New at Reason

Julian Sanchez | April 7, 2005

Religious pharmacists say dispensing emergency contraception violates their principles; others contend they've got an obligation to fill any legitimate prescription. Kerry Howley wonders why anyone's got to go to a pharmacist for the stuff in the first place.

Comments

|4.7.05 @ 1:41PM|#

Completely glosses over the fact that the drug is not as benign as aspirin. It acts as massive dose of conventional birth-control hormone drugs, and can have serious side effects.

The FDA said: "The sponsor�s application contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old."
You really shouldn't go dumping chemicals that affect reproductive biochemistry into potentially still-developing reproductive systems.

They presented the drug manufacturer with a legitimate concern, which has not yet been addressed. Therefore, the drug will stay off the OTC market.

|4.7.05 @ 2:01PM|#

Completely glosses over the fact that the drug is not as benign as aspirin. It acts as massive dose of conventional birth-control hormone drugs, and can have serious side effects.

Then list the side effects in big bold letters, shut the fuck up, and get out of the way. There are "side-effects" to walking out your front door every morning. You might get hit by a bus. You might have a brain anurism. You might trip and crack your head open. Yet, we don't have to have permission to walk out the front door, do we?

"You really shouldn't go dumping chemicals that affect reproductive biochemistry into potentially still-developing reproductive systems."

Is that really your call to make, or the FDA's? I'm sorry, but the FDA has outlived its usefulness. Cases like this just highlight that fact.

"They presented the drug manufacturer with a legitimate concern, which has not yet been addressed. Therefore, the drug will stay off the OTC market."

What's that "legitimate" concern? The one you listed above, that is hasn't been tested on enough 14-16 year olds? Please. If that's your "concern", then put a big fucking label on the bottle that says "should not be taken by anyone under the age of 17", then, again, shut the fuck up and get out of the way.

The FDA has illustrated, time and time again, that its policies hold up drugs that, if left to the natural checks and balances of the free market, might have saved lives or helped people's situations immensely, while the only ones who would have really suffered adverse consequences are the ones who were too ignorant to heed the warning labels.

Here's the solution, yet again: disband the FDA. Replace it with a small organization which requires drug makers to list any known risks and side effects. Then...you guessed it...shut the fuck up and get out of the way.

But as we all know, that's not gonna happen. Why? Because of genuine ethical concerns? Oh, hell no----it's because of all the entrenched beaurocrats and industry pukes whose livelihoods depend on this regulatory scheme. Doctors need their monopoly on prescribing drugs. Pharmacists need their monopoly on selling them. The pharmaceutical giants need their sweet state-enforced monopoly on producing them (since the FDA's requirements necessitate years of up-front capital for new products that might not produce a profit for many years, small competition is essentially impossible). And the FDA, well, think about how many people work for them. WHy give that up? None of these powerful groups want to sacrifice their gold-mine monopolies. Which is why evil shit like this, and like the Imclone disaster (wherein a post-chemo-recovery drug spent an extra year on the shelves, instead of out on the street saving lives, because of FDA paperwork and red tape, and was reintroduced and approved in the exact same form), happens all too frequently.

|4.7.05 @ 2:05PM|#

Oh right, Jon, I forgot: But it's for the children!

What a bunch of shit. Even if we grant that dubious pretense, it's no reason to deny access to emergency contraception to millions of adult women.

And the rationale itself is just a transparent attempt by the right to keep this off the market, dressed up in the guise of "safety" concerns (Hmmm just like they dress up creationism in the guise of science... do we see a pattern of deception here?).Well I suspect that most of those you pretend to be so concerned for would be pleased to have you mind your own business and let them make their own decisions.

|4.7.05 @ 2:18PM|#

Yet, we don't have to have permission to walk out the front door, do we?

Not yet, but don't tempt them.

And good call Evan! People should take responsibility for their own health.

