Zyprexa
Judge Decides
Which Journalists Have
First Amendment Rights
By Evelyn Pringle
17 January, 2007
Countercurrents.org
The
judge issuing injunctions in the Eli Lilly-Zyprexa-Documents case has
decided that reporters at the New York Times enjoy the full protection
of the First Amendment but that other reporters and media outlets do
not.
The secret documents at the
center of this hailstorm were provided to the New York Times, and several
other journalists, by the same source. The Times took the lead and ran
a series of articles quoting the documents, and an editorial calling
for a Congressional investigation of Eli Lilly.
On December 29, 2006, Lilly
obtained a temporary injunction ordering a list of people, including
many authors and journalists, to return the documents and not disseminate
them further which included Terrie Gottstein, Jerry Winchester, Dr Peter
Breggin, Dr Grace Jackson, Dr David Cohen, Bruce Whittington, Dr Stefan
Kruszewski, Laura Ziegler, Judi Chamberlin, Vera Sherav, Robert Whitaker,
and Will Hall.
At a January 3, 2007, even
though he was not asked to, Judge Weinstein announced that he was not
going to issue an injunction against the Times and specifically stated:
"The court takes no
position on whether and how they can be used by others who received
them from other sources. After all, the New York Times has disseminated
them. This court is not going to issue an order telling the New York
Times to return the documents. So everybody has access to them."
However, following a few
weak arguments by Lilly attorneys during the hearing, the court extended
the injunction, not to cover the Times, but to include the Wiki internet
web site, Eric Whalen's web site, the Alliance for Human Research Protection
web sites, and the MindFreedom web site.
The Times still has the documents
which are now off-limits to other all the journalists, and notably,
Lilly has not even bothered to ask the court to order the Times to return
them or not disseminate them further.
For its part, when the Times
first broke the story, and Lilly started publicly mouthing off about
obtaining injunctions to get the documents back, the Times basically
said that it would not return them. “Our customary practice is
to retain documents which we legitimately required during our news gathering
process and which are likely to be relevant to future reporting,”
said Times attorney, George Freeman, in a Times article on December
20, 2006.
There are certainly no gripes
against the Times itself because the information in the documents probably
would have remained hidden forever had it not been for the Times. But
a judge and a corporate giant can not decide that a reporter at the
Times will be afforded more freedoms than any other reporter in this
county.
The decision to allow one
newspaper to publish important information and not others, should have
all journalists enraged. Lilly's ability to get a court to issue an
injunction against any journalist at the drop of a hat should be troubling
to all members of the media.
Freedom of the press can
not be based on the size of a publication or its readership, or in the
case of the Times in this instance, the recognition of the power and
availability of funds of a newspaper to rise up and fight against a
violation of that right.
Last month, the Times reported
that the documents show Lilly concealed the side effects of Zyprexa,
specifically weight gain and diabetes, because the company knew the
information would have a negative effect on sales, and also that Lilly
directed its sales representatives to encourage doctors to prescribe
Zyprexa off-label to patients who were not schizophrenic or bipolar.
The documents quoted by the
Times were designated as confidential pursuant to Case Management Order
3, a Protective Order entered on August 9, 2004, which gave Lilly the
right to designate documents confidential, so long as Lilly in good
faith believed that they were. Legal experts now contend that the information
quoted by the Times was never entitled to protection.
Several persons listed in
the injunction have obtained attorneys to fight for the public's right
to know what's in the documents. Attorneys representing interested parties
include, Lilly attorney, Sean Fahey, of Pepper Hamilton LLP; Ted Chabasinski,
on behalf of Judi Chamberlin and MindFreedom; John McKay, represents
Jim and Terrie Gottstein; and Alan Milstein appears on behalf of Ms
Sharav, the AHRP, and Dr Cohen.
On January 9, 2007, attorney,
Fred von Lohmann, of the Electronic Frontier Foundation, jumped in the
ring by filing a motion on behalf of John Doe, a citizen-journalist
who contributes to the Wiki web site, to object to the injunction that
names Wiki.
A January 8, 2007, brief
filed by Lilly states: "The materials at issue here are subject
to a valid protective order under Rule 26(c)(7) for trade secrets and
other confidential information, and thus irreparable harm will result
in the absence of an injunction."
The brief also cites a case
that says, "It is well settled law that the harm caused by loss
of trade secrets cannot be measured in monetary damages."
The conduct revealed by the
Times could not possibly constitute protected trade secrets by any stretch
of the imagination. Since when did teaching sales reps how to convince
doctors to prescribe drugs off-label, for uses never intended, become
a trade secret?
And since when is it a trade
secret for a company to conceal the lethal side effects of a drug for
10 years, knowing full well that millions of people are at risk of being
injured or killed?
What "irreparable harm"
could come to Lilly that would justify allowing even one more person
to take Zyprexa without full knowledge of the health risks linked to
the drug?
Granted, the loss of what
Lilly is trying to claim are "trade secrets" might lead to
monetary damages, as it well knows. So far, to keep these "trade
secrets" buried during the first 2 rounds of litigation, the company
agreed to fork out more than $1 billion to Zyprexa victims who were
willing to sign gag orders and remain silent, but thousands more are
waiting in the wings for the start of round three.
When reviewing the court's
broad injunctions, it is impossible to figure out what happened to Judge
Weinstein since he wrote the book, Individual Justice in Mass Tort Litigation
(2005), in which he could have been discussing the Lilly-Zyprexa-Document
saga when he stated:
"A publicly maintained
legal system ought not protect those who engage in misconduct, conceal
the cause of injury from the victims, or render potential victims vulnerable.
Moreover, such secrecy defeats the deterrent function of the justice
system."
