Zyprexa
Cat Out Of The Bag
By Evelyn Pringle
21 December, 2006
Countercurrents.org
Documents
acquired by the New York Times from attorney Jim Gottstein show that
Eli Lilly ran a "Viva Zyprexa” marketing campaign to convince
doctors to prescribe Zyprexa off-label and between 1999 and 2002, its
sales doubled from $1.5 billion to $3 billion.
Although most people would
recognize that the Zyprexa cat cannot be stuffed back in the bag, Lilly
nonetheless, got a judge to issue an order on December 15, 2006, in
attempt to get the documents returned which states in relevant part:
James Gottstein, Esquire,
is in possession of documents produced by Eli Lilly and Company in the
above-captioned action in violation of CMO-3, and has been so notified
by counsel for Eli Lilly and Company without response by Mr. Gottstein.
Mr. Gottstein has further
disseminated these documents to additional third parties in violation
of CMO-3.
Mr. Gottstein shall immediately
return any and all such documents (including all copies of any electronic
documents, hard copy documents and CDs/DVD).
In addition, although Lilly
does not mention how hard it is working behind the scenes in the courts
to get the Zyprexa documents back in the bag, in a December 18, 2006,
press release, the drug maker denied all wrongdoing and states that
Lilly "vigorously objects to the characterization of company practices
in a New York Times article based upon selective documents illegally
leaked by plaintiffs' lawyers."
Market Watch even says that
Lilly denies it "vehemently."
To that I says, "So
what's new?"
A drug company gets busted
red-handed illegally promoting a dangerous and useless drug for uses
not approved as safe and effective by the FDA, and its always denial,
even in cases such as this where the documents are indisputable.
Its difficult to believe
that the person who wrote this press release did it with a straight
face. It also leads the mind to wonder how much Big Pharma pays a person
to write an out and out fraudulent press release these days.
Here! Here! Lilly also says
it "deplores the illegal release of select confidential documents,"
in its statement.
To that I say, "I'll
bet."
"This illegal and selective
disclosure of incomplete information," the company writes, "will
cause unwarranted concern among patients that may cause them to stop
taking their medication without consulting a physician."
To that I say, "we can
only hope."
"The Times," Lilly
whines, "failed to mention that these leaked documents are a tiny
fraction of the more than 11 million pages of documents provided by
Lilly as part of the litigation process."
This statement begs the question
of how would reading 11 million other documents change what is said
in the documents quoted by the Times?
Picturing somebody trying
to read eleven million documents simply tells me that Lilly tried to
send the plaintiffs' legal team on a wild goose chase to find a few
needles in a haystack and apparently some diligent attorneys were up
to the task because they caught the goose and found the needles.
But there must be a lot more
needles to find because Lilly is showing signs of outright paranoia
and desperation in wanting those documents out of the public domain.
In fact, on December 19, 2006, Lilly got the court to issue an Order
for Mandatory Injunction directed at Mr Gottstein which states in relevant
part:
Mr. Gottstein shall immediately,
upon receipt of this Order, provide to Special Master Woodin and the
parties a listing of all persons, organizations or entities to whom
any documents covered by this Order, or any subset thereof, were provided.
Mr. Gottstein shall, within
24 hours of this Order, identify to Special Master Woodin and the parties,
by specific bates stamp, those the particular documents to any person,
organization or entity noted above, which shall also include the date
and location such documents were disseminated.
Mr. Gottstein shall immediately
take steps to retrieve any documents subject to this Order, regardless
of their current location, and return all such documents to Special
Master Woodin. This shall include the removal of any such documents
posted at any website.
Mr. Gottstein shall take
immediate steps to preserve, until further Order of the Court, all documents,
voice mails, emails, materials, and information, including, but not
limited to all communications, that refer to, relate to or concern Dr.
Egilman or any other efforts to obtain documents produced by Eli Lilly
and Company.
For his part, Mr Gottstein
is not an attorney in the lawsuit in which Lilly got the judge to allow
the company to hide the documents in the first place. He obtained them
in another case and therefore, he surely would not be covered by any
protective order.
Mr Gottstein is an advocate
for patient rights and sits at the helm of, "The Law Project for
Psychiatric Rights (PsychRights)," a public interest law firm that
has mounted a legal campaign against forced psychiatric drugging all
around the country.
His only interest in disclosing
the documents appears to be a noble one; to alert unwitting doctors
and Zyprexa patients about the high risk of injuries and death associated
with the drug that Lilly has been successfully concealing for a decade.
