July 22, 2008

The Zyprexa Chronicles: Zyprexa Judge Slams FDA, Eli Lilly

Late last week, US District Court Judge Jack Weinstein shot off his mouth in an opinion he filed in the midst of a merry-goround of opinions being filed as various Zyprexa cases under his purview are shaped up to march toward trial or settlement. Recently, Weinstein pressed Eli Lilly to settle all outstanding Zyprexa claims and various estimates put that figure at over $7 billion. Lilly has already settled about $1.3 billion in claims over its handling of Zyprexa.

Anyway, the judge let the FDA have it right in the kisser over Zyprexa, which, as most of you know, has been linked to thousands of cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:

"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Weinstein's opinion is well-supported by the facts and he had more to say about the FDA in his opinion, which you can read here (pdf file). As he notes elsewhere in the opinion, the drug regulators in other countries were not fooled by Lilly's various smokescreens, but the FDA was.

He also went after Lilly:

"Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation....Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO."

RICO is the federal Racketeer Influenced and Corrupt Organizations statute that was designed to prosecute various mafia families. That acronym coming out of the judge's pen should have Lilly running for its settlement checkbook.

I must say that after documenting the Zyprexa scandal for much of the last two years, it is nice to have the judge overseeing many of the cases basically agree with most of my assertions about how Lilly handled the drug and lied to millions of Americans. The RICO bit is just icing on the cake.

Via Pharmalot.

Posted by Philip Dawdy at July 22, 2008 11:39 AM
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Comments

Applaud your blog!

This Judge is what 83 years old? I don't think he will stand for stonewalling Lilly causing him any embarrassment.He is famous for his handling of the 911 payout cases with Godspeed.

Another thing,where is the proof of Lilly's fame/claimed $1.2 billion payout? They have not paid my claim yet!

Posted by: Daniel Haszard at July 22, 2008 01:30 PM

Awesome judge. I believe anyone who ever TOOK Zyprexa ever should be paid something. Like the US Paxil settlement suit.

In cases where documentation of increased psychosis, weight gain, high lipid levels occured these people (like my daughter) can't get into the lawsuit via diabetes.

I'd love to be able to show that judge my daughter's photo of a 100 lb weight gain on a 13 yr old, who was given Zyprexa in 1999, as an 11 year old!

Talk about pain and suffering!

Posted by: Stephany at July 22, 2008 02:00 PM

cases of diabetes, hyperglycemia, massive weight gain, deaths and other problems:
Philip,
Why are you making such a big deal about it?
You're a panic monger!
Come on! These side effects are ailments! Death! Aren't we all going to die?
Diabetes, hyperglycemia and gaining weight... just change the diet!
Nothing to be scared!
BTW: This is IRONY!
When will they finally create the "Irony Mark"?
In Brazil nobody has a clue about it all.
Not even about SSRI, benzodiazepines -it's already on the book that they are addictive because they cost too low - Champix is being prescribed and God knows what's happening.
I talk to some psychiatrist and their reply is:
SILENCE! Some of them even avoid me now! I appear they turn the other way.
Zyprexa is being used to treat street-drugs problems. SILENCE!
SILENCE, SILENCE... and side effects being kept covered.
The patient claims is feeling this or that and the answer is still:
"-It's all in your head!" ( it's tru but also in the body) "-My other patients don't suffer these effects."
And they keep on changing from one SSRI to another. Till the patient, if major depressive, end up receiving ECT or is declared dysthymic. So... there's nothing we can do!
Jesus! I can't face any psychiatrist any longer. I start laughing when I'm told that "-She/he is out of Brazil in a Congress!"
Good! hehehe
Another diploma to the wall. And the patients believe they are in front of the Messiah!

"Isto aqui Yô Yô! É um pouquinho do Brasil Ya Ya!"

