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Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data Part II
Washington, DC: Attorney Jim
Gottstein is the director of the Law Project for Psychiatric Rights, a
public interest law firm that has mounted a campaign against forced
psychiatric drugging all over the country. He represents mostly
indigent clients through his non-profit organization and is not
involved in the lawsuits filed against the atypical makers by patients
or their families.
In turning the secret Eli Lilly documents over to the press, Mr
Gottstein's goal was the same as Dr David Egilman's, to alert the
public about Lilly's off-label marketing schemes aimed at getting
doctors to prescribe Zyprexa to more patients who were unaware of the
serious health risks associated with the drug.
Zyprexa was approved only for the treatment of adults with
schizophrenia in 1996, and it wasn't until several years later, that it
was approved for short-term treatment of adults with manic episodes
associated with bipolar disorder.
In a February 13, 2007, interview with the Anchorage Daily News, Mr
Gottstein explained that the secret document showed the rate at which
Zyprexa caused diabetes, massive weight gain and other metabolic
problems and how Lilly trained sales staff to mislead doctors about the
drug's association with diabetes and illegally promoted Zyprexa for
off-label use with children and the elderly.
As the playing field stands today, the average American alone would be
lucky to find any law firm financially strong enough to take a drug
giant like Lilly with its billions of dollars of power and a well that
will never run dry in large part because the illegal off-label
marketing of Zyprexa is ongoing and continues to earn billions of
dollars each year.
However, a small group of patient advocates that included some of the
most well-known psychiatric drug experts, journalists, and attorneys in
the US went head to head with Lilly in the public battle in a US
District Court in New York that dragged out over 2 months to lift an
injunction that barred the public disclosure of information about the
serious adverse effects of Zyprexa that Lilly had successfully kept
hidden under a court order until the documents were leaked to the press
in December 2006.
Lilly filed the motion for the injunction in attempt to get the
documents back under seal and succeeded in muzzling just about every
expert in the US involved in the fight to dismantle the mass-drugging
schemes put in place by the pharmaceutical industry over the past 10
years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and
Dr Stefan Kruszewski, as well as the award winning journalist, Robert
Whitaker, who wrote "Mad in America," and revealed all the negative
information that showed up in the clinical trials conducted on Zyprexa
and the other atypicals.
The score looked bad for the home team early on when Lilly won the
second round by getting the court to add the names of two of the
world's most powerful patient advocacy groups to the injunction, along
with their internet web sites and leaders, including Vera Sharav,
director of the Alliance for Human Research Protection, and Judy
Chamberlin and David Oaks from the international organization
MindFreedom, a coalition of about 100 advocacy groups in 13 different
At the time, Mr Oaks said, "This appears to be about Eli Lilly using
its billions of dollars to try to intimidate grassroots critics."
The New York legal battle turned into an all out war when Ms Sharav and
Dr Cohen brought in the high profile attorney, Alan Milstein, to file
their own motion asking the judge to unseal the documents because they
should have never been designated confidential to begin with.
"What is abundantly clear," Mr Milstein told the judge in a hearing, "is that they are not trade secrets."
"Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo," he said.
"What Lilly wants to prevent, 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," Mr Milstein
said in the hearing.
Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and
his wife Terrie, and then attorney, Fred von Lohmann of the Electronic
Frontier Foundation, widened the battlefield by filing a brief on
behalf of John Doe, described as a citizen-journalist who wanted to
publish the secret documents on web sites because they were "plainly
related to a matter of overriding public concern."
California attorney, Ted Chabasinski, jumped in the ring on behalf of
Robert Whitaker, Judi Chamberlin, and David Oaks. "While the injunction
purports to be an attempt to recover the documents," he wrote in a
letter to the judge, "it is clear that its real purpose is to
intimidate Lilly's critics, and the court should refuse to cooperate
Mr Chabasinski told the court that criminal charges should be filed
against Lilly executives for illegally marketing Zyprexa for unapproved
uses, with full knowledge that thousands of patients were being injured
and killed. "If executives can go to prison for stealing their
companies' money," he told the judge in a letter, "surely those who
steal people's lives deserve at least the same fate."
