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…
This post originally appeared on my blog.
Prediction: Pfizer is about to blow GSK out of the water w/the fine THEY’LL have to pay over Chantix lies!
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How can we make the CEO’s of these companies personally liable for the deaths and misery with jail times and loss of jobs? Not golden parachutes. This is how we’ll get this stuff to stop. Lawsuits and jail time for every complicit person who knew they were harming people. Like the Nurenburg trials.
I know GSK made a lot more than $3 bill in profit so this is still just a cost of doing business unless there are penalties for someone besides stockholders and taxpayers.
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Corinna: A commenter on the NYT article about the GSK fine calculated the quarterly profit at 7.2 billion. So 3 billion represents about 6 weeks worth of profit (not revenue) for GSK, if that quarterly figure is accurate.
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(I submitted this same comment to Alison’s blog, and it is under moderation at this time)
Your points are important ones. However, Charles Ornstein of ProPublica and the AHCJ 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.
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“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.”
Yeah, because Eliot Spitzer, a guy known for his unprotected sex with teenage runaway hookers, is well known for his valiant efforts to stop human rights abuses and hates to see toxic drugs put inside teenagers’ bodies…
“Davis, 32, said she first knew Mr Spitzer, 49, as “James”, one of the biggest spenders among the more than 10,000 clients she amassed in five years of running escort agencies in Manhattan. Although he “seemed nice enough” at first, he later drew complaints from the girls that he “was getting rough and too aggressive”. Mr Spitzer hated to use a condom and would try to trick girls into unprotected sex.”
http://www.theaustralian.com.au/news/governors-sex-secrets-laid-bare/story-e6frg6tf-1111118859395
Yeah right, Spitzer, keen crusader for the youth of New York state huh?
And the GSK fine is 3 weeks revenue.
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Whatever you think of his personal choices (which were pretty disgusting to me), Spitzer and his office did lead the charge and set the stage not only for a lot of states questioning and suing big drug companies for their lies, but also for the news media finally providing coverage that counters the propaganda about the “Brave New World” of psych meds. It’s possible a person can do good things and also do evil things in another context.
I’m also glad the attorney who sparked the efforts got appropriate credit for her inspiration and hard work.
—- Steve
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32 years old is not a “teenage runaway hooker” and it sounds like Spitzer reluctantly used condoms.
The truth is bad enough without exaggeration.
Agree that Spitzer is a mixed bag, like all heroes. I honor the guy for going after corporate interests injurious to the public good.
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“Dupré described leaving home at age 17 to escape a broken family and abuse”
http://en.wikipedia.org/wiki/Ashley_Alexandra_Dupr%C3%A9
No exaggeration. Would you like to retract your allegation I exaggerated?
There were plenty of hookers, of various age, the star one, was in fact a teenage runaway.
And I maintain slapping a pharma company on the wrist by taking 3 weeks revenue from them is nothing to write home about.
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Calling a 32-year-old woman a “teenage runaway hooker” is like calling Barack Obama a “teenage basketball player.”
At the time Ashley Dupre met Eliot Spitzer, she was 22. There is no evidence Spitzer hired teenage prostitutes.
While runaway teenagers may become prostitutes, and Spitzer hired prostitutes, associating Spitzer with teenage runaway prostitutes is a “straw man” argument used, as is typical for that type of argument, to inflame the accusation.
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Altostrata, not only would your screen name be a good name for a drug company, it sounds like a drug company name, as in ‘I own stocks in Altostrata’, you keep hitting me with this ’32 year old’?
Who is the 32 year old? there is no 32 year old.
Dupre began working at the escort agency when she was a teen, and she was in fact a runaway. She was one of dozens and dozens of hookers from the agency that the ‘Manhattan Madam’ ran, and sure, so what if that particular girl was 22 and 3 years into her prostitution career when she became one of the many? so what?
The escort agency had dozens of girls, hundreds over the years, many of them under 20 years of age. Dupre was 19 when she joined the agency.
He was considered a ‘hobbyist’ and is reported to have hired dozens and dozens of girls.
Some of them would likely have been under 20 at the time he ‘met’ them.
Your vigorous defense of a Governor who was a ‘john’ multiple times a week to countless exploited women is perplexing.
I guess anyone who throws you a bone in your attempts to blame drug companies for suicides is worth defending to the hilt eh?
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These fines are a fraction of what these companies made off these drugs. Let me know when a high level corporate criminal goes to pound me in the you know what prison. Until then, this is just the cost of doing business.
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This is an award only for malfeasance in the US, could other countries reduce their deficits slightly by suing pharma?
