December 18, 2006

The Zyprexa Chronicles: Lilly Downplays Risks Of Zyprexa, Busted By The Times

I have several thoughts in light of Saturday's revelations in the New York Times that Eli Lilly, according to documents obtained by the paper, had been telling its sales reps to downplay risks of weight gain, boosted sugar levels and diabetes in patients using its star drug Zyprexa to treat schizophrenia and bipolar disorder. You should read the article here and draw your own conclusions. If Eli Lilly's corporate behavior in regards to Zyprexa is anything approaching its deceit around the side effects of Prozac (a point so well-documented that it's now practically common cultural knowledge), then I expect further revelations to come forth. I want to be careful in what I say, but the Times itself made a comparison between Zyprexa and Vioxx:

"As did similar documents disclosed by the drug maker Merck last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects."

The documents that the Times got its hands on were made available to the paper by Jim Gottstein, an attorney in Alaska. The documents were available as a result of discovery proceedings in a class-action lawsuit alleging diabetes and other injuries (including deaths) connected with the use of Zyprexa. The case was settled last year for either $690 million or $750 million, depending on whose account you trust. The settlement forced Eli Lilly to take a loss for one quarter in 2005. The monies have not yet been distributed to plaintiffs and Eli Lilly's internal documents were unavailable to the public because a judge had ordered them sealed.

Gottstein was peripherally connected to the case and, in connection with another case he was working on, he got ahold of the documents. Since he was not a party to the class action suit, he was not bound by the court's seal. I know Gottstein a little bit and am confident in saying he felt morally compelled to ensure that the public knew about the company's behavior. He is owed many thanks.

In addition, I'd like to thank the Times for its recent coverage of mental health issues, especially those involving atypicals, and Alex Berenson for reporting Saturday's fine article. The NYT has been the only mainstream media outlet to comprehensively take up the issues around mental health and psych meds in a skeptical fashion. I hope that the paper will continue to do so.

At this point, the judge in the class action should unseal all documents in the case relating to Zyprexa's safety, efficacy and effectiveness, as well as any documents relating to clinical trials of the drug. In addition, the judge should unseal any and all other documents in the case. The FDA as well should release any and all documents concerning Zyprexa. So should any psych researchers who have done studies on Zyprexa. At this point, it would be unethical to do otherwise.

The public has a right to know the truth and to, then, draw its own conclusions about the drug and Lilly's behavior. I know I am just a little old patient (and an unemployed journalist with a blog), and that we are all supposed to go sit off in the corner and let Big Pharma, the FDA, researchers, the American Psychiatric Association, the federal government and mental health advocates decide how the mental health game will be played, defined, advertised, spun, justified and otherwise ginned-up, but there are millions of patients who take Zyprexa--as well as other chemically-similar atypical antipsychotics--and they have an absolute right to know the truth about Zyprexa and the other atypicals. My rough estimate of how many Americans take the atypicals is between 6 million and 10 million people. This includes over 1 million children.

Reportedly, there have been two dozen deaths associated with the use of Zyprexa and there have been reports of deaths and adverse events tied to the use of atypicals in children.

Regular readers know that I have been asking questions about the safety, efficacy, effectiveness and ethics of use of the atypical antipsychotics for over a year. In addition, I have been asking about how substantive the evidence was for doctors to jump the fence with these drugs and use them as a long-term treatment for bipolar disorder. I have also been asking questions about how studies on these drugs have been conducted as well as how the drugs are marketed.

I am trying my best to keep an open mind about these drugs, but at this point I have to say that their long-term use in bipolar disorder is not justified. If anyone wants to offer arguments countering that assertion, you know where to find me.

I think that their casual use in our culture is ethically problematic. I think that it is time to drop the "yes, we know atypicals are problematic, but they are the best option for schizophrenia" spin that is floated by doctors and mental health advocates. Being skeptical and honest in the face of strong evidence is hardly crossing the "oh, but we'll scare off people from being diagnosed, or seeking help, or taking their meds if we are honest" line that many doctors, researchers and mental health advocates employ as a justification for keeping their lips zipped when some of these same folks tell me privately that they agree with me.

What's more, the atypicals have not proven out as good replacements for the first-generation antipsychotics in treating schizophrenia--and that's not my opinion. It is an assertion backed by two non-Pharma funded, long-term studies, as well as other evidenece. The drugs' 8 to 20 times price differential as compared to the older antipsychotics is not justified by either the drugs' long-term performance or their side effect profiles. If someone would like to offer me evidence to counter any of my assertions, feel free.

