Disgraced FDA Official Goes Back to Big Pharma

As a 33-year-old Wall Street insider known for recommending hot medical stocks, physician Scott Gottlieb was a surprising choice for FDA deputy commissioner for medical and scientific affairs, an appointment named 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 the market, but a string of suicides and the violent death of Dallas musician Carter Albrecht in 2006 left 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 op-ed 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 that hormone replacement therapy (HRT) was bad 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.

In an angry December op-ed in the Wall Street Journal, Gottlieb wrote that since Evista has now been approved to reduce the risk of developing some breast cancers, 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 said, 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 that 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 for preventing and treating osteoporosis but also for reducing the risk of some types of breast cancer and heart attack, stroke or other cardiovascular problems in at risk patients.