November 15, 2018  Last Update: November 27, 2017, 8:52 pm

Glaxo SmithKline Guilty: $3 Billion Fine for Wellbutrin, Others

Wellbutrin is a GlaxoSmithKline (GSK) prescription drug allegedly illegally marketed for substance abuse. Wellbutrin was approved for depression. GSK has been fined $3 Billion.

Widespread news today that GlaxoSmithKline admitted guilt in a landmark case involving misleading marketing claims, bribes, improper rebating, and failure to report safety issues around many of their most successful drugs over a 6 year period. The details are amazing.

This story about GlaxoSmithKline throwing cash and bling at greedy doctors reads like a Miami Vice episode. Are these pharma companies the new drug dealers?

Doctors received spa vacations and other trips, membership privileges at private clubs, concert tickets, and more. In many cases doctors received large speaking fees on speaking tours in desirable travel destinations.  PharmaLive.com quoted an attorney “Kelton” saying “The gravity of Glaxo’s conduct cannot be overstated… it’s fair to conclude there has been almost no limit to what pharma companies have done to sell their products.”

"GSK sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few," said Carmin M. Ortiz, U.S. attorney in Massachusetts.
- USA Today

Wellbutrin for Substance Abuse & Sexual Function?

Part of the investigation focused on Wellbutrin, which GlaxoSmithKline sales reps were allegedly pushing onto doctors for off-label use as a therapy for substance abuse. Among the details is an interesting connection with Dr. Drew, the celebrity rehab TV host. According to Pharmalot.com, Dr. Drew was paid 2 large sums of money by Glaxo, and promoted Wellbutrin for sexual function  in his television and radio appearances.  Wellbutrin was never approved for treating sexual dysfunction, and one of the infrequent negative side effects of Wellbutrin  is decreased sexual libido. Pharmalot notes that increased libido is also listed, but as a rare side effect.

While the $3 billion fine is the largest ever levied against a drug company (so far), GlaxoSmithKline did not specifically admit guilt for the off-label marketing claims. That was apparently part of the settlement. Nearly 2 billion of the 3 billion total was set aside for civil settlements expected for those marketing issues.

The company promoted Wellbutrin, a depression medication, for unapproved uses including weight loss, sexual dysfunction and substance abuse. Some sales representatives referred to the drug as “the happy, horny, skinny pill,” according to the fact sheet."

What is Wellbutrin?

Wellbutrin is bupropion, which according to wikipedia was once known as amfebutamone and is also marketed as Wellbutrin, Zyban, Voxra, Budeprion, and Aplenzin. Under US law, a licensed medical doctor can prescribe medications for uses other than the uses approved by the FDA. However, pharmaceutical companies cannot promote those uses for their products. The drug manufacturers may only market exactly as they have been approved for marketing by the lengthy and strict FDA marketing approval process. So while an MD may prescribe Wellbutrin for substance abuse, the pharmaceutical company cannot provide any communications about that use, since Wellbutrin was only approved by the FDA for depression.

Wellbutrin is widely noted to be incompatible with alcohol, and has been noted to decrease sensitivity to the effects of alcohol (potentially encouraging more risky behavior at higher levels of alcohol intake). It is also abused as a recreational drug.

GlaxoSmithKline fined $3B for marketing Wellbutrin as “the happy, horny, skinny pill,” and other wrongs
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