R C Dean|4.7.05 @ 2:19PM|#

"Emergency" contraception - excellent spin. I hope somebody got a bonus for thinking that one up.

And I say that as someone who thinks this ought to be available to anyone stupid enough (as in, too stupid to use ordinary contraceptives), or irresponsible enough (as in, too selfish to live with the consequences of their decision to have unprotected sex) to need it.

After all, since it has to be taken within 72 hours, it is of no use to those who use ordinary contraceptives, which do occasionally fail, since you don't know they have failed until long after 72 hours have elapsed.

But hey, its a free country. God knows fortunes have been made selling to the stupid and irresponsible before.

|4.7.05 @ 2:19PM|#

Some drugs are prone to abuse -- addictive painkillers, antibiotics (which create superbugs when overused), insulin (which is misused by people with eating disorders). There's an argument for not letting adults buy those OTC. I don't see that argument applies emergency contraception, unless (as is likely) those who oppose making it available OTC view any use of contraception as abusive.

|4.7.05 @ 2:23PM|#

Then...you guessed it...shut the fuck up and get out of the way.

I can always count on Evan Williams' invective to bring a smile to my face, nay, make me laugh out loud.

|4.7.05 @ 2:23PM|#

R C Dean: you've never heard of a broken condom?!?

|4.7.05 @ 2:28PM|#

Some drugs are prone to abuse -- addictive painkillers, antibiotics (which create superbugs when overused), insulin (which is misused by people with eating disorders). There's an argument for not letting adults buy those OTC.

So? Why do we need to protect people from themselves? All drugs should be legal and freely available (at least to adults - just to head off the inevitable clamoring about "children!"). Whatever someone chooses to do with them is no business of yours or mine.

|4.7.05 @ 2:29PM|#

"Oh right, Jon, I forgot: But it's for the children!"

No, it's much worse than that. It's for JEEZ-us!

|4.7.05 @ 2:29PM|#

"you've never heard of a broken condom?!?"

Must not have any experience with Trojan. My one box trial left me wanting to kick some Trojan Man butt. It is almost enough to make you doubt the market.

Seriously, how can they have such a huge market share with that product? I don't understaaannd!

|4.7.05 @ 2:31PM|#

"Some drugs are prone to abuse -- addictive painkillers, antibiotics (which create superbugs when overused), insulin (which is misused by people with eating disorders). There's an argument for not letting adults buy those OTC."

And this argument is spurious. Unless we're talking about true externalities, then it's of no concern that certain individuals don't have enough self-control to refrain from abusing. The only one of those listed above that I care a whit about are antibiotics, because they have a definite external effect on communities as a whole. Quite frankly, the gubmint isn't (shouldn't) be here to protect me from myself, but only to protect me from others.

|4.7.05 @ 2:34PM|#

There are plenty of medications sold over the counter that are potentially harmful to children. Aspirin, for example.

|4.7.05 @ 2:35PM|#

'But hey, its a free country. God knows fortunes have been made selling to the stupid and irresponsible before."

I don't know, R.C., if you never do anything stupid or irresponsible you must lead a boring life.

What is irresponsible to one person is just fun to another - like riding motorcycles for example. They don't call them "donor-cycles" for nothing, yet a lot of people take great pleasure in doing something I might think is stupid or irresponsible. More power to 'em!

|4.7.05 @ 2:36PM|#

The FDA has kept it prescription-only because many in congress are uncomfortable with the concept

I love the way Kerry says that. Not "...because many in Congress believe that the risks outweigh the benefits", not "...because of scientific data showing that this medication needs to be monitored by doctors" but simply because Congress is uncomfortable.

Which is not to say that those other reasons would justify keeping it prescription-only, but at least they would have some rational foundation so you could sort of comprehend it. But instead, well, Congress just feels uncomfortable, so that's good enough!

