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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
Tough question and well stated. I’d side with you as my own I believe responsible use of many OTC painkillers has cured (with exercise) a bad sciatica problem. If it is less dangerous than Tylenol, what are we waiting for?
Ibuprofen and Naproxen are both available OTC. Celebrex should be, too. And if it is OTC, it does not have to be covered by insurance, thus you, and not your insurance company, pay for it. The drug companies who make those medicines , and the pharmacies who sell them, provide excellent literature for patients to read, explaining all the uses and potential side effects. OTC medicines assume the intelligence of human beings, and their ability to understand what they are taking.
The pharmaceutical industry, along with the supplements industry, are developing many things that can cure our ails but carry risks. How do we manage the benefit / risk trade-off?
In the absence of sensational claims, I woulds give that power to the individual.
Preach. You’ve said nothing unreasonable.
The problem is that everyone wants someone to protect them from their own judgment and their own decisions. We should stop doing that.
I’d love to have otc options. I’m in charge of me and my health and while I can’t control the education of others, I can educate myself. Why should that option be kept from me just because somebody else is an idiot?
I read the whole required documentation for any drug I take. How do we deal with those who don’t or unable to do so?
Heh, heh.
I’ll stick to sound waves.
Case in point:
Joint Commission is being sued for their contribution to the opiate crisis.
We don’t.
People don’t real the calories on food or the warnings on cigarettes. Do you think it’s really a complete lack of knowledge? Most people I know are afraid of taking too much ibuprofen, despite the fact that they can take twice as much under pharmaceutical guidelines! They’re afraid that they’ll somehow get poisoned or dependent.
What do you do when people are just…well…dumb?
Well, there are scary things that I learned in high school when a classmate attempted suicide with acetaminophen/Tylenol and I learned of its liver damage risk. From then on, I read everything about everything I take. I know we can’t expect everyone to be as obsessive on this as I am, but we need to let the benefit / risk equation move toward benefit.
Darwin.
But then the lawyers get involved. Hence the risk adverseness of our drug approval system.
No, not Darwin. That’s how it is that people can sue when they break into a house and hurt themselves. It’s not reasonable, but it’s the letter of the law.
The law is there to, largely, protect the stupid.
There’s a lot of stuff where, even though it’s cruel, we should let people learn. Sometimes that’s particularly harsh and may include death. But I wonder if it isn’t a kindness.
The risk of sudden death by cardiovascular event is small, and I believe negligible to a great many people who just want to regain dexterity and mobility in order to function. One of my sources up above says Vioxx was pulled for quadrupling heart attack risk (though note an already-small risk quadrupled may still be small), and that Celebrex may increase heart-attack risk by about a third. For many, that’s an acceptable risk.
If I had to weigh “accidentally frying Midge’s liver while she’s still using it” or – even worse – “accidentally frying a child’s liver because he got into the Tylenol despite our padlock” against “Midge’s risk of heart attack increases by a third”, the choice is easy for me. My father, on the other hand, did not want to take a drug that increased his risk of heart attack (possibly because he believed his risk was already unacceptably high, or maybe he didn’t see the point of a drug that would raise his risk while making the rest of his life more bearable when he was already taking another drug to lower heart-attack risk).
Ulceration from long-term NSAID use is no fun (and also sometimes life-threatening – but did I mention no fun?). Celecoxib has some risk of this, too, but noticeably less than current OTC NSAIDs.
I think you’re spot on here, Midge. Very thoroughly researched and couched in some very profound human truth regarding suffering.
Far more drugs should be available OTC. I guess the theory of prescription drugs is that your doctor will patiently explain to you the proper use of the drug, as well as the risks and side effects. And will then re-explain it each time the prescription is renewed. Only then can you be trusted to have that drug in your medicine cabinet.
In what fantasy world does that happen? In my experience, most doctors just say “take this drug, it will help with your <whatever>; here’s the script.” Sometimes, not even that. Sometimes, in my experience, after the doctor has seen me an assistant comes in and gives me the script. “Here, the doctor wants you to take this.” Not good enough. Personally, I’m not putting any drug in my body until I get on the internet and research the drug, looking for interactions, side effects, and other risks. Because I don’t trust the doctor to have done that. I know that doctors get most of their information about drugs from the drug company reps who are, shall we say, optimistic about outcomes. Doctors are also, often, in too much of a rush to check for known drug interactions.
I recognize that there is not much chance that the FDA is going to trust the stupid hoi polloi to manage risks when it comes to their own health. So I have a proposal that is intermediate. Instead of a prescription, let the doctors issue a license to buy that particular drug in the same way you would buy an OTC drug. In other words, you would see the doctor once (during which visit the doctor would presumably have the fantasy conversation where he explains the proper use and so on). After that, the patient would be treated as an adult and could buy the drug as needed without running back to the doctor for permission.
Good grief. Here’s where we need to start, tort reform.
Yes! It’s not your neighbor’s responsibility let alone the/any government or insurance company. It is your responsibility.