However, it now looks like Lilly's has not been acting alone, but rather
with a few accomplices embedded in the US court system.
Mr Gottstein legal pursuits
do not involve chasing the almighty dollar; his organization helps people
who ordinarily have little or no money. For instance, earlier this year
Mr Gottstein won a landmark case before the Alaskan Supreme Court that
found Alaska's forced drugging regime to be unconstitutional, in Myers
v Alaska Psychiatric Institute, 138 P3d 238 (Alaska 2006).
Mr Gottstein says he took
on this case because he was concerned about the rights of those people
who find the drugs like Zyprexa both unhelpful and intolerable. "No
other field of medicine allows this sort of forced treatment,"
he points out.
“For people who want
to try non-drug approaches," he explains, "the research is
very clear that many will have much better long-term outcomes, including
complete recovery after being diagnosed with serious mental illness."
He says the massive forced
drugging is turning many patients into drooling zombies and preventing
them from going on to live the full lives they could otherwise enjoy.
On appeal, Mr Gottstein argued
that the provisions governing authorization of treatment with psychotropic
medications violate the Alaska Constitution’s guarantees of liberty
and privacy and the Supreme Court agreed.
"In our view,"
the Court wrote, "before a state may administer psychotropic drugs
to a non-consenting mentally ill patient in a non-emergency setting,
an independent judicial best interests determination is constitutionally
necessary to ensure that the proposed treatment is actually the least
intrusive means of protecting the patient."
In its decision, the Court
addressed the class of drugs known as psychotropic medications. "Because
psychotropic medication can have profound and lasting negative effects
on a patient’s mind and body," the Court stated, "Alaska’s
statutory provisions permitting nonconsensual treatment with psychotropic
medications implicate fundamental liberty and privacy interests."
In addition to a compilation
of published studies, the PsychRights' website has a wealth of information
about psychiatric medications. However, in light of the above injunction,
who knows how long it will be permitted to provide information about
the dangers of Zyprexa.
The internal Lilly documents
that Mr Gottstein provided to the Times cover the period 1995 to 2004,
and clearly show that Lilly tried to hide information about Zyprexa’s
link to drastic weight gain even after it knew that 30% of patients
on Zyprexa (olanzapine) for more than a year gained 22 pounds, and some
as much as 100, a factor known to cause type-2 diabetes.
As far back as November 1999,
emails show that Lilly was worried that if the risks became know it
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 to Lilly employees that
announced the formation of an "executive steering committee for
olanzapine-associated weight changes and hyperglycemia."
In 2000, a group of diabetes
doctors retained by Lilly to consider a possible link between diabetes
and Zyprexa warned Lilly that "unless we come clean on this, it
could get much more serious than we might anticipate," in an email
from one Lilly manager to another, quoted in the Times.
In March 2002, a document
shows that Lilly dismissed a plan to give psychiatrists information
about how to treat diabetes, worrying that it would remind them of the
risk. "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 an email quoted in the Times.
In 1999 and 2000, Lilly considered
ways to convince primary care doctors who did not see patients with
schizophrenia or manic depression, to prescribe Zyprexa. In one document,
an unnamed Lilly marketing executive wrote that these doctors “do
treat dementia” but “do not treat bipolar; schizophrenia
is handled by psychiatrists.”
As a result, “dementia
should be first message,” of a campaign to primary doctors, according
to the document, the Times said.
It also noted that some primary
care doctors “might prescribe outside of label.”
If an epidemic of adult schizophrenia
and manic-depression occurred since Zyprexa came on the market in 1996,
I find it amazing that I somehow missed it.
But I must have because the
Times describes a 2001 company meeting with Zyprexa sales representatives,
where a Mr Bandick praised 16 sales reps for the number of prescriptions
they had convinced doctors to write, according to a script prepared
in advance of the meeting.
The Times states: "More
than 100 other representatives had convinced doctors to write at least
16 extra prescriptions and thus “maxed out on a pretty sweet incentive,”
Mr Bandick said.
So the question here is,
how could 100 sales reps get doctors to write prescriptions for a drug
only approved for schizophrenia or manic depression for 16 more people
if they were not promoting the drug for other uses?
Lilly apparently expects
us to be stupid enough to believe that all these doctors in every state
in the US, many of whom were general practitioners, came up with the
idea to prescribe Zyprexa to every Tom, Dick and Mary for every indication
under the sun right out of the blue.
(Evelyn Pringle
,[email protected],
is a columnist for OpEd News and an investigative journalist focused
on exposing corruption in government and corporate America)
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