In the largest health care fraud settlement ever, GlaxoSmithKline has agreed to pay the whopping sum of $3 billion, the U.S. Justice Department announced earlier today. The reason? GlaxoSmithKline was caught marketing two popular antidepressant drugs — Paxil and Wellbutrin — for populations and indications they were never approved for.
In the U.S., the Food and Drug Administration (FDA) must approve all prescription medication uses and who they can be marketed to, based upon scientific studies the pharmaceutical must develop, fund and publish. Pharmaceutical companies then have to ask for permission to add those uses or populations to the drug’s existing approval.
Many drug companies, including GlaxoSmithKline (GSK), have sought to cut corners in getting these additional formal approvals, because all of that additional research costs time, money and effort on their part. So in the past, they’ve “soft marketed” these drugs for these additional uses through the salespeople who try and sell the drug to individual psychiatrists and physicians.
Perhaps, finally, drug companies will get the message. You may get away with such marketing practices for awhile, but eventually some whistleblower is going to (thankfully) turn you in.
So what did GSK do, exactly? Three things:
Prosecutors say GSK encouraged use of Paxil for children although it was not approved for anyone under 18.
The company also promoted Wellbutrin for uses besides major depressive disorder, its only approved use.
They say that between 2001 and 2007 GSK failed to report on two studies of the cardiovascular safety of Avandia, a diabetes drug.
Sadly, the fine is actually less than the company thought it would be:
Glaxo is pleading guilty to these violations of FDA regulations, which are misdemeanors. It has set aside $3.5 billion to cover the cost of the fines and other penalties related to the government’s seven-year probe of the company’s marketing practices for Paxil, Wellbutrin and Avandia, three of its blockbuster drugs.
And overall, we have to put the fine into some sort of context.
GSK had $11.7 billion in Paxil sales 1997-2006, according to data the company supplied as a part of a lawsuit. And that was just in the U.S. for a nine-year period.
It’s likely that GSK realized similar sales numbers for Wellbutrin during the years it was under patent.
According to litigation experts, the company has paid out more than $2 billion prior to this settlement to resolve a series of patient-filed lawsuits over Paxil.
Combined with the $3 billion fine, it still doesn’t appear to make GSK feel any real pain, because the company still managed to make billions of dollars from the sales of all three drugs.
All we can do is hope that such fines don’t make drug companies simply look for more clever ways to hide such marketing efforts, but that that they quit them altogether. And if they do the math, they may find it’s actually cheaper to do the additional research and run it through the FDA’s regulatory process for additional use and population approvals, than it is to try and sneak these things under the table through their sales and marketing departments.
And pharmaceutical companies wonder why they have such a reputation problem…
Read the full story: Drug giant pleads guilty, fined $3B for drug marketing
7 comments
Little too late as pointed out above. Personally, I have no idea why colleagues write for Paxil these days. It has a horrible withdrawal syndrome with abrupt or short term taper, causes weight gain in more than 50% of patients, sexual dysfunction in men over 70% of the time, and inhibits the metabolism of other drugs to a point it is nearly contraindicated as a poly pharmaceutical agent.
Wellbutrin has some negatives, a major one being no real indication as an anxiolytic, but has been a good medication for those who have been SSRI’d to excess. Why it has not gotten much cheaper having been out for nearly 20 years still annoys me!
Being charged with a fine and paying it are still two different things. We’ll see if the punishment is applied, or, GSK gets an out for supporting PPACA. Oh yeah, many of you forgot about that little arrangement, eh?
Dear Dr. Hassman,
Paxil (paroxetine) is the least selective and ‘clean’ SSRI, ie has more noradrenergic-system affinity, and more antycholinergic/muscarinic activity comparing to any other medication from this group. It has potential advantages – in particular high noradrenegic affinity makes it probably the most logical choice when switching from one SSRI to another due to lack of response (STAR*D choice for nortryptyline as one of subsequent options was not random). Also its side-effects stemming from antycholinergic/muscarinic affinity may be of some use in cases when one needs more sedation. On the other side its weaker serotoninergic activity causes less initial side-effects than in case of other SSRIs (nausea, restlessness). As a consequence is less frequently producing serotoninergic syndrome that has been recently thought to be more common (especially as a subacute type) than it was estimated initially.