And I agree 100% with:
The real scandal is not that women are being denied birth control, but that they have to ask for it. There is no reason why a woman's access to contraception should depend on a single Roman Catholic with a conscience, or why a pharmacist should have to weigh the decision between denying a woman her prescription and violating deeply held moral beliefs.

The scenario that I debated with Jennifer a week or two ago, of a rural woman with a puritan pharmacist, is a false dichotomy. Open up other distribution channels and let women and rape crisis centers stock up, so that a single pharmacist no longer has so much power over anybody.

|4.7.05 @ 2:44PM|#

"I love the way Kerry says that. Not "...because many in Congress believe that the risks outweigh the benefits", not "...because of scientific data showing that this medication needs to be monitored by doctors" but simply because Congress is uncomfortable."

Well, given that the scientific advisory board has voted in overwhelming favor of OTC, how could Congress justifiably make either of the two former claims? Are they all scientists? Why even have a scientific advisory board? It seems entirely plausible to say that Congress simply feels uncomfortable with it...given that the scientific board has given it a resounding "yes".

|4.7.05 @ 2:53PM|#

While I'm sort of indifferent either way, there's no way to list an entire medical education on the side of a bottle. End-users have no capacity to diagnose or evaluate themselves for all the sorts of drug reactions, counter-indications, and periodic evaluation needed to take all sorts of drugs.

Now, the reason I wouldn't cry many tears in a perfect world over people buying all sorts of crazy medications and simply proscribing them for themselves is that anyone that stupid probably deserves what happens to them. Unfortunately, it's not a perfect world, and because they'll most likely end up in some emergency room, on Medicaid or whatever, I have to pay for it in the end.

|4.7.05 @ 3:02PM|#

FDA criteria for over-the counter status

As someone who's taken Claritin, I'm curious as to what made it eligible for prescription in the first place, but is now eligible for OTC.

Must be the "new and improved super-safe formula."

|4.7.05 @ 3:32PM|#

As someone who's taken Claritin, I'm curious as to what made it eligible for prescription in the first place, but is now eligible for OTC.

IIRC, HMOs and other insurers sometimes lobby the FDA to give a drug OTC status -- that way they don't have to pay for prescriptions.

|4.7.05 @ 3:38PM|#

After a product has been on the prescription market long enough to have extensive safety data for a large number of patients, manufacturers can request approval to go OTC. Claritin is an exception, in that it was driven by insurance companies who wanted to stop paying for it. Since it was soon to go generic, the Pharma didn't fight very hard. This points out the financial incentives for keeping drugs prescription-only and therefore covered by insurance.

The fact is that there is insufficient data on Emergency Contraception to send it OTC. There are legitimate concerns about women taking this too late, and yielding not contraception, but babies with birth defects.

The FDA has plenty of problems, but surely Vioxx etc demonstrate that the solution is not that it should send things OTC even faster than it does.

Finally, there are product liability concerns that might preclude Pharma from wanting to sell this OTC. With doctor supervision, the Pharma is less exposed to misuse and big tort claims. You can't force Pharma companies to offer these drugs over the counter.

|4.7.05 @ 3:42PM|#

One other important factor to note about the prescription to OTC switch - pharmas get 'rewarded' with extended exclusivity in return for taking drugs OTC. So don't be surprised to see a high correlation between the switch and approaching patent expiration dates.

|4.7.05 @ 3:44PM|#

You can't force Pharma companies to offer these drugs over the counter.

Nobody is suggesting that. Just get the FDA out of the situation, and allow the Pharma companies decide for themselves whether they want to risk the liability by going OTC. This is simply not a decision that the central gov't should be making----it should be a decision made by the interested parties, namely, the buyer and the seller.

|4.7.05 @ 3:58PM|#

Well, given that the scientific advisory board has voted in overwhelming favor of OTC, how could Congress justifiably make either of the two former claims? Are they all scientists?

Evan,

When has that ever stopped them? Lest we forget, 3 weeks ago they were making medical diagnoses by watching video snippits.

