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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
Women who may become pregnant are especially supposed to avoid large amounts of vitamin A. I’ve tried other fish oils, though more as a “this is supposed to be good for you” thing than “wow, I see results!” Googling now, I see it is possible to find low-vitamin-A cod-liver oil. I can try it.
There is a form of fish oil available by prescription, incidentally. Here’s an amusing take on it:
I have a compromise position. Behind the counter sales. You can walk into a pharmacy, and walk out with Montelukast the same day without a prescription. However, you have to have a chat with the pharmacist first. You get an FDA approved info sheet, and the pharmacist explains the details. You sign off that you have gotten the sheet, and you are good to go.
Pharmacists typically are providing consultation with patients on using medication – in fact, you have to decline the consultation even if you have gotten the medication many times before. Pharmacists will generally have as much if not more knowledge of drug effects as doctors
Then you have people like me, you know, the “on rare occasions” thus and thus will be a reaction. I am almost always that “rare patient.” Many of these medications act as a “vascular dilator” which on me means a massive migraine. If the medication contains MSG, Suflites or an opioid real or synthetic, it will also act as a vascular dilator. I was recently given a prescription for Barrett’s Esophagus, Gastritis and Esophageal Stricture. The prescription was for Omeprazole, generic for Prilosec. As most of you know I have chronic vertigo from a damaged vestibule nerve. Within a day or two, the vertigo was worse, then by day 4 I could not even stand the vertigo was so bad I was spinning. I researched the drug and discovered that one of the side affects could be, “dizziness.” I talked to the pharmacist, about the other 4 or 5 drugs on the list the doctor said I could try if the Omeprazole didn’t work. He said they all would cause dizziness if the Omeprazole did. In addition in my research, it said not to use this drug if I had certain symptoms, and sure enough I have all those symptoms but the doctor prescribed the drug anyway.
I stopped taking the drug 5 days after I started it and it took just about that much time for the spinning to stop. I notified the doctor and they wanted me to come in for more test, one of which is dropping a wire down the back of my nose and throat. I said forget it. I haven’t been back. I have been using Ranitidine at bedtime, and about once a week 400 mg of Ibuprofen when the pain is so bad I can’t sleep.
I’ve had just about every test for this condition except that wire down the nose test, which is to determine if my esophagus is pushing the food into the stomach, which it is because I can feel it going into the stomach. I am on a strict GERD diet, and eat nothing that produces acid. At this point I don’t know what else to do, but I’m in pain all the time. There is only one Gastroenterology Clinic in Kalispell.
I researched all this btw on the Mayo Clinic web site.
@katebraestrup and @midge While I am an advocate of fish old in general, in my experience, cod liver oil seems to be the best in terms of it’s anti-inflammatory effect (which is the primary reason why I take it). I should also make a couple of qualifications: When I talk about taking 8 gel caps I don’t mean those big horse pills that you can buy in large jars from your local superstore (I find those extremely hard to swallow and I’d probably vomit if I took more than 2 of them)—4 of the capsules that I take are roughly equivalent to slightly more than a teaspoon full of oil. Also, if you don’t notice an improvement in your symptoms after about a week (two at the very most), then it probably isn’t going to help you. As far as vitamin-A toxicity is concerned, I’m not a doctor, and I encourage you to do your own due diligence regarding the appropriate amounts and ratio between vitamin-A and vitamin-D in your cod liver oil supplement. In short, as with anything in life, do your best to inform yourself, use your good judgement and weigh the relative risks and rewards.
Have you tried another proton pump inhibitor like Protonix?
You might want to do some research into glutamine—my bother and a friend have found glutamine to be effective in keeping their GERD symptoms in check. I don’t usually have acid reflux problems, but on the odd occasion when I do, I also find it to be very effective (within 15 minutes).
No, it is on the list the pharmacist said would also cause the “dizziness.” It isn’t just a little dizziness, it actually causes me to spin around and fall to the floor, unable to find my way upright again. Total vertigo with no relief. After a time, I start up-chucking, not able to hold food down.
It’s a risk I’d be willing to take, should it ever come to that.
OTC rescue inhalers exist, but their availability has been spotty – the FDA appears nervous about allowing those on the market, too, and so seems to pull various models off the OTC shelves with fair regularity.
When there’s an OTC rescue inhaler available, I could see it being pharmacy policy to ask purchasers of Montelukast, are you using it for asthma, and if so, do you have a rescue inhaler? Oh you don’t? Well we want you to buy on of those, too, then. Though I wonder if even having such a policy would horn in on somebody else’s prerogative to “diagnose and treat”.
