NYTimes article on Zyprexa

[Linda25]

http://www.nytimes.com/2006/12/17/business/17drug.html?pagewanted=3&_r=1&th&emc=th

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Hi there Linda :) how've you been doing?

it is good of you to share this article.

... distressing... yet more distressing is that it should be surprising but somehow it doesn't surprise me. the medical field is not exempt from the "anything to sell product" line of thought sadly. imagine how many diabetics have been induced this way. :(

~ waves ~

[waves]

hi. the first time i opened this link, it worked. tonight, it didn't... i had to register (free btw) and also enabled my browser for cookies even though i hadn't done anything to change anything in between. hmmph. ok so i thought, if others are also having this problem, i will post the text, accreditation included.

i have to make two posts because the text is too long... wahhh.

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Eli Lilly Said to Play Down Risk of Top Pill

Article Tools Sponsored By
By ALEX BERENSON
Published: December 17, 2006

(page 1 of 2)

The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.
Skip to next paragraph
Darron Cummings/Associated Press

Zyprexa is Lilly’s top-selling drug, with sales of $4.2 billion last year.
Joshua Borough for The New York Times

James B. Gottstein, a lawyer who represents the mentally ill, said the documents about Zyprexa’s side effects raised public health issues.

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.

Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.

But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.

“Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.

At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another.

And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs.

The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said.

Lilly also said the documents should not have been made public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.”

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. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year.

The documents — which include e-mail, marketing material, sales projections and scientific reports — are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexa’s side effects, the documents show.

In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexa’s reputation. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” a Lilly manager wrote in a March 2002 e-mail message.

But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.

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end page 1 of 2, continues in next post...

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... continues from post above

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Eli Lilly Said to Play Down Risk of Top Pill (continued)

Article Tools Sponsored By
By ALEX BERENSON
Published: December 17, 2006

(continued - page 2 of 2)

Some top psychiatrists say that Zyprexa will continue to be widely used despite its side effects, because it works better than most other antipsychotic medicines in severely ill patients. But others say that Zyprexa appears no more effective overall than other medicines.

And some doctors who specialize in diabetes care dispute Lilly’s assertion that Zyprexa does not cause more cases of diabetes than other psychiatric drugs. “When somebody gains weight, they need more insulin, they become more insulin resistant,” Dr. Joel Zonszein, the director of the clinical diabetes center at Montefiore Medical Center in the Bronx, said when asked about the drug.

In 2003, after reviewing data provided by Lilly and other drug makers, the F.D.A. said that the current class of antipsychotic drugs may cause high blood sugar. It did not specifically single out Zyprexa, nor did it say that the drugs had been proven to cause diabetes.

The drugs are known as atypical antipsychotics and include Johnson & Johnson’s Risperdal and AstraZeneca’s Seroquel. When they were introduced in the mid-1990s, psychiatrists hoped they would relieve mental illness without the tremors and facial twitches associated with older drugs. But the new drugs have not proven significantly better and have their own side effects, said Dr. Jeffrey Lieberman, the lead investigator on a federally sponsored clinical trial that compared Zyprexa and other new drugs with one older one.

The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues.

“Patients should be told the truth about drugs like Zyprexa,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.

In its statement, Lilly called the release of the documents “illegal.” The company said it could not comment on specific documents because of the continuing product liability suits.

In some ways, the Zyprexa documents are reminiscent of those produced in litigation over Vioxx, which Merck stopped selling in 2004 after a clinical trial proved it caused heart problems. They treat very different conditions, but Zyprexa and Vioxx are not entirely dissimilar. Both were thought to be safer than older and cheaper drugs, becoming bestsellers as a result, but turned out to have serious side effects.

After being pressed by doctors and regulators, Merck eventually did test Vioxx’s cardiovascular risks and withdrew the drug after finding that Vioxx increased heart attacks and strokes.

Lilly has never conducted a clinical trial to determine exactly how much Zyprexa raises patients’ diabetes risks. But scientists say conducting such a study would be exceedingly difficult, because diabetes takes years to develop, and it can be hard to keep mentally ill patients enrolled in a clinical trial.

