Posts filed under Emergency Contraception

Change You Can Believe In (Vol. III, No. 12): Emergency Contraception.

From the New York Times (December 7, 2011). Boldface mine, for the parts that feel like getting kicked right in the stomach.

WASHINGTON — For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season.

The contraceptive pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and they still will because of the decision by the health secretary, Kathleen Sebelius. If taken soon after unprotected sex, the pill halves the chances of a pregnancy.

Although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so, an F.D.A. spokeswoman said… .

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Until now.

Ms. Sebelius’s decision on an emotional issue that touches on parental involvement in birth control for teenage children is likely to have powerful political reverberations. Scientists and politicians have been at odds for years over whether to make Plan B available over the counter. The Bush administration at first rejected over-the-counter availability for women of any age, but ultimately allowed it for women 18 and older. After a federal court order, the Obama administration lowered the age to 17 in 2009.

With Ms. Sebelius’s decision on Wednesday, the Obama administration is taking a more socially conservative stance on Plan B, one closer to that of the Bush administration than to many of its own liberal supporters … .

For Dr. [Margaret] Hamburg [head of the Food and Drug Administration], the studies and experts all agreed that young women would benefit from having easy access to the pill and did not need the intervention of a health care provider. The agency’s scientists, she wrote, determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.

… Dr. Susan Wood, a former F.D.A. assistant commissioner who resigned in 2005 to protest the Bush administration’s handling of Plan B, said that there were many drugs available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

Acetaminophen can be fatal, but it’s available to everyone, Dr. Wood noted. So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?

… The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have endorsed over-the-counter access to emergency contraception. Plan B was approved in 1999 as a prescription-only product, and it initially had few sales. In 2003, advocates filed an application for over-the-counter sales.

An expert advisory committee recommended approval, and scientists within the Food and Drug Administration unanimously supported that recommendation. Their rationale was simple: women can decide on their own when they need to take it, the drug is effective and its risks are minimal — particularly compared with pregnancy. But in a highly unusual move, top agency officials rejected the application because, some said later, they feared being fired if they approved it.

The agency delayed reconsideration for years despite promises by top Bush administration officials to do so. Then in 2006, the Bush administration allowed over-the-counter sales to women 18 and older but required a prescription for those 17 and younger. In 2009, the F.D.A. lowered the easy-access age limit by a year after a federal judge ruled that its decision had been driven by politics and not science.

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Progressive Pro-Choice Peace President Barack Hussein Obama would like the Washington Post to know that he didn’t do it. He didn’t do it, but he dug it.

President Obama said Thursday that he supports his administration’s decision to block unrestricted sale of the morning-after pill to people younger than 17, a move that dismayed women’s advocates when it was announced by Health and Human Services Secretary Kathleen Sebelius.

Sebelius said Wednesday that she had overruled the Food and Drug Administration, which had decided to make the contraceptive available to people of all ages directly off drugstore and supermarket shelves, without a prescription.

Obama said he did not get involved in the decision to require a prescription for girls 16 and under before it was announced, leaving it up to Sebelius.

But, he said: I will say this. As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.

And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old, going to a drug store, should be able to, alongside bubble gum or batteries, purchase a powerful drug to stop a pregnancy, Obama said. I think most parents would probably feel the same way.

— Rob Stein and Anne E. Kornblut, Obama defends administration’s refusal to relax Plan B restrictions, The Washington Post (Dec. 8, 2011).

Especially parents who are trying to win a political election. I wonder if they bothered to ask an 11-year-old girl, who is afraid of becoming pregnant, how she feels about it?

About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, Sebelius said.

— Rob Stein and Anne E. Kornblut, Obama defends administration’s refusal to relax Plan B restrictions, The Washington Post (Dec. 8, 2011).

Therefore, the state should ensure that the youngest girls of reproductive age are forced to get pregnant.

Back in the New York Times:

Norman Ornstein, a resident scholar at the American Enterprise Institute, said the Obama administration may be trying to assuage Catholic bishops and others angered in recent weeks by a decision requiring that health insurance programs created under the new health reform law offer contraceptives for free.

