New Year, New Pills? What has Changed?

More Birth Control pills are on the market today than ever before, and new ones are coming. In fact at Women's Health Practice we are recruiting for a birth control study, if you are interested call 217-356-3736. So what do you think, is the contraception revolution is back? We can think back to the start of the revolution. Russell E. Marker, one of the five principal founders of oral contraceptives, worked on the problem of making cheap progesterone. At the time of his research at Pennsylvania State University in 1935, it required 2500 pregnant pigs to produce 1 mg of progesterone. He then discovered that Beth’s root in North Carolina, then a popular herbal remedy for menstrual pains, also a species of Trillium the wild Mexican Yam, contained a plant steroid disogenin that could be manufactured into progesterone. The first birth control pill that was approved in the United States was Enovid-10® in 1960. By 1988 63 million women were using oral contraceptives worldwide.

So how far have we come exactly? In the 1950s we had five methods of contraception that were used in the US these were condoms, douches, withdrawal, rhythm and diaphragms. Generally, not very effective. Fifty years later the top five methods are in order of use: female sterilization, male sterilization, oral contraceptives, condoms and withdrawal. Family size by the 1950s had dropped dramatically over the last turn of the century with over 40% of families having less than two children, and almost 20% of families with less than one child but behind the data were the dramatic impact of illegal unsafe abortions, and rising rates of hysterectomy. For almost five decades the unplanned pregnancy rates remain stuck at about ½ of all conceptions yearly, and these rates are just now dipping lower mostly due to the use of other even more effective methods such as IUDs.

 The contraceptive revolution awakened in the 1970s which is more remembered for the tunes that we associate with the summer of love than the remarkable gains in public health brought to us by The Pill. But then the revolution stalled. Reasons for the lack of progress includes: tort reform, biased media reporting, withdrawal of companies from R and D. Hundreds of methods were being studied around the world in the 1990s, but why were only three new methods approved in the US in the past decade? Finally I can report seeing the glimmer of the newest dawn of contraception revolution, but lack of funding is still glaring. In 15 minutes we spend more money on the pentagon than on all of contraception research each year. And though a handful of companies have stayed in contraceptive R and D the gains are slow. The process too costly, and both the real costs of litigation against methods and the fears of the economic impact of litigation plagues us and is often sited as the reason more companies don’t jump in. My industrial engineering colleges say that if you have something that is 98-99% effective for the job it is supposed to do, that is not what you typically look to replace. Sterilizations are in the 98% effective range. And in fact, in spite of the removal of 98% of the hormone dose since the initial 1962 formulation of the oral contraceptive (OC) pill in an effort to enhance the safety of the medication, perfect use contraceptive effectiveness of the pill remains at about 99%. I still argue we need another contraception revolution. Yet the United States still has the highest rates of unplanned pregnancy in the industrialized world. More alternatives are still needed, because typical use of contraception doesn’t offer American couples that 99% degree of success we’d assume from reading the package labels of the methods. We now have many generic pills, that complicates taking the birth control pills as their colors in sequence doesn't always copy the exact color scheme of your branded pills according to a new study.

Not only are OCs effective, they are safe, and they confer dramatic non-contraceptive benefits like less anemia, fewer ovarian cysts, less endometriosis, and less PMS. OCs works hormonally, in a sense, by mimicking pregnancy, and thus the women enjoy the protection against things they would be protected against if they would have had multiple pregnancies including protection against ovarian cancer and uterine lining cancer (endometrial), and rates of these diseases have dramatically fallen. Those same protections are offered to the users of vaginal rings called NuvaRing, and birth control patches and there is evidence that even DMPA, Nexplanon and the Mirena IUD can cause protection from those cancers as well. Currently only one patch is on the US market, but other patches are coming.  IUDs, unlike sterilization, are reversible and effective contraception but they don’t make our top 5 list because of faulty epidemiology that has led to the erroneous American public perception that they lack safety. But a new dawn is coming for IUDs in the US as changes to the health care system make them more affordable, and many women are taking a new look.

 Over 80 million women in China currently safely use the IUD which is a method effective at preventing pregnancy as surgical sterilization and do not increase infection (a very slight risk of infection right with insertion) or fertility. IUDs do protect against endometrial cancer as well. If it weren’t for the not for profit Population Counsel bringing back IUDs when all US companies had abandoned this method due siting litigation costs as the reasons. Serele lost more money defining the product than they were able to make in marketing and selling the IUDs.