Mr Chabasinski informed the court that the secret documents were
evidence of Lilly executives' "criminal behavior" and their
"willingness to kill people for profit." He also made it known that he
was encouraging members of the public to contact state attorney
generals and was directing private citizens to a list of current
contact information for each state posted on the Mindfreedom web site.
And some citizens did just that. Richard Bleecker, whose nephew died
unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey
attorney general and stated: "In your capacity as New Jersey's Attorney
General, I ask that you launch an investigation into Eli Lilly's
violation of the public interest by its concealment of the risks of
"Despite the FDA restrictions on use and warning labels," he wrote,
"the drug continues to be vigorously promoted by Lilly and prescribed
for patients in record numbers, including children."
He pointed that the state itself had an interest in the matter "since
government programs like Medicare and Medicaid purchase over 70% of the
Zyprexa sold in the USA, taxpayers in our State as well as across the
nation are footing most of the bill."
"I appeal to you, to investigate Eli Lilly's willingness to see
patients suffer and die to enhance its profits," Mr Bleeker wrote.
Over 10 states have now sued Lilly for Medicaid fraud over the
off-label marketing of Zyprexa. And for good reason according to a
report in the March 23, 2007, New York Times, that said Zyprexa costs
more than $300 a month and is the single biggest drug expense for state
Medicaid programs with spending of more than $1.3 billion in 2005.
During court hearings, several people restrained by the injunction
testified about why the documents should be made public which resulted
in media reports about what was in them before the legal battle even
For instance, at a January 17, 2007, hearing, Mr Gottstein was asked,
"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 Zyprexa?"
And he answered: "Absolutely."
He was then asked whether he feared there would be thousands more cases
of harm to people from Zyprexa, while Lilly was settling cases out of
court, and Mr Gottstein said yes, and that he wanted the documents
released "to protect people from this drug."
Mr Milstein told the judge that the documents were critically important
to saving human lives and said, "this Court should in no way assist
Lilly in keeping them from the public."
At the same hearing, Lilly attorneys asked Ms Sharav why she was
interested in the documents and she said because they documented 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."
"And instead of warning doctors who are widely prescribing the drug,
Eli Lilly set about in an aggressive marketing campaign to primary
doctors," she testified.
Ms Sharav told the court, "This is a safety issue," and "to continue to
conceal these facts" from the public "is not in the public interest."
She said, "this is about the worst that I have seen."
"It borders on indifference to human life," she told the judge. "Eli
Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular
damage and they set about both to market it unlawfully for off label
uses to primary care physicians."
She said Lilly taught primary care doctors to diagnose patients as
bipolar if they experienced mania after taking antidepressants. "That
is absolutely outrageous and that is one of the reasons that I felt
that this should involve the Attorney General," she testified.
Mr Sharav also objected to the off-label sale of Zyprexa to kids.
"Little children are being exposed to horrific diseases that end their
lives shorter," she testified.
She said, "the reason the drug became a four and a half billion dollar
seller in the United States is because they encouraged the prescription
for children, for the elderly, for all sorts of reasons."
"I consider that a major crime," she told the judge and said she asked
Mr Gottstein for 2 copies of the documents so that she could deliver
one copy to the New York attorney general.
By the time of that hearing, Ms Sharav no doubt was aware that the
crime was ongoing because in January 2006, USA Today reported that
although the atypicals are not approved for any use with children, the
prescription rate for children "is growing dramatically faster than the
rate for adults," quoting Robert Epstein, chief medical officer for
Medco Health Solutions, pharmacy benefit managers.
In addition, an assessment by Christoph Correll, of the Child and
Adolescent Psychiatric Clinics of North America, showed Zyprexa to be
the worst of the atypicals for kids and listed the side effects of
diabetes and weight gain with the drug as "severe."
