Pharmaceutical

Yaz and Yasmin Back in the Spotlight

Birth Control, Coming off the pill, Pharmaceutical

Guest Post by Holly Grigg-Spall, Sweetening the Pill

Last year the FDA made the decision to keep the birth control pills Yaz, Yasmin, and Beyaz on the market despite controversy over corporate corruption of the review process.These drugs are back in the spotlight.

The French health minister has called for doctors to stop writing prescriptions, 2,000 lawsuits against Bayer launched in Canada last month, and Marie Claire Australia dedicated five pages to an in-depth feature about the side effects, instigating an investigation by the country’s top current affairs show Today Tonight.

Bayer has gone about settling the 13,000 lawsuits in the US out of court, likely with the hope of keeping the details of confidential files regarding marketing techniques and research out of the public eye. Unperturbed by mounting reports from women of the myriad health issues caused by their products, the company launched Yaz Flex in Australia at the end of 2012. The first oral contraceptive on the Australian market presented as being for the purpose of preventing periods, Yaz Flex comes in a digital dispenser that records how many pills have been taken and alerts the user when she’s missed a dose. There are enough tablets to allow for just three breaks a year. In the US in April the FDA, equally unperturbed, ruled that pharmaceutical company Activis can start selling generic versions of Yaz, providing a low-cost version of what has been the most expensive oral contraceptive of recent years.

The feature in Marie Claire Australia generated 300+ comments on the magazine and television show’s Facebook pages. Many of the commenters were women who had developed blood clots when taking these brands. Some had made the connection at the time and others made the link only as a result of the coverage after months or years of not knowing why they had endured the injuries. Some of the women were presently experiencing the symptoms of a blood clot mentioned in the show and made the decision to stop taking the pill as they typed.

The piece was written by a long-time member of the Yaz and Yasmin Survivors forum and balances interviews with women who suffered the serious physical side effects with those who have been victim to the serious psychological side effects. I’m among those who experienced a long list of negative physical and psychological effects when taking Yasmin for more than two years and it was this forum that prompted me to stop taking it.

Monash University in Australia is one of the few facilities to have undertaken research into the correlation between birth control pills and depression. Professor Jayashri Kulkarni found that women on the pill were twice as likely to experience depression, anxiety, and mental numbness (known as anhedonia). The Yale Daily News reports that in the wake of her research receiving a little media attention Dr Kulkarni received more than 300 emails from women “clearly describing when they went off the pill that they felt subjectively more happy. The anhedonia, for example, disappeared, the irritability disappeared, the sense of poor self esteem disappeared”.

She is now focusing her attention on researching what she believes to be the particular psychological impact of the Yaz brands, those pills containing the synthetic progesterone drospirenone and low-dose synthetic estrogen.

Although there is no direct-to-consumer advertising in Australia these brands of pill gained popularity there just as they did in Europe and Canada. It is interesting to note that Marie Claire US ran an article in 2011 titled ‘The New Super Pill’ that named Yaz and Yasmin as the latest, greatest “no-acne, no-bloat and pms-be-gone” pills that also allow you to “shorten your period”. The pages of magazines such as Marie Claire in the US are usually scattered with adverts for Yaz and Yasmin, the NuvaRing, Nexplanon impant, and Mirena IUD. The print and television commercials often play on the same insecurities reflected and bolstered by the majority of the women’s magazine articles.

Articles with headlines like that of the Marie Claire Australia piece, “Bitter Pills: The Birth Control With Deadly Side Effects”, are usually accused of scare-mongering women off the pill unnecessarily despite the fact that reactions suggest they might well be saving lives. Generally women who decide they don’t want to take one brand are presented with another — and how many women know Yaz Flex, Yaz, Yasmin and Beyaz are 99% similar in composition and won’t just be shifted among the four? Judging from the comments responding to the piece, women who decide they are done with birth control pills are likely to be offered a Mirena IUD, implant, or Depo shot, all of which hold their own set of deadly and life-shattering side effects.

