Several new birth control products have hit the market that prevent monthly menstruation in addition to preventing pregnancy. The latest, Lybrel ® (Wyeth), does this for an entire year. You have all read the pros and cons of this: some advocacy groups believe that the medical establishment is robbing women of their right to be a full, natural woman. While drug companies and doctors are talking about treating women with horrendous, debilitating monthly periods and giving those with a busy schedule the freedom from monthly inconvenience from bleeding. Today, I am going to take a slightly different approach to this debate.
Throughout the years, no single sub-group of patients has been taken advantage of like women with ‘feminine problems’. Whether we are talking about heavy periods, urinary incontinence or osteoporosis, the medical establishment has had a field day with them. The party line is that it’s all in the name of science and women’s health. The truth: it’s all in the name of market share and profit.
As a practicing obstetrician-gynecologist, I learned early on that any ‘new-fangled’ product presented to me by a drug company should be scrutinized and suspected of mischief from day one. Only after careful consideration should I consider recommending it to my patients, or using it in the operating room. What follows are a couple of examples of the rise and fall of medical technologies in women’s health. I will end with my take on the new wave of extended cycle birth control pills. I will continue to use the term ‘medical establishment’ to refer to the complex web made of drug companies, hospitals, clinics, physicians, insurance companies and all of the administrative structure surrounding them.
‘Anchor’s Aweigh!’
Stress urinary incontinence (SUI) is defined as leakage of urine from the urethra during strain. Classically, this happens to post-menopausal women who have had children at some point in their lives. The exact mechanism which causes this to happen is debated but, in a nutshell, it has to do with the breakdown of the structures which normally support the urethra. When these structures are damaged by the pressures of carrying a pregnancy, delivering the baby and weakening due to lack of estrogen after menopause, the urethra does not close well when a woman coughs, laughs, climbs stairs, etc. and urine leaks out. The condition is bothersome, embarrassing and horribly under-reported. About 10 million women suffer from this condition in the United States.
This figure, 10 million women, causes drug and device manufacturers to salivate: a large, untreated population who would like to get better. So, they make products to help make them better. In the past fifteen years, there have been literally dozens of different products marketed to try to treat SUI. They range from injected'bulking agents', to 'tension free tapes' to specialized procedures which graft tissue from other parts of the body (fascia lata from the thigh, for instance) underneath the urethra. Each time a new product came out, the manufacturer sent its army of salespeople to conventions, hospitals and clinics trying to convince the doctors their that their product was the best.
Now, there is one other technique which did not last very long: the bone anchor. The idea was to put a suspension device under the urethra that would not move. The answer: fix the sling to the pubic bone! Sounds like a great idea, except when the patient develops severe post-operative pain or osteomyelitis (infection of the bone- a nasty one to treat). To add insult to injury, it turns out that bone anchors do not really work any better than the methods that existed at the time. The result: a bunch of bone anchors got used, some women got better, others stayed the same and a very unfortunate few wound up with complications that never would have happened with other available surgical techniques. Back to the drawing board, eh?
‘Snap Decisions’
Hip fractures are a serious condition for elderly women. About one fourth of the women who experience a hip fracture will die within a year due to related complications. The economic burden of osteoporosis hip fractures has been estimated to be between seven and ten billion dollars annually. The best way to ‘treat’ this problem is to prevent it from happening in the first place. A healthy diet, calcium and vitamin D supplementation and avoiding smoking are the best primary prevention strategies. But, how do you know if you have osteoporosis or not? Well, you get a DEXA scan which measures the amount of mineralized bone you have left compared to a young, healthy woman (a T-score) and compared to a woman your same age (a Z-score). Using these criteria, a physician can determine whether or not you are at risk for a fracture and if you should start taking additional medications to ‘build-up’ your bones.
Now, DEXA machines are big and expensive. But, what if you could have one right in your very own office? Well, you can... sort of. Several companies manufacture DEXA machines which measure bone density in the wrist or heel. These machines are inexpensive, compact and portable. What’s more, you can even bill the patient’s insurance company for using it. Great stuff!
However, numerous studies have shown that the measurements these machines generate do not correlate very well with those of the larger machines which measure the bone density of the hip and spine. As a matter of fact, expert opinions and medical evidence do not support their use to diagnose osteoporosis or make treatment decisions. So why bother having them at all?
Physicians run their practices in ways that will allow them to stay open and deliver efficient care to their patients. They sometimes do things that are not supported by medical evidence simply because an insurance company wants them to do it. These instances are usually not harmful, but are often times stupid. Heel and wrist DEXA is one of these instances. If insurance companies will pay for it, a physician can send them a bill, receive the payment and use it to pay for the clinic’s electric bill, staff salaries, etc. so they stay in practice. If it’s not hurting anyone, what’s the big deal?
I think we can all see the problem with this situation. Even though it gets paid for, this test is essentially worthless. At best, it is harmless and is just a revenue generating device that a physician uses to keep their practice solvent. At worst, it could misdiagnose a patient with osteoporosis and they begin a medication unnecessarily, or it could miss the diagnosis entirely and someone who actually had osteoporosis would not know it. All the while it is a waste of time and money. I still see these things being marketed. I do not know why.
