The battle for birth control

It’s been 46 years since the Food and Drug Administration approved the first oral contraceptive. Now, in a nation that just topped 300 million people, nearly 39 million American women use birth control, with more than 40 configurations of the Pill to choose from. Readily available birth control seems a given. In the past five years alone, we’ve seen the Nuva Ring, the patch and a new implant come on the market. They’re all variations of the same thing—hormonal contraception—and there are more types of them available than ever before. (See “New birth control methods” sidebar.)

A 2005 survey conducted by the National Family Planning and Reproductive Health Association found that 98 percent of all women who’ve had sex have used contraception, 88 percent of Americans support access to contraception, 80 percent of anti-abortion advocates support access to birth control, and 85 percent (including 8 of 10 Republicans), find using contraception to be morally acceptable.

Even so, there is a quiet, but increasingly persistent move to get rid of them. Some anti-abortion groups are taking a stand not only against abortion, but also against contraception. And while there have been opponents to contraception since Cleopatra reportedly used an apricot seed as a makeshift IUD, many of them are now moving from the fringes into high-ranking governmental positions, where they’re making key decisions about reproductive health.

Back to Plan B
One of the most recent and notable changes in the world of birth control was the FDA approval this past August—after three years of delay—to make Plan B available over-the-counter. Plan B, also known as “the morning-after pill” is a form of emergency contraception (EC) to be used to prevent pregnancy after sex has occurred. It can work up to 120 hours after sex, but it’s most effective when taken within 24 hours. The move to make it available over the counter allows a woman to get it as fast as she needs it rather than, for example, wait over a weekend for a doctor’s prescription. Plan B is not, as some have claimed, an abortion pill.

“It prevents pregnancy,” says Pat Elzy, legislative affairs director of Planned Parenthood Mar Monte in Reno. “It does not cause abortion. It prevents the need for abortion.”

According to the Guttmacher Institute, nearly half of America’s 6 million annual pregnancies are accidental, and half of those result in abortion. The Health Department reports that, in 2000, Washoe County’s teen pregnancy rate was 33 per 1,000. Plan B, its advocates say, could sharply reduce the nearly 1 million abortions performed each year in the United States.

Many wonder how something taken after sex isn’t abortion-causing. So here’s a recap of how babies are made: In a process that can take up to 120 hours, the egg drops (ovulation), the sperm then comes to fertilize the egg (fertilization), creating an embryo. Then the embryo travels down the fallopian tube to attach to the uterus. It’s this point, implantation, that the American College of Obstetricians and Gynecologists, leading medical societies and even the U.S. government consider the beginning of pregnancy. Since Plan B can’t affect a fertilized egg attached to the uterine wall, the FDA says the drug can’t cause an abortion, that it won’t work if a woman is already pregnant, and it won’t harm an already established pregnancy.

On the other hand, the abortion pill, RU-486, causes a woman to miscarry an already well-established pregnancy.

Plan B works much like regular birth control, primarily by preventing ovulation. Also like birth control, depending on where a woman is in her cycle, it may occasionally prevent fertilization, and in some cases could also prevent implantation.

Lauded as a way to prevent both pregnancy and abortion, Plan B was expected to be supported by both pro-lifers and pro-choicers. However, the theory that Plan B could prevent implantation of a fertilized egg runs counter to the views of many anti-abortion advocates, who believe life begins at fertilization, not at implantation. So according to their beliefs, the drug would be an abortifacient and not a contraceptive.

“There is no direct evidence that [Plan B] blocks implantation,” says Dr. Susan F. Wood, former director of the FDA’s Office of Women’s Health, who resigned from that position in 2005 due to the FDA’s repeated and suspect foot-dragging on making a decision to approve Plan B for over-the-counter. She told the New York Times magazine, “We can’t tell for sure because very little research has been done on direct implantation of human eggs. You run into moral problems doing research on a woman’s body and a human embryo. And since half of all fertilized eggs do not implant anyway, it would be difficult to know if this was the mechanism responsible.”

But pro-life advocates don’t want to chance it.

“Pregnancy is now defined as not until a newly conceived human being is planted in the womb,” says Don Nelson, president of the Sparks-based, anti-abortion group Nevada Life. “But it’s indisputable that life begins at conception.”

Conception, to him, is at fertilization, which is something Plan B can interfere with. “That’s something pro-life women need to know,” he says.

He says that while Nevada Life isn’t necessarily against contraception, “we’re against abortion, and if it has abortifacient properties, we’re against it.” Plan B, he believes, has abortifacient properties.

But this is where it gets tricky. If pro-lifers view Plan B, a contraceptive that functions much like regular birth control pills, as an abortifacient, then most current available forms of contraception would be seen as potential abortifacients, too. Even natural breast feeding can hinder implantation.

