December 26, 2007
From Wall Street to the FDA to Off-Label Drug Huckster for
Lilly.
The Strange Career of Scott Gottlieb
By MARTHA ROSENBERG
http://www.counterpunch.org/rosenberg12262007.html
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