Warning Labels For Diabetes Drug Side Effects.
The recent kerfuffle over the diabetes drug Avandia has caused the FDA to ask the drug company that makes Avandia and a similar drug, Actos, to include a “Black Box Warning” on the package inserts for the drugs, telling patients that the drugs might increase the risk of heart attacks.
I’m not sure what good the Black Box Warning will do. I mean, how many people even receive a copy of the drug inserts for the drugs they take? Even if they get them, how many people actually read the things?
The diabetes drug metformin has a Black Box Warning about lactic acidosis. I would have read it, but I fell asleep while reading Table 8, “Summary of Mean Percent Changes from Baseline in Major Lipid Values at Final Visit (18-Week Studies),” trying to compare it with Table 4, “Summary of Mean Percent Change from Baseline of Major Serum Lipid Variables at Final Visit (29-Week Studies),” and wondering why they were “changes in major lipid values” in Table 8 but “changes of major serum lipid variables” in Table 4.
But just in case Black Box Warnings do help, I think maybe we should issue such alerts for things other than drugs. For example, driving while making cell phone calls to your bookie probably has a lot of harmful side effects in addition to the losses you incur when you put next month’s mortgage payments on a horse named Escargot (now you know why your father told you to study French). So how about making your cell phone display a black box everytime you try to dial: WARNING! Using this cell phone while driving a motor vehicle may have harmful side effects such as death, loss of limbs, blindness, increased insurance rates, or scratches on your new red Maserati quattroporte.
Eating has side effects. Why doesn’t the FDA require refrigerator manufacturers to warn us about that, like they make them warn us we shouldn’t do other tempting things like using our toasters in the shower.They should insist on a Black Box Warning on the front of every fridge. WARNING! Eating has harmful side effects such as burping (3% compared with 1% on placebo), stretching of belts (55% compared with 20% placebo), food allergies, horizontal expansion, tooth decay, deciding what to do with leftovers, destruction of bathroom scales in a fit of pique, and having less room for beer. Besides, if we didn’t eat, we wouldn’t have to shop for groceries, and then we wouldn’t have to keep making that agonizing decision about whether to ask for paper or plastic.
Perfume has side effects. I see a Black Box Warning on all perfume bottles. WARNING! Using this perfume may lead to romantic entanglements, which could lead to marriage, which could lead to children, which could lead to the need for a larger house, which could lead to a huge mortgage, which could lead to bankruptcy, which could lead to an inability to get more credit cards, which could lead to an inability to shop at expensive perfume stores. Use caution when applying this product or, even better, simply buy this expensive product and put it on a shelf, unopened.
Studies have shown that fire fighters have up to 136% higher rates of heart attacks when fighting fires than when doing slightly less exciting things like washing fire trucks or playing pinochle in the firehouse.Yet no one is suggesting any fire fighter–related Black Box Warnings. I think these should be required on all fire engine books and toys. WARNING! Using this toy could cause your child to become interested in fire fighting as a career. This means that your child would not become a doctor, as you’d hoped, and thus the child next door, whose father is worth $10 million, might decide to marry someone else. Furthermore, if you had a stroke and you were at death’s door, you’d have to rely on the advice of strangers instead of a child with an MD, and death might be the outcome. Better you should buy your child a nice book on dinosaurs instead.
Finally, I don’t see why all children aren’t slapped with Black Box Warnings as soon as they’re born, at least until we can figure out how to put the warnings on them when they’re in the womb, where they’d show upon the ultrasound photos. Warning! Raising this child may have serious side effects such as lack of sleep, cleaning yuchy stuff off the floor, having to care for dogs and cats and turtles and gerbils you don’t really want, going to PTA meetings, spending sleepless nights when the child learns to drive, worrying about whether to have an awkward conversation about drug use and sexually transmitted diseases, spending $500,000 for college tuition and then finding out your child wants to be a fire fighter after all, worrying that the child has married the wrong person, wondering why you never see your grandchildren, and hating the nursing home your child forced you to move into.
Sort of makes Avandia and Actos mild in comparison, doesn’t it.