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Attorney Subpoens J&J, AstraZeneca and Lilly for Hidden Antipsychotic Data Part I
Washington, DC:Alaska attorney Jim Gottstein has issued subpoenas for the discovery of any suppressed data on the atypical antipsychotic drugs Zyprexa, Risperdal, and Seroquel which
he says is necessary before a Forced Drugging Petition can possibly be
considered for approval for a client he is representing.
Mr Gottstein contends that the information sought from Eli Lilly,
AstraZeneca and Johnson & Johnson will show that the side effects
of the drugs were well-established by the drug makers' own clinical
trials and therefore, his client should not be forced to take such
medications against his will.
to Mr Gottstein, various off-label combinations of Risperdal, Seroquel,
Zyprexa and the anti-seizure drug Depakote have been administered to
his client in the past, over his objections, which have not been FDA
approved as safe or effective for use in any patient.
The subpoena issued to Sidney Taurel, Chairman and CEO of Eli Lilly
calls for the production of the same documents requested by Congressman
Henry Waxman (D-Cal), as chairman of the House Oversight and Government
Reform Committee, on March 1, 2007.
On March 1, 2007, Rep Waxman sent letters to both Lilly and
AstraZeneca, requesting extensive information about their marketing
practices. The letter to Lilly states in part, "Allegations have been
raised that Eli Lilly misled physicians and inappropriately promoted
off-label uses of Zyprexa," and requests information relevant to these
The letter asks for a list of all Zyprexa trials, studies, or reports;
all presentations given to employees who promoted Zyprexa; information
shown to physicians; presentations related to prescribing patterns,
continuing medical education, and off-label use; and all documents and
correspondence related to funding for nonprofit professional
organizations or consumer patient groups.
The letter to Astra basically asks for the same documents except that
Rep Waxman asks for more information related to the physicians and
authors involved in company sponsored studies on Seroquel and writing
However, Rep Waxman also asked Lilly to turn over a batch of documents
that were kept under seal for years with a court order issued by a
federal court in New York, but were provided to him by Attorney
Gottstein in December 2006, which Rep Waxman subsequently returned to
Lilly on December 21, 2006, to honor the court order.
Mr Gottstein originally obtained the documents by subpoenaing Dr David
Egilman, who served as a plaintiffs expert witness in the Zyprexa
Products Liability litigation, pending in the United States District
Court in the Eastern District of New York (MDL 1596), for a case
unrelated to the Products Liability case.
The MDL 1596 litigation involved tens of thousands of lawsuits filed by
Zyprexa victims who alleged that Lilly illegally marketed the drug for
off-label uses and concealed the serious side effects known to be
associated with Zyprexa for a decade.
As soon as Mr Gottstein received the documents he provided copies to
reporter, Alex Berenson, at the New York Times, and to a number of
other journalists, patient rights activists and advocacy groups and
several leading experts on psychotropic drugs.
Once a medication is approved to treat one condition, doctors may
prescribe it off-label for other indications if they think it will be
effective, but drug makers are barred by law from encouraging
physicians to prescribe a drug for uses other than those listed on the
FDA approved label. But in recent years, its a well-known fact that
off-label promotion has become the industries primary marketing tool
when it comes to psychiatric drugs.
"Off-label" use also includes treating an approved condition for a
longer duration of time, or in combination with other drugs, or at a
different dosage, or with a different patient population such children
or the elderly, than are listed on the label.
Zyprexa (Lilly), Risperdal (J&J) and Seroquel (AstraZeneca) belong
to a class of drugs known as "atypical" antipsychotics. The other
atypical drug include Abilify (Bristol Meyers Squibb), Geodon (Pfizer)
and Clozril (Novartis).
The drugs were FDA approved only to treat schizophrenia and the manic
phase of bipolar disorder in adults and have never been approved for
use in combination with each other.
The many lawsuits filed against Lilly allege that the company's
off-label marketing campaigns included influencing doctors to prescribe
the drug to millions of patients ranging from toddlers to the elderly
for an exhaustive list of unapproved uses such as anxiety, sleep
disruption, mood swings, post-partum depression, autism, attention
deficit hyperactivity and dementia.
According to Harrisburg Pennsylvania psychiatrist, Dr Stefan
Kruszewski, the atypical drugs can increase the risk of drastic weight
gain, diabetes, pancreatitis, hypertension, heart attacks and stroke.
"The drugs can cause both a severe metabolic syndrome consisting of
obesity, diabetes and cardiovascular problems," he explains, "at the
same time that they cause the neurological side effects as the older
antipsychotics such as akathesis, a severe restlessness and tardive
dyskinesia an often irreversible movement disorder."
As an expert witness in the case, Dr Egilman reviewed the Lilly
documents kept under seal by the court order and learned that Lilly had
indeed engaged in a massive off-label marketing scheme to increase
profits by encouraging doctors to prescribe the drug for unapproved
uses and had concealed the drug's serious side effects.
As a physician, after learning what was in the documents and knowing
the harm that was sure to come to patients who continued to take
Zyprexa, Dr Egilman was clearly facing a major ethical dilemma.
At the time, Lilly had already managed to keep the documents hidden by
settling out of court with about 8,000 Zyprexa victims in 2005 by
paying close to $700 million, after only five plaintiffs had provided
depositions and before any substantive depositions could be taken from
any of the Lilly defendants.
