September 03, 2009

Pfizer Settlement Includes Much Off-Label Promotion of Geodon and Kickbacks To Docs For Zoloft

The Geodon portion of Pfizer's record $2.3 billion criminal and civil settlement with the Department of Justice yesterday was much larger than I'd thought. What's more, now that details of the settlement are out, it is clear that the company was paying kickbacks to doctors to prescribe Zoloft which is the company's now off-patent anti-depressant.

From HHS's press release, the $1 billion combined federal and states civil settlement contains $301,462,065 attributable to illegal off-label promotion of Geodon, the company's weak-selling antipsychotic. The painkiller Bextra made up $502,524,316 of the $1 billion, so it's clear that Geodon was a big piece of the settlement.

Specifically, the settlement covers off-label promotion of Geodon for the following unapproved conditions:

"Depression, Bipolar maintenance, Mood disorder, Anxiety, Aggression, Dementia, Attention Deficit Hyperactivity Disorder, Obsessive compulsive disorder, Autism, Posttraumatic stress disorder, Unapproved patient populations (including pediatric and adolescent patients), Dosages above approved maximum."

That's a slew of off-label marketing and it's nonsense that it was going on. I'm not aware of any documents in the public realm related to all that activity. but if Pfizer settled claims connected with it, then you know they did it.

What's even more impressive is that the $1 billion portion of the settlement also included $49,844,714 for paying kickbacks to health care providers in connection with the marketing of a number of other Pfizer drugs including Zoloft.

The settlement doesn't include any sanctions against doctors who took kickbacks, but I have to question why these doctors aren't being named and why their medical licenses aren't in jeopardy, at a minimum.

Both Eli Lilly and Bristol-Myers Squibb have in recent years settled charges brought by the Department of Justice for the illegal off-label promotion of antipsychotics. Lilly even pleaded guilty to a federal criminal misdemeanor earlier this year.

In addition to now being able to call Lilly a criminal company, we can now apply the same terminology to Pfizer, although that behavior seems to have been mostly in relation to Bextra.

I'm curious, given all this criminal behavior, as to why companies like Lilly, BMS and Pfizer as well as their lobbyists are allowed to have any role whatsoever in negotiating health care reform.

Posted by Philip Dawdy at September 3, 2009 12:01 AM
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Dawdy said: "I'm curious, given all this criminal behavior, as to why companies like Lilly, BMS and Pfizer as well as their lobbyists are allowed to have any role whatsoever in negotiating health care reform."
Obviously they need to negotiate health care reform to ensure that either the rules governing off-label promotion are relaxed or that enforcement is minimized.

Posted by: CL Psych at September 3, 2009 09:15 AM

They're still doing it!
The following article about Lyrica was in More Magazine's Sept '09 issue (Pg 198), disguised under "Health News". It says it was written by Elizabeth DeVita-Raeburn (staff writer, I'm guessing);

"Title: Quelling Restless Legs
If you're plagued by restless legs syndrome (RLS), which can worsen with age, you may soon sleep better. Pregabalin (also known as Lyrica), a drug widely used to treat anxiety and other medical conditions, may ease the creepy, tingly sensations of RLS that can awaken people during the night as well as prevent them from falling asleep, according to a new study presented at the American Academy of Neurology’s annual meeting.
Scientists gave the drug or a placebo to 58 people suffering from RLS. At the end of 12 weeks, nearly two thirds of the people who took the drug were totally symptom free, and the symptoms of those who weren’t completely cured had improved by 66 percent.
The people who took Pregabalin also experienced deeper sleep than those who hadn’t.
Pregabalin hasn’t yet been FDA-approved to treat RLS, but if exercise and other medication haven’t solved your leg problems, ask your doctor if you’re a candidate for off-label use.
Side effects can include dizziness, drowsiness and dry mouth."

The press release didn't mention that they promoted Lyrica for Restless leg or Anxiety, but clearly, they have.

Posted by: Damaged at September 3, 2009 10:29 AM

""The settlement doesn't include any sanctions against doctors who took kickbacks, but I have to question why these doctors aren't being named and why their medical licenses aren't in jeopardy, at a minimum.""

