The FDA approved gabapentin (Neurontin) for partial seizures in 1993, but Parke-Davis, a former division of Warner-Lambert, the drug's manufacturer, knew where the real money was. (N Engl J Med 2009;360:103.)
The company had a plan to make the chronic pain and psychiatric drug available for off-label use in 15 other conditions, including fibromyalgia, bipolar illness, migraine, ADD, and sexual dysfunction, according to the journal. Drug representatives were told to encourage Neurontin use up to 4,800 mg a day, and by 2000, 78 percent of gapapentin was written off-label, and sales exploded to $1.3 billion, up from $98 million in its first two years.
Pfizer then hired a marketing firm to aggressively market Neurontin to physicians, according to the journal article. Some doctors were given $1,000 just to put their names on papers that were ghost-written by the company. Others were paid $1,200 for enrolling their patients in “research” as a way to get more of their patients to try Neurontin. Much of the “science” was fabricated by the pain specialist Scott Rueben, MD, or the company. The FDA, with no knowledge of the fabricated studies, approved Neurontin only for post-herpetic neuralgia in 2002.
Sales were up to $3 billion a year by 2004, the journal authors wrote. The illegal marketing practices were in federal court by this time, and after the drug became generic in 2004, Pfizer pled guilty to Medicaid fraud for its marketing scheme and agreed to pay a fine of $430 million, a fraction of what it had made. Neither Warner-Lambert executives nor physicians who received kickbacks were indicted, but Dr. Rueben was imprisoned in 2009. (The Wall Street Journal. March 11, 2009; http://on.wsj.com/2GygWbG.)
The use of gabapentin (and pregabalin [Lyrica], a gabapentin precursor) tripled from 2002 to 2015. Some 57 million prescriptions for gabapentin were written in the United States in 2015, a 42 percent increase since 2011, partially in response to the paranoia surrounding physician prescribing during the “opioid crisis.” (N Engl J Med 2017;377:411.) Gabapentin was one of the top 10 most commonly prescribed medications in the United States by September 2017. (JAMA 2018;319:776.)
Meanwhile, recent studies found that gabapentin fails to show benefit in neuropathy from chemo (Cancer 2007;110:2110) or chronic low back pain (PLoS Med 2017;14:e1002369). Also, gabapentin in postherpetic neuralgia and diabetic neuropathy is associated with pain reduction of at least 50 percent but in only 14 to 17 percent more patients than placebo, and it's associated with more dizziness. (JAMA 2018;319:818.) Gabapentin and pregabalin have now become the new drugs for abuse, with around one of five opioid abusers also using gabapentin. (Drugs 2017;77:403; “Opioids Not the Only Pain Meds that Lead to Abuse,” EMN 2017;39:1; http://bit.ly/2GONfDA.)
The real mystery is why medical providers are still writing for gabapentin and pregabalin. Do providers not keep up with the literature or has the phobia to prescribe opioids become such a leviathan that providers are willing to prescribe a useless, expensive medication with significant side effects and abuse potential just so they can say it was a nonopioid?
They are not alone. A 2017 review of low back pain treatment from the American College of Physicians promotes gabapentin as a nonopioid option (Ann Intern Med 2017;166:480), and the Centers for Disease Control and Prevention does the same in its recent recommendations for chronic pain management. (JAMA 2016;315:1624.) Shame on us all.
Knowing what we know now about gabapentin and pregabalin, we have a professional obligation to stop prescribing these drugs. More than that, we need to educate patients about this and ask them to stop taking the drug. Saying “but the patient feels like it helps” or “their insurance pays for it” are just excuses to avoid the known facts that gabapentin and pregabalin are ineffective and overpriced with significant side effects and abuse potential.
The Opioid Link
Read InFocus by James R. Roberts, MD, about how gabapentin became a drug of abuse. Page 8.