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« Rockstar's Challenge The RantsCatching Up: On Katrina, William, John, John and Jon »

More Stupid Excuses from the FDA
2005.09.01 (Thu) 14:36

We saw yesterday that the FDA has once again failed to make the morning after pill available without a prescription. According to ABC News:

The FDA on Friday postponed indefinitely its decision on whether to allow the morning-after pill, called Plan B, to sell without a prescription. The agency said it was safe for adults to use without a doctor's guidance but said young teenagers still needed a prescription and that it couldn't determine how to enforce an age limit a decision contrary to the advice of its own scientific advisers.

...

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.

...

Plan B opponents, who consider the drug tantamount to abortion and have intensely lobbied the Bush administration to reject over-the-counter sales, praised [FDA Commissioner Lester] Crawford's move, saying easier access to emergency contraception may encourage teen sex.

But contraception advocates called Friday's action a case of politics trumping science, saying easier access to the pills could halve the nation's 3 million annual unintended pregnancies. FDA's scientists say the pills are safe, used by more than 2.4 million Americans and millions more women abroad with few side effects, and in December 2003 the agency's scientific advisers overwhelmingly backed over-the-counter sales for all ages.

FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Maker Barr Pharmaceuticals reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor's note saying an age limit could be enforced just as it is for sales of cigarettes.

The drug has no effect if a woman already is pregnant. It works by blocking ovulation or fertilization, or possibly by interfering with implantation of a fertilized egg into the uterus, the medical definition of pregnancy.

Let's break this down. Reasonable people can disagree about whether minors should have access to this medication without a prescription. So, setting that aside for a moment, why the hell wouldn't the second application — which asked for a scenario in which adults can buy the medication over-the-counter and minors would still need a doctor's permission — be granted? The FDA's own science advisors are clearly saying that the pill is safe for all ages, so what's the problem?

Of course, the "problem" for opponents of the pill isn't physical, but rather spiritual. Some of them seem to view taking this pill to be the same as an abortion. However, the fact that the pill does nothing if pregnancy has already occurred makes their point not only irrelevant to an FDA policy decision (since abortions are legal), but also patently incorrect.

Then there are those who seem to think that, like other birth control devices such as condoms, access to this pill will incite teens to have sex. Wake the fuck up, people. Minors are having sex, and will continue to do so no matter what forms of birth control are or are not available to them. Instead of living in a world of denial, how about we focus on reality? For example, the reality that since minors are already having sex, access to this pill could prevent them from also becoming pregnant.

Look at it this way: if a prescription was required to buy condoms, do you think the use of condoms would increase or decrease? We're willing to bet that fewer people would go through the trouble, expense, and/or embarassment of asking their doctors for condoms. And if the use of condoms decreased, we're willing to bet that instances of unwanted pregnancies would increase as a result. Continuing to mandate prescriptions for the morning after pill perpetuates a similar situation.

In addition, you only have a 72 hour window from the time that you perform the horizontal bop in which to take this pill. Which is more likely to fit within such a window: walking into a pharmacy and buying the pill, or scheduling an appointment with your doctor and getting a prescription, then walking into the pharmacy and buying the pill? This can be further complicated by the jungles of red tape and bureaucracy that many health care providers now make people wade through in order to fill a prescription. For example, some providers make it prohibitively expensive to get prescription medications in person, and instead push their users to order online. All of these factors just make it harder for a woman to procure and use in a timely manner a medication that has been deemed to be both safe and effective.

Now, reasons such as these for stifling methods of birth control are old hat to us — we've heard them from the religious nutbags for years now. However, the FDA is breaking out a new excuse — they can't determine how to enforce an age limit. They can't determine how to enforce an age limit?! Is it just us, or is that the most pathetic load-of-crap excuse imaginable?

