Wednesday, August 6, 2008

Alaska Zyprexa: Follow Up

My guru warned me years ago that anyone who wrote a long psychiatric report must be trying to hide something. I have in my time seen reports over 70 pages or more, often from psychiatrists acting in a private capacity. Independent expert opinion is indeed subjective, and none more so than arguments in the courts of law on psychiatric matters.

This is a follow up to my earlier post on Alaska, Good Friday Earthquake and Zyprexa.

In March Eli Lilly settled the Zyprexa case for $15 million, according to the New York Times. (Alaska v. Eli Lilly and Co., 3AN-06-05630 CI, Alaska Superior Court, Anchorage District)

Bloomberg News filed a motion to unseal all the documents related to the case and was granted the motion in July. They reported:

Lilly Trained Sales Force to Ignore Drug's Risks (Update2)

“Eli Lilly & Co. trained its sales force to downplay risks for Zyprexa and encourage doctors to prescribe the drug beyond approved uses for schizophrenia and bipolar disorder, according to court documents.

“Lilly's research showed some patients on Zyprexa gained as much as 80 pounds and that the incidence of high blood sugar at diabetes levels was 3.5 times higher than for placebos, according to documents filed in a lawsuit brought by the state of Alaska.”

“We believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue,'' the company said in the sales document, which was provided for the Alaska case. “Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace.''

Strong words indeed, sounds more like a task for Bond. Psychiatrists better watch out.

But this is not just about psychiatrists.

“Zyprexa became the company's top-selling drug, with $4.76 billion in sales last year -- about a quarter of Lilly's revenue. Company sales representatives disputed or ignored the risks and pursued primary-care and nursing-home doctors as well as psychiatrists.”

There were more than 20 million pages of submission. 20 million pages!!!

How did Bloomberg sieve through 20 million pages? Good job, Bloomberg.

Lilly faces suits by nine other states alleging failure to warn and improper marketing, separate consumer-protection investigations in about 30 other states and an investigation of off-label marketing by the U.S. Attorney in Philadelphia.

“Lilly pushed Zyprexa sales to primary care physicians and doctors in nursing homes for patients who weren't diagnosed with schizophrenia or bipolar disorder, according to complaints filed by Montana and Mississippi.”

Those interested may like to read the full
Bloomberg account.

There are some gems in the quotes:

“Zyprexa's attributes line up so beautifully in the elderly,'' Alan Breier, then-team manager for the drug, told the group. “The need for better treatment in Alzheimer's and other elderly conditions is so paramount and so key.''

But Zyprexa wasn't approved for use with Alzheimer's or for elderly conditions.

“He's talking about the characteristics of the molecule which might make it a good agent for Alzheimer's,'' Sidney Taurel, current Chairman testified. "He was not giving them instructions as to what to do the next day in the field.''

Very smart answer indeed. But that is not the end of it.

“The doctor's thinking that he does not see a schizophrenic or bipolar patient,'' Bandick said in a December 2000 internal e- mail to the marketing department. “But he probably does see patients with symptoms of behavior, mood and thought disturbances,'' he wrote. "Even if the doctor does not have diagnosis, he should treat anyway.''

It was not until October 2007 when Lilly finally added to its packaging a warning about weight gain.

Documents show that in 2002, the Zyprexa sales force was advised:

“We will NOT proactively address the diabetes concern.”

An in true Olympian spirit, they proclaimed:

“The competition wins if we are distracted into talking about diabetes.”

Let us wait and see what the judges in other States think. The earthquake in Alaska happened a while ago but this one may rumble on a bit longer.

We doctors must continue to resist being badgered, coerced and manipulated by pharmaceutical sales reps.

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Anonymous said...

Zyprexa has generated a lot of bad press for Eli Lilly and they still have unresolved Zyprexa settlement claims.
Eli Lilly is 'reaping the whirlwind' for aggressive marketing of Zyprexa that has caused suffering and deaths.
Zyprexa is being avoided by doctors they aren't prescribing it for new patients at all anymore.
Daniel Haszard 4 year Zyprexa patient who got diabetes from it.

Anonymous said...

When I was 8 years old, I had a minor problem with anxiety. The doctor prescribed zyprexa, as anxiety was an off label use for it. At the time zyprexa was not even approved for pediatrics. It was right after that that I started gaining a ton of weight. Four years later, at the tender age of 12 I was diagnosed with type 2 diabetes. All the efforts I have made, to lose weight, to exercise, and everything else did not help. I am on an insulin pump. I am extremely insulin resistant. I already (at the ripe old age of 19) have nerve damage in my legs from the years of uncontrolled diabetes. (No matter how hard I try, my numbers just don't come down.)
I am about to win a ton of money. I am going to be rich. Awesome. NOT. All the money in the world does not make up for the suffering I have been through. You can't buy human life with money. I have such anger at the doctor for prescribing this drug to me. I have anger towards lilly for hiding the facts that could have saved me and allowed me to live life as a regular kid.
Every time I open a new bottle of insulin, and see the packaging....that says Elly Lilly on it I am consumed by anger. This is THEIR fault! And they are making thousands of dollars off of me and my diabetes.

This drug should be pulled from the market.
Zyprexa kills.