same article I excerpted from yesterday, on mcmanweb ...
In 1999, GSK published a study showing that Lamictal was effective for treating bipolar depression in its acute (initial) phase. The finding was at best ambiguous, as the study failed on its primary endpoint.
GSK spent the next six years working to come up with a study that would impress the FDA. (The FDA looks for at least two successful trials.) In all, GSK sponsored seven more acute phase trials testing Lamictal for unipolar and bipolar depression. In each of these studies, Lamictal failed to beat the placebo. Predictably, none of these studies was published.
But GSK did come up lucky in two long-term studies showing that, compared to lithium, Lamictal worked better at delaying relapses into bipolar depression. These studies had a major flaw in that the long-term phase only included patients who had responded to lithium or Lamictal during the initial phase of the study. In other words, "nonresponders" likely to fail had been weeded out.
Another point: Virtually all the patients in the study relapsed anyway. It just took the Lamictal patients a bit longer, so the two studies basically proved nothing.
Nevertheless, on the strength of these two studies, in 2003 Lamictal received an FDA indication for "bipolar maintenance."
Chances are you have heard your doctor sing praises to Lamictal as the magic bullet for treating bipolar depression, even though there is absolutely no scientific evidence to support this. Predictably, GSK did nothing to disabuse patients and clinicians of the notion. Quite the contrary, GSK launched an aggressive advertising and marketing campaign targeted specifically at bipolar depression.
Four North American treatment guidelines, including one put out by the American Psychiatric Association, bought into the hype and came out recommending Lamictal as a first option for treating acute bipolar depression. Ironically, treatment guidelines are supposed to be "evidence-based." (A more recent guideline put out by the APA finally got honest.)
It doesn't stop there. Enter the competition. In late 2003, Eli Lilly received a true FDA indication for its combo Prozac-Zyprexa pill, Symbyax, to treat bipolar depression. Confident its own med would crush the competition, Eli Lilly sponsored a head-to-head trial (with no placebo group) pitting Symbyax against Lamictal under conditions that gave its own drug considerable home field advantage.
Part of the home field advantage included a short seven-week trial period. This is because Lamictal requires a slow titration, involving gradually raising doses over six weeks. Surely, Symbyax would outperform a drug not yet out of the starting gate. But - surprise - on the important measure for bipolar depression, Lamictal and Symbyax ended up in a virtual dead heat. Not only that, those on Lamictal had way fewer side effects.
Here's how Eli Lilly spun the study (published in 2006):
[Symbyax]-treated patients had significantly greater improvement than [Lamictal]-treated patients in change from baseline across the 7-week treatment period on the Clinical Global Impressions-Severity of Illness scale ...
The best way to explain the spin is this: If Eli Lilly were AIG (which went belly up in 2008 in one of the biggest financial scandals in history), they would be reporting record profits.
Ironically, the one unambiguous finding in favor of GSK's Lamictal came from the competition.
Take home message: Psychiatrists swallow this type of bullshit wholesale everyday, which then gets passed on to you as medical advice. Caveat emptor.