Plan B: Preventing Pregnancy or Promoting Promiscuity?

Jessica didn’t expect to meet someone. In December she had separated from her husband of ten years and was still finalizing her divorce. The last thing on her mind was starting a new relationship.

“Divorces take a long time … I wasn’t looking to get involved with anyone. Unexpectedly I met someone I liked and we went out,” the 32-year-old said.

After one of their dates they went back to her place at the end of the night.

“I found myself in a situation where I didn’t have a box of condoms,” said Jessica, who had stopped taking birth control during her marriage. “I knew I had that option, and that I didn’t have to stop and say ‘I can’t do this,’ I had the option to go ahead with what was going on.”

The option was Plan B, also known as emergency contraception or the morning-after pill.

Jessica, who did not want to use her real name, went to Planned Parenthood of Collier County the next day and got a prescription for the drug. She also got a new prescription for birth control pills.

“[A pregnancy] would’ve been very difficult. I was in the process of getting a divorce, and I was not ready at the time to say to the person I was seeing that I was ready to have a child with them. If I did get pregnant, making the decision to have an abortion or not would have been much harder.”

Jessica did not know that at the time she could have gone to the pharmacy and purchased Plan B without a prescription. After more than three years of contentious debate, the FDA approved Plan B for over-the-counter sale to people over age 18 in August 2006. The first packages of the OTC drug made by Barr Pharmaceuticals were shipped to stores in November.

However, depending on which pharmacy she chose, her chances of actually walking away with the two little white pills would have varied greatly. Some pharmacies in the area do not carry the non-prescription form of Plan B at all, some only carry a few or just one package at a time, and others still aren’t clear on the FDA guideline governing the sale of the OTC form of

the drug.

Barr’s application to the FDA to sell Plan B without a prescription was one of the most scrutinized and controversial proposals in the agency’s history. Yet, despite three years of discussion, non-prescription Plan B hit the market with as much controversy and confusion surrounding the product, its safety, how it works, and its potential for public health gains as ever.

Behind the Counter – Behind the Curtain

“As a man, you cannot buy the over the counter version of Plan B,” the pharmacist at the Publix on Pine Ridge Road in Naples told coastalbeat.com over the phone. “Only women who are over 18 can get it, a man can’t because they could turn around and give it to an underaged girl.”

The pharmacist was, in fact, incorrect. The FDA only prohibits the sale of OTC Plan B to people under 18, but does not distinguish between male and female customers in its guidelines.

But the Publix pharmacist is by no means the only person who is unclear on the rules regarding the drug. This is partly because the FDA has never imposed such restrictions before.

Before approving OTC Plan B the FDA took the unprecedented step of asking Barr to write up a policy for restricting access people under age 18. When it was finally approved, the nonprescription form of the drug was placed behind the counter, and pharmacists were directed to ask customers for identification.

What the Publix pharmacist might have been thinking of is the bevy of objections raised during the FDA’s approval process for nonprescription Plan B.

“One concern is that it could be slipped to women or adolescents without their knowledge,” said Wendy Wright, President of the pro-life organization Concerned Women for America, which lobbied against the approval of OTC Plan B.

Photo by Tovin Lapan

“You could use it to cover up statutory rape … a 40-year-old man could give it to a 14-year-old girl,” Wright added.

While the CWA and other groups strongly opposed the non-prescription sale of the drug, claiming concerns over lack of medical oversight and the safety of women, other organizations including Planned Parenthood and NARAL Pro-Choice America have hailed the FDA’s decision as a step forward for women’s health in the U.S. and are against the age restriction.

“The American Academy of Pediatrics did not support the age limit. Although we would like to see it available to younger women, our focus is to make sure as many women as possible have access,” said Ted Miller, director of communications

for NARAL.

Much of the back and forth between the two sides has revolved around how Plan B works, and its safety. Doctors have used hormones as post-coital contraceptives in emergency cases since the 1970s. Later on, higher doses of birth control pills were used as emergency contraception, but that was complicated as there are many different types of birth control of varying strengths and hormone combinations. In 1999 the FDA approved the prescription-only sale of Plan B, a high dose of the hormone progestin (which has been used in birth control pills for 35 years). Plan B is two pills taken 12 hours apart as soon after sex as possible, but no later than 120 hours.

