Joseph Saunders, who has sued Lilly on behalf of eight patients, says
it defies common sense that Zyprexa became a bestseller.
James Gottstein heads PsychRights, a group that fights unwarranted forced drugging and electroshock to mental patients.
Dr. David Egilman, facing possible criminal charges, admitted in
writing that he violated a court order to keep Lilly documents secret.
Shahram Ahari says Zyprexa salesmen were coached how to deal with doctors worried about weight and diabetes issues.
Dr. David Healy, a pharmacology expert, says that with its side
effects, "What you've got is a drug that has very little to recommend
Breaking News Video
It sounds like a cosmic, FDA joke:
The Food and Drug
Administration approves the antipsychotic drug Zyprexa to treat adults
with schizophrenia or bipolar disorder. It becomes a market wonder, a
bestseller. But the side effects turn out to be dangerous; some
patients develop diabetes.
Some 30,000 people sue the
manufacturer, Eli Lilly. The pharmaceutical giant shells out more than
$1-billion to settle the cases.
Here comes the punch line:
Though studies show that kids are even more susceptible to Zyprexa's
dangerous side effects, now Lilly wants the government's seal of
approval for adolescents to use it. And the FDA is about to say yes.
* * *
Like a mounted animal head hung as a trophy from the hunt, a framed
copy of a $2.8-million check from Bayer pharmaceutical hangs in the law
office of Joseph Saunders. The check says: It's my business to sue drug
companies, and I'm good at it.
Saunders practices in Pinellas Park, but hundreds of lawyers like him across the country have found a niche suing Lilly.
He has eight Zyprexa clients. Most are psychotic. Most suffer from
diabetes, which can cause kidney failure, heart disease, liver damage,
They were prescribed Zyprexa during the time
doctors swooned over the big new thing. Approved by the FDA in 1996,
Zyprexa was one of a new class of drugs called atypicals, marketed as
powerfully effective for people suffering the dreadful psychotic breaks
of schizophrenia and bipolar disorder.
And -- this was key --
the new drugs were less likely to cause the tremors and facial tics
that sometimes accompanied older drugs.
Zyprexa was deemed so
safe, doctors began prescribing it "off-label" to treat depression,
anxiety, ADHD, even sleeplessness. As it turned out, studies would show
that Zyprexa may be the most effective of the new class of
antipsychotic drugs, but it's also most likely to cause serious weight
gain and elevated blood sugar levels.
Saunders says you can't
win a lawsuit against a drug company just because you suffer a side
effect. But pharmaceuticals do have a legal responsibility to warn
doctors about known risks.
The tens of thousands of lawsuits
contend that Lilly did not fully disclose risks it discovered during
studies conducted to get FDA approval for Zyprexa, risks that became
more apparent in the years after the drug hit the market.
preapproval studies lasted six weeks, not nearly time for diabetes to
manifest itself, Saunders says, but there were red flags. Some 29
percent of participants gained significant amounts of weight. Rapid
weight gain puts people at higher risk of developing diabetes.
Lilly spokeswoman Marni Lemons allows that a majority of people who
take Zyprexa gain a lot of weight. And some of them develop diabetes.
But only a small percentage of those who gain weight on Zyprexa develop
diabetes. Also, people with schizophrenia and bipolar disorder are at
higher risk of diabetes no matter what drug they take.
"It's a very complicated subject," Lemons said. Bottom line: No data directly finds that Zyprexa causes diabetes.
So why did Lilly pay $1.2-billion to settle 30,000 claims?
"Even when a company has a really strong defense, as we believe Lilly
did, going to court poses very real financial and business risks,"
Lemons said. "Lilly has a responsibility to its shareholders and
employees -- as well as to health care professionals and patients -- to
move beyond this litigation at the lowest possible cost."
Saunders counters that Lilly treats lawsuits as a cost of doing
business: $1-billion in settlements sounds like a lot, he says, but
it's chump change compared to the tens of billions the company has made
since Zyprexa came on the market.
Lilly has more than private
attorneys to worry about. Nine states have sued, claiming the company
illegally promoted unapproved uses of Zyprexa and downplayed its side
effects. The states want to be reimbursed hundreds of millions for
Medicaid dollars they paid for Zyprexa.
In 2003, the FDA
directed that not only Zyprexa, but all atypical antipsychotics carry a
warning about increased risk of hyperglycemia and diabetes.