This is a Brazilian song. Just in case any Brazilian comes here!
They go to my blog but pretend to be in another country or ask their acquaintances in USA to send the copy to them!
I laugh! What else can I do?
Cry?
Nope! Not anymore. It's not me who is supposed to cry.
It's your turn my dear psychiatrists. It's your turn to cry. If you all have any sense of dignity left!
When you go to bed before sleep today think a little bit about what you're doing with people's mind, body and soul and if what you're receiving is worthwhile. Is it really worthwhile? Are you sure? Think twice, think ten times. How much is enough? What else do you need? Just keep on in this status...
Just take some notes and perhaps by the end of this decade, who knows the next, you will have a little bit of humanity in your heart, mind or soul.
"It has become appallingly obvious that our technology has exceeded our humanity."
Albert Einstein
Einstein is watching you!
As a matter of fact he is waiting to a little chat.
We all be there to see! It will be funny! Einstein was a funny man. Have you noticed that psychiatrists in general, therapyfirst exclude you out please, have no culture? They don't know literature, arts, philosophy... i don't want them to be an expert!
They usually don't know the basic! Perhaps they ask if Plato is the name of a dish!
Physicians in general are stupid.
They don't even know their own field! Wow!
I have crossed the line here.
I only want to report that the first psychiatrist I went, he's already dead... was a man of culture and we spend a whole section discussing Nietzsche.
He knew a lot! All the story about his sister Elizabeth changing his brother's work to fit Nazism and the whole stuff. He said I was not depressed and I needed therapy. Unfortunately he gave me clonazepam for the others made me feel more and more anxious.
I'll send it now for I'm writing more and mo....
:)
I only come to remark that RICO means RICH in Portuguese.
I ended up scribbling all of this!
Dear psychiatrists: next time leave a comment on my blog. There are even two posts written in Portuguese.
You know? The vast majority don't speak English!
Needless to say they don't read either...
Ok Philip. I'll stop.
But at least I'm laughing!
thank you because this month have been quite stressful.
One of the things that made me happy was your birthday!
:)

Posted by: Ana at July 22, 2008 02:08 PM

PS: Sorry! Forgot to say that psychologist are also avoiding me. When I tell them some stories they don't know and I invite them to come to FS they start fearing what they don't know and also you, Philip. You're being feared in Brazil.
hehehe
this is a huge compliment!
They don't read English...

I hope you all can laugh with me!

Posted by: Ana at July 22, 2008 02:12 PM

If you read the following, you have been forewarned this is not a PG comment, so with this disclaimer offered up front, don't bother commenting to me if Philip prints it and keeps it on this commentary site.

Fuck Lilly!!! Their history with minimizing the consequences of their products goes down as one of the most shameful events in the pharmacology industry, starting with Prozac and continuing to what bullshit they try to sell with Cymbalta.

They are the most corrupt motherfuckers in the field, and should justice prevail, this company going belly up will be a good day in my life. The reps have no soul for the most part, the district managers are evil, and god knows what to label the administration in Indianapolis. And every one of my colleagues who have colluded with this scum should burn in hell with them.

Just an opinion.

Do you get the sense I do not like Lilly? I will say this to risk being hypocritical: I do prescribe prozac (generic forms) and see some applicability to Cymbalta, but the keys to using these meds is start low and go slow in titrating up to a reasonable dosage. They have had positive impacts with some people, so to dismiss them entirely is too extreme for me.

thanks for the info, FS.

Posted by: therapyfirst at July 22, 2008 02:39 PM

I agree it is a pleasure to read the judge's words as you say, Phillip. Unfortunately, however, it will be a cold day in hell should there ever truly be a criminal trial for those at Lilly's who have killed people with this drug by hiding its lethal side effects and trainings its drug reps like robots to avoid the "d" word (diabetes). So I am glad for the words but there seems to be some sort of law that says greedy killers in the Pharma industry never have criminal trials - my idea of justice.

Posted by: Ellen at July 22, 2008 03:47 PM

I was presscribed Risperdal. I was told it is safe. It caused me such sevre akthasia that I would stand up and sit down for hours on end (until it was out of my bloodstream) It caused me to go the ER vomiting with severe dizziness. It caused me to fall asleep at dinner, barely able to keep my eyes open. It caused heart palpitations.

All anti pschotics should be banned IMO. After I stopped (on my own - the skrink kept incresing dosage even when I told her of the side effects ) I got better. My condition was misdiagnosed in the first place.

Being on these drugs is like being raped. When someone forcibly inserts their [male organ] into a womann it is rape. When I doc forcibly injects meds into a patient it is also rape. But IMO worse than rape. It should carry the same jail time as rape.

nuff said. peace out.

Posted by: Kevin at July 22, 2008 04:00 PM

I've read a long time ago that the initial dose for Prozac was designed to be 5 mg.
I believe the first dose is 20 mg, isn't it?
Strange!
As far as Cymbalta is concerned I will never understand why a drug that killed 5 people, suicide and one of them hanged herself on Lilly's facilities, can be on the market. How can drugs that blah, blah, blah..... for decades can be prescribed like water.
It's as if TGN1412 could be on the market despite all that has happened.
I will never, ever understand it!