When it was introduced, Zyprexa was the third and most heralded of the atypical antipsychotics. With psychiatrists eager for new treatments for schizophrenia, bipolar disorder, and dementia, Zyprexa’s sales soared.

But as sales grew, reports rolled in to Lilly and drug regulators that the medicine caused massive weight gain in many patients and was associated with diabetes. For example, a California doctor reported that 8 of his 35 patients on Zyprexa had developed high blood sugar, including two who required hospitalization.

The documents show that Lilly encouraged its sales representatives to play down those effects when talking to doctors. In one 1998 presentation, for example, Lilly said its salespeople should be told, “Don’t introduce the issue!!!” Meanwhile, the company researched combinations of Zyprexa with several other drugs, hoping to alleviate the weight gain. But the combinations failed.

To reassure doctors, Lilly also publicly said that when it followed up with patients who had taken Zyprexa in a clinical trial for three years, it found that weight gain appeared to plateau after about nine months. But the company did not discuss a far less reassuring finding in early 1999, disclosed in the documents, that blood sugar levels in the patients increased steadily for three years.

In 2000 and 2001, more warning signs emerged, the documents show. In four surveys conducted by Lilly’s marketing department, the company found that 70 percent of psychiatrists polled had seen at least one of their patients develop high blood sugar or diabetes while taking Zyprexa, compared with about 20 percent for Risperdal or Seroquel. Lilly never disclosed those findings.

By mid-2003, Lilly began to change its stance somewhat, publicly acknowledging that Zyprexa can cause severe obesity. Marketing documents make clear that by then Lilly believed it had no choice. On June 23, 2003, an internal committee reported that Zyprexa sales were “below plan” and that doctors were “switching/avoiding Zyprexa.”

Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.

“From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives,” said Dr. James Phelps, a psychiatrist in Corvallis, Or. ‘Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company.”

Dr. Phelps says that he tries to avoid Zyprexa because of its side effects but sometimes still prescribes it, especially when patients are acutely psychotic and considering suicide, because it works faster than other medicines.

“I wind up using it as an emergency medicine, where it’s superb,” he said. “But I’m trying to get my patients off of Zyprexa, not put them on.”

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(end article)

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bump for newcomers oldcomers lurkers... all interested.

[houghchrst]

This medication was on my list of possibles when I went to see my *pdoc* last week and she flat out told me that she would not prescribe it for me because it has such a high risk of possible weight gain. I am already overweight and she didn't want to make it worse. Guess she already knew.

[Bdix30]

Its too bad about the weight gain; although it was the only AP that worked for my son; and the only side affect was constipation. To be honest we'd of used it even if there had been weight gain as it was necessary.....and i'd take an overweight son over a dead one anyday.

He's currently not on an AP and doing wonderful; but if the need ever arises again Zyprexa is what were using.

[waves]

I would like to share with you this personal testament from a fellow BrainTalk member:
Zyprexa less tardive more diabetes (http://brain.hastypastry.net/forums/showthread.php?t=2962) - here are some excerpts:

How does zyprexa cause diabetes?

What occurs is there is a TEN times greater incident of becoming a type 2 diabetic from zyprexa. [info source?] The prevailing theory is because it causes weight gain which itself is a precursor for diabetes AND more sinister it may actually poison the pancreatic beta cells killing them off.

I took zyprexa starting in 1996 the year the FDA approved it, which was ineffective for my condition and gave me diabetes.
...
Zyprexa has been linked to causing diabetes and pancreatitis.
...
I was prescribed Zyprexa from 1996 until 2000. In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.
...
Where Eli Lilly's negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it.

~ waves ~

[waves]

This Zyprexa thing is really like walking a tightrope isn't it.

My GP just so happens to be a diabetologist, nice huh? She is good, and pity because of my move i have to change :( ... but i digress. here's some some info from my GP/diabetologist (http://brain.hastypastry.net/forums/showpost.php?p=68898&postcount=4) and a bit more from me.

