FacebookTwitterGoogle+RedditEmail

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

 

 

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

May 05, 2016
David L. Glotzer
Welcome to Fortified Europe: the Militarization of Europe’s Borders
Adam Szetela
Beyoncé’s “Formation” and the Boutique Activism of the Left
Bruce Lerro
Lost at Sea: Left Liberals Have No Party
Paul Cochrane
Hot Air in the Saudi Desert: a Kingdom in Descent?
Brian Terrell
My Visit to a Las Vegas Jail
Judith Deutsch
The Military’s “Securitization” of Climate Change
Phyllis Bennis
Kunduz Bombing: Proof the Pentagon Should Not Be Allowed to Investigate Itself for War Crimes
Chad Nelson
When Compassion is Terrorism: Animal Rights in a Post-911 World
Dan Arel
Making Sanders’ Dream a Reality Through Political Activism
Kent Paterson
Ten Years Later: Reflections on the Legacies of Immigrant Spring
Serge Halimi
Why Firefighters are Against Free Trade
Andrew Stewart
Green Bernie or Green Party Machine?
Binoy Kampmark
Yuri Gagarin in Space: the Politics of Cosmic Discovery
Hayes Rowan
This Naming of Things
May 04, 2016
Kshama Sawant
It’s Not About Bernie: Why We Can’t Let Our Revolution Die in Philadelphia
Conn Hallinan
Baiting the Bear: Russia and NATO
Joshua Frank
Hanford’s Leaky Nuke Tanks and Sick Workers, A Never-Ending Saga
Paul Craig Roberts
TIPP: Advancing American Imperialism
Ted Rall
Hillary to Bernie Supporters: Don’t Vote for Me!
Eric Draitser
Hillary Clinton and Wall Street’s Neoliberal War on Latin America
Leslie Scott
The Story of Jill Stein: Putting People, Peace and the Planet Before Profits
Ann Garrison
Building the Greens Into a Mass Party: Interview with Bruce Dixon
Tom Clifford
Crying Rape: Trump’s China-Bashing
Lawrence Davidson
Getting Rid of Bad Examples: Andrew Jackson & Woodrow Wilson
Ellen Brown
Bank of North Dakota Soars Despite Oil Bust: A Blueprint for California?
Nelson Valdes
Is Fidel Castro Outside or Part of Mainstream Thinking? A Selection of Quotes
Jesse Jackson
Don’t Send Flint Down the Drain: Fix It!
Nathan Riley
Help Bernie Keep His Halo
Rivera Sun
Remembering Nonviolent History: Freedom Rides
Clancy Sigal
Rachel and the Isolationists: How Maddow Blew It
Laura Finley
Changing the Conversation About “The Woman Card”
CJ Hopkins
Coming this Summer … Revenge of the Bride of Sophie’s Choice
May 03, 2016
Gary Leupp
Hillary Clinton’s Foreign Policy Resumé: What the Record Shows
Michèle Brand – Arun Gupta
What is the “Nuit Debout”?
Chuck Churchill
The Failures of Capitalism, Donald Trump and Right Wing Terror
Dave Marsh
Bernie and the Greens
John Wight
Zionism Should be on Trial, Not Ken Livingstone
Rev. John Dear
A Dweller in Peace: the Life and Times of Daniel Berrigan
Patrick Cockburn
Saudi Arabia’s Great Leap Forward: What Would Mao Think?
Doug Johnson Hatlem
Electoral Votes Matter: Hillary Clinton or Bernie Sanders vs Donald Trump
Chris Gilbert
Venezuela Today: This Must Be Progress
Pepe Escobar
The Calm Before the Coming Global Storm
Ruth Fowler
Intersecting with the Identity Police (Or Why I Stopped Writing Op-Eds)
Victor Lasa
The Battle Rages on in Spain: the Country Prepares for Repeat Elections in June
Jack Rasmus
Is the US Economy Heading for Recession?
FacebookTwitterGoogle+RedditEmail