4 ms·

And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the arti

And this article doesn't even cover 95% of the problems with the FDA, many of which are as bad or worse. But on this topic, here is a good example that the article missed: http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9... Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents would stop spending money on them.

refurb 12y ago
The FDA's actions in this case are understandable. Proving that CNS drugs work is a huge pain in the ass and the FDA knows this. There is a huge placebo effect (that is interestingly increasing over time) and the our tools to measure depression frankly suck (too subjective). Yes, a number of antidepressant trials failed to show efficacy. However, a few of the trials did show improvement. The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have). Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.
- Alex3917 12y ago
  > The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?
AdamMickiewicz 12y ago
I'm sorry, I thought that FDA is there precisely to protect us from ineffective or dangerous drugs. Not to cover it up to protect the big pharma.

refurb 12y ago

The FDA's actions in this case are understandable. Proving that CNS drugs work is a huge pain in the ass and the FDA knows this. There is a huge placebo effect (that is interestingly increasing over time) and the our tools to measure depression frankly suck (too subjective). Yes, a number of antidepressant trials failed to show efficacy. However, a few of the trials did show improvement. The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have). Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.

Alex3917 12y ago
> The FDA decided that allowing patients access to a potentially helpful therapy (antidepressants do help some patients) is better than just pulling the product off the market. I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?

AdamMickiewicz 12y ago

I'm sorry, I thought that FDA is there precisely to protect us from ineffective or dangerous drugs. Not to cover it up to protect the big pharma.