I think they’re trying to create some political balance, Mr. Ornstein said.

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Yes, a balance. Marvel as President Obama, liberal voters and the Catholic Bishops defy gravity in a spectacular balancing act! Right on top of a terrified 12 year old girl’s body.

This decision is inexcusable. And what makes it even worse is having to watch to the newsmedia calmly discussing the political calculations that went into it, as if what really mattered here had nothing to do with the lives affected by this decision, with the girls who have to live in fear of an unwanted pregnancy because their access to basic medical treatments has been regimented and sacrificed for the sake of a Democratic politician’s political prospects — as if what was really worth discussing was whether that palavering creep and the rest of his administration will be able to effectively exploit this regulatory backstab to increase their chances at holding onto political power for another four years. There are no English words for just how contemptible this shameful display is.

See also:

Let the hand-wringing begin

Nobody likes to have an abortion, and nobody would like to have one even under the best of conditions. Things are much better now than they were in the dark days of back-alley butchers; and they could be made much better yet if it weren’t for miles of punitive regulations and red tape made with the explicit purpose of making abortions harder for legally vulnerable women to obtain. But even without the cultural bullies and screaming protestors, even without the government-imposed cartel costs and the intense curtailment of options for procedures, your choices would still in the end be between invasive surgery of some form or another or drugs that make you nauseous and bleeding over the course of a few days. Of course abortion is not the horrendous experience that anti-choicers repeatedly make it out to be; it is far safer and quicker and easier on both patient and provider than nearly every other kind of surgery that there is. It’s safer and less psychologically taxing than giving birth. (Somehow these comparisons don’t seem to get made very often by either the anti-choice leadership or their foot soldiers. How strange.) But root canals are very safe and relatively simple too; that doesn’t mean that anyone is excited to have one.

But so what? Nobody goes around talking about the terrible tragedy of root canals either, or about the need to reach across the divide to unite with the anti-root-canal community (I take it that there are some Christian Scientist types who oppose dental surgery out of deeply felt religious conviction) in order to prevent unwanted tooth decay. Nobody feels the need to prefix every remark about their support for the right to get a root canal with a half-hour of qualifications and apologies. Yet the Party Hack wing of the Democratic leadership seems to have decided, yet again, that this is just what they need. Here, for example, is how Hillary Rodham Clinton decided to celebrate the anniversary of one of the greatest political triumphs for women’s liberation in recent history:

In a speech to about 1,000 abortion rights supporters near the New York State Capitol, Mrs. Clinton firmly restated her support for the Supreme Court’s ruling in Roe v. Wade, which legalized abortion nationwide in 1973. But then she quickly shifted gears, offering warm words to opponents of legalized abortion and praising the influence of “religious and moral values” on delaying teenage girls from becoming sexually active.

There is an opportunity for people of good faith to find common ground in this debate — we should be able to agree that we want every child born in this country to be wanted, cherished and loved, Mrs. Clinton said.

Her speech came on the same day as the annual anti-abortion rally in Washington marking the Roe v. Wade anniversary.

Mrs. Clinton, widely seen as a possible candidate for the Democratic Party’s presidential nomination in 2008, appeared to be reaching out beyond traditional core Democrats who support abortion rights. She did so not by changing her political stands, but by underscoring her views in preventing unplanned pregnancies, promoting adoption, recognizing the influence of religion in abstinence and championing what she has long called teenage celibacy.

She called on abortion rights advocates and anti-abortion campaigners to form a broad alliance to support sexual education — including abstinence counseling — family planning, and morning-after emergency contraception for victims of sexual assault as ways to reduce unintended pregnancies.

We can all recognize that abortion in many ways represents a sad, even tragic choice to many, many women, Mrs. Clinton told the annual conference of the Family Planning Advocates of New York State. The fact is that the best way to reduce the number of abortions is to reduce the number of unwanted pregnancies in the first place.

