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From Wall Street to the FDA to Off-Label Drug Huckster for Lilly

The Strange Career of Scott Gottlieb

by MARTHA ROSENBERG

As a 33-year-old Wall Street insider known for recommending hot medical stocks, many were surprised when physician Scott Gottlieb was named FDA deputy commissioner for medical and scientific affairs in 2005.

"Gottlieb has an orientation which belies the goal of the FDA," said Dr. Jerome Kassirer, former editor of The New England Journal of Medicine.

"The appointment comes out of nowhere," said former FDA Commissioner Donald Kennedy.

"Anything but a reassuring signal," said Time magazine.

As critics feared, soon after assuming the number two FDA position, Gottlieb had to recuse himself from resource planning for a possible bird flu epidemic because of financial ties to Roche and Sanofi-Aventis. He also had to bow out of work related to Eli Lilly, Proctor & Gamble and five other drug companies.

When three people in a multiple sclerosis drug trial lost blood platelets and one died, he called stopping the study "an overreaction" because the disease not the drug might be to blame.

And when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year, underlings received accusatory emails from Gottlieb.

His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer’s stop smoking drug, varenicline, to market but a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht leave many asking if that was such a good thing.

"The truth is, the FDA’s required trials reveal limited information," Gottlieb wrote presciently in an oped in the Chicago Tribune in 2005. "In many cases, it is only afterdrugs are on the market for many years and given to thousands of patients that their true benefits (sic.) are revealed."

Gottlieb even trashed the definitive Women’s Health Initiative (WHI) study that found hormone replacement therapy (HRT) was bad not good for women’s health, saying the results "were rushed to print with a cleverly orchestrated PR blitz."

Now that he’s left the FDA, Gottlieb is helping sell Lilly’s osteoporosis drug Evista which the company was convicted in 2005 of marketing, off label, for anti cancer and heart disease purposes.

Since Evista has now been approved to reduce the risk of developing some breast cancers writes Gottlieb in an angry oped in the Wall Street Journal in December, doesn’t that transform Lilly’s "speech ‘crime,’ by some measures, into a public service?"

Penalizing Lilly’s off-label promotion of Evista may have proved "fatal" for "patients and doctors who rely on the latest clinical information to make hard decisions," Gottlieb says implying physicians are lost without input from drug reps with Bachelor of Science degrees.

But of course this is not the first time Lilly has had "free speech" problems.

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.

MARTHA ROSENBERG is staff cartoonist on the Evanston Roundtable. She can be reached at mrosenberg@evmark.org