View Full Version : Warning on Wellbutrin!


NinjaStyle
07-04-12, 08:42 AM
Eventhough this story is headlining the news today, I haven't seen it mentioned here. It's not my intention to discredit whatever medication you choose to take as long as it does what it's supposed to do: help :)
But please keep in mind that Wellbutrin was only ever prooved to help depression in adults. Studies in younger people showed in best cases no effect at all, and in worst cases a worsening of how they fealt, and a growth in su´cidal thoughts.
Anyway, here's some small parts of the gazillion posts, so you can make up your own mind, based the whole story :)


"NEW YORK Ś GlaxoSmithKline agreed to pay $3 billion to resolve criminal and civil charges for promoting the drugs Paxil and Wellbutrin for uses not approved by the Food and Drug Administration - such as treating children for depression and treating adult patients for obesity, anxiety, addiction and Attention Deficit Hyperactivity Disorder."

"The company also "spent millions of dollars" to doctors to promote off-label uses of the drug. To encourage these off-label uses, the company allegedly gave doctors spa visits, concert tickets and trips to Europe and Hawaii."

"The company's guilty plea and sentence will now need to be approved by a federal court in Massachusetts. "For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," Stuart F. Delery, head of Justice's civil division, said at the news conference."

FocusPocus10
07-06-12, 04:38 PM
You registered an account merely to post this? What are your motives?

Chicchick
07-12-12, 05:15 PM
I'm considered younger than a formal "adult" and Wellbutrin saved my life. :umm1:

beltoller
07-15-12, 12:19 AM
I'm considered younger than a formal "adult" and Wellbutrin saved my life. :umm1:

I agree with you. Although I'm not familiar with the specifics of the legal case mentioned, in general, I think that punishing pharmacuetical companies for recommending off-label use of certain medicines straight-jackets progress and shows a true lack of understanding of how science actually works in the real world.

Things are not cut and dried. My spouse was fortunate to find a doctor who prescribed a med that is primarily used for heart patients and happened to work fabously in her case for anxiety issues.

More likely than not, its probably GREED on the part of the self-serving law-suit industrial complex at work.

The effects such have on true medical science advancement are chilling...

purpleToes
07-15-12, 03:59 AM
I think it's absolutely fine and desirable that doctors should have the freedom to prescribe off-label, but I think it's a bad idea to let pharmaceutical companies market drugs for purposes that haven't met the evidence requirements for FDA approval. Given free reign to claim anything they want to about a drug, the pharma companies' incentive will be for saying whatever makes sales. Doctors need unbiased information about drugs. While it's true that they currently get most of that information from the drug companies, at least the claims based on FDA approval were independently verified by an agency that works for the public.

beltoller
07-16-12, 10:16 AM
I think it's absolutely fine and desirable that doctors should have the freedom to prescribe off-label, but I think it's a bad idea to let pharmaceutical companies market drugs for purposes that haven't met the evidence requirements for FDA approval. Given free reign to claim anything they want to about a drug, the pharma companies' incentive will be for saying whatever makes sales. Doctors need unbiased information about drugs. While it's true that they currently get most of that information from the drug companies, at least the claims based on FDA approval were independently verified by an agency that works for the public.

Is that what happened in this case? The pharms were making official claims?

I could see that point as well.

Lunacie
07-16-12, 12:20 PM
Eventhough this story is headlining the news today, I haven't seen it mentioned here. It's not my intention to discredit whatever medication you choose to take as long as it does what it's supposed to do: help :)
But please keep in mind that Wellbutrin was only ever prooved to help depression in adults. Studies in younger people showed in best cases no effect at all, and in worst cases a worsening of how they fealt, and a growth in su´cidal thoughts.
Anyway, here's some small parts of the gazillion posts, so you can make up your own mind, based the whole story :)


"NEW YORK Ś GlaxoSmithKline agreed to pay $3 billion to resolve criminal and civil charges for promoting the drugs Paxil and Wellbutrin for uses not approved by the Food and Drug Administration - such as treating children for depression and treating adult patients for obesity, anxiety, addiction and Attention Deficit Hyperactivity Disorder."

"The company also "spent millions of dollars" to doctors to promote off-label uses of the drug. To encourage these off-label uses, the company allegedly gave doctors spa visits, concert tickets and trips to Europe and Hawaii."

