A woman who walked into her doctor’s office forty years ago with the topic of birth control on her mind had limited options. If she was looking for a hormonal contraceptive, those choices effectively collapsed to one: the pill.

Introduced in 1960, the pill is sometimes considered this century’s greatest advancement in the field of women’s health, as well as the one with the greatest impact on society. Before the pill, the best options for birth control had been the diaphragm and the (male-controlled) condom.

More hormonal delivery systems, such as the patch, the ring, and the shot, have expanded both the market and the options for women. While every woman must find the one that works best for her, health care professionals note there are no major differences between these four top choices.

“The only difference is how you take them,” said Emily Briglia, Supervising Counselor at SBI Health Education’s Sexuality Education Center, and psychology and health and human service major at UB. “It’s a good thing, because it provides people with more options, and more ways to prevent pregnancy.” But the choice of contraceptive has to be made on an individual basis, especially since it has become clear over the last few years that different methods can have adverse, and sometimes fatal results on different women.

An Old Standby Learns Some New Tricks

While new birth control options abound, more women still stick with the pill than any other method. More than 18 million women rely on the oral contraceptive, and they can choose from over 40 different products.

While the popularity remains, the pills women are popping now have come a long way from the contraceptive their mothers were introduced to in the sixties. Most pills are now low dose, meaning they contain less of the synthetic forms of the hormones estrogen and progesterone (called progestin) than before. There are also pills that contain only progestin for patients who do not wish to raise their levels of estrogen.

The pill still works much the same. It deals a relatively steady dose of synthetic estrogen and progesterone, the female reproductive hormones, to prevent the peak of estrogen that would signal ovulation. If used properly, no egg will be released and it will be impossible for the woman to become pregnant.

That is, if it works. Many in the health field will be quick to point out that the pill is not 100 percent effective, even when users take their pill every day at the same time as prescribed. If a pill is missed then the hormone levels will fall out of regulation, increasing the chance that the effects of the pill might not work.

“In terms of effectiveness, it really comes down to how responsible you are,” advised Briglia. “If you have an irresponsible person who’s not good at remembering something every day, then the pill’s obviously not for them.”

While it is certainly true that failing to take the pill correctly will decrease its effectiveness, some are looking to the content of today’s pills as an explanation for an increase in instances of pregnancy in women using the pill.

The original pills contained 180 micrograms of estrogen, while the upper tier of today’s offerings contain 35. The most popular birth control pill on the market, Ortho TriCyclen Lo, has 25 micrograms. The reason for the cut was to increase the safety of the pill; pumping less estrogen into the body means a lower risk of blood clotting and their possibly deadly results. Other forms, often called minipills, contain no estrogen at all and only progestin.

Many medical professionals maintain that low dose and progestin-only birth control pills are no less effective than their stronger predecessors. “Progestin-only pills are not any less effective at preventing pregnancy,” said Sue Gerbers, Nurse Practitioner at Buffalo General Hospital Women’s Health Clinic. “They are mainly for women who can’t tolerate estrogen.”

Last week, however, a story was released through multiple news sources that said the FDA was in fact considering revamping the rules for the pill in the face of rising failure rates. Though the way the story was presented caused some alarm, the only conclusion the FDA reached, through the advisement of a panel of experts, was that current clinical trials are not sufficient to compare the effectiveness of different forms of contraception.

The FDA also asked contraceptive manufacturers to present a more representative sample of users in their clinical trials. With hormonal contraception, a woman’s weight, her cardiac history, and whether she smokes can make a world of difference, and drug companies often exclude risky subjects in tests. But in the real world, clinical conditions are rarely the norm. Doctors must screen their patients carefully, to make sure that each woman gets the safest and most effective treatment. That can vary from person to person.

“I screen the patients that I see,” said Gerbers. “I look at their history, if they’re smoking, and their age when recommending a form of birth control.” If there’s one thing that’s for certain, women have a wide variety of choices in pills, and with good reason. “They have so many different types of pills because of side effects,” said Briglia. “Side effects are totally dependant on the person.”

