February 1, 2007
Zyprexa Injury Clock Keeps Ticking Away
on-going legal battle over the disclosure of secret Eli Lilly documents
that reveal the serious health risks associated with Zyprexa and the
company's off-label promotion of the drug involves a matter of grave
But observers on the sidelines of this courtroom
circus say the conduct of the judge in helping Lilly keep documents
secret that give the specific details of an illegal marketing scheme
that is literally killing people is almost as disturbing as the
The off-label prescribing of Zyprexa has
created a public health crisis. According to the New York Times, the
secret documents show a pattern of unlawful activities that may have
left the 20 million individuals who have taken Zyprexa with incomplete
information regarding the side effects of the drug.
trained psychiatrist, Dr Stefan Kruszewski, reports that Zyprexa
increases the risk of obesity, diabetes, hypertension, cardiovascular
complications, heart attacks and stroke.
Keeping in mind that
the FDA says that only between 1% and 10% of adverse events are
reported to the agency, a study conducted 5 years ago, in the July
2002, issue of Pharmacotherapy, reviewed the adverse event reports
submitted on Zyprexa and found that of the 289 cases of diabetes
reported, 225 of the patients were newly diagnosed.
also identified 100 Zyprexa patients who had developed ketosis, a
serious complication of diabetes, 22 cases of pancreatitis, a
life-threatening inflammation of the pancreas, and 23 deaths associated
with the drug.
Zyprexa is an antipsychotic approved by the FDA
to treat adults with schizophrenia and bipolar disorder only. But
doctors are prescribing the drug for conditions, treatment durations,
and patient populations for which it was never intended and worst of
all it is being widely prescribed for children.
in February 2006, public health officials in Florida ordered an
investigation into why the number of children who are prescribed
antipsychotics billed to Medicaid in Florida had nearly doubled in five
years, from 9,500 children to almost 18,000.
The lawsuits filed
against Lilly to recover the money paid for Zyprexa by state Medicaid
programs due to the company's off-label promotion say the drug is being
sold for unapproved uses such as anxiety and other mood disorders,
sleep disruption, autism, attention deficit disorders, hyperactivity,
According to the attorney general of
Mississippi, about 10% of Zyprexa patients on Medicaid in that state,
have developed diabetes. In fact, the health problems associated with
Zyprexa have become so prevalent, that one class action lawsuit is
demanding money to cover the medical monitoring of all patients who
took Zyprexa but have not yet been diagnosed with high blood sugar,
diabetes, or pancreatitis.
Children on Zyprexa are developing
life-long injuries. At the annual meeting of the American Academy of
Child and Adolescent Psychiatry in Washington, DC, on October 20, 2004,
researchers from the Johns Hopkins Children's Center reported that
atypical antipsychotics were found to trigger insulin resistance in
children. The researchers evaluated 11 children who gained significant
amounts of weight while taking the drugs.
Weight gain is a
known risk factor that contributes to insulin resistance. Insulin is
produced by the pancreas to help cells absorb glucose and provide
energy. When resistance occurs, the pancreas tries to keep up with the
demand by producing more insulin until it eventually cannot keep up,
and excess glucose builds up in the bloodstream which can increase the
risk of type-2 diabetes, heart disease, and stroke.
children in the John Hopkins study who were on moderate or high doses
of an antipsychotic developed symptoms of insulin resistance, and three
of the 5 children on low doses did as well.
The study's lead
author, Dr Mark Riddle, director of the division of child and
adolescent psychiatry at the Center, said, "The insulin resistance seen
in these children was greater than what would be expected from weight
gain alone, suggesting there is a factor distinct from excess weight
that directly induces insulin resistance."
Experts say Zyprexa
is poison for some people. According to Dr Louis Caplan, Professor of
Neurology at Harvard Medical School, there is overuse of antipsychotics
in patients admitted to hospitals. "These drugs," he said, "are often
given in high doses to very sick patients in intensive care units or on
medical and surgical units," in the February 21, 2006, journal
"They cause symptoms and neurological dysfunctions
that are a common reason for neurological consultations in the
hospital," Dr Caplan warns.