R C Dean|4.7.05 @ 4:01PM|#

R C Dean: you've never heard of a broken condom?!?

Sure I have. Never experienced it myself, but then I've always tended toward committed relationships with women on the pill.

I don't know, R.C., if you never do anything stupid or irresponsible you must lead a boring life.

Who said I had anything against taking risks and being irresponsible? You've obviously never gotten into the passenger seat of my car for a run to the liquor store.

Remember, I'm all in favor of this stuff being sold OTC! Did you read my post at all? I hope somebody makes a fortune on this stuff! God knows I've parted with enough of my cash being stupid and irresponsible.

I'm just not kidding myself about who will be buying "emergency contraception" and why.

The Wine Commonsewer|4.7.05 @ 4:05PM|#

Evan, I think we have to make a distinction between the reasons why the drug is kept off the OTC trade in the context of modern rules and our libertarian desire to legalize all drugs and dispense with the dispensation of prescriptions.

I'm fine with OTC of everything from Cocaine to Heroin to the morning after pill to Dr. Roy's Tonic--WITH OR WITHOUT warnings or disclaimers.

The Wine Commonsewer|4.7.05 @ 4:07PM|#

Sera, believe me if FDA could regulate Aspirin they would. If it came to market today it would never be approved for OTC use.

And yes, I can assure that you don't want to take a chance and give little kids aspirin. Ever.

Morat|4.7.05 @ 4:08PM|#

"Insufficient safety data" my ass. You'd think EC was a brand new drug (it's not) that's cutting edge in the US (it's not).

I have no idea if it's OTC in Europe or not, but I damn well know that the "morning-after pill" is routinely used in both the US and in Europe enough to know -- pretty damn well -- whether it's safe enough to sell OTC.

The science panel -- the people who we pay to have a fuckin' clue about the matter -- are pretty damn sure it's safe. The politicians, whom we pay to deny reality and send pork home, don't think it is. I know which side I trust.

fyodor|4.7.05 @ 4:17PM|#

Who said I had anything against taking risks and being irresponsible? You've obviously never gotten into the passenger seat of my car for a run to the liquor store.

And if something goes wrong on that trip (and if couldn't, then there's no "risk"), where will they cart you off to? The emergency room, duh. Calling the need for a day-after pill an emergency doesn't say anything in particular about what kind of person is in that situation. Speaking of which...

I'm just not kidding myself about who will be buying "emergency contraception" and why.

Apparently you think of them as some sort of lower class of human. If that's not what you're saying, you're doing a damn good job of misleading us all. And I'd call that attitude smug and classless.

But don't worry, I know you're all for making day-after pills available OTC. You're the one who brought up this other issue.

|4.7.05 @ 4:22PM|#

as far as plan b, or EC goes, most hospitals keep a supply on hand for post-rape kit emergencies.

|4.7.05 @ 4:24PM|#

Lest we forget, 3 weeks ago they were making medical diagnoses by watching video snippits.

There's a very simple way to resolve the issue of how to dispense the morning-after pill:

Bill Frist can watch a short video clip of a woman who experienced side effects, and then report back to us on whether it's safe for OTC use.

|4.7.05 @ 4:29PM|#

Thoreau,

Better to let Delay do the analysis in that case. Although he'd probably prefer a picture of the cell cluster so he could declare it a person, and close the issue.

|4.7.05 @ 4:32PM|#

David-

We could always have Bill Clinton do the analysis. He'd examine some videos, but they'd be of a totally different type. And he'd probably do some field trials as well.

However, he might quibble with the instructions: "Best taken within 72 hours of sexual intercourse." Clinton would demand clarification of what exactly qualifies as "sexual intercourse."

|4.7.05 @ 4:33PM|#

I did not have sexual relations with that clinical trial participant.

|4.7.05 @ 4:52PM|#

This isn't just about emergency contraceptives, either. Just a few months ago, I read that a pharmacist wouldn't fill a woman's regular birth control prescription because of his "moral" objection to it.