Women commented on the Facebook pages that they had made an appointment with their doctor only to be told not to worry and keep on taking their pills. Yet more remarked on their anxiety over stopping taking them as the article described the difficulties women experienced after they came off. Among women sharing doubts over whether the implant or shot should be their next choice, one woman asked:

“What other safer alternatives are there to birth control pills then?”

These articles don’t tend to go into the non-hormonal alternatives for contraception and cycle health that could support women in their choice not to take these drugs, and leave those scared of side effects to struggle along feeling trapped between pharmaceuticals and unwanted pregnancy, or on pharmaceuticals and not looking like the models in the magazines. That support needs to be out there and easy to find, or we will continue to see messages like this, sent out into the silence:

“I have been on Yaz for 3 months and just recently got switched to Yaz Flex yesterday so that it’s easier for me to remember takin it on time etc. by my doctor. I told her about what’s been happening in the last month or so, and she just gave me a cream for rashes etc. BUT I am seriously concerned as to if what I am experiencing is normal or not. I may be over reacting, I was put on this pill to regulate and lighten my period and also for my acne, it has helped a lot, but in the last month or so I have been experiencing an extremely itchy face, I have been finding it hard at times to breath and I’m very shortened in breath, it’s starting to scare me a lot. My heartbeat is irregular and I feel extremely light headed. I have been also experiencing horrifying migraines and headaches. I’m only 15 I may just need more understanding to what is happening if it is normal, somehow I feel it’s not please help :,(“

Hormone Imbalance: Breaking the Silence

Birth Control, Coming off the pill, Hormones, Pharmaceutical

Guest Post by Leslie Carol Botha Women’s Health Freedom Coalition Coordinator, Natural Solutions Foundation

I still remember the first Society for Menstrual Cycle Research Conference I attended in Tucson, AZ in June, 1999. The statement that made the most impact was the collective concern that in ten years there might no longer be a menstrual cycle. It turns out the truer words were never spoken.

In the past 40 years, the pharmaceutical industry has spewed out and packaged and repackaged so many synthetic hormone contraceptives – pills, injections, and implants that virtually eliminate the menstrual cycle.  It also amazes me that in the 30 years I have been involved with the women’s health movement condoms and spermicide are still the safest and most effective contraceptive on the market.

However, a new trend is emerging as condoms and birth control pills are being pushed on the back burner because of ‘human error’. Women and men are not always diligent or careful about condom use, and many girls and women forget to take their pills.  What is now being prescribed to adolescent girls — whether or not they are sexually active — are implants and injections. Health considerations are not taken into consideration, nor are hormone levels. Somehow the pharmaceutical industry still views this as a one-size-fits-all prescription for all women, no matter their age of their state of health.

Menstrual cycle advocates are most aware that birth ‘control’ is about control…controlling the woman’s body with potentially harmful synthetic hormones. What has been overlooked are education and natural methods of fertility awareness.

While our focus recently has been on the politics of birth control, another ugly monster has reared its head and that is the silent epidemic of hormone imbalance. Not only is this the result of taking synthetic hormones for birth control but our environment, our foods, and water supplies are filled with estrogen mimickers upsetting the delicate orchestration of hormones in our bodies.

Another concern is the excess estrogen stored in women’s bodies and passed on genetically to their offspring.  It is possible that their children are hormonally imbalanced at birth.

Either way, the damage has been done. I believe we are at the tip of the iceberg in this silent epidemic and that hundreds of thousands of women are being misdiagnosed and over-prescribed. In most cases, thyroid imbalance is not considered as a cause of depression, and the prescribed fix is generally Prozac or a higher dose of synthetic hormones.

In 2009, I posted an article to my blog, from eHow editor, Shelly Macrea titled: What is Hormone Imbalance?, a very informative article and probably one of the first pieces for a general audience on the myriad of conditions that hormone imbalance can cause.

