Midpack
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Did anyone else see this segment on 60 Minutes last night? I was stunned, not by the effectiveness of anti-depressants specifically, but by how marginally effective drugs are FDA approved, put on the market and prescribed. WOW!
Per the FDA - if a drug proves effective in two clinical trials, it can be approved, even if the same drug has failed to provide better results than a placebo in ten other trials. Silly me, I just assumed to be approved, the drug would have to prove effective in a majority of the trials at the very least.
Some quotes (italics my remarks) that I can't get my head around, full video below.
Treating Depression: Is there a placebo effect? - 60 Minutes - CBS News
Per the FDA - if a drug proves effective in two clinical trials, it can be approved, even if the same drug has failed to provide better results than a placebo in ten other trials. Silly me, I just assumed to be approved, the drug would have to prove effective in a majority of the trials at the very least.
Some quotes (italics my remarks) that I can't get my head around, full video below.
From the Dr taking the counterpoint in favor of marginally effective drugs. "Especially for the mildly depressed, using a different methodology, he finds that the drugs help 14 percent of those moderately depressed, and even more for those severely depressed. Thase: I wish our antidepressants were stronger. I hope we have better ones in the future. But that 14 percent advantage over and above the placebo is for a condition that afflicts millions of people, that represents hundreds of thousands of people who are better parents, who are better workers, who are happier and who are less likely to take their life." And 6 times as many who take anti-depressants without benefit, at what cost to all of us?
Here he offers that anti-depressants are effective for moderately depressed patients in 14% of cases, and in his opinion that's worth the cost overall (an $11.3 BILLION dollar industry, how much of that provides an actual benefit?). WHAT??
To approve any drug, the Food and Drug Administration merely requires that companies show their pill is more effective than a placebo in two clinical trials - even if many other drug trials failed.
Brown: The FDA for antidepressants has a fairly low bar. A new drug can be no better than placebo in 10 trials, but if two trials show it to be better, it gets approved.
Stahl (CBS): Does that make sense to you?
Brown: That's not the way I would do it if I were the king. But I'm not.
Dr. Tom Laughren, director of the FDA's division of psychiatry products, defends the approval process.
Stahl (CBS): We're told you discard the negatives. Is that not right?
Tom Laughren (FDA): We consider everything that we have. We look at those trials individually--
Stahl (CBS): But how are you knowing that the two positives deserve bigger strength in the decision?
Laughren (FDA): Getting that finding of a positive study by chance, if there isn't really an effect, is very low. I mean, that's basic statistics and that's the way clinical trials are interpreted. A separate question is whether or not the effect that you're seeing is clinically relevant.
Stahl (CBS): Okay. Is it clinically relevant?
Laughren (FDA): The data that we have shows that the drugs are effective.
Stahl (CBS): But what about the degree of effectiveness?
Laughren (FDA): I think we all agree that the changes that you see in the short-term trials, the difference between improvement in drug and placebo is rather small.
Stahl (CBS): It's a moderate difference.
Laughren (FDA): It's a small, it's a modest difference.
It's so modest - that in Great Britain the National Health Service decided to dramatically revamp the way these drugs are prescribed. It did so after commissioning its own review of clinical trials.
Tim Kendall (UK NHS): We came to the conclusion that for mild to moderate depression, these drugs probably weren't worth having.
Stahl (CBS): At all.
Kendall (UK NHS): Not really.
Treating Depression: Is there a placebo effect? - 60 Minutes - CBS News
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