Bobi i hear you loud and clear - i saw my pdoc today and, well long story short i was a mess - and even only a moderate mess compared to some incidents at home, which i did tell him about tho, with great difficulty.

He wants me to take Zyprexa for 10 days ...and then we'll see... I even argued/negotiated with him. Unlike him, he insisted. He really insisted. Well, since I did take it for 6 months and my post blood check was fine tho, so hopefully i'm a lucky one. :o

Oh and you are the one to tell Bobi - my parents' fridge keeps being replenished with Brie, Camembert, Asiago... sigh. Also they keep buying dern sweets. In 3 days or less i will want to eat out the fridge totally. :( And i am supposed to try to resist, i suppose. My strategy for resisting is don't buy the dang things!!!

I lost about 18 pounds of my previous 40 pound gain... sigh... at least I already have a few larger sizes around. Dang does that stuff work tho! I have taken it sporadically (day or two) for breakthrough sx ... in that sense it's Tony the Tiger's GRRREAATTT.

It just :mad:GRRR:mad: sucks having to choose between a dangerous dysphoria v.s. a "stabilized... never know for how long" BD plus potential diabetes.

~ waves ~ about to toss 10 mg down the gullet.

[Bdix30]

I hear you on that! I packed on 50 after I quit smoking, lost it, but only after ditching all (and i mean ALL) of the diets my doctor put me on. Instead of calorie counting/carb counting, i SOLELY did portion control. There is no way I am ever giving up my cheeses and breads; just aint gonna happen.......so I'd end up starving and resisting it for a week and then binge for two weeks and gain more. Now I eat what I want to eat, I just force myself to portion it appropriately. (unless its popcorn, I still eat the whole bowl saturday nights when we watch movies lol....but at least I use molly mcbutter vs a cup full of of real LOL)

Use it for the 10 days, feel better, then decide whether to continue with it. I still keep some on hand "just in case" since it can be used on a temporary as needed basis....just havnt had one yet since we pulled him off it. ***knocks on wood***

Crossing my fingers and toes the 10mg does wonders for ya! *hugs*
Bobi

[Mari]

Wow, Bobi,
I just caught the news that your son is off Zyprexa and doing fine. That is wonderful.
Good going on the diet too. I bet that you feel like a new person.
Mari

[Bdix30]

Thanks Mari :)
I do feel pretty good; except I am extremely out of shape. Even thinner, it still winds me to walk 6 blocks. My hubby and I just bought mountain bikes and plan on biking with the boys all summer.

And yes, he's off the zyprexa and has been for several months - still has his quirks, but zero mania and depression issues. Was a lot of issues leading up to pulling him off, and we weaned him rather slowly, but in the end worked out great; I'll post the whole story when I have more time.

How are you? I miss you. Everything still going ok with the new apartment? Husband? I hope all is as well as can be.
Bobi

[Mari]

Dear Bobi,
By any chance do you run kind of high energy? Is that your natural mode?
My husband is like that. He has quiet times, but doesn't need them as much as others I think.

Or elseI am so used to feeling like a slug thanks to the med side effects.

I am amazed by anyone raising children AND cooking for them.
People don't do that. You have great love them and I am taking a guess that you LIKE cooking/providing for them.

The thing about being out of shape is that it is not hard to change.
I read on another forum about a therapist who used therapy time to put on sneakers and WALK with the patient while they talked.
That would annoy me, but the patient said it was helpful and it seems like the therapist did help.
I like my therapists less bossy. Boy that would be a turn off.

I walked for 20 minutes on the tread mill and did 10 minutes of light weights at the gym with my girlfriend last night/Wed.
I think that this will help me get back into a routine. Soon I will be able to walk a fast 45 minutes. OK, not soon soon. But soon enough.

Moutain bikes!!!!
You have moutains?!??! So cool.
Are they brown like Nevado mountains?
Snow topped right now?
I live on the east coast and we don't really see mountains unless to drive to Allegany and see the old gentle mountains in parts of Ohio, Kentucky, Tennessee, upper Carolinas, Va.........