There are currently age restrictions in place for both tobacco and alcohol products. If we're trying to stop minors from purchasing this medication without a doctor's authorization, why wouldn't the same system be put in place for this pill? And before someone reminds us that the age restrictions for tobacco and alcohol are far from perfect in their application, we'll remind that imaginary person that such lapses haven't caused those products to be pulled from the market until a foolproof system is designed. We'll also throw in the fact that, since this pill has been determined to be medically safe, it is certainly less harmful than both tobacco and alcohol, so lapses in the pill's age restriction policy wouldn't be nearly as harmful as allowing minors to purchase beers and butts.

Due to this frustrating stance by the FDA, Susan Wood, the Director of the FDA's Office of Women's Health, has resigned her position. Her statement said:

"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," wrote Wood, who also was assistant commissioner for women's health. "The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health."

While we certainly support Susan Wood's decision, we can't help but be depressed that the net result is the loss of a voice of reason within the FDA.

So, to recap, the morning after pill has been tested and deemed safe for all ages by the FDA's science advisors. It isn't the same as an abortion, which is a legal procedure anyway, since it doesn't work after conception has taken place. Minors are having plenty of sex without access to this medication, and they will continue to have sex no matter what the future holds for this pill. This pill has an 89% effective rate which could put a huge dent in the three million annual unwanted pregnancies. Such a step would certainly lower the demand for actual abortions, which are more invasive and more costly. Similar age restrictions already exist for alcohol and tobacco products, so determining a system to restrict sales to minors is not an issue. The use of this medication is time-senstive, and removing the need for a prescription would result in more women getting the medication in time to prevent pregnancy.

Given all this information, the FDA has still decided to cozy up with the religious right by denying an effective and valuable medication to American women, and in the process, they have forced out their own Director of Women's Health.

Lovely.


— • —
[  Filed under: % Civil Liberties  % Government & Politics  % Religion  ]

Comments (17)

Grendel, 2005.09.01 (Thu) 21:17 [Link] »

Well, in the interest of fairness there exists a bit of an argument in their favor they're not even using, so I'm going to type in a whisper so the religious right doesn't pick this up as one of their arguments......shhhhh.

When adolescents engage in sex and want to use protection, they currently use condoms, if anything. If the 'morning after' pill were available they most likely would not use condoms. Both prevent pregnancy at an acceptable rate, but only one also guards against the HIV virus and other STDs. Shhhhhhhhhhh.

This appears to be a case where the religious right knows they have no substantive argument against Plan B and have confabulated reasons, but their real motive is to not allow any incremental move towards reproductive freedom. They fear allowing Plan B is a crack in that wall, and will eventually lead to nonprescription availability use of the new contraceptive by sexually active adolescents.

Personally, when I was 16 years old I found that my hulking 6'5" 250 lb frame and Motor City Madman hair to be a highly effective pregnancy preventative -because it was an effective sex preventative.

[[[sigh]]]



Mongrel, 2005.09.02 (Fri) 04:25 [Link] »

Grendel- some counselling from the pharmacist whilst filling the script should ease that a little. As long as the recipients are aware that 'plan B' is the "Oh crap, I did something silly" and that 'Plan A' is in fact responsiblity and a tiny bit of foward thinking (making sure one of you has a pack of condoms).

In opinion is if the schools weren't pressured into not teaching Sex Ed. by exactly the same sort of people who don't want this to go ahead our countries would have alot less unwanted pregnancies and fewer STDs. Teenagers are horny little buggers and if they're not taught acceptable behaviour then it's not really all their fault after all it's easier tho make them HLB with condoms and awareness of morning after remedies than it is to try and stop them being HLBs...



Grendel, 2005.09.02 (Fri) 08:11 [Link] »

American public schools are the last place I want my kids learning sex education. Until they master teaching things like, oh, math, science, English, and history, I'd prefer to handle it myself.

I have 9 kids, from age 7 to 25, and you might not believe the horror tales I could tell you about the American school system.



Rockstar, 2005.09.02 (Fri) 09:50 [Link] »

Gren:

The easy way to prevent this pill used as primary birth control is to educate young women on how it feels to take.

