GlaxoSmithKline (GSK), the British pharmaceutical company behind the drugs Paxil, Wellbutrin, and Advair, pled guilty to federal charges of misconduct in the marketing of its products, July 2. The company will pay out $2 billion plus a $1 billion criminal fine, amounting to the largest health care fraud fine in history.
According to a statement released by the United States Department of Justice (DOJ), GSK was found guilty of, “unlawful promotion of prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.”
The DOJ alleges that from 1998 to 2003 GSK illegally marketed the drug Paxil for the treatment of depression in minors, even though the Federal Drug Administration never approved the medicine for children. The department also claims that Wellbutrin, a drug approved only for Major Depressive Disorder, was promoted for weight loss and the treatment of sexual dysfunction.
The heavily publicized asthma drug, Advair, was promoted for “first-line therapy for mild asthma” when it was never medically approved for that condition. Other misbranded drugs included diabetes drug Avandia, anti-epileptic drug Lamictal, and post-operative nausea drug Zofran.
In a statement on the company’s website, CEO Sir Andrew Witty remarked: “We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.” However the statement also says that GSK “does not constitute an admission of any liability or wrongdoing in the selling and marketing of [its products].”
The DOJ contends that the company, “paid kickbacks to health care professionals to induce them to promote and prescribe” medications that were never approved for certain conditions. This form of aggressive marketing is what U.S. State Attorney John Walsh called out as a major concern through the government statement.
“Patients rely on their physicians to prescribe the drugs they need,” Walsh said. “The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs.”
Brett Penager, chief marketing officer for local chiropractic centers Chiro One, said he was not surprised by the DOJ’s statement.
“The promotion of drugs within the U.S. has continued to escalate,” said Penager. “There’s a lot of great pharmaceutical companies do to support the human condition, but the over use of [medication] has become an epidemic.”
Penager believes that while prescription medications do have their place in health care they should be used appropriately and only when necessary.
“In the U.S. we use drugs as a form of healthcare without it having to be a crisis.”
While the government’s fine against GSK is the largest to date, it is not the first. ProPublica, a non-profit investigative news platform, published on July 3 that in the past three years there have been six multi-million dollar fines levied against pharmaceutical companies for “inappropriately, and in some cases illegally promoting prescription drugs.”