"The company's guilty plea and sentence will now need to be approved by a federal court in Massachusetts. "For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business," Stuart F. Delery, head of Justice's civil division, said at the news conference."

It's customary to provide a link when you post information like this.

Here's what I found with Google:
http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?_r=1&pagewanted=all
and
http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

purpleToes
07-17-12, 12:30 AM
Is that what happened in this case? The pharms were making official claims?

I could see that point as well.

Yes, I believe so, because they were prosecuted under, among other laws, the False Claims Act.

Although, note that according to the official DOJ document (http://www.justice.gov/usao/ma/news/GlaxoSmithKline/Settlement_Fact_Sheet.pdf) (thanks, Lunacie), the promotion of off-label uses was often done through marketing strategies designed specifically to avoid the claims appearing to be "official" or coming from the pharma company. E.g., GSK hiring a contractor to write an article for a medical journal to misrepresent one of GSK's failed studies as showing that Paxil was well tolerated and effective for adolescents - then using that published journal article as part of its marketing materials.

beltoller
07-24-12, 10:42 PM
Yes, I believe so, because they were prosecuted under, among other laws, the False Claims Act.

Although, note that according to the official DOJ document (http://www.justice.gov/usao/ma/news/GlaxoSmithKline/Settlement_Fact_Sheet.pdf) (thanks, Lunacie), the promotion of off-label uses was often done through marketing strategies designed specifically to avoid the claims appearing to be "official" or coming from the pharma company. E.g., GSK hiring a contractor to write an article for a medical journal to misrepresent one of GSK's failed studies as showing that Paxil was well tolerated and effective for adolescents - then using that published journal article as part of its marketing materials.

Ah, thats really too-bad. Really muddies the waters for us all. If they aren't careful, its going to end up with an outright ban on any off-label uses or put so many stipulations/paperwork on it that most physicians would probably not recommend off-label, even if they thought it worthy to give it a go.

The goose that lays the Golden Egg.

purpleToes
07-25-12, 12:07 AM
Ah, thats really too-bad. Really muddies the waters for us all. If they aren't careful, its going to end up with an outright ban on any off-label uses or put so many stipulations/paperwork on it that most physicians would probably not recommend off-label, even if they thought it worthy to give it a go.

The goose that lays the Golden Egg.

I think you're getting this backwards.

The intention of prohibiting the marketing - by a drug's manufacturer - of off-label uses is meant to make off-label prescribing safer. The purpose is to curb the powerful forces of drug company marketing from influencing prescribers' decisions with self-serving, unsupported claims, whether through traditional or stealth marketing.

I consider this a very pro-patient move on the part of the Justice department and I think it demonstrates support for, rather than antagonism toward, the principle of appropriate off-label prescribing.

beltoller
07-25-12, 02:37 AM
I think you're getting this backwards.

The intention of prohibiting the marketing - by a drug's manufacturer - of off-label uses is meant to make off-label prescribing safer. The purpose is to curb the powerful forces of drug company marketing from influencing prescribers' decisions with self-serving, unsupported claims, whether through traditional or stealth marketing.

I consider this a very pro-patient move on the part of the Justice department and I think it demonstrates support for, rather than antagonism toward, the principle of appropriate off-label prescribing.

I believe us on the same page - I'd meant it was too bad that the pharms marketing dept ( and you have to read in Sales as well ) had resorted to blatantly deceptive and fraudulent methods to increase sales. The lack of self-regulation in the pharm. industry could lead to sweeping draconian measures (in the attempt to bring the ind. under control) that prohibit off-label use or more likely, make it prohibitively combersome. The opposite end of the spectrum.

purpleToes
07-25-12, 03:06 AM
I believe us on the same page - I'd meant it was too bad that the pharms marketing dept ( and you have to read in Sales as well ) had resorted to blatantly deceptive and fraudulent methods to increase sales. The lack of self-regulation in the pharm. industry could lead to sweeping draconian measures (in the attempt to bring the ind. under control) that prohibit off-label use or more likely, make it prohibitively combersome. The opposite end of the spectrum.