The consensus from your Rockstar's many women (lie) is that it makes you incapacitatingly (is that a word?) sick for several days (true).

P.S - Just checked out your (Grendel's) website for teh first time. In the illustrious words of Eric Cartman: Kickass!



MBains, 2005.09.02 (Fri) 14:19 [Link] »

Rockstar! Dude! You're KIDDIN' me! You just now checked Occam's Daily Shaving site???

LOL!

Good stuff abounds my skeptical hounds.

Uh, hhhmmm, unless you work for the W Regime...



Rockstar, 2005.09.02 (Fri) 15:23 [Link] »

//hangs his head in shame for not having reviewed skeptomaniac before today...//



Tom from the Two Percent Company, 2005.09.02 (Fri) 18:07 [Link] »

The discussion above is why we left it at "Reasonable people can disagree about whether minors should have access to this medication without a prescription." Yes, the best answer is to make it available to everyone (since it's safe) and to ensure that people (including minors) are informed about condoms, safe sex, the morning after pill, and sex in general. However, we understand that kids will be kids, and that there are reasonable arguments for restricting the access of minors.

All that aside, we do not believe that reasonable people can disagree on whether adults should have unrestrcited access to this medication. Sure, adults are also capable of being horrifically misinformed, but that's their own problem to deal with.



Grendel, 2005.09.02 (Fri) 19:00 [Link] »

RE: The Skeptomaniac -Thank you very much! I sincerely appreciate that. I'm inching towards a major revamp and have much new material to add.

BTW, any and all the "usual suspects" that frequent or are in some affiliated with 2% are perfectly welcome to C&P snatch whatever they wish from it.

BTW, did y'all see where McCain has now joined Frist and Bush in recommending that IDiocy be taught along with evolution in American public schools?

The irony is that MIT & Washington U have completed mapping the chimp gene, which, of course, pretty much completes the establishment of evolution, not that there was doubt.

From Bob Park's worthy 'What's New' weekly column:

"4. THE CHIMP: COMPLETE GENETIC MAP CONFIRMS DARWIN'S THEORY.
Scientists at MIT and Washington University, St. Louis, announced Wednesday that they have determined the precise order of the 3 billion bits of genetic code needed to make a chimpanzee. There is only a 1 percent difference from the human genetic code. But for that 1 percent, chimpanzees would have a seat in the UN. Robert Waterston, who led the Washington University team, was quoted in yesterday's Washington Post saying, "I can't imagine Darwin hoping for a stronger confirmation of his ideas."

What's New website:

http://www.bobpark.org/

(Be sure to refer to the very last line on his page the next time someone accuses skeptics and/or scientists of having no sense of humor).



God's Personal Contraception Consultant, 2005.09.04 (Sun) 11:33 [Link] »

If Plan B is just a large does of regular birth control, which is the greatest contraceptive ever, can we take this opportunity to encourage young girls to get a prescription for regular birth control? Then some of them might actually use it as a stash of plan B while others would actually start taking it regularly.



Fan-man, 2005.09.07 (Wed) 16:53 [Link] »

The second application that would give adults the right to purchase the drug over-the-counter should have been approved. Requiring a prescription for a drug that has been deemed "safe for all ages" by the FDA is tantamount to discrimination. If it's safe, it's safe-----put it on the shelves of the local drug store. If a prescription is required, you better have health insurance or not only will you be paying for the drug, you'll be paying an inflated amount of money for an office visit. The decision is discriminating against those who don't have or can't afford health insurance.
The FDA is in bed with the major health care providers and help regulate the industry by limiting profit for the drug manufacturers until the drug's patent is about to expire. You saw the same thing go down with Rogaine and seasonal allergy medications like Claritin. When the FDA lets the drug go over-the-counter, they want the consumer to have choices. The FDA wants parody among the producers. In the meantime, they can slow sales by requiring a prescription.



Grendel, 2005.09.07 (Wed) 20:47 [Link] »

"The FDA wants parody among the producers."

Hah! Candidate for Typo Of The Year?!

