Blog of the Society for Menstrual Cycle Research

Sex, Lies and Pharmaceuticals

December 16th, 2010 by Chris Hitchcock

There’s a new book about the intimate role of the pharmaceutical industry in the construction of diseases, using the example of FSD (female sexual dysfunction). The authors are Ray Moynihan, an Australian investigative journalist with a longstanding interest in this topic, and Barbara Mintzes, Assistant Professor in the Department of Pharmacology & Therapeutics at the University of British Columbia. I haven’t yet seen the book, but listened to the webinar, which is now available on the Canadian Women’s Health Network (CWHN) website.

There were a few things that struck me. One is how blatant the interference of the pharmaceutical industry can be. For example, the webinar includes a reference to an email sent to Lenore Tiefer letting her know that a formative 1997 meeting about female sexual dysfunction was only open to those who were either part of or willing to work with the pharmaceutical industry. Another was the way in which the language about the medical understanding of the cause of FSD tracked the introduction of 3 different potential drugs, each with different targets and different mechanisms. So far, each drug has failed in clinical trials.

The medicalization of human sexuality separates our bodies from our emotional lives, and creates a framework within which emotional or relationship difficulties are seen as being caused by the biological, rather than being interdependent. And little attention is paid to the ways in which pharmaceutical cures may even create relationship problems that were not there before.

There are, of course, parallels with other cases. For example, the idea that menopausal is a hormone deficiency disease makes it much easier to argue that every healthy menopausal woman should take hormone replacement therapy. This replacement language is unfortunately still alive and well in both medical and popular usage.

Another parallel is the construction of “premenstrual syndrome” into a psychiatric diagnosis. This has been provisionally incorporated into the Diagnostics and Statistics Manual (DSM) of the American Psychiatric Association, initially as “Late Luteal Dysphoric Disorder”, now “Premenstrual Dysphoric Disorder”. Among other things, this construction supported the repackaging and marketing of Prozac as Sarafem for this newly created psychiatric disorder, extending the marketability of Prozac beyond its patent expiry date.

The APA is currently working on DSM V, to be published in May, 2013, and there is an opportunity for activism. So far, PMDD is listed in the “needs more research” section. But chances are it will be put forward again for the next edition.

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Public may be invited to comment on suitability of funded research projects

December 9th, 2010 by Chris Hitchcock

Apparently in the US the Republicans are advocating that the general public be given the opportunity to comment on the usefulness or suitability of publicly funded research. While on the face of it this might not seem to be related to menstruation research, it allows targetted campaigns against controversial research, such as that related to sexuality, abortion, etc. Moreover, stigmatized areas of research, like those related to menstruation, may also trigger reactions from people who feel that this is not a suitable topic for study.

In any case, it’s worth double checking titles and lay abstracts with this potential scrutiny in mind.

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Mammography and the cycle – timing improves accuracy

December 7th, 2010 by Chris Hitchcock

According to this article in the journal Radiology, menstrual timing affects how sensitive screening mammography is. The authors analysed the results of screening mammographies collected as part of the Breast Cancer Surveillance Consortium. They used menstrual timing (week of the menstrual cycle).

Overall, they found that there were no patterns, but when they subdivided by how recently women had had a mammogram, they found some interesting patterns. For women who had had a screening mammogram during the previous 2 years, they found that the mammography was more sensitive (correctly identified those with breast cancer as having breast cancer) during the first week of the cycle. For women having their first mammogram, the pattern was reversed, with screening during the first week tending to be less sensitive. And for women who had a prior mammogram more than 3 years previously, there was no pattern. The abstract says that menstrual timing did not affect the overall rate of detecting cancer. Other online coverage of this result quotes the author as saying that the difference between the first time detections and the detections in regularly screened women might be due to a difference in the size of tumours found – large tumours are picked up on first screenings, while subsequent screenings tend to find smaller tumours.

The study involved fairly large numbers (about 1200 cases of breast cancer in 380 000 mammograms), the results were found in subgroup analysis and the significance levels were around the 0.05 level. So it’s worth viewing these results with caution, and looking for confirmation in future studies.

In any case, those women with cyclic breast tenderness probably already know that mammograms are less painful if you time them appropriately, and it’s good that that coincides with the best sensitivity for women getting regular screening.

