Zyprexa has generated a lot of bad press for Eli Lilly and they still have unresolved Zyprexa settlement claims.
Eli Lilly is 'reaping the whirlwind' for aggressive marketing of Zyprexa that has caused suffering and deaths.
Abilify is now the most popular anti-psychotic favored among psychiatrist. What the managers at Eli Lilly should consider is how Zyprexa is being avoided by doctors they aren't prescribing it for new patients at all anymore.
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Daniel Haszard 4 year Zyprexa patient who got diabetes from it. http://www.zyprexa-victims....
Anti-Psychotic Drugs (Zyprexa) Change Metabolism
Study out on Eli Lilly Zyprexa causing diabetes
“Based on these findings we concluded that male rats treated with olanzapine experienced an early disruption of energy metabolism.
In the study 18 male rats were randomly assigned to one of three groups: (1) those receiving the conventional antipsychotic drug haloperidol (HA); (2) those receiving the atypical antipsychotic drug olanzapine (OL); or (3) the control (CO) group which did not receive either drug.
The medicines were given in food for a period of six weeks. Female rats were excluded to eliminate bias in the study since antipsychotic-induced weight gain in female rodents is likely related to an interaction of the drugs with estrogens.
Testing after four weeks found that the concentration of blood sugar (as glucose) was higher in OL rats (0.87 g/l) than in CO rats (0.75 g/l) and the levels increased more rapidly after a glucose meal. Testing six weeks later found fasting blood sugar levels continued to rise in OL rats (1.46 g/l vs. 1.25 g/l in CO rats) while the level of lipids (fats) in the blood was similar for both groups.
Although there was no difference in body weight gain or food intake, the proportion of fat stored in the abdominal cavity was higher in OL rats (1.63%) vs. CO rats (1.44%).
The HA rats did not vary in any way with the control group at any time. They exhibited a lower blood sugar level after a glucose meal and a lower proportion of intraabdominal fat store (1.44%) than OL rats.
Senior study author Dominique Hermier said, “Based on these findings we concluded that male rats treated with olanzapine (Zyprexa) experienced an early disruption of energy metabolism. This was a result of the fat tissue we observed and the impairment in blood sugar regulation which are both associated with metabolic syndrome and subsequent risk of diabetes.”
"Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives.
Connecticut Sues Lilly Over Zyprexa
Inside INdiana Business (press release), IN -
(NYSE: LLY) over Zyprexa. Connecticut Attorney General Richard Blumenthal accuses the pharmaceutical giant of illegally marketing the antipsychotic drug
Press Release
March 11, 2008
Attorney General Richard Blumenthal today sued Eli Lilly and Company, Inc. for illegally marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug's serious side effects, for more than a decade.
Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children.
The deceptive marketing campaign dangerously concealed risks associated with Zyprexa, including diabetes, cardiovascular problems, and significant weight gain.
In a lawsuit filed today, Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa.
"The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems," Blumenthal said. "This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.
"Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa.
"Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes."
Blumenthal sued pursuant to the Connecticut Unfair Trade Practices Act (CUTPA) and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) on behalf of Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr. and Department of Social Services (DSS) Commissioner Michael Starkowski.
Despite only limited studies on its efficacy and safety, and only limited federally approved use, Zyprexa has become the third best-selling drug in the world as a result of Eli Lilly's illegal promotions - prescribed to more than 12 million people and grossing an estimated $22 billion to date.
The Food and Drug Administration (FDA) approved Zyprexa, or olanzapine, only for use in treatment of schizophrenia and bipolar mania. In order to maximize profits, Eli Lilly created unlawful enterprises to promote Zyprexa for unapproved uses, while trying to avoid federal prohibitions against off-label drug marketing.
Under the façade of independence, doctors at "educational" forums urged peers to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, while omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.
In reality, Eli Lilly paid these "independent" physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties.
In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.
Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder.
Through the Connecticut Medical Assistance Programs (CMAP), the state pays for part or all medical benefits for enrollees, including pregnant women and newborns, adults with disabilities, people age 65 and older, and people living in nursing homes.
Between 1996 and 2006, the CMAP spent more than $190 million on Zyprexa. Millions of additional dollars have also been spent to treat injuries related to their use of Zyprexa.
Eli Lilly's illegal marketing enterprises and schemes included the following:
PEER-SELLING ENTERPRISE: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended "educational" events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors' financial ties with Eli Lilly.
