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Eli Lilly to pay $1.4B for off-label drug marketing
Capital Journal ^ | January 16, 2009 | Capital Journal Staff

Posted on 01/27/2009 6:05:02 PM PST by bdeaner

PIERRE — State Attorney General Larry Long announced Thursday that South Dakota has joined with other states and the federal government and reached a $1.4 billion settlement with Eli Lilly and Co., to settle allegations it engaged in an off-label marketing campaign that improperly promoted the anti-psychotic drug, Zyprexa.

Eli Lilly will pay the states and the federal government a total of $800 million in damages and penalties to compensate Medicaid and various federal health care programs for harm suffered as a result of this conduct.

South Dakota’s total settlement recovery is $1.4 million. Of that amount, South Dakota will keep $475,000, which represents the state’s share of the Medicaid loss, with the remainder going to the federal government for its share.

Between September 1999 and Dec. 31, 2005, Eli Lilly willfully promoted the sale and use of Zyprexa, primarily through a marketing campaign called “Viva Zyprexa,” for certain uses which the Food and Drug Administration had not approved.

Eli Lilly’s activities in the “Viva Zyprexa” campaign promoted Zyprexa not only to psychiatrists, but also to primary care physicians, for such unapproved uses as the treatment of depression, anxiety, irritability, disrupted sleep, nausea and gambling addiction.

In implementing the campaign, Eli Lilly also provided remuneration and other things of value to physicians and other health care professionals.

As a result, Eli Lilly caused physicians to prescribe Zyprexa for children and adolescents, dementia patients in long-term care facilities, and in unapproved dosage amounts, all of which are uses that were not medically accepted indications for which state Medicaid programs would approve reimbursement.

As part of the settlement, Eli Lilly will enter a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General which will closely monitor the company’s future marketing and sales practices.

This settlement is based on four cases that were filed or consolidated in the United States District Court for the Eastern District of Pennsylvania by various relators — private parties that filed actions under state and federal false claims statutes.

The South Dakota Medicaid Fraud Control Unit and the South Dakota Department of Social Services assisted in recovering the settlement money.


TOPICS: Crime/Corruption; Culture/Society; Front Page News; News/Current Events
KEYWORDS: antipsychotic; bigpharma; elililly; pharmaceuticals; psychiatry; zyprexa
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1 posted on 01/27/2009 6:05:03 PM PST by bdeaner
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To: bdeaner

So they will jack up the prices of their products to cover the tab? this is just another tax, don’tcha know. Not condoning what they did but for anyone except for the lawyers involved, how is this going to improve things?


2 posted on 01/27/2009 6:28:38 PM PST by NonValueAdded (Confidential to MSM: "Better Red than Read" is a failed business model.)
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To: bdeaner

No mention that I see..

What about the individual who actually paid out of his pocket for this stuff? Does he get his money back from the pharmacy?


3 posted on 01/27/2009 6:34:39 PM PST by George from New England (escaped CT 2006; now living north of Tampa Bay)
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To: bdeaner

how many billions will we be able to fine AlGore as his theories prove off-label? Number 1: if polar ice cap not melted in 5 years, $2b fine for Gore.


4 posted on 01/27/2009 6:36:38 PM PST by gusopol3
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To: NonValueAdded

It won’t improve things. You’re right, it’s just another tax. I would go further and say it’s nothing more than a payoff. They should be prosecuted, but the FDA is in bed with them, so it won’t happen.

Zyprexa is not the only drug they’ve done this with, and their flagrant unsubstantiated recommendations for all their psychotropics (Cymbalta is another good example) are despicable.

Big pharma is so full up with greed that there’s no room for ethics anymore.


5 posted on 01/27/2009 6:39:55 PM PST by agrace
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To: agrace

if it hadn’t worked for the off-label indications (what are the agents that have FDA approval for these symptoms?), they never would have made billions on it.


6 posted on 01/27/2009 6:43:25 PM PST by gusopol3
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To: gusopol3

They’ve made billions because they spend millions on marketing, not because they actually work. Most studies show, for example, that antidepressants work about as often as placebos, but because pharmaceutical companies don’t have to publish all their drug trials, they pick a couple good ones and have their reps spout sunshine and lollipops while they buy the doctors lunch.


7 posted on 01/27/2009 6:55:06 PM PST by agrace
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To: agrace

a little Scientology here.


8 posted on 01/27/2009 6:56:35 PM PST by gusopol3
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To: bdeaner

Wonder if it works for said problems.


9 posted on 01/27/2009 8:06:27 PM PST by Eagles6 ( Typical White Guy: Christian, Constitutionalist, Heterosexual, Redneck. (Let them eat arugula!))
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To: Eagles6

“The Constant Gardener” comes to mind, except the drug was called Dyprexa in the movie. Zyprexa has killed many patients by making them diabetic within 3 months of taking the drug. Die in their sleep from the effects of diabetic coma.


10 posted on 01/27/2009 9:00:18 PM PST by quickquiver (No, means N O.)
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To: NonValueAdded

This is a significant result, because it sets a legal precedent. Pharmaceutical companies will have to severely limit their market push for drugs. Most importantly, they will no longer be able to market most psychiatric drugs to general physicians without great risk of lawsuit. That will eliminate a lot of the problems that have been very common in medicine — inappropriate use of psychiatric medication based on professional incompetence —, because of the lack of training in most general physicians when it comes to psychiatric diagnosis, assessment, and treatment.