Lilly continued to market its drug as more effective but no more
dangerous than its competitors. Only this fall did the company agree to
change Zyprexa's label to state that its tendency to increase blood
sugar levels, another diabetes risk factor, is higher than its
Asked Saunders: "Why did it take 10 years to
warn people about something they knew from their clinical trials? The
reason is clear: They were making billions and billions of dollars
* * *
The telephone call that James Gottstein took late last year was a bolt from the blue.
An attorney in Alaska, Gottstein heads a group called PsychRights,
which presses litigation against forced psychiatric drugging and
electric shock. The caller, a stranger Gottstein never had spoken with,
said he had documents that could help lead Gottstein's group to the
The caller, David Egilman, worked as a
consultant for a law firm that had thousands of clients suing Lilly
over Zyprexa. In that job, he was given access to thousands of pages of
internal Lilly documents, but they were under protective order; it was
illegal for him to make them public.
What happened next is
disputed, but a quite furious U.S. district judge, Jack B. Weinstein,
determined this is how his court order was violated:
At the suggestion of a New York Times
reporter, Egilman called Gottstein and -- wink, wink -- suggested he
find a separate case in which he could subpoena the Lilly documents
from him. Gottstein could get copies to the aforementioned reporter
before Lilly and the courts could act to stop it.
The deed done, Lilly officials were furious. As Gottstein put it, "They came after me like a Panzer division."
Judge Weinstein, who called it a conspiracy to assist the stealing of
protected documents, tried to get the copies back. But they had hit the
There were internal memos, showing Lilly's marketing strategy aimed at downplaying weight gain and any link to diabetes.
There was a memo from a Lilly employee in 2000 fretting that doctors
the company hired to study the diabetes connection had warned that
"unless we come clean on this, it could get much more serious than we
There were letters from doctors who raved
about the drug's effectiveness but warned Lilly that patients were
developing diabetes at an alarming rate. Like this one from 2001, from
Dr. Clif Tennison, in Knoxville: "It is troublesome, frustrating and
occasionally irritating to repeatedly hear the official line that a
relationship between Zyprexa and diabetes is unclear, that diabetes is
known to occur more frequently in mentally ill people with or without
meds, etc. We know that.
"But we also know that our Zyprexa
patients gain weight and that they do develop diabetes. It feels as if
our concerns are being dismissed, and that if we would just listen to
the experts, we wouldn't worry about this anymore."
and Gottstein paid a price for making the documents public. Threatened
with criminal prosecution, Egilman signed a mea culpathat said he had
provided an "incomplete subset" of the Lilly documents. He paid the
company $100,000, which Lilly donated to charity.
who maintains he did nothing improper, says Lilly is still going after
him, for civil sanctions that could ruin him financially and for
criminal contempt. He says it has threatened to go after his law
When he answered the phone that day, who knew what
lay ahead? "I do think it was important to get this information out.
People should be informed of the risks before they decide to take these
drugs. So for me, it was worth it."
* * *
Spring 1998. Like zillions of undergrads, Shahram Ahari was finishing
college, looking for that first job. He had finished Rutgers University
with a degree in molecular biology, biochemistry and Asian studies.
A friend's brother landed him an interview with Eli Lilly. The job, salesman.
Ahari knew zip about pharmaceutical sales, but he loved what he heard:
$50,000 base salary, $10,000 to $15,000 annual bonuses, stock options,
a free car, great health benefits. Meals on a hefty expense account.
To hawk Zyprexa, he says, the pitch was simple: "Encourage doctors to be the first on their block with a brand-new toy."
When he made sales calls, he was armed with data from an independent
company that tracked every prescription the doctor made that month. It
helps to know that the doc you are about to pitch prescribes more of
your competitor's drug, say, Risperdal. You can take some gratuitous
pot shots at Risperdal in your pitch.
The job mostly was
about befriending doctors and leveraging their emotions, Ahari says,
though favoring them with goodies didn't hurt. Salesmen wooed doctors
with free samples, treated them to expensive dinners and paid them to
give speeches at seminars.
"It practically sold itself," said Ahari, who sold Zyprexa in New York from 1998 to 2000.
The gravy train hit some bumps. Reps started hearing from doctors
concerned about patients "blimping up." Competitors hammered them on
it, derisively twisting Zyprexa's generic name, olanzapine, into
The Zyprexa sales reps eagerly awaited word
from Lilly's brand team on how they should deal with the
weight/diabetes issue. Ahari says this is what they came up with: Tell
doctors to instruct patients to drink a glass of water before and after
they eat, to suppress appetite.
"We'd have to do it with a straight face," Ahari said, "and after a while, it just became uncomfortable."
