and perhaps more importantly, the introduction of patient package inserts, PPIs. The new FDA requirements resulted in the inclusion of printed information about risks, ingredients and side effects in pill packets, and eventually in all pharmaceuticals.

Women’s health activists went on to work for tampon safety regulations in the 1980s, resulting in an FDA mandate for consistency of absorbency ratings and warnings regarding tampon-associated Toxic Shock Syndrome (TSS); withdrawal of fen-Phen diet pills in the 1990s; ongoing revisions of the ACOG guidelines for VBAC (vaginal birth after cesarean) and so many other issues in support of women’s health, safety and well-being.

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.

In the case of these Mirena parties, the expert spokesperson that Mom Central used was Barb Dehn, Nurse Practitioner and member of the Mom Central Advisory Board. Barb is the author of a series of Blue Orchid Guides on women’s health topics like breastfeeding and menopause. In addition to those guides, Blue Orchid Press also has a Partner Program:

Should menstruating women be permitted on submarines?

January 11th, 2010 by Elizabeth Kissling

The Royal Navy's newest state-of-the-art submarine leaves Barrow-in-Furness to begin sea trials.Britain’s North West Evening Mail reports that nation’s department of defense is considering whether or not to allow women to serve on subs. Women have gone to sea on submarines in pilot studies in the past, but presently only the Norwegian, Danish, Swedish, Australian, and Canadian navies allow women on submarines.

The primary objections to the new inclusiveness are the possibility of minute radiation affecting chromosomes in pregnancy; screening equipment in submarine toilets that may not be capable of dealing with items like tampons; and the belief that having women and men working in close, cramped quarters could “create tension.” Plus, “it might worry submariners’ wives if women go on subs,” according to one merchant seaman who is a Petty Officer in the Sea Cadet corps.

However, it’s the Ministry of Defense that will be making the decision. A spokesperson told the paper, “The UK is bound by law to reassess occupations from which women are excluded every eight years. We expect the review will be completed in early 2010 and once the results have been evaluated we will publish our conclusions.”

Until then, I’ll join the Evening Mail in letting local businessperson Sally Broom have the last word.

“As far as I am aware, the only ‘official’ reasons for women not being allowed to spend time in submarines at depth are lack of facilities, and medical concerns surrounding pregnancy. In this case facilities should be made available and there should be no issue for women who are not pregnant.

“A traditional and ‘unofficial’ viewpoint is that the presence of women leads to lack of focus. But the idea that, as soon as a woman sets foot on a submarine with a team of highly drilled, disciplined men, the whole thing would collapse into a lustful mess is an absurd insult to both male and female sailors.

Body Scans, Disability, Menstruation, and Security Theatre

January 5th, 2010 by Elizabeth Kissling

Image of backscatter X-rayThere’s an intense, important discussion going on at FWD/Forward about how the latest ramp-up of security theatre of air travel could affect persons with disabilities. Blogger Lauredhel points out that the following items all show up in a back-scatter x-ray produced by a full-body scanner:

  • Urinary catheters.
  • Incontinence pads.
  • Colostomy and ileostomy bags.
  • PEG feeding tubes.
  • Mastectomy prostheses.
  • Certain medication pumps and implanted ports, such as insulin pumps.
  • TENS machines.
  • Pacemakers.
  • The bodies, including genitalia, of transgender and intersex and genderqueer people.

Lauredhel notes, “All of these are the signs of bodies already marginalised. Some of these signs may be clear on current security screenings – some may not.” She explains how the resulting invasion of privacy is likely to be even more invasive than for able-bodied, cis-gendered, cissexual folks.

The list suggests that menstrual pads and tampons will also be visible. Will menstruating travelers be asked to confirm that they’re indeed menstruating? Will they be compelled to prove that item is really a tampon and not a concealed weapon? And what about menstruators who are transgender, intersex, genderqueer, or otherwise do not conform to conventional expectations about gender expression? Will they be subject to further interrogation or required to “prove” their sex?

If you didn’t already hate flying and the aggravation of TSA security theatre, you will.

Pills and Soap: Birth Control Now Available without Prescription in London Pharmacies

December 23rd, 2009 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall, freelance writer (“Sweetening the Pill“)

NHS poster announcing availability of The Pill without prescription.In the summer of this year, I was researching for a feature for Easy Living magazine on the potential side effects of the birth control pill and when searching for a news hook for the piece, I found out about the preparation of a NHS scheme which would allow oral contraceptives to be distributed from pharmacies without a prescription. At that time, all of the doctors I interviewed expressed concerns about this development, even the most conservative GPs who stubbornly dismissed my concerns about side effects.

