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mental health mondays :: off the beaten path

i've mentioned before that i get migraines. they invariably sneak up on me in the middle of the night, which is a pain not just because it sucks to start the day with a migraine, but because the only medication my doctors have been able to give me is something that must be taken as soon as you feel the very first symptoms of a migraine coming on. i'm not one of the "lucky" thirty percent of sufferers who get an aura 24-48 hours before a migraine sets in, which means that by the time i'm aware of one, it's already in full force and the medication i have is useless. i gave what i had to dom, who generally gets more advance notice and i've never bothered to get a new prescription.


something that i have done, however, is raid my stash of meds for some form of benzodiazepine. if you have issues with anxiety and panic attacks, doctors will generally give you a prescription for one of these to keep on hand "just in case". personally, they don't do much for me on that front, but i continue to fill the prescriptions for one reason: they're the only thing that offers a little relief when i have a migraine. i can't explain the chemistry behind it; certainly one of the effects of a benzo is that it relaxes you, so it's possible that this in itself does some good. another theory is that, if migraines are a very mild form of epilepsy, benzos might help because they are a mild form of anti-convulsant. either way, they take the edge off.

what i've just confessed to is in a legal grey area. it's my prescription, after all, and i am supposed to be taking it on an as-needed basis, which is what i'm doing. it's just that what the drug is supposed to be needed for and what i need it for are two different things, which is a bit sneaky. that would seem like a bit of a slippery slope to some, but it's actually pretty common, with things like cardiac and asthma medications being used for ulterior purposes. it's most common, however, with psychiatric meds. there are good things and bad things about this, but what's truly disturbing is that it's become so normalized that no one is talking about it.

clear sailing?
in order to be approved to treat anything, drug companies must show that they have conducted various sorts of testing and shown a clear and consistent result that backs the claims they are making. the language of the claims is often very restricted [although companies are not restricted to using only those claims when advertising or promoting a drug]. claims don't just deal with what a drug says it can do, either. testing submitted must also indicate the safest maximum dosage, the length of time a drug can safely be taken and the ages for which it is appropriate. [getting drugs approved for the very old or the very young is a whole separate set of hurdles.] off-label prescribing involves going outside the boundaries of any of these variables.

one study found that 96% of off-label psychiatric prescriptions have no scientific data to back them up, which is troubling to say the least. the most common off-label uses are exceeding the maximum recommended daily dose and keeping a patient on a drug longer than recommended. the logic behind doing this is that the patient hasn't responded well or has responded well: if a patient's symptoms show improvement, but not enough improvement, within the parameters of the recommended dosage, a doctor might decide that the risk isn't sufficiently high and recommend taking more of the drug each day; on the other hand, if a patient has responded well to a drug that has only been proven safe to take for a year, a doctor might want to avoid the disruption and frustration of having to discontinue one set of meds and find another. there isn't data to back these uses up, because once the "safe zone" is established, there's no incentive for pharmaceutical companies to test outside it. there are specific thresholds that must be met when it comes to dosage and duration and once a company has established what those are, they don't test any further. so the doctor is extrapolating the likelihood of something bad happening and weighing the risks and benefits. but that doctor doesn't have any real evidence to back up those extrapolations.

probably the most controversial use of medications is outside the age range for which they are approved. older patients who may be experiencing signs of senility [on top of a mental disorder] or children who are starting to exhibit worrying signs often fall outside the testing parameters used to get a drug approved. brains in "transitional" phases can react quite differently to drugs than those that are, relatively speaking, stable and for that reason, most pharmaceutical companies don't start off applying for a claim that their product can be used for children or the elderly. so a doctor, looking for a solution, may work from the assumption that the drug should do more or less the same thing as it would to a regular adult. [50-75% of psychiatric drugs given to children are prescribed off-label.]

feeling armpathy?
that sounds a bit horrible, but consider the position of the doctor: 80% of conditions described in the diagnostic and statistical manual have no medications that are recommended to treat them. the only "cure" is therapy. that's all well and good, but therapy can take months or years to be effective and most doctors don't want to leave a patient suffering for that length of time, especially since mental disorders have a tendency to disrupt a person's ability to work, sleep, relax or interact with other people. furthermore, there are very few options that are even available for patients in certain groups [children, the elderly, people with certain health conditions], so if those don't work, then the doctor is faced with the choice to abandon drug therapy entirely or try something experimental. makes a good "what would you do?" question, i think.

