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unixronin: Galen the technomage, from Babylon 5: Crusade (Default)
Unixronin

December 2012

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Friday, February 29th, 2008 10:50 pm

Recently, Prozac and related SSRI antidepressants were dealt a blow when it was made public that Eli Lilly, Glaxo-SmithKline and the other manufacturers of the drugs had failed to disclose data from unfavorable clinical studies that showed patients using SSRIs had an increase as much as four to one in suicide risk.  Now, a new study from Hull University, using the data submitted to the FDA to gain approval for the drugs, has found that for most patients, SSRIs are no more effective than a placebo.

Eli Lilly, of course, defends the drugs' effectiveness; and another researcher, the head of psychopharmacology at Bristol University, says that "if they provide some sort of placebo benefit, this shouldn't be discounted."

Now, the thing that immediately occurs to me is this: If you have the choice between a placebo that is medically inert, and has no side effects that aren't psychosomatic, or a drug that performs no better than the placebo, but has a vicious side-effect profile and may quadruple your likelihood of suicide ... aren't you better off with the placebo?

Clarification:

I should point out that I have not read the studies cited; I have only read summaries.  My intention here was not to discuss the studies per se, but rather to question the idea that it's still a good idea to use a drug with known severe side-effects for it's placebo-like effect if it's (allegedly) no better than a placebo.

Saturday, March 1st, 2008 04:16 am (UTC)
The study from Hull is nice for grabbing headlines, but it does have some significant flaws. For one thing, they claimed a broader sweep of application of results from what they actually studied. They reviewed studies people who were less depressed and then said their results were true for people who were a lot more depressed---without any grounds other than assertion for saying so, apparently.

I haven't read the actual Hull meta-study, just a critique of it, but apparently there's a lot there to critique.

For another thing, sometimes there are significant reasons other than "we didn't like the results" for not including a study in the FDA trials such as tinkering in studies to try to find the right effective doses or serious methodological or design flaws in the excluded study. Apparently this wasn't covered to the satisfaction of the person whose review I read.

"Most patients"---again, I could show easily that for most patients with an upper respiratory infection, antibiotics are no more effective than a placebo. If a whole lot of those patients had colds as opposed to a bacterial infection, I'd get that result---but antibiotics are effective in people who have the condition for which they should be prescribed.

The guy from Bristol is just an example of someone making a lousy argument in defense of his position on an issue. I could argue that clouds cause rain because anything up in the sky when it rains is a partial cause of the rain. It's a lousy argument, but clouds still cause rain.

The increase in suicide risk is common to all antidepressants in the initial phase because when you have someone who is extremely depressed, they frequently want very much to kill themselves but don't have the energy or willpower to follow through with it. Because the energy and willpower often kick back in before the will to live does as depression lifts, these people start feeling better enough to follow through with killing themselves, so they do. It's a problem with all antidepressants, including the ones in use for decades.

The drugs wouldn't be increasing suicide risk if they weren't lifting severe depressions--because the lifting of the depression itself is what increases risk.

After patients get past those first weeks where their antidepressants start to kick in and get to where they've fully kicked in, they're out of the woods as far as antidepressant-related suicide risk goes, and their suicide risk is lower overall because their depression is lifted.

It's a study with some very sensationalist conclusions that got a lot of press. It just happens that not all of their conclusions logically follow from what they actually studied.