Okay: back to the OP. . .
The FDA does not exist to bring drugs to market; it exists to stop people from getting hurt by a new product. What is the best way to do that? No new products! That is what would make them the most happy.
The Army hands out 800 mg Motrin like candy. The nickname for these Motrin is “Ranger M&Ms.” It’s amazing stuff.
I would say, though, stay upright 30-40 minutes after taking ibuprofen. Otherwise, like me, you might wind up in the ICU for four days with esophageal lesions, ready to perforate.
I couldn’t agree more. I have pretty severe osteoarthritis and the thing that helps the most is to keep moving. It was so much easier to do when vioxx was available. It really helped a lot. I have trouble with the NSAIDs, Tylenol only helps so much. I would love to have Celebrex available OTC. I’d take my chances.
We called ’em “Vitamin M” in the Navy PT world.
Well, now, that is interesting, because many red-blooded Americans do believe that the opiate crisis is mixed up with America’s institutions failing the rural poor, for example, and the Joint Commission on Accreditation of Health Care Organizations (JCAHO) is one such institution – out of many, of course.
I think most of the talk of “America’s institutions” refers to socio-economic conditions – the idea that there are too many deaths of despair because there is too much despair. Summarizing Case and Deaton,
So the JCAHO doesn’t strike me as the natural institution to blame for this.
Still, those of us trained in the necessity of taking responsibility for our own health and managing the risks that come with it (taking care not to overuse drugs that might be “too much fun”, accepting that our pursuit of functionality might mean unexpectedly dropping dead earlier than otherwise) might seem like freaks to a lot of ordinary Americans. Cruel freaks, too, in that we take a hard-nosed attitude toward patient responsibility.
I’m not saying the hard-nosed attitude is wrong (it just seems like reality to me), just wondering what happens if it can’t be made popular. Maybe @titustechera wishes to weigh in on that aspect.
Have you tried cod liver oil? Cod liver oil is cheap, safe and great for controlling inflammation in the body. The key is to take a lot of it (~8 soft gel caps every day) at the beginning to get things going and then back off a bit (~4 gel caps every day) for maintenance.
EDIT: Please note that I’m not a doctor and you need to be careful about vitamin A toxicity. Consult your healthcare professional about safe vitamin A and D intakes.
How often would patients be expected to renew that license, though? I can’t picture the government issuing a license like that with no expiration date.
Until your doc retires, provided you’re not taking a drug with extra restrictions on it, a prescription can already kinda sorta function as such a license, at least as far as what the patient sees: pharmacist calls doctor to renew prescription, doctor says, “OK.” It’s extra hassle for both doctor and pharmacist, of course. It does give doctors the option of refusing to renew until the patient gets his heinie down to the office for a checkup, though, so the doctor can see how he’s doing.
Or, get it in liquid form and put a coupla glunks in your
morningevening whisky.Even better! =) Taking it in liquid form really is the best way, but for the uninitiated it can be tough. I swear by cod liver oil and it has done wonders for my knees and wrists—of course individual mileage may vary, but it’s a case of having nothing to lose, especially when considering the alternatives.
EDIT: Please note that I’m not a doctor and you need to be careful about vitamin A toxicity. Consult your healthcare professional about safe vitamin A and D intakes.
How often do you renew your driver’s license? Every five years? That would work for me. Also, I don’t like being blackmailed into a doctor visit. The first time my internist tried that (denying a prescription renewal) I told him that if he wants to see me, give me a call or send me an e-mail. There is no need for blackmail, and please don’t do that. I also have to admit to a suspicion that what is really happening is that his schedule is a bit light and he needs to fill it up with otherwise unnecessary office visits.
By the way, on the subject of e-mails, every doctor I know is still communicating by fax, and they never have an e-mail address on their card or website. Maybe that’s some kind of idiotic HIPPA requirement, but I am not filled with confidence by the fact that my doctors are all using technology that has been obsolete for 20 years. If they are doing the same thing with their medical technology as they are with their communications technology, then I would not be surprised to find leeches in their office.
There are many values that we balance against the risk of death or a shortened lifespan. Exposure to vicarious trauma correlates with a variety of stress-related diseases and is supposed to shorten one’s lifespan. The wardens and I discuss this sometimes: If we knew for sure that responding to tragedies would knock five years off our lives, would we still do it? Yup.
If my loved one knew that the medications she takes to control psychosis and whacked-out mood swings shortened her life by five years would she still take them? Hell yes.
And of course, there is the joke (a favorite among Braestrups) about whether a macrobiotic diet and daily strenuous exercise makes you live longer, or does it just feel longer? We increase our chances of premature demise merely for the sake of sitting in front of a computer…typing words…for hours…
when we could be training for a marathon (just kill me now).
I get annoyed with people who refuse to take medications. Life is short. There’s work to do. If a pill can alleviate your pain and make you useful to someone whose pain is pill-proof, swallow the dang pill and get going.
blech. But I’ll try the capsules—thank you! (Cod liver oil is better/different from Fish Oil?)