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Give Me Misery or Give Me Death?
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?
Published in Healthcare
I make sure to lay on my right side since I often need to take it right before bed or in the middle of the night.
Since the opening of your stomach is on your left side, this does a good job of keeping the contents where they need to be with the help of gravity.
To cite a non-medical example – the infamous Ford Pinto fuel tank. Statistical analyses of the Pinto and fuel fires show something very interesting (and I wish I had the source to hand, but I can’t remember it at the moment): The Pinto was no more unsafe in regards to fuel fires than other cars of the time. Several other US compact cars of the time were, statistically speaking, just as unsafe, or even more unsafe, than the Pinto. Yet the Pinto got the attention. The way the Pinto mounted the fuel tank was considered industry-standard for that sort of car at that time. Media hysteria drew attention to the problem only in respect to Ford, and then only because of the infamous Delorean memo about cost savings vs. lawsuit payouts.
It was so painful to “like” this comment.
Very interesting. I am an asthmatic, and I take Montekulast daily. In recent years, I have had very little trouble with my asthma.
Hi, @mendel,
I realize I forgot to @mention you. If you do have time, I am rather curious about this, for reasons mentioned in the quoted comment.
Midge, I’m not in any way defending the fact that so many drugs remain prescription-only. From a theoretical standpoint, I find prescriptions to be a silly construct for any drugs without the potential for extreme abuse (such as certain painkillers) or harm to others (such as antibiotics). After all, one of the drugs with the most destructive side effects and potential for abuse is already available OTC to anyone over the age of 21.
I do think consulting with a medical professional is incredibly wise prior to taking almost any medication, although this should be common sense and not require legal sequestration. I also think prescriptions are necessary and proper for patients whose drugs are paid for in whole or in part by taxpayer money – if someone’s spending my money on expensive goods, I want a check in the system somewhere.
My main point was that the reasons why so few drugs make the Rx-to-OTC switch have much less to do with technocrats at the FDA thinking they understand your issues better than you do, and much more to do with a perfect storm of laws, numerous well-entrenched (and often well-meaning) private sector interest groups, and our convoluted structures for financing health care. No one factor is the primary cause, but the effect is blazingly clear: drug companies on the whole show much less interest in applying for Rx-to-OTC switches than they do in applying for new Rx drugs and/or extending the patent protection on existing Rx drugs.
Indeed, while this cuts against the typical Ricochet narrative, the FDA actually started trying to streamline the process for Rx-to-OTC switches back in the Obama administration by re-interpreting its own rules and applicable laws.
I’m also not going to comment too much on the specifics of any individual case. I don’t work for Merck and I’m not well-versed on the details of this specific case, so any comments I made would not be very helpful in any case. Thus, most of my previous comments should not be taken as applicable to the situation of montelukast, but rather to explain the background influences and incentives which were tipping the scale of those proceedings before they even began.
Besides, I think the real solution to inaccessible medications is trying to approach the structural causes and not take on ad hoc battles, which tend to use tremendous resources for (relatively) small victories, even though they are obviously much larger for the individuals affected.
Just a few comments on montelukast:
You can read all 67 pages of the Advisory Committee hearing here.
Just from skimming the transcript, it’s fairly clear that there wasn’t any single specific concern. The physicians’ doubts circle mainly around the general complexity of the drug, as you mentioned before – it’s approved for numerous indications, and the specific dosages, risks, concomitant medications, etc. differ for each of those indications. The main concern was how to make this complex information easily understandable both to adults and teens. Suicide was only one of many of the specific harms discussed.
That certainly seems like a weak concern, but the panel voted 11-4 against, so the concerns were obviously widespread.
This underscores one of my bigger points: the real nannies in the FDA are often not the FDA bureaucrats themselves, but the MDs they call on for advice. Most of these MDs were pediatricians at larger regional hospitals, so they’re neither in private practice nor big shot academics with big agendas.
We obviously can’t paint all MDs with one brushstroke, but most of the “Advisory Panels” I’ve worked with tend to be populated with physicians who tend toward a view that many patients can’t be trusted to make decisions for themselves. Part of this is likely self-selection: the types of doctors who set themselves up for being invited to an advisory panel probably already have an inflated view of their own importance. Part of this is financial: doctors would lose a lot of money if patients didn’t need to come to them first.
But I think many doctors genuinely feel that an untenably large share of patients would do themselves more harm than good if left to their own devices regarding Rx drugs. Whether true or not, this will be a difficult hurdle to surmount, since no major regulatory changes to medical treatment are possible without MD buy-in.
Thanks, Mendel!