So what did they do?Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company
Paxil: GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though it has not been approved for use in children. This means GSK was encouraging depressed teens to use their medicine which may not be safe or effective in this group. To make matters worse, GSK published a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. They also suppressed two other studies which also failed to demonstrate efficacy while promoting the drug.
This is a drug that, since 2004, has carried a black box warning that antidepressants in this class increase the risk of teen suicide. Thus GSK appears to have misled patients who are at risk of harm from their product into using it.
Repulsive.
Wellbutrin: A drug that was approved for major depression was also being promoted for use in diseases where it had not been proven safe or effective. These include weight loss, sexual dysfunction, substance addictions and ADHD. Promotion included paying doctors to speak for the off-label use, sham advisory boards, and supposedly promoting its illegal use through sponsored education in Medical Schools.
Avandia: Glaxo failed in its obligation to monitor the safety of this drug after it entered the market for 6 years. Even where the European regulators forced that studies be done to address concerns over the safety of this diabetes medicine, Glaxo ignored the outcomes of those studies. This is a drug that is now known to increase the risk of congestive heart failure and heart attack.
Advair: Despite being medically inappropriate and unapproved, this drug was promoted for first line treatment of mild asthma and chronic obstructive pulmonary disease sufferers by providing GPs with kickbacks for prescription.
Lamictal While only approved for epilepsy, this drug was promoted for pain management.
Zofran Approved only for post-operative nausea, this drug was promoted for morning sickness in pregnant women. Such a move is horrifying and recalls the lessons (un)learnt from thalidomide.
These acts are criminal. How many have died unnecessarily as a result of this unconscionable conduct.