Then last week it hit British newspapers that this scheme had recently launched in the areas of London that have the highest rates of teenage pregnancy. Bold, bright posters in the style of laundry soap adverts exclaiming that the Pill is now available without prescription are up in pharmacy windows of Lambeth and Southwark. According to the news reports the pharmacists involved were given three weeks of training in order to provide consultations for young women looking to start taking oral contraceptives or wanting to move from the Pill to long acting methods like the injection, the implant or the hormonal IUS. The implication was also there that if young women came to the pharmacy for the emergency contraceptive pill then their consultation would involve the suggestion that they start on the Pill or a long-acting method.

The British government can’t seem to figure out how to handle their teenage pregnancy problem. They are looking for a quick, effective, wide-reaching fix that doesn’t cost much – certainly not as much as working with individual teenage girls to discuss their attitudes towards relationships and definitely not as much as providing holistic sex education that covers both the technical and emotional aspects. The NHS as a countrywide health service can be brilliant at organizing awareness campaigns – such as their quit smoking scheme – but providing the Pill without prescription is a step in the wrong direction.

Aside from the fact that this proposal will, without a doubt, devalue the Pill as a drug, a medication, and thus make it appear harmless, and therefore keep women ignorant of its potential impact on their health and wellbeing and prevent them from seeing the signs of side effects – any ‘consultations’ provided by pharmacists are very unlikely to be comprehensive or cautious. We already know how most doctors deal with doling out the Pill – many simply do not tell the truth about how it works, and do not talk about the potential problems it might cause, particularly in terms of mood and emotions.

The pharmacists have probably been told to check the teenagers weight and blood pressure on their first visit – but what about scheduling follow up appointments? Will the teenage girl go back every six months and check in with the pharmacist for another consultation? How many packets of the Pill will they be given to start? It can be assumed busy pharmacies aren’t going to want to have a constant round of check ups and would be more inclined to hand out Pills literally over-the-counter after an initial talk. This goes against even the loose policies presently in place for obtaining prescriptions. Women must return to their GP every three or six months to check for problems such as the increased blood pressure, migraines or breathing difficulties that might suggest a blood clot formation.

Most women get the Pill from their GP, but often family planning clinics are much more interested, at least in the UK, in the side effects a woman might suffer from on different brands. This new scheme appears to stem from the root idea that teenage girls are secretive about taking the Pill and therefore want to avoid their family GP. The spokespeople for the scheme have said teenagers go into, say, the Boots pharmacy to buy cosmetics, so they can pick up the Pill easily and inconspicuously. It seems very doubtful that teenage girls really have this problem with people knowing they are on the Pill. Would these consultations, like those available at a family planning clinic, involve discussion of condoms and the necessity that they are used for casual sex at all times? If teenage girls are using condoms properly then they wouldn’t need to take the Pill, and they definitely need to use condoms to prevent getting or passing on STIs.

Who Lacks Health Literacy?

December 18th, 2009 by Elizabeth Kissling

You may have heard the news that 23 hormone replacement therapy lawsuits filed by women diagnosed with breast cancer were dismissed by a New York judge this week. Judge Martin Shulman granted Pfizer’s motion to dismiss for two reasons: the plaintiff’s delayed filing exceeded the the three-year statute of limitations in New York, and that “the potential risk of contracting breast cancer from taking HRT medication was well known at all times out there in the stream of public information.” Oddly, Judge Shulman simultaneously asserted “that the debate over HRT health problems has not yet been settled.”

I can’t argue about exceeding the statute of limitations, but it’s difficult for a judge to assert that breast cancer risk of hormone therapy is well known public information. The Lancet reported today that up to half of US adults have trouble interpreting medical information, displaying low levels of health literacy. Health literacy, according to The Lancet, is the ability to comprehend and use medical information that can affect access to and use of the health-care system. Health literacy is more than reading and comprehending news reports of medical issues (which are often of poor quality – see Health News Review for sharp analysis of health news); one must also know how to navigate the complexities of the health care system, including knowing how and when to question one’s physicians and pharmacists.

It’s also hard to argue that HT risks are well known when gynecologists, the primary prescribers of HT, refuse to believe the scientific evidence. In 2000 – well after 1990s publication of data from the Heart and Estrogen/Progestin Replacement Study (HERS), a prospective, randomized, double-blind study of 2,763 women with coronary disease which found no benefit of hormones in preventing heart disease – 94.6% of American gynecologists surveyed recommended HT during menopause. Denial continued even after the Women’s Health Initiative (WHI) study – a large, prospective, randomized placebo-controlled trial of estrogen (with and without progestin) in healthy menopausal women – was stopped early in July 2002, because the treated group experienced higher rates of breast cancer, cardiovascular disease, as well as other risks of harm.

