Subject(s): Dept of Justice DoJ Crimes, Drug Companies, Marketing, Drugs Prescription, FDA, Health Care Costs, Health Care Liability, OpEdNews, Press Release
Local Area(s): Australia, Canada, New Zealand, US Midwest, US northeast, US Northwest, US South, US Southeast, Washington D.C.
The revelations that Eli
Lilly concealed the side effects of Zyprexa and promoted the drug for
unapproved uses is not newly discovered misconduct. It is a persistent
pattern of conduct indicative of a nasty habit that needs breaking.
the secret company documents were leaked to the press last month by
attorney, Jim Gottstein, the focus has been on Zyprexa; but a year ago
it was Evista, and before that it was Prozac.
In the case of
Evista, approved for treating post-menopausal women with osteoporosis,
Lilly concealed data that showed an increased risk of cancer. On
October 24, 2002, the Cancer Prevention Coalition issued a press
release that said Lilly suppressed evidence that women taking the drug
were at an increased risk of developing ovarian cancer.
is ample scientific evidence that Evista poses risks of ovarian
cancer," said Dr Samuel Epstein, MD, Chairman of the Prevention
The data revealed "an 8 percent increased incidence
of ovarian cancer in white females over 65, those most likely to be
treated with Evista, from 1997 to 1999," he said.
study," Dr Epstein wrote, "found that the drug was shown to induce
ovarian cancer in rats and, at doses well below the therapeutic, in
He noted, "the strong scientific consensus that the
induction of cancer in well-designed studies in two species creates the
strong presumption of human risk."
Dr Epstein also cited a 2001
study by the University of Southern California that found Evista
increases the growth rate of ovarian cancer cells in laboratory
studies, and may increase risks of recurrence of ovarian cancer.
called Lilly's suppression of its own evidence "reckless and
threatening to women's health and life," and the FDA's approval of
Evista without the cancer warning "equally reckless."
2002, the US Department of Justice began looking at Lilly's off-label
marketing of Evista, and in March 2004, the US Attorney's office in
Pennsylvania announced it was investigating the company's marketing
practices for Evista, Zyprexa and Prozac.
The DOJ's three-year
investigation found that Lilly illegally marketed Evista for the
prevention of breast cancer and heart disease. The DOJ noted that sales
reps sent letters to doctors to promote unapproved uses and that Lilly
produced a videotape in which the company claimed Evista was "the best
drug" for the prevention of osteoporosis, breast cancer and heart
In December, 2005, Lilly agreed to pay $36 million to
settle criminal and civil charges related to the illegal marketing of
Evista. The company paid a $6 million criminal fine, a $6 million
forfeiture to the federal government, and $24 million to settle a civil
Lilly's settlement agreement also included the
standard, but useless, permanent injunction and consent decree in which
Lilly agreed not to engage in illegal marketing and promotional
In the case of the antidepressant, Prozac, a
selective serotonin reuptake inhibitor (SSRI), Lilly's concealment of
the increased risk of suicide and violence associated with the drug is
FDA approved in 1988, Prozac was promoted off-label
for everything from shyness to eating disorders to low self esteem.
Within three years, annual sales of the drug were nearly $800 million.
Newsweek put a Prozac pill on its cover with a headline calling it a
breakthrough drug. Even healthy people were asking for Prozac, the
But with the massive off-label sales, so came
the less newsworthy adverse events. The reporting system for
prescription drugs in the US is called Medwatch. Within 10 years of
Prozac's arrival on the US market, there were 39,000 adverse events
submitted to Medwatch, a number said to represent only between 1% and
10% of the actual number.
"So, if we get 39,000 adverse event
reports about Prozac, the number of people who have actually suffered
such problems is estimated to be 100 times as many, or roughly four
million people," investigative journalist Robert Whitaker explained in
an interview for Street Spirit in August 2005.
"This makes Prozac," he said, "the most complained about drug in America, by far."
were more adverse event reports received about Prozac in its first two
years on the market than had been reported on the leading tricyclic
antidepressant in 20 years," he added.
On December 18, 2003,
Lilly sent letters to healthcare professionals in the UK, saying that
Prozac was not recommended for children for any use, but issued no
warning to doctors in the US.
In a situation similar to the
Zyprexa document case, a couple years ago, the British Medical Journal
received a series of internal Lilly documents and studies on Prozac
from an anonymous source. The BMJ sent the documents to authorities,
including US Congressman Maurice Hinchey and the FDA.