At the time I had three responses (with an average of 30,000 unique visitors a month.) In June of this year, another post on the article (which by this time was buried in my archives) appeared from a woman suffering anxiety due to hormone imbalance. And then another post appeared and I decided to bring the article out of the archives and re-post it. What ensued was a steady stream of women commenting on almost a daily basis on their extreme anxiety and depression and the myriad of misdiagnosis and drugs they were prescribed. I am posting the link here so that others can read what I believe should be of concern to all of us: Hormone Imbalance Anxiety, A Precursor to Other Health Issues.

In March of this year, I posted Laura Wershler’s article Coming off Depo Provera Can Be a Woman’s Worst Nightmare. Once again, truer words were never spoken. More and more women are now posting about their experiences on this drug – and the ensuing hormone imbalance and health issues.

Women are suffering.

This is an insidious ‘War on Women’. On the one hand we have had to fight for our reproductive rights and the availability of birth control – on the other hand it is the same birth control that is slowly killing us.

When Breastfeeding Isn’t Best

Hormones, Pharmaceutical

Paula Modersohn-Becker (Public domain), via Wikimedia Commons

Let me say up front that I have limited direct experience with adoption. Some members of my extended family have adopted children, another has given up an infant for adoption, and I have friends who have adopted children, and other friends who are adopted. It was one of those adopted friends who pointed me to this uncritical article from last fall about the practice of adoptive mothers ‘learning’ to breastfeed.

I’ve placed learning in scare quotes because this article isn’t about adoptive mothers developing a skill. It’s about taking high-risk drugs so that they can have the experience of breastfeeding their adopted children, even though they will be unable to produce enough breastmilk to nurse exclusively. But by taking combined oral contraceptives continuously for several months (which, contrary to the popular belief asserted in the article, does not “trick the body into thinking it’s pregnant”) and following up with domperidone, an antiemitic drug which sometimes has the side effect of causing lactation — even in men — some adoptive mothers are able to force their bodies to lactate.

What’s so terrible about this, you may be wondering. Domperidone isn’t approved by the FDA for use in the US, even for its intended purpose in treating nausea and vomiting, so it is usually purchased by ordering from other countries. The FDA, however, has not been silent about domperidone: The agency has issued multiple safety alerts, advising healthcare professionals and breastfeeding women NOT to use the drug. Although the amount bioavailable to the infant is small, domperidone is excreted in breastmilk.

The hormones in the birth control pill are also excreted in breast milk, and are suspected to promote growth of breast cancers, if not actually cause them. (And who can forget that immortal bit of testimony from the Nelson Pill hearings in 1970, “Estrogen is to cancer what fertilizer is to wheat”?)

I appreciate the desire of new moms to bond with their babies, I really do. But if you’re willing to take these kinds of risks with your own health and your baby’s, I have to wonder if your desire to breastfeed is really about the relationship with your child.

When One Less Becomes One More

Health Care, New Research, Pharmaceutical

Abnormal Pap Smears, Cervical Dysplasia and Cervical Cancer Spike Post-HPV Vaccination

Guest Post by Leslie Botha, Women’s Health Freedom Coalition Coordinator, Natural Solutions Foundation,
and Janny Stokvis, VAERS Research Analyst

 

In 2006, the HPV vaccine Gardasil touted to prevent cervical cancer was introduced to a public generally unaware of the Human Papillomavirus or its threat to adolescent girls and women. However, the public was quickly informed of the dangers of the virus when Merck launched an aggressive advertising campaign designed to capture the attention of girls/women ages 9 to 26 with a catchy jingle and their now famous line: “One Less Girl to Get Cervical Cancer.” Adolescent girls were dancing and singing that they will be ‘one less girl’ in unison with the award-winning TV commercial.

According to Neon Tommy, the online publication for the Annenberg School for Communication and Journalism, USC, the promotion was successful. In 2008 Merck’s marketing techniques even earned Gardasil a “pharmaceutical brand of the year” award from Pharmaceutical Executive for its ‘savvy disease education,’ and for building ‘a market out of thin air’.

