Morning-After Pill May Go Over the Counter

NYTimes ^ | 5/19/03 | KATE ZERNIKE

[RJCogburn]

For years, public health advocates were frustrated that most women did not know about a drug that could prevent pregnancy even if taken several days after sex.

Its potential to reduce the abortion rate was enormous, and opponents of abortion generally did not oppose it. But that potential was unrealized, largely because the two companies distributing the drug in this country were so tiny that they could barely afford advertising. People who did know about it often confused it with RU-486, the abortion pill.

But in the last year, so-called emergency contraception has started to come out of the shadows. Three million doses of one pill have been sold since 1999, and the maker of another says its sales increased 50 percent last year.

On Thursday, New Mexico became the fourth state to allow pharmacists to dispense the drug directly to women, enabling them to avoid trips to a doctor for prescriptions. Legislators or pharmacists in at least 14 states are agitating to do the same.

One company that sells the pills, the Women's Capital Corporation, has applied to the Food and Drug Administration for permission to sell them over the counter. The other, Gynetics, says it, too, expects its product to be sold over the counter by the end of next year.

The president of Women's Capital says she is in discussions with several large drug companies about buying the drug once it is approved for over-the-counter sales, which would put advertising and distribution might behind it.

The American College of Obstetricians and Gynecologists has sent letters to its 43,000 members urging them to give patients advance prescriptions of the emergency contraceptives. Planned Parenthood offers 24-hour online prescriptions in seven states. Fifty-two percent of university health clinics dispense the pills, according to The Journal of American College Health.

Awareness of the pills seems to be growing as well: a Kaiser Family Foundation survey, to be published in Self magazine next month, found that 6 percent of American women had used them, triple the percentage three years ago. In 1997, 1 percent of women reported using the pills. Sixty-eight percent of women know about them, the survey found, an increase from 51 percent in 2000 and 41 percent in 1997.

"It's really a thousand flowers blooming," said James Trussell, director of the Office of Population Research at Princeton University, and one of the earliest advocates of emergency contraception. "What started off as a tiny band of people is now a much larger one, and people are starting to act on their own."

Emergency contraception has been an unlikely story from the start. Jane Boggess, director of the Pharmacy Access Plan, which advocates wider distribution of the drug, calls it "the little engine that said it could."

In 1974, a Canadian researcher reported that taking a high-dose regimen of birth control pills within 72 hours of unprotected sex could prevent pregnancy. While RU-486, or mifepristone, is often called the morning-after pill, that description more accurately applies to emergency contraceptives. RU-486 triggers an abortion up to 12 weeks after conception. The emergency contraceptive pill prevents conception.

Researchers say they still do not know how the pill works. It either delays ovulation or prevents a fertilized egg from attaching to the uterus. Depending on which brand is used and how early it is taken after sex, it prevents pregnancy in 75 to 89 percent of cases. New research shows that it can prevent pregnancy even if taken five days after sex. The regimen is two pills taken 12 hours apart, containing a high dose of progestin and, in the case of one drug, Preven, estrogen.

The pills are essentially birth control pills in higher doses.

But as their name suggests, they are not intended as regular birth control. They are for what advocates say they hope are rare instances of unprotected sex, or when, say, a condom breaks. As posters in one advertising campaign say, "Accidents happen."

The pills are available over the counter in more than a dozen countries. France offers them in schools, to girls as young as 12. But large drug companies shied away from distributing them in this country, to avoid controversy and because they were not highly profitable.

For years, some family-planning clinics would cut up packets of birth control pills to use as morning-after pills. In 1997, the Food and Drug Administration declared the regimen safe, and it took the unusual step of putting out a notice seeking a company willing to produce a morning-after pill.

Roderick Mackenzie, a former drug company executive, took up the offer and founded Gynetics, which in 1998 won approval for the first morning-after pill, known as Preven. The next year, the drug agency approved Plan B, a pill distributed by Women's Capital, formed by women's health advocates.

Without the money to advertise the pill, the companies began urging its use at college health clinics and family planning clinics. Women's Capital did not offer Plan B to retail pharmacies until two years after it was approved.

"We did it upside down," said Sharon Camp, the company's chief executive. "Usually you start with the high-profit prescribers, then it trickles down to the public health sector. We did it just the reverse."

Much of the support has come from pharmacists, who argue that they should be the primary distributors because time is critical in taking the pills and many women cannot get to their doctors in time.

