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American Morning

Paging Dr. Gupta: Kids, Antidepressants

Aired January 30, 2004 - 08:47   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


SOLEDAD O'BRIEN, CNN ANCHOR: Let's check in once again at the CNN Center with Dr. Sanjay Gupta. We're talking about children and antidepressants this morning.
Sanjay -- good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning.

A hotly debated topic. When you talk about depression and children and the drugs used to treat them are very, very important topics. And because the prescriptions used to treat that depression are also going up in number, a lot of scrutiny coming into that process.

A couple of interesting things about that. First of all, a particular pharmaceutical company is not required by the FDA to actually disclose the results of its trials unless that drug is being actively marketed to a particular group -- in this case, children.

So, let's say, for example, there have been several negative trials about a drug -- i.e., showing that it didn't work very well -- the public might not actually get that information if the drug is not actually being advertised.

Why is this important? Because, in children, there is only one drug right now that is actually approved by the FDA to actually be used in children, and that drug is Prozac. But a lot of medications are actually being used off-label -- Paxil, Zoloft among them -- to try and treat depression, even though they're not actually approved by the FDA.

There is going to be a meeting on Monday, Soledad -- that's the news -- three days from now, a meeting of the FDA to actually determine whether or not all of the trials that a pharmaceutical company has regarding a particular medication should be made public. Certainly, doctors want that information. A lot of patients do as well -- Soledad.

O'BRIEN: So, why has there been so much criticism of these pharmaceutical companies, then?

GUPTA: Well, you know, it's interesting. The sort of Gestalt (ph) whenever a company has trials, is to release the positive trial information, to release the trials that actually show the drug works, not the negative trial information. And that's for obvious reasons. You don't want to be putting trials out there showing that your drug doesn't work. But more specifically, though, there was an example recently, GlaxoSmithKline and Paxil. That is a common antidepressant. That medication in Britain underwent three negative trials, in children again, showing that the medication was really no better than a placebo as far as children goes.

The warning, though, that the Brits put out regarding this medication was that it should not be prescribed as a new therapy, citing hostility, agitation and suicidal thoughts as reasons for that. When that same warning was translated in the United States, the warning was: no recommendations can be made regarding Paxil and Paxil CR.

So, you can see, Soledad, two very different warnings, both based on the negative trials regarding the specific medication. That has created a bit of flack and a bit of scrutiny.

O'BRIEN: How do the trials differ between adults and children? Are they essentially the same trial?

GUPTA: Well, you know, I think an important point about that -- and most of the researchers we've talked to agree on this -- children should not be considered as small adults. They're very different physiologically, things like that.

With regards to the clinical trials themselves, parental consent is a very important part of that. That's important because you're automatically introducing another party. Close monitoring, even closer perhaps than in the adult trials. Lots of attention to minimizing risks. A real balance, though, with regards to trials in children needs to be struck between the safety issues and the overall efficacy of the medications -- a much tighter balance perhaps than even in the adult trials -- Soledad.

O'BRIEN: Well, if they won't reveal the data, and if some of these trials may not even actually be -- or some of these medications may not actually be beneficial in any way for children, I guess the question would be: How do parents know exactly what they should do?

GUPTA: Well, I think that's a really important point. And obviously, I should point out that there are medications sometimes, such as Prozac, that might be very good for children for their depression. And no one is suggesting that kids not get -- seek treatment in some way, shape or form.

But here are tips, though, and these are tips that we have gotten from various doctors in the field. If a medication doesn't feel right, don't do it. And, you know, medication is not the end-all with regard to treating depression. Know the risks and benefits of treatment. Ask about that when you get prescribed a medication for your child. If there is any unusual reactions, report those right away as well as side effects. Make sure that the treatment is balanced, and what we mean by that is balanced with perhaps counseling in school, interactions in school, things like that. All of that needs to be balanced with regards to treatment of depression. This is a contentious rule, and we're going to keep you up-to- date on that hearing on Monday regarding the FDA. But those are some tips for now -- Soledad.

O'BRIEN: Sanjay, thanks.