Oh I'm sure there are a whole host of excuses. The reality is though that so many doctors do this, take kickbacks and prescribe meds off label in order to continue getting the free vacations and such, that if there was a precedent set of persueing criminal charges against those doctors or taking thier license to practice away, it would just be too risky because since so many doctors do it, we could possibly end up with a shortage of doctors.

There ought to be some legislation passed though that says FROM THIS POINT FORWARD, any doctor who accepts kickbacks in any form other than sample medications (because really this does help a lot of patients out when they hit a brick wall with thier health insurance prescription coverage) will be at risk of prosecution AND loosing thier medical license. If the law was made retroactive or a precedent was sent of bringing charges or licensure consequences against doctors for prior acceptance of kickbacks and changing thier prescribing habbits in order to obtain those kickbacks, we really could end up with a shortage of doctors, no joke. And ESPECIALY of psychiatrists. Though if psych docs are rxing meds for conditions that they don't work for, maybe a lot of patients would do better with no access to psych docs at all versus access to scumbag greedy unethical practicioners.

I've been to see quite a few different psych docs in my search for just ONE that was willing to talk about medications, how they are THOUGHT to work, the REALITY of side effects and adverse reactions, the reality of the reactions I have had to medications NOT being "all in my head", etc., in an HONEST and RESPECTFUL manner. What I have learned from the experiences of seeing all these different psych docs (from well known private practices to university doctors and less expensive less well known doctors) is that I DO BETTER WITHOUT WORKING WITH A PSYCHIATRIST than I ever did while working with one. They are ALL dissrespectful and use thier knowledge of psychology to manipulate thier patients into being complient with WORTHLESS and even HARMFUL treatment plans. They actively work to make thier patients more self doubting than they already are (which can really screw with a persons ability to sel monitor and be eompowered in the process of keeping themselves well), they invalidate real and accurate observations on the part of the patient about how a treatment has worked for them in the past or is working for them, and they manipulate the patient into believing that the doctor who see's them for 15-50 minutes maybe twice a month actually knows more about thier own wellbeing and reactions to the treatments they prescribe than does the patient that is experiencing them 24/7. And if you DARE to try and stand up to your psychiatrist and say "No really doctor, I KNOW that X,Y or Z medication makes me much worse off and I don't think it is safe to try that type of medication again, no matter what you think or your sources tell you".... well be prepared to have the doctor DECIMATE your psychologcal wellbeing by telling you that you are delusional and that you will NEVER GET BETTER if you keep being "paraniod" and unwilling to accept the "help" they are trying to give you. HA! Help? Yeah, it's soooo helpful to put a patient back on a medication that they have had repeated adverse reactions to. right. sure.

As it is I just use my general practicioner to rx me the meds that I feel safe taking and trying and monitoring myself and my reactions to them WITHOUT the biased input from a psychiatrist. I've been able to keep myself more stable by depending on MY OWN opinion and knowledge about how a medication is effecting my wellbeing than I ever did listening to a psychiatrists treatment suggestions. I think it is because I KNOW MYSELF better than any psych D could AND without thier INTERFERENCE and know it all dissrepectful "direction" of my treatment and MANIPULATION of my own self knowledge, I make better decisions.

I mean really how can a doctor help a patient at all if the entire time they are working with the patient all they try to do is make that person doubt themselves and thier observations of how a medication is effecting thier wellbeing BECAUSE they have a vested interest in keeping that patient unwell just in order to get them on a certain medication... and then once they get them on that certain medication and the patient comes back and says "doc I really feel worse on this treatment" they tell the patient that it's all in thier head (that they are being paraniod or whatever) and they just need to increase the dose.

I have never once had a psychiatrist LISTEN to any of my own opinions about myself and what treatments work best and the reasons why I believe one class of medications is safe for me while another is definately not safe. They just push and push to get you on the newest most expensive meds out there that give them the best kickbacks (Do you know even though I had already had one seriously bad adverse reaction to Zoloft - ie a suicidal reaction-, that even after I told my doctor about that they put me back on Zoloft despite my concerns, and then after having the EXACT SAME reaction to the medication a second time, and telling every doctor after then about BOTH reactions, I still have had at least 1/2 of the doctors I have seen since then try to get me to go back on Zoloft. Now it all makes sense, now that I know that pfizer was giving serious vacations and such kickbacks to doctors.)

