the other side

men discuss pregnancy protection

In the world of pharmaceuticals, drug manufacturers have a limited amount of time to own the market with a new drug. That time recently ran out for Barr Laboratories, Inc. and one of its brand name oral contraceptives.

The recent expiration of a three-year new drug product exclusivity agreement that gave Barr Laboratories exclusive rights to sell Seasonale, an 84-day birth control regimen, was not renewed - meaning other drug companies can join the market previously owned by Seasonale and offer less expensive, generic versions.

Seasonale, which gained approval from the Food and Drug Administration in September 2003, gives women the option of having four periods a year as opposed to a traditional 13. A pack of Seasonale and other similar hormone-containing off -brands contain enough active pills to last women 12 weeks as opposed to the three weeks of many other, more traditional, birth control pills.

When the pill hit the market, many women expressed concern about having a period once every three months as opposed to once every 21 to 28 days. But as Seasonale and other drugs like Nordette and Levora are gaining popularity in the oral contraceptive market, men as well, are growing concerned about the pill’s safety and effectiveness.

While sitting down for a recent interview about birth control, a group of college-age men told College Avenue how birth control options are viewed from a man’s perspective and their opinions on oral contraceptives like Seasonale.

One of their major concerns is that a three-month regimen of pills could hide a few tell-tale signs of pregnancy. When many women and men, including the College Avenue panel, use a skipped period as an early sign of pregnancy, waiting three months for a woman’s period can bring some anxiety.

Joe*, a junior sociology major, and his ex-girlfriend, who used an oral form of contraception, experienced a pregnancy scare after she was 18 days late for her monthly cycle.

Because these men say a skipped period is the most obvious sign to them that a woman could be pregnant, they don’t favor an 84-day birth control regimen. Instead of knowing about a possible pregnancy at the end of a month, they wouldn’t know for three months.

Many questions arose during the panel discussion, with the men not knowing many details of the 12-week pills, such as the hormones in the pills, how those hormones compare to other birth control pills and if it really is safe for women to skip periods.

Tanja Andreas, a family nurse practitioner in the Women’s Clinic at Hartshorn Health Services, says there’s really nothing for sexually active men and women to worry about. There are some side effects, she said, such as spotting, nausea and breast tenderness that can occur during the first few months of use, but they usually subside. There are no health risks for skipping periods.

“The beauty of (Seasonale) is it’s another choice but not drastically different,” she said. “The formulation of pills like Seasonale is the same as several other birth control pills already on the market. Seasonale is different because it’s the first pill to be FDA approved to do so for 12 weeks.”

The pregnancy scare came as an extreme shock for Joe since he said he always uses a condom, no matter who his partner is and whether or not she is using any kind of contraception. He says it’s a precaution he takes not only for pregnancy risks but also to protect against sexually transmitted diseases.

And even though Seasonale and other oral contraceptives have about a 99 percent success rate for preventing pregnancies, that still isn’t enough for these men to go without the rubber.

“Even if she was my girlfriend, I would still use (a condom) as a backup method,” said Tim, a freshman business major at Front Range Community College. “It’s better to be safe than sorry.”

“Yeah, it’s definitely a backup,” said Mike, a senior biology major at CSU. “I don’t want to catch anything.”

Another concern the men have is how effective a long-term pill can be, especially if the woman forgets to take her daily pill.

A pill can only be effective as long as the woman taking them is responsible enough to take it the same time every day, Mike said.

“I’m skeptical about the girl always taking the pill,” he said. “I don’t trust that she would always take it and never forget and skip a day. At least you know a condom is there.”

Since FDA approval in 2003, Barr Laboratories, Inc., has earned millions from the sale of the Seasonale pill. In the second quarter of fiscal year 2006, the company’s earnings report states “sales of Seasonale increased 40 percent to $29 million … compared to $21 million for the prior year period.”

HHS sticks to prescribing the less expensive, generic versions of Seasonale. A HHS prescription costs $90, a significant savings compared to the $160-plus women could pay for the brand name. Local pharmacies varied in price with the most expensive pharmacy - Safeway, 460 S. College Ave. - charging $198.99 for brand name Seasonale. And now that a market is developing for contraceptives like Seasonale, there may be an even newer oral contraceptive option for women.

Librel is a pill that claims to end periods all together. Women would continuously use active birth control pills, thus never having a period again. The drug manufacturer intended to seek FDA approval in 2005 but there has been a hold on the process.

Andreas doesn’t believe there would be much of a market for a contraceptive like Librel.

“On hormones,” she said. “Periods are usually so light and short on combination oral contraceptive pills that (periods) are rarely a real hassle.”