Technically, on February 13, 2007, Lilly scored a knock-out punch when
the judge issued a permanent injunction prohibiting Mr Gottstein and Dr
Egilman from further disseminating the documents and allowed Lilly to
keep them sealed under a court order.
However, the judge also acknowledged in his written ruling that there
was no way he could not enjoin the world by extending the injunction to
the internet and by that time the worldwide web was flooded with all
the damning information.
And Lilly would soon learn that the push to make the information public
extended far beyond the courtroom. On February 23, 2007, a grass roots
advocacy group issued a press release to rally support for Mr Gottstein
for providing the documents to the media and to announce the "The Just
Say "Know" to Prescription Drugs Campaign," with a goal of getting one
million people reevaluate the prescription drugs they were taking.
"If there is a case that dramatically highlights the need to stop
blindly taking prescriptions drugs, this is it," said Dr Greg Tefft,
co-founder of the Campaign.
"We're talking 20 million people potentially at risk and more being added daily," he added.
The group set out to educate the public about off-label prescribing and
what consumers must do to protect themselves against Zyprexa, or other
drugs, when they are prescribed without warnings about side effects or
"We are convinced that the way to solve this problem is to work the
demand side of the market," Dr Tefft said. "We are going directly to
consumers and encouraging them to know what they are taking."
Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio
series and Dr Laurence Simon provided information to consumers about
the drug and they set up an official web site for the Campaign is
A month and a half later, on April 4, 2007, the ranking Republican on
the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was
knocking on Lilly's door with a letter to the CEO saying, "I have an
obligation to ensure that the public's money is properly spent to
provide safe and effective treatments to the vulnerable populations
that are beneficiaries of the Medicare and Medicaid programs."
"I am aware of several pending products liability actions regarding
Zyprexa," he said, "and questions have been raised regarding safety
information and marketing practices relating to that drug."
Senator Grassley also wrote, "I understand that Eli Lilly produced
certain documents in the course of these litigations that shed light on
issues of interest to the Committee," referring to leaked documents and
said, "please provide to the Committee all documents and materials,
including, but not limited to, emails, letters, reports, and memoranda,
that were made available ... pursuant to pretrial discovery in In re
Zyprexa Prods. Liab. Litig."
And in the end, it could be said that injunction or no injunction, the
small group of warriors led by Mr Gottstein and Dr Egilman, who bravely
banded together against the billion dollar giant helped make Lilly's
worst nightmare come true by fighting against the injunction and
keeping the spotlight on the documents that the company fought so hard
to keep hidden, not so much from the public, but from the stockholders.
According to legal experts, Lilly's desperate filing for the injunction
had nothing to do with the lawsuits filed by private plaintiffs because
that litigation was the least of its worries being the company was
settling the cases for peanuts with plaintiffs signing confidentiality
agreements that would shut them up for life.
However, following the public disclosure of proof that Lilly had
engaged in a 10-year illegal off-label marketing scheme while
concealing the adverse effects of Zyprexa, the company was hit with the
big Kahoona, when 4 class action lawsuits were filed in April 2007 on
behalf of shareholders, alleging the fraud by Lilly and its top
executives had cost them more than $30 billion, and the evidenced cited
to support the allegations was the information from the secret
documents that resulted in the battle over the injunction.
It remains to be seen whether these shareholder lawsuits will do
anything to stop the drugging of kids in the US because as it stands
right now the mass drugging campaign appears to be unstoppable. On
September 5, 2007, Rob Waters reported that the number of antipsychotic
prescriptions for children doubled to 4.4 million between 2003 and
2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a
Mr Waters also reported that the growth was most dramatic in the
youngest children with 20,280 prescriptions written for kids aged 4 and
younger, a five-fold increase over 2003, and with 5- to 9-year-olds,
prescriptions increased almost six-fold to 710,937 in 2006.
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