In 1998, Washington State took advantage of state regulations that allowed doctors to delegate some tasks to assign to pharmacists the task of dispensing emergency contraceptives. Doctors issue standing prescriptions for the drug, and the pharmacists dispense the pills and monitor the patients. New Mexico, Alaska, and California have approved similar arrangements.

At Ross Valley Pharmacy in Marin County, Calif., Paul Lofholm had been cutting up birth control packets for distribution at Planned Parenthood clinics for years. Now, he says, distributing the morning-after pill has become a "regular business." A store pharmacist remains on call around the clock.

Jerry Karbeling, senior vice president of the Iowa Pharmacy Association, said: "There's a desire, especially from people who are graduating from pharmacy schools right now, to be involved in something more than just handing out pills and bottles. We've been saying for a long time that the pharmacist is the most accessible health care professional."

Still, some controversy lingers. A few large chain pharmacies have refused to stock the drug. The American Life League, a group that opposes both abortion and birth control, says it considers the morning-after pill an abortion drug. In the Maryland House of Delegates, a debate this year over allowing pharmacists to distribute the pills quickly became one about teenage promiscuity and abortion.

But in general, advocates of abortion rights say it is far easier to talk about emergency contraception than it is to talk about RU-486 or abortion. Many people who oppose abortions support birth control as a way to prevent them. The National Right to Life Committee, for example, the nation's most prominent antiabortion group, has said it will not take any position on the application to make emergency contraception available over the counter. Even the American Life League said it did not plan to oppose approval.

The Food and Drug Administration would not comment on the pending application, other than to say a decision would probably be made within 10 months. Some pharmacists and doctors who support the use of the pill have argued that it will be used as regular birth control if made over the counter, particular among teenagers. But studies showed that making it available did not prompt women to use it repeatedly. Of 540 women in one study, Dr. Camp said, 10 used it more than once.

The pills disrupt the menstrual cycle and can cause nausea, which dissuades regular use. So does the price. The morning-after pill typically costs $20 to $30 a dose, more than the cost of a month's supply of birth control pills. While the pill has been most popular among women ages 19 to 29, studies showed it was not widely used by teenagers.

Gradually, it is gaining acceptance. Thomas Purdon, who as president of the American College of Obstetricians and Gynecologists recommended providing advance prescriptions, said some of his colleagues at first opposed this. But the practice, Dr. Purdon said, has become more common. "We're gradually breaking down the barriers."

Sales reflect that. Gynetics said its sales had increased 50 percent last year. Plan B has sold three million doses since it was approved in 1999, with the numbers doubling each year. The Alan Guttmacher Institute estimated that the pills prevented 51,000 abortions in 2000.

[RJCogburn]

A good idea.

[IronJack]

Its potential to reduce the abortion rate was enormous

It seems to me that abortion by pharmaceutical means is just as morally repulsive as abortion by surgery.

[merak]

Isn't it something to have a grandiose cause like right2life just get bypassed by events and history?

[HuntsvilleTxVeteran]

Does any reputable media outlet have this info
or only the nyslimes?

[TxBec]

As posters in one advertising campaign say, "Accidents happen."

Life is not an accident.

[xsmommy]

excellent point, Bec!

[hellinahandcart]

If they could only come up with an after-the-fact pill that would prevent fertilization, then they'd have something.

Since even the manufacturer can only boast of 75 - 89% effectiveness ("Take this and your chances of getting pregnant are only 1 in 5!! Woohoo!!"), I'm not sure they're such a bargain. And I'm definitely not sure how many "prevented pregnancies" can be attributed to this pill. Are they assuming that every act of unprotected sex would have resulted in conception without it?

[LadyDoc]

No it's not a good idea.

you will see girls using them over and over again. But in the rape studies, the pill has to used right away and even then has only the abiity to lower the pregnancy rate by 60 percent.

In true (i.e. violent) rape, the pregnancy rate is much lower than in normal intercourse...(if you want to know why I'll email you the x rated reasons).

Teens who come to the ER claiming "rape" (date rape usually) often go home and don't take the pills correctly. After two days, they don't work very well. So you are giving a pill to a girl who might very well become pregnant. And the severe nausea from the pill will make some people not take all the pills, especially teenagers.

However, by giving a false impression that these pills will prevent pregnancy, you will have an increase in unprotected sex: why bother when you can take a pill tomorrow. This will lead to the increase of Chlamydia etc...

So this is a nice thing for the "sex and the city" type sluts who forget to use the pill and for married ladies who are relying on condoms.

But the dirty little secret is that in England they are giving these out to 12 year olds in schools. And this is aimed at teens, not older women who often have tubal ligations....

