Blog of the Society for Menstrual Cycle Research
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.
Yes, the hormone therapies prescribed for women in perimenopause and beyond have already been suspect. Especially after the initial Women’s Health Initiative (WHI) trial results in 2002 (but even before that), researchers documented the health risks associated with the use of hormones during menopause, especially combination hormone therapies (therapies including estrogen plus progesterone, such as Prempro). SMCR’s Jerilynn Prior has done plenty of work on this as has SMCR’s Paula Derry, and WHI researchers and spokespeople have had to come out about many of the health risks as well. Now, this week, we find out that not only is there an increased risk of breast cancer for women who use these hormone therapies but that, according to a New York Times article published on Tuesday, “Women who took hormones and developed breast cancer were more likely to have cancerous lymph nodes, a sign of more advanced disease, and were more likely to die from the disease than were breast cancer patients who had never taken hormones.” According to this New York Times article, this report is the first to reveal WHI death rates.
After the dust settled from the original WHI reports about the risks of hormone therapies, researchers and doctors often made claims that it was still okay for women to be on hormone therapies for an extended period of time. Instances of death (instead of just disease/illness) are now causing some researchers and doctors to come forward and say that it is no longer safe for women to be on hormone therapies for this amount of time. Dr. Chleblowski, an author of the latest study about women’s mortality, is quoted in the New York Times article as saying that women should not stay on Prempro for more than a year or two.
Bottom line, these drugs are dangerous for women. The older we get, the more we realize that illness, disease, and death are a normal part of life. I find myself realizing this more and more each day as I watch people around me get sick, die, or have to deal with the loss of loved ones. But illness, disease, and death caused by prescriptions and indirectly by doctor’s care (what is often termed iatrogenic illness or death) is just not okay – especially when more caution could be used. Sure, it’s happened all throughout history. Plenty of people died so we could have Aspirin, Viagra, epidurals, Coumadin, birth control pills, safe abortions, hysterectomies, and pacemakers, just to name a few. But, as a doctor quoted in the New York Times article says, “The fallback is that doctors and patients should be deciding this on a one-to-one basis, weighing risks and benefits,” [but] “How do you do that when you don’t know what the risks are?”
We know that doctors are left in a precarious position, as are female patients, as they contemplate the use of hormone therapies….but what these articles and reports aren’t saying outright is that it is probably better NOT to use these drugs unless we absolutely have to. I was listening to Detroit’s NPR station driving home from work yesterday and heard even Dr. Susan Hendrix, a Detroit-based WHI researcher and doctor say, “maybe we can now just laugh at hot flashes,” instead of rely on combination hormone therapies to help us. At least that’s what she was inferring. We don’t completely understand all of the risks of combination hormone therapies but we know they include possible cancer and death, and delayed diagnosis of cancer as well (which means further death). Since yesterday was “Love Your Body Day,” I think perhaps we need to love our bodies more by remembering that some of the signs and symptoms we experience (such as hot flashes and irregular bleeding in menopause, no matter how hard to deal with) are not life-threatening, are completely normal, and can be dealt with without drugs — because the alternative is not so benign. Why should women continue to worry about whether they’ll die by Prempro? It seems WHI results are beginning to get even clearer, and I’ll be interested to see whether rates of prescription decrease after this last report. I also wonder what the makers of Hot Flash Havoc might think of this.
Nearly a year ago, we shared news of FDA approval of tranexamic acid tablets as treatment for heavy menstrual bleeding. Today we learned of successful clinical trials of the drug this purpose: The current issue of Obstetrics & Gynecology includes the results of a double-blind placebo-controlled study of tranexcmic acid tablets, in which the drug “was well tolerated and significantly improved both menstrual blood loss and health-related quality of life in women with heavy menstrual bleeding.”
