Still more controversy over this group of medications. A new study suggests that patients with bipolar disorder who take these anti-epileptic drugs donot have an increased risk of committing suicide, despite FDA warnings to the contrary ( back story here).
Bipolar patients treated with antiepileptics attempted suicide at the same rate as patients who received no medication or lithium. The rate of suicide attempts was higher before patients began taking the meds than afterwards, according to the study in the Archives of General Psychiatry (see abstract). And compared with patients taking no drugs, those on a single antiepileptic had a reduced risk of suicide attempts.
The study, which analyzed records collected between 2000 and 2006 on 47,918 bipolar patients from the PharMetrics Patient Centric Database, a national claims database, was led by Robert Gibbons of the University of Illinois at Chicago, whose previous study on antidpressants and suicides was controversial. Two years ago, he published a study in the American Journal of Psychiatry blaming a 14 percent rise in teenage suicides - from 2003 to 2004 - on the widespread publicity given links between antidepressants and suicide (background here).
Why did the study differ from the findings of the FDA meta-analysis of randomized clinical trials? "There are several possibilities," the researchers wrote. "First, the FDA analysis was based on adverse event reports of suicidal thoughts and behavior, whereas our analysis is based exclusively on suicide attempts. Second, the FDA meta-analysis combined several indications including psychiatric, pain, and epilepsy. Note that the FDA's subanalysis for psychiatric indications was not significant. Third, most of the suicidality events in the FDA analyses were observed for only 2 of the 11 AEDs, lamotrigine and topiramate.
"Fourth, the results of the FDA analysis could be affected by 2 ascertainment biases. Patients treated with a drug will have more adverse effects than patients taking a placebo and, therefore, more opportunity to describe their suicidal thoughts.16 Suicide attempts by an overdose of study medication will result in contact with the health care system (eg, an emergency department), and therefore have a greater likelihood of being detected than an overdose while taking placebo."
In the latest study, the researchers wrote their analysis "reveals that there is a selection effect, in that the pre-treatment suicide attempt rate is five times higher than the rate in untreated patients. If pre-treatment suicide attempt rates reflect the severity of illness, it is the more severely impaired patients who receive treatment with an antiepileptic drug or lithium. Nevertheless, the post-treatment suicide attempt rate is significantly reduced relative to their elevated pre-treatment levels to the level found at or below patients not receiving treatment."
The study was funded by the National Institute of Mental Health and the Agency for Healthcare Research and Quality. Gibbons has served as an expert witness for the US Department of Justice, Wyeth, and Pfizer, regarding Neurontin, one of the drugs reviewed in the study. Other disclosures: John Mann received research support from GlaxoSmithKline and served as an adviser toi Lilly and Lundbeck Pharmaceuticals. C. Hendricks Brown directed a suicide prevention program at the University of South Florida that received funding from JDS Pharmaceuticals.
4 Comments
Gibbons and Mann, are nothing more then Idustry apologists with a blowhorn in hand. I would like to see these two characters investigated.
Bipolar, as defined today, is just the new "Disease De Jour" of the day...
I'm so happy to see that the so-called "suicide experts" have branched out into protecting the profits of another class of drugs besides SSRIs.
But before we leave that topic, I have a point to make.
Mann served as an expert for Glaxo in Paxil suicide cases. How is it that he presumably had access to the same studies as plaintiff's experts, such as Joseph Glenmullen, who reported that in adult studies conducted with Paxil in the late 1980s, before it was ever approved, people on Paxil were 8 times more likely to become suicidal than people taking placebos.
How did Mann ever respond to that report, does anybody know? Grassley discussed it at length in the congressional record.
In fact, Grassley supposedly asked for an explanation from Glaxo and the FDA. Does anybody know what happened there?
Glaxo by the way, has been busy quietly settling suicide cases left and right once jury trials were set to begin.
I hear birth defect cases are being quietly settled as well. Surprise, surprise.
One more thing for Ed, who I think does such a wonderful job that I hate to even bring it up but I think it's important.
The headline for your blog gives the impression that epilepsy drugs are flat out cleared as far as increasing suicide risk.
But as I understand it, the study was actually only on people with bipolar disorder and the drugs are prescribed for a multitude of ailments on and off-label so I think the headline could potentially give many users the wrong message.
Again, I almost hate to even mention it because I can not say enough about your reporting, and I certainly know it was not intentional.
Well I did one time tell my ex husband I didn't want to live anymore. I didn't think anything of my tegretol. But my mom told me when I was a teenager and they put me on tegretol I acted totally different. I tried to run away. She said I they were trying out different epilepsy drugs and they took me off of that and put me on Dilantin. I was put back on Tegretol when I was pregnant. My mom to this day still tells me to tell the doctor to put me back on Dilantin.