"Old sick people with abnormal
brains do not tolerate these drugs well," he says. "In patients with
Lewy-body disease and some Parkinsonian syndromes, their use is a
disaster, setting patients back for weeks," he warns.
FDA approves a drug, it also approves the labeling which explains the
manner in which the drug is to be prescribed. While doctors may
prescribe drugs as they see fit, its illegal for drug companies to
promote drugs for uses outside the labeling.
vividly evidenced here, drug makers do it and get away with it all the
time and the leaked Lilly documents prove that the US court system is
aiding and abetting drug companies in hiding their illegal marketing
For instance, in one article, the Times quotes a sealed
document that served as a script for a company meeting in 2001, where a
Mr Bandick praised sales representatives for the number of new Zyprexa
prescriptions they got doctors to write. According to the script, more
than 100 representatives convinced doctors to write at least 16 extra
The legal battle over the documents began in
December 2006, when Dr David Egilman, provided the documents to Alaskan
attorney, Jim Gottstein, and Mr Gottstein turned them over to Alex
Berenson, a reporter for the New York Times.
Dr Egilman first
learned about Lilly's illegal conduct when he reviewed the documents a
few years back as an expert witness in the Zyprexa litigation. However,
when Lilly was successful in the settling the cases out of court, Dr
Egilman was forcibly silenced because the court allowed Lilly to
continue to keep the documents hidden with a protective order.
soon as the articles began to appear in the New York Times, describing
an off-label marketing scheme called, "Viva Zyprexa," Lilly got a judge
to issue a mandatory temporary injunction on December 18, 2006,
ordering Mr Gottstein to return the documents and list the names of
everyone he disclosed them to or discussed them with.
supplied the list, Lilly got the court to issue a second temporary
injunction on December 29, 2006, to prohibit the dissemination of the
documents by Terrie Gottstein, Jerry Winchester, Dr Peter Breggin, Dr
Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan Kruszewski,
Laura Ziegler, Judy Chamberlin, Vera Sherav, Robert Whitaker, and Will
The above list reads like a Big Pharma hit list. It
includes about every well-known expert on the side effects of
psychiatric drugs in the US, as well as the journalists and authors who
have investigated and written most extensively about the misconduct of
drug companies when it comes to the off-label promotion of drugs, and
Conspicuously absent from the injunction
is the New York Times and the reporter who actually used the documents
when writing five articles on the matter. Most curious is the fact that
Lilly has never even asked the court to issue an injunction for the
On January 3, 2007, a hearing was held on a request by
Lilly to extend the temporary injunction, and to force Mr Gottstein to
appear in New York City for a deposition within 5 days, as a prelude to
charging him with civil and criminal contempt of court for publicizing
As a result of that hearing, several more
entities were added to the injunction list including Eric Whalen and
his web site at www.joysoup.net; the MindFreedom web site at
www.mindfreedom.org, and the Alliance for Human Research Protection
(AHRP) web sites at www.ahrp.org and www.ahrp.blogspot.com.
again, the Times and Alex Berenson were not added, and in fact, during
the hearing, Judge Jack Weinstein said he was not about to issue an
injunction against the Times.
By its own estimate in the
media, Lilly produced approximately 11 million documents in discovery
for Zyprexa litigation thus far, and has designated them all
confidential pursuant to Case Management Order 3, a protective order
entered on August 9, 2004.
