Over-the-counter pill pushed

IT’S not addictive, it’s easy to take and 50 years of use shows it’s safe.

So why do women still need a prescription for the birth-control pill? A move to make oral contraceptives available over the counter is gain­ing momentum in the United States — and any regulatory changes there would have significant ramifications for Canada.

Proponents of taking the pill off prescription-only status say the bene­fits outweigh the risks, the potential for misuse is minimal and easier access could help lower rates of un­intended pregnancies and abortions.

But the prospect of women gaining unfettered access to the pill has some doctors and sexual-health counsellors uneasy. Would women still see their doctor for Pap smears? Could they safely screen themselves for contraindi­cations — conditions under which the pill should not be used? Would it unleash a marketing bonanza for drug-makers and a huge increase in users?

Nevertheless, a Canadian leader in reproductive medicine and editor of the Journal of Obstetrics and Gynae­cology Canada says it seems wrong and paternalistic that, half a century after the pill’s debut in the U.S. and 41 years after it came to Canada, women still cannot get access to the most effective, self-administered birth control on the market without a doctor’s blessing.

Men aren’t required to have a tes­ticular or prostate exam before using condoms, Dr. Tim Rowe has argued in the pages of his own journal.

"Leaving (the pill) as a prescrip­tion- only issue does have detrimental effects on access, because there really are women who fear going to the doctor because they’re going to have to have a pelvic exam, or they’re going to have to have some sort of invasion of their privacy," Rowe, head of the division of reproductive endocrinology and infertility at the University of British Columbia, said in an interview.

"Men certainly wouldn’t put up with that. Women put up with it as a matter of course."

Rowe says attempts to sell the pill over the counter would meet the same opposition as the human papillomavirus (HPV) vaccine that protects against the most common sexually transmitted infection in Canada. In the minds of some people, he says, the pill and the HPV vac­cine only encourage promiscuity and sexual liberation.

"A sector of the population feels that’s not right, that abstinence be­fore marriage is the only acceptable thing."

But, "I think we need to explore it," he says. "We have to be cau­tious in every sense, but at the very least we need to have an exploration going forward about what possibly could be the harm in it?"

Thousands of women have been there: "As every woman who has run out of pills on a Sunday or forgotten to take them along on vacation knows, refills are not always easy to come by," Kelly Blanchard, president of the non-profit Ibis Repro­ductive Health wrote in a New York Times editorial in June.

But it’s not just a matter of conven­ience, she said. "Women don’t need a doctor to tell them whether the need the pill — they know when they are sexually active and want to avoid pregnancy. Pill in­structions are easy to follow: Take one each day. There’s no chance of becoming addicted. Taking too many will make you nauseated," Blanchard writes, "but won’t endanger your life, in con­trast to some over­the- counter drugs like analgesics."

Rowe, who, be­cause of his editor­ial position, has no links, commercial or professional, to any relevant stake­holders, says the pill is "supremely efficient" in preventing pregnancy, and the number of side-effects "abso­lutely minimal."

Over-the-counter antihistamines that cause drowsiness during driving are potentially far more dangerous, he argues. He’s convinced certain levels of safety could be injected into any over-the-counter rollout of the pill — clear instructions for use, information on side-effects and com­plications and reminders for women to get screened for cervical cancer.

The analogy he likes to draw is with cigarettes: "With all their health risks, why do we have cigarettes for sale whenever anyone wants them?"

Last year, Canadian retail drug­stores filled 10.3 million prescriptions for the pill, according to prescription drug-tracking firm IMS Health Can­ada, making oral contraceptives among the top 20 most-prescribed medications in the country. Oral con­traceptives are prescribed not just for birth control, but also for abnor­mal bleeding and other conditions.

The pill has been one of the most studied drugs in medicine. Two years ago, a landmark study published in the British medical journal The Lancet found that the pill not only reduces the risk of ovarian cancer, the most lethal of all gynecological tumours, but that the protection lasts decades after the patient stops taking the pills.

