Pharma: May 2009 Archives


May 27, 2009

William Saletan has a confusing article in Slate about GW Pharma's new cannabis-based product, Sativex:
Sativex is a cannabinoid pharmaceutical product standardized in composition, formulation, and dose, administered by means of an appropriate delivery system, which has been, and continues to be, tested in properly controlled preclinical and clinical studies. Crude herbal cannabis in any form--including a crude extract or tincture--is none of those things.
So there. Sativex isn't pot. It's a carefully refined derivative: "Once the plants have matured, they are harvested and dried. GW then extracts the cannabinoids and other pharmacologically-active components ... [to] arrive at a pharmaceutical grade material." Patients are further expected to regulate their intake to separate pot's approved effects--relief of pain and spasms--from its unapproved effects:
By careful self-titration (dose adjustment), most patients are able to separate the thresholds for symptom relief and intoxication, the 'therapeutic window', so enabling them to obtain symptom relief without experiencing a 'high'.


Every feat of re-engineering challenges our moral and legal assumptions. In the case of Sativex, two positions are under attack: the left's lazy tolerance of recreational marijuana in the guise of legalizing medical marijuana and the right's opposition to medical marijuana on the grounds that it's just a pretext. By refining, isolating, and standardizing pot's medicinal effects, pharmaceutical companies are showing us how to separate the two uses. Are you for symptom relief or getting stoned? That used to be a fuzzy question. Now it's concrete: Do you want the reefer or the spray?

As far as I can tell from the above, the story is that Sativex does get you high if you take enough; it's just that they're packaged it in a such a way that it's easy to take a small enough dose that it relieves whatever symptoms you allegedly have without getting you high. On the other hand, if you take a higher dose, presumably you do get high. But of course, the same thing is true of pharmaceutical opioids as well, and people abuse them. To the extent to which we have deterred such abuse it's because we have found opioids which provide pain relief with less euphoria and/or we've adulterated them so it's unsafe to take enough to get really high (e.g., the acetaminophen in vicodin). And of course we still have plenty of abuse of high-end opioids like demerol. I don't see any evidence that either of these has happened with Sativex.

Maybe I'm missing something, but I don't see how this usefully divides the world between people who are in favor of getting high and people who are in favor of symptom relief. On the contrary, Sativex seems like a new cool way to get high without the inconvenience of lighters, coughing, smelling like smoke, etc. I'm sure there are some people who like the ritual of actually smoking pot, but I suspect most would be perfectly happy to skip that and just get high. How exactly does being able to buy the active ingredients at Walgreens discourage use by stoners?


May 8, 2009

I'll be the latest person to pile on Mike Galanos's piece in CNN about how Plan B shouldn't be available OTC to 17 year olds:
Think of a 17-year-old girl. Most of the time she's a high school senior, still living at home with Mom and Dad. She still needs her parents in the tough times. But they will be cut out of a traumatic situation. All thanks to U.S. District Judge Edward Korman. Korman stated in his order, "The record shows that FDA officials and staff both agreed that 17-year-olds can use Plan B safely without a prescription."

Now keep in mind birth control pills require a doctor's prescription, but a drug that is more powerful doesn't? The effective ingredient in Plan B is the synthetic progestin levonorgestrel and this is also found in daily oral contraceptives. Some forms of birth control that require a prescription have levonorgestrel, while Plan B has significantly more of the synthetic hormone. Do we really want our daughters putting something like this in their bodies without a doctor? I still want Mom and Dad in on this.

This is bogus on a number of levels.

First, oral contraceptives arguably should be sold OTC (Grimes summarizes the debate here). The only real arguments for requiring a prescription are (1) that it forces women to get seen by their doctors, which is otherwise good, but sort of paternalistic and (2) that compliance isn't as good if you get them in a non-medical setting. As for the "more powerful" argument, that doesn't follow at all. There's a difference between occasional and acute usage. If I have a bad muscle sprain and need to take 2400 mg/day of ibuprofen, even for a few days, I think nothing of it, but I would see a doctor before settling into a regime of 1200 mg/day for the rest of my life. Third, pregnancy really is pretty bad for you and there is plenty of evidence that emergency contraception is safe, so it's not really like you need a doctor to make these tradeoffs for you. Finally, what the heck do mom and dad have to do with this medical argument? Unless they're doctors, they're no more qualified than the woman/girl to have an opinion.

