Defendants rebutted this claim by offering the testimony of Dr. Robert Gibbons, a professor of statistics at the University of Illinois at Chicago, where he is also the Director of the Center for Health Statistics. Dr. Gibbons is one of a handful of statisticians worldwide who has been elected to the Institutes of Medicine of the National Academy of Sciences. Dr. Gibbons also reviewed clinical trial data for the use of Neurontin for migraine prophylaxis, and concluded that the trials show there is a “trend in the direction of increased benefit” for migraine patients using Neurontin. However, when the Court directly asked Dr. Gibbons if Neurontin is “effective or not effective for migraine,” he responded that “there’s a trend toward effectiveness … [but] I can’t say statistically that it is [effective].”
Gabapentin and suicide attempts
by Gibbons RD, Hur K, Brown CH, and Mann JJ.
Pharmacoepidemiological Drug Safety. 2010 19[12]:1241-7.
[full text online]
PURPOSE: On 16 December 2008, FDA issued a class warning for antiepileptic drugs and suicidal thoughts and behavior. The purpose of this study was to determine if the antiepileptic drug gabapentin increases risk of suicide attempt in patients to which it was prescribed for various indications.
METHODS: We conducted a pharmacoepidemiologic study in which suicide attempt rates were compared before and after gabapentin was prescribed. We used the PharMetrics medical claims database to study the relationship between gabapentin and suicide attempts in a cohort of 131,178 patients with a 1-year window of information before and after initial prescription. Patients had diagnoses of epilepsy, pain disorders, bipolar illness, major depressive disorder, schizophrenia, and other psychiatric disorders.
RESULTS: Overall, there was no significant difference in suicide attempt rates before [3.48/1000 patient years–PY] versus after [3.45/1000 PY] gabapentin prescription. Pre-prescription suicide attempt rates were five times higher in psychiatric populations compared with non-psychiatric populations leading us to analyze the two groups separately. No drug effect was detected in the non-psychiatric populations. Significant reductions in suicide attempt rates were seen for bipolar disorder [47.85/1000 PY versus 31.46/1000 PY], major depressive disorder [17.30/1000 PY versus 12.66/1000 PY], and other psychiatric disorders [12.84/1000 PY versus 10.14/1000 PY]. Person-time analysis revealed an overall significant reduction in suicide attempt rates [2.01/1000 PY on drug versus 2.30/1000 PY off drug].
CONCLUSIONS: This study finds that gabapentin does not increase risk of suicide attempts in non-psychiatric populations and is associated with a reduction in suicide attempt risk in patients with psychiatric disorders.
His study was triggered by an FDA STATISTICAL REVIEW AND EVALUATION of ANTIEPILEPTIC DRUGS AND SUICIDALITY released in May 2008 that resulted in a label warning about suicidal behavior and ideation with all antiepileptic drugs [AEDs], including Neurontin, with this table. Neurontin was not the major offender:
| Risk by indication for antiepileptic drugs in the pooled analysis | ||||
| Indication | PLACEBO /1000 |
DRUG /1000 |
Relative Risk |
Risk Difference |
| Epilepsy | 1.0 | 3.4 | 3.5 | 2.4 |
| Psychiatric | 5.7 | 8.5 | 1.5 | 2.9 |
| Other | 1.0 | 1.8 | 1.9 | 0.9 |
| Total | 2.4 | 4.3 | 1.8 | 1.9 |
You’ll be relieved to know that I’m not going to go postal reanalyzing Dr. Gibbons’ statistical study of 131,178 Managed Care records like I did with his antidepressant papers. I agree with Judge Saris. In my lightly informed opinion, Neurontin is a non-issue. I see lots of patients on it up here in Appalachia. When I ask what it’s for, they say "it’s for my bipolar" or "it’s for my pain" or "I don’t know." I offer non-epileptics the chance to stop it in my endless campaign to decrease pill counts [note: with taper]. Most do and some don’t. Either decision seems to come out the same – no difference. I give "real bipolar" patients other medications, so I have zero experience using Neurontin for anything. That’s not my point here.
As was made very clear in the article in my last post [a symptom…] and in Judge Saris’ well researched decision, the whole Neurontin craze was an industry initiated scam – one that cost Pfizer $95 M and cost the rest of us a lot more. Other than being a reasonably well-tolerated anticonvulsant, Neurontin has no real place in the psychiatric pharmacopoeia. And as for Dr. Gibbons’ paper, his study implies that taking Neurontin decreases the suicide attempt rate in bipolar and other psychiatric conditions. It’s an odd assertion to make since, with only occasional exception, even Parke-Davis and Pfizer run Clinical Trials are unable to demonstrate Neurontin’s efficacy in psychiatric illness.
Maybe Gibbons is a reactionary incensed about the leftward tilt of the FDA?
Gibbons is once again on the presenter list for Charlie Nemeroff’s Psychiatry Grand Rounds this “academic” year at Miami. So is Martin Keller. And so are a few others from the Rogue’s Gallery of Psychiatry. It seems they all want fun in the sun. And there is no better place to have fun than in Charlie’s haunt.
A further question: Is there any way of finding out how many “academic” Psychiatry departments have invited Nemeroff (or the rest of the Rogue’s Gallery) to present at Grand Rounds? I ask because an invitation is usually regarded as a sign of esteem in the field.
Remarkable!
I don’t know how to see about Nemeroff’s invites. I’m betting on zero to none [but he does have a way of rising from the ashes when you least expect it]…
That didn’t take long. Here he is at NYU in January:
http://www.veomed.com/grandrounds/archive&vid=817631&gnr=824342
Check this out:
http://tinyurl.com/9s4xxft
fyi http://www.nejm.org/doi/full/10.1056/NEJMp1210007?query=TOC
Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50
last paragraph
“Only in the past decade, through the action of the Reforming States Group, the Drug Effectiveness Review Project, and most recently funding of comparative effectiveness research through the American Recovery and Reinvestment Act, the Affordable Care Act, and now the Patient-Centered Outcomes Research Institute, have we begun to catch up on the vital project of comparing therapeutics so that American consumers and their physicians can make meaningful treatment decisions — the project that motivated Kefauver’s original investigations a half century ago.”
Jeremy A. Greene, M.D., Ph.D., and Scott H. Podolsky, M.D.
N Engl J Med 2012; 367:1481-1483October 18, 2012DOI: 10.1056/NEJMp1210007