And the first batch out of court settlements did nothing to deter the
off-label sales of Zyprexa. According to Lilly's SEC filings, sales in
the second quarter of 2006 totaled $1.12 billion, or a 2% increase over
the second quarter of 2005.
In addition, Dr Egilman was aware that the company was getting ready to
settle with about 18,000 more Zyprexa victims, and that the second
round of settlements would guarantee that the secret documents would
And as a condition of settlement, the 28,000 plaintiffs had to sign
agreements promising never to discuss the charges made against the
company related to Zyprexa.
According to several plaintiffs who settled out of court, they we were
not aware that there were documents that showed in many instances that
Lilly knew full well that the injuries suffered could occur and had
intentionally concealed the information from doctors and patients
because it would have had a negative impact on Zyprexa sales.
In fact, these plaintiffs said they were never told that these secret
documents even existed much less that by signing settlement agreements
they would be allowing more patients to be injured or killed because
the documents would remain sealed.
They also said that they were completely surprised to learn that their
attorneys had access to documents that could have been presented to a
jury to prove that the allegations in their lawsuits were true when the
media began reporting the story in December 2006.
For instance, a November 12, 1999, letter from a Dr Albert Marrero, to
Lilly's medical director, described the blood sugar problems occurring
in patients. "We have had eight patients out of possibly thirty-five
patients on Zyprexa show up with high blood sugars," he stated.
Dr Marrero also told Lilly: "Two patients had to be hospitalized due to
out of control diabetes....We have certainly never seen this with
Haldol, Navane, Risperdal and others to this extent," he wrote.
A November 1999 report showed that after examining 70 clinical trials,
Lilly found that 16% of patients on Zyprexa for a year had gained over
66 pounds but instead of informing doctors of this information, the
company used data from a smaller group of trials to say about 30% of
patients gained only 22 pounds.
Another document showed that in 2000, after a group of diabetes doctors
retained by Lilly substantiated the diabetes risk, a Lilly manager
stated in an email, "unless we come clean on this, it could get much
more serious than we might anticipate."
A email dated two years later in March 2002, shows that Lilly shot down
a plan to provide doctors with information about diabetes, because it
would draw too much attention the risk. "Although M.D.'s like
objective, educational materials, having our reps provide some with
diabetes would further build its association to Zyprexa," the email
Although the documents clearly show that Lilly had knowledge of these
life-threatening health risks in 1999, it did not add a warning about
blood sugar levels and diabetes to the Zyprexa label until the FDA
forced it to in the fall of 2003. In fact, Japan and the UK issued
warnings about the increased risk of diabetes in 2002.
According to Ellen Liversridge, whose son took Zyprexa and gained 100
pounds before he fell into a coma and died of profound hyperglycemia in
2002, "both the FDA and Lilly fought putting a warning on the label,
until articles on the front pages of the New York Times, Baltimore Sun,
and Wall Street Journal so embarrassed the FDA that they finally gave
in to adding the warnings."
But even then she says, the FDA required the same warning on the labels
of all atypical drugs, "when Zyprexa was associated with a 37% higher
increase in the risk of diabetes when compared to other medications."
However, the secret documents show that Lilly was hard at work behind
the scenes to make sure that the new warnings would have minimal
effects on Zyprexa sales. A July 7, 2003, memo titled, "Diabetes
Update," described a plan to protect doctors who were afraid of being
sued for prescribing Zyprexa after the news of the diabetes risk became
public that would indemnify doctors who continued to prescribe drug
"We must embrace the fact that many physicians are curtailing their use
of Zyprexa (particularly in the moderately-ill patient and in the
maintenance phase)," the Update said,
"solely on the basis of personal fear (of being sued)."
"Indemnification represents the most meaningful demonstration of
confidence in Zyprexa--both with our customers and with our employees,"
The memo also discussed a plan to pay millions of dollars to the
National Alliance on Mental Illness, the most notorious industry backed
front group in the nation, to help downplay the news about the diabetes
The public health crisis created by patients who developed diabetes as
a result of using Zyprexa is real. A Medicaid fraud lawsuit filed
against Lilly by the attorney general of Mississippi in July 2006,
alleges that about 10% of patients who used Zyprexa in that state have
developed insulin-dependent diabetes and some are children, the
When forced to make a decision on whether to warn the public about
Zyprexa or abide by a court order that could result in the death and
injury of thousands upon thousands of more people, Dr Egilman obviously
followed the natural instinct of any decent human being and gave up the
Whether or not he actually realized what consequences he might face is
anyone's guess, but he no doubt recognizes the consequences of crossing
the drug giant today.
On September 7, 2007, Lilly issued a press release with the headline:
"Egilman Admits Wrongdoing in Illegally Releasing Documents to New York
Times and Resolves Case to Avoid Possible Civil and Criminal
The release said that Dr Egilman will pay $100,000, and in return, the
company "agreed to forego seeking criminal and civil penalties against
Dr. Egilman for his illegal activities."
Although it will be interesting to see how many "Good Samaritans" will
stick their neck out for the common good after hearing about Dr
Egilman's fate, it is apparently still easy to find doctors willing to
prescribe Zyprexa off-label because SEC filings show Lilly earned $4.36
billion from the drug in 2006
With all that said, on September 6, 2007, it was certainly a Deja Vue
moment when the judge in Mr Gottstein's latest case against forced
drugging in Alaska, issued an order to have the court hearing and file
closed, even though the client had elected to have it open.
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