The moral questions, including Plan B’s potential effects on sexual promiscuity, held up for three years the FDA’s decision to make Plan B available over the counter.

What went down at the FDA
Plan B has been available by prescription since 1999. In April 2003, Plan B’s manufacturer, Barr Pharmaceuticals, applied to sell it over the counter. The FDA’s joint advisory panel voted 28-0 in December 2003 that it was “safe for use in the nonprescription setting.” They voted 23-4 to approve it for over the counter sales. It was approved at every level of the agency’s staff. But then Dr. W. David Hager, appointed by President Bush in 2002 to lead the agency’s Reproductive Health Drugs Advisory Committee, voiced concern about the drug’s potential increased effects on teen promiscuity. The FDA’s staff presented him with studies showing no increase in teens’ sexual activity when Plan B was available to them and that both the American Academy of Pediatrics and the Society for Adolescent Medicine endorsed the over-the-counter status. Others in the agency said such concerns were moral rather than safety issues and shouldn’t play a part in the FDA’s decision. In May 2004, the FDA rejected the application, citing some of Hager’s reasons.

In a sermon, Hager later said, “I argued from a scientific perspective, and God took that information, and he used it through this minority report to influence the decision. Once again, what Satan meant for evil, God turned into good.”

Barr Pharmaceuticals reapplied two months later, asking to sell it over the counter to women ages 16 and up in order to deal with the teen issue. The FDA delayed the decision again, seemingly indefinitely. Dr. Wood then resigned over what she called the “abortion politics” behind the delay. Democrats in Congress asked for an investigation into what they perceived as politics and beliefs trumping science. The Government Accountability Office concluded that the rejection of approving OTC status for Plan B was “not typical.” It found that top agency officials decided to reject the initial Plan B application months before a scientific review was complete. Sens. Hillary Clinton and Patty Murray held up the nomination of Andrew von Eschenbach as FDA commissioner until the agency decided one way or the other. It was approved in August 2006 and is expected to be widely available over the counter for women 18 and older in 2007.

“It’s long overdue, and it’s an important victory,” says Elzy. “But we’re concerned that it restricts teens without any scientific basis for it. Anything you do to make it harder for a teen to prevent pregnancy is bad policy and bad medicine.”

Barr Pharmaceuticals plans to launch a study of teenage use of Plan B to try to get the age restrictions lifted.

Contra Contraception
A look into President Bush’s beliefs and those of his appointees within the FDA sheds some light on the Plan B delay.

When WorldNet Daily correspondent Les Kinsolving asked press secretary Scott McClellan four times if President Bush supported contraception, McClellan said, “I think the president’s views are very clear when it comes to building a culture of life.” Kinsolving replied, “If they were clear, I wouldn’t have asked.” McClellan responded, “And if you want to ask those questions, that’s fine. I’m just not going to dignify them with a response.”

A less blatant response is Bush’s appointment of people like Dr. Joseph B. Stanford to the FDA’s Reproductive Health Drugs Advisory Committee in 2002, knowing that Stanford was opposed to contraception. Stanford wrote in a 1999 essay: “Sexual union in marriage ought to be a complete giving of each spouse to the other, and when fertility (or potential fertility) is deliberately excluded from that giving, I am convinced that something valuable is lost.”

The administration’s views are also glimpsed in next year’s federal budget. Under President Bush, spending to support abstinence programs shot up from $80 million in 2001 to a recommended $204 million in the 2007 budget.

The Government Accountability Office released a study in April that found administrators in many countries were forced to cut funds intended to fight mother-to-child HIV infection in order to finance abstinence programs. The state department, on the other hand, said the Bush administration’s ABC policy promoting “abstinence, “being faithful” and then “condoms” cut HIV transmission rates in Uganda, Zimbabwe and Kenya, and that “male faithfulness” has increased.

This focus on abstinence appears to have played a part in the delay of the OTC approval of Plan B. Dr. Florence Houn, director of the office that evaluated the Plan B application, said in a July 18, 2006, deposition: “I think since at least in 2000, we—we in HHS, Health and Human Services—are aware that then-secretary Tommy Thompson’s goals and strategic objectives for the Department, when they involved unintended pregnancies … was the advocacy of abstinence. And under the president’s management agenda, the Department’s strategic plans and goals are cascaded down to agencies, to supervisory heads in our performance evaluation. So I think that the availability of Plan B over the counter raised concerns on whether this was counter to the strategic goals of the department.”

While the Catholic Church is against artificial forms of birth control, the issues surrounding contraception are more than just sex and abortion for many pro-lifers and social conservatives. They’re also about the focus on the individual at the expense of family and society.