With doctors he knew well, he said his pitch was blunt: "Would you rather have a skinny, unwell patient or a fat, stable one?"
Doctors started reporting patients developing diabetes. "That was a
big, scary thing," Ahari said. If the FDA required that Zyprexa carry a
black box warning about diabetes, "it would have been death,
He says sales reps were instructed to deflect
the issues of weight gain and diabetes. "We were taught to downplay it
and negate it, or to change the topic."
Lemons, the Lilly
spokeswoman, says the company can't be certain what every sales manager
told their sales reps, but "that has never been our corporate policy."
She questioned Ahari's objectivity because she said he is now a paid
witness for trial attorneys taking on pharmaceutical companies.
Ahari says he was a paid witness in just one case, which was about
preserving the confidentiality of physicians' prescribing patterns.
Today he does public health research on biological disaster
preparedness at the University of California, San Francisco. He
lectures on how sales reps influence physicians, and he has applied to
Like many critics, Ahari came to feel Zyprexa
was effective, appropriate for many people. But he believed that the
brass at Lilly downplayed the weight and diabetes problems because the
clock on the patents was ticking. The thinking was, "we may as well
milk it while we can."
* * *
with all the lawsuits, Zyprexa remains Lilly's best-seller. Some
22-million people have taken it. In just the first six months this
year, sales topped $2.3-billion.
Lilly can ride the Zyprexa
money machine until its patent runs out in 2011. But thanks to a carrot
offered by the FDA, the company is in line to get an extra six months
That will allow Lilly to keep making top dollar before generic versions can come on the market and the price falls.
That's where expanding the government's seal of approval to use Zyprexa on adolescents comes in.
Though the FDA approved Zyprexa only for use on adults with
schizophrenia or bipolar disorder, psychiatrists prescribe it "off
label" to children.
Drug companies had no incentive to study
whether giving powerful antipsychotics to kids is safe, not with
doctors already prescribing their drugs to children by the fistful.
That's why the FDA offered to extend exclusivity of the atypical
antipsychotics by six months if the companies studied their effect in
It has made for a bizarre left-hand/right-hand situation.
On one hand, federal and state investigators are looking into whether
Lilly and other drug companies downplayed risks and illegally promoted
their drugs for unapproved uses.
On the other hand, the FDA
is looking into expanding the approved use of the identical drugs.
Already this year, the FDA has approved the atypicals Risperdal and
Abilify for use in adolescents.
Evidence suggests that the dangerous side effects of Zyprexa in adults are more pronounced in children.
A study published in August compared several atypical antipsychotics in
the treatment of early onset schizophrenia. Kids on Zyprexa gained so
much weight, the Zyprexa arm of the study was discontinued.
Another study, published in the American Journal of Psychiatry in
October, found Zyprexa effective in treating bipolar mania in
adolescents. But in the three-week study, kids on average gained more
than 8 pounds and had elevated glucose and cholesterol levels.
In an accompanying editorial, Dr. Jon M. McClellan, an associate
professor of psychiatry at the University of Washington, wrote that
"the long-term consequences of obesity, dyslipidemia and insulin
resistance -- and the risk of diabetes and cardiovascular disease --
raise serious questions over the risk-benefit ratio of olanzapine as a
first-line treatment in juveniles."
McClellan said in an
interview that parents tell him their kids on Zyprexa are always
hungry, ravenous even. "A kid comes in and a week later they've gained
4 pounds, they look puffy," he said.
Adults taking Zyprexa
may gain 5 to 15 pounds in a year, he says, but kids may gain that in
three weeks. Over time, some have gained more than 50 pounds.
A three-person FDA panel that reviewed Lilly's application for approval
of Zyprexa for adolescents had reservations about the studies and
initially recommended denial. The vote was unanimous.
Thomas P. Laughren, director of the FDA's Division of Psychiatric
Products, said the FDA should not follow the expert panel's
Lilly had submitted two studies, with
patients roughly split between sites in the United States and Russia.
The three-member FDA team was troubled that the positive results mostly
came from the Russian sites.
But Laughren noted that FDA inspectors visited the Russian sites and "they found no evidence for fraud."
He said the side effects in children -- weight gain, somnolence,
sedation, fatigue, dizziness and dry mouth -- were similar to what has
been seen in adults, "however, with some differences in magnitude."
Those differences need to be reflected on the labeling, Laughren said
in a memo, but he concluded that Zyprexa is "effective and acceptably
safe" for treatment of adolescents with schizophrenia and bipolar
One of the world's most prominent pharmacology experts shudders at the prospect of the FDA approving Zyprexa for adolescents.
