Saturday, December 16, 2006

NY Times: Lilly Downplayed Harmful Side Effects of Zyprexa

Zyprexa, a drug used to treat mental illnesses, has been Eli Lilly's best-selling drug for several years now. The drug also has serious side effects the company deliberately downplayed according to the NY Times. The Times reports:

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.

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.

Laying aside what one might think of Lilly's conduct in marketing its drug, the federal watchdog agency, the FDA, hasn't exactly been looking out for consumer interests. The Times writes, "In 2003, after reviewing data provided by Lilly and other drug makers, the FDA 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."

Personally, I think we would be better off without the FDA regulating drugs. The FDA is in the pockets of the industry, and drug companies often hide behind an FDA stamp of approval to avoid liability. If the drug companies had to stand behind their own products without clinging to the FDA's skirt, they might be more forthcoming about their drugs' risks, and some drugs might not ever be put on the market.

Lilly claims the documents provided to the Times for this story were illegally disclosed. According to the story, Lilly has paid out substantial settlements to plaintiffs already--about $750 million involving 8,000 patients--and has potentially more product liability exposure.

It is also worth noting that Lilly has been a pioneer in the industry when it comes to treating diabetes. Bipolar disorder is one of the conditions Zyprexa is used to treat. Is it just me, or are there a lot of people being diagnosed as bipolar--what used to be considered a rare condition?


Anonymous said...

Convenient that the leading company in the world that makes most of the planet's insulin supply and other diabetes related pharmaceuticals also happens to make a widely prescribed drug that CAUSES diabetes and high blood sugar. I don't even want to think about the bad karma of the Lilly execs who knew this and did nothing to raise awareness of this or even actively covered this up.

Wilson46201 said...

An oddity of Indiana Township law requires Township Trustees to buy insulin for needy citizens. No other drug is so covered - any guesses as to why this one medication is specified?

Luckily the advent of Medicaid and Medicare has obviated the need for such specific assistance. As I recall, Center Township has had to purchase insulin only once in the last 15 years or so...

Hoosier Pete said...

You can't have it both ways.

On one hand many complain that the drugs aren't approved fast enough. Now we are complaining that they are not investigated thoroughly.

Which is it?

We live in an interesting age of medicine, where several new advancements are really experiments in how humans with diverse chemical and genetic makeups deal with different compounds.

Once something goes unplanned, we call for heads to roll. While at the same time, we are asking for increasing speed toward possible cures and vaccines for more and more diseases.

Yes, Gary, there is an increase in the number of bi-polar diagnoses, but your post implied that it was to make a profit, rather than actually help someone.

I have no issue with being a watchful eye on the pharmaceutical industry, but let's be fair about it and not roast the golden goose on subjects that we have only a smidgin of the facts.

Daniel Haszard said...


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 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

Anonymous said...

"Is it just me, or are there a lot of people being diagnosed as bipolar--what used to be considered a rare condition?"

i think it's just you, gary. we have a daughter who was diagnosed as bipolar after her first year in college. looking back on both sides of our family, we could see this gene rage among our aunts, uncles, and grandparents.

we've been very grateful for what big pharma has been able to provide to make our daughter able to better function in the world. it wasn't zyprexa, and it's definitely not a silver bullet, but it's made her able to cope and to realize that if she works at it, she can actually function in this world.

we expect that in another couple of years, she'll complete her doctorate in a field of science. she still has a lot of issues to deal with, but with supportive family and a good outlook, this brain based disorder can be managed.

Anonymous said...

as the initial individual who reported to the fda the link between diabetes and high blood sugar with the risk of coma relating to the use of zyprexa that created the intitial duke university study, you can rest assured that lilly is nothing but a bunch of liars who will go to any length to protect their dangerous product and 4 billion a yr earnings from this drug. lilly has already settled a class action for 700 million yet not admitting fault to anything. there are still many more serious injuries out there to settle up also.
take this drug at your own risk. zyprexa is a very dangerous drug to many who take it.