For over a year, I have been pointing out that mental health advocates, the federal government, doctors and the American Psychiatric Association should demand that the prices of these drugs be radically-slashed. I have said that doctors have over-stepped their ethical boundaries in pressing their patients to use these drugs long-term for bipolar disorder. Why they continue to remain mute is beyond me. Why NAMI National continues to coddle these drugs and their makers is beyond me as well, given that the group is the so-called "Nation's voice on mental illness."

It is time for the mental health industry to start asking skeptical questions about these drugs, if they are to retain any shred of credibility. It is time, also, for clinicians and researchers to publicly share their thoughts about these drugs. I am sick and tired of docs hiding behind the curtain and wringing their hands over whether their "colleagues" will stab them in the back if they speak up. The medical profession has an ethical responsibility to be open and honest with patients.

When I began this blog in September 2005, I was criticized by some readers for being too skeptical about atypicals, especially where I was questioning their long-term use in bipolar disorder. As well, when I made similar points in a Seattle Weekly article a year ago, my reporting was challenged and one local psychiatrist went so far as to question my sanity. So did some of the paper's readers.

Based upon recent revelations about Zyprexa and other atypicals, I would say that not only was I on-point, but that I was restrained in whatever criticism I offered. As usual, if anyone would like to offer countervailing evidence, let me know about it.

Posted by Philip Dawdy at December 18, 2006 12:01 AM
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Comments

Where can I find more information on the deaths associated with Zyprexa? I was recently prescribed Zyprexa after a lengthy stay in a mental health facility. Zyprexa was a god send to me then, when no other medication would deliver me from a horrific manic episode.

I agree that we as patients should be vigilant when considering the safety of our medication. However, it is such a double edged sword. Without the drug that lacks a sure footed safety record, I would still be in the hospital.

But, now of course, I'm a little freaked out about this news. ;-)

Posted by: stacekir at December 17, 2006 10:03 PM

never mind on getting me the info on the deaths cited . . . I found it all . . .looking like I can look forward to losing my girlish figure

I'm far to vain to gain an extra 100 pounds . . .time to find some new meds

Posted by: stacekir at December 17, 2006 10:07 PM

Eli Lilly ZYPREXA LIES!

Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa".

Eli Lilly zyprexa cost me over $250.00 a month supply out of my own pocket X 4 years and has up to ten times the risk (over non users) of causing diabetes and severe weight gain.

Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how does Zyprexa get to be the 7th largest drug sale in the world?
Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.

The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 7 states (and counting) going after Lilly for fraud and restitution.
I was ordered to take it beginning in 1996 for my PTSD for 4 years more,it was useless for my symptoms.Lesson learned...you shouldn't give a major tranquilizer like zyprexa which makes you 'sleepy' to a hyper-vigilant patient.

There is a clinical difference between hyper-vigilant and harmful aggression.
Only 9 percent of adult Americans think the pharmaceutical industry can be trusted right around the same rating as big tobacco.


---
Daniel Haszard zyprexa-victims.com

Posted by: Daniel Haszard at December 18, 2006 07:59 AM

Zyprexa fucked up my daughter's brain, end of story. Once on it, she could never go off. The doctor told her at a very young age, "you are lucky to live now, because Zyprexa is so new, if you lived in 'the old days' all you would have been able to take is Lithium."

I say to anyone who releases internal documents for the good of the public gets my thanks.

The first drug in a local county psych ward given to agitated patients upon admit is Zyprexa Zydis. Dissolves under the tongue, nice and smooth. How do I know? First hand on-site experience. Zyprexa is here to stay in the State and County facilities in Washington state. They have a contract for it.
No wonder there are so many "revolving door patients". Maybe the attorneys down at mental health court that complain so much about "revolving door patients" should chart what medications these clients/patients are on. Maybe then their own workload could be reduced.
There are more than doctors who need to stand up and speak out with honesty.
Caseworkers. Attorneys in public defense teams. Judges. Nurses. General staff. Directors of hospitals. Parents. Teachers. Need I say more?

Posted by: Stephany at December 18, 2006 08:37 AM

I read the Drugging of the American Mind article and suddenly feel like my struggle for the last year has been normalized. Thank god. But that's the catch, it also means that that frustration is going to continue. I keep breaking through with terrible bouts of insomnia that lead to what I term "nasty mania"...all of the serated edges of mania none of the heady, glittery stuff that I had before I started meds. I've been taking Zyprexa for a PRN since I left the hospital earlier this year. It puts me into oblivion. I keep thinking that something is wrong with me, that I'm at fault for not getting better, for not being "stable" for more than a month or two at a time. I keep waiting for something to give. But, its not that is it? Its the nature of the beast (which I'm still learning) and the nature of our meds...which are less than ideal.

