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.
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 a cartoonist for the Evanston Roundtable in Evanston, Illinois.
Anytime my doctor tries to prescribe medicine I ask
1. have you read the research
2. who paid for the research
3. what were the parameters
If they can’t answer 1,2,3 my next question is how do you know it’s safe???
If all patients did it maybe the doctors would look more into it and demand more from the pharma salespeople
Corporate whores pimping themselves to political whores and being brought to you by the media whores. The D.C. good ole boy network has never been so sexually active in its whole life. Must be Viagra.
Hoa binh
And I thought Viagra would turn dysfunctional conservatives into liberals.
My doctor knows I do not trust the current FDA and don’t want to take any medication that hasn’t been in use for 10 to 20 years. Wherever possible he prescribes the oldest, safest generic available.
It’s been a while (pre-Bush) since any government agency, including the FDA, has been ALLOWED by the agency heads appointed by Bush to do its work as it should be done. Government “for the people” has been sabotaged by market fundamentalists who place profits and shareholder returns above every obligation to us citizens.
January 2009 still seems so far away.
Heck of a job Gotty!
BERNICE: Right on!
EZEFLYER: Was it Viagra or a rival “brand” that mentioned a potential more than 4 hour erection as a side effect. I’d just like to interview any woman who rode that horse that long? Any statistics from women on that?
Think of this as a delayed-reaction kickback. Take a kickback while in office, and there’s a 1% chance someone might investigate you. But arrange for the kickback and perks to take effect after you retire from public service, perhaps delayed by a year or two as law requires, and you’re good to go.
And then there’s medical marijuana. Natural, reduces pain and Bush is against it.
Did you hear about what Eli Lilly did to David Healy? In the following, Shafer points out how Eli Lilly acted in Cheney-like fashion to silence whistle-blowers (ie those who did the research for their drugs and found that the drug had - er - bad side-effects):
“Biomedical conflicts of interest: a defence of the sequestration thesis-learning from the cases of Nancy Olivieri and David Healy”
http://www.umanitoba.ca/centres/ethics/downloads/Biomedical_conflicts_of_interest.pdf
Here is another one which basically says that even when doctors think that they are not being influenced by the free gifts given to them by drug companies, they are:
“Doctors, drug companies, and gifts”
http://www.umanitoba.ca/centres/ethics/downloads/Doctors_drug_companies_gifts.pdf
Hey, there are some, like Cheney and Bush, who consider mutual backscratching legitimate government practice, but it seems that even those who would be shocked by how beholden Bush or Cheney are to big Pharma seem unwilling to accept how much they too have fallen under the spell.
Bernice, you have a smart doctor since adverse reactions to drugs tends to show up during the first 10 years after approval (even when there is an absence of a “file drawer effect” just the act of trying the drug out on a wider range of people reveals more bad reactions).
dlnelson7 says: If all patients did it maybe the doctors would look more into it and demand more from the pharma salespeople
Your points 1-3 are good. I would be wary of any doctor who gets all his information on new drugs from the pharma salespeople - even if their package includes a research article it is apt to be the one out of 20 which puts the drug they are peddling in the best light.
Scott Gottlieb: A physician I wouldn’t trust…..if my life depended on it.
I’ve been micromanaging my 86 yr old mother’s health care for years, including literally telling the doctors which drugs I wanted her on, which drugs I wanted discontinued, which to cut the dosage in half, etc… I’m convinced that if I’d just let the professional drug pushers have their way, she’d be gone long ago. My main source has been the book:
” Worst Pills, Best Pills” by Sydney Wolfe, MD and Public Citizen Health Foundation (one of Nader’s groups)
miftin, I don’t know if you are a better son or a better daughter than I am. May you enjoy each extra day.
Ken Mitchel, of course Bush is against Pot - he sees it as unfair competition for Eli Lily.
BTW - have you heard of Marc Emery - seems as if the rising loonie had affected the American demand for pot.
B.C. pot prices hit by rising loonie
Marc Emery, head of the B.C. Marijuana Party, said there are several factors behind the rising price of B.C.’s most infamous export, including tighter border security and the loonie’s steady ascent over the past five years. …
The well-known marijuana activist is currently fighting an extradition order by the U.S. Drug Enforcement Agency for allegedly selling millions of dollars worth of marijuana seeds to Americans through his mail order business.
http://www.cbc.ca/canada/british-columbia/story/2007/09/27/bc-budpricesup.html
Marc Emery on The Hour:
http://www.cbc.ca/thehour/video.php?id=713
Though I have no interest in using Pot, but I think that if left to our own devices (ie no American interference) Canadian law enforcement would be more focused on serious drugs such Crystal Meth.
But as devestating as Crystal Meth appear to be to a person - even over the short term - it poses less of a threat to Eli Lily than does pot. In fact, since some who come off Crystal Meth are so messed up - sometimes permenently (from what it says in the paper), they may be more likely to need use of Eli Lily’s products just to get by afterwards.
This is a poorly written, badly edited article. Note the misplaced quotation marks and typos. E.g., “Gottlieb even trashed the definitive Women’s Health Initiative (WHI) study that found hormone replacement therapy (HRT) was bad nor good [sic]….”