Posted by: Ana at July 22, 2008 04:18 PM

@ therapyfirst: this is not a PG rated comment either:

fuck the psychiatrist who rx'd Zyprexa to my daughter at age 11 in 1999! Lilly and the execs can all go to hell, and so can the psychiatrist who told her to "take a walk" when she gained 100 lbs!!!

who in their right mind rx's that shit out to a child!? a decade ago!

Posted by: Stephany at July 22, 2008 05:06 PM

Because I felt very strongly about the Viva Zyprexa matter, (although none of mine have taken the drug) I linked to a certain zyprexakills.tor file and allowed my machine to upload many of the million plus filed papers available, via tor multiple user sharing. Eventually,this led to the total crash of that PC, which, I subsequently had to replace. Nevertheless, it was a small price to pay to spread the word.
Thank you Philip, and thanks to all the others who sacrificed money and time, and even risk to reputation, to bring these things to light.
I'm glad Federal Jurist Jack Weinstein has given this opinion, as it appears to vindicate all those involved – including one John Doe--citizen journalist - in Weinstein's prior fed. court ruling, re. breach of court seal.
Maybe you will include the links from your site to this comment for the further elucidation of the uninitiated.
Regards,
Stuart.

Posted by: Stuart Jones at July 22, 2008 05:09 PM

Therapy First, how do you evaluate whether a drug is positive for a patient? The reason I am asking is that I could have sworn a 4 med cocktail was working great only to realize as I tapered off of it, it really had been horrific. Psych meds have a reputation for spellbinding effects, you know. Hope I am using the right word.

Anyway, my psychiatrist would have agreed that the meds were wonderful when actually, they destroyed my life and gave me among other things, a hearing loss and cognitive side effects.

How do you distinguish between a med really working vs. meds that are simply making the patient and psychiatrist think they were working?

Posted by: AA at July 23, 2008 05:27 AM

@AA,
Could you explain what cognitive side effects you're experiencing?
Thank you.

Posted by: Ana at July 23, 2008 11:59 AM

Hi Ana,

Memory loss, horrible spelling when I used to be a great speller, and weird typing problems. My brain will know what I want to type but it comes out completely different. I have to do alot of editing.

I also have trouble locating things right in front of me. I had that even before meds but I swear the problem has worsened.


Posted by: AA at July 23, 2008 05:48 PM

To therapyfirst: have you any involvement with the International Center for the Study of Psychiatry and Psychology?
To AA: I also noticed the typing problems, thinking of typing a letter and reaching for a different one.

Posted by: Sophia at July 23, 2008 06:42 PM

to AA:
"How do I evaluate whether a drug is positive for a patient?"

From my perspective, I never focus solely on the medication. I embrace what is called the biopsychosocial model to mental health care, so I look at the biology, the psychology, and the sociology of the patient in front of me. What I hope to see meds do as PART of the treatment process is control those symptoms that will inhibit the patient from successfully navigating change and improving insight if they remain.

As an example, people with definable Major Depression have vegetative symptoms like disruptions in sleep, changes in appetite, decreased energy, profound negativity, and in more serious cases, suicidality. What I see meds do for the better is improve sleep and appetite, increase energy, lower the negativity and reduce if not eliminate the suicidality. So, the patient is hopefully able to work on addressing the issues that could be fueling the depression, or caused by the depression, and I think meds play at least some role in improving motivation and instilling some hope.

A very wise mentor in my residency taught me that "change begets change". To me, for a patient to be comfortable agreeing to try a medication is creating a change, and people can build on that. Notice I don't sell the meds as the cure all. Therapy is the cornerstone to restoring sound mental health. To talk, to listen, to consider new ideas and frames, these are powerful processes. Meds open doors to me. What the patient can do once through these doors is mostly up to them. We as providers aid, we don't do for the patient.

Just my opinion, but I see it work.

Thank you for the question. I hope you'll pursue further thoughts if you are involved with treatment.

One caveat: I dislike antipsychotics outside the use of psychosis. they have a limited role in mood disorders and agitation, but that is the key word: limited!!! they are oversold these days, and the consequences are now playing out. That is why I so hate what Lilly did with Zyprexa, and all the stupid other companies with their sister compounds want to ride the Zyprexa express to financial windfall. Fuck 'em all for their greed!!! Astra Zeneca for seroquel, fuck 'em! Pfizer for Geodon, ditto!!! And the new scum of the earth, Bristol Myers for Abilify, they take marketing to a new low. I relish picking up the newspaper or reading Philip's latest posting and learning of the troubles BM (ironic shorthand, eh?) will endure once their poisons are documented. It is a shame too, because the drug has some promise. But, remember the 4 P's of pharmacology: promise, panacea, placebo, and poison. Every drug goes through this process. Some survive, some get screwed. No place for profit in health care, I'll die believing this.