Most of this is true enough, as far as it goes. Nobody wants abortion instead of widesperad contraception and responsible sexual education. Nobody likes to get an abortion. And in the present political and cultural climate, all too many women are made to feel far worse about their decision to have an abortion than should be. Fine. But the latter isn’t an unchangeable given; it’s a political fact that is enforced by a constant and intentional climate of harassment and intimidation. And the fact that we’d rather women were able to avoid unwanted pregnancy in the first place is no reason to spend hours hand-wringing over it and apologizing for it unless you already think that there’s something wrong with getting an abortion. But why should you think that?

Actually, there is one other reason that you might do all that hand-wringing. You might be cavilling in spite of your own beliefs because you think that kind of dissembling is politically useful. I hate to say it about Hillary — she gave such a great speech at the March and all — but it’s hard to know what else to conclude about this particular strategy:

Mrs. Clinton’s address came as the Democratic Party itself engages in its own re-examination of its handling of the issue in the wake of Senator John Kerry’s loss in the presidential race.

Democratic senators such as Harry Reid of Nevada and Dianne Feinstein of California have also pressed for a greater focus on reducing unintended pregnancies, and some Democratic consultants have urged that party leaders mint new language to reach voters who identified moral values as a top issue for them in last November’s election.

Jesus Christ people. Look. No. Just, no.

First, you’re not trying to mint new language. You’re repeating the same crap that you did for the past 12 years. Here, for example, is how Electable John Kerry answered questions on abortion during the second and third debates:

Mr. Schieffer Senator Kerry a new question for you. The New York Times reports that some Catholic archbishops are telling their church members that it would be a sin to vote for a candidate like you because you support a woman’s right to choose an abortion and unlimited stem call research. What is your reaction to that?

Mr. Kerry I respect their views. I completely respect their views. I am a Catholic. And I grew up learning how to respect those views, but I disagree with them, as do many. I believe that I can’t legislate or transfer to another American citizen my article of faith. What is an article of faith for me is not something that I can legislate on somebody who doesn’t share that article of faith. I believe that choice, a woman’s choice is between a woman, God and her doctor. And that’s why I support that. Now I will not allow somebody to come in and change Roe v. Wade. The president has never said whether or not he would do that. But we know from the people he’s tried to appoint to the court he wants to. I will not. I will defend the right of Roe v. Wade.

Now with respect to religion, you know, as I said I grew up a Catholic. I was an altar boy. I know that throughout my life this has made a difference to me. And as President Kennedy said when he ran for president, he said, I’m not running to be a Catholic president. I’m running to be a president who happens to be Catholic. Now my faith affects everything that I do and choose. There’s a great passage of the Bible that says What does it mean my brother to say you have faith if there are no deeds? Faith without works is dead. And I think that everything you do in public life has to be guided by your faith, affected by your faith, but without transferring it in any official way to other people. That’s why I fight against poverty. That’s why I fight to clean up the environment and protect this earth. That’s why I fight for equality and justice. All of those things come out of that fundamental teaching and belief of faith. But I know this: that President Kennedy in his inaugural address told of us that here on earth God’s work must truly be our own. And that’s what we have to - I think that’s the test of public service.

And before that in the second debate:

DEGENHART: Senator Kerry, suppose you are speaking with a voter who believed abortion is murder and the voter asked for reassurance that his or her tax dollars would not go to support abortion, what would you say to that person?

KERRY: I would say to that person exactly what I will say to you right now.

First of all, I cannot tell you how deeply I respect the belief about life and when it begins. I’m a Catholic, raised a Catholic. I was an altar boy. Religion has been a huge part of my life. It helped lead me through a war, leads me today.

But I can’t take what is an article of faith for me and legislate it for someone who doesn’t share that article of faith, whether they be agnostic, atheist, Jew, Protestant, whatever. I can’t do that.

But I can counsel people. I can talk reasonably about life and about responsibility. I can talk to people, as my wife Teresa does, about making other choices, and about abstinence, and about all these other things that we ought to do as a responsible society.

But as a president, I have to represent all the people in the nation. And I have to make that judgment.