Six years later, it appears that ‘one less’ is now turning into ‘one more’ as reports of abnormal pap smears, cervical dysplasia and cervical cancer are appearing in the HPV vaccine targeted market.

Table prepared and provided by authors

As of May 12, 2012 the Vaccine Adverse Event Reporting System (VAERS) showed there have been 26,050 reports of adverse events (including 849 reports from boys/men ages nine to 26) post-HPV vaccination. The National Vaccine Information Center (NVIC) estimates only 1 to 10% of the vaccine-injured are reporting.

Of concern is the significant increase in reporting for cervical abnormalities reported to VAERS each month. Of even more concern is that the American College of Obstetrics and Gynecology has raised pap testing guidelines to age 21 leaving many adolescents without proper cervical screening tools post-vaccination. Yet a significant number of events are being reported by an age group that typically does not develop cervical cancer until age 50 or older. According to Stokvis, some of the reports of cervical abnormalities are occurring four to five years post-vaccination.

Abnormal Pap Smears: 490 (greatest number of incident reports age 14 to 26)
Cervical Dysplasia: 195 (greatest number of incident reports age 14 to 26)
Cervical Cancer: 56 (greatest number of incident reports age 16 to 26)

In January 2012, the American Journal of Obstetrics and Gynecology published the ATHENA HPV study announcing the results of a large cervical cancer screening trial, enrolling 47,208 women 21 years of age or older at 61 clinical sites throughout the United States. The authors reported that in a sub group of 12,852 young women, the HPV vaccine reduced HPV-16 infections only 0.6% in vaccinated women vs. unvaccinated women. Most disturbing are the data that showed other high-risk HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than unvaccinated women. In fact, the study reported that the increased rate of infections by carcinogenic HPV types in vaccinated women (other than those targeted by Gardasil®) is four to ten times higher than the reduction in HPV 16/18 infections.

Why are these numbers of great concern? According to 2005 -2009 data reported by the National Cancer Institute,

The median age at diagnosis for cancer of the cervix uteri was 48 years of age. Approximately 0.2% were diagnosed under age 20; 14.0% between 20 and 34; 25.9% between 35 and 44; 23.9% between 45 and 54; 16.7% between 55 and 64; 10.7% between 65 and 74; 6.1% between 75 and 84; and 2.6% 85+ years of age.

The problem is that the FDA has not recommended a reliable HPV screening assessment prior to the mass vaccination program. In addition, the CDC estimates 25,000,000 people have been previously exposed to HPV.

In September 2011, Norwegian immunologist, Charlotte Haug, M.D., Ph.D. raised the issue of potential HPV virus replacement in her opinion paper in the New Scientist titled: “We Need to Talk about HPV Vaccination Seriously”

There is another serious question that may be answered sooner:  what effect will the vaccine have on the other cancer-causing strains of HPV? Nature never leaves a void, so if HPV-16 and HPV-18 are suppressed by an effective vaccine, other strains of the virus will take their place. The question is, will these strains cause cervical cancer?

Dr. Haug noted that vaccinated women showed an increased number of precancerous lesions caused by strains of HPV other than HPV-16 and HPV-18. She also wrote “…the results are not statistically significant, but if the trend is real – and further clinical trials should tell us in a few years – there is reason for serious concern.”

Even in 2009, a voice of concern by medical researchers about virus replacement was raised:

…However, the biological mechanisms of different HPV types are not yet fully understood, and the significance of cross-protection is limited by a small number of lesions, short study period, and lack of data on ICC. It is worth noting that following HPV vaccine implementation, other high-risk HPV types than HPV 16 and 18 could replace the biological niche of HPV 16 and 18, thereby causing a relatively greater proportion of cervical cancer and cervical cancer precursors cases [9,10]. If this occurs, there is a potential to offset the benefits of vaccination. HPV vaccination evaluation programs should consider this possibility and evaluate changes in HPV type distribution in high-grade lesions and ICC over time relative to HPV types found in the general population with documentation of HPV vaccination history. Long-term follow-up during further vaccine evaluation is expected to address those two issues.

