Editing Pfizer (section)

====2004 Illegal marketing of gabapentin for off-label uses settlement====
In 1993, the [[Food and Drug Administration]] (FDA) approved [[gabapentin]] only for treatment of [[seizures]]. [[Warner–Lambert]], which merged with Pfizer in 2000, used [[continuing medical education]] and [[medical research]], sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for [[off-label use]]s such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses.<ref>{{Cite journal |vauthors=Steinman MA, Bero LA, Chren MM, Landefeld CS |date=August 2006 |title=Narrative review: the promotion of gabapentin: an analysis of internal industry documents |journal=[[Annals of Internal Medicine]] |volume=145 |issue=4 |pages=284–93 |doi=10.7326/0003-4819-145-4-200608150-00008 |pmid=16908919 |doi-access=free}}</ref> In 2004, the company paid $430{{nbsp}}million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the [[False Claims Act]].<ref>{{Cite journal |last=Henney JE |date=August 2006 |title=Safeguarding patient welfare: who's in charge? |journal=[[Annals of Internal Medicine]] |volume=145 |issue=4 |pages=305–7 |doi=10.7326/0003-4819-145-4-200608150-00013 |pmid=16908923 |s2cid=39262014}}</ref> A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis.<ref>{{Cite journal |vauthors=Mulleners WM, McCrory DC, Linde M |date=August 2014 |title=Antiepileptics in migraine prophylaxis: An updated Cochrane review |journal=Cephalalgia |volume=35 |issue=1 |pages=51–62 |doi=10.1177/0333102414534325 |pmid=25115844 |s2cid=43079346|doi-access=free }}</ref> The [[American Academy of Neurology]] rates it as having unproven efficacy, while the [[Canadian Headache Society]] and the [[European Federation of Neurological Societies]] rate its use as being supported by moderate and low-quality evidence.<ref>{{Cite journal |vauthors=Loder E, Burch R, Rizzoli P |date=June 2012 |title=The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines |journal=Headache |volume=52 |issue=6 |pages=930–45 |doi=10.1111/j.1526-4610.2012.02185.x |pmid=22671714 |doi-access=free |s2cid=540800}}</ref>