Spitzer on drugs

New York Times readers with troubled kids must be very confused today. Yesterday, a front page story claimed that antidepressants worked wonders on children. Then, 24 hours later, the paper of record gave similar front page treatment to news that New York State Attorney General Eliot Spitzer had sued GlaxoSmithKline for failing to reveal clinical trial data showing its antidepressant didn't work in kids.

Why the discordant messages? The first story reported the early results from a government-funded clinical trial showing that Prozac was better than talk therapy or a placebo. An objective source? Hardly. The trial was conducted by Dr. Graham Emslie, a Texas-based psychiatrist who is one of the nation's leading advocates of medicating depressed children. Emslie's corporate client list reads like a who's who of the drug industry and includes Eli Lilly, maker of Prozac. Alas, the Times never told its readers this fact.

Though funded by NIH, Emslie's was a curiously designed trial. It looked only at Prozac, the first serotonin reuptake inhibitor. Previous trials had already shown it to be the only SSRI that was effective in kids. For some reason, the government didn't ask Emslie to compare it to other SSRIs.

Despite the missing comparisons, the Times story did nothing to differentiate Prozac from its many me-too SSRI rivals, which have entered the market in the years since Prozac's spectacular debut. The headline suggested that all "antidepressants" were effective in children.

The Spitzer suit, coming only a day later, must have embarrassed the Times editors into giving it the same front page placement. Had they fact checked their headline the previous day, they would have learned that copycat SSRIs like Paxil and Zoloft have never been shown to be effective in children. In fact, tests submitted to the FDA for patent extensions revealed just the opposite: they were no better than placebo.

Moreover, there are dozens of lawsuits across the country alleging the drugs have caused suicides and suicide idea formation in some youths who take them. Unpublished clinical trial data obtained in those lawsuits formed the basis of Spitzer's suit.

Meanwhile, the Food and Drug Administration's inquiry into the suicide side effects of SSRIs continues. Despite an internal review suggesting most of this class of drugs has no efficacy in kids (why would you accept any risk if there is no benefit?), the agency has refused to follow its British counterparts and ban their use in children. It awaits a comprehensive data review by Columbia University psychiatrists, which is due out this summer.

This scenario should sound familiar to anyone who remembers the government's response to the Enron scandal. While the Securities and Exchange Commission dithered, the crusading A.G. from the Empire State rushed in to fill the void. Now we have a similar situation unfolding in drug regulation.

I applaud Spitzer. But in the end, state regulation is no solution. No state official, no matter how aggressive, has the scientists, the experience or the clout to effectively take on Big Pharma. Only the FDA can protect the American people from dangerous drugs. And when it comes to kids, they should err on the side of caution.

Posted by gooznews at June 3, 2004 10:04 PM