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Bravo Alison,
Our Madness Radio listening club up here in Vancouver, Canada will be tuning into Will Hall’s 2009 interview with you (http://www.madnessradio.net/madness-radio-paxil-trial-alison-bass) to celebrate what we hope will finally start the dominoes falling thanks to the efforts of folks like you, Rose Firestein and Bob W.
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I’d like to see a documentaries made in the U.S., Shelly Jofre’s series of Panorama programs that ran on the BBC – starting in 2002, that publicized the full details of *study 329* (Paxil)– and other bogus antidepressant studies done on children. Her work led to a N.I.C.E. guideline on pediatric depression in 2004– recommending AGAINST using SSRIs in children.
We have not begun to make any real progress toward the only issue that really matters: PROTECTING OUR CHILDREN FROM the dangerous effects of the UNETHICAL, CRIMINAL PRACTICES OF the likes of : J. Biederman, T. Wilens & T. Spencer—
A celebration seems a bit premature and possibly a tad over presumptuous— if one is truly concerned first and foremost about the well being and safety of our children!
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To clarify: Shelly Jofre’s work as an investigative journalist and documentary film maker is very bold and direct— as compared to the weak kneed song and dance that is going on in the U.S., where the story and drama is about intrigue and $$$ penalties!
Passion for the welfare of children? Ain’t seen it played out- YET, in any public venue — surely not in the courtroom!
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sobered and reproached for a momentary relapse into idiot hope and a bit of gratitude. a momentary break from the years of aching over the debilitation due to forced drugging of our own. thanks for the reference to Jofre’s series. we’ll look for it.
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What remains disheartening is that the press has devoted so little coverage to the plight of those who were prescribed antipsychotics (on and off label, primarily and adjunctively), developed metabolic syndrome and failed to seek redress. Where consumers are supposedly empowered it is telling that relatively few have sought damages. No doubt, pharmaceutical firms benefit greatly from sales to those unlikely to litigate.
Vioxx settlements on behalf of individuals came to $4.85 billion. Can the settlements with individual plaintiffs who have taken antipsychotics and claimed injury compare?
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To: Boston-based contributors to this blog post,
Martha Coakley, MA’s Attorney General, is the lawyer who needs to be informed of “public corruption, violation of the public trust” perpetrated by HMS professors: J. Biederman, T. Wilens and T. Spencer; that each has:
1) either documented or spoken in medical teaching forums that : ” Mental illnesses are *brain disorders*, with biochemical imbalance as cause; drugs balance and thus treat these *brain disorders*”.
2) each has either documented or spoken in medical training forums that : promoted the use of psychiatric drugs in children and adolescents, claiming these drugs are : FDA approved, safe and effective treatments for children as young as 3 years old.
3) In 2009, one year after being invvestigated for conflict of interest related to receiving over 1.2 million dollars from Pharma co.’s ,Dr. Tim Wilens published “Straight Talk about Psychiatric Medications for Kids”. This 217 page book contains every falsehood discussed in the *media*; has NO footnotes, or references to scientific evidence, and is cited as a major reference for several other leading treaters of mental illness in children/adolescents in the Boston area.
4) Harvard researchers are now working hard on a campaign to identify a new mental disorder: IED, Intermittent Explosive disorder, that will take the heat off the recently publicized bipolar diagnosis boom. SSRIs have been named as a treatment preference that is earmarked for a *guideline*.
5) SSRI risks/dangers inefficacy–ALL WELL KNOWN and easily substantiated by even lay people like, Shelly Jofre, BBC journalist.
6) ALL of the above point to :Willful deceit for financial gain that has caused GRAVE harm to children/adolescents— those of US who aren’t allowed to say, “NO” to psychiatric assault!!
Martha Coakley needs to be informed, so that our attorney general can step up to the plate–via:
“The Criminal Bureau works to protect the public by investigating and prosecuting a wide range of criminal cases. These include public corruption, financial fraud, and other violations of the public trust, organized crime, major narcotic offenses, appellate issues, insurance and unemployment fraud, environmental crimes, internet and online crimes, and more. The Criminal Bureau’s investigations are supported by a team of State Police detectives.”
I am planning to exercise my access to state government, my freedom of speech via local media- and my no longer containable outrage—
My new motto: “The gloves are off…”
I do not want to hear about any celebrating going on–UNTIL we have succeeded in PROTECTING our children !
In other words, I won’t be paying any more attention to the *Reality TV * mentality of this scourge— and anyone who is somehow earning $$$ from anything short of facing down the REAL criminals.
No guts..NO GLORY!!
🙂
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