How are you? I miss you. Everything still going ok with the new apartment? Husband? I hope all is as well as can be.
Bobi
Work is a big effort for me.
So the apt might wait for a few more months.
I think we need a few more pieces of furniture. I spend too much time on the computer because, get this, the computer chair is the best chair in the place.

Hubby is soon going to put together two book cases he bought a while a go.
It won't help. We have too much stuff and hubby has less interest in throwing it out than I do.

You should see our kitchen. It is huge. I love it. Someone we have managed to junk it up so that the system doesn't seem to work and things feel crowded and jammed in.
Ok. I let him cook. But still.

More than you asked for.
lol
Mari

[yoyo_girl]

trust me, when zyprexa works when nothing else does, you don't care if it makes you sprout an extra arm from your forehead.

[houghchrst]

That extra arm thing, isn't it funny that we would give up looking normal to just feel normal.

[bizi]

Just caught up with this thread...
bobi that is great about your son.
I hope you are well.
(((HUGS)))
bizi

[yoyo_girl]

i'm sorry guys, didn't mean to sound snarky. It wasn't intended that way. My bad.

[Bdix30]

Dear Bobi,
By any chance do you run kind of high energy? Is that your natural mode?
My husband is like that. He has quiet times, but doesn't need them as much as others I think.

Yes, I have always been high energy. I'v learned alot about myself through the years especially since having kids, and I know that when I have downtime I get depressed and anxious; always have. So even if I feel like total crap, I have to force myself to be doing something, even if its laying on the couch reading a book to the kids. When I'm idle, I'm counterproductive to myself.


I am amazed by anyone raising children AND cooking for them.
People don't do that. You have great love them and I am taking a guess that you LIKE cooking/providing for them

LOVE it. I really enjoy cooking. I catch a lot of flack from my childless friends about how women are more then just caregivers (which is true) but I am really in my element when I am doing stuff with/for the kids, or in the kitchen. I feel I am hardwired that way. Sometimes I wish I had an exciting job like an attorney or doctor just because....well I dont really know why lol....but I truely believe I was just made to be a mom. (keeping in mind I screw up ALOT, but I still love it)

The thing about being out of shape is that it is not hard to change.
I read on another forum about a therapist who used therapy time to put on sneakers and WALK with the patient while they talked.
That would annoy me, but the patient said it was helpful and it seems like the therapist did help.
I like my therapists less bossy. Boy that would be a turn off.

Yep, a therapist that forced me to exercise would get the boot....fast like. But what a great therapist for someone who would benefit from that! Thanks for the encouragement here! Sometimes I forget that being out of shape now doesnt mean I will be forever.

I walked for 20 minutes on the tread mill and did 10 minutes of light weights at the gym with my girlfriend last night/Wed.
I think that this will help me get back into a routine. Soon I will be able to walk a fast 45 minutes. OK, not soon soon. But soon enough.

EXCELLENT! 20 minutes on the treadmill would kick me in the shorts right now; but I'll get there eventually too! Nice job Mari!

Moutain bikes!!!!
You have moutains?!??! So cool.
Are they brown like Nevado mountains?
Snow topped right now?

Yep. I'm still in Idaho. Mountains everywhere. In fact they are prettier then Nevada mountains.:D We are about 15 minutes from a national forest, and about 90 minutes from Yellowstone National Park. We like to go hike and play there in the summer; this year we will take the bikes and try to avoid having a heart attack LOL.


Work is a big effort for me.
So the apt might wait for a few more months.
I think we need a few more pieces of furniture. I spend too much time on the computer because, get this, the computer chair is the best chair in the place.

Hubby is soon going to put together two book cases he bought a while a go.
It won't help. We have too much stuff and hubby has less interest in throwing it out than I do.

You should see our kitchen. It is huge. I love it. Someone we have managed to junk it up so that the system doesn't seem to work and things feel crowded and jammed in.
Ok. I let him cook. But still.

HAHA! Blame any problems in the kitchen on him then! :p About the furniture; alot of people dont like 2nd hand anything, but you can go to second hand stores and thrift stores, and find NICE furniture sets for a couple hundred bucks. Steam clean it, or buy some of that couch cleaner foam in a bottle and its good as new.