In an editorial in Catholic Online called “Women Forgoing Contraception? Good!” Matt Abbott quoted the late Mother Teresa: “In loving, the husband and wife must turn the attention to each other as happens in natural family planning, and not to self, as happens in contraception. Once that living love is destroyed by contraception, abortion follows very easily.”

Abortion rights advocates counter that abortion follows easily when there is no contraception to prevent the pregnancy.

Abbott concludes with his own thoughts: “We will not see a drastic drop in unintended pregnancies, sexually-transmitted diseases or abortions unless and until the vast majority of people begin to respect the moral law. This means no sex outside of marriage and the use of natural family planning (for serious reasons) within marriage.”

Contraception, then, is not even acceptable within marriage.

Cynthia Dailard of the nonprofit Guttmacher Institute, which promotes sex education, told the New York Times magazine: “Ten years ago, the fight was all about abortion. Increasingly, they have moved to attack and denigrate contraception. For those of us who work in the public health field and respect longstanding public health principles—that condoms reduce STDs, that contraception is the most effective way to help people avoid unintended pregnancy—it’s extremely disheartening to think we may be set back decades.”

Nelson of Nevada Life thinks looking back isn’t such a bad idea. “Problems like AIDS and the 40 or 50 STDs we have now that we didn’t have before this proliferation of the sex revolution and contraception—we didn’t have these things back in the day before the sexperts and the population planners and free-love revolution got going,” he says. “That is a direct impact from that. … Some say you can’t go backwards. But this is one of those times when it might be good to go back and look at what worked before.”

Conscience unclear
The debate about Plan B and emergency contraception has entered the nation’s pharmacies, heightening some groups’ views that Plan B should be available over the counter.

Due to some pharmacists refusing to fill prescriptions for emergency contraception like Plan B, more than a dozen states have considered measures for “conscience clauses” that would allow for the refusal.

The New York Civil Liberties Union filed suit against three pharmacists in upstate New York who refused to fill Plan B prescriptions. According to the NYCLU, one pharmacist told the prescribing provider that emergency contraception “should be inconvenient” for women and their doctors and that women who needed it were “irresponsible and should suffer the consequences.” In 2004, a pharmacist in Denton, Texas, cited “religious convictions” for refusing to fill a rape survivor’s prescription for emergency contraception. Furthermore, a study of nearly 600 Catholic hospital emergency rooms found that only 28 percent offered EC to rape victims.

A national survey conducted in December 2005 found that 69 percent of U.S. pharmacists felt they should have the authority to refuse to fill EC prescriptions. Only 23 percent said patients’ rights should prevail if a legal drug is prescribed. Conversely, 70 percent of doctors and physicians felt pharmacists should be required to fill the prescription.

In 2000, a Carson City pharmacist refused to fill a woman’s emergency contraception prescription. He gave her no reason for doing so, and he didn’t refer her to another pharmacy. Planned Parenthood looked into it and found that Nevada law is silent on the issue of whether a pharmacist can or cannot refuse to fill a prescription based on moral grounds.

Since 2001, a few bills and regulations attempting to deal with the issue have arisen but died in the Nevada Senate.

In the fall of 2005, the members of the Nevada State Board of Pharmacy took it upon themselves to propose regulations that would set standards for refusing to dispense lawful prescriptions.

“We decided after a lot of fodder from different legislators that we should back out of the conscience part having to do with religion,” says Larry Pinson, director of the Nevada State Board of Pharmacy.

What they did decide was that pharmacists don’t have to fill prescriptions they find to be unlawful, “potentially medically harmful to the health of the patient,” fraudulent or “not for a legitimate medical purpose.” They left the question of whether pharmacists can refuse to fill based on moral grounds up to state legislators. The next session of the Nevada Legislature begins in February 2007.

Washoe County Assemblywoman Sheila Leslie says she’s not aware of any bill drafts on the subject. “But it’s come up in the last two sessions; I wouldn’t be surprised if it comes up again,” she says. “If it starts happening, and we have well-documented cases of people being denied their prescriptions, I think you’ll start seeing something pretty quick.”

So while there is no law or regulation saying pharmacists can refuse based on moral grounds, neither is there a law saying they can’t. Pinson told the Las Vegas Sun in December 2005, “As the law is now, there is nothing that mandates a pharmacist has to fill anything.”

Nevertheless, Elzy thinks the pharmacy board regulation is a step in the right direction. “But there could be stronger protections for patients,” she says. “’Potentially harmful to the patient’ wasn’t defined, and that’s a concern Planned Parenthood mentioned at the Board of Pharmacy and public hearings. But the decline option is based on professional judgment, not personal beliefs. I think that’s a positive step.”