The study’s auth­ors said the protec­tion outweighed the increased risks of other cancers, including cancers of the breast and cervix, and that the pill that helped usher in the sexual revolution of the 1960s may already have prevented some 200,000 ovarian cancers and 100,000 deaths from the disease worldwide. The Lancet editors argued that the case for making the pill available without prescription "is now convincing.

"Women deserve the choice to obtain oral contraceptives over­the- counter, removing a huge and unnecessary barrier to a potentially powerful cancer-preventing agent," they said.

Ovarian cancer is highly lethal be­cause symptoms are so vague, most tumours aren’t detected until they’re far advanced.

In Canada, the vast majority of prescriptions for the pill are for com­bination pills containing synthetic forms of estrogen and progesterone, a formulation that shouldn’t be used by women with a history of blood clots, heart disease, mi­graines, liver disease and other conditions. Because progestin­only pills have fewer risks, a working group in the U.S.

is looking at pursuing an over-the­counter designation for that type of pill first.

There’s also some precedent: Plan B, a brand of progestin-only pills ap­proved for emergency, or "morning after," contraception, is now sold over the counter.

But if women could get the pill without a prescription, would they stop having regular gynecological exams? Studies suggest no.

Dr. Dan Grossman co-ordinates the Oral Contraceptives Over-the-Counter Working Group, a coalition of health professionals, non-profit advocacy groups and university­based researchers. In a study with the University of Texas, Grossman and colleagues followed two groups of women for nine months: about 500 women living in El Paso who were crossing the border into Mexico, where pills are available without pre­scription, and 500 women who were getting their pills in public health clinics in El Paso.

"Even women who were getting their pills in Mexico had very high rates of getting Pap smears in the recommended frequency," says Grossman, an obstetrician/gynecolo­gist with the Cambridge, Mass.-based Ibis Reproductive Health.

"These were often poor women who didn’t have health insurance — that’s why they were getting their pills in Mexico. But they were still finding a way to get their Pap smears."

The Ottawa-based Society of Obstetricians and Gynaecologists of Canada doesn’t have a formal position on the issue, per se, says associate executive vice-president Dr. Vyta Se­nikas. "Certainly we were very much for Plan B being over-the-counter."

She said that the society’s guidelines from 2004 state that, while a pelvic exam is an important part of "well-women care," it isn’t a prerequisite for providing hor­monal contracep­tion.

The reality, doctors say, is that pelvic exams are being tied to the pill. Some provinces have registries in place that send out notices if a woman is overdue for a Pap, but not all. "There’s difficulty in get­ting women in for Pap smears, be­cause no one likes them. There’s not a lineup for Pap smears in my office," says Dr. Debbie Penava, an associate professor in the department of obstet­rics and gynecology at the University of Western Ontario and director of the Women’s and Children’s Health Informatics Unit at the Schulich School of Medicine and Dentistry.

"What’s happened over time is that people hold the birth-control prescription hostage for a Pap, which no one has wanted," Penava says. "It makes the physician seem like the bad guy or the gatekeeper."

Penava says the greatest risk with a progestin-only pill is that, if not used correctly, it’s not very effective. It needs to be taken within the same two hours, every day. Progestin-only pills work in part by thinning the endometrium, the inner lining of the uterus. If not taken at the same time each day, breakthrough bleeding or ovulation can occur.

"It’s a safe medication," Penava says. "It’s just not an effective birth­control method. "What I say to my patients is, you may as well walk around the bed three times and say a prayer."

She also said the issue of teen pregnancies is far more complex than just the availability of birth control.

"Some of these teens want to be preg­nant. They don’t have self-esteem, they want someone to love them.

That’s a huge, huge societal issue."

Either way, it could take years for the pill to be sold over the counter. A spokesman for federal Health Minis­ter Leona Aglukkaq said a manufac­turer would have to make a submis­sion providing evidence the pill could safely be used in a "non-prescription" setting. Drug regulators would then have to review the data.

— Postmedia News