It’s true that women suffering side effects from the pill can try to switch brands. With the host of different synthetic hormones and dose sizes, women can find the pill that works best. And the market is about to give women even more options. The newest generation of pills promises women the ability to eliminate their periods altogether.

Seasonale, from Barr Pharmaceuticals, cuts a woman’s periods down to four per year. The secret isn’t revolutionary; instead of giving women three weeks of hormones and a week of placebo pills to allow for her period each month, Seasonale comes with 84 active pills to last a woman nearly three months. By keeping the hormones steady, the uterine lining never builds up and an egg never releases, negating the need for menstruation.

Not everyone will be comfortable with the concept of reducing or eliminating periods. At the same time, the method is not a medical secret. Women have always been able to forgo their period for a time by not taking their placebos and continuing with active pills, though there has been no product designed to used in such a manner until now. The worry is that a constant dose of estrogen might be more than the body can handle. “Seasonale has a got a little bit of added risk of blood clots,” said Briglia. “You’re putting more hormones in your body.” Seasonale contains 30 micrograms of synthetic estrogen.

There are definite benefits to the pill, however. Experts are quick to point out that modern women are probably ovulating more often than nature intended, as they are pregnant less often than in the past. With hormonal birth control, ovulation does not occur, and that would be made doubly certain without a week of placebos. By cutting down on the number of times a woman ovulates during her lifespan, the ovaries could be spared a lot of strain.

Evidence shows that women who have fewer cycles over the course of their lives (whether due to pregnancy or hormonal contraception) reap certain rewards. “People who are on the pill throughout life are at lower risk for ovarian cancer,” said Gerbers, “and women who haven’t had a baby yet are at a higher risk.” Wyeth Pharmaceuticals will soon be taking this approach to the next level with Lybrel, a pill with 20 micrograms of synthetic estrogen, and designed to be taken every day, year round, eliminating menstruation. Lybrel was recently approved by the FDA, and should be on the market soon.

Patch Perils

Bringing up the forefront of the “new wave” of birth control solutions, Ortho-McNeil’s Ortho Evra Patch represented the first easy alternative to The Pill. For women who had difficulty remembering to take a pill every day, the patch had one immensely attractive feature: you only have to change it once a week. Through changing it thrice and then allowing a week for menstruation, it mimicked the pill in every way. According to Sue Gerbers, “The patch is similar to the pill, but with slightly higher estrogen—it’s just more convenient.”

When Ortho Evra hit the market in 2002, things seemed to be going well. Women quickly adopted the patch, and a year later the Johnson and Johnson subsidiary conducted a survey that indicated nine out of ten patients preferred the patch to their former birth control method. Women were assured at every step of the way that the patch was just as safe and effective as the pill. More than five million women have used it to date.

Then some disturbing information began surfacing. Hormonal contraceptives have long been known to pose an increased risk of blood clotting, as estrogen promotes blood coagulation, but cases of strokes and other clot-related problems seemed to be higher than in the pill. The Associated Press filed a Freedom of Information request for clinical trial information from the FDA and, in July of 2005, released an article that reported that the risk of dying or suffering a survivable blood clot on Ortho Evra was three times higher than that of the pill. It was estimated that about a dozen women died from patch-related clots in 2004, when 800,000 women were on the patch.

The AP report also stated that the FDA had noticed the potential problem before approval, but made no suggestion of a follow-up study beyond the normal requirements for new drugs. By this time the lawsuits had already started, and this information opened the floodgates. By the end of 2006, over 1,000 women had filed lawsuits against Ortho McNeil and Johnson and Johnson, many in class action lawsuits. The plaintiffs claim that Ortho McNeil knew about the increased blood clot risk, but went ahead and released the pill anyway.