Bad enough that she has to visit a gynecologist every freakin' year to make sure she still needs it(what a racket - there goes a co-pay), then has to fight the pharmacist to get it.

How many teenage pregnancies could we prevent if we could just pick this up OTC? Who can ever know? I'm sure my own teenaged daughter would have avoided it if she had been able to get a pill without having to tell me about it.

Just let us have it, for chrissakes! We'll let them know if it's fucking us up with side effects.

Bill Clinton|4.7.05 @ 5:07PM|#

I did not have sexual relations with free form's daughter.

|4.7.05 @ 5:22PM|#

That pharmacist's shouldn't have sole control over birth control distribution doesnt' mean it should be sold next to the candy aisle and tossed about willy nilly.

Centers monitoring and educating about safe use are a great way to go.

|4.7.05 @ 5:47PM|#

"Completely glosses over the fact that the drug is not as benign as aspirin. It acts as massive dose of conventional birth-control hormone drugs, and can have serious side effects."

As opposed to, you know, pregnancy. Which, as we all know, is completely without side effects, hormone doses, and negative outcomes for fourteen year old girls.

|4.7.05 @ 5:50PM|#

joe, I think that is the best argument ever made on behalf of contraceptive pills.

It's a little like the argument for chemotherapy: Yeah, it messes you up royally, but a brain tumor (just like John Kerry ;) is even worse.

|4.7.05 @ 6:07PM|#

thoreau,

It also works when the theocrats adopt their "we care a lot about the poor women who are tricked into having abortions" pose.

|4.7.05 @ 6:19PM|#

R C Dean, you seem to be making some pretty rash judgements about who will and who wont be using the EC pill.

Why do you give a damn? So what if sluts become the primary consumers of the EC drug what harm does that do you? Does it bother you that some women are sexually active, some more then others?

That seems to be your motivation for denying the drug. Pretty shallow....

|4.7.05 @ 6:32PM|#

For the record, if easy access to Plan B means that my slutty cousin stops popping out kids that she isn't fit to raise, I'm fine with sluts popping as much Plan B as they want.

|4.7.05 @ 7:50PM|#

Remember, I'm all in favor of this stuff being sold OTC! Did you read my post at all?

R.C., uh, yes, I did read your post. I never said you were against it being OTC, did I (did you even read MY post)?

I was referring to the disparaging tone you took with those that might find themselves in need of "emergency" contraception or whatever you want to call it. You certainly came across as pretty smug about it. Perhaps you are as scornful towards your own admitted irresponsibility or perhaps it is only sexual irresponsibility that is deserving; I couldn't really tell. So, if I have misinterpreted your post, I apologize. As someone who as been um... "involved" in the need for said contraception myself, maybe I just took it a bit too personally.

|4.7.05 @ 11:23PM|#

RC Dean is correct in identifying "emergency contraception" as a misnomer; in many if not most cases, this "contraception" doesn't prevent conception, but rather causes the destruction of an already-conceived embryo by making implantation impossible -- ie, it induces abortion.

And that's why it should be treated differently from true contraceptives.

|4.8.05 @ 1:20AM|#

crimethink,

Why does that mean it should be treated differently? Granted there is dispute over how it works, but even if in every case it prevents implantation, so what? It's still none of Jon's or your business; abortion is legal. That is simply the legal reality at this point. If it is your position that should be changed, fine (though I would disagree), but unless it is I fail to see how you make the logical leap that it should be treated differently. Well, technically I would agree in that it ought to be easily available anywhere without a prescription... but I doubt that's what you had in mind.

|4.8.05 @ 1:21AM|#

Morat: Amy Alkon talked about this story in her blog. I don't agree with her entirely, but she comments toward the end that no prescription is required in six states, but it's still a hassle there; in contrast, in France you can get it just by asking.

|4.8.05 @ 6:54AM|#

crimethink, EC is not necessarily different from other forms of "contraception." The pill, for instance, will prevent implantation and growth of an embryo, whether or not an actual embryo exists. It doesn't prevent fertilization. The iud irritates the lining of the uterus to the point that, again, even an existing embryo will not implant, but instead be shed with the menses. So these, too, are "after the fact" forms of birth control, except that they are used in a daily/consistent manner.

