I'll let you be the judge. First you have to decide what a crime is. Then does the penalty fit the crime. So here are some facts. You decide if it's a crime or not and, if so, is the punishment enough to keep them from doing it again.
The company in question is GlaxoSmithKline, LLC. They produce Paxil, Wellbutrin, and Avandia.
Paxil was promoted for treatment of depression for children under 18 years old. They published and distributed material about the efficacy in the treatment of depression for in this age group. They sponsored dinner programs, spa programs, and other activities for doctors to attend seminars to promote the use of Paxil for depression in children.
Wellbutrin was promoted for weight loss, treatment of sexual dysfunction, substance abuse, and hyperactivity. GSK paid millions of dollars to doctors to attend and or speak at meetings to promote these treatments with Wellbutrin.
Avandia. Used to treat diabetes.
Evidence: The FDA never approved the use of Paxil for the treatment of depression in children. GSK published misleading information in there reports about the efficacy of treating depression in children and left out two reports that failed to demonstrate its efficacy. Paying medical doctors to attend meetings, paying for rooms, food, and special activities is known to be an act of fraud, kickbacks, and rewards schemes.
When it comes to Wellbutrin they used sales representatives, fake advisory boards, and alleged independent continuing medical education (CME) programs to promote Wellbutrin for these unapproved uses.
They failed to include safety data about Avandia. Such studies included concerns about the safety of Avandia in regards to the circulatory system.
What do you think? Are these crimes or simply oversights?
Here is the civil settlement agreement. CSK was found guilty of promoting the drugs Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered use, and paying kickbacks to physicians to prescribe these drugs as well as the drugs Imittex, Lotronex, Flovent, and Valtrex; making false and misleading statements concerning the safety of Avandia; reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
The punishment: Pay $3 billion to resolve criminal and civil liability and execute a five-year corporate integrity agreement with the Department of Health and Human Services.
This is a taken directly from the press release issued by the U.S. Department of Justice. GSK also would plead to misdemeanor charges to other violations of marketing and selling procedures.
So does crime pay? GSK stock rose 1.6% after the settlement. They can keep selling their products. They lost no licenses and can still make money from Medicare and Medicaid.
Oh yeah — The $3 billion will be funded through existing cash reserves. References available upon request.
Bottom line is trust your health to only you. Eating right, exercising, breathing correctly, stretching, and keeping a well adjusted nervous system will help you to not need to take these drugs.
Stay well. Dr. Bob