Ortho McNeil currently maintains that there is no problem with the patch, and it remains on the market. In November of 2005, the FDA changed the patch’s label to indicate that the patch exposes women to sixty percent more estrogen than the pill, and that the risk of venous thromboembolic disease (the formation of blood clots that can move to the lungs or brain) is also greater. Another change was made in September 2006 to incorporate information from two new studies.

The 61-page FDA prescription label now warns that users will receive more estrogen because “first-pass metabolism,” or going through the stomach and liver, is avoided since the estrogen is absorbed through the skin and directly into the blood stream. The pill also offers spikes in estrogen levels, since one must be taken daily. Conversely, the patch delivers a constant stream for seven days. These elements account for the higher amount of estrogen a patch patient absorbs. The FDA also warns that exposing the patch to heat (being in a hot tub or even the sun) will speed up the absorption rate.

The new warnings stem from two 2006 studies with conflicting findings. A Boston Collaborative Drug Surveillance Program study, published in Contraception, a scientific journal backed by the Association of Reproductive Health Professionals, found that there was no increased risk of blood clots for those who used the patch instead of the pill. A similar study by i3 Drug Safety, and released on the same day, concluded the risk of a blood clot was doubled by the patch.

The disparity between the studies has left the relative safety of the patch in a gray area. An Ortho McNeil representative told Generation that the company does not comment on the Ortho Evra patch’s safety or the ongoing litigation surrounding it, but maintains, “When used as labeled, Ortho Evra is an effective birth control device.”

Doctors seem to be divided on the patch. Some are calling for the end of its prescription, while others feel the jury is still out. Customers are already starting to make up their minds, however. According to Rose Zendano, Supervising Pharmacist at the Sub-Board I Pharmacy, there has been a decrease in the number of patch prescriptions filled. “I used to fill it quite a bit more,” said Zendano. It was still the second best seller at the pharmacy for the 2005-06 school year, however. Ortho McNeil declined to comment on the status of patch sales.

Injections Step Down, Rings Move Up

For those who are forgetful, yet are concerned about the patch’s recent press, other hormonal options remain. The first is the oldest form of hormonal contraception besides the pill. Depo Provera, or the shot, was developed in the early seventies but did not become approved for U.S. use until 1991. It is an injection of progestin that is given every three months. Most women will stop menstruating after their second shot, as the ovaries will cease to release eggs.

The downside of Depo Provera is that the woman must make a clinical appointment every 13 weeks to get another shot. Weight gain is also a common side effect. Many women are also put off by the fact it can take up to two years for regular fertility to be restored once going off the shot.

More disturbingly, information has emerged over the last 15 years that shows the shot can decrease bone density; the FDA has issued a “black box” warning, the strongest warning label available, on Depo Provera, and Health Canada has advised women that the shot should be used for the shortest amount of time possible. Pfizer, the shot’s maker, has issued similar warnings to women.

The FDA has recently approved a form of Pfizer’s contraceptive, called Depo-subQ provera 104, for the treatment of pain associated with endometriosis, a condition where the uterine lining grows outside the uterus and forms painful cysts. This shot was earlier approved for use as a contraceptive.

The new kid on the block, and a choice increasing in popularity among students according to the SBI Pharmacy, is the NuvaRing. Organon USA’s plastic circle is designed to be inserted into the vagina, where it remains for 21 days, at which point the user removes it. Much like the patch, it releases a steady stream of hormones and is removed to allow for a woman’s period. It can stay in during sexual activity, and the ring’s makers maintain it should cause no discomfort.

The initial results have been more promising than those for the patch. Since the ring delivers its hormones vaginally, it doesn’t have to pump so much estrogen into the body. Also, a patient callback study showed that new users of NuvaRing had fewer callbacks to their doctors in the first three months of use than with the patch or pill. It has been on the market since 2002, just like the Ortho Evra patch.