The doctors listed in the injunction have all authored books, studies,
or papers in many different publications on issues related to the information
revealed in the Lilly documents. The chilling effect of the court's
orders is most obvious as it applies to these doctors.
In addition to their own
journalistic writings, they have been quoted as experts by this author,
and many others, in countless articles related to psychiatric drugs
long before the new Lilly documents surfaced, yet they are now barred
from discussing anything about the secret documents with this journalist
or anyone else.
Dr Cohen is the author or
co-author of over fifty articles in publications such as the American
Journal of Psychiatry, Ethical Human Sciences and Services, and the
Encyclopedia of Psychology, as well as twelve books and monographs.
Getting the court to muzzle
Dr Kruszewski was a major victory for Lilly. He is on record telling
this author early last year that Zyprexa increased the risk of obesity,
diabetes type II, hypertension, heart attacks and stroke, "at the
same time that it continues to cause neurological side-effects like
the older antipsychotics."
And furthermore, he is quoted
as saying Lilly knew about these health risks for years and failed to
warn the public, in articles published months before the new documents
emerged to validate his assertions.
Dr Jackson, author of, Rethinking
Psychiatric Drugs, is definitely not on Lilly's Xmas card list either.
In addition to the book and papers she has written, in 2003, she reviewed
documents obtained under the FOIA, regarding to the FDA's approval of
Zyprexa, and provided written and oral testimony under oath in a lawsuit
about the statistical manipulation used by Lilly when obtaining FDA
approval for the drug.
Ms Chamberlin has been an
author, lecturer, and activist in the field of patients' rights for
many years, and sits on the board of MindFreedom International, a coalition
of about 100 advocacy groups in 13 countries that provides the public
with information on all the latest safety issues and legal developments
as they relate to psychiatric drugs.
Investigative journalist
and author of, Mad in America, Robert Whitaker, likely holds the number
one spot on Lilly's hit list of despised journalists. Lilly's legal
team is probably still celebrating the victory of getting his name added
to the injunction.
The lack of friendship between
Bob and Lilly dates back to November 1998, when he wrote a series titled
"Doing Harm: Research on the mentally ill," that was published
on the front page of the Boston Globe, and reported that in pre-marketing
clinical trials, Zyprexa was linked to life-threatening adverse effects
in 22% of the adult patients tested.
Mr Whitatker has been investigating
and reporting on Lilly and Zyprexa more persistently than any other
journalist. In 2005, he used the FOIA to obtain FDA data and reported
that Zyprexa's adverse effects included cardiac abnormalities and hypotension;
Parkinson-like motor impairment; unbearable restlessness (akathisia);
and acute weight gain (50%) that increased the risk of diabetes, or
basically the same information revealed in the leaked documents.
Vera Sharav, president of
the Alliance for Human Research Protection, and Lilly are not the best
of buddies either. She has reported extensively on all issues related
to Lilly and Zyprexa as they have developed over the past several years.
In fact, the AHRP sends out
daily Infomails on the internet that provide all the up-to-date information
on drug safety and legal issues to advocacy groups, members of the scientific
community, public officials, the media, medical journal editors, and
attorneys.
In addition, Ms Sharav has
authored articles appearing in Ethical Human Psychology and Psychiatry,
Journal of Disability Policy Studies, and American Journal of Bioethics.
And last but not least, there
is Dr Breggin, the author of countless books on psychiatric drugs, who
represents a nightmare in broad daylight to every corrupt pharmaceutical
company on earth. Dr Breggin makes a habit of exposing drug makers that
conceal dangerous side effects of psychiatric drugs which in Lilly's
case, not only includes Zyprexa but Prozac as well.
Its not too difficult to
figure out why Lilly does not want these incriminating secret documents
to be added to the collection that this group of authors has managed
to gather on its own over the years, whether it be through litigation
or by use of the FOIA.
There is a full hearing set
for 2:00 pm on January 16, 2007, for all the attorneys to argue for
and against the injunction. Hopefully, one of the attorneys will bring
up the fact that allowing Lilly to keep these documents secret for all
these years, while the company agreed to pay out over a billion dollars
in out-of-court settlements, has done nothing to curb the off-label
marketing of Zyprexa.
As a vivid example of Lilly's
off-label promotion efforts revealed in the documents, in one article
last month the Times quoted an August 2001, email from a doctor that
was sent to both Lilly and the FDA, complaining about an off-label presentation
made by a Lilly sales representative.
The doctor said the sales
rep “presented an elderly female patient who was presented to
her physician by her family complaining of insomnia, agitation, slight
confusion, and had no physical finding to explain her state."
The doctor said the sales
rep then suggested that Zyprexa might be prescribed for this patient
and he went on to describe his interaction with the sales rep in the
email stating:
“I inquired what Zyprexa
was indicated for she then indicated that many physicians might prescribe
an antipsychotic for this patient. I then asked for her package insert
and read to her that her product was indicated for schizophrenia and
bipolar mania — neither of which the presented patient had been
diagnosed with."
The truth is, the off-label
marketing schemes discussed in the documents have been so successful
that a medication, approved only for an extremely limited population
of adults with two types of mental illness, has magically transformed
into a best selling blockbuster.
If Lilly had stopped promoting
the off-label use of Zyprexa, by now declining sales figures would be
showing up in the company's earnings reports, because there has been
no epidemic of mental illness to account for the massive number of prescriptions
still being written.
But there has been no decline
in sales. In fact, according to SEC filings, for the third quarter of
2006, Zyprexa sales overall totaled $1.085 billion, a 5% increase over
the same quarter in 2005. In the US, the filings state, sales increased
3%, to $519 million, and prescription volume held steady during the
first nine months of 2006.
[email protected]
(Evelyn Pringle is a columnist
for OpEd News and an investigative journalist focused on exposing corruption
in government and corporate America)
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