THE ROLE OF PHARMACIES: Eli Lilly targeted pharmacies, particularly those that serviced long-term care facilities. Typically, an Eli Lilly sales representative and a pharmacy would agree that the pharmacy formally request funding from Eli Lilly in order to present an "educational program" - for example, a program on the treatment of dementia.
Both the pharmacy and the Eli Lilly representative would agree that the program include a presentation by a doctor - hand picked by Eli Lilly - who would promote off-label use of Zyprexa for dementia. The Eli Lilly sales representative would file a formal request funds from Eli Lilly for an educational grant. Eli Lilly would issue a check to the pharmacy and the pharmacy would issue a check to the doctor, concealing compensation from Lilly to the physician.
PUBLICATION ENTERPRISE: Eli Lilly created a "Publication Enterprise" that hired writers to create articles, and then paid specialists to "author" the articles. The articles only included favorable results of Eli Lilly's own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa's efficacy for bipolar disorder.
PUBLIC PAYER ENTERPRISE: Eli Lilly captured the Medicaid and Medicare markets by paying officials in various states, paying them substantial sums of money to spread falsehoods regarding the efficacy, safety and side effects of Zyprexa and to promote off-label use.
Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid - among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to over-medicate senior citizens in nursing homes and adolescents in detention centers with antipsychotics.
Source: Office of the Connecticut Attorney General
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This is Shocking!
Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use. Eli Lilly has been charged in allegedly pushing the drug for children in more than one state.
Recently a parent wrote to us about her two sons. She received pressure to place them on ADHD drugs as early as Head Start. Over the years, they were on a cocktail of various psychotropic drugs. At one time, they were place on Zyprexa and according to the mother more than doubled their body weight.
A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder. Perhaps it is statistics like these that caused the FDA to finally require warnings on the labels of the ADHD drugs.
The use of atypical antipsychotics for children should be banned.
About 30 state attorneys general have subpoenaed documents detailing Lilly's sales practices for Zyprexa as part of a civil investigation under state consumer protection laws
A risky drug may get wider marketThe FDA may approve Zyprexa for kids
Zyprexa is the product name for Olanzapine,it is Lilly's top selling drug.It was approved by the FDA in 1996 ,an 'atypical' antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.Zyprexa has been linked to causing diabetes and pancreatitis.
Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly's $14.6 billion revenue last year.
Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta?
Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place! I was prescribed Zyprexa from 1996 until 2000. In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.
All the psychiatrist I've interviewed and the information on line presents zyprexa as a worse offender than the other Atypicals such as seroquel.My clinic has stopped prescribing zyprexa except as emergency PRN.
The PDR classifies zyprexa as 'severe' for causing weight gain and diabetes and seroquel as 'moderate'.
Of course the 50 year old Thorazine didn't cause diabetes and is many times cheaper but it could cause tardive dyskinesia.
Where Eli Lilly's negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it.
Lilly's incentive not to readily disclose is they had billions coming in from state medicaid scripts.
For the first four years that Eli Lilly Zyprexa was sold in the US, the promotion of the drug for any use other than adult schizophrenia was illegal. When the FDA approves a drug for a specific use, it can only be marketed for that use. Eli Lilly gained approval for schizophrenia in 1996 and the drug was not approved to treat bipolar disorder until 2000.
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Schizophrenia is considered the most severe of all mental illnesses and is said to occur in only about 1% of the population.
Experts say it would be highly unlikely that a competent psychiatrist could misdiagnosis this condition because the symptoms are so extreme and distinct.
Once a drug is approved to treat one condition, it is legal for doctors to prescribe the drug for other uses. These unapproved uses are referred to as "off-label," and can mean prescribing a drug for a longer duration than specified, at a different dose, in combination with other drugs, or with a different patient population than listed on the label.
The Food, Drug, and Cosmetic Act prohibits companies from promoting a drug for uses other than those approved and the Federal Anti-Kickback Statute prohibits companies from providing remuneration to induce or reward doctors for prescribing products for beneficiaries of Federally funded health care programs such as Medicare and Medicaid.
Accordingly, during the first four years that Zyprexa was sold in the US, Lilly sales representatives were not allowed to discuss any use other than adult schizophrenia and discussions of other uses were not allowed in any company funded event. Lilly itself noted at a July 20, 1995 presentation that the market for Zyprexa was limited the year before it was approved, estimating the total schizophrenia market to be only about $1 billion.
However, the drug was Lilly's best selling product by 2000, with worldwide sales of $2.35 billion, according to Lilly's 2001 Annual Report filed on January 28, 2002.