Some of you may recall that in my book, Capitalizing on the Curse, I argued that the addition of PMDD to the DSM-IV and the re-branding of fluoxetine HCI as Sarafem are linked. It was no coincidence that pharmaceutical manufacturer Eli Lilly sought a unique FDA approval for Sarafem as treatment for PMDD just as the patent on Prozac, also composed of fluoxetine HCI, was about to expire. Eli Lilly initially secured the patent for Sarafem until 2007, and it is no longer the only FDA-approved treatment for PMDD.
Lilly must be in need of a new way to keep milking the cash cow. How fortunate that new research suggests that Prozac can relieve garden-variety PMS as well. A neuroscientist at the University of Birmingham presented research last week at the British Science Festival that asserts a 2mg daily dose of fluoxetine in the week before menstruation could alleviate PMS. She tested it for three years on rats. Of course, rats don’t actually experience PMS, so they were “induced to have PMS-like symptoms”.
Every time I read another article about new treatments for PMS, I remember Joan Chrisler’s comments about over-diagnosis of PMS and PMDD (which are both associated with high levels of relationship and family stress): “We’re conditioned to want a pill. Instead of something you might need more, like a nap or a divorce, or the ERA.”
An open-access article published in PLOS Medicine yesterday, Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, presents an article describing the ways in which the pharmaceutical industry used a medical education & communication company to produce ghostwritten articles that inserted marketing messages into articles published in medical journals.
This article is the first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer). It reveals the ways in which pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy (HT)—and to cast competing therapies in a negative light. These articles were widely circulated to drug reps and doctors to disseminate the company’s marketing messages. The analysis appears in this week’s PLoS Medicine.
Wyeth used a medical education & communication company, DesignWrite, to produce ghostwritten articles in order to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ‘‘benefits’’ of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles, writes Fugh-Berman.
The analysis revealed that DesignWrite was paid US$25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid US$20,000 each.
The analysis concludes that “Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.”
In July 2009, PLoS Medicine, represented by the public interest law firm Public Justice, and The New York Times acted as intervenors in litigation against menopausal hormone manufacturers by 14,000 plaintiffs whose claims related to the development of breast cancer while taking the hormone therapy Prempro (conjugated equine estrogens). This resulted in a US federal court decision to release approximately 1500 documents to the public. The Wyeth Ghostwriting Archive is available at http://www.plosmedicine.org/static/ghostwriting.action or through the UCSF Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp
Funding: The author received no specific funding for this article.
Competing Interests: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. She was not paid for any part of researching or writing this paper. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.
Citation: Fugh-Berman AJ (2010) The Haunting of Medical Journals: How Ghostwriting Sold ‘‘HRT’’. PLoS Med 7(9): e1000335. doi:10.1371/journal.pmed.1000335
(This blog largely lifted from the article press-release).
Longtime readers may recall that late last year, the New York Times published an essay about how hard Big Pharma has worked to market menopause as an estrogen deficiency disease. Despite that exposé and others of the well-documented risks and limited benefits of hormone therapy, plus thousands of lawsuits pending over the role of HT in breast cancer, there’s apparently still quite a large potential market for pharmaceutical treatments for menopause (and other women’s health concerns).
To find out exactly how to mine that market, you can purchase the research report titled Women’s Health Therapeutics Market to 2016 – High Unmet Need will Drive the Uptake of Novel Drugs in Menopause and Osteoporosis from GBI Research. The report promises the following:
- Analysis of the women’s health market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain and Japan.
- Market characterization of the women’s health market, including market size, annual cost of therapy, sales volume and treatment usage patterns.
- Key drivers and barriers that have a significant impact on the market.
This will better allow you to “align your product portfolio to the markets with high growth potential” and “develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth”. Not to mention the ability to “reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with more efficiency and better safety”.
It all looks very useful. Too bad I don’t have an extra $3500 in my back pocket.
The New York Times published an op-ed piece a few days ago about making the birth control pill available without a prescription. Kelly Blanchard, president of Ibis Reproductive Health, offers the following rationale:
Women don’t need a doctor to tell them whether they need the pill — they know when they are sexually active and want to avoid pregnancy. Pill instructions are easy to follow: Take one each day. There’s no chance of becoming addicted. Taking too many will make you nauseated, but won’t endanger your life, in contrast to some over-the-counter drugs, like analgesics.
