FDA

Former FDA Deputy Commissioner Gottlieb Now Pushing Big Pharma Drugs

Wednesday, July 23, 2008 by: David Gutierrez, staff writer
Tags: Scott Gottlieb, health news, Natural News

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(NaturalNews) Scott Gottlieb, the former FDA Deputy Commissioner for medical and scientific affairs, is now actively involved in the marketing of Eli Lilly's drug raloxifene, marketed as Evista.

Due to his Wall Street connections with the pharmaceutical industry, Gottlieb frequently had to recuse himself from discussions that were part of his FDA duties. He gained notoriety for calling the early termination of a multiple sclerosis drug study "an overreaction," even though three participants had died, and was highly critical of the groundbreaking Women's Health Initiative study, which found that hormone replacement therapy posed more risks than benefits to women's health.

In 2005, Eli Lilly was convicted of illegally marketing osteoporosis drug Evista for off-label treatment and prevention of heart disease and cancer. According to Justice Department documents, Eli Lilly decided to market the drug off-label when early sales of the drug for osteoporosis alone proved disappointing.

Now Gottlieb has accused the government of unfairly penalizing Eli Lilly, with potentially "fatal" consequences for patients, because new studies have led the FDA to approve Evista for use in preventing breast cancer. Eli Lilly's illegal, off-label marketing was, in fact, a "public service," Gottlieb says.

But like the related treatment of hormone replacement therapy, Evista has come under fire for posing unacceptable risks to women's health. Like hormone replacement therapy, Evista increases the risk of fatal blood clots, including "venous thromboembolism and death from stroke," according to the product's warning label. In tests on mice and rats, doses of Evista lower than those regularly prescribed were observed to induce ovarian cancer.

Evista acts on the body's estrogen receptors to selectively inhibit and increase estrogen-like activity in various parts of the body.

According to the Women's Health Initiative study, hormone replacement therapy leads to a 26 percent higher risk of breast cancer, a 29 percent higher risk of heart attack, a 41 percent higher risk of stroke and a 100 percent higher risk of blood clots.

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