Posted by: Priscilla at December 18, 2006 11:55 PM

The fault is in the doctors who pretend mental illness is a brain chemical imbalance. There is no test for any brain chemical imbalance.
Once the patient takes or is forced to take psych.medicine THEN there is a real brain chemical imbalance.
Speaking out against the drug co. and psychiatry is dangerous. Psychiatry can jail and drug or ECT you against your will .Drug Co makes Billions every year and wants to continue to make that money.
People in positions of power and authority want to keep their power/etc and have no reason to rock the boat.In 1900 1 in 350 people was crazy today its 1 in 50
soon to be 1 in 10 as at least 10% of all N. American children are on ADD drugs.
Society shall reap what it sows

Posted by: Mark at December 23, 2006 09:07 PM

Not to burst all your bubbles, but in Australia our medical professionals do actually advise on the risk of Zyprexa prior to treatment with it and dealing with depression, BPD and schizophrenia are difficult enough in itself. I have been taking Zyprexa for two months now and for the first time in 5 years I don't have psychotic symptoms. Maybe instead of just relying on medical professionals you should do some of your own due dilligence and look at sites such as www.crazymeds.org who also list the potential harms of the drug. For a lot of us, this medication has saved our lives (and before I get flamed, no I don't work for a drug corporation, I am just a sufferer of Borderline Personality Disorder who has actually received from long sought after peace from this drug). In summary, theres always the other side of the story. No drug taking is without consequence, prescription or otherwise, but I know I'd rather have to watch my sugar intake, exercise every day and be ABLE to do these things with the help of Zyprexa.

Posted by: Ryan at January 11, 2007 01:51 AM

Ryan, you might have been advised in Australia but I wasn't! I've been taking Zyprexa for three weeks and gained 3.5kg's. I'm on a diet, I wonder if it will work. I read of the side effects in the box but I must admit it is a godsend for me but now i'm worried about the deaths and diabetes etc.

Posted by: Lisa at January 31, 2007 01:59 PM

i am taking zyprexa for more than 10 jears i have boren its only getting worse can anybody help me because i dont know whats happening with me its like im getting scizofrenic of these medinines.i am afraid because i cant do my toilets now im taking lax for more than 2 months i was 75 kg now in 1 week i lost 15 kg.dont know whats happening

Posted by: amanda at February 20, 2007 05:12 PM

My 16 yr old daughter became a scheduled patient in australia and she is being injected with Zyprexa 5mg on top of 20mg oral dose daily. Few doctors know that injecting loads the blood 5x more than oral which would therefore amount to an illegal dosage. On top of that she has 2 drugs. Her initial problem was akathesia bought on by Tegretol when she had epilepsy.The MIMS manual 2005 says Zyprexa hasn't been studied in effects and safety on kids under 18yrs and caution with epileptics and if there is a family history of breast cancer not to be used (this applies to my daughter). It is a neurotoxin.You read the side effects in the US documents as the Oz warnings are slimmer-side effects add up to psychosis and she spends her days delerious and sick.
When psychiatry turned biological it was tragic for my daughter - the drug companies wrote the Mental Health Act.

Posted by: margaret at March 5, 2007 01:55 PM

In February 2007, the Proceddings of the National Academy of Sciences identified the Histamine 1 receptor as a major factor for the development of weight gain in atypical antipsychotic users (zyprexa, being one of these drugs).The Atypical antipsychotics, risperdal, zyprexa and clozaril block this receptor; zyprexa and clozaril block it rather substantially. Most likely, though not confirmed scientifically, histamine 1 receptor blockading could further account for hyperglycemia and diabetes development in some of the patients that use this drug.
Researchers at Johns Hopkins additionally found that AMPK levels were quadrupled in the hypothalamus as a result of taking some of these three atypical antipsychotics.AMPK is the master switch that regulates many of the body's internal metabolic functions including insulin sensitivity, glucose transport functions and lipogenesis functions to name a few. Most likely hyperglycemia found in people that use these drugs
will be associated with the abnormal levels of AMPK. Interestingly, in research, leptin based therapeutics were successful in returning AMPK levels back to normal in mice that were given the atypical antipsychotics. Leading to the possibility that a leptin based drug for humans could be developed in the future for alleviating the irreversible hyperglycemic conditions found in atypical antipsychotic users.That is a scientific venue that could be developed and come to medicinal fruition in the few years ahead, potentially, with some luck of some savvy researchers in the field. Nevertheless, Solomon Snyder of Johns Hopkins conducted this original research found in the PNAS literature and a researcher by the name of Meltzer
wrote a more comprehensive commentary on the issue. For additional information on this research, one should go to the following web site article, titled: "Atypical Antipsychotics Activate Hypothalamic AMPK", Elizabeth M. Adler Science's STKE. More extensive information detailing the specifics of this research can be found in this article.

Posted by: Harry Horton at April 21, 2007 12:05 PM

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