Even though the above published papers raise important questions, this study out of the UK titled, “Potential overestimation of HPV vaccine impact due to unmasking of non-vaccine types: quantification using a multi-type mathematical model“, published on May 14, 2012, cites, “There could be an apparent maximum increase of 3-10% in long-term cervical cancer incidence due to non-vaccine HPV types following vaccination”. The authors, from the Health Protection Agency in London conclude that “[u]nmasking may be an important phenomenon in HPV post-vaccination epidemiology, in the same way that has been observed following pneumococcal conjugate vaccination”.

The data in the age group of the injured girls reporting abnormal pap smears, cervical dysplasia, and cervical cancer indicate that the HPV virus replacement or unmasking is an issue that needs to be examined immediately. An award-winning advertising campaign that ‘created a market out of thin air’ for Gardasil® use in an uneducated and misinformed demographic is no excuse for the distribution of a ‘cervical cancer’ prevention vaccine that has not been ‘evaluated for the potential to cause carcinogenicity and genotoxicity’. It is obvious that that ‘one less girl to get cervical cancer’ is becoming ‘one more girl’ to get a myriad of adverse reactions including cervical cancer.

 

O Canada! Gardasil® Vaccine May be a Medical Experiment on Older Women

Health Care, Pharmaceutical

Guest Post by Leslie Botha, Broadcast Journalist

It appears that women ages 27 to 45 in Canada are being subjected to the same type of Gardasil® advertising campaign adolescents and their families are in the United States. The full page advertisements are running continuously in magazine supplements in Sunday newspapers north and south of the border.

‘Now women ages 27 to 45 can benefit from Gardasil®’. Say what? Benefit from what? ‘Talk to your health care professional today.’ Now, I am not sure of what is going on in Canada – but in the U.S., healthcare professionals have nearly become pharmaceutical sales representatives, and women cannot go in for a doctor’s exam without being pressured to go on the birth control pill or get vaccinated. In fact, a stamp is now placed on a patient’s chart to remind doctor’s if the adolescent is in the process of getting the three-shot Gardasil® series or has been ‘counseled and refused’ vaccination.1

According to the U.S. FDA, there is no health benefit to getting Gardasil® for women ages 27 to 45. Then why is the vaccine being offered to older women in Canada?

Only the Facts Ma’am

In April 2011, after a long awaited decision the U.S. FDA ruled against Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil® use to an older population of women.

In a brief statement Merck stated that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL® was updated to state that GARDASIL® has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.”1

Within the same month Merck issued a press release announcing Health Canada had approved use of Gardasil® for women ages 27 – 45 for preventing cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by HPV strains 6, 11, 16, 18. Health Canada was surprisingly silent on the HPV vaccine issue and did not release a statement of their own.2

This should have been the first red flag for Canadian women. According to Pharmalot, “Although Canada is a smaller market than the U.S., the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.”3

The needed revenue is due to the decreasing uptake and non-completion of the three-shot series in the U.S. Health insurance records have shown that among 19 to 26-year-old women who received their first Gardasil shot, the number of 19 to 26-year-old women completing the 3-shot series dropped from 44 percent in 2006 to 23 percent in 2009. A similar decline was seen in the pre-teen demographic where 57 percent of girls in 2006 completed the vaccine series, compared to 21 percent in 2009.4

Perhaps another notable step for Merck will be to go back to the FDA with data from Canada to prove that Gardasil® can be demonstrated to prevent cervical cancer in this older demographic. This is a highly likely scenario, since the CDC has stated: “While there are well-established cancer registries in the United States, it will take decades before the impact of the vaccine on cervical cancer is observed.”5

What is potentially wrong with Gardasil® use in older women?

