Tuesday, February 26, 2008

sign me up for a sugar pill

It's midterms, which means my awareness of the world has shrunk to the space between my coffee pot and desk, but a friend insisted that I pay attention to this story right now - and I'm glad he did. PLoS Medicine has just published a report titled Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration; granted, it's one of those titles that doesn't immediately tell you what it's about (and since I'm in the middle of preparing a few abstracts, as well, my brain is itching to red pencil it, but I digress). So what is this unwieldily-titled paper about? According to the succinct title The Guardian gave their report of the issue, it's simple: prozac, used by 40 million people, does not work. From that article,
Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs.

The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.
Kirsch and company go on to emphasize that counseling should be the first choice, and medication a very last recourse. But the researchers also go on to emphasize that this raises broad questions about drug data reporting and drug licensing; in an article at BBC News, Dr. Tim Kendall argues that drug companies should be forced to publish all their data, regardless of conclusion - something that many people have been arguing for years, and has come up in this blog recently.

Part of the reason that this is a new, and believed to be groundbreaking study (at least by the researchers) is that Kirsch and colleagues requested the full set of trial data on four drugs (prozac, seroxat/paxil, effexor, and serzone) from the FDA via the freedom of information act; two newer drugs (celexa and zoloft) were excluded because the full information wasn't yet available via the FOA. They argue that this additional and unpublished research shows that there is simply no benefit to the drugs.

Now it should go without saying that this is a research study, and anyone taking these drugs shouldn't decide to stop taking them without first consulting your prescribing physician. That said, while I take an anti-depressant that's not on the list, under the theory that it will decrease the pain I experience by increasing the dopamine in my brain, I think I'll be printing out the PLoS Medicine report and taking it in for a discussion with my own doctor.

Perhaps most to the point, I do agree with the researchers and commentators who say that this, more than anything, emphasizes that all research collected on a medication should be reported - positive, negative, or neutral. It's becoming obvious that we can't trust the FDA to make decisions on the effectiveness of these drugs; that doctors and patients are going to have to become the experts, or at least have all the data at their fingertips in order to make their own informed decisions.

And with that, I ought to get back to midterms. See you all in another day; I've got a collection of things to bring up once I'm out from under this epistemological cloud.


A said...

Wow. I am astonished. I haven't looked at the journal article in detail yet, but...wow. Antodepressants are so much a part of American culture.

Anonymous said...

Kelly, welcome back, we missed you!

Sue Trinidad said...

Great to have you back, Kelly! Good luck with midterms.

Kelly Hills said...

Thanks for the welcome backs, folks. I finished midterms (minor cheer, chorus of angels, etc), only to be immediately felled by Flu 2.0.

This, I am assuming, is my body's way of telling me I'm too old (at 32) to keep pulling all-nighters. I am not amused.

And yes, to be honest, this article really surprised me, too, and for much the same reason A~ said. Antidepressants are so much a part of our cultural landscape - pop culture books have been written about them! - and medical treatments, where you pop a pill now before even considering that quaint and old fashioned talking things out... and for most people, a sugar pill is as effective?

On the one hand, the power of the brain is an amazing thing - that we just need to believe we're getting better (and it might have some to do with the actual cause of needing the pill in the first place, right?), but on the other... the grossest of fraud.

It's a weird one to even think about; antidepressants are so pervasive it's hard to think of even what it means, that they're so uneffective for the majority of people taking them.

Evelyn said...

I know that you said it seems that the difference in effectiveness with the most severely depressed people is because the placebo is less effective, rather than the drug being more. But I wonder if it's a case of anti-depressants being overprescribed to people who are simply sad, rather than actually suffering from a chemical imbalance in their brains.
We have a general understanding that depression is not the fault of the depressed. Maybe for people who can't seem to "snap out of it", a pill works because it makes their depression an external thing with a concrete solution.
I agree that counseling should always be the primary course for dealing with depression, and medication a last resort, but Dumbo didn't learn to fly until he had his feather.
(and wasn't there a recent report that a great many doctors give out placebos without patient knowledge in order to placate patients who don't actually need medication?)