Neurontin®
Do not discontinue taking any medications without first consulting your physician.
Neurontin® & Bipolar Disorder: Unapproved use, Unexpected consequence
Neurontin®, or gabapentin, is a $2 billion a year blockbuster drug. Originally marketed by Parke-Davis (now a division of Pfizer), it was approved by the FDA in December 1993 for use as an add-on drug in the treatment of epilepsy—an extremely limited market. In order to increase sales of this niche drug, Parke-Davis itself marketed Neurontin as treatment for various unapproved and unproven medical situations, a patently illegal practice. Now, over 80% of Neurontin’s prescriptions are for off-label uses.
Neurontin’s manufacturer has finally admitted to its wrongdoings, but has left in its wake a slew of patients and doctors ill-informed and unprepared to deal with the dire consequences of bad science and deceitful marketing: not only is Neurontin largely ineffective as a treatment for many of the off-label uses for which it was recommended, including bipolar disorder, that ineffectiveness may increase the risk for suicidal behavior.
What are “off-label” uses?
Off-label use of a drug is when a drug is prescribed for uses that have not been approved by the FDA. Doctors can legally prescribe drugs for off-label uses, based upon their own experiences or the studies of other doctors, and this practice has been used for years, often with great resulting effectiveness.
However, when a pharmaceutical company promotes a drug for off-label uses, as Parke-Davis did in its promotion of Neurontin, it is illegal, not to mention dangerous. As revealed in a July 2003 installment of Dateline NBC , in the case of Neurontin, this illegal practice had some devastating consequences: when the drug was marketed as treatment of bipolar disorder, an untested situation for which it was later proven to be largely ineffective, suicidal behavior was the result of users’ bipolar disorder going essentially untreated.
Their scheme to get everyone taking Neurontin consisted of grossly deceptive methods, including posing salesmen (or “medical liaisons”) as physicians in order to disguise their sales pitch as doctor-to-doctor advice and paying doctors to legitimize company-sponsored marketing articles published as independent studies.
What off-label uses was Neurontin marketed for?
In a teleconference to the Neurontin sales force, a top-level executive at Parke-Davis was recorded as telling medical liaisons:
Pain management, now that’s money. Monotherapy, that’s money. We don’t want to share these patients with everybody; we want them on Neurontin only. We want their whole drug budget, not a quarter, not half, the whole thing.... That’s where we need to be holding their hand and whispering in their ear: “Neurontin for pain, Neurontin for monotherapy, Neurontin for everything.” ...I don’t want to hear that safety crap either; have you tried Neurontin? Every one of you should take one just to see there is nothing ... it’s a great drug.
And the sales force performed their task admirably: Neurontin’s most recent sales figures topped $2 billion per year, over 80% of which was for off-label uses.
Some of the most common unapproved uses Neurontin was marketed to treat include:
- Bipolar disorder
- Anxiety issues including Obsessive Compulsive Disorder (OCD)
- Attention Deficit Disorder (ADD)
- Pain syndromes: Peripheral Neuropathy, Diabetic Neuropathy, Trigeminal Neuralgia, Postherpetic Neuralgia
- Migraine
- Reflex Sympathetic Dystrophy (RSD)
- Lou Gehrig’s disease
- Restless Leg Syndrome (RLS), Periodic Limb Movement
- Essential Tremor
- Drug and Alcohol withdrawal seizures
- Alone for epilepsy, as monotherapy
Though Parke-Davis tried to convince everyone that Neurontin was as safe and beneficial as pure water and should be prescribed accordingly, such was not the case. For too many people taking Neurontin, there were no benefits, and that in itself is dangerous. When those taking Neurontin for bipolar disorder experience no benefits, they are essentially untreated, a risky state for one suffering from such a serious condition. Bipolar disorder is characterized by manic highs and depressive lows, and during those lows sufferers may be more prone to suicidal behaviors.
Studies that examined the evidence of Neurontin’s effectiveness in off-label uses have determined that the drug is far less useful than any of the approved alternatives, and in any case, should never be used alone. According to a special series reported on NPR’s news and information show All Things Considered , one study sponsored by Parke-Davis, Neurontin’s maker, even showed that a placebo was more effective than Neurontin in the treatment of bipolar patients! But the results of that study were withheld by Parke-Davis until 2000.
What has been done to protect consumers?
In May 2004, Pfizer pleaded guilty to criminal charges stemming from the illegal marketing schemes practiced in the promotion of Neurontin. As part of a whistle-blower suit brought by one of the medical liaisons, Pfizer agreed to pay $430 million in criminal and civil penalties; the civil fines will be distributed among Medicaid agencies and state consumer-protection agencies.
However, even though the whistle-blower suit and the ensuing criminal penalties against Pfizer have been well publicized, still over 80% of the Neurontin prescriptions are for off-label uses that were illegally advocated for by the pharmaceutical company, which was only interested in profits. Many doctors and patients are painfully unaware of the crime perpetuated against them and the resulting risks to the health and well being of Neurontin users.
In the interest of informing the unsuspecting public about Neurontin users’ risks, the FDA is currently being petitioned to change Neurontin’s label and issue a “Dear Doctor” letter to warn of an increased risk of suicidal behavior. According to the FDA’s own adverse event reporting database, Pfizer alone reported 25 completed suicides linked to Neurontin use between 2000 and 2003, a number that increased significantly in the last 6 months reported.
What should I do?
Never discontinue any medication without first consulting a physician. However, if you or someone you love is currently taking Neurontin for bipolar disorder, or any other mental, emotional, or behavioral condition, you should be aware that there may be no unbiased studies to justify that prescription. Discuss any concerns you may have about Neurontin with your prescribing doctor.
Sources:
“Drug giant accused of false claims,” Dateline NBC, 11 July 2003
“The Selling of Neurontin,” All Things Considered, NPR, 16 January 2003
“Citizen Petition to Request Addition of Postmarketing Suicide Reports to the Neurontin Labeling,” www.fda.gov, Docket # 2004P-0235/CP1, 18 May 2004
Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.
Neurontin® is a registered trademark of Pfizer Inc. The reference to the registered trademark of Pfizer Inc is used here only for the purpose of identifying the product in question.
This law firm is not affiliated with, sponsored by or associated with Pfizer Inc, Dateline NBC, NPR, or the FDA.