Celecoxib and Monteleukast should be OTC as should most non narcotic, CNS altering meds.
They are both very good drugs.
You are dead wrong about Vioxx though. Friends/Patients of mine died from it and Merck lied through their teeth, widespread. Their entirety of executives involved in the Vioxx cover-up should burn in hell.
Hate it when that happens.
Thanks for sharing your experience, John. I think that it’s probably wise to use fish oil preparations with low to no vitamin A content (all of the preparations that I’ve seen in my local drugstore have some combination of vitamins A and D). As I’ve said, I’m not a doctor, and I certainly don’t want to cause anybody any harm. Maybe cod liver oil isn’t as innocuous as I thought—there does seem to be some conflicting information out there. So I encourage people to talk to their healthcare professional and not an armchair doctor on a political website.
Do you consider Vioxx too risky, period, or was the misrepresentation of the risk the problem?
The arthritis in my wrists is painful, sharply localized and poorly responsive to drugs. Only one has ever been effective, Vioxx. Similar drugs such as ibuprofen, aspirin and Celebrex don’t do much for my wrists. So from 1999, whenVioxx came out, my pain was wonderfully controlled. I could operate, sew, drive, play the oboe and tennis without pain.
When Vioxx was pulled in September 2004, I heard about it on the radio while driving home. Stopped the car, turned around, went back to the office, took all the samples in my closet and in my tenant Doc’s closet. I used them on alternate days with Celebrex, a similar drug, and got over a year out of them. Curiously, I have found that Celebrex is more effective for post-operative pain than other drugs of its class.
What a great drug Vioxx is, nothing else helped my arthritis like Vioxx, not even Celebrex. But Vioxx is gone. My wrists now hurt all the time, although certain strength exercises will give a few hours of comfort.
You can thus imagine my delight three days ago, while doing a final clean out on the office I am closing largely due to the effects of Obamacare, to find ten one-week starter packs of Vioxx in the back of a drawer.
Is it safe to use pills that expired in 2003? Well, I dunno, but two days’ use hasn’t killed me yet. And my wrists feel better than they have since 2004.
If I ran the FDA, Vioxx and Celebrex would be OTC.
My Doctor(s) communicate via email. It’s a Kaiser provided email server/account. But email never the less.
John, I take G/C/M regularly. Here is my totally anecdotal finding: I feel great when I’m taking it. So great, and the effect is so innocuous, that oft times I’ll either forget to take it or not prioritize having it available (trips, etc.). That’s when I notice the difference. Then I’ll kick myself, start taking it again, the effect is slow over time but later I feel wonderful, then I pull the same boneheaded stunt.
Only in cases of an extreme pain disorder, as an adjunct to multiple other meds, and with frequent cardiovascular monitoring , would I risk it on myself or anyone I cared about. I take celebrex daily, sometimes 2 of them.
While this is a great topic to bring up, the dearth of Rx-to-OTC conversions is really a symptom of much larger problems in our healthcare system.
Yelling at the FDA for being to nanny-statish is emotionally pleasing but misses the real underlying causes. For that, it helps to first follow the money.
As was already pointed out, many (if not most) Americans get their prescription drugs heavily subsidized (by their insurance or Uncle Sam), but have to pay for OTC medications out of pocket. That means that even if the list price of a drug decreases when it goes OTC, many customers will be paying more at the cash register for it. And the types of Americans with generous prescription drug coverage also tend to be the ones who vote the most: the elderly and the upper-middle-class.
Add to this the fact that the pharmaceutical companies would see their margin on each unit sold decrease with the conversion to OTC, as well as less volume on some drugs when people suddenly had to pay more out-of-pocket for them. So what are the chances of enacting a change that would make influential voters pay more while making an influential lobby earn less?
And this doesn’t even touch on the real elephant in the room, the group that benefits most from keeping most drugs under lock and key: the doctors who write the prescriptions. Making lots of drugs OTC means much less revenue for doctors. And even though we all think of big pharma as the strongest lobby in the healthcare field, the AMA and friends have just as much cash and millions more grassroots members on their team. And even many of the FDA decisions are actually driven by independent MD’s: for instance, the decision to keep montelukast/Singulair prescription-only was not actually made by the FDA, but by an FDA Advisory Panel comprised primarily of….wait for it….MDs in active practice.
The FDA is an easy (and often very worthy) target. But it’s really just the public facade for an entire hidden network of players with a vested interest in keeping drugs off the shelf.
This is where we, as a species, are our own worst enemy.
