new prez + change = science/politics*

Last night, I was delighted to read that a federal judge ruled that the Bush administration was wrong and determined that Plan B (emergency contraception) should be available without a prescription to girls as young as 17. Ok, so the previous age was 18, but still! This is a big step in the right direction. Now, if we can just get Plan B to be truly available over the counter, as opposed to behind the counter and under the judgmental eyes of a pharmacy tech, everything would be awesome!

If you recall, Plan B was held up for OTC approval in the FDA by many Bush cronies who did not want this pill to be available to teens because of the potential for the creation of teen sex cults!!! No, seriously. That was one of the reasons. Their line of reasoning was that, with increased availability to Plan B, teens would not be able to control their raging hormones any longer and engage in wanton (unprotected) group sex and then pop Plan B pills like candy afterwards. This wasn't based on actual facts (naturally, this was the Bush Administration after all) or anything. In fact, studies showed that teens didn't engage necessarily in careless sex if Plan B was available to them. In fact, their sexual habits showed no change.

But we all know that the Bush administration was averse to science and research and facts (global warming is another great example).

After 8 years of anti-science crap, we now have a president who does not place politics over science. Last month, the new administration worked to remove one of Bush's last acts known as the Provider Refusal Rule. Essentially, the Provider Refusal Rule or "Conscience Clause" (was written to be incredibly ambiguous and open to interpretation on purpose) allowed for religious ideology in the clinical setting. Under the rule, workers in health-care settings -- from doctors to janitors -- can refuse to provide services, information or advice to patients on subjects such as contraception, family planning, blood transfusions and even vaccine counseling if they are morally against it.

For example, if a clinician felt uncomfortable providing birth control or a Plan B prescription or the HPV vaccine, it was within his/her right to refuse to provide it to their patients. The thing is that judgment has NO place in health care, especially religious judgment. If you have a problem dispensing birth control (but not Viagra), then don't be a pharmacist. Don't want to perform an abortion if the mother's life is in danger? Well, then maybe you shouldn't be an OBGYN.

It's the same thing outside of health care. Do you hate Latinos and think gays should burn in hell? Then you wouldn't want my job. So why was the health care field specifically targeted in the Conscience Clause? Because of abortion, of course!

As a public health geek, it is so refreshing to have a president who thinks sound science should be the basis for policy as opposed to religious ideology. The NY Times piece above quoted Dr. Susan Wood, former director of the Office of Women's Health at the FDA who resigned because she didn't want to be part of Bush's morality militia. She commented, "There is a new chance to restore the scientific integrity of the F.D.A.”

Oh God I hope so.

*the title should be read as: new president plus change equals science over politics.

the war on birth control

Back in July, I wrote a little post on the war against contraception. It was a reaction to the lawsuit brought on by the Center for Reproductive Rights against the Food and Drug Administration to force them to make Plan B (aka “emergency contraception) available over the counter for women of all ages. Even though Plan B has already been made available “behind the counter” without a prescription, it is not available to teens without a prescription. Teens have a much higher rate of unplanned pregnancy than adults.

I’m reposting because a war against all contraception is being waged and the time to fight back is next Tuesday at the polls. I understand that there are other pressing issues to think about when voting—illegal immigration, the war in Iraq, gas prices, gay marriage. But as a female voter, I am compelled to think about just how much power the government has over me and what I choose to do in the privacy of my bedroom.

the fight against birth control is a fight against women

Just a warning, I’m feeling a soapbox moment coming on. Yesterday, a co-worker passed along an editorial from the New England Journal of Medicine--Plan B, Reproductive Rights, and Physician Activism by Rebekah E. Gee, MD, MPH. The author is one of two people who brought on the lawsuit against Wal-Mart in Massachusetts for refusing to fill a prescription for Plan B (the morning-after pill which is 75% effective in preventing pregnancy if taken within 72 hours of having sex). The article details her story and we all know how it ends. Wal-Mart is now stocking all of their pharmacies with Plan B (or so they say). Currently, there is a case up in New York against the Food and Drug Administration, who has unreasonably blocked Plan B’s over-the-counter status. The article also mentions a growing anti-contraception movement in the United States (which is definitely felt here in my office). My question is why? Why is this country so against contraception?

The easy answer is to blame the religious right. Their claim that access to contraception promotes sexual promiscuity is baseless (where’s the research?). During the FDA’s Plan B deliberations, there was a concern being passed around that teenagers’ access to Plan B would lead to sex cults. Really? Sex Cults? Come on. In reality, the research shows that access to Plan B does not change the sex habits of teens.