The CDC estimates approximately 20 million Americans are currently infected with HPV. Another six million people become newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives. 6

Gardasil® was not designed to treat pre-existing HPV infections – and therefore it was tested on women who were not exposed to HPV. This type of pre-screening prior to vaccination is not available to medical consumers in the U.S. or in Canada and was actually discouraged by the FDA.

This alone gives rise to a major concern because women are mostly unaware they have been exposed to HPV. In addition, women who are not aware they have the virus but get the vaccine could suffer outbreaks of genital warts or abnormal precancerous lesions. Both conditions require extensive treatment. 7

Why is this happening? A chart in the May 2006 FDA Vaccines and Related Biological Products Advisory Committee’s report clearly shows that women who have been previously exposed to HPV and who are vaccinated with Gardasil® have a vaccine efficacy rate of -44.6%, and -32.5% post Cervarix, placing those vaccinated at an increased risk of developing cervical cancer, as well as suffering from other adverse reactions. 8

According to American Cancer Society estimates, deaths from cervical cancer fell by 74% between 1955 and 1992, mostly due to Pap smear screening. The rate continues to fall 4% annually without Gardasil®. Hopefully, there will not be an increase in cervical rates due to the HPV vaccines. That unfortunately will remain to be seen, although reports of cervical dysplasia and cervical cancer are being reported by young women post vaccination.

One thing is clear – women are the only ones who can protect their pelvic goldmines from exploitation. Meanwhile, unsuspecting women of all ages, all over the world are receiving a vaccine that will no doubt be become known as the great travesty of the 21st century. Our sisters in Canada need to be paying attention to what is happening in the U.S. before they partake in what may be a potential medical experiment with dire consequences for them and more profit for Merck.

References

1. Ob. Gyn News, May 17, 2012

2. Pharmalot, FDA Rejects Gardasil For Use In Most Adult Women, April 6, 2011

3. Pharmalot, Canada Approves Gardasil For Use In Most Women, April 28, 2011

4. Fox News, Fewer girls completing all three HPV shots, May 18, 2012

5. Post-licensure monitoring of HPV vaccine in the United States, Centers for Disease Control and Prevention, Vaccine. 2010 Jul 5;28 (30):4731-7. Epub 2010 Feb 25.

6. Cervical Cancer Prevention, Health Professional Version, National Cancer Institute (NCI)

7. Judicial Watch Special Report on Gardasil: How Safe And Effective Is It?, September 22, 2011

8. FDA Vaccines and Related Biological Products Advisory Committee Report, May 2006

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

Birth Control, Law/Legal, New Research, Pharmaceutical

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.

When I heard that the FDA was asking for a comparison between pregnancy risks and the risks of Yaz and Yasmin, and that the women’s health groups were calling for, in their letter to the FDA, a comparison between these oral contraceptives and other brands not containing drospirenone, I immediately wanted to know why the comparison was not between using these pills and not using them — as in using other forms of non-hormonal contraception with similar effectiveness. This would produce the biggest gap, and put the statistics in starker relief.

There is too much dependent on the FDA not acknowledging the efficacy of non-hormonal contraceptives or admitting that research funded by the pharmaceutical company producing the drug is not reliable. These were for some years the most popular oral contraceptives. It is important that it is believed that there truly is an “arc of history and progress that protects women.”

Even the women’s health group representatives appear to understand this as a blip in an other uninterrupted history of outstanding service. To my mind, such behavior by the FDA should raise some serious suspicions of their motivating force. They advise that women should discuss this with their doctors – doctors who probably know less than I do, due to time constraints, inclination, as well as doctors that could well be directly or indirectly benefitting from backing Bayer.

If it’s taken this long to get a tentative admission of the blood clot risk, what do we not know about the other side effects of these pills? What were the benefits, outside of preventing pregnancy, of Yaz and Yasmin that the FDA saw as so important to women?

The reaction of the women’s health groups suggests an attempt to work within the system, rather than against it.  Does the FDA see itself as protecting the freedom of the millions of women who decided to take Bayer’s oral contraceptives, the millions that made it a bestseller? When a corporation can and will do anything to sell its product in ways that even the most cynical consumer would find shocking can we uphold the notion of informed consent?

