Doctors retire. That’s the context of my recent experiment in “detoxing” from two prescriptions, both of which strike me (but not yet the FDA) as good candidates for over-the-counter (OTC) sale. (Most striking detox effect so far: a massive earache.) One is Celecoxib, an anti-arthritis drug. The other is Montelukast, an anti-asthma and anti-allergy drug. What’s scary about selling both these drugs OTC is allegedly death.
Celecoxib is a Cox-2 inhibitor, and those drugs as a class still haven’t completely aired out the stink of death brought on by Vioxx. Montelukast maybe sometimes cause psychiatric side-effects, according to postmarketing reports, raising the specter of suicide (though postmarketing reports could report anything as a side-effect, short of “pet turtle died”). But the most frightening thing about Montelukast appears to be that it’s an effective asthma control medicine, and the FDA is apparently nervous about making effective asthma control medicines available to consumers directly.
This nervousness is maybe not completely bonkers. In an affluent country, where asthma treatment is widespread, it might be easy to think of asthma as mostly a quality-of-life issue when, if left totally untreated, asthma can kill. Keeping asthma from killing you (or just keeping down costly ER trips from when asthma almost kills you) is mainly a matter of patient education and what are, in an advanced medical system like ours, pretty basic medications. (Getting beyond just not dying, into a good quality of life with asthma, is harder.)
Montelukast isn’t a rescue medication. It controls asthma long-term, and yes, there’s a risk that some folks will just tool down to the drugstore to get some Montelukast for their asthma without ever seeing a caregiver who’d prescribe rescue medication and run them through asthma-education basics, thus lulling themselves into a false sense of security until the day when, without rescue medication or the education to recognize the danger, they keel over and die.
Indeed, Merck wasn’t even trying to get approval for Montelukast as an OTC anti-asthma drug, because the FDA is that nervous about letting Americans feel like they can treat their own asthma unsupervised. Merck merely sought approval for Montelukast as OTC anti-allergy drug. The FDA worried, though, that too many consumers would see Montelukast marketed OTC for allergy treatment and also mistake it for an effective anti-asthma drug – because it is.
Pfizer, which is currently trying to get Celecoxib approved for OTC use under the brand name Celebrex, likes to point out Celecoxib’s safety relative to current OTC painkillers and even advertises a study showing its promise as an antidepressant (in the study, Celecoxib was paired with an official antidepressant, but the Celecoxib-antidepressant group improved even before the official antidepressant kicked in, suggesting antidepressant effects from Celecoxib alone, although of course Pfizer can’t just come out and say that). Now, you might not trust big pharma to tell the truth about its own drug, but both the claim of OTC-quality safety and of antidepressant effects seem plausible to me. (Tylenol zaps your liver, current OTC NSAIDs risk GI ulceration and kidney damage, Celecoxib is mostly easier on your innards than that, and it turns out telling depression and inflammation apart is actually pretty heckin’ hard, and palliating one tends to palliate the other.)
Whatever you think of the ethics of turning to any drug for mere palliation, making available an OTC drug that effectively treats pain and maybe gloom, too, without sharing the dangers of other OTCs – and without being, ah, as fun as, say, opiates – sounds like it could be useful. (Celecoxib is only a party drug in the sense that, if arthritis is what’s keeping you off the dance floor, it can help with that. To borrow a phrase from @judgemental, both Celecoxib and Montelukast aren’t “happy” drugs, just “not crappy” drugs.)
But maybe you’re still afraid of people dying from cardiovascular events brought on by Cox-2 inhibitors like Celecoxib. Maybe you’re afraid of people dying because they won’t understand that Montelukast, while it’s an effective asthma medication, isn’t a rescue asthma medication and that effective OTC drugs can’t save asthmatics from ignorance. Maybe life is so precious to you that you think it’s more important to prevent deaths that might be caused (even indirectly) by these drugs than it is to make it easier for Americans to alleviate their misery by purchasing these drugs OTC.
Life isn’t that precious to me.
Which is not to say I don’t consider life – especially lives not my own – precious. Just that I consider chronic misery a fate, if not worse than death, then certainly worse than a small risk of death.
Generally, what frightens me about life-threatening stuff isn’t the prospect of death, but the prospect of almost-death: of making it through technically alive, but in no condition to function. I know others evaluate the moral calculus differently. My own father did, and though it mystified me, it was his choice to make, not mine. But what I notice is that misery, bad enough for long enough, makes it difficult for even the stoic to live up to expectations, and if you’re not living up to at least some expectations, then what’s the point?
OTC medications, on the other hand, can make it easier for folks to live up to expectations without having to go through the (for some people prohibitive) process of first visiting a gatekeeper for a prescription.
Plenty of arguments for fewer restrictions on pharmaceuticals revolve around rights and responsibilities: that people have the right – and also the responsibility – to choose what goes into their bodies. But here I’m focusing on one specific choice: misery or death. How much should our fear of death limit our access to palliation? Is it especially important to not let death stand in the way of decent palliation when the palliative can’t get you high?
Montelukast and Celecoxib strike me as well within the realm of what even the fairly death-averse could feel comfortable ingesting without physician oversight – safer than Tylenol, for example, with its liver toxicity. But then, if it were up to me, Vioxx wouldn’t have been pulled off the market just for the potential (and to me, at least, pretty negligible) side-effect of sudden death. Vioxx gave people their lives back because it gave people their functionality back. Risking your life a little to get your life back doesn’t strike me as such a bad deal, but maybe I’m weird. What do you think?