[Conspiracy Guy]

Years ago I tried the day after pill for men. Now I have 2 college seniors. Crappy aspirin.

[TxBec]

But as their name suggests, they are not intended as regular birth control. They are for what advocates say they hope are rare instances of unprotected sex, or when, say, a condom breaks. As posters in one advertising campaign say, "Accidents happen."-snip-

The American College of Obstetricians and Gynecologists has sent letters to its 43,000 members urging them to give patients advance prescriptions of the emergency contraceptives.

Ok which is it? sounds like pre-planning to have an "accident"..

...and all that "little engine that could.."..."It's really a thousand flowers blooming"...stuff?? (rolling my eyes here)

[xsmommy]

advance prescriptions of the emergency contraceptives

You are absolutely right, it is a preplanned emergency. i am going to accidentally have sex this weekend, doc, so please give me a prescription.

[MHGinTN]

The emergency contraceptive pill prevents conception. In some cases it will prevent ovulation, but the implied notion that in preventing implantation or ending implantation very early, 'conception is prevented' is a typical mischaracterization by implication. The author sought to leave an incorrect impression because it appears to serve an agenda of the author. ... 'Lying to serve the greater good'? Well, let's see ...

Researchers say they still do not know how the pill works. Yet the article states confidently that '... pill prevents conception.' It either delays ovulation or prevents a fertilized egg from attaching to the uterus. If it prevents a conceptus (it is not a fertilized egg, since as soon as fertilization has occurred, a new individual human organism exists, called an embryo or zygote, but not a fertilized egg) from attaching or not remaining attached for life support ... because the conceptus is alive and seeking to survive. Depending on which brand is used and how early it is taken after sex, it prevents pregnancy in 75 to 89 percent of cases. New research shows that it can prevent pregnancy even if taken five days after sex. It may prevent pregnancy from continuing, in the majority of cases, rather than preventing pregnancy from occurring ... and that is yet another example of deceit offered to serve an agenda. Pregnancy is thus assumed to be the phenomenon of a conceptus implanting in the uterine lining or other tissue of the female host body, which of course is in contradiction to assertions and assumptions offered in other portions of the article. I detect an agenda the author wishes to serve.

[MHGinTN]

ping-kaching

[TxBec]

fertilized egg = "the accident"

[MeekOneGOP]

Thanks for the ping. I heard this mentioned on the radio this morning on the way back from Bally's.

[NYFriend]

So you don't carry a spare tire in your car?

I admit that these girls are irresponsible, but I don't want them to have kids either.

The real big issue in my mind is that, since we don't know how this pill works, we don't know for sure that it isn't causing an abortion. If it prevents an egg from being released from the ovum, then it falls outside of the Catholic Church's definition of abortion. We don't know.

[MeekOneGOP]

Morning-After Pill May Go Over the Counter

Excerpt:

For years, public health advocates were frustrated that most women did not know about a drug that could prevent pregnancy even if taken several days after sex.

Its potential to reduce the abortion rate was enormous, and opponents of abortion generally did not oppose it. But that potential was unrealized, largely because the two companies distributing the drug in this country were so tiny that they could barely afford advertising. People who did know about it often confused it with RU-486, the abortion pill.

But in the last year, so-called emergency contraception has started to come out of the shadows. Three million doses of one pill have been sold since 1999, and the maker of another says its sales increased 50 percent last year.

On Thursday, New Mexico became the fourth state to allow pharmacists to dispense the drug directly to women, enabling them to avoid trips to a doctor for prescriptions. Legislators or pharmacists in at least 14 states are agitating to do the same.

One company that sells the pills, the Women's Capital Corporation, has applied to the Food and Drug Administration for permission to sell them over the counter. The other, Gynetics, says it, too, expects its product to be sold over the counter by the end of next year.

The president of Women's Capital says she is in discussions with several large drug companies about buying the drug once it is approved for over-the-counter sales, which would put advertising and distribution might behind it.

Please let me know if you want ON or OFF my General Interest ping list!. . .don't be shy.

[xsmommy]

i am pretty sure that it is an abortificant. it destroys a fertilized egg, and is definitely against the Catholic church teaching.

[Redwood71]

This is the liberal replacement to teaching morals in the schools, after the government stopped it saying "church and state" because they donated less than 5% of the school budgets nationally.

Isn't it wonderful that the consumation of love can be replaced for a virgin 14 year old by a get out of jail free card so they can find something to do on a Saturday night? So much for the virtues of wearing white.

[Beck_isright]

The ultimate male birth control method:

Make your wife wear a Rosie O'Donnell mask to bed every night.