Another Psychiatric Med Debacle: Glaxo Agrees to Pay $3 Billion in Fraud Settlement

Here we go again.

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants [Paxil, Wellbutrin, Avandia] for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also includes civil penalties for improper marketing of a half-dozen other drugs.

I read this yesterday in the NY Times and although I am happy someone thought this company’s behavior heinous enough to blow the whistle (thank you), I couldn’t help but keep going back to this part of the article:

Prosecutors said the company had tried to win over doctors by paying for trips to Jamaica and Bermuda, as well as spa treatments and hunting excursions. 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.

Heinous. It’s bad enough (wrong!) for a company rep to offer a gratuity in exchange for a professional ‘favor’ but it is another thing entirely to accept the proffered goodies and commit criminal acts.  And, in this case it’s the very professionals we patients trust with our lives who are the ones perpetrating the crimes.

The damage created by GSK’s shenanigans is so far reaching that even when patients were trying to act as their own advocates and read the literature and the studies, they weren’t even accurate.

I could go on and on about the obvious (how we mental illness patients truly are the victims not only of our illness but also the victims of greed) and the not so obvious (where can a mental illness patient who wishes to be well informed about their med find trustworthy studies that were not funded by the manufacturing company).

By far, there is no evidence that every drug-maker is fabricating studies, offering doctors fabulous bribes and being unscrupulous in general. However, having been prescribed two out of the three drugs cited in the complaint, this GSK debacle has really left a bad taste in my mouth.  Whereas I always had some skepticism regarding the medical profession, especially where psychiatric drugs are concerned, I now have graduated to a vote of no-confidence.  Especially given the dialogue I’ve been having over the last six months with my Drs over Abilify. (**Note that Abilify is NOT manufactured by GSK and is NOT a part of this fraud settlement. I am merely drawing a parallel from my own recent experience.  End legal disclaimer.)

One thing is for certain, going forward I will do my utmost to find studies that are not funded by drug companies and I will refuse to take a med that hasn’t been approved by the FDA for the specific purpose in question.  I understand there is the concept of ‘off-label use.’  But do we really believe that antipsychotics should be prescribed as sleep aids and PTSD meds when the FDA isn’t near approving those drugs for those purposes?  Not.  I think it’s prudent to exercise a good dose of skepticism when you see the pens in your Drs cup holder, the clock on the wall, the posters in the waiting room and the coatrack in their office, all branded with the name and logo of said antipsychotic (true story).  Is it really OK for kids to be prescribed adult antidepressants when the FDA hasn’t approved them for such use? Does it make it OK to slap an afterthought label warning the potential of suicide is higher in children?  No.  Trust was misplaced in big pharma and in some cases in the doctors themselves.  For all of those parents whose children committed suicide due to improper use of antidepressants, I am so, so sorry for your loss.

There is something terribly, terribly wrong with the whole picture here; the ease with which doctors can be swayed to prescribe improperly, the mechanics with which drugs can be prescribed for off-label use and the frequency with which it happens in the US, the lack of corporate morals across the globe.  I truly wish I had the answer or even knew where to start to try and fix it.

Hi 🙂
Hope you are well?
Very interested in this post and wondered if you would mind if I reblogged it over on the Mental Health Writer’s Guild blog so that other members can benefit from it?

Please let me know if that is ok with you?
Many thanks.
Kind Regards and God bless.
Kevin.

Hi, Kevin!

Hanging in there, how are you?

Sure – reblog anywhere you’d like! This is such an important topic on so many levels. Glad you liked the post.

Hope all is well with you – let’s catch up soon. V

I wouldn’t be surprised if the makers of Abilify (Bristol-Myers Squib?) engaged in the same activities, given my experience. I talked to a pdoc for the first time for two seconds, and all he did was give me Abilify samples and tell me to go on my merry way.

Makes you feel special, doesn’t it? I’m sure you’re right about Abilify, too. Wouldn’t be at all shocking if Bristol-Myers Squib joined in the fun at some stage.

Great post! Perhaps it could be reblogged on Canvas?

I think what is most important here is: do you trust your doctor? I have a lot of faith in mine and I know she milks the pharma reps for as many samples as possible so her patients don’t have to pay outrageous prices for drugs that may or may not work for them. She gives me two months of things and always checks in with me once a month to see if something is working or not. But I have questioned the judgement of some of docs I’ve had previously. Ones who are too eager to prescribe and don’t even tell you about the “special offers” you can get from the company (1st month free, discount cards, etc.) I have to research each medication before filling the script for those doctors because I am uncertain about it. But I have a lot of faith in doctors who work with me and allow me to make my own choices.

Personally, I think a lot of the blame comes down to the doctors. It’s reprehensible that the drug companies do this but I think the doctors must accept a lot of the responsibility as well. A truly reputable doctor would never accept a vacation in exchange for pushing a particular medication.

Thanks – you’re right…I really should reblog on Canvass.

The doctors really are the ones to blame. They took the gratuities and wrongfully prescribed the meds. Heck, even if they didn’t take the gratuities and still wrongfully prescribed. They should all have their licenses yanked.

Found an interesting article on Time’s websire this AM: http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-wrongdoing/http://healthland.time.com/2012/07/05/breaking-down-glaxosmithklines-billion-dollar-wrongdoing/ It breaks down exactly what happened with each med. Better get a cocktail before you read this one.

I vote for automatic weapons. But a firing squad will suite, too.

Every time I see the Cymbalta ad on TV claiming it relieves chronic pain, I want to bite off someone’s (pharm executive) ear. Are docs really going to prescribe an antidepressant for fibromyalgia? Oh, the humanity!

Cymbalta is evil, evil stuff. I remember the ER Dr getting really mad at my psychiatrist for even prescribing it when I wound up in said ER for Cymbalta withdrawal difficulties.

I hope you’re doing well, Sandy!

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