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.
Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa".
Eli Lilly zyprexa cost me over $250.00 a month supply out of my own pocket X 4 years and has up to ten times the risk (over non users) of causing diabetes and severe weight gain.
Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how does Zyprexa get to be the 7th largest drug sale in the world?
Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.
The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 7 states (and counting) going after Lilly for fraud and restitution.
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Daniel Haszard www.zyprexa-victims.com
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Danny Haszard (1 articles, 0 quicklinks, 0 diaries, 50 comments)
on Thursday, January 25, 2007 at 2:12:52 PM
