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Dr. Bob is Robert Hsiung, MD,
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Posted by river1924 on December 21, 2006, at 9:20:34
December 21, 2006
Disparity Emerges in Lilly Data on Schizophrenia Drug
By ALEX BERENSONFor at least a year, Eli Lilly provided information to doctors about the blood-sugar risks of its drug Zyprexa that did not match data that the company circulated internally when it first reviewed its clinical trial results, according to company documents.
The original results showed that patients on Zyprexa, Lilly’s pill for schizophrenia, were 3.5 times as likely to experience high blood sugar levels as those taking a placebo, according to a February 2000 memo sent to top Lilly scientists. The memo is one of hundreds of internal Lilly documents provided to The New York Times by a lawyer in Alaska who represents mentally ill patients.
But the results that Lilly eventually provided to doctors until at least late 2001 were very different. Those results indicated that patients taking Zyprexa were only slightly more likely to suffer high blood sugar as those taking a placebo, or an inactive pill.
Another Lilly report, from November 1999, shows that Lilly found after examining 70 clinical trials that 16 percent of patients taking Zyprexa for a year gained more than 66 pounds.
The company did not publicly disclose that figure, instead focusing on data from a smaller group of clinical trials that showed about 30 percent of patients gained 22 pounds.
Weight gain and high blood sugar are important risk factors for diabetes, and the question of whether Zyprexa causes diabetes has been a subject of scientific debate for several years.
Lilly says no link has ever been proven.
In response to questions about the difference between its first view of the data and its subsequent public description, Lilly issued a statement yesterday saying that the later figures were accurate and the information in February 2000 was out of context.
In yesterday’s statement, the company said that after the February 2000 memo, it re-examined its clinical trial results and found errors in its “final, standard quality check of the data.”
But the February 2000 document, which is labeled “Confidential,” does not indicate that the figures it contains are preliminary. In fact, in a footnote, it explains that the data exclude patients “from whom there was a probable lab error.”
A separate document from November 1999 includes handwritten figures identical to those from the February document, with additional detail about the increases in blood sugar that patients suffered.
The revised figures were shared with the Food and Drug Administration, Lilly said. It did not say whether it had ever disclosed the initial data to the F.D.A.
The F.D.A. did not respond to requests for comment yesterday.
The 2000 memo indicates that it was prepared as Lilly considered changing Zyprexa’s prescription label to provide doctors with more information about the drug’s potential to raise blood-sugar levels.
The issue was crucially important to the sales prospects of Zyprexa, which was introduced in 1996. Psychiatrists were already increasingly aware by 2000 that Zyprexa caused severe weight gain in many patients.
“In 1999, we already were thinking this drug causes weight gain — that’s clear — and there could be a lot of other metabolic consequences of that,” Dr. David N. Osser, a psychiatry professor at Harvard University, said yesterday. “The weight gain itself is a known risk factor for diabetes.”
The February 2000 memo was prepared as background for a meeting of Lilly scientists to the possible changes for Zyprexa’s label.
According to the memo, Lilly scientists initially wanted to propose a relatively straightforward statement on the label that high blood sugar had been observed in patients taking Zyprexa in clinical trials. That change was never made.
Lilly’s analysis in early 2000 came at a time when some doctors and regulatory agencies were beginning to question whether Zyprexa could cause increases in blood sugar or diabetes. Although Lilly says that no link between Zyprexa and diabetes has ever been proven, the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other, similar drugs.
Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in sales in 2005, which represented 30 percent of Lilly’s overall revenue. Zyprexa’s active ingredient is a potent chemical that binds to receptors in the brain to reduce the hallucinations and delusions associated with schizophrenia and acute bipolar disorder. About two million people worldwide took Zyprexa last year.
At the February 2000 meeting for which the memo was prepared, the agenda was to discuss Zyprexa’s tendency to cause high blood sugar, which is medically known as hyperglycemia.
According to the memo, Lilly had reviewed data from its clinical trials and found that “the incidence of treatment-emergent hyperglycemia in olanzapine group (3.6%) was higher than that in the placebo group (1.05%).” Olanzapine is the generic name for Zyprexa.
But when Lilly subsequently discussed the clinical trial results with doctors, it used a different comparison. Lilly told doctors that Zyprexa had caused 3.1 percent of patients — not 3.6 percent — to have high-blood sugar. And it said that 2.5 percent of patients on the placebo — not 1.05 percent — had high-blood sugar. As a result, the rates of high blood sugar in the two groups seemed almost identical in the revised data.
Posted by linkadge on December 21, 2006, at 10:34:31
In reply to Ongoing zyprexa lawsuit, posted by river1924 on December 21, 2006, at 9:20:34
You'd think with the controversy about fluoxetine related supressed data, that Lilly would smarten up.
Linkadge
Posted by laima on December 21, 2006, at 11:19:04
In reply to Re: Ongoing zyprexa lawsuit, posted by linkadge on December 21, 2006, at 10:34:31
They supressed data about prozac, too?? Like what?
Any long term or permanent stuff? I didn't know.In one of the New York Times articles, it said that a number of doctors no longer believe the information Lilly gives them. Now I understand why.
