I was glad to see that the New York Times‘ reporters covering GlaxoSmithKline’s $3 billion settlement tipped their hat to former New York Attorney General Eliot Spitzer. After all, it was his crew and specifically a pioneering attorney by the name of Rose Firestein who dreamed up the idea of suing Glaxo for consumer fraud, paving the way for Glaxo’s record-breaking $3 billion take-down.
I told the story of how Rose and her colleagues at the New York AG’s office first brought the second largest drug company in the world to heel in Side Effects. But who knew that other state and federal prosecutors would pay such close attention to Rose’s novel interpretation of applying consumer fraud statutes to the deceptive marketing of Paxil for off-label use in children?
It was Rose Firestein who unearthed the tactics that federal prosecutors now claim GlaxoSmithKline used to deceive American families about Paxil. It was she who first noticed that an article, published in a prominent medical journal and used by Glaxo to market Paxil as safe and effective in children actually showed the opposite — that Paxil not only didn’t work in children but was more likely than a sugar pill to make them suicidal. As I and others have revealed (in books and blogs), that journal article actually misrepresented data from a clinical trial. Here’s what the Times today says about it:
In the case of Paxil, prosecutors claim GlaxoSmithKline employed several tactics aimed at promoting the use of the drug in children, including helping to publish a medical journal article that misreported data from a clinical trial.
Over the past three or four years, one major pharm company after another — Pfizer, Abbott, Johnson & Johnson, Forest Labs, Eli Lilly, Astrazeneca and now GlaxoSmithKline — has been forced to pay record-breaking fines for the similarly deceptive and fraudulent marketing of their off-label drugs (Neurotonin, Risperdal, Celexa, Seroquel, Zoloft, Zyprexa, Wellbutrin). To think that all of these successful prosecutions started with a brainstorm that Rose Firestein had while taking a shower one cold February morning in 2004.
I hope that the state and federal prosecutors who are now raking in the dough for their financially strapped governments give Rose and her colleagues at the New York AG’s office their due. I also hope that Andrew Witty, the CEO of GlaxoSmithKline, is speaking the truth when he says that these fraudulent research and marketing practices are a thing of the past. If only…
Your points are important ones. However, Charles Ornstein helpfully tweeted the link to the DOJ GSK evidence, and in perusing some of it, I found:
Over 43 million dollars worth of missing misbranded Paxil and Wellbutrin. It’s unknown whether patients already took these medications.
There will be no enforcement of the 5 year limited agreement for GSK to follow its stated policies and procedures.
The DOJ agrees not to criminally prosecute.
The FDA was a victim.
There is no provision for identifying, notifying and helping harmed patients/victims.
GSK identified and went after “targets” of all kinds: academic institutions (Harvard, Rockefeller U and Columbia are on the 1st tier, I’m sure they’re happy to read;, “thought leaders” – physicians who contracted to do the illegal offlabel marketing – and many are named in the evidence; peer reviewed journals – again by tiers of influence – JAMA and the NEJM are up there along with Science and Nature; likely prescribers – those physicians who adamantly deny that they EVER could be influenced by pharma marketing – heh; and patients of all ages – who were getting the DTC advertising via TV, women’s magazines, their doctors’ offices and all over the internet.
http://www.justice.gov/opa/gsk-docs.html
This morning, Richard Horton, The Lancet editor, tweeted to ask me to find GSK references to it as a Tier 1 marketing target for bupropion sr. I did so and tweeted it. (It’s on p 25 of the 5th pdf in the complaint evidence)
There is a lot contained in the primary documents that hasn’t been reported. I hope it gets some attention from journalists.
Does Tim Bousquet from the Coast know of these developments?