Over-the-Counter Emergency Contraception: A Newsmaker Interview With David A. Grimes, MD

Laurie Barclay, MD

September 30, 2002

Oct. 1, 2002 — Editor's Note: Should emergency contraception (EC) be made available over the counter (OTC)? More than 70 organizations, including the American Public Health Association, filed a Citizen's Petition with the Food and Drug Administration (FDA) on Feb. 14, 2001, requesting that it be made available without a prescription, as it is in other countries including parts of Canada, the U.K., Morocco, Norway, Sweden, Finland, Israel, France, Belgium, Denmark, Portugal, South Africa, and Albania.

Proponents of prescription-only access cite concerns about reliance on EC rather than on planned contraception or abstinence, which, given the high failure rate of EC, could have the unintended effect of increasing unwanted pregnancies or sexually transmitted diseases (STDs). Ethical and moral objections include the claim that EC is a euphemism for early abortion and that OTC access might make it more difficult for some women to "just say no" to unprotected intercourse.

In a sounding board article in the Sept. 12 issue of the New England Journal of Medicine, David A. Grimes, MD, argues in favor of immediate switch to OTC status for EC, suggesting that the prescription requirement causes more harm than good. Medscape's Laurie Barclay interviewed Dr. Grimes, who is vice president of biomedical affairs at the Family Health Institute of Family Health International in Research Triangle Park, North Carolina, to find out more about his views on this controversial issue.

Medscape: What is the present legal status and availability of EC?

Dr. Grimes: It's available nationwide by prescription. In Washington and California, pharmacists can dispense it without a doctor's prescription, so it's available behind-the-counter, so to speak. But we need to make EC available OTC, sitting on the shelf with the aspirin and acetaminophen. We need to remove all restrictions on access to EC drugs.

Medscape: When do you anticipate a final decision from the FDA on OTC availability of EC?

Dr. Grimes: The petition was filed on Valentine's Day of 2001, and the FDA has made no motion yet. I've written them several times inquiring about the reasons for the delay and finally got a generic letter from Janet Woodard saying that the subject raises "serious issues." But I've taken part in the largest trials of EC, and I just don't know what these "serious issues" are. There have been no reported deaths or serious adverse events from EC, while the alternative — pregnancy — is risky business in many parts of the world. I'd love to know what serious issues the FDA is worried about that those of us in the field have missed.

On the other hand, there are several hundred deaths each year from use of OTC aspirin and acetaminophen, prompting the FDA to consider adding warning labels or other additional information. But right now these products can be purchased by children without any warnings at all, so the FDA's policy with respect to EC is inconsistent at best.

I don't know why there has been such a delay by the FDA in granting OTC status to EC, but an editorial in a Florida newspaper, which I cite in my New England Journal of Medicine article, suggests that abortion politics have stalled it, and that the present administration is squeamish about all issues that have anything to do with sex.

Medscape: What are the medical objections to OTC availability?

Dr. Grimes: When I wrote the article, I really had to stretch to come up with any. In fact, the editor had to suggest a few. Almost all the objections are social rather than medical.

Medscape: How do you address those who are concerned that OTC availability will become a substitute for regular contraception or for abstinence?

Dr. Grimes: There are four studies which suggest that advance access to EC does not prevent use of regular birth control. When legalized abortion became available we heard the same argument, but going through an induced abortion actually encourages women to use birth control methods subsequently. Repeated use of EC wreaks havoc on a woman's cycle, so the resulting menstrual chaos acts as a powerful deterrent to using this method too often.

Medscape: Could the high failure rate of EC have the unintended effect of increasing unwanted pregnancy? What about ectopic pregnancy?

Dr. Grimes: Relying exclusively on EC is a bad idea, as it has a 15% or greater failure rate. But it's clearly more effective after unprotected intercourse than doing nothing. Ectopic pregnancy is always a concern, and EC does not prevent it, because its mechanism of action is to prevent implantation of the fertilized egg into the uterine lining. But the prevalence of ectopic pregnancy is fairly high anyway, and there are no data on whether EC increases or decreases the risk or has no effect.

Medscape: If EC is available OTC, might it decrease condom use or abstinence, thereby increasing STDs?