The minimally invasive technique of endoscopic sterilization “belly button tubals” revolutionized female sterilization. Prior to the advent of this technique in the 70s tubal ligation procedures were a 5 day inpatient affair. The method is now the number one method used in the US and tubal sterilization is double the rate of vasectomies, although 1/5 women sterilized experiences significant regret about her decision, a preventable issue if she were to use an IUD instead. In the US sterilization can now be done in the office setting with the newly available Essure tubal coils, which take a mere few minutes under local to insert, and can be performed with the menses eliminating NovaSure operation. Injectable steroids have enjoyed incredible successes in pregnancy prevention.

In fact the progesterone injection called Depo Provera affords the same pregnancy prevention as tubal sterilization. With only 4 injections needed per year, compliance is fairly easy. Market penetration for this method has begun to shrink after a report questioning the bone impact of the method which very effectively suppresses both estrogen levels and ovulation. No actual cases of osteoporosis or bone fractures occurred in the users, but many women are being refused more than two years of Depo Provera use. The makers of Depo Provera briefly rolled out Lunelle, a similar product with less progesterone, and some estrogen, but when packaging glitches pulled the product off the shelf the new pharmacy owners never sought to re-market. In the US for each 1% less effectiveness because of incorrect or inconsistent use represents about 100,000 unplanned pregnancies. And this accounts for the literally three million unplanned pregnancies in the US per year, of which 1.2 million still end in abortion. Compliance counts for a lot! Not that the makers of contraceptive steroids haven’t tried actually there’s a spearmint version of the pill you can chew. The patch, essentially the hormones of the pill delivered through the skin, allows for more consistency. This is due to fewer health behaviors (to constantly use pills over 5 years you have to swallow almost 1800 pills, patches are changed three time a month, so only 39 behaviors a year) and studies back up that patch users are about 10% more consistent than pill users, and that improved compliance is the same across all age groups. Patients and physicians stall the rebirth of the contraception revolution as well. Women will consult a physician on method initiation but half of all women who stop their method of birth control do it without consultation. We may be seeing available in the future a new 3 month ring, already available in Chile and Peru, that contains Progesterone only, and is known as Progering.

Furthermore, about one in 5 will stop their method without any plan for any replacement method. The inconsistent use is not all blamed on leaving the package on the shelf. Medical providers need to shoulder some blame, studies indicate that they have misconceptions regarding medical contraindications and confusion regarding age, how many pregnancies a woman has had and marital status. Clinicians for instance may not prescribe OCs to women with medical conditions such as diabetes despite the fact that we are without any studies to show that steroid contraception use worsens the medical condition. In fact, recent studies have shown decreasing risks of stroke, breast and ovarian cancer, heart attack and blood clots with second- and third-generation oral contraceptives. We could prevent 80% of ovarian cancer cases if all women used the pill for at least 20 yeas (we can’t all of course). Rational use and the most updated information reported by the WHO working group in 2004, and updated by our CDC in 2010 and can be easily accessed on their web site  There is a lack of understanding regarding what is necessary for safe use of a method.

Pap smears are good preventative care, but they do not contribute to the safety of use of contraceptive methods, women need access to methods whether or not they have gotten a pap smear. Even the American College of Obstetricians and Gynecologists say that we should consider making birth control pill available over the counter, because protection against, or planning for, pregnancy should be a woman's most important consideration in her overall health. Thus medical provider requirements of certain tests, and scheduling frequent follow up visits, are merely barriers to continuation of effective contraception.

Although training for physicians in the provision of OCs is common, provider training in newer methods, like the newest IUD, or the newest form of sterilization, is still spotty nation wide where many gynos are trained in facilities that do not perform sterilizations or offer contraception. So keeping methods available may be more of an issue than you think. In 1965, a mere 40 years ago 30 states had laws prohibiting or restricting the sales and or use of contraceptives. New contraceptive alternatives are slowly coming, and we are now get access to the Implanon single rod implantable method, actually a two implant rod system was approved in 1996, but never rolled out for public use.  And we do have the Nexplanon, a newer version of the Implanon. In the studies of Implanon rods there wasn’t a single pregnancy. I can hear the humming again: “be sure to wear some flowers in your hair”.

 Adapted from News Gazette Health Article Submission.