Sure, to you, one risk easily outweighs the other. But as a group, humans are much more afraid of certain types of death than others. Indeed, two threads on Ricochet right now demonstrate this well-known phenomenon: the thread about how terrorism deserves to be more feared than other types of death, and the thread about the mass shooting in Texas. As we all know, mass shootings comprise a statistical rounding error of all homicides in the US, but as a society we focus much more on them. Same, of course, for our relative fears of flying vs driving compared with their actual relative risks.
The same applies to adverse reactions to drugs: as a society, we’re much more afraid of them than of “the devil we know,” i.e. the symptoms of a known disease. Just look how widespread the paranoia over vaccines is, even on the right. Like flying, we have an “irrationally” large fear of adverse effects of drugs.
Now envision a very plausible real-life scenario: the main worry with approving montelukast for OTC was misuse in teenagers. Take the widespread use the drug would enjoy if OTC, multiply by its low-but-non-zero rate of triggering serious adverse events, multiply again by an inevitable increase in misuse without the need for a doctor’s prescription, add in random mortality which coincidentally occurs after taking any given drug, and then apply normal variation in random events:
At some point, there will be a string of 10-20 teenagers across the US who die/are gravely injured shortly after taking OTC montelukast within the span of a week or two. The press will pick up on this hot story. The public, which is notoriously bad at probability, will assume there’s something nefarious going on. The drug company will deny hiding any knowledge of unknown risks, thereby looking like it’s trying to cover something up. And overnight, the demand for montelukast evaporates, through no fault of its own.
What drug company making decent revenue off a drug wants to risk that kind of nightmare?
It seems to me that both Merck and Pfizer were interested in bringing these drugs OTC now that these drugs have gone generic for prescription. I am guessing Merck and Pfizer aren’t just doing this just out of the goodness of their hearts, but because there’s something in it for them (which is fine). So I get “make influential voters pay more” in this instance, but I’m less sure of the “making an influential lobby earn less”.
One reason I focused the OP on the tradeoff between misery and death: I know it’s not just about the FDA. As you say,
On the other hand,
it does seem like Merck was willing to risk that kind of nightmare in order to make Montelukast OTC (and I’m with Merck that the risk is worth taking).
From my point of view, as an ER physician I think this is really great, although I wish it was Hospitals and Doctors who filed the suit. We were bullied by JCAHO and the Feds into writing narcotic Rx’s for decades. That damn “pain scale” was a gigantic hammer.
Not in this case. JCAHO deserves this. They were a huge influence on the increase in narcotics prescribing in the US.
Serious question here:
How sure are we that the reported rare psychiatric effects of Montelukast are really due to Montelukast?
I know from a PR perspective, it doesn’t matter if they are.
That said, people with asthma, atopy, and allergies (those most likely to benefit from Montelukast) are already at higher risk of suicide.
I remember what it was like to be young and prone to random bouts of misery that unsurprisingly left me mad at the world and mad at myself most of all before I had developed the confidence to assert that it wasn’t just me, something was wrong (or even the full awareness that something was wrong), and I wasn’t merely a badly-behaved, “crazy” child.
In cases where a child is put on Montelukast, then starts acting out, and the acting-out ceases when the Montelukast stops, it’s more reasonable to suspect it was the Montelukast itself. But our very fear of adverse drug effects means, if there’s a drug involved in something awful, we’re prone to suspect it was the drug, and that leads me to treat the significance of Montelukast’s purported psychiatric effects with some skepticism.
There’s a HIPPA issue with using email. It’s supposed to be encrypted. Most docs are therefore leary.
“Yes, organizations can send PHI via email, if it is secure and encrypted. According to the HHS, “the Security Rule does not expressly prohibit the use of email for sending ePHI. … Essentially, you can send ePHI via email, but you have to do it securely, on HHS terms.”
It’s a big big fine if you screw up.
Were they worried teens taking Montelukast would be more likely to be irresponsible with rescue medication? Were they seriously worried about teenage suicide or “postal episodes” due to Montelukast?
Or was the worry something more like, teens would pair Montelukast in hopes of avoiding opiate itching, and then when the teens died from overdoses, Montelukast would also be blamed (for seeming to make opiate use more tolerable)?
Point taken. I just hate the whole “let’s sue!” thing. While we are at it, can we just ditch JC? Pain scale. Most patients look at you like you have 2 heads when you explain this to them. One person’s 2 is another person’s 10.
Yes! This was my first thought when you mentioned Vioxx. That it worked so well for some people that it was monstrous to take it off the market for a slight increase in risk of death. I feel so sorry for the people that depended on it.
omg, when someone told me you could take 600 or 800 mg of ibuprofen, it was a godsend. It never worked for me at 400.
Duplicate post.
Anarchy. ;)