In October, the FDA told Lilly to stop falsely claiming antidepressant Cymbalta produced "significantly less pain interference with overall functioning" and start mentioning its side effect of liver toxicity.
And documents from its Viva Zyprexa campaign show Lilly marketed the atypical antipsychotic for off label use among elderly patients though an increased risk of death in older patients is a warning on its own label.
Nor is Evista a misunderstood wonder drug.
Launched in 1998 to disappointing results, Justice Department documents reveal Lilly brand managers decided to market off label uses for Evista to boost sales.
And when 20 million women quit HRT in the early 2000's, marketing Evista (raloxifene), a selective estrogen receptor modulator (SERM), as a kind of anti estrogen or good estrogen made sense.
Like HRT, researchers hinted Evista was an all purpose, youth giving drug, not just preventing and treating osteoporosis but reducing the risk of some types of breast cancer and heart attack, stroke or other cardiovascular problems in at risk patients.
Dr. Elizabeth Barrett-Connor, head of epidemiology at the University of California, San Diego called a 2002 Evista study, "exciting because it offers new hope in treating heart disease, the biggest killer of women, while at the same time strengthening their bones."
Barrett-Connor also assured the public that hormone therapy had "no significant effect on the risk for stroke among postmenopausal women with coronary disease" in an article in the American Heart Association's journal, Circulation, in 2001, paid for by hormone maker Wyeth-Ayerst Research.
Unfortunately, Evista is a little too much like HRT, which, contrary to what appeared in Circulation, causes a 26 percent increased risk of breast cancer, 29 percent increased risk of heart attack, 41 percent increased risk of stroke, and 100 percent increased risk of blood clots according to WHI figures.
Not only does Evista cause lethal blood clots--its warning label says "Increased risk of Venous Thromboembolism and Death From Stroke"--it increases the risk of ovarian cancer say some clinicians.
"Evista induces ovarian cancer in both mice and rats," wrote Dr. Samuel S. Epstein, professor of environmental medicine at the University of Illinois School of Public Health in the Chicago Tribune in 1998. "Furthermore, carcinogenic effects were noted at dosages well below the recommended therapeutic level."
In 2001 scientists at the University of Southern California also found Evista stimulated the growth of ovarian cancer cells.
"In breast and uterine cancer it does not appear to be a problem; in ovarian cancer it may stimulate the cells," said Dr. Richard Paulson, a professor of obstetrics and gynecology referring to laboratory studies.
Evista advertising is also like HRT, relying on ageism, sexism and fear-mongering to sell product with the patronizing tag line, Protect Her Bones Protect Her Breasts, and a female model symbolically covering her breasts with her arms.
No, off label marketing of Evista is not a public service. But Gottlieb's departure from the FDA might be.
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