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Ghostwritten articles funded by Wyeth overstated benefits and downplayed harms

September 8th, 2010 by Chris Hitchcock

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).

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How to overcome resistance to Cycle-Stopping Contraception (a physician’s guide)

May 12th, 2010 by Chris Hitchcock

If you’re wondering why your doctor might not take you seriously when you question taking the pill to abolish your periods, you might want to look at this piece of advice.

I had a look at the Clinical Advisor magazine information – it looks like they pay for articles, help to massage them into shape, but as far as I can tell the articles are not peer-reviewed, and the editorial staff do not have any credentials after their names, so they look like non-medical people. But it is freely available on the web, and apparently gets sent to many practicing physicians and nurses. And it’s a lot more readable than other sources of medical education.

The article is framed as a doctor-to-doctor question:

What can I do to overcome patient resistance to continuous use of oral contraceptives (OCs)? So many women say it’s not natural.—SHERRY HILL, ARNP, Bothell, Wash.

And, the answer? Explain the physiology, explain that there is no build up of old blood, that menstrual flow doesn’t have any effect on infections or toxins. And, for talking points, use the educational materials about cycle-stopping contraceptives on the Association of Reproductive Health Professionals web page (coincidentally funded with unrestricted educational funds from companies who happen to make cycle-stopping contraceptive products). And use Malcolm Gladwell’s 2000 article, John Rock’s Error, to reframe monthly menstrual flow as a historic anomaly (“you don’t need that old-fashioned thing”) and help women to see their regular menstrual flow as unnatural, so that the synthetic drugs you are suggesting will seem less unnatural by comparison.

But, ultimately, “if a patient feels that a monthly withdrawal bleed suits her best, many OCs containing 21 active pills and seven inert pills are available.”

I guess the option of using non-hormonal contraception just won’t come up.

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“Why I’ll never take the pill again”

May 11th, 2010 by Chris Hitchcock

In an article in today’s Independent, Holly Grigg-Spall presents an alternative to the current celebrations of the pill. It’s an important message to add to the collective contemplation of what the pill has meant to women and to women’s lives, and interesting reading. The pill prevents pregnancy, but not everyone likes how they feel when they take it, and women’s experiences are often not heard or dismissed. In a world where proponents of the pill see it as a cure for all things menstrual, and recommend it as therapy for the painful cramping that the majority of teenagers experience, it is important to also say that there are significant side effects for some women that affect quality of life.

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50 years of The Pill

May 9th, 2010 by Chris Hitchcock

Today’s the day, ironically enough on Mother’s day, that marks half a century since the FDA approved the pill for contraceptive use in the USA. And, for better or for worse, it’s become part of the fabric of our culture, and allowed women to have both family and a career by providing reliable family planning. Although, as many have commented, the pill may get more credit than it deserves, it serves as a powerful symbol of women’s liberation and sexual freedom.

Recently, in the Vancouver Art Gallery, I learned that, around this time, feminist painters were bringing the body back into art, challenging the largely male trends of abstractionism. Ironically, at the same time, feminist psychologists were working to remove the body from the psychology of women, challenging the prevailing wisdom that the narrative of woman is the narrative of her womb, and that when it ceases to be productive, so does she. How does the pill, with its chemical silencing of women’s reproductive endocrinology, fit with this interplay between owning and disowning our female bodies? And how can we own our bodies without allowing them to be our only defining features?

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Extreme Fem-Care

April 26th, 2010 by Chris Hitchcock
Found on the web

Found on the web

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The Pill in the News

April 25th, 2010 by Chris Hitchcock

This week was a big one for media coverage of the 50th anniversary of the Pill. And it looks like this is also being taken as an opportunity to reflect on women’s history over the past 50 years, which will also be a good thing. Women often lose our history, and those of us who are 70 now grew up in a very different reality than those of us who are 20. I am 45, smack in the middle of that span, and it’s very interesting to me to look both forward and back. We are living through incredible changes in social history, and we need to know this to understand what is going on today and what will happen tomorrow.

The pill made the front cover of Time magazine. The author, Nancy Gibb, makes some very good points about how the existence of the pill changed young women’s ideas about the possibility of planning a career path that included being sexually active (probably in the context of marriage) but with control over the timing of pregnancy.

