On Tuesday,
Judge Jack Weinstein of the United States District Court for the Eastern
District of New York issued a permanent injunction prohibiting attorney Jim
Gottstein and Dr. David Egilman, an expert witness in litigation involving
Zyprexa, from further disseminating certain Eli Lilly documents that were
sealed with a court order until Mr. Gottstein released them to the media in
December 2006.
After reviewing the documents as a plaintiff�s expert in the
underlying Zyprexa litigation, Dr. Egilman became so alarmed over what he found
that, as a physician, he believed he had an obligation to find a way to make
the information public.
In an effort to get the documents out from under the court
order, attorney Gottstein subpoenaed Dr. Egilman for a deposition in a lawsuit
unrelated to the Zyprexa case and asked him to send the documents for review
ahead of the actual deposition date.
As soon as Mr. Gottstein received the documents he provided
copies to reporter Alex Berenson at the New York Times, along with a number of
other journalists and patient rights activists and groups.
Mr. Gottstein argues that the public has a right to know the
truth about the risks associated with the drug. �The files show that the
manufacturer hid vital information about the drug�s safety,� he states, �not
only from patients, but also from doctors.�
�Zyprexa has killed
and permanently sickened thousands of people who have taken it,� he says.
Mr. Gottstein openly admits that he wanted to get the
information out to save lives. �The bottom line is patient safety,� he said.
The documents quoted by Mr. Berenson, in articles for the
Times, showed that Lilly had concealed Zyprexa�s links to weight gain, high
blood sugar, and diabetes for a decade.
The documents also reveal that Lilly trained its sales
representatives to increase prescriptions for Zyprexa by influencing doctors to
prescribe it for off-label conditions, and with patient populations such as
children for uses that have never been tested or approved by FDA.
Zyprexa is an antipsychotic approved for the limited use of
treating adults diagnosed with schizophrenia or bipolar disorder, and yet it is
currently Lilly�s number one selling product with sales over $4 billion last
year; some 20 million people have taken the drug.
To date, Lilly has paid about $1.2 billion to settle roughly
28,000 lawsuits out of court, filed on behalf of persons who were injured or
died after taking Zyprexa. However, another batch of plaintiffs is already
lined up for the next round of litigation.
A secret document not cited in the Times, shows exactly what
was going on behind the scenes to prevent a freefall in Zyprexa sales when
Lilly knew for sure that the FDA was going to order a black box warning on
Zyprexa about diabetes and the American Diabetes was also ready to release a
statement on the issue.
A July 7, 2003, Lilly memo titled, �Diabetes Update,� said
that a way to get doctors to keep prescribing Zyprexa when news of the diabetes
risk did come out was to legally indemnify doctors who prescribed it. �Indemnification
represents the most meaningful demonstration of confidence in Zyprexa -- both
with our customers and with our employees,� the memo stated.
�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 memo said, �solely
on the basis of personal fear [of being sued].�
In translation, that comment means doctors might curtail the
use of Zyprexa in patients who may not need it because they are no longer
psychotic, whereas Lilly tries to convince doctors to keep patients on Zyprexa
for life as a maintenance program.
Lilly apparently pulled this indemnifying stunt with doctors
when the truth about the risks of Prozac leaked out from documents also sealed
with a court order. �Our experience with Prozac,� the memo states, �confirms
the impact and goodwill of such an initiative.�
It�s not clear from the memo whether Lilly did in fact
indemnify doctors, because the memo states: �We are investigating the viability
of this action and are preparing a business case analysis for senior management�s
consideration--ASAP.�
However, the memo does make one thing clear: that Lilly knew
the plan was improper evidenced by a comment that the American Medical
Association considered indemnification an �inappropriate incentive� to doctors.
The memo also spoke of a plan to pay the National Alliance
on Mental Illness, the most notorious Big Pharma backed front group in the US,
millions of dollars to help downplay the news about diabetes and Zyprexa.
The memo said the plan was to �mobilize our allies� and
provide �NAMI a multimillion dollar grant to stage a national screening� to �help
educate physicians and patients on the inherent risks of diabetes -- regardless
of the antipsychotic.�
It�s also unclear here, whether NAMI did �stage� a national
screening or how much money the group was paid if it was paid.
It should be pointed out that there was not one peep in the
memo about lets hurry up and warn patients and doctors about the risk of
diabetes before more people are harmed; it was all about damage control because
Lilly knew that information about diabetes was about to become public, but
certainly through no fault of its own.
In announcing his ruling in favor of allowing Lilly to keep
the documents sealed, Judge Weinstein issued a 78-page opinion which states in
part: �Publication of the protected documents has already created irreparable
harm to Lilly by revealing its trade secrets, confidential preliminary
research, and merchandising techniques.�
This may be true. If the disclosure of these documents
prevents even one person from taking Zyprexa without knowing about the health
risks involved, the ends will justify the means, and Mr. Gottstein and Dr.
Egilman should be declared saints.
But the truth is that they probably will have saved many
lives, because on February 13, FDA scientist Dr. David Graham, the guy brave
enough to blow the whistle on Merck and Vioxx, testified at a US House of
Representatives Energy and Commerce Subcommittee hearing and said the off-label
use of antipsychotics like Zyprexa to sedate nursing home residents kills
roughly 15,000 people a year.
Dr. Graham also told members of the committee that Lilly and
the FDA had known �for a long time� that Zyprexa caused weight gain that can
lead to diabetes.
In addition, for the umpteenth time, Lilly�s conduct of
concealing side effects identified in its own research from doctors and
millions of consumers is not entitled to protection under the umbrella of �confidential
preliminary research� or �trade secret� or �merchandising techniques.�
Furthermore, engaging in illegal marketing schemes to promote
the sale of Zyprexa off-label to the elderly and children, does not qualify for
protection under �trade secret,� or �merchandising techniques.�
Judge Weinstein also said releasing the documents �has made
settlement of the remaining MDL and state cases and trials more difficult by
creating probable prejudice largely irrelevant to the issues posed by the
pending cases and by making impartial juror selection more difficult.�
This would be a wonderful outcome as well. The minds of
potential Zyprexa jurors will hardly be poisoned by the truth.
Besides, there is a reason why trials are public in this
country. Americans have a right and a need to know when giant corporations are
knowingly causing harm.
The judge also states that the release of the documents �may
have adversely affected prospective plaintiffs who may be less willing to sue
if their intimate medical problems can be revealed through violation of the
court�s protective orders.�
That statement at best is speculation and at worst plain BS.
In response to the many articles that I have written on this
topic, the only uniform complaint that I have received from past Zyprexa
plaintiffs is that they signed agreements without knowing that Lilly documents
produced in litigation proved that Lilly definitely knew about the risks of
weight gain, high blood sugar, and diabetes long before the FDA ordered the
black box warning.
And they each agreed on one other point. Each said they did
not know that by signing the agreement they might be helping Lilly to keep this
kind of information hidden from doctors and future Zyprexa patients.
Granted, concealing information with court orders that will
have a negative impact on sales has become a marketing technique for Lilly, but
it�s high time for the courts in this country to quit helping companies hide
evidence that shows people are being killed and injured, while they con injured
victims into settling their cases for peanuts while the executives of the
companies doling out the poison go to sleep at night counting their millions
instead of sheep.
Evelyn Pringle is a columnist for OpEd News and an
investigative journalist focusing on exposing corruption in
government. She can be reached at: evelyn.pringle@sbcglobal.net.