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jake-head-shot.jpgJake Young is a MD/PhD student at Mount Sinai School of Medicine focusing in Neuroscience. He is due to graduate in 2032. He received a BS and a MS in Biological Sciences from Stanford University -- where he spent most of his time drinking heavily and building vegetable catapults instead of learning information that would now be eminently useful. When he is not failing terrifically to perform his sworn duties, he enjoys watching bad movies, ethnic food, and running.

Pure Pedantry is a blog about science -- social sciences and otherwise -- as well as academic and scientific culture. No one can live on science alone, so I also like to dwell on pop culture, periodically explore the humanities, and indulge in other types of geeky goodness.

Jake is joined periodically by two wonderful guest bloggers: Kara Contreary and Kate Seip. See the About Page.

DISCLAIMERS: 1) Jake Young is not a licensed physician (yet). He is merely a medical student. The information published on this site is not intended for use in medical decision making. Please seek advice from a licensed, medical professional before making any health decisions. 2) The opinions expressed are my own or those of my co-bloggers. They do not represent the views of SEED magazine or the educational establishments we currently attend.

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NYTimes publishes evidence Eli Lilly played down the risks of Zyprexa

Category: Drugs
Posted on: December 18, 2006 10:11 AM, by Jake Young

Yet again, a drug company is playing damage control for failing to come clean about a drug's side effects. It makes me so mad when companies do stuff like this because it is such a preventable problem. In this case, the drug in question is Zyprexa (olanzapine) -- presently one of the go-to drugs for the treatment of schizophrenia -- and the company in question is Eli Lilly:

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.

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.

...

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. (Emphasis mine.)

I have a one word response to that: horseshit.

The suggestion that the Zyprexa is not correlated with obesity and by extension diabetes requires sticking your fingers in your ears and going la-la-la-la to the outcome of nearly every patient who takes the drug. Later in the article, they analogize Zyprexa to Vioxx. I take issue with that analogy because the cardiovascular side effects of Vioxx were exceedingly rare events. Zyprexa causing weight gain and diabetes isn't rare. It is a side effect so common that they make you memorize it in medical school pharmacology courses. That is the definition of common as I understand it.

What is so frustrating about this is that it didn't need to be this way. What would have happened if Lilly had done the right thing and told the patients and doctors the truth?

I assert that would have done little or nothing to hurt sales. Zyprexa is an atypical antipsychotic. Atypicals were developed because earlier anti-psychotics have side effects that are even worse than diabetes -- like tardive dyskinesia. Given the choice between this and side effects that are even worse, doctors are going to pick the drug that has the best outcome even if that drug can give you spectacular weight gain.

When are drug companies going to learn that you make way more money in the long run by being honest. By being dishonest, you are risking huge litigation to prevent side effects from being known that in most cases are not fatal to sales. I don't necessarily agree with all the litigation that is going on, but you know that you are opening yourself up to lawsuits when you behave like this.

When it comes to fights over drug pricing, I tend to argue that drug companies should be able to charge what they want. When they do stuff like this, it makes it more and more difficult to argue for an unregulated drug market. Therefore, drug companies who do this not only hurt themselves -- they hurt the entire industry.

Comments

Lilly shouldn't have waited so long to 'fess up about this. However, among many people [psychiatrists] this should have been *common knowledge*. The American Diabetes Assn. has had warnings about antipsychotics and other psych meds for some time and has info for MDs that commonly treat diabetes about them.

Posted by: natural cynic | December 18, 2006 12:52 PM

How long ago was Lilly supposed to have been concealing this information? In the Wayback archives, as far back as 2003, I find warnings on the official Zyprexa website that the medication's side effects include weight gain. In the warnings section on the drug information sheet, the first two sections are about hyperglycemia and diabetes and increased risk of death in elderly patients with dementia. It doesn't look like anything was being hidden.

Posted by: Stephen | December 21, 2006 12:26 PM

At a glance,zyprexa was promoted 'off label' to uses that weren't FDA approved.This opens up a can of worms for patients like myself took it for PTSD for which it was ineffective and moreover gave me diabetes.

True,leaked documents don't convey the 'whole picture' but what is compelling is that zyprexa is the 7th some say 5th largest drug sell in the world and Eli Lilly's #1 drug sale by their own admission.
This is for a drug that won't get you "high" cost $2.50 a pill and only indicated for less than 1% of the population.

Hello! Somebody in Lilly land is pushing zyprexa hard-Daniel Haszard

Posted by: Daniel Haszard | December 28, 2006 6:14 AM

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