So, the religious right is against contraception and abortion. If they’re against abortion, how do you prevent unplanned pregnancies (which I’m assuming is the reason why women have abortions)? What is the realistic solution to preventing an unplanned pregnancy? Contraception. Yet (according to conservatives) women are not to have access to contraception or abortion. In fact, according to our government, condoms aren’t all that effective in preventing STD’s and pregnancy either. So it would be better to bring in an unwanted child into the world (or possibly put them up for adoption in our over-crowded foster care system)? Or perhaps all women should just wait until marriage to have sex. If you never marry, then you’re shit outta luck.

What about women? It doesn’t seem fair that we let our government dictate what we should and should not do with our own bodies. There is very clear bias against women here. For example, there is no controversy over pharmacists refusing to fill prescriptions for Viagra. The sole purpose of Viagra is to restore men’s sexual abilities, certainly not to procreate in their old age. However, some pharmacists won’t fill prescriptions for birth control because it’s morally wrong. Really now? I don't see any moral "correctness" in Viagra. Frankly, I don’t see anyone campaigning against vasectomies either.

98% of women use contraception (according to data from Planned Parenthood). Perhaps a woman’s first consideration before voting should be her sex life. Sadly, there are people out there who are fighting to make sure we don’t have one.

it's like they took the words right out of my mouth

I was going to write some more about Plan B today. Then I opened up my email today and found the electronic version of the Daily Trojan, one of the best collegiate newspapers out there. In the DT is an editorial from the editors about yesterday's FDA decision. It's short, sweet, and exactly what I wanted to say.

FDA birth pill decision doesn't go far enough

The Food and Drug Administration Thursday approved Plan B, an emergency contraceptive pill, for over-the-counter sale to adults.

Not to be confused with RU-486 - the so-called "abortion pill" that kills off embryos up to two months after conception - Plan B has proven effective in laboratory trials at preventing fertilization, provided it is taken within 72 hours of unprotected sex. And what's more, it's proven to be extremely safe.

So it's logical to assume that the decision-making process regarding its sale without a doctor's prescription was open-and-shut.

Wrong. Instead, Plan B's manufacturer, Barr Pharmaceuticals, unwittingly found itself at the epicenter of an intense, three-year ideological mud-slinging contest, with the Bush administration's conservative base arguing that the drug's free sale would encourage further the dreaded American promiscuity.

When these old-fashioned moral arguments didn't make much of an impact, conservative political action groups quickly produced "research" of their own illustrating the drug's alleged medical danger - though neither legitimate researchers nor the FDA's extensive review process could turn up similar results.

So while the eventual, common-sense decision to approve its free sale should be applauded, it's unacceptable that minors will still be required to get a doctor's prescription to buy the drug.

Indeed, the age restriction, an obvious peace offering to the Christian right, might seem harmless, but will in practice prevent many women under 18 - arguably the group most susceptible to the negative effects of unsafe intercourse, particularly given the state of sex education in America's public schools - from getting help when they need it most.

America long ago strayed from its Puritan roots. And while the morality of teenage sex is still up for debate, that it's occurring in massive numbers is no longer a question.

Forcing our teens - who might need Plan B the most - to jump through the same old hoops merely ensures that what could have permanently alleviated America's teenage-pregnancy problem, will instead sit on the shelf, waiting for another buyer.

cliff notes version of "small victory for Plan B"

Hey peeps,

I apologize for the technical jargon from the previous post. I just got so excited about the news that I only posted the press release without comment from me. My bad. Also, I got the impression from Washington Cube's comment that perhaps a Cliff Notes version of my previous post is needed. So here goes.

Today, the FDA has granted over-the-counter status for Plan B (aka emergency contraception, aka "the morning-after pill") provided that you're 18 years old or over. For those of you living under a rock (if you're a boy, I guess you're forgiven but you should know this anyways), Plan B, if taken within 72 hours of unprotected sex, has an 85% chance of preventing pregnancy.

Now for my opinion (what's that you say? you didn't ask for it? oopsies). This is a big victory for college-aged women everywhere. Back in the day when I was in school, how great would it have been to just walk into a store and pick this stuff up whenever you needed it? On the other hand, it's not technically "over the counter" if you're not letting teens to get it. This means that it will probably be under lock and key at your local CVS, or you may need to ask a pharmacist for it. Who's to say that some 16-year-old who had unprotected sex with her loser boyfriend doesn't have a cool, 19-year-old sister to get it for her? Kinda defeats the true "behind the counter" status, doesn't it? Oh well...whatever you have to do to make your conservative base happy....

What's that you say? The FDA is supposed to be a nonpartisan government agency? Hmmm...how very interesting.

small victory for Plan B

The following is from the FDA:

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
Prescription Remains Required for Those 17 and Under

The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.

Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:

· Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

· Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;

· Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

· Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to OTC use. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package.

The agency remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.

For more information on Plan B and today's action, please see: http://www.fda.gov/cder/drug/infopage/planB/default.htm.

I believe there will be a press conference at noon.