Definition of “Emergency”

Needs Work

With all the methods of hormonal contraception, one would imagine that women would have little trouble staying protected against pregnancy. In reality, a new two-dose emergency contraception that just recently gained over-the-counter status has seen an increase in use that is making some medical professionals nervous.

Plan B, developed and released by Duramed Pharmaceuticals, a division of Barr Pharmaceuticals, is designed to be administered after unprotected or inadequately protected sex. It is what is known as “emergency contraception,” and health professionals universally stress the importance of the former word in the group. “I wouldn’t use it as a contraceptive,” said Nurse Practitioner Gerbers. “If you’re using it as one, just go on a birth control plan.”

Plan B contains two pills of 0.75 mg of Levonorgestrel, a synthetic progesterone. That level is a massive dose, akin to taking 10 to 40 birth control pills at once (depending on the pill’s strength). The first should be taken as soon as possible after unprotected sex, as the effectiveness decreases sharply after 72 hours and is virtually nothing after five days. The second pill is taken 12 hours later. The large doses of hormones make it more difficult for a fertilized egg to implant itself in the uterine lining, and may also stop an egg from releasing or sperm from fertilizing an egg. The menstruation cycle is interrupted, and will resume sometime during the next month. According to Barr, if it is used correctly Plan B can reduce the risk of pregnancy from a single act of unprotected sex from a normal eight percent down to one.

“Basically, Plan B is the same exact thing as hormonal birth control, it’s just obviously a much higher dose,” said Emily Briglia. That does not mean it can be considered as an alternative to the pill, however. “The reason we don’t recommend constant use is that it’s not effective,” Briglia continued. “If you’re on a consistent birth control, that’s a lot more effective.”

It still remains unclear as to whether women will heed these warnings, however. Plan B, or “The Morning After Pill” as it is often called, was approved for over-the-counter sale to those over 18 last year, and one can obtain it without prescription at places like the SBI Pharmacy. “We fill quite a bit [of Plan B],” said Supervising Pharmacist Rose Zendano.

That’s a fact that concerns Zendano. She also says that the pharmacy hands out Plan B to many repeat customers, indicating that some may be relying on Plan B as their primary form of contraception. Besides being less effective than a regular contraceptive, the fact that emergency contraception is over-the-counter means that those who buy it might not be exposed to the counseling and information users of birth control are given.

Emily Briglia says that SBI Health Education used to do a brief phone consultation with those purchasing Plan B. Now, students can go directly to their pharmacists. Patients would be informed of how Plan B works, that side effects are generally similar to those associated with the pill (nausea is among the top problems), and that Plan B is not an abortion pill. “Many people have that misconception,” Briglia said. But Plan B is distinctly different from RU-486, commonly known as the abortion pill. “If you’re already pregnant, [Plan B] can’t do anything to you.”

There is significant controversy surrounding the use of Plan B, but most of it surrounds moral implications. Some worry that reliance on Plan B, which does not protect against sexually transmitted diseases, will increase the frequency of STDs. Others say that it will promote promiscuity, as when the pill played a large role in sparking the sexual revolution.

Then there is the fear of unknown side effects. There are no studies that evaluate the long-term effects of repeated Plan B usage, mostly because the drug is so new. For now, medical professionals are most concerned with the implications of women making Plan B into Plan A. Zendano, for one, would like to stop handing out so many boxes of Plan B. “I see the repeat people,” she said, “and I think they need to be educated…it has to start somewhere.”

Like most issues concerning sex, few things are certain when it comes to hormonal contraception. Women have more choices than ever when it comes to finding the method best for their own bodies, but abstinence remains the only method that has 100 percent success in preventing pregnancy. There is risk associated with any form of hormonal contraception, and that risk is compounded when you consider the fact none of these methods protect against the transmission of STDs.

Different women will have different results with all of these methods, and that is why they must consult their doctor or OB-GYN before beginning any form of hormonal birth control. “The type of birth control is a matter of personal preference,” said Gerbers. “Talk with your health care provider.”