We live in a very different time to 1970 when the result of the Nelson Pill Hearings was the inclusion of an insert in birth control pill packets. Then, the other noise of advertising – both overt and hidden – was not loud enough to drown out the message. We are now far happier with corporations telling us what to do than we are with being dictated to by the government. Consumer-driven choice keeps women on the pill – with doctors swapping them between the many brands as side effects appear. Laura Wershler and I put together a guide to a birth control rebellion. We live with a culture that stresses there is no alternative – to the pill or the system that supports it.

To quote a recent New Yorker piece by Margaret Talbot, by the way of Karl Marx, perhaps we must admit that – “Women make their own circumstances but not under circumstances of their own making” – and work from there.

Off the Pill, Off the Magazines

Birth Control, Health Care, magazines, Pharmaceutical

Guest Post by Holly Grigg-Spall

“Less stressed, thinner and more interested in sex.” – but not buying magazines.

In a recent issue of the UK’s Stylist magazine — a weekly women’s glossy that is available for free at tube stations and selected clothing stores — there was an article headlined ‘What does 10 Years On The Pill Do To You?‘ As a result of my on-going blog, Sweetening the Pill, which documents my experience of coming off the contraceptive pill, I was contacted by the writer to provide some quotes for this piece. Unfortunately, I was edited out. As a journalist myself, I understood this situation has little to do with the writer’s choice of content and more to do with the magazine editor’s final say on what was most fitting for the feature. Yet the title question is the very crux of my blog: having taken the Pill for 10 years, stopping as a result of discovering the answer to this very question.

 

Photo Credit: Anthony Easton // CC 2.0

According to the Stylist piece the answer is that the Pill changes your memory skills, lowers your libido, makes you attracted to the wrong kinds of men for you, changes weight distribution, prevents you building muscles, make you retain water, make you depressed and jealous…and how can you tell if this all is just you or the Pill? You can’t and you shouldn’t try to find out, is the message here. We are advised to not take a break from the Pill, not even for a week, and if you are concerned, just ask for a different brand from your doctor. There is no discussion of non-hormonal alternatives. There is also no discussion of the benefits of not taking the Pill, of allowing your body to ovulate once a month.

 

My answer to this question was: “The Pill has a whole body impact. Taking the Pill shuts down a woman’s hormone cycle — and the ovulation and menstruation that is an essential part of this cycle — and replaces it with a low stream of synthetic hormones. This has an affect on every organ in the body — the impact is wide-reaching and crudely administered. The peaks, troughs, and plateaus of a woman’s ‘natural’ cycle are wiped out. The monthly hormone cycle is integral to many of the body’s central functions, including the metabolic, immune, and endocrine systems. This changes everything — from your sense of smell to your libido to your ability to absorb vitamins from your food.

 

Many women have said to me that coming off the Pill was ‘life-changing’ and, as someone now two years off the Pill after ten years on, I have to agree with the description. The life-threatening potential effects of the Pill get publicity — the blood clots and strokes — but the quality of life-threatening and the emotional and mental effects are barely discussed. Fatigue, muscle loss, urinary tract infections, bleeding gums, stomach disorders, flu-like symptoms, hair loss — relatively minor physical issues caused by the Pill that together can make life very hard. Depression, anxiety, panic attacks, rage, paranoia — all issues brought on by the Pill, due to a combination of switching off the hormone cycle and vitamin B deficiency. I experienced the whole package and when I wasn’t bordering on nervous breakdown I was flatlining, barely able to feel anything at all.”