Hinchey sent the materials to psychiatrist, Dr Peter Breggin, author of
Talking Back to Prozac, and The Anti-Depressant Fact Book, who reviewed
the documents and issued a January 12, 2005 report.
examining the documents, Dr Breggin confirmed their authenticity as
those that he had evaluated in the early 1990s when he served as an
expert for the combined Multi-District Litigation concerning Prozac. He
in fact testified about the documents during a trial in 1994 after
which, he says, they seemed to just disappear.
One group of
documents he examined, contained a study by the FDA on the increased
post marketing reports of "hostility" and "intentional injury" by
patients on Prozac. For this study, the FDA compared patients using the
antidepressant, trazodone, with Prozac patients, and found a 24-fold
relative increase of reports of hostility and intentional injury per
prescription of Prozac compared to trazodone.
The documents Dr
Breggin reviewed also contained graphs showing a 40-fold relative
increase in reports of suicide attempts, overdose, and psychotic
depression in patients on Prozac compared to patients on trazodone.
August 6, 1989, Lilly document says that doctors should be warned that
Prozac patients were at a higher risk of suicide unless they receive a
sedative, stating: "The counterindication because of acute suicidality
should become a warning whereby the physicians should be advised that
in the absence of sedation, the risk of higher suicidality should be
taken into account."
A June 13, 1990, letter to Lilly from a
concerned doctor states: "There appears to be growing concern that
Prozac may somehow trigger a suicidal preoccupation in a small subset
of patients and that their families should be warned of this potential
risk. It is certainly possible that some of the cases reported are
"coincidence" in that the depressed person may have attempted suicide
independently of Prozac. However, some of these cases appear to be in
patients taking Prozac for reasons other than depression."
two months later, on August 31, 1990, Lilly sent out a Dear Doctor
letter assuring health care professionals that there is no "causal
relationship between Prozac and suicidality (ideation or acts)."
hidden Prozac documents have come back to haunt Lilly. On January 14,
2005, a class action lawsuit was filed in Canada with claims that Lilly
withheld information on the safety of Prozac. The plaintiffs contend
that the reason Lilly failed to disclose the documents was because they
showed a drastic increases in suicide attempts and other violent acts
in patient using Prozac when compared to four other drugs.
the 1990s, while swearing publicly that Prozac did not increase the
risk of suicide or violence, Lilly quietly settled lawsuits out of
court and was able to keep the incriminating evidence hidden by
obtaining court orders to seal the documents, just as it had been doing
with Zyprexa until the latest batch of documents was leaked to the
Since the FDA was placed on permanent vacation when
George W Bush took up residence in the White House, these days
litigation appears to be about the only means available for unearthing
hidden studies that show a drug's adverse effects.
In the case
of Zyprexa, Lilly has so far settled with an estimated 26,000
plaintiffs, at a cost of over $1 billion. The incriminating documents
leaked to the press last month, came to light during litigation with
these plaintiffs but even after the litigation was settled, they were
kept under seal with a court order.
Since the documents were
made public, Lilly's legal team has spent about every other day in
court trying to silence the messengers, Dr David Egilman and Jim
Gottstein, and get the incriminating evidence back under seal, albeit
without much success.
In a January 15, 2007, legal filing, a
Lilly attorney quotes a comment by Judge Brian Cogan in a previous
court hearing who said, Mr Gottstein had "deliberately and knowingly
aided and abetted Dr. David Egilman's breach of CMO-3."
responsive filing from Mr Gottstein should say that by issuing a
protective order to suppress these documents to begin with, the court
deliberately and knowingly aided and abetted Lilly in the off-label
sale of Zyprexa by concealing the drug's side effects from tens of
millions of consumers and prescribing physicians.
documents show that Lilly concealed information about Zyprexa's link to
severe weight gain, high blood sugar, and diabetes for a decade and
because Lilly promoted Zyprexa off-label for so many uses, more than 20
million people have taken the drug. It is Lilly's best-selling product,
with sales of about $30 billion since its arrival on the market in
1996, according to the January 20, 2007, New York Times.
the latest development in the Zyprexa saga, last week Illinois and
Vermont joined a coordinated five-state investigation of Lilly's
"The states are investigating whether
Lilly tried to hide Zyprexa's risk of causing weight gain and other
risks associated with diabetes and whether the company promoted Zyprexa
for use in patients who do not have schizophrenia or bipolar disorder,"
the Times reports.
The larger question would seem to be, were
the roughly 26,000 plaintiffs who entered into out-of-court settlements
aware of the contents of the hidden documents and did they understand
that by settling out of court Lilly would be permitted to keep the
information secret knowing full well that more victims would be injured
or killed by Zyprexa?
Information for injured parties can be found at Lawyers and Settlements.com
Evelyn Pringle is a columnist for OpEd
News and investigative journalist focused on exposing corruption in
government and corporate America.
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