Some argue that a girl can get an abortion without parental notification in some states, so why not Plan B? But just because those states got it wrong by leaving parents out of the loop doesn't mean others should follow suit. And the larger point is, society must help parents, not undermine their rights by keeping them in the dark on their child's life-changing decision.

Here's some perspective for you: In most states, minors can't get a tattoo, body piercings or go to a tanning salon without a parent's permission, but we are going to leave them alone to take Plan B.

I suppose there's legitimate room for discussion about whether or not we should have parental notification laws for abortion, but this just ignores the very real issues with them. To state the obvious: many kids (especially girls) have sex even when their parents disapprove or without their parents knowledge. If they suddenly find themselves in a situation where they need EC, either because they have a condom failure or (shocking, I know) they had unprotected sex, having to ask their parents to get it comes with a huge amount of baggage. And we haven't even gotten to situations where the pregnancy is a result of abuse by a family member. None of this applies to tattoos, body piercings, or tanning salons. Again, it may be the case that it's still better policy to require parental consent (I don't think so, but that's not my point here), but it's disingenuous to suggest that there's a straight line from tattoo parlors to Plan B.

I question that, when we are cutting a doctor out of the decision to administer a powerful drug. Timing is essential to the drug's effectiveness, Plan B supporters say, so getting parents and doctors involved would unnecessarily delay the teen's ability to pop the pill the "morning after." Does it really take that long to get a prescription

This is a joke, right? Try to put yourself in the position of a 17-year-old girl who just had a condom break. You've got to get up the nerve to tell your parents you're having sex with your boyfriend and then calm them down enough to get to the doctor and get a prescription, all within 72 hours? That doesn't seem like a lot to ask? Even if all you have to do is see a doctor without your parents, might there not be some logistical difficulties, like figuring out where to get one that won't show up on your families insurance paperwork? And because of the time limit, this essentially sentences some girls to either an abortion or carrying the pregnancy to term, neither of which is that attractive if you didn't want to get pregnant in the first place.

I also don't buy the argument that this will help with unplanned pregnancies and abortions. The Center for Reproductive Rights says making Plan B more widely available could reduce them, but The New York Times reports that since 18-year-olds were allowed to get Plan B without a prescription in 2006, there has been no evidence of it having an effect on the country's teen pregnancy or abortion rates.

This is distressing, but I don't see how this is an argument against giving 17-year-old girls choices.

But let's get back to the first point: We are making it available to high school girls. We're enabling teenagers to act carelessly with an easy way out. During a recent discussion on my show, Jackie Morgan MacDougall, supervising producer of the Web site, said it best. "Teenagers are known for thinking they're untouchable and here we are saying that they can continue to do that and that there aren't any consequences." With Plan B, they can do it now and deal with it later.

Don't tell me high school dynamics won't play in here. The boyfriend will talk his girlfriend into unprotected sex with the promise of buying the "morning after pill" the next day. Any 17-year-old boy will be able to buy this drug, just as any 17-year-old girl will.

Yes, this could encourage unprotected sex and that means a greater risk for sexually transmitted diseases. What about the 17-year-old girl who may get Plan B for her 15-year-old sophomore friend? These are the kind of decisions high school girls will make.

Wait, what? In my book, things that are fun (like sex) are good. Things that aren't fun (like getting pregnant when you don't want to) are bad. Things that make it possible to do things that are fun without experiencing things that aren't fun are also good. This is the part that makes me nuts about this kind of article (and also William Saletan's article, to some extent); what's careful and what's not is situation-dependent. Just like you can safely climb more aggressively when you're roped up than when you're not, a different level of care is appropriate if you can get EC than if you can't. Having sex (or any other activity) involves a certain level of risk, and it's not careless or irresponsible to take such calculated risks, nor is it careless or irresponsible to adjust your behavior when superior protection becomes available.

Now, clearly there's still a pretty significant level of residual risk in terms of STDs to be concerned about, but consider that as an argument against EC. The underlying logic of Galanos's position is that we should deny girls EC so they'll be more afraid of pregnancy and thus use protection against STDs. That's a pretty crude kind of reasoning (paternalistic again) and it's imposing a significant cost on those girls who get pregnant when they otherwise would not have for a more or less theoretical incentive benefit.

I think the 15-year old part is your hint to the real objection: we don't want teenage girls having sex, so anything that makes it less risky is bad. Needless to say, I don't subscribe to this theory.