Now, I believe that you can take that position and not be pro-abortion, but you have to afford people their constitutional rights. And that means being smart about allowing people to be fully educated, to know what their options are in life, and making certain that you don’t deny a poor person the right to be able to have whatever the constitution affords them if they can’t afford it otherwise.

That’s why I think it’s important. That’s why I think it’s important for the United States, for instance, not to have this rigid ideological restriction on helping families around the world to be able to make a smart decision about family planning.

You’ll help prevent AIDS.

You’ll help prevent unwanted children, unwanted pregnancies.

You’ll actually do a better job, I think, of passing on the moral responsibility that is expressed in your question. And I truly respect it.

Apparently the apparatchiks have decided that there isn’t enough hand-wringing and pandering to the sensibilities of the Religious Right there. I don’t know how you could add any more hand-wringing and searching for “common ground” with the Christian Right there without the references to a woman’s right to an abortion disappearing entirely, but there you have it.

Guess what? It didn’t work then and it won’t work now. Why in the world do they think that it would? Are they trying to win votes from the Christian Right? Do they honestly think that moving the political debate over reproductive freedom back from abortion to the Sanger-era fights over birth control and sex education is going to improve the political climate in this country?

In other words: stop treating the right to abortion like you treat free speech rights for the Klan. If you don’t think there’s anything wrong with abortion then quit hemming and hawing forever about how much you respect the position of people who do and how much you’d like to work with them on birth control. You’re wasting your time: a lot if not most ofthem also hate birth control and sex education anyway. And in the process of wasting your time you are also dissembling about your real motives and spitting on women’s struggle for freedom.

Incidentally, Rox, among the reasons I like Howard Dean as much as I do is that in the heat of an election, this is how he answers a question about abortion:

Diane Rehm: We have seen reports that builders across the country are refusing to participate in the construction of Planned Parenthood buildings. What would you do about the threats to freedom for a woman to choose?

Howard Dean: Well, I think that’s a very dangerous game those builders are playing, especially in the city of Austin, which is where it’s going on. Were I down there I would immediately refuse to do business with any of the contractors who were boycotting that. So all groups can play that game; you have the right-wingers playing the game today, but other groups who may disagree with that can also play that game. And I think that’s a mistake for them to do that.

I am pro-choice. I’m a doctor; I frankly believe that it’s none of the government’s business to interfere in a woman’s making decisions about her own healthcare. And I tend not to be very supportive of efforts to enforce political points of view on individuals’ healthcare, and that’s what’s going on in Austin, Texas.

On the Diane Rehms show, WAMU, 2004-12-01 10:00am (they don’t seem to have a transcript; the question is around 45’45” on the audio version)

Elsewhere he’s also directly, and without apology or cavil, taken on both parental consent restrictions and late-term abortion bans, and pointedly insisted that on the issue of abortion, We can change our vocabulary but I don’t think we ought to change our principles..

Second, even if this were a new tack, and even if there were any reason to believe that it would get anything worth accomplishing accomplished, why would you think that women’s control over their own bodies is an acceptable bargaining chip? Women are not pawns to be sacrificed for better board position. Lots of Democrats bolted the party in the late 1960s to become Republicans because the national leadership would no longer keep silent about Jim Crow and the efforts of efforts such as the Mississippi Freedom Democratic Party finally broke the Eastland-Wallace white supremacist stranglehold on the Southern state parties. That lost the Democrats a lot of voters. The difference even lost them several elections. So what? Does anyone think that it would be a good idea to endlessly fret about how to reach out across the divide and find common ground to bring the Klan vote back into the party?

To hell with that. If you’re going to get hung up on winning political office, this is not how you should be trying to do it. Falling back on the apparatchiks and electable candidates using electably mealy-mouthed rhetoric doesn’t work and it wouldn’t have gained anything worth winning even if it did. Meanwhile, the other side won’t believe it, your side won’t pull out the stops for you, and the people in the middle won’t know where the hell you actually stand.

If Democrats are looking for new language with which to frame the abortion debate, I’d like to suggest a good old standard: ABORTION ON DEMAND AND WITHOUT APOLOGY.