Ah, I missed your point, sorry. Yeah, I see what you're saying about overreaction, and I agree it's in our culture's character for that to happen. But physician autonomy and their freedom to prescribe off-label has a such a long and venerable tradition, I think it will be a long time, or take a major tragedy for things to shift so far in the other direction. (Although, it seems like the medical profession is letting their autonomy be eroded by abortion laws without much of a fight, so maybe it's closer than I think.)

Sunlight
03-13-13, 02:32 AM
This isnt surprising to me at all. the pharmaceutical industry is not 100% about helping people and improving the quality of their lives with medication, obviously they are to a degree, their product has to appeal to the public and have some good effects, it has to be helpful in some ways and have quality, otherwise it wouldn't sell.
But I think that way to often people will walk into a psychiatrists office with the idea that the drug they are going to receive will work perfectly and make their lives so much better because that's really a nice thought to have, isn't it?
But if you take the time to think about it, to observe all sides of the situation, the pharmaceutical industry is a part of corporate America, pharmaceutical companies are not non-profit, they are corporations. Corporate America is about their MONEY first and foremost, they are not there to cater to you, they are there to cater on what will make them money.
Psychiatrists, not all, but an amount of them, will accept offers from these companies and push medications on people who really dont need them, if they are really greedy they will push a medication on you knowing that you will likely get bad side effects and when you come at them with those bad side effects they will be quick to prescribe you another medication to "offset" the effects on your prescribed medication. In a way they are legal drug dealers.
Im saying this from personal experience, because my psychiatrist is a coldhearted guy, he wears gold and italian loafers & he is mostly about his money. He tries to pretend otherwise but I can see through him, I'm saying this because as a 16 year old female, i'm 5;4 and 93 pounds. He perscribes me 50 mg Vyvanse , he measures my quality of life based on my grades and school attendance, I havent been doing well at either because my IQ is high enough to catch up on anything quickly and he has been pushing to to prescribe me wellbutrin, with a pleading look on his face,, I know my drugs, and I know that at 93 pounds and already being on a stimulant wellbutrin will most likely do some damage, but I say i'll try it because if I try it and dont like it I dont have to take it, no big deal. The first 2 days were good, the 3rd day my heart was beating so fast and I felt so much stress and anxiety that I couldnt handle anything and lied in bed picking at my face all day.
All im saying is that no one should blindly follow everything a psychiatrist says to you, or anyone for that matter, without really doing your research, thinking for yourself or considering their motives, because otherwise you can really get screwed over. There are people who are players in this world and there are people who are easily played, there is a good and bad side to every situation, so people should really examine the pros and cons before trying any and every medication suggested to them.

Abi
03-13-13, 03:18 AM
This is old news.

To my knowledge, the only issues that GSK was convicted off wrt Wellbutrin were:

* Promoting off label use for obesity

* Promoting off label use for lack of libido

There were other issues regarding Pax and one other drug; I don't know about the details there.

FogNoggin
03-13-13, 08:42 AM
This doesn't necessarily mean the drug doesn't work for off label use, Just not approved (yet) by the Food and Drug Administration.

So far I believe wellbutrin is helping me in certain ways for my ADD.

Abi
03-13-13, 08:57 AM
Yup. It helps a lot with my bipolar related cognitive deficits.

It also... offsets the weight gain and loss of libido caused by my other meds, to some extent.

FogNoggin
03-13-13, 09:15 AM
Yeah, it's not the best, but it's the best I've had so far and it's better than no medication at all.
Oh, and wellbutrin makes me feel happy and that ain't bad at all, happiness can create motivation and can stop 'couch lock'

Jshect
03-24-13, 01:28 AM
Yes I have noticed it actually increases your sexual activity as opposed to the SSRI's which do the opposite, and it gives me more energy which has increased my activity level which caused weight loss, so I don't think those off-label promotions have no merit. However, I think the warning about increased suicide idealization needs to be taken seriously, because I have noticed it in myself from time to time. The medication seems to give me a irritable, emotional, impulsive restlessness that when mixed with depression could increase risk for suicide.

ThomasElliot
03-31-13, 04:57 PM
I really found no use for Wellbutrin at all. It did nothing for my ADHD. When I came off the medication, I spiraled into a depression the likes of which I had never ever experienced.

I think my level of ADHD was too high for a drug like Wellbutrin, which is why it didn't work for me.

Glad that it works for some though.