When issuing CMO-3, the court gave
Lilly the right to designate documents confidential, as long as Lilly
"in good faith" believed that they were. However legal experts say the
secret documents at issue here never should have been covered by a
According to attorneys in the case, in
entering CMO-3, the court did not articulate the reasons why a
protective order was necessary or set forth any criteria to use when
determining whether a document was actually confidential and deserving
Yet instead of keeping the focus on why the 11
million documents were ever permitted to remain hidden in the first
place, Judge Weinstein is allowing Lilly to hammer away at the
messengers who gave the documents to the press, after deciding that the
information needed to be circulated before more people were injured and
In a January 17, 2007, hearing, Mr Gottstein was asked:
"In this particular case involving Zyprexa, at the time you subpoenaed
Dr. Egilman, had you the impression that Eli Lilly had deliberately
withheld from the public and from physicians adverse side effects of
He answered: "Absolutely."
Mr Gottstein was
then asked whether it was his impression that there were thousands of
cases of harm to people from Zyprexa, while Lilly was in the process of
settling cases out of court, and he said yes and that was why he wanted
the documents out there "to protect people from this drug."
had nothing to gain personally by providing the documents the Times. Mr
Gottstein testified that he does not represent clients who were injured
by Zyprexa for money damages and that his sole interest was protecting
On January 25, 2007, in response to a request for Dr
Egilman to appear at a deposition in preparation for Lilly to file
civil and criminal contempt of court charges against him, though his
attorney, Dr Egilman informed Lilly's legal team that he will refuse to
testify under the protection of the Fifth Amendment.
A number of
persons restrained by the injunction have obtained attorneys to file
briefs with First Amendment arguments including the public's right to
know what is in the documents and some people appeared at the last
Ms Sharav and Dr Cohen point out in their brief,
that they are not ex-employees of Lilly who have stolen trade secrets.
They are merely a public health advocate and a professor who seek to
share Lilly's own words with the public and they view exposing the
information that "Lilly wants so desperately to keep hidden" as their
primary public role.
Ms Sharav testified at the January 17,
2007, hearing, and when asked why she was interested in the documents
by a Lilly attorney, said because they document the fact that Lilly
knew in 2000, that Zyprexa caused diabetes, "from a group of doctors
that they hired who told them you have to come clean."
instead of warning doctors who are widely prescribing the drug," she
testified, "Eli Lilly set about in an aggressive marketing campaign to
"Little children are being given this drug,"
she said, "Little children are being exposed to horrific diseases that
end their lives shorter."
"Now, I consider that a major crime,"
she stated, "to continue to conceal these facts from the public is I
think really not in the public interest. This is a safety issue."
Lilly's attorney asked the court to strike her comments from the record but the request was denied.
Alan Milstein, appeared on behalf of Ms Sharav, the AHRP, and Dr Cohen,
and toward the end of the hearing noted that in handling the underlying
Zypexa litigation, the judge had had occasion to look at the documents
in question or at least to read the Times articles and stated: "What is
abundantly clear is that they are not trade secrets."
in no way fears dissemination of these documents to their competitors,
to Merck or to Glaxo," Mr Milstein told Judge Weinstein.
Lilly wants to prevent," he said, "is the public at large, the
consumers of its products, from seeing these documents and learning the
truth about the product that Lilly produces and the way it markets it."
"Documents like that are not confidential and should not be marked confidential," he stated.
the end of the hearing, the judge instructed the parties to file more
briefs and another hearing is scheduled for February 7, 2007, for oral
In the latest turn of events, right out of the
blue, Judge Weinstein issued an order this week with an "invitation"
for Mr Berenson to appear in court to give testimony and be
cross-examined on whether he participated in a conspiracy with Mr
Gottstein and Dr Egilman to violate the original court order that
sealed the documents.
In the meantime, while this circus plays
out in the courts, every day thousands of doctors and patients are
making uninformed decisions on whether to use Zyprexa. And the injury
clock is ticking. Allen Jones, a former fraud investigator in the
Pennsylvania Office of Inspector General, states: "My best effort at
correlating dollars spent with deaths suggests that people may be dying
from side effects at the rate of at least one death for each one
million dollars spent on the drug."
Authors Bio: Evelyn Pringle is a columnist for OpEd News and
investigative journalist focused on exposing corruption in government
and corporate America.