No "moral" difference. Only a planning difference.

|4.8.05 @ 8:44AM|#

crimethink says,

RC Dean is correct in identifying "emergency contraception" as a misnomer; in many if not most cases, this "contraception" doesn't prevent conception, but rather causes the destruction of an already-conceived embryo by making implantation impossible -- ie, it induces abortion.

And that's why it should be treated differently from true contraceptives.

I love how every fertilized egg that doesn't penetrate the uterine wall is supposedly "aborted". Well, then, holy shit, imagine how many trillions of "abortions" happen every single year at the hands of cruel orthotricyclen users. Murderers!

What's next? Where will the fundies shift the line to this time? Is "pulling out" going to be considered "abortion" too? Oh, oh, imagine all the unfertilized "potential humans" that are "aborted" every time an unimpregnated female has her period! Murderers!

This is getting just a bit absurd, wouldn't you say? If orthotricyclen is murder, then I know alot of people who should be in prison (just about every woman I know, to be exact).

|4.8.05 @ 9:01AM|#

I believe that is why the Catholic Church still opposes all forms of birth control except barriers.

The horror! The carnage!

R C Dean|4.8.05 @ 9:55AM|#

Geez, you try to make a point about what a great piece of PR the term "emergency contraception" is, and everybody gets their knickers in a twist. To clarify:

"Emergency contraception" is great PR. I hope someone got a bonus for coming up with that. Much better than the perhaps more accurately descriptive "morning after pill."

I have zero objections to this stuff being sold OTC.

But lets not kid ourselves about the market for it. The vast, vast majority of this "emergency" contraception will not be sold to people who use any kind of contraception the way God intended (before or during the actual sex). Someone whose pill failed will not be able to use it at all because they won't know about it within the 72 hour window. Ditto for most other contraceptive failures (with the occasional catastrophic condom rupture that actually gets noticed at the time being an exception). You cannot make a market for EC based on broken condoms, folks.

No, the market for this stuff is people who are too stupid or irresponsible to use contraception the right way. Stupid and irresponsible people have rights, too! Hell, they need 'em more than most, and big pharma deserves every chance to pick their pockets.

Is that Libertarian enough for ya?

|4.8.05 @ 10:16AM|#

RC Dean,

On the one hand, you may be right. Women who don't use the pill and sleep with men who don't use condoms are may be more likely to use emergency contraception than those who take such precautions.

On the other, I would doubt that couples merely having unprotected sex, or people who engage in lots of sex with multiple partners. For one thing, taking the morning after-pill is hardly pleasant, certainly not something that can be done regularly.

I would guess that it fills the accidental(broken condom), unintentional (girl who slept with a guy after a night out), or worse (rape victim) market. Not necessarily an irresponsible bunch of people.

|4.8.05 @ 1:57PM|#

...people who use any kind of contraception the way God intended (before or during the actual sex).

The way God intended?? I take it you're joking but it's hard to tell with your posts. At any rate your latest post seems to clarify my previous quandary - it is only sexual irresponsibility as opposed to driving fast (which as one poster pointed out may require "emergency" services as well) that deserves such scorn. Who cares what reason people have for needing it - never got caught up in the heat of the moment without any pre-planned contraception? Well, then I repeat my statement about a boring life. At any rate I'm glad you're libertarian enough not to try to stop it, but that does not mean we can't criticize your disparaging those who fail to use contraception as "God intended." It's your right to do so, of course, and it's our right to think that's more than a little condescending.