I would LOVE to see the doctors that have made me more ill in the past due to thier being more concerned about getting free vacations than my wellbeing, and thus putting me on medications that were OBVIOUSLY unsafe for me go to jail or loose thier licenses. These are suppossed "healers" who LIED to me and messed with my psyche and ability to trust myself and have confidence that I could play some part in my own treatment and direction of getting well... all in order to get me on a specific medication (and it's not like they are even sly about it. Once they make thier suggestion about the medication they prefer you get on, if you don't want to try that medication they just try every trick in the book to try and get you on THAT medication, even if you are trying to get them to put you on a med that is almost exactly the same in it's mechanism of action but just isn't THAT medication. The 1st thing they do is use the "this medication works in X,Y and Z way in the brain. And when that doesn't work because you actually know about how all these different psych meds are THOUGHT and claimed to work and you can quote from the PI sheet the pharmacological actions/mechanisms of action of the medications and can say; "well the med you are suggesting works in the exact same way as the med I'd rather try, except the med I'd rather try is cheaper/has less side effects/has been shown to be more effective etc etc." THEN they turn to the next thing in thier bag of tricks (if they don't 1st try just straight out LIEING about how the medication you are suggesting works differently than the way in which you KNOW it works - In THIS case I have ALWAYS made them pull out the BIG PDR and go over the COMPLETE PI sheet, so that I can call them on thier BS and say; "see it says RIGHT HERE exactly what I was saying about how the medication works.... and even then I have had some doctors STILL try to LIE about this and say "well they don't publish everything about how a medication works in the PI sheet"... ummm yeah, sure they don't! ) so, anyways, if they don't resort to straight up lieing about the mechanisms of action of the medications in question then they turn to the next trick which is for them to say; "well I know the meds both work the same way BUT I've seen in my practice better reactions from patients with similar symptoms to yours to the medication that I am suggesting. And when THAT doesn't work and you STILL insist on trying the medication that you feel is a safer option (for good reason because you've done a LOT of research into all the treatment options available) THEN they turn to straight up psychological war-fare and start accusing you of being paraniod of them, or delusional because you think you could ever be smart enough to have any opinion regarding which medications are better on the risks versus benefit ratio, and when THAT doesn't work they will straight up tell you that if you wont "work with them" that you will never get better and there is no hope for you (hey I am the one PAYING you to work FOR ME right? Where the hell do they get off pulling that move?))......
..... Well I would love to see all the doctors that have pulled this crap with me in order to get kickbacks at my expense, loose thier licenses and go to jail BUT if that were to happen I am CONVINCED that there would only be about 10 to 20% of the practicing psychiatrists left to treat patients. IF even that. It's like I said, I tried and tried and tried for YEARS to find a repectful and honest psychiatrist and now I have given up the search due to getting sick of ALWAYS running into the SAME type of dissrespectful manipulative crap and having it effect me in negative ways due to the fact that since the psychiatrist is the authority figure it would always mess with my mood and make it worse, even when I knew EXACTLY what they were doing and why.

Sometimes I wonder, due to the fact that the way in which all these different psychiatrists have gone about trying to convince me to take the more expensive harder pushed medication versus trying something I am comfortable trying, has been soooo similar, I really wonder if the drug companies have not just set about having thier representatives go around telling doctors why they should use thier psych med off lable for every condition in the book and offering kickbacks if they do so... but if they ALSO have the reps tell the doctors HOW TO GO ABOUT CONVINCING SKEPTICAL PATIENTS TO TAKE THIER MEDICATION VERSUS TRYING SOMETHING ELSE. It wouldn't suprise me at all. In fact it would suprise me more if the pharmacuetical companies haven't taken the time and done the research into how to manipulate skeptical patients into trying a medication they don't believe they need or think is not appropriate for thier person situation and condition. I wonder if that will ever come to light.

Posted by: katielou82 at September 4, 2009 01:42 PM
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