Court
Allows Eli Lilly To
Bury Zyprexa Documents
By Evelyn Pringle
23 December, 2006
Countercurrents.org
Alaskan
attorney, Jim Gottstein, says that after being served with a mandatory
injunction, he has returned the internal Eli Lilly documents that he
obtained in litigation and provided to the New York Times to the court.
Information from the documents
related to Lilly's antipsychotic drug, Zypexa, was highlighted two days
in a row in front-page articles in the Times
The documents reveal the
illegal marketing schemes used by Lilly to make Zyprexa its best-seller,
which the company has managed to keep hidden for years by entering into
out of court settlements in civil lawsuits which included confidentiality
clauses and by getting judges to place the documents under protective
orders to shield them from public view.
For instance, the documents
under seal here are from a case where Lilly entered into an out-of-court
settlement in June 2005, and agreed to pay $690 million to cover claims
by about 8000 Zyprexa victims. But in order to get paid, the plaintiffs
were required to sign a confidentiality clause and basically keep their
mouths shut about Zyprexa from then on.
Its really comical the way
Lilly keeps acting all indignant over the disclosure of these documents
as if they contain brand new charges, when the company has been under
federal and state investigations related to its off-label marketing
of Zyprexa for several years already. The company is also facing Medicaid
fraud charges in lawsuits all over the county.
In 1996, Zyprexa was approved
for the treatment of adults with schizophrenia, and a few years later,
it was approved for short-term treatment of adults with manic episodes
associated with bipolar disorder.
Yet despite these extremely
limited approved uses, Zyprexa went on to become the top selling antipsychotic
worldwide with an estimated 20 million people having used the drug and
Lilly’s best-selling product, with $4.2 billion in sales in 2005,
which translates into 30% of its total revenues.
The documents provided to
Times, span a decade and clearly show that the company promoted off-label
the sale of Zyprexa for uses not approved by the FDA as being safe and
effective. They also reveal that Lilly knew about Zyprexa's link to
drastic weight gain and diabetes for years but failed to inform prescribing
doctors and consumers.
In fact according to the
Times, Lilly knowingly distributed false information to doctors about
the risks as late as 2001. On December 21, 2006, the Times reported
that the information provided to doctors about the blood-sugar risks
of Zyprexa did not match data circulated inside the company after a
review of Lilly's clinical trials.
The Times quotes a Lilly
report from November, 1999, that shows that after examining 70 clinical
trials, Lilly found that 16% of patients taking Zyprexa for a year had
gained over 66 pounds. But instead of making these findings public,
the company used data from a smaller group of trials that showed roughly
30% of Zypexa patients gained 22 pounds.
Mr Gottstein is not involved in the case in which the judge issued a
protective order In re: Zyprexa Products Liability litigation, MDL No.
1596, United States District Court, Eastern District of New York (MDL
1596), "in any manner whatsoever," he says.
He is the leader of, "The
Law Project for Psychiatric Rights (PsychRights), a public interest
law firm devoted to the defense of people facing forced psychiatric
drugging against their will.
Currently, Mr Gottstein represents
an Alaskan patient and says the injunction will prevent him from using
the Lilly documents to show that the side effects of Zyprexa are well-established
by the company's own clinical trials and therefore, his client should
not be forced to take such drugs against his will.
In Myers v Alaska Psychiatric
Institute, 138 P.3d 238 (Alaska 2006), a case argued by Mr Gottstein
last summer, the Alaska Supreme Court ruled that Alaska's forced drugging
procedures were unconstitutional because they did not require the court
to find such drugging to be in the person's best interests, and that
there were no less restrictive
alternatives.
In order to present the evidence
in the case he is handling now, Mr Gottstein is looking to the Alaskan
courts to issue a ruling that says his client's right to avoid forced
drugging outweighs Lilly's right to keep the information about risks
hidden.
He says the documents are
highly relevant to a court inquiry, now required in Alaska, before a
court can make an informed decision about whether to order forced drugging
for his client.
In a December 17, 2006, letter
to the court in the New York case, Mr Gottstein stated: "In large
part, this state of affairs has been created by the lies told by the
manufacturers of psychiatric drugs."
"My impression is,"
he wrote, "that Eli Lilly's lies about Zyprexa form the basis of
the plaintiffs' claims in MDL 1596, but that is not PsychRights' focus."
"PsychRights' focus,"
he explained, "is helping people avoid being forcibly drugged pursuant
to court orders, where the courts have been, in my view, duped by Eli
Lilly and other pharmaceutical company prevarications."
"In my view," Mr
Gottstein concluded, "the proper disposition of the question would
be in favor of my client's right to inform the court of the extreme
harm caused by Zyprexa, which Eli Lilly has successfully hidden for
so long, while making its billions off the pill."
A court hearing was held
in Brooklyn, New York, on a December 18, 2006, on a motion by Lilly,
asking the court to order Mr Gottstein to the return the documents to
the court, and to bar him from disseminating them any further.
According to the transcript,
Lilly also asked the court to require Mr Gottstein to "preserve
all emails and all correspondence of any kind, whether it's voice mail,
written letters, emails, so that we can pursue a contempt proceeding
against both he and Dr Egilman."
Even though the Lilly documents
prove that the company knew that Zyprexa was causing diabetes, and kept
pushing the drug anyways, potentially harming millions more patients,
the judges gave Mr Gottstein hell and threatened to find him in contempt
for doing nothing more than warning the public about the side effects
of Zyprexa after Lilly concealed the information for a decade.
There is not one single word
in the transcripts about Lilly knowingly injuring and killing people
with Zyprexa or illegally pushing the drug to unwitting victims for
off-label use.