‘Twelve, Four Or None- You Choose’
Menstrual suppression, the use of a drug to prevent a woman’s monthly period, is not new. Doctors have been using birth control pills of varying formulations for decades to do this. However, what is new is the package they come in. Instead of having placebos at the end of every month, there are placebos at the end of every three months or the end of every year. When a woman takes the placebos, she has bleeding from the uterus that exits the vagina and simulates a menstrual period. The bleeding she has is not menstruation. It is a withdrawal bleed. Menstruation is caused by hormonal changes which surround ovulation. Withdrawal bleeding is caused by stopping the administration of progestin (one of the components of birth control pills). There is nothing natural about the latter: never has been, never will be.
Evidence from the medical anthropology literature suggests that human beings did not always menstruate twelve times a year (see Strassman, B in The Journal of Women’s Health: March, 1999:193-202 for an example). Theories surrounding this perspective have to do with the number of times women got pregnant, the length of time they breastfed and the absence of artificial light. Regardless, the phenomenon of twelve to thirteen menstrual cycles per year is a relatively recent one in evolutionary terms.
So, if a woman does not really ‘need’ her period every month, and the bleeding that happens at the end of the pack of pills is not a period anyway, are the 56 or 77 ‘extra’ hormone containing pills in the extended regimen packages dangerous? Is this prolonged exposure to hormones going to wind up being bad for women’s health? So far, the evidence says no.
The trials so far have shown no increase in the adverse events associated with these pill formulations compared to other oral contraceptives. Women return to normal menses after a year of oral contraceptives in about a month. It will be many, many years before we know if administering oral contraceptives in this manner increases a woman’s risk for breast, endometrial or ovarian cancer. Traditional pills decrease the risk of endometrial and ovarian cancer, the extended cycle pills probably do, too. Biopsy studies of women’s uteri following a year’s worth of prolonged suppression with hormonal contraceptives showed absolutely no pathological changes. My suspicion: it’s perfectly safe.
The hormone free week in pills which causes a withdrawal bleed is not medically necessary. As a matter of fact, about 5% of women have no withdrawal bleeding when they take the pill anyway. The only reason why the placebos are in the pack is to simulate menses. The hormones taken are metabolized out of her body in the same amount of time whether she has been taking them for 21 days or 21 months. And for any amateur pharmacologists out there, the fact that they are steroids and thus fat soluble does not make a difference.
‘What Good Is It?’
Imagine a woman who misses three or four days of work every month because she is bed-ridden with cramps during her period. She has so much bleeding that she has to use adult diapers and sleep on towels so that she does not ruin her sheets. She has been admitted to the hospital for a blood transfusion in the past because she became so anemic, she might have had a heart attack, stroke or kidney failure if she did not. I have treated women who fit this description more than once. Every gynecologist in this country has patients like this in their practice at some point in time. Stopping her menstrual cycle can improve her quality of life and keep her out of the hospital. Hopefully, it can even save her from having a hysterectomy.
By packaging oral contraceptives in an extended cycle, to have a withdrawal bleed every three months or every year, accomplishing this goal is much easier. If we were to use a 28-day pill, she would have to refill it every 21 days. This presents a problem. The pharmacy may refuse to refill it. Her insurance company may refuse to pay for it. Now, she’s stuck. Having this packaging will save patients that truly need this therapy a lot of headache.
Moreover, believe it or not, some women do not mind going without a period! Some women prefer not to deal with tampons or pads every month. My wife is one of them. She has not menstruated or had a withdrawal bleed for 5 years. She loves it, and would not have it any other way.
‘If only there was ‘man-struation’...’
If we look at the first two examples, the medical establishment’s reasoning for developing the extended cycle pills is obvious: to make a new drug that physicians will prescribe and people/insurers will pay for. That is it. There is no ulterior motive, there is no grand plot to take away ‘womanhood’. Drug companies want money. Advertisers want to tell people about the ‘new and improved’ thing on the market. Patients want the best, new treatments. Physicians want the patients in their practice to be happy. So, we get new drugs, new equipment and new therapies. Welcome to America!
The reason why this is getting such hype is because it deals with sex. In addition, it deals with one of the most private events in a woman’s life. Because men have for centuries controlled women through subjugation, stigmatization, force and shame, the fact that many people view these pills as an intrusion of the medical establishment into a woman’s life is not a surprise. Do not get me wrong here, the medical establishment already does plenty of bad stuff- to everyone. This time, it is not so sinister.
If males had ‘man-strual’ cycles every month, we would probably have monuments, ceremonies and sporting events surrounding them. If it were a bothersome event, like a woman’s period can be, you better believe we would have a drug to control it- just like we do for hair loss and impotence. If indeed there were such a thing as ‘man-struation’, pills would have come in a pack like this years ago. These ‘new birth control pills’ are not a sinister attempt to subjugate women, they are a (slightly less) sinister way to get your money.
For any woman out there who is considering contraceptive methods and/or menstrual suppression, talk to a doctor whom you trust. If you do not have one of those, here is my advice: if you don’t want your period, you don’t have to have it. If you like your period the way it is, don’t take extended cycle birth control pills, there are other ways to avoid getting pregnant.