Plan B works in one of several ways: it can prevent ovulation; prevent the sperm from fertilizing the egg; and it is possible that the drug alters the lining of the uterus and prevents implantation of the embryo. The drug works much like the intrauterine device (IUD). It is difficult to be absolutely sure how Plan B works in each case because experiments are not done on pregnant women. Plan B will have no effect on an already implanted embryo. Also, the manufacturer and physicians make it clear that Plan B is for emergency use only. The drug is less than 90 percent effective, and does not prevent the transmission of sexually transmitted diseases.

In April 2003 Barr submitted its application for the OTC Plan B to the FDA. The initial application was rejected, the first time in the history of the FDA that an application for an over the counter drug was rejected after the organization’s advisory committee had recommended approval. Although the American Medical Association had recommended Plan B for non-prescription sale as early as 2000, the FDA raised concerns over the safety of teenagers. Before the application was revised to include age restrictions and finally approved in August 2006, the FDA failed to meet statutory deadlines for a decision twice. Two high-ranking FDA employees, including the director of the office for women’s health Susan Wood, resigned, and U.S. Senators Hillary Clinton and Patty Murray threatened to block the nominations of FDA commissioners twice in order to spur a decision.

“The [FDA] leadership had chosen to delay indefinitely a decision about switching emergency contraception to nonprescription status,” Wood wrote in an October 2005 New England Journal of Medicine article explaining her resignation.

“I believed in doing so, they were disregarding the scientific and clinical evidence and the established review process and were taking and action that harms women’s health by denying them appropriate access to a product that can reduce the rate of unplanned pregnancies and the need for abortions.”

While the two sides of the debate disagree on how it started, both believe that the approval process was highly politicized.

Photo by Tovin Lapan

“The abortion advocacy groups … it was a major political issue for them. They were losing in court cases and in state elections on abortion issues and they wanted to have another issue where they could have a victory,” Wright said.

Those in support of OTC Plan B say the CWA and their backers unnecessarily complicated the debate. Opponents of approval stated that increased access to contraception would lead to promiscuity among teens.

“Some people think that if you have an air bag in your new car you are going to crash the car just to see if the air bag works,” said Char Wendel, CEO of Planned Parenthood Collier County.

A 2005 study published by the Journal of the American Medical Association showed that access to contraception did not affect sexual behavior in young women.

“Ideology is preventing the acceptance of scientific data,” Wendel said. “This comes down to wanting to control what women have to plan their lives. Young people could lose basic rights in this climate.”

Opponents of nonprescription Plan B also raised concerns over allowing minors to self-administer a high dosage of hormones. In Florida, a minor does not need parental consent to get a prescription for birth control, which can be used as emergency contraception. Plan B was designed specifically to eliminate the calculations that had to be made previously with birth control to determine the proper dose for emergency contraception purposes.

“It is safe as Prilosec, which someone could be taking over the counter for acid reflux but could be masking a bleeding ulcer,” Vicki Traxler, a physician’s assistant at a Naples ob-gyn, said. “You can find 17-year-olds that are more responsible than 19- or 20-year-olds … Sure there would be a benefit to see a doctor [to get Plan B] so you can get other information, but you can’t overdose on Plan B.”

Nonprescription Plan B is available in over 45 countries. During the confirmation hearing for FDA commissioner Andrew von Eschenbach, who had expressed that very concern in explaining the agencies delay in a decision on Plan B, U.S. Senator Tom Harkin of Iowa was dismayed at the idea that “our young women are stupider than the girls in these countries, that they are more illiterate, that they can’t even read the label. But the young woman in Togo can?”

In the end, a compromise was reached that seemed to satisfy no one: the age restriction and behind-the-counter status. Proponents of Plan B say the rules are unnecessary and contradict medical and scientific studies, while opponents say Plan B has not been studied enough to warrant nonprescription sale.

The age restriction may even be unconstitutional. In the 1977 Supreme Court case Carey v. Population Services International, the high court ruled that a New York law banning the sale of non-prescription contraceptives by anyone other than a pharmacist, banning the sale or distribution of contraceptives to anyone under 16 years old and banning contraceptive display and advertising “clearly burdens the right of such individuals to use contraceptives if they so desire, and the provision serves no compelling state interests.”

You say fertilization,

I say implantation

January 22 was the 34th anniversary of the U.S. Supreme Court’s decision in Roe v. Wade. Outside the Planned Parenthood branch off Goodlette-Frank Road in Naples there was a rally celebrating the decision, and a protest by pro-life organizers across the street.

Kellye Hohmann, 18, took a day off of school to come to the protest with her mom, Trish.

“I’ve a friend that took [Plan B], I yelled at her. It’s still abortion, you’re still killing something,” Hohmann said as she held a sign reading “Abortion is death in any language.” “Condoms are fine, but I see Plan B as abortion.”