GUPTA: All right, thank you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com.






Aired January 30, 2004 - 08:47   ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
SOLEDAD O'BRIEN, CNN ANCHOR: Let's check in once again at the CNN Center with Dr. Sanjay Gupta. We're talking about children and antidepressants this morning.
Sanjay -- good morning.

DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning.

A hotly debated topic. When you talk about depression and children and the drugs used to treat them are very, very important topics. And because the prescriptions used to treat that depression are also going up in number, a lot of scrutiny coming into that process.

A couple of interesting things about that. First of all, a particular pharmaceutical company is not required by the FDA to actually disclose the results of its trials unless that drug is being actively marketed to a particular group -- in this case, children.

So, let's say, for example, there have been several negative trials about a drug -- i.e., showing that it didn't work very well -- the public might not actually get that information if the drug is not actually being advertised.

Why is this important? Because, in children, there is only one drug right now that is actually approved by the FDA to actually be used in children, and that drug is Prozac. But a lot of medications are actually being used off-label -- Paxil, Zoloft among them -- to try and treat depression, even though they're not actually approved by the FDA.

There is going to be a meeting on Monday, Soledad -- that's the news -- three days from now, a meeting of the FDA to actually determine whether or not all of the trials that a pharmaceutical company has regarding a particular medication should be made public. Certainly, doctors want that information. A lot of patients do as well -- Soledad.

O'BRIEN: So, why has there been so much criticism of these pharmaceutical companies, then?

GUPTA: Well, you know, it's interesting. The sort of Gestalt (ph) whenever a company has trials, is to release the positive trial information, to release the trials that actually show the drug works, not the negative trial information. And that's for obvious reasons. You don't want to be putting trials out there showing that your drug doesn't work. But more specifically, though, there was an example recently, GlaxoSmithKline and Paxil. That is a common antidepressant. That medication in Britain underwent three negative trials, in children again, showing that the medication was really no better than a placebo as far as children goes.

The warning, though, that the Brits put out regarding this medication was that it should not be prescribed as a new therapy, citing hostility, agitation and suicidal thoughts as reasons for that. When that same warning was translated in the United States, the warning was: no recommendations can be made regarding Paxil and Paxil CR.

So, you can see, Soledad, two very different warnings, both based on the negative trials regarding the specific medication. That has created a bit of flack and a bit of scrutiny.

O'BRIEN: How do the trials differ between adults and children? Are they essentially the same trial?

GUPTA: Well, you know, I think an important point about that -- and most of the researchers we've talked to agree on this -- children should not be considered as small adults. They're very different physiologically, things like that.

With regards to the clinical trials themselves, parental consent is a very important part of that. That's important because you're automatically introducing another party. Close monitoring, even closer perhaps than in the adult trials. Lots of attention to minimizing risks. A real balance, though, with regards to trials in children needs to be struck between the safety issues and the overall efficacy of the medications -- a much tighter balance perhaps than even in the adult trials -- Soledad.

O'BRIEN: Well, if they won't reveal the data, and if some of these trials may not even actually be -- or some of these medications may not actually be beneficial in any way for children, I guess the question would be: How do parents know exactly what they should do?

GUPTA: Well, I think that's a really important point. And obviously, I should point out that there are medications sometimes, such as Prozac, that might be very good for children for their depression. And no one is suggesting that kids not get -- seek treatment in some way, shape or form.

But here are tips, though, and these are tips that we have gotten from various doctors in the field. If a medication doesn't feel right, don't do it. And, you know, medication is not the end-all with regard to treating depression. Know the risks and benefits of treatment. Ask about that when you get prescribed a medication for your child. If there is any unusual reactions, report those right away as well as side effects. Make sure that the treatment is balanced, and what we mean by that is balanced with perhaps counseling in school, interactions in school, things like that. All of that needs to be balanced with regards to treatment of depression. This is a contentious rule, and we're going to keep you up-to- date on that hearing on Monday regarding the FDA. But those are some tips for now -- Soledad.

O'BRIEN: Sanjay, thanks.

GUPTA: All right, thank you.

TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com.