Raena Morgan: If the FDA is there to protect us, is it possible for a drug to get to market that will cause us harm?
Dr. Timothy Scott: Oh it is, it happens every year. We have 45 class one recalls, on average, every year. Class one recalls are those recalls, which we're talking life threatening, permanent kind of damage to the human body. So we're talking things like Baycol and Fen-Phen. Serious blunders to let that drug on the market. And yet 45 a year are recalled. So yes. We have 250 class two recalls a year.
Morgan: What's that?
Scott: Less serious, but nevertheless, have side effects that are serious enough that we need to recall the drug. So, no, drugs are often dangerous that get approved by the FDA, that's the nature of the process.
You have to remember for one thing, the drugs do not have to work to get approved, they have to be better than the placebo. Better than placebo. In other words if I give you a drug and you say you feel better, you're over your depression. More so than you would if I gave you a sugar pill. In fact, any drug that causes a side effect, any drug that causes you to be a little shaky, any drug that gives you the dry mouth, any drug that causes ringing in your ears, is going to have a better response than a drug that's purely sugar. And consequently, even though the drug may not be about depression, treating depression, it may not have any benefit in that regard at all. If you recognize I'm on a real drug, I have ringing in my ears, my mouth is dry, I'm shaky, then you're going to have it reported that it works better than the placebo. It can get approved. There's also a cost-benefit analysis that the FDA is supposed to do. OK, these drugs have some real negative effects, but is it possible that because all the people with depression would be helped so much if they had something to relive that depression, we need to approve these drugs. That's a very subjective issue, and because that's part of the process, it does in fact, happen, that drugs get approved, because a judgement is made. And it may not be a good judgement call...
Morgan: It's a subjective judgement...
Scott: It's subjective. And so drugs to get approved that should never be approved. That happens every year, many times, every year. That's why we have so many recalls, absolutely.
Dr. Timothy Scott discusses the how and why dangerous drugs, many that later get recalled, get approved for use in the first place. You might be surprised at the low standards some drugs need to get approved for use.
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