Instead, Judge Brian Cogan,
granted Lilly's motion, and told Mr Gottstein's attorney that his client,
"deliberately aided and abetted Dr Egilman in getting these documents
released from the restriction that they were under, under the protective
order. He knew what he was doing, and he did it deliberately."
Judge Cogan went on to tell
the attorney, "your client should be on notice that of this moment,
he is under a mandatory injunction to return those documents ... to
take them down from any websites that he may have posted them on, and
to take any reasonable effort to recover them from any sites or persons
to which he has delivered them."
On December 18, 2006, at
an earlier telephone conference in Brooklyn, Judge Roane Mann also did
not utter one word about Lilly's illegal conduct, but instead admonished
Mr Gottstein for not playing fair with poor Eli Lilly in making the
information about Zyprexa public, stating:
"I personally am not
in a position to order you to return the documents. I can't make you
return them but I can make you wish you had because I think this is
highly improper not only to have obtained the documents on short notice
without Lilly being advised of the amendment but then to disseminate
them publicly before it could be litigated. It certainly smacks as bad
faith."
These judges apparently believe
that an expert, such as Dr David Egilman, who is hired to review documents
in a case and subsequently learns that people are being seriously injured
and killed, should be forced to keep that knowledge a secret if a judge
issues a protective order.
There is something very wrong
with this picture. It begs the question of how can an ethical doctor
not speak if he knows that patients are being harmed
The reason always cited for
the need to keep documents under seal is the claim that the information
contains trade secrets. However, just as Lilly has done here, drug companies
have for too long been abusing the process by using protective orders
to hide illegal conduct by concealing documents that show the company
is illegally promoting the off-label use of a drug or that a drug can
cause serious injuries or that a drug does not work.
In a case like this, if a
court truly does not have a choice and is required to seal documents
even when they show blatant illegal conduct on the part of a drug company,
then Congress had better get busy and pass a law to stop the use the
US court system to protect what could very easily be described as corporate
murder.
In response to an earlier
article on this issue, reader Larry Bone wrote and asked this author,
"Is the corruption on this so widespread that no one would dare
prosecute?"
"It is criminal behavior,"
he points out, "on a huge scale that is being virtually totally
ignored by the authorities responsible for the public safety."
"I just feel,"
Mr Bone wrote, "that there has to be an attorney or someone in
a judicial or ethical capacity who would have the guts, and persistence
to prosecute Lilly."
"It seems incredibly
ridiculous," he states, "let alone obscene, that such blatant
wrongdoing seemingly continues to be ignored by the legal authorities
with jurisdiction over these sorts of cases."
"If these companies
believe they have done nothing wrong," he says, "then let
them prove their innocence in court."
Ellen Liversridge also wants
a criminal investigation of Lilly. She lost her 30-year-old son, Rob,
to the adverse effects of the drug. "He gained almost 100 pounds
while taking Zyprexa," Ellen says.
"Rob lapsed into a coma,"
she recalls, "and died of profound hyperglycemia four days later
on October 5, 2002."
"I believe that the
people who did this should have a criminal trial," Ellen says.
"Enron executives went to prison for wiping out people's life savings,"
she points out.
"Lilly executives should
go to prison," she says, "for knowingly being responsible
for people's deaths, shattered families; ruined and grieving families."
Ellen has nothing but praise
for the New York Times and its source. "I am grateful to Jim Gottstein
for making available this awful truth and hope it results in justice
being done."
"If there can ever be
justice for a crime as heinous as this," she adds.
Daniel Haszard, of Bangor
Maine, feels the same way. In 1996, he was prescribed Zyprexa off-label
to supposedly treat Post Traumatic Stress Disorder, and he remained
on the drug for 4 years.
Although he paid $250 a month
for the drug, Mr Haszard says the drug did not relieve his symptoms
of PTSD at all and in early 2000, he was diagnosed with diabetes.
He was shocked to hear the
diagnosis, he said, because there was no history of diabetes in his
family. Just as thousands of other Zyprexa victims, Mr Haszard did not
make the connection between his diabetes and the drug until he saw a
commercial for a law firm in December 2005.
Zyprexa causes diabetes,
he says, and public health programs are left to pick up the tab for
the medial expenses. According to Mr Haszard, "there are now 7
states going after Lilly for fraud and restitution," related to
the promotion of Zyprexa for off-label use and the concealment of its
risks.
Dr Stefan Kruszewski, MD,
a Harvard trained, certified psychiatrist in adult, adolescent, and
geriatric psychiatry, from Harrisburg, Pennsylvania, also finds Lilly's
conduct appalling.
"Neither health professionals
nor consumers," he states, "can accurately provide information
about the risk and benefits of a drug like Zyprexa - or any drug for
any condition - without a comprehensive awareness of the risks and benefits."
"If the clinical research
data regarding effectiveness, efficacy or safety is sequestered or misrepresented
from observation studies, randomized drug trials or meta-analyses,"
he says, "then it is not possible for any provider to give any
patient what he or she needs to make an informed consent."
"At that point,"
Dr Kruszewski says, "individuals receive drugs that may or may
not help them, but always at their own peril."
"Zyprexa causes both
a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular
problems," Dr Kruszewski advises, "at the same time that it
continues to cause neurological side-effects like the older antipsychotics."
"Zyprexa and its antipsychotics
cousins," he explains, "were marketed to be safer and easier
to tolerate because the pharmaceutical companies said that the newer
drugs caused fewer neurological injuries, like restlessness or ‘akathesia,’
and tardive dyskinesia."
Those assertions are false
he says, and "what we have now is a drug whose massive revenues
and promotion are based upon faulty disclosures by Eli Lilly."
(Evelyn Pringle [email protected]
is a columnist for OpEd News and an investigative journalist focused
on exposing corruption in government and corporate America)
Leave
A Comment
&
Share Your Insights