Err why is a non lethal, not particularly damaging drug going to be an unethical drug trial?
Ben Goldacre talks about it here (http://www.badscience.net/2011/03/when-ethics-committees-kil...)
We have a variety of treatments that work for some people, but not for others. Combining these sometimes-effective evidence based treatments with the ethics panel weirdness above makes it hard.
People with depression are at increased risk of suicide. They are also at increased risk of suicide during recovery. (Perhaps they are so depressed that they lack motivation to complete suicide, and recovery gives them enough motivation to complete suicide but not enough mood recovery to stop).
That was the propaganda explanation that pharma companies created so they could still sell their drugs even though they cause suicidal ideation and increased suicide rate. It doesn't actually make any scientific sense though, because if you give healthy control volunteers SSRIs then they still have increased levels of suicidal ideation.
Do you have a citation for this? I've only ever heard the "too depressed to commit suicide" theory, so if there's evidence for the alternative, I'd be really interested in seeing it.
I would advice against drawing any strong conclusions from this.
And in any event, it's the best research we have. The idea that SSRIs make people suicidal by eliminating their depression doesn't even make sense, because placebos are just as effective as SSRIs for treating depression but they don't cause an increase in suicidal ideation or actual suicides.
Very interesting! Source?
edit: hivemind
Antidepression drugs, indeed all psychoactive drugs, are always a potential ethics issue. Consider the brouhaha that erupted when it was discovered that some antidepression drugs caused people to commit suicide or have suicidal thoughts:
http://www.medicinenet.com/script/main/art.asp?articlekey=31...
A quote: "The FDA has warned that children and adults taking antidepressants can become suicidal in the first weeks of therapy and that physicians should watch patients closely when first giving the drugs or changing dosages. The FDA is asking drug manufacturers to place explicit warnings about the drugs' side effects, including the risk of suicide, on their labels."
Any human-administered drug is a potential ethical issue, from vitamins upward. Imagine a study in which an experimental group is given a daily vitamin, and a control group is given a placebo but told they're receiving a vitamin. Several years go by and the relative health of the study participants is closely monitored.
Can you not see the ethical issue here? Can you not imagine the lawsuits that would result from the parents of those in the control group who perhaps didn't thrive as expected, or for some completely imaginary consequence having nothing to do with the vitamin study, but sufficient to sue for civil damages?
And finally, depression drugs are hardly "non lethal, not particularly damaging". They are a source of great controversy and have been the focus of a number of conflicts over the years.
After all, what you're generally trying to find out is whether the new treatment is better than what you already have - just being better than a placebo isn't very informative.
If you're interested in this sort of thing, I strongly recommend reading Ben Goldacre's work[1].
[1] Start at badscience.net.
That's one of the reasons such studies are so unreliable -- they depend on a comparison of two or more drugs that may operate in different ways, rather than comparing a drug to the absence of a drug.
The result is predictable -- unbiased meta-analyses show that antidepressants don't work:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fj...
This is not to say that wouldn't have been the outcome anyway, regardless of the methods used, only that testing two drugs at once introduces confounding factors.
Not necessarily. Imagine testing a drug that's supposed to reduce the suicide rate among teenagers, and yes -- it's been done.
Compare suicide rates, write up the result, then spend the next five years in court listening to outraged parents.
The outcome is that these kinds of drugs are no longer tested on humans. Antidepressants are at the top of the list of drugs that are difficult to realistically test, which explains why they were falsely believed to work for so long. On that topic, a recent meta-analysis reveals that they don't work:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fj...
A quote: "Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance."
Translation: "we located all those studies the drug companies suppressed, and when they are included in a balanced analysis, it wipes out the scientific justification for prescribing these drugs."
As far as the issue with some anti-depressives and suicide, the main issue was that drug trials showing this had in some cases been systematically downplayed and in some cases suppressed outright by the companies seeking to profit from these drugs. So the problem there was not with the procedure of medical trials, but rather with the corruption of the procedure of medical trials, for profit.
1. Never said it.
2. It's unethical unless one acquires informed consent from adults. Many of the adults in these studies don't understand enough to give informed consent, and many of the studies involve children.
> So the problem there was not with the procedure of medical trials, but rather with the corruption of the procedure of medical trials, for profit.
And that's the contextual background for any clinical study of antidepressants. Most adults think antidepressants work, but studies show that they don't work:
"Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration":
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fj...
A quote: "Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance."
A situation ripe for exploitation.
It's essential in a discussion like this to quote the other person directly, word for word, as I have just done.
> And to claim that any clinical study of antidepressants is corrupted for profit ...
Circle where I ever said this anywhere. Want to have an imaginary debate? Make stuff up.
> would seem to ignore the fact that the evidence you are using about anti-depressants not working comes from clinical studies.
You're confused. Comparing industry-funded studies, in particular when only those with positive outcomes were even published, to a meta-analysis by non-industry sources that gather and analyze all studies, published and unpublished, is to compare apples and oranges.
For the second, you said it was the contextual background of any clinical study, before then going on to compare clinical studies which you are now saying shouldn't be compared.