Hohmann’s feelings about Plan B are not uncommon, and pro-life organizations have argued that Plan B acts as an abortafacient (something that causes an abortion), because of the possibility that the drug could prevent a fertilized egg from implanting in the uterus. Plan B is not at all related to RU-486, the abortion pill. Whether or not Plan B is an abortafacient depends on how you define the beginning of pregnancy.

In 1965, the American College of Obstetricians and Gynecologists (ACOG) adopted this definition: “conception is the implantation of a fertilized ovum.” The AMA and the federal government also use this definition. However, some groups, like the CWA, argue that the fertilization of the egg constitutes a pregnancy.

“That definition is totally out of line with scientific and medical guidelines, they are trying to confuse Plan B with an abortafacient,” Miller said about the idea that pregnancy begins at fertilization.

Pro-life organizations insist that it is the doctors who have redefined the beginning of pregnancy, including Judi Katz of Naples’ Action for Life chapter who also insists Plan B is an abortafacient. Yet, there is still no concrete evidence that Plan B affects the uterine lining and prevents implantation.

“When I came to Planned Parenthood in Collier County nine years ago, I was under the naïve assumption that we could work with pro-life organizations,” Wendel said. “We both want to stop abortions. But they want to limit or deny access to one of the best ways to prevent unwanted pregnancies, contraception.”

l l l l l

“We only get one package of nonprescription Plan B from the warehouse at a time,” a pharmacist at the Wal–Mart on Collier Blvd. in Naples said over the phone. “We sold our one package yesterday so it will be a few days before we get another one in, if you need it right away you should go somewhere else.”

Photo by Tovin Lapan

One of the key arguments for making Plan B over the counter was its “emergency” application. Plan B is more effective the sooner it is taken, and is best used within 72 hours of coitus. The theory is that something that is used in such a capacity should be made readily available in order to have the greatest positive impact on public health.

coastalbeat.com found in an informal survey of local pharmacies that the chances of being able to quickly procure OTC Plan B are hit and miss. Various CVS, Walgreens, Target and Publix pharmacies in the area all had it in stock. But Costco in North Naples did not have the nonprescription variety and the pharmacist there said they knew of no plans to start offering it. The average price for the drug is around $40.

Proponents of OTC Plan B believe that the drug could have a significant effect on the number of unplanned pregnancies and abortions in the United States. In 2000 there were an estimated 1.31 million abortions in the United States. Planned Parenthood and their research wing, the Guttmacher Institute, believe improved access to Plan B could lead to as many as 800,000 fewer abortions each year. The Institute also estimates that close to half of all pregnancies in the U.S. are unplanned. But Plan B opponents argue against those numbers.

“The latest research shows in countries where Plan B has been available over the counter, that it has had no effect on abortion rates,” Wright said. “Studies have also shown that the drug might not even be as effective as they say.”

While the studies regarding Plan B’s effect on the rates of unplanned pregnancies and abortions are still new and inconclusive — a lot of factors can affect abortion rates including poverty rates and access to medical care — proponents of OTC Plan B say any increased access to contraception is a step forward.

“Timely access to Plan B is essential to preventing unplanned pregnancy. People who oppose abortion should be working to improve access to contraception not to block access,” Miller said.

No end in sight

Both sides of the debate over nonprescription Plan B have vowed to continue fighting; proponents for increased access for minors, and opponents to get the approval revoked or at least increase restrictions.

Nevertheless, it is clear that everyone except for those most involved in the issue, from pharmacists to consumers, has a nebulous understanding of how Plan B works and the FDA regulations governing its distribution. A great deal of the debate focuses on the semantic arguments of medical definitions and speculation on how the drug actually works, two things that are unlikely to be resolved any time soon.

The debate will surely continue. The need for alternative contraceptives may be greater now than ever. On January 24, the Associated Press reported that the FDA is reviewing its guidelines for birth control pills because studies show “newer contraceptives appear to be less effective — with twice the failure rate at times — than previous products.”

Both sides claim the same end goal, ending abortion, whether it is by abolition or by good family planning and access to birth control. It’s their differing opinions on how to get there that caused three years of turmoil and political posturing at the FDA and in the U.S. Congress.

Jessica is one person who was relieved to have Plan B available when she needed it.

“I was really glad I had that option. Condoms aren’t always the greatest, they don’t always stay on and things happen … We’re all human, and we all do things impulsively that aren’t the smartest things to do. It gives the person an option, instead of crossing their fingers and hoping for the best.”

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