Map of life expectancy at birth from Global Education Project.

Thursday, October 29, 2009

There are pills that make you large . . .

but the pills the FDA approves don't do anything at all. Schwartz and Woloshin have a kvetch, that a lot of information the FDA has about the drugs it approves don't make it onto the "label" -- actually a many-page document which is supposed to discuss the risks, benefits, indications and counterindications. The drug companies write these labels themselves, and the FDA just approves them. So, no big surprise, they tend to overstate the benefits and underplay the downside.

However, I take a further lesson from the cases they discuss, which is that some of these drugs never should have been approved in the first place, because they don't actually work. And not surprisingly, these drugs that don't actually work are often among the most heavily marketed and the biggest sellers.

Take Lunesta. If you own a television, you have been exposed to countless visions of formerly sleepless, cranky people passing instantly into sweet oblivion and awaking as though dipped in the fountain of youth. But as it turns out:

Lunesta sales reached almost $800 million last year. Clinicians who are interested in the drug's efficacy cannot find efficacy information in the label: it states only that Lunesta is superior to placebo . . . The FDA's medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.

Oh. So what are we spending the $800 million for?

Well, it's not the FDA's job to decide whether a drug is actually worth anything. It just has to be superior to placebo, not necessarily in any clinically significant way. And while risk of serious adverse effects could make a drug non-approvable in principle, there aren't any clear criteria for deciding when risks outweigh benefits to the extent that a drug should not be approved. Indeed, risks often emerge after approval but seldom lead to withdrawal.

But it has to be somebody's job to make the judgment that it just doesn't make sense to prescribe this drug. That's the agency we don't have here in the U.S. - and no, it's not in any of the Senate bills.


roger said...

so it's an expensive, more effective placebo. pt barnum had our number.

kathy a. said...

interesting stuff.

this is somewhat off-topic -- i'm having a real concern about a med prescribed to a friend for an off-label use, and what a mere mortal like me can figure out is that my friend seems to be acting as a guinea pig for unproven medicine.

the med is Nimodepine, which i understand is used for a certain kind of brain hemorrhage. she has NOT had a neuro consult, and does not have an acute problem. she has some chronic auto-immune and pain disorders, and recently was diagnosed with mitochondrial disease. the med was prescribed because of a short episode of feeling thick-tongued, which the mito doc thinks might be "brain spasms."

my friend essentially blames all medical problems in her family on this mitochondrial disease, from serious physical ailments through her daughter's serious mental illness. and i've been urging caution because i cannot see that mitochondrial disease is a well-developed area of medicine, with proven treatment results.

but i'm horrified that she was prescribed what sounds like a powerful medicine with potentially serious effects, on the basis of a transient and minor symptom, without a real neurological evaluation. it's one thing to prescribe placebos, but i've got all kinds of red flags waving about this noncholant off-label use.

kathy a. said...

obviously, i'm not a medical doctor or pharmacologist. all i've got is dr. google and some native skepticism. maybe there are a lot of important things that i'm missing.

Cervantes said...

"Brain spasms?" WTF is that supposed to mean?

Cervantes said...

If this physician thinks your friend may have had vasospasms, that indicates a medical emergency and should have meant going to the ER without passing go and without collecting 200 dollars. If the doctor believes in "brain spasms," he probably should stick to taking care of Teddy Bears.

The drug is a calcium channel blocker, not dangerous, but this doctor would seem to be very dangerous. The whole story is weird as hell.

kathy a. said...

well, i think it is weird as hell, too. not a lot of what i'm hearing is making a lot of sense to me.

i've never heard the term "brain spasms" before, and the closest thing i can up with colloquially is something like a petit mal seizure. and [a] this doesn't really sound like one, although i guess it could be a symptom, and [b] that's a neurological condition, which [c] needs competent assessment.

greg said...

Take Lunesta. If you own a television,

Precisely. I find that the solution for so many of these problems is not to own a television.