I have used this medication for almost 15 years (not as the first choice antidepressant) but never had any complaint re more severe withdrawal symptoms than with other SSRIs. Is it better than other SSRIs? No – but there are patients who respond better to paroxetine than to any other SSRI.
As per Wellbutrin (buproprion) – just an update from the Old Europe – this has only recently been registered in the UK (and the rest of Europe) as antidepressant – before it had been registered as a medication for smoking cessation here! But most interestingly GSK is purely British in origin and Wellbutrin name even comes from the name of one smaller UK pharma companies acquired by the Glaxo (which later merged with SmithKline, hence acronym – GSK), namely Wellcome. As far as I am aware, Wellcome unsuccessfully tried to register it as antidepressant in the UK many years ago, but they managed to register it in some European countries. I heard some anecdotal stories from colleagues who used it and their impression was rather clear – they were mostly surprised why it is so popular in America because they could not see anything – no side effects, but no response as well…
I think that the whole story only shows how much we are influenced by a pharma industry, but also by a culture, and biased by a placebo effect that is really high in the treatment of depression.
Best regards
Greg Wisniewski (Ireland)
I have been practicing 20 years and my experiences with Paxil above stand as seen. I have NO alliances with any pharmaceutical company now or at any time in my past, and know what patients see as tolerated versus disrupted.
Frankly, I do not see the point of your “rebuttal”.
I regret to inform you that, in my experience, Paxil is the absolute worst and most dangerous anti-depressant and that it has essentially ruined my life. The “rebuttal” on these comments from Greg Wisniewski sounds more like a drug company representative trying to do damage control – but could very likely be a smug psychiatrist/doctor who has prescribed Paxil to dozens of people over his career trying in vain to justify the use of it. I also highly doubt that he has taken it for 15 years – but strongly suspect he is affiliated in some way with GlaxoSmithKline.
At any rate, having been there and done that myself, I can assure you that Paxil has extremely dangerous side effects – including agitation to such a degree that it can and has led to homicide and suicide. Last year marked the first time a judge has ruled that SSRIs were involved in causing a homicide. There is a well known case in Canada where a man suffering from Paxil side effects murdered his son (David Carmichael).
I have known several other people that have taken Paxil, including my brother. After a week on the drug, he ended up in the psych ward because he was unable to sleep. Paxil is ridiculously stimulating – as is Wellbutrin. Around the same time, I had an adverse reaction to Paxil and sliced my arm open and also ended up in the hospital. This is merely the tip of the iceberg. From all of the damage caused from this insidious drug, I should qualify for a class action lawsuit and should receive a very large sum of money for all of the years lost and suffering endured.
Let’s also not forget that there are 2 other class action lawsuits against Paxil: one involving BIRTH DEFECTS from pregnant Paxil-users and the other involving the drug companies lying and raising the prices of generic Paxil. There was also one regarding the “discontinuation syndrome”.
great article but a whole lot of unanswered questions remain. by having had a the ” opportunity ” to have recieved the benefit ofa psychiarrist prescribing me a off brand antidepressant while i was also and e knew it taking sodium dilantin and tubenol he found it impossible to understand why i was : subjet to erractic and sudden displays of antisocial behaviours”. for some reason none of the doctors or neurologists i had spoken to over the past 15+ years considered that there might be a link to the antidepressant ( despitehis knowing i had requested the man;s assistance in having an assesment for a.d.h.d. he decided that despite having sustained multiple U.R.T.L. trauma i was mereley depressed) the anticonvulsants and allergic to the carrier ( soy based gelatin capsule) the antidepressant was contained in.
what i am asking is which medical professional will own up to having effectively caused at least 20 years of the hellish nightmare my life as beenlike. i guess not one of them has the testicular fortitude to at least say ‘m sorry for what i did.
How do the victims of this abuse receive any benefits from the fine? I think we should also be looking at the effects of prescribing these mind altering drugs to adults as well. My family has been subjected to irreparable damages from these drugs.