By Diane Carman
A few decades ago, unmarried women could not get birth control pills.
Lawmakers controlled access to the drugs to such a degree that some women actually had to bring a note from a minister saying they were about to be married to get a prescription filled before their wedding night.
Suddenly in 2014, the idea of selling birth control pills over the counter is all the rage among politicians hoping to woo women voters.
But the women’s health care community is far from unanimous in supporting the political campaign for over-the-counter access to the Pill, a drug that has been available in various forms by prescription for more than 50 years, but has been covered by most insurance plans only since the passage of the Affordable Care Act.
Concerns still remain about the risks associated with birth control pills, and physicians say the new long-acting reversible contraceptives are a far better choice for most women despite that politicians don’t find them nearly as sexy a topic on the campaign trail.
The American Congress of Obstetricians and Gynecologists (ACOG) generally favors over-the-counter access.
It endorsed the sale of birth control pills over the counter in 2012. In its announcement at that time, the congress said, “Oral contraceptives should be sold over the counter in drugstores without a doctor’s prescription. Easier access to (contraceptives) should help lower the nation’s high unintended pregnancy rate, a rate that has not changed over the past 20 years and costs taxpayers an estimated $11.1 billion annually.”
ACOG has strenuously avoided endorsing proposals by political candidates this year, however. In a statement posted on the organization’s website, ACOG President John C. Jennings said that over-the-counter access to contraceptives “should be part of a broader dialogue about improving women’s health care, preventing unintended pregnancies, and increasing use of contraception, including long-acting reversible contraception. Over-the-counter access should not be used as a political tool by candidates or by elected officials.”
Dr. Kristina Tocce, associate professor of family planning at the CU School of Medicine, agrees and said most physicians look to ACOG for direction on this issue.
“Our go-to guidance document is the ACOG committee opinion,” Tocce said. “That really gives a lot of data.”
Physicians have been trained in a culture of prescription-only birth control pills, she said, “so it’s logical for them to think women need to be screened by professionals to avoid harm. But the studies show women do a really good job of screening themselves.”
ACOG emphasized the importance of annual gynecological exams, but did not recommend that they be required to obtain birth control pills. Instead it suggests giving women a questionnaire to help them self-screen for risk factors before purchasing birth control pills.
Planned Parenthood skeptical
Planned Parenthood, which lobbied the Food and Drug Administration for more than a decade to gain approval for over-the-counter sale of emergency contraceptives, is taking a decidedly cautious tone in this debate.
“It’s complicated,” said Vicki Cowart, president and CEO of Planned Parenthood of the Rocky Mountains. “Over-the-counter birth control is not a bad idea in itself. But it’s not a simple thing.”
Despite all the controversy surrounding FDA approval of over-the-counter emergency contraceptives, from a public health standpoint, that really was a simple thing.
First, Cowart said, Plan B One-Step (the morning after pill) is a progestin-based drug, not a combination estrogen/progestin drug like most oral contraceptives, so it has few side effects. It also must be taken as soon as possible after unprotected sex to be effective, so eliminating the need for a doctor visit actually makes the likelihood of its success much greater. And then there’s the fact that only one dose is recommended.
Most women who take oral contraceptives take them daily for years, multiplying the chances of side effects.
“There are no data that show that Plan B is harmful in any population of patients,” Tocce said. “It is amazing” that it took so long for the FDA to approve Plan B.
Clearly the agency was responding to political pressure from people in the anti-abortion community who confused the drug with medication to terminate a pregnancy.
“People did not realize that Plan B doesn’t cause an abortion,” Tocce said. “It prevents ovulation. That debate we saw with FDA approval was crazy.”
A similar lengthy and highly-charged political debate likely would occur with consideration of over-the-counter sales of oral contraceptives.
“I don’t think the Senate can just tell the FDA to do it,” said Cowart, “and the FDA hasn’t even started the process. It probably would take years.”
Further, while Planned Parenthood “is all about access,” Cowart said one of the biggest barriers for women seeking birth control is cost, and over-the-counter sales of contraceptives likely would increase costs for women.
Only since the passage of the Affordable Care Act have most health insurers been required to cover the cost of oral contraceptives, saving women approximately $600 per year in unreimbursed prescription drug costs.
“Women didn’t pay $480 million for contraceptives last year,” Cowart said. “We’ve taken a step in the right direction. I don’t want to see a reversal.”
Of course, lawmakers could expand the Affordable Care Act to cover over-the-counter birth control pills, removing the financial barrier to access.
Cowart also differs with ACOG on the question of whether women should be left to screen themselves for health risks.
“Women need the health care provider’s perspective to make the right choice,” she said.
Side effects can be deadly
For some women, birth control pills can be dangerous, even with doctor’s supervision.
Kathy Zolla, a teacher at Denver School of Science and Technology, developed a life-threatening blood clot when she was a 22-year-old college student.