Dr. David Healy, a professor of psychiatry at the University of North
Wales, says that even in adults, Zyprexa should be used only as a
backstop, after other antipsychotics have been tried and failed.
"It ought not to be used in children at all," he said. "It is going to
be marketed as a safe and gentle drug. It is not a safe and gentle
drug. I think it's an extremely dangerous drug. The idea that it's
going to be given to children on a large scale is quite scary."
Times researcher Caryn Baird contributed to this report. Robert Farley can be reached at firstname.lastname@example.org or (727) 893-8603.
VERY interesting.It just shows me that I'm right about ALL depression
drugs causing huge appetite and also causing people that have never
drank to become alcoholics. My son is on Lexapro with huge appetite and
weight gain and is now an alcoholic.
12/19/07 11:10 PM
Pharmas should be investigated by the FBI as a threat to American
citizens, internal memoes and research documents be seized, and
evidences not be protected by courts. Like the Enron criminals, Lilly's
CEO belongs to two places: prison and hell.
12/17/07 02:18 PM
WHY isn't EVERY newspaper and news outlet reporting on this? It's
pretty damn important stuff for people to know. But nope, instead we're
going to let a whole generation be drugged into oblivion. "Psychosis"
in children used to be called imagination.
12/17/07 02:06 PM
How can you trust the FDA to protect the public when some members have
an association with drug companies? Drug advertising on TV is so
unethical by pushing drugs on people. The irony is the whole "war on
drugs". Such hypocrisy.
12/17/07 07:47 AM
And the FDA has nothing to do with the sudden rise in Autism!Hummmm I
don't think thousands of parents could be wrong! Greed! If you don't
take care of your health no one else will! Do your research...for your
kids sake!Can't put your trust in Dr's!
12/17/07 02:50 AM
Who believes the FDA today? Why did MD's accept "education" from those
who sell the educators' product? Yes, medical doctors really are that
lacking in mental ability
12/16/07 10:46 PM
Drugs & money - Is there really any difference between zyprexa
& crack? GREED is their common element. Drug company's are only
interested in $$$ - they are legal versions of crack dealers. Drugs
& money makes the world, or at least the USA, go round.
12/16/07 09:25 PM
Lilly waited 10 years to warn of diabetes while Wyeth waited 10 years
to warn of homicidal ideation with Effexor! One side effect kills the
patient, the other kills anyone nearby, ie: the latest-Omaha &
Colorado. drugawareness.org, ssristories.com
12/16/07 04:29 PM
EXCELLENT ARTICLE!!! A glimpse into reality in the pharmaceutical
world. This is FAR FROM a single incident! Drug companies do this kind
of thing regularly. Read their internal memos on antidepressants which
also increase diabetes. drugawareness.org
12/16/07 03:43 PM
Two of my now-close friends have lost their adult sons to this drug. It
is horrifying that the incompetent FDA would take this step. It should
be off the market.
12/16/07 02:35 PM
It is about time this was reported. I gained 60lbs and got diabetes in
6 weeks. How are people supposed to get health insurance woth diabetes?
12/16/07 02:24 PM
Xyprexa, as most anti psychotics, must be kept out of reach of
children. Parental education should be the rule in cases like these, as
these drugs are a wildcard in a child's development and easily create
lifelong dependency. Educate, not medicate.
12/16/07 02:06 PM
This is outrageous that the State of Florida in the financial condition
that it is in subsidizes this and other drugs like it. It will stop
with a multi billion dollar fine for damages.
12/16/07 01:27 PM
This is the exact reason I did my research before my child even
received any of his shots! The drug companys are out to make a buck!
They don't care about our well being!Do your research before you allow
your child any meds/shots!
12/16/07 11:24 AM
What a sad state of affairs. Lilly CEO Taurel is pals with our
president. That probably clinched this terrible deal. My son was killed
by this horrible drug and it has pretty much ruined my life. Where is
our Congress in all this? Nowhere.
12/16/07 10:50 AM
Thank you St. Petersburg Times. This article may save a few lives.
12/16/07 08:07 AM
alot of hype here, pull out of lilly, is what im reading ,,cause its a
big scam this drug,,,and there giving it to the strung out sugar
babies..for no reason except that the parents need to take a month long
course on .calorie counting , sugar andfat
12/16/07 07:42 AM
Why can't anybody see how dangerous this drug really is. Our government
haggles about it and the tv media ignores it. I am a diabetic from
taking zyprexa. No history of diabetes or symptoms. Please do not let
them start giving this dug to children.
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