 

The whole body impact, although alluded to in the Stylist piece, is not considered head-on. What does it mean to take such a powerful drug every day for years when you are not sick? And when there are as effective alternatives for pregnancy prevention? On a second, and third reading of the piece I cannot see mentioned an unequivocal benefit of taking the Pill other than pregnancy prevention until we reach the last refuge of the worried magazine editor — the box-out — in which ‘the benefits of taking the Pill’ are listed. These include pregnancy prevention (of course), protecting women from the already very rare ovarian cancer in a very minimal way, and cutting the risk of iron deficiency anemia. Then cited is that bizarre piece of research that surfaced last year which claimed women on the Pill are 12% less likely to die, of any cause. As though Pill-taking were a key to eternal life. To a studied reader, it’s a paltry gathering of research – even I, as anti-Pill as I am, could come up with a better list. And so why this pushiness in the feature itself when it comes to keeping women on the Pill?

 

Women’s magazines are happy to provide endless advice regarding all elements of women’s lives — from what we should eat to what we should wear to how we should have sex — but when it comes down to the Pill, which at least in the UK the majority of their readers will be on, they are uniformly nervous about passing judgment. We are bombarded with the supposed best and the only and the top ten ways to make every element of our lives better, happier, sexier and more fulfilling, but when it comes to the Pill any tentative dip into the potential negative effects is quickly qualified by a zealous idolatry. This despite the fact that most of the magazines’ preoccupation with improving their readers sex lives would suggest they would be very much against women being sexually dissatisfied and having low libido, as the research cited claims of those who take the Pill. If 50% of women, and so therefore their readers, do experience negative mood changes as a result of the Pill, as is also mentioned here, why not dedicate some time to what these might be and how to notice them? Even better, why not interview some real women about this? Considering the magazines are otherwise full of personal experiences of cancer, domestic abuse, drug addiction, and infidelity, this would seem a natural choice.

 

In the US this jumpiness could be put down to the proliferation of advertising for birth control Pills that pay for the features to be published. But in the UK, direct-to-consumer advertising for drugs is against the law. The one exception I noticed of a brand being discussed encouragingly in a British magazine was on the release of Yaz. It’s skin-clearing and weight loss promises were too much to ignore. In this piece two brands are mentioned and only to reference their relative cheapness in comparison to other Pills and as a consequence their promotion by NHS doctors in the UK. Although I have to say, when I was on the Pill the most expensive one out there was all the rage in doctor’s surgeries – Yaz – which suggests someone somewhere was benefiting monetarily from this.

 

Dr. Erika Schwatz is quoted as saying in response to the question of who a woman would be if she hadn’t taken the Pill for a decade, that “She’d probably be less stressed, thinner and more interested in sex.”

 

A woman who is less stressed, thinner and more interested in sex is, I would guess, less likely to buy a magazine. I buy magazines to make myself feel better, because in my feelings of deficiency I expect a magazine to hold the answers I need to be happier. When you’re stressed and depressed you buy more stuff – because you think that stuff will improve your life. That’s why we call it ‘retail therapy.’ The answer to many questions posed in magazines is to buy more stuff. I doubt this is a conscious understanding by magazine editors, although they do know they only exist because of product advertising. Yet the Pill is part of the agenda of women’s magazines whether they are aware of it or not.

New versions of menstrual suppression drugs on the way?

Health Care, New Research, Pharmaceutical

Successful tests on rhesus monkeys are a long way from clinical trials on women, but this is interesting to those of us following the conversations and debates about cycle-stopping contraceptives: new research testing progestin antagonists indicates that the drug can be successful in suppressing menstruation without necessarily suppressing ovulation. Another variant of the drug can suppress both menstruation and ovulation.

Dr. Robert Brenner, who is the lead researcher conducting these studies in the Division of Reproductive Sciences at Oregon Regional Primate Research Center, notes that this has potential beyond just a new lifestyle drug:

I would emphasize that we are not talking here only about lifestyle choices but also about the potential to bring relief to the many women who suffer years of misery from distressing complaints such as endometriosis, and painful and excessive monthly bleeding. In fact, excessive bleeding is one of the major reasons that women undergo hysterectomy, and this treatment may also reduce the need for this surgical procedure, with all its attendant risks and costs.