I have mixed feelings, myself. I’m in favor of just about anything that makes contraceptives more accessible to the people who need them, but I fear that the likely increase in cost of OTC pills means the availability won’t benefit those who most the need them – the young and the poor. Also, there are some contraindications for pill use, such as high blood pressure, history of migraine, and use of certain anti-seizure drugs for epilepsy. And despite the happy, shiny images of Yaz and Seasonique commercials, some women just can’t tolerate the side effects, for any number of reasons.
What do you think, re:Cycling readers?
In the flood of media commemorating the 50th anniversary of FDA approval of the birth control pill, this story from the Washington Post about its newest iteration may just slide under your radar: FDA approves new birth control pill from Bayer.
Bayer, as you may recall, is the manufacturer of Yaz and Yasmin, which is currently facing more than 1100 U.S. lawsuits and two Canadian class action suits. The new drug, Natazia, contains various dosing of estrogen and progestin throughout the cycle, making it the first four-phase hormonal contraceptive. The new pill uses dienogest, rather than drospirenone, the synthetic progestin in Yaz that is the apparent source of its dangerous side effects. The most common side effects of Natazia in clinical trials included irregular bleeding, headaches, nausea, and vomiting.
Yaz and Yasmin are Bayer’s best-selling prescriptions, by the way - combined sales for 2009 were $1.64 billion.
Recently the New York Times published a long article entitled the Estrogen Dilemma. It’s an article rich with many issues, and previous blogs have critiqued its uncritical acceptance of the timing hypothesis, and its failure to distinguish between the transient symptoms of perimenopause, early menopause, and the rest of your long, healthy, post-menopausal life.
But it is quite remarkable to me that, when speculating about potential hormonal treatment for poor memory and issues of staying on task, the only steroid hormone that seemed to be on anyone’s radar was estrogen. The writer had a lot of space (7600 words) and gave the scientist a lot of freedom to speculate, so I’m guessing that the absence of progesterone in the article is a true representation of her conceptual blind-spot. Progesterone was mentioned a few times, in the context of protection from uterine cancer, and in the context of using MPA (a synthetic relative) as a possible scapegoat in interpreting the WHI randomized hormone therapy trial data. But never did I see any suggestion that progesterone might be anything other than a necessary evil.
In fact, there are some intriguing new research areas that look at progesterone as therapy in neurological domains.
So, in a free-wheeling article about how scientists are exploring possibilities, it’s interesting that the possibilities seem to be limited by a cultural bias towards estrogen.
So here’s an odd little study: when women are given a choice between oral contraceptives and the contraceptive vaginal ring, what characteristic is most highly correlated with a slightly greater interest in using the vaginal ring? If you said “tampon use”, you’re right!
Among contraceptive vaginal ring and OCP users, 247 (79%) reported using tampons. Contraceptive vaginal ring users were not significantly different from OCP users in terms of age, race or ethnicity, marital status, insurance, body mass index, or parity. Adjusted analysis indicated that tampon users were more likely to choose the contraceptive vaginal ring instead of OCPs.
The study was published this month in Obstetrics & Gynecology. The researchers conclude, “but all women should be offered the contraceptive vaginal ring regardless of experience with tampon use”. No kidding. Sadly, they don’t appear to be offered any non-hormonal contraceptive options, as this research was conducted in conjunction with The Contraceptive Choice Project, described in the research report as “a longitudinal study of 10,000 St. Louis area women promoting the use of long-acting, reversible methods of contraception and evaluating user continuation and satisfaction for all reversible methods.”
It seems to me that the researchers want to predict contraceptive choices based on how willing contraceptive users are to touch their own genitals, but apparently they can’t directly ask them. They might accidentally discover an interest in using a diaphragm or cervical cap!