Dr. Anarchy answers your mail

A new advice column—sure to be syndicated in a newspaper near you soon. Because everything is simpler when you reject the State as such.

Dear Dr. Anarchy: How could a dangerous provision be signed into law without anyone in Congress actually having read it?

Sincerely,
Worried in Washington

Worried: To be GOVERNED is to be watched, inspected, spied upon, directed, law-driven, numbered, regulated, enrolled, indoctrinated, preached at, controlled, checked, estimated, valued, censured, commanded, by creatures who have neither the right nor the wisdom nor the virtue to do so.

Politicians are never going to stop being irresponsible. That is their job. I suggest that you dump them.

Yours,
Dr. Anarchy

Dear Dr. Anarchy: My pharmacist is refusing to fill prescriptions for emergency contraception because he’s a sexist prick. What can I do?

Truly,
Bristling in Britain

Bristling: Your pharmacist only has the power to be a slimy control freak because a bunch of politicians—most of them men—have given him exclusive control over whether or not you and your neighbors can get needed medicine—by banning you from buying it over the counter. I suggest that you dump them immediately.

Yours,
Dr. Anarchy

Dear Dr. Anarchy: We have reached the point where serious lawyers are being paid serious fees by a big company to shut down the PB&J operation of a grocery store. How can we fix a broken patent system?

Sincerely,
Flummoxed in Florida

Flummoxed: Abolish it.

Sincerely,
Dr. Anarchy

Dear Dr. Anarchy: Can this marriage be saved?

Yours,
Hopeful at the Home Journal

Hopeful: No. Marriage can’t be saved. Abolish it.

Yours,
Dr. Anarchy

Next week: Dr. Anarchy answers your tax questions!

EC OTC in OZ

Update: fixed typos and relocated the Extended Entry into the main text.

Here’s some more good news on the Emergency Contraception front: while the FDA process has advanced to the point where EC will probably be available over-the-counter sometime or another soon, Australia is quickly moving one step ahead of the United States: Emergency Contraception is set to become available over-the-counter in Australia tomorrow, January 1.

This isn’t to say that Australia’s EC situation is advanced over that of the United States in every respect. One major difference is that whereas the medical community in America largely supports the FDA’s move towards OTC availability, the medical community in Australia is at best nervous about the move, and in some cases directly opposed. The main issue for them, though, seems not to be the sort of religious Kulturkampf that flares around the American side of the debate. Rather, Australian doctors just seem to be more accustomed than American doctors to controlling the medical lives of their patients, and more jealous at giving up that power. For example, consider this Foucaultian bit of paternalism:

But Australian Medical Association president Bill Glasson said he was concerned that pharmacists were not legally required to record a woman’s visit.

I think that they really need to rediscuss how it is going to operate in the interest of good medical care, Dr Glasson said.

The pharmaceutical society’s national president, Jay Hooper, said many pharmacists would take it upon themselves to record each time a woman wanted the pill.

Not that American doctors don’t also sometimes engage in this tracking and scummy hectoring. At the Auburn University Student Health Center, for example, you could obtain EC—but they’d note when you got it, throw a bunch of red tape in your way, and if I recall correctly, they’d only let you have it once a semester. (The idea in both cases is for doctors to be able to lecture women that they decide are making unhealthy lifestyle choices. I am all for encouraging women to make healthy lifestyle choices, but I can’t imagine that an emergency situation to prevent a pregnancy is the appropriate time to do it, or that forcing women to listen by restricting access to EC until you’re done lecturing them is the appropriate way to go about it.) But the American medical community does not seem particularly squeamish about giving up that control if it means that women are more able to prevent unwanted pregnancies: the American Medical Association and the American College of Obstetricians and Gynecologists both lobbied for, and strongly supported, the FDA advisory panels’ decision. In Australia, however, the Australian Medical Association seems nervous and is ready to develop their own house guidelines to try to minimize the freedom it will offer women.

