NYTimes: PsychRights Exposes Eli Lilly Psychiatric Drug Fraud

[mindfreedom-news at intenex.net]

Psychiatric drug maker exposed in NY Times today (17 Dec. 2006)

The NY Times today spotlights PsychRights founder Jim Gottstein's  
exposure of illegal fraud by Eli Lilly about hazards caused by their  
psychiatric drug Zyprexa. PsychRights is a sponsor group of  
MindFreedom International. Congratulations Jim for this major victory!

See the article:

http://www.mindfreedom.org/aff-spon/act/usa/psychrights/nytimes- 
gottstein-vs-eli-lilly

or: http://tinyurl.com/ycsgcv or:

http://www.nytimes.com/2006/12/17/business/17drug.html? 
ex=1166936400&en=49ecabeacfb44013&ei=5070&emc=eta1

BELOW is the text, please forward:

December 17, 2006

Eli Lilly Said to Play Down Risk of Top Pill

By ALEX BERENSON

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.

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.

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.”

- end -

More info on PsychRights see http://www.psychrights.org

~~~~~~~~~~~

Do you want to...

* Win human rights campaigns in mental health?

* End abuse by the psychiatric drug industry?

* Support self-determination of psychiatric survivors?

* Promote safe, humane, effective options in mental health?

You are not alone! MindFreedom is a nonprofit human rights group that  
unites 100 sponsor and affiliate groups with individual members, and  
is accredited by the United Nations as a Non-Governmental  
Organization (NGO) with Consultative Roster Status.

MindFreedom is one of the very few totally independent groups in the  
mental health field with no funding from governments, drug companies,  
religions, corporations, or the mental health system. While most of  
MindFreedom's members are psychiatric survivors, *all* who support  
human rights are invited to join and become active leaders.

http://www.mindfreedom.org

MindFreedom International Office: 454 Willamette, Suite 216 - POB  
11284; Eugene, OR 97440-3484 USA

web site: http://www.mindfreedom.org
e-mail: office(at)mindfreedom(dot)org
office phone: (541) 345-9106
toll free: 1-877-MAD-PRIDe or 1-877-623-7743
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Please forward.

"Human salvation lies in the hands of the creatively maladjusted." -  
Martin Luther King, Jr.

~~~~~~~~~~~

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