things get even more complicated when you have a doctor who uses the "logical extension" argument to prescribe a drug off-label. [this is actually what i'm doing with my benzodiazepines.] in this case, the doctor is assuming that if a drug does "x", then it stands to reason that it should be able to do "x + 1". don't worry, that's all the algebra for today. that can mean that s/he uses a drug for a completely different purpose, based on its mechanism of action, or in combination with another drug, understanding that the combination should achieve an end to which either on its own would be insufficient. we all like to think that such logic puzzles are common sense, but consider that even experts don't know the exact way in which a lot of psychiatric meds work and you start to see where things could go awry. [it's not just psychiatric drugs, either. technically, biochemists haven't even figured out the exact mechanism of action of aspirin.]

off-label prescriptions can help provide valuable information on a drug's potential for other applications. [and if you're nervous about the idea of being used as a human guinea pig, ask yourself this: how do you think they get the drug approved in the first place?] it can also offer a fast solution or stop-gap measure while waiting for other methods to work. but it's a risk and all risks are susceptible to failure. furthermore, if a drug is used repeatedly off-label for a specific condition, it dissuades pharmaceutical companies from conducting the testing necessary to prove that it is effective and safe. and this happens with alarming frequency. anti-psychotics are increasingly prescribed to help with insomnia, which is like seeing a big spider and getting rid of it by running it over with your car. sure, it'll help you sleep, but it's likely to do a great deal more that might not be to your liking.

what's the worst that could happen?
one of the most surprising examples i came across of this sort of prescribing is lamictal [lamotrigine]. it is currently one of the most, if not the most commonly prescribed drugs for bipolar disorder, particularly type 2. because it has a much lower side effect profile and is generally much better tolerated than the "heavy-duty" drugs like lithium and valproate [which are now reserved more for patients who have experienced full-on psychosis as a result of their manias]. used alone or in concert with other drugs, lamictal is a  mood stabilizer that is particularly effective against bipolar depressions and helps to steady the boat. so it might surprise you to know that it's not actually approved for use in the treatment of bipolar disorder type 2 in either the u.s. or canada. its first application was as an anti-convulsant and it was used to treat epilepsy. when it was discovered that it actually functioned as a mood stabilizer [one of the only true mood stabilizers available], approval was gained to have it prescribed for bipolar disorder type 1. and that's all it's approved for.

ironically, lamictal doesn't seem to be as effective against bipolar type 1, especially not alone, because it's not as effective at controlling acute manic episodes. so doctors prefer to prescribe it for forms of bipolar disorder where the patient is in less acute need of calming. this has been done for so long that a lot of doctors might be surprised to know that it isn't an officially sanctioned bipolar 2 medication. but because it's now so commonly used as such, there's no incentive whatsoever for its manufacturer to actually conduct testing to prove that it's effective for that particular form of bipolar. it's not like official approval is going to increase the number of cases of bipolar disorder.

as i said near the beginning of my post, there are arguments for and against off-label prescribing. what can't be argued is that, with mental health becoming a greater and greater concern and in-patient resources becoming more and more taxed, it is well past the time when these things need to be discussed publicly. because educated guesses are only going to get us so far and we shouldn't be happy with medical treatment based largely on guesswork anyway.

Comments

Jerod Poore said…
I can avoid seizures by taking a benzo. Except most of my classic generalized seizures occur when I'm asleep. So I know where you're coming from.

As someone who is epileptic and has had all of three migraine events in my life, all of which ranked at the very bottom of the migraine suckage scale, let me tell you, they are not a "minor" form of epilepsy. Seizures can, but rarely do last for more than a day. Granted, some can be fatal when they last that long, but not all of them. Migraine-intensity pain is incredibly rare in epilepsy. I'm not familiar with any kind with that much pain for days. Migraines and epilepsy may very well be on the same continuum; if so, the former is not a lessor form of the latter.

As for Lamictal - the main problem with its failure to work is not using it as directed by GSK and the FDA: as a replacement for a med or med cocktail that already works. Lamictal doesn't stop, it prevents reoccurrence.
Kate MacDonald said…
"On the same continuum" is a MUCH better way of putting it, Jerod. Thank you.

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