Dr. Grimes: This is very fuzzy thinking. I have a coffeemaker in my kitchen that brews a perfectly delicious pot of coffee, but it does no good at all at receiving incoming faxes. Nor should we expect any form of contraception to prevent STDs — the sole purpose of contraception is to prevent pregnancy. Women relying on IUDs to prevent pregnancy don't typically use condoms either, unless they're concerned about STDs, but that doesn't mean we limit their access to the IUD. By all means, condoms should be used by those who are at risk of contracting STDs, but this doesn't mean they shouldn't have easy access to EC.

I get very irritated with public health messages implying that everyone should have gratuitous counseling about safe sex. If I know my patient is engaged exclusively in a monogamous relationship, it's insulting to counsel them about safe sex, as if I'm implying that they're unfaithful. If someone is concerned about an unwanted pregnancy, it doesn't necessarily mean they should be concerned about the risk of contracting an STD.

Medscape: How likely is it that users of EC available OTC would use it correctly, following label directions, taking a pregnancy test first, understanding decreased efficacy if they are taking antibiotics or anti-epileptic drugs, remembering to take the second dose 12 hours later, realizing that they might be unprotected if they vomit either dose, having access to meclizine or other antiemetic if needed, and seeing a doctor or taking a pregnancy test if their period doesn't resume in three weeks?

Dr. Grimes: Questions like this are demeaning and patronizing to women. Why shouldn't they be able to use the product correctly? If this were a form of contraception that men could use, I'll bet questions like this would never come up.

Anyway, vomiting is infrequent, and we're not sure whether women are unprotected if they vomit, since some argue that hormone serum levels must have already increased for emesis to occur. In a randomized controlled trial, giving meclizine before levonorgesterel alone (Plan B) significantly decreased the incidence of vomiting.

Ongoing controlled trials with Plan B will help determine the efficacy of a single dose and of twice the dose taken at the same time. So a single dose of EC might turn out to be adequate, in which case the issue of remembering to take the second dose wouldn't come up at all.

Medscape: Do you think socioeconomic factors, rather than sex differences, might play some role in the ability to follow instructions correctly? Might some argue that those who have unplanned, unprotected intercourse might be less likely to follow through with detailed instructions?

Dr. Grimes: When people are scared, their behavior changes dramatically. A pregnancy scare could be enough for users to follow instructions to the letter. And if their period doesn't return in three weeks, you can be sure they'll find out if they're pregnant.

Medscape: What about the argument that OTC availability of EC will cause fewer women to consult their physicians about birth control methods and related issues?

Dr. Grimes: Well, you'll note that I've listed this one first in the section of my article dealing with objections to OTC availability. But the reality is that counseling by physicians has not been shown to have much impact on birth control anyway. A lot of things we do don't amount to a hill of beans. In some studies, abstinence counseling has caused increased unwanted pregnancies.

Making EC available OTC does not impede any woman from seeking consultation with any physician at her convenience, it just relieves her of having to do so at 3 a.m. or of having to wait to start EC. The sooner EC is started after unprotected intercourse, the more effective it is. Besides, there really is no need for a woman to have a follow-up visit after using EC unless she doesn't resume menses in three weeks or unless she develops abdominal pain or other possible symptoms of ectopic pregnancy.

 

Medscape: In countries with OTC access to EC, how has this affected the rate of unplanned pregnancy and of STD? Have any cost-benefit analyses or epidemiological studies been done, or are any planned?

Dr. Grimes: A French study done in the first year after EC became available OTC suggests that it was highly successful in that women had no problems with following label instructions for EC use. But no postmarketing surveillance studies or epidemiologic studies are planned. How would you do such a study, and how would you interpret the results? Finding a change in rate of unplanned pregnancy or of STD and attributing it to OTC availability of EC would be an ecological fallacy. That would be like finding that the number of telephone poles in a city is correlated with the number of heart attacks, and concluding that telephone poles cause coronary artery disease.

Medscape: For those women who do seek medical advice about EC, either before or after they need it, what should their doctors tell them?

Dr. Grimes: As in any birth control discussion, all options should be discussed, with the pros and cons of each. Of the two EC formulations currently available, studies have shown that Plan B is more effective and has fewer gastrointestinal side effects than does Preven (ethinyl estradiol and levonorgestrel).

Medscape: Is there anything you'd like to say in closing?

Dr. Grimes: Every day that goes by without OTC access to EC hurts women's health. Although there won't be any data on the actual efficacy of having EC available without a prescription, projections of the numbers of women who would use it and the staggering number of unwanted pregnancies suggest that it could decrease induced abortions by about 800,000 each year.

N Engl J Med. 2002;347:846-848

Reviewed by Gary D. Vogin, MD

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