There’s a Time editorial here.

And there are a few interviews with Nancy Gibb, the author of the Time article, on Time’s own web page, on CNN, and NPR (Gather.com).

In the Huffington Post, Christianne Northrup discusses important social and medical context for decision-making about contraception, including the Pill.

Katrina Onstad wrote about the pill’s birthday in Chatelaine magazine.

Books and book reviews on the anniversary of the pill:

Michelle Goldberg reviews a new book about the pill in the American Prospect.

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Neurology and steroid hormones – where is progesterone in this discussion?

April 23rd, 2010 by Chris Hitchcock

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.

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More on life-giving female fluids

April 23rd, 2010 by Chris Hitchcock

When I was pregnant and then learning to breast-feed my daughter, my doula told me that breast milk had great anti-biotic properties, and that it was good to use on eye-infections and cuts. Turns out that there is science behind that. Not only that, but now scientists have shown that breast milk contains substances that may kill cancerous cells. They’re calling the extracted substance HAMLET – not sure why a substance extracted from lactating women would be named after a grieving, tortured young man struggling with suicidal and homicidal thoughts, but I’ll leave more thoughts on that to those who are better at post-modern analysis.

It reminds me of the idea of harvesting stem-cells from menstrual blood. And also some questions about that. Like, is this one of the cases where it matters what produced the menstrual blood? Not all episodes of menstrual bleeding are the same. So how does stem cell quality differ among these different sources of uterine blood?

  • a normal ovulatory cycle
  • normal-length but anovulatory cycle
  • very long or irregular cycles, which tend to be anovulatory
  • withdrawal bleed when you are on the pill
  • or even a post-menopausal vaginal bleed from taking sequential hormone therapy

I don’t even know if anyone is asking these questions, because there is relatively little interest or appreciation in the varieties of sources of menstrual blood and how it might change its quality.

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Does your birth control method stop your cycle?

April 20th, 2010 by Chris Hitchcock

It’s starting. With the approaching 50th anniversary of the birth control pill, there will be a flood of anniversary celebrations and reviews of birth control methods. Which is good. We should have those discussions more often. Just say “no” (on the part of parents who don’t want to hear about it) is a big contributor to unwanted teen pregnancy.

Today’s Wall Street Journal is running an article called The Birth-Control Riddle. The riddle is apparently the high rate of unwanted pregnancy, despite the availability of a range of effective birth control methods. And, as befits the Wall Street Journal, each birth control method is accompanied by a price tag, so you can make an informed consumer decision.

But what I noticed was that there is no real awareness of what we at SMCR feel is an important consideration: Does your birth control method stop your cycle?

Some methods do – they deliver progestins and/or estradiol in high enough doses to act on the parts of the brain that normally make the hormones that talk to the ovaries that stimulate growth of a follicle, then trigger its release. This is a complex, whole body system, that normally we only notice because of uterine effects (that would be menstrual bleeding or pregnancy). And as a culture we have fairly casually accepted the idea that it is optional, and perhaps even optimally replaced by a pill made by a drug company.

When addressing the (no longer so) new extended use cycle-stopping contraceptive options, the WSJ glibly explains that “Experts say there is no health reason that women need to have a period if they are not ovulating or building up uterine lining each month.” In other words, so long as your uterus is not endangered (by pregnancy or endometrial cancer), there is no worry. Never mind that both estrogen and progesterone act on receptors throughout the body (bone, skin, blood vessels, brain, gut, breast), or that the synthetic estrogens and progestins don’t quite act in the same way, and we don’t quite completely understand how yet. And it’s just a change of schedule, so what difference can it make that your tissues are stimulated for 12 (or 52) weeks at a time instead of 3 before they get a break?

The problem is, with changes in the schedule of delivery and the reduction in hormone-free time, we really won’t know whether there are any consequences for a while. Oral contraceptives are taken by healthy young women, so the base rate of problems is low, and you need large numbers to measure the rates of serious side effects. I haven’t heard any further about the post-marketing surveillance studies for blood clots (venous thromboembolism) that the FDA asked Lybrel to conduct following its 2007 approval. But those 5-year followup data should be out around 2013. It will be interesting to see whether they are published, or just submitted as a report to the FDA. I’m guessing that will depend on whether the company likes the story they tell.

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.