Eli
Lilly: The Habitual Offender
By Evelyn Pringle
27 January, 2007
Countercurrents.org
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.
After 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.
"There is ample scientific
evidence that Evista poses risks of ovarian cancer," said Dr Samuel
Epstein, MD, Chairman of the Prevention Coalition.
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.
"Lilly's own study,"
Dr Epstein wrote, "found that the drug was shown to induce ovarian
cancer in rats and, at doses well below the therapeutic, in mice."
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.
He 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."
Also in 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 disease.
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 lawsuit.
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 practices.
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 legendary.
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 magazine noted.
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."
"There 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.
Congressman 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.
After 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.
An 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."
Yet 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)."
The 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.
Throughout 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 press.
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."
A 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.
The secret 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.
In the latest development
in the Zyprexa saga, last week Illinois and Vermont joined a coordinated
five-state investigation of Lilly's marketing practices.
"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 an investigative
journalist. She can be reached at: [email protected]
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