> You'd think with the controversy about fluoxetine related supressed data, that Lilly would smarten up.
>
>
> Linkadge
Posted by linkadge on December 21, 2006, at 18:37:21
In reply to Re: Ongoing zyprexa lawsuit » linkadge, posted by laima on December 21, 2006, at 11:19:04
Supposedly they supressed data relating to the propensity of fluoxetine to cause akathesia. They have also been acused of being selective about the efficacy data of fluoxetine.
I was also under the impression that they supressed data about fluoxetine related agression and or suicidal ideation.
I'm not up on it all though.
Linkadge
Posted by laima on December 21, 2006, at 19:17:38
In reply to Re: Ongoing zyprexa lawsuit, posted by linkadge on December 21, 2006, at 18:37:21
Posted by blueberry1 on December 21, 2006, at 19:35:58
In reply to Ongoing zyprexa lawsuit, posted by river1924 on December 21, 2006, at 9:20:34
Scary stuff, especially considering I've been on prozac and zyprexa for about 10 years. Stopped prozac a month ago. Down to 1.25mg zyprexa and seems impossible to get off of. Akathesia, tremors, and metabolic hormonal imbalances are obvious. No weight gain though. That leveled out long time ago. Now I just got the fun stuff that makes life a misery. I wonder how to get on board a class action lawsuit?
Posted by Sebastian on December 22, 2006, at 14:07:28
In reply to Re: Ongoing zyprexa lawsuit, posted by blueberry1 on December 21, 2006, at 19:35:58
Zyprexa raises blood sugar artificialy. Ever since cutting my dose in half my blood sugar has droped consistently. And when I take a pill and wait 3 hours blood sugar is higher, no food or drink. The problem was high blood sugar in the morning, I take zyprexa at bed time. Now that I cut the dose in half and quit taking it for a couple of days, morning blood sugar is normal again.
Abilify does not raise blood sugar.
Posted by jimmygold70 on December 22, 2006, at 16:35:53
In reply to Ongoing zyprexa lawsuit, posted by river1924 on December 21, 2006, at 9:20:34
Eli Lilly is launching a huge multicenter study of Zyprexa combined with Glucopage (metformin) for preventing its weight gain (and possibly other side effects such as diabetes). Interesting, isn't it?
Posted by notfred on December 22, 2006, at 16:50:24
In reply to Zyprexa raises blood sugar artificialy on its own, posted by Sebastian on December 22, 2006, at 14:07:28
> Zyprexa raises blood sugar artificialy.
I would suspect Zyprexa causes insulin resistance,
not that Zyprexa raises blood sugar itself. If blood sugar is raised that is an effect, not a cause. Look at insulin processes to find the cause.Metformin has been out for decades, making it a safe drug, in that we know its effects across millions of people over decades. If you must take Zyprexa then Metformin would be a cheap effective treatment.
However, I think no one should take AP's unless they have a psychotic condition. MAOI's and benzos are safer. Zyprexa should be kept as the last option for non-psychotic conditions. There is no proof that low doses and/or infrequent doses protect one from the movement disorders.
Posted by med_empowered on December 22, 2006, at 17:18:05
In reply to Re: Zyprexa raises blood sugar artificialy on its, posted by notfred on December 22, 2006, at 16:50:24
yeah...I think part of the problem here is that Lilly got greedy and started whispering into doctor's ears: "zyprexa for...EVERYTHING" And it worked. Zyprexa and other atypicals are being used for anxiety and sleep, depression, agitation, so on and so forth. Its ridiculous.
I think its worth noting that when neuroleptics first hit it big in the 50s with the glut of phenothiazines on the market, they were also being used for everything. They were being used in combo pills with amphetamine (eskatrol, thora-dex) and with barbiruates (Janimine--stelazine plus amytal) and for psychosis and depression and anxiety and "hyperkinetic children"...so on and so forth. Enter the 70s, and the "discovery" of TD...then in the 80s, finally, shrinks started to lay off the over-RX-ing of APs, but mostly just because they were being sued left and right, and many of these lawsuits proved both successful and expensive (not to mention embarassing for a profession that has never really been well respected by other docs or the public at large).
So...yeah. Maybe some good will come out of all this. Maybe docs will stop giving everybody neuroleptics (hey, maybe one day they'll even let the schizophrenic people try something else).
Posted by Sebastian on December 25, 2006, at 14:08:32
In reply to Eli Lilly - huge Zyprexa + Anti-Diabetic study!, posted by jimmygold70 on December 22, 2006, at 16:35:53
Yeh, I was debating taking a med to lower blood sugar with the zyprexa, but instead I lowered the dose to 5mg, which brought my blood sugar back to normal. Guess 10mg is too much.
Posted by Sebastian on December 25, 2006, at 14:13:35
In reply to Re: Zyprexa raises blood sugar artificialy on its, posted by notfred on December 22, 2006, at 16:50:24
I've taken zyprexa for 10 years with no movement disorders. I was very psychotic 10 years ago and zyprexa cured that(figure of speach). Now I want off it and can't because of bad withdraw, like I can't eat food, can't sleep. So I'm taking half the 10mg dose now with good results and my blood sugar is normal again!!!
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