Talk To Me
When a clinical study is described by The New York Times as a “landmark government-financed” study, that’s a pretty good tip off that we’re all supposed to give a respectful bow and accept the results as gospel. After all, landmarks stand for the ages, and government financing, well, that’s the gold standard of impartiality right?
All of my skeptical alarm bells started clanging earlier this month when the Times and other mainstream media outlets reported that a National Institutes of Health (NIH) study showed that Prozac was more effective than counseling (or “talk therapy”) in helping teens overcome depression.
And just as I suspected, there’s a cow in the ointment, because: A) Drawing conclusions from the current results is ridiculously premature, and B) If you insist on jumping to conclusions, then the real headline is not about the effectiveness of the drug, its about the drug’s danger.
There’s your landmark right there.
The kids are alright
The new study won’t be published until this summer. But drawing on reports from several news outlets we can piece together the basic nuts and bolts.
The NIH enlisted about 440 kids, aged 12 to 17, who were diagnosed with moderate to severe depression. The subjects were then assigned to four groups:
- Daily dose of Prozac
- Daily placebo
- Talk therapy with no medication
- Prozac and talk therapy combined
Treatments lasted for 36 weeks, but during the first 12 weeks, 61 subjects dropped out of the study for reasons unreported at this point. Using a common psychological measurement scale, the combined talk therapy and Prozac group had the best outcome, with 71 percent responding well to treatment. Among those who received only Prozac, 61 percent responded well, while 43 responded well to talk therapy alone. In the placebo group, 35 percent responded well.
“Case closed,” was the general tone of the news reports. Combine Prozac with counseling, and well over two-thirds of the kids improve, they said. Don’t want to bother with therapy? No problem – just back up the Prozac truck and plenty of kids will be chipper again in no time.
Unless they decide to harm themselves.
High stakes
As I mentioned above, these results are far too premature for the Times or anyone else to start throwing around a term like “landmark.”
The subjects in the study were tested for 36 weeks, but the reported results are only based on an analysis of the first 12 weeks. So since we don’t know what the analysis of the remaining 24 weeks might bring, maybe we should keep the corks in the champagne bottles for just awhile longer. Or at the very least, the NIH shouldn’t deliver thumbs-up information that doctors and parents of young patients may act on.
But what received even less attention was the rate of attempted suicides among the subjects. Buried deep in the Times report is the information that among those who finished the study but didn’t take Prozac, there was one suicide attempt. And among those who did take the drug: five attempts.
If I’m a parent with a depressed teen, I can’t like those odds.
Pass it on
Most people never lay eyes on a drug company study – they get their information about studies from the mainstream media. And it’s been obvious for a long time that some of the gritty and most revealing details of most of these studies never make the 6:00 o’clock news.
Of course, the media isn’t completely to blame for this. When drug companies conduct studies that produce unwanted outcomes, the results may end up as part of the FDA’s public record, but only the studies that deliver positive conclusions are promoted for high-profile publication and then given a big shove into the mainstream spotlight.
That’s one of the reasons why New York State is suing GlaxoSmithKline (GSK), makers of the antidepressant Paxil. The NY suit charges that GSK suppressed four studies that concluded the drug was ineffective in treating adolescents. The suit also claims that the studies draw a possible link between Paxil use and suicidal thoughts among adolescent users.
Did you hear about those four studies on the news? Nope. Not a peep. Not until the NY attorney general decided to do something about them. And although the outcome of this lawsuit will be a long time coming, I’m hoping that the notoriety of it will be enough to create my favorite kind of regulation: Water Cooler Regulation. When people start talking about the dangers of antidepressants for kids around the water cooler, that will do more to inform the public than any number of government-mandated warning labels.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
“Antidepressant Seen as Effective in Treatment of Adolescents” Gardiner Harris, The New York Times, 6/2/04, nytimes.com
“Prozac Use by Teen Seen as Effective” Reuters, 6/2/04, msnbc.msn.com
“Prozac ‘Best for Children'” Mark Sage, The Journal, 6/3/04, icteesside.icnetwork.co.uk
“NY State Sues Drug Giant” CBS News, 6/3/04, cbsnews.com