Disgraced Former FDA Official Now Marketing Lilly Drug
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 after...drugs 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 nor 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.