(I got my bookshelves at the savlation army for 2 bucks each! The only thing that didnt look perfect was the top of the actual shelf where you put the books, but you dont see that anyway with the books on them!)

Talk to you soon!
Bobi

[dyslimbic]

http://www.abc.net.au/rn/allinthemind/stories/2007/1860792.htm

[waves]

I ran into this before... not via this report... the statistic tho, and haven't been able to find it since!!!

Thanks So much.

It seems the full transcript won't be available till thursday... i wonder if those are published on the web gratis?

Anyway, this is good. this is good!

~ waves ~

[Mari]

Dear Bobi,
My hubby is high energy and reacts in similiar ways. If he is tired and grouchy, sometimes the best thing to do is get him pointed toward a project -- like cooking.

He doesn't seem to need as much down time as other people I've known. He is usually doing something or sleeping.
I so love a person who can enjoy sleep. :)

LOVE it. I really enjoy cooking. I catch a lot of flack from my childless friends about how women are more then just caregivers (which is true) but I am really in my element when I am doing stuff with/for the kids, or in the kitchen. I feel I am hardwired that way.

I got irked reading this. Or let's say I got p!ssed. What is wrong with people? :mad: Do other people think it is ok to give input into how you manage your home and your time?!?!

I suppose you are more gracious than I would be about those types of comments.
I wish more of us could see that people are living out their own "hard wiredness" and that not all of us are going to be on the same path.
Geez.

I think we've talked about this before. Perhaps other people feel a bit weird about how they make choices after they observe you. Instead of honoring your life, they comment on it to make themselves feel better.


Yep. I'm still in Idaho. Mountains everywhere. In fact they are prettier then Nevada mountains.:D We are about 15 minutes from a national forest, and about 90 minutes from Yellowstone National Park. We like to go hike and play there in the summer; this year we will take the bikes and try to avoid having a heart attack LOL.

I mentioned the Nevado moutains because I remembered them from a Reno trip to visit ex-husband's family. I was in Salt Lake City one time too. I think we saw beautiful mountains -- can't remember much because my brain is foggy.
Your mountains sound like a great playground for kids and grown ups.


HAHA! Blame any problems in the kitchen on him then! :p
I thought about this after I wrote to you. I think that we will have to get control of the kitchen in order for me to get a handle on eating healthful foods. Hubby says he'll help organize. Should canned olives be in three different places? ....One of my iron skillets is rusty because he was putting wet dishes on top of it to DRY. He doesn't quite get the whole iron skillet thing anyway, preferring teflon.

About the furniture; alot of people dont like 2nd hand anything, but you can go to second hand stores and thrift stores, and find NICE furniture sets for a couple hundred bucks. Steam clean it, or buy some of that couch cleaner foam in a bottle and its good as new.
Up until a few years ago I got all my stuff this way. A friend liked to go garage saling. She would give me her finds.
I found my very first set of silverware/cutlery in a dumpster.
I got lots of stuff when people moved out of an apt and left stuff near the dumpster for others. I do the same thing if I get tired of something and have to let it go -- put it out where other people will have a chance to recycle it.

But I think I have to have a cheap new leather love seat type thing for the living room. And maybe a few other things. Right now the living room has one sofa, two televisions and a full floor of clothes and papers and mail. But for some reason I think that the love seat will solve the problems. :) We went window shopping one day before Thanksgiving and we haven't gotten back to making the decision yet.
Hubby is ok about spending the money but
he is worried about not having enough room in the living room -- what with all of my crap on the floor.

Take care.
Mari

[waves]

welll... thread seems to have digressed... but so do i lol too much lately :D

[waves]

bumping thread for newbies

also see the following transcript (now available online) of 3 March 2007 from All In The Mind "The Zyprexa Story - i'm quoting the post here, since the first one is "lost" in amidst our chatterings ;), anyway, here's the link:
http://www.abc.net.au/rn/allinthemind/stories/2007/1860792.htm