Wed, Jun 04, 2003 page16

• A pill for every spill

  US women are playing global catch-up with the morning-after pill

  • By Pat Reber / DPA
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  American women led the global fight for equal rights and access to birth control, but when it comes to emergency contraception -- a potent antidote to unplanned, unprotected sex -- they are lagging way behind.

  That will change if the US government's Food and Drug Administration (FDA) decides to do what at least 26 other countries have done and declare Plan B, a morning-after pill, an over-the- counter medication.

  Women's Capital Corp, a small firm created specifically to produce the medication in the late 1990s, submitted its application last month asking for approval for pharmacists to dispense the emergency contraception nationwide without a doctor's prescription, a company spokesman said.

  

  Women and the pill -- the debate goes on and is now focusing on a new pill for ``the morning after'' unprotected sex.

  PHOTO:DAP

  The medication, despite its limited availability in the US, has already reduced the number of annual abortions by 51,000 by preventing pregnancy within hours after unprotected sex, the Alan Guttmacher Institute estimated.

  Plan B and a second emergency contraceptive are currently available in four US states from pharmacists, meaning women in the other 46 states must make appointments with their physicians to get a prescription for the pills.

  Since unprotected sex most likely occurs in the evenings and weekends when doctors are not in the office, women outside the four states often miss the crucial 24- to 72-hour period necessary for the pills to be effective.

  Over the counter

  "We are asking for over-the-counter status of the product," said a company spokesman. "This would enable women to go directly to their pharmacists and get the product without a doctor's prescription."

  The morning-after pill was already available over the counter in 26 countries by 2000, which were: Albania, Israel, Senegal, Belgium, Ivory Coast, South Africa, Benin, Lithuania, Sri Lanka, Cameroon, Madagascar, Sweden, Denmark, Mauritius, Switzerland, Finland, Namibia, Togo, France, Norway, Tunisia, Gabon, Portugal, Britain, Guinea and Republic of Congo.

  Despite its limited availability in the US, where it was first introduced in 1997, the number of American women using Plan B has doubled every year, the company said. Currently, 6 per cent of American women have used one or the other morning-after pill, triple the percentage from three years ago, the Kaiser Family Foundation confirmed recently.

  The morning-after pill involves administration of two concentrated birth control pills -- preferably within 24 hours, but up to 72 hours after unprotected intercourse -- and is 75 percent effective, said the Alan Guttmacher Institute in New York.

  The Plan B pill consists of 0.75 milligrams of levonorgestrel, a progesterin product in two doses. The two pills are about the equivalent of 40 daily birth control pills, a company spokesman said. Before the morning-after pill came on the market, in fact, some physicians would direct pharmacists to cut up packets of the monthly pills for patients in need, including rape victims, to use in a similar way.

  The name, Plan B, implies what it means -- that morning-after pills should not be used for regular contraception. Plan A, the ideal plan, entails anything that involves thinking ahead -- such as the daily preventive pill, condoms or other birth-control methods.

  Noting the worldwide success of emergency contraception, however, the FDA in 1997 took the unusual initiative of getting the drug manufactured in the US by declaring it safe and seeking a company to produce the pills.

  "I know that the data show that this is safe and effective," Dr. Paul Blumenthal, an obstetrician who heads contraceptive research and programs at Johns Hopkins University's Bayview medical centre, said in a telephone interview. "It meets all the criteria that would ordinarily have to be met by any other over- the-counter drugs. You could probably argue this is safer than aspirin."

  French better

  He said that some of the data that the FDA will use to evaluate the drug are from studies conducted in Europe on two drugs used there, Norvelo and Postinor, which are the same drug as Plan B.

  The effects of the drugs can be seen in France, where the abortion rate has become one of the lowest in the world. The rate is 12 abortions per 1,000 women aged 14 to 44, or half the US rate.

  Emergency contraception has been available in France since the early 1970s. In 1999, concerned that the abortion rate had stopped falling, the government made the medication available without a prescription. A year later, high-school nurses could provide the drug without parental permission, the institute said.

  The morning-after pill should not be confused with RU-486, the abortion pill that is administered up to the first 12 weeks of pregnancy and after the egg is implanted in the uterus. RU-486 was approved for use in the US just recently and amid protests by anti-abortion groups.

  There has been little protest from such groups against the application by the Women's Capital Corp -- possibly because the groups are convinced that the morning-after pill works similarly to the preventive birth-control pill by interfering with ovulation, fertilization or implantation of the egg in the uterus.

  Describing the impact of discussions about the morning-after pill in France, Elizabeth Aubeny, president of the French Association for Contraception, was quoted as saying, "The more you talk about contraception, the more women use it and the fewer abortions there are."
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