11 posted on 01/27/2009 10:06:01 PM PST by bdeaner (The bread which we break, is it not a participation in the body of Christ? (1 Cor. 10:16))
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To: gusopol3

Haha.


12 posted on 01/27/2009 10:06:45 PM PST by bdeaner (The bread which we break, is it not a participation in the body of Christ? (1 Cor. 10:16))
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To: agrace

You’re right about the FDA. But I don’t think the situation is hopeless. There are multiple avenues of attack here, such as targeting the researchers of the drugs who are in bed with Big Pharma, like Joe Biederman (sp?) who just got nailed to the wall in November for taking money from J&J under the table, because he was getting paid off to create a fake diagnosis of bipolar disorder for kids in order to create a market for the atypical antipsychotic.


13 posted on 01/27/2009 10:09:57 PM PST by bdeaner (The bread which we break, is it not a participation in the body of Christ? (1 Cor. 10:16))
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To: Eagles6

The evidence based on the same class of drugs says that, no, these drugs don’t even work (over the long run) for the symptoms they were designed to treat — psychosis and mania. New MRI research is showing that these drugs cause permanent damage to the brain — frontal lobes, and limbic system are damaged, and there is a overproduction of cells in the extrapyramidal regions of the brain. So, over time you get irreversible side effects like tardive dyskinesia and akithesia — not to mention the weight gain, diabetes and other side effects — so that it is no wonder psychiatric patients have such high mortality, even when accounting for suicides. And it also accounts for why people in third world countries, who do not take anti-psychotric medications, are 16 times more likely to recover from their disorder, in comparison to patients in the U.S.


14 posted on 01/27/2009 10:13:58 PM PST by bdeaner (The bread which we break, is it not a participation in the body of Christ? (1 Cor. 10:16))
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To: bdeaner

Interesting. Thanks.


15 posted on 01/28/2009 1:44:55 AM PST by Eagles6 ( Typical White Guy: Christian, Constitutionalist, Heterosexual, Redneck. (Let them eat arugula!))
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To: bdeaner

the most compelling evidence that you are largely a propagandizer rather than an enlightener are the huge piles of bricks now standing virtually empty all over the country, built in the era when there was no “BIG PHARMA,” called state hospitals, where that supposedly less beguiled populace housed its mental patients for decades .


16 posted on 01/28/2009 3:07:46 AM PST by gusopol3
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To: gusopol3

Ha, no. Evangelical Christian with personal experience and lots of research here.


17 posted on 01/28/2009 7:24:04 AM PST by agrace
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To: gusopol3; bdeaner
the most compelling evidence that you are largely a propagandizer rather than an enlightener are the huge piles of bricks now standing virtually empty all over the country, built in the era when there was no “BIG PHARMA,” called state hospitals, where that supposedly less beguiled populace housed its mental patients for decades .

"Mental hospitals began to empty after 1955. New Jersey state hospitals, for example, held 15,000 patients then and only about 4000 today. This massive "decarceration" is widely credited to the success of the psychotropic drugs, but there is really no evidence for this. The rates of release from mental hospitals began to rise in the United States and England in the late 1940s and early 1950s, before the drugs were introduced. Prison release rates also began to rise shortly afterward. The trend toward decarceration in both kinds of institutions resulted from a recognition of the astronomical costs of the new hospitals and prisons that would be required without a reversal of the trend toward incarceration. The availability of drugs cannot explain the increased release rates in prisons, nor for the high release rates for patients with chronic brain syndromes who rarely were treated with drugs."

From this article on psychotropic drug use in mental hospitals

18 posted on 01/28/2009 7:39:03 AM PST by agrace
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To: agrace; gusopol3; bdeaner
From another article, called Anatomy of an Epidemic: Psychiatric Drugs and the Astonishing Rise of Mental Illness in America (Ethical Human Psychology and Psychiatry, Volume 7, Number I, Spring 2005) -

In 1955, there were 559,000 people in public mental hospitals, or 3.38 people per 1,000 population. In 2003, there were 5 .726 million people who received either an SSI or SSDI payment (or from both programs), and were either disabled by mental illness (SSDI statistics) or diagnosed as mentally ill (SSI statistics).' That is a disability rate of 19.69 people per 1,000 population, which is nearly six times what it was in 1955 (Table 2).

19 posted on 01/28/2009 7:44:02 AM PST by agrace
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To: agrace
hey pick a couple good ones and have their reps spout sunshine and lollipops while they buy the doctors lunch.

there is a commandment about bearing false witness. These kind of statements come directly from NYT and so forth who have certainly established their objectivity,and certainly many such statements are directed at home schooling also, as home schoolers, like certain corporate sectors including pharmaceuticals, were perceived by the left to be bulwarks of the Republican electoral coalition, and therefore were to be degraded by all means available, including people sitting home and Googling with some sort of axe to grind.

20 posted on 01/28/2009 7:56:59 AM PST by gusopol3
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