I don’t think, incidentally, that the attitude is a matter of misogyny, exactly. But it is directly connected to patriarchy—it’s a matter of the authoritarian sense of entitlement that modern doctors have always felt and acted out vis-a-vis their patients. The condition exists in Australia and America both, but with regard to over-the-counter pills the Australian medical community seems to have divorced itself from it less than their American counterparts. Consider: at the same time as EC becomes available over the counter for the first time in Australia, so will ibuprofen. And this has caused no small degree of consternation for the Australian Medical Association:

Also from Thursday stronger pain relief medication will be available in supermarkets, a move that has angered and confused doctors and pharmacists. Dr Glasson said the pain killer ibuprofen, contained in products including Nurofen, should only be sold under the supervision of pharmacists. It’s a dangerous move and it’s a backward step.

Patients have to look at the medical aspects of these drugs and get good advice that only the friendly pharmacist can give. Paracetamol is much kinder on the stomach.

Ibuprofen, an anti-inflammatory drug, was only available in pharmacies until the Government ratified the new regulations in October.

Products containing ibuprofen have been available in supermarkets in the US since 1984 and in Britain since 1996.

The teeming masses of Ozzies will now be able to buy Advil without a doctor’s learned advice! O tempora! O mores!

But however the doctors and pharmacists may whine, the women of Australia have every reason to celebrate. A happy New Year’s to the reproductive rights community in Australia — good show!

Signs and Portents for EC OTC

Good news this month for women’s reproductive freedom! The widespread availability of emergency contraception (EC) is one of the main breakthroughs for women’s reproductive freedom in the past 10 years. So it’s even better to see that two advisory panels of the FDA recently voted to recommend that EC be made available over-the-counter without the need for a doctor’s prescription. You need to take EC within 72 hours of unprotected sex for it to prevent an unwanted pregnancy, and it gets less effective as time goes on; waiting around for a doctor and a pharmacy are not always a viable option. And there is no possible case to be made that it fails the FDA requirements for over the counter availability. Drugs are supposed to be made available OTC when (1) it is safe to use without a doctor’s supervision, and (2) the instructions are simple enough for self-medication based on the included instructions. That EC is safe, and doesn’t need close observation from a doctor, has been made obvious by all the scientific data and by the past 30 years of experience with both off-label uses of conventional oral contraceptives, and dedicated morning-after pills like Preven and Plan B. How about the simplicity of use? Well, here I’ll defer to Connie Schultz, who investigated the matter for the Cleveland Plain Dealer:

Still, … I thought it only fair that I try to decipher them for myself. The kind folks at Planned Parenthood of Greater Cleveland gave me a sample packet. To make it as difficult as possible, I imagined being a sexually active teenager who had abstinence-only sex education.

Would I, could I, understand what I was reading?

Instruction No. 1: Take the first tablet as soon as possible within 72 hours of unprotected sex.

Instruction No. 2: Take the second tablet 12 hours after you take the first tablet.

I think we women can handle it.

This is some great news. Unfortunately, it is only a promissory note for things to come: the FDA nearly always follows the recommendations of its advisory panels, but even if it is pretty sure that it will make EC over the counter, it is entirely unclear when it will do so. The Bush Administration’s FDA has a long record of foot-dragging on this issue, and it has taken two years of untiring activism to get to this point — quite in spite of the fact that the petition obviously meets all the relevant criteria. But the most recent events are a victory to be celebrated, and the light at the end of the tunnel is now in sight.

Now, here’s a question: chemically, Emergency Contraception is indistinguishable from a large dose of conventional oral contraceptives; dedicated EC drugs were developed based on a good 30 years’ worth of doctors’ off-label recommendations for using OCs. (If a patient needed emergency contraception, the doctor would offer a prescription for OCs and suggest that the patient take several at once.) So if safety and ease-of-use arguments show that EC meets the FDA’s requirement for over the counter drugs, then a fortiori they ought to show that the good old birth-control pill meets those requirements too. So while we work towards getting the government out of women’s medical decisions for the morning-after pill, why shouldn’t we also start thinking about a campaign to get the government out of women’s medical decisions for the conventional birth-control pill too?