Zolla had taken oral contraceptives on and off for several years for medical reasons and later as birth control. Then she was driving from her parents’ home in Colorado back to school in Lawrence, Kan., after Thanksgiving and Interstate 70 was closed due to weather. The detour turned into a 12-hour drive that she suspects caused a blood clot to form in her femoral vein.
She started experiencing pain in her hip and thought she had pulled a muscle. “I was doing all kinds of stretching, which in retrospect was not a great idea,” she said.
Then on Dec. 30, she said, “I noticed my leg was swollen and kind of blue, and I just lost it.”
She went to the emergency room, where an ultrasound revealed a clot.
“The doctor said it was the size of his thumb,” Zolla said.
She spent three days in the hospital on IV blood thinners and was sent home with nine shots of blood thinners to administer herself, and a prescription for Coumadin, which she had to take for six months.
She also was told she will never be able to take hormones again.
“The worst thing, though, was when I got pregnant last year,” she said.
She knew any pregnancy would be high risk, given her health history, but when she went to the doctor for her first pre-natal check-up, she learned she would have to give herself shots of blood thinners daily for 10 months.
Her healthy daughter, Madeline, was born in August and Zolla is still required to give herself the shots daily. “It’s no fun,” she said. “I don’t like needles.”
For Zolla, keeping birth control pills behind the counter is a no-brainer.
Denver consultant Colleen Feely agrees.
When she was 27 years old, Feely, 56, was diagnosed with Budd-Chiari Syndrome, a life-threatening blockage of the hepatic vein, which connects the heart and the liver.
Three months after the diagnosis, Feely had acute liver failure and had to receive a liver transplant.
“I had taken the pills for about 10 years and at that time I was a smoker,” Feely said.
While doctors never would attribute the condition to birth control pills unequivocally, they speculated that the combination of smoking and the relatively high doses of estrogen in older oral contraceptive formulas most likely caused clots to form in the hepatic vein and damage her liver.
While her transplant was successful, Feely was warned never to have children due to the anti-rejection drugs she must take.
Risks still lower than many OTC drugs
“No drug or intervention is completely without risk or harm,” says the ACOG opinion on over-the-counter birth control. To put it in context, it cites the risk of gastrointestinal bleeding from taking aspirin and the risk of liver damage from acetaminophen (Tylenol) as examples of common drugs with serious side effects.
For women taking birth control pills, blood clots occur at a rate of 3-10 per 10,000 women-years, according to ACOG research. The risk is far higher for pregnant women – 5-20 per 10,000 – and even higher postpartum at 40-65 per 10,000.
Tocce also noted that the ACOG report cites numerous studies that found women were highly capable of determining their risk factors.
“We’ve found there’s a lot of room to ensure we can provide birth control pills over the counter safely,” she said. “We need to respect the ability of the patients to evaluate their level of risk.”
The one important risk factor that women might have difficulty evaluating, Tocce said, is high blood pressure. Without access to information about their blood pressure, women may not be able to answer that question accurately.
For both Tocce and Cowart, though, a key issue being ignored in the debate about over-the-counter birth control pills is that they may no longer be the best form of contraception for most women.
While oral contraceptives have been a popular and effective form of birth control for women for over 50 years, they are not necessarily the safest and most effective form of birth control in 2014.
“I rarely give prescriptions for birth control now,” said Tocce. “When my patients come in asking for birth control pills, if we go over all the methods that are available across the spectrum, a majority leave with long-acting reversible contraceptive devices.”
Devices such as IUDs and contraceptive implants have higher initial costs than getting a prescription for oral contraceptives ($500 to $800 or more), but they last up to 12 years and don’t require women to remember to take a pill every day.
“For many women, if cost is not an issue, the choice is for long-acting reversible contraception,” said Cowart. Planned Parenthood has seen an increase in requests for these methods now that insurance plans cover the costs.
In study after study, Tocce said, the number of unintended pregnancies is reduced dramatically with the long-acting contraceptive devices.
“We’ve had amazing results with this” among teenagers as well as adult women, Tocce said. “I just hope all the attention to over-the-counter birth control doesn’t distract people and actually end up limiting our patients’ options.”
Even after experiencing serious side effects from oral contraceptives, Zolla and Feely said they understand why women are willing to accept the risks.
Zolla’s doctors said her experience occurred in about 1 in 10,000 women taking birth control pills.
“If I had been told that in advance, I would have taken that risk,” she said. “Think about it, 1 in 10,000 compared to the chance of getting pregnant.”
After what she’s been through, however, she will never take oral contraceptives again. She plans to switch to an IUD.
But Zolla can imagine a circumstance where a woman might be tempted to buy over-the-counter birth control pills after experiencing a blood clot because it would be easy and convenient, and she might just assume it won’t happen again. “What would be there to stop someone?”
No matter how many times you hear about side effects, Feely said, “It’s like those commercials on TV all the time.
“You hear them, but you never think it will happen to you.”