WHI was a large, primary prevention trial that contained enough subjects (more than 27,000) to answer the research question; used a design widely acknowledged to be the standard in testing therapeutic efficacy; tested Prempro, the most popular hormone combination; and was monitored by a data safety monitoring board using pre-established criteria. Practitioners should have been satisfied that the question of estrogen as a health-protecting drug had been resolved. Instead, a storm of protest erupted from physicians who could not, or would not, believe the results. Objections to the WHI results (almost exclusively from gynecologists) were so widespread that the media characterized the WHI results as confusing and controversial.

In truth, there was no confusion about the data, which were monotonously consistent with HERS and other randomized controlled studies. [Fugh-Berman & Scialli, 2006]

Why do gynecologists, judges, and others still regard this question as unsettled? Scholars offer several explanations. Paula Derry (board member of the Society for Menstrual Cycle Research) proposed in a 2008 article that faulty decision-making criteria are in play, such as

not valuing rigorous scientific thinking (e.g., ignoring normal rules for judging what counts as scientific evidence, sometimes while claiming to be scientific); not placing a primary value on avoiding harm (e.g., considering heart disease outcomes while not simultaneously considering other risks such as stroke); and basing judgments on a preconception about menopause (i.e., that menopause is an estrogen deficiency disease that causes health problems). [Derry, 2008]

Adriane Fugh-Berman and Anthony Scialli also say the perception of menopause as an estrogen deficiency disease still influences doctors. They speculate that certain features of the unique culture of obstetrician-gynecologists are involved in the continuing promotion of HT. For example, gynecologists are one of few medical specialties that see mostly healthy patients.

Managing medications in healthy women gives a doctor something to do and ensures a continuing relationship with women no longer in need of obstetric expertise.The promise of eternal youth ensures the patients’ consent and gratitude. Healthy women require little or no monitoring and are resilient enough to survive most prescriptions.

FDA Approves Mirena for Heavy Bleeding

October 1st, 2009 by Elizabeth Kissling
Illustration from Feminist Women's Health Center

Illustration from Feminist Women's Health Center

The Federal Drug Administration (FDA) announced today that Mirena® has been approved for use as treatment for heavy menstrual bleeding. Mirena® is an intra-uterine device (IUD) for preventing pregnancy. It combines the technology of old-school IUDs with the hormone levonorgestrel, a synthetic progesterone.

I’m a little puzzled, though, by the apparent limited usage recommended: the press release states,

The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention.

This sounds like Mirena® is approved for women who already using IUDs. So if you’re already using Mirena® for birth control, congratulations. Now you can use it to reduce menstrual flow.

For those keeping score at home, Mirena® is manufactured by Bayer, also makers of beleaguered birth control pill, Yaz.

BBF: Best Bones Forever

September 3rd, 2009 by Elizabeth Kissling

DotgirlDot Girl™ First Period Products, a retailer of first menstrual period kits for pre-teen girls, announced today that they are partnering with Best Bones Forever!, a national campaign led by the U.S. Department of Health and Human Services’ Office on Women’s Health.

It’s hard to get cranky about a federal program that seems to consist mostly of PSAs about good health habits for girls, but a couple of things about this particular campaign make my SpideySense tingle:

  1. The press release about this new partnership states that Dot Girl™ is based in Seattle and was founded by sisters Terri Goodwin and Kathy Pickus with the intent to help parents manage the often difficult conversation about menstruation with their prepubescent daughters. The sisters’ products also “create empowered young women who have a positive first period experience.” But a closer look at the contents of the Dot Girl’s First Period Kit suggests a close relationship with Kimberly-Clark: it contains two Kotex products and coupons for discounted purchase of other Kotex products. I also note that the name and logo of the company, Dot Girl, evokes the red dot used in Kotex commercials and logos. Kotex received a lot of kudos when their Red Dot campaign was first launched in 2000, for its playfulness and for being the first advertising campaign in the U.S. to use the word “period”.
  2. The Kit also contains a sample package of “Scensibles™”, labeled “scented bags for clean, easy, discreet disposal of feminine care products” and a package of hand wipes. I suppose these are included because periods are so smelly and dirty; apparently empowerful young women need to be very clean. In the U.S., it is not unusual for key developmental moments such as menarche to be marked by increased consumer behavior but it still rubs me the wrong way that an organization purportedly focused on helping girls and their parents with this transition tries to do so by selling stuff – especially unnecessary stuff with shaming implications.
  3. I also note that all the material about how to develop and maintain healthy bones makes no mention of the link between bone health and menstruation. With each ovulatory cycle, the ovary secretes progesterone, which stimulates the production of osteoblasts. Osteoblasts are cells that build new bone. If menstruation is irregular or suppressed with cycle-stopping contraceptives (which work by suppressing ovulation), bone health can be negatively affected.
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.