(parity)



Fan-man, 2005.09.07 (Wed) 22:21 [Link] »

Yeah, a typo of sorts. I meant "parity" but my mind moves faster than my fingers. Plus, people at work keep interupting me with their technical questions and shit.... what the fuck? I'm ranting over here...



Grendel, 2005.09.08 (Thu) 17:32 [Link] »

Man, I HATE that from co-workers when I'm posting. And my KIDS!

"Daddy, we're hungry.. we haven't eaten since Friday......"

"Dammit! Daddy's BUSY. Find somethign to do!"



Fan-man, 2005.09.08 (Thu) 22:13 [Link] »

I asked Mrs. Fan-man her opinion on the issue with her being, well, a female and all. She had more questions than I had answers. For instance, she asked if "safe for all ages" meant the pill was as safe as taking an aspirin for example. I don't know? She mentioned that if she had a really bad headache, she might be tempted to take more than the recommended dose of pain reliever; that said, if a scared teenager doubled or tripled the dosage to "ensure" effectiveness, would that also be safe? Maybe the FDA is pretty sure, but not absolutely sure. Maybe leaving the drug in the hands of a doctor may help spread out the blame if the captain of the cheerleading squad keels over after mis-using the drug. Think of all the drugs the FDA made available via prescription that have since been rescinded. Diet pills containing ephedra come to mind. Several professional athletes died while taking over-the-counter health supplements containing ephedra before the FDA acted to ban that drug from over-the-counter supplements. Are they gun shy or is there another reason for not making the drug available?

I'm just playing devil's advocate. I think the FDA is feeling moral responsibility they should leave at home.



Mongrel, 2005.09.12 (Mon) 07:57 [Link] »

Fan-man, over here (UK) it'd be expensive to try the "One is good therefore three are better" approach. The pills are sold under a few brands but the main (first to market) was Levonelle - it comes as a single tablet currently retailing at £25 or so. It's free on prescription but Doctors will only prescribe upon demand, if you want a stockpile or a "better safe than sorry" they'll push to more conventional birh control aids.
As I mentioned previously upon request to buy the pharmacist is legally obliged to run through the side effects (minimal), how and when to take and drug interactions. Morally I'd be surprised if most Pharmacists didn't offer counselling and if it was required a suggestion to visit the Family Planning Clinic to get a regular course of 'The Pill'.

More information at Net Doctor



Fan-man, 2005.09.12 (Mon) 11:01 [Link] »

Pharmacists are legally obliged to run through the side effects, possible interactions and the how/when stuff with any drug they prescribe. That's a non issue. The issue at hand is whether or not the FDA deems the morning after pill safe enough to be sold over-the-counter. The morning after pill is essentially the same thing as the daily birth control pill, only in a concentrated dose. Niether one is available over-the-counter in the US. Is the reason medical or moral? A reasonable person would have to think it was a medical reason, since teenage girls can buy condoms without mandatory counselling or a prescription. Morning after pills, regular birth control pills and condoms are all three used to prevent pregnancy-----I was only trying to guess why a prescription is needed for two out of three. Regardless of cost, are the pills safe as aspirin? I'm guessing they don't know or they have a moral issue with the pill's potential availability to youth.



Mongrel, 2005.09.13 (Tue) 04:37 [Link] »

I'd guess at mostly a moral issue. Search this site for Levonelle (can't link directly, sorry) and choose "Levonelle One Step, SPC. Section 4.8 lists the undesirable effects, most of which I would describe as very mild.
As far as I know you need to see a Doctor to get birth control pills so that the appropriate ones can be prescribed. Messing chemically with any persons hormones requires a little trial and error to get maximum efficiency with minimum side effects, not forgetting the regular checkups the Doctor will ask you to attend to make sure there are no longer term reactions.
Personally having seen the arguments over here when OTC 'Morning after' pills were made available it did seem to be thinly disguised Moral Outrage, focussing on the fact that we are just encouraging our youth to throw away what few morals they had left and hang the consequences.




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