Sorry for the end rant. It's a tender topic to me? Good luck in your pursuits, AA.

Posted by: therapyfirst at July 23, 2008 07:41 PM

to sophia:

No, I do not, I do not even know of the organization. Something I should be interested in learning of?

Posted by: therapyfirst at July 23, 2008 08:31 PM

It's an organization I read about in Bruce Levine's "Surviving America's Depression Epidemic..." He also is not fond of the American Psychiatric Association, and seems to find it a valid and validating alternative.

Posted by: Sophia at July 24, 2008 01:43 PM

Therapy First

Thank you for answering my question and you mentioned some good criteria for evaluating whether a med is effective.

The point I was trying to make was that a professional like yourself could think a med was effective when actually, it wasn't such as what happened in my case. I was no longer suicidal from the Prozac induced side effect and was sleeping great. But I ended up suffering severe adehenia (sp?) because of the meds.

How does a professional like yourself distinguish between true effectiveness and false effectiveness?

AA

Posted by: AA at July 24, 2008 02:26 PM

Here's the link to the site Sophia (I assume this is the one)is talking about:

International Center for the Study of Psychiatry and Psychology, Inc..

Looks like there's a conference coming up:

"EFFECTIVE TREATMENT APPROACHES TO EMOTIONAL SUFFERING: RECOVERING THE SOUL OF PSYCHOTHERAPY"

Posted by: Stephany at July 24, 2008 02:42 PM

@AA,
Thank you for your reply.
I've already heard about these symptoms.
"Memory loss, horrible spelling when I used to be a great speller, and weird typing problems. My brain will know what I want to type but it comes out completely different. I have to do alot of editing.

I also have trouble locating things right in front of me. I had that even before meds but I swear the problem has worsened."

Memory lost is already known.
The spelling problem I've heard about it on Charles Medawar site.
There was a man who said he suffered the same you mentioned about spelling and he claimed it was hard to find a word on dictionaries.
He also had to edit many times what he wrote.
He ws already out of SSRI for more than 1 year.
It seems it affects language center.
Thank you.
I was already suspicious these where the cognitive impairments you suffered.
Try drawing!
Who knows forcing your brain to achieve other things can do you good?
Try writing with your left hand.
Try learning an instrument.
I'm just giving some hints with no scientific data whatsoever.
But who cares about it nowadays?
:)

Posted by: Ana at July 25, 2008 12:47 AM

To AA re July 24, 2:26 question:

"true vs false effectiveness..."

One thing that has always fascinated me about the use of medications, not necessarily the medication itself, is how people report a positive effect so quickly when it is doubtful the medication has begun to affect the person.

That is a placebo effect to me, and there are at least two ways to approach this response:

You could ask the patient to stop the medication and reinforce their suggestability to change is high, so maybe just therapy alone could have the strongest impact, or, leave the medication as is and hope the patient won't come back and ask for higher dosages, which always runs the risk of side effects occurring, and just focus that the patient saw progress and reinforce adjunctive therapy stay in place.

the only way to know if a medication is doing something, positive or negative, and there is a sense of wariness to the reaction, is to stop the med and see what happens in the next 4-6 weeks, the period of time where medication response usually is gone. It is a risk, but if the issues are causing concern, that is what you have to try, for the most part.

Regarding someone else asking me a question about therapy, at a different posting, and I think it was Ana, I can only tell you this(whoever asked):

therapy is part of the treatment process, and to me it is less invasive, so that is why I sell it and that is why I use my alias. If you believe in the biopsychosocial model, that is why therapy is part of care. And, even though I am a psychiatrist, I do not embrace freudian principles, and don't do much with psychodynamic models, although this paradigm has its place for some people. Cognitive behavioral therapy is well documented to help with various diagnoses, so I use that with patients as able.

For what it is worth to the readers, I just throw out this question: if meds are seen as such a detriment and are so destructive, what is the alternative to treating true illness? That has been asked before and I don't feel most detractors have offered a substitute that has a history of significant success, significant to me helping 2/3 of people at least.

Hope these opinions are of value.

Posted by: therapyfirst at July 26, 2008 09:59 AM

"Interpersonal phenonemology" is a term coined by Loren Mosher, I believe, as a very effective treatment for severe mental disturbance. It is discussed at length in the book "Soteria." It was studied at length and documented quite carefully. We are starving, in my opinion, for methods and environments like Soteria houses.

Posted by: Sophia at July 26, 2008 10:33 PM
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