Zyprexa was approved for adults with bipolar disorder in 2000 and US sales rose 23% over 1999, to $1.69 billion in 2000. The next year, it became Lilly's first product to have sales in excess of $3 billion worldwide, and US sales rose 29% to $2.18 billion, according to the Report.
Experts say there is no way that Zyprexa could have become Lilly's most widely prescribed drug in the US without influencing doctors to prescribe the drug off-label. For instance, even though Zyprexa was approved to treat the manic phase of bipolar disorder only, which is typically brief, patients were kept on the drug for years.
The report noted that both commercial and Medicaid populations experienced increased use and that one study documented a 75% increase in the commercially insured population of 0-17 years from 1997 to 2001, and another study of use in the commercial managed care population from 1996 to 2001 found a 127% increase among children aged 0 to18.
The study found that antipsychotic use in the Medicaid populations in the late 1990s was already 3-4 times higher than commercial populations but also grew in the early 2000s. In Texas, prescription rates for kids rose 141% between 1996 and 2001 and in another program in the Midwest, usage grew 304% over the same time period, the report stated.
The authors said the analyses reveals that the drugs are used to treat a broad spectrum of disorders, and some of these disorders, such as attention deficit hyperactivity disorder and major depression, "clearly do not call for antipsychotic treatment."
The study found that in the 0 to 5 age group, 53.8% of the antipsychotics were prescribed for ADHD and in the age group 6 to 12, 48% were prescribed for ADHD.
The report noted that the use of antipsychotics with children under 6 is generally not recommended and "should be considered only in very rare circumstances."
A September 2007 study in the Archives of General Psychiatry, reported that the number of children in the US diagnosed with bipolar disorder had increased from about 20,000 in 1994 to roughly 800,000 in 2003.
One of the world's leading experts on psychopharmacology, UK psychiatrist and professor, Dr David Healy, author of, "The Latest Mania: Selling Bipolar Disorder," says bipolar disorder in children is all but unrecognized outside the US and it is unlikely that a significant proportion of these children would actually meet the DSM criteria for the disorder.
Former Federal fraud investigator, Allan Jones, says the atypical makers were able to turn the schizophrenia drugs into cash cows by influencing the doctors and state officials involved in the approval of formularies that specify the drugs that can be used by persons covered by public health care programs.
Lilly's off-label marketing of Zyprexa has come under scrutiny in the past several years, in large part, because lawmakers and law enforcement agencies became suspicious about the skyrocketing costs of a drug approved to treat such limited conditions being prescribed to so many patients in public health care programs.
According to Lilly's SEC report, Medicaid fraud lawsuits filed against Lilly thus far include the states of Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, and West Virginia. Arkansas is the latest state to file a lawsuit.
The Medicaid fraud allegations include that Lilly illegally marketed Zyprexa for off-label uses while concealing the serious health risks associated with the drug, and most specifically high blood sugar levels, extreme weight gain and diabetes.
The lawsuits seek to recover not only the money paid to purchase Zyprexa for patients on Medicaid but also for the medical care of persons injured by the drug. Mississippi alleges that about 10% of the Medicaid patients who took Zyprexa in that state have developed diabetes which will require life-long care.
In private litigation, since June 2005 Lilly has entered into settlements with approximately 30,200 claimants in the US for about $1.2 billion and there were still about 350 lawsuits covering about 540 claims pending in the US at the time of the August 2007 filing.
However, off-label prescribing has obviously not ceased because in 2006, Zyprexa sales were $4.3 billion and for the second quarter and first half of 2007, US sales of Zyprexa increased 4% and 5%, respectively, and international sales increased 14% during both periods, according to Lilly's SEC filing.
by Evelyn Pringle adapted with permission
A big hurdle with the Zyprexa issue is Lilly's credibility over their continuous PR on how they are going to pay out $1.2 billion in damages.As long as they keep up this rhetoric and don't actually pay the issue won't go away.
Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
Not fair!
Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa".
Eli Lilly zyprexa cost me over $250.00 a month supply out of my own pocket X 4 years and has up to ten times the risk (over non users) of causing diabetes and severe weight gain.
In 2004, the American Diabetes Association found that Zyprexa was more likely to cause diabetes than many other antipsychotic drugs.
A big hurdle with the Zyprexa issue is Lilly's credibility over their continuous PR on how they are going to pay out $1.2 billion in damages.As long as they keep up this rhetoric and don't actually pay the issue won't go away.
They need to think about 'putting their money where their mouth is'.
Don't shoot the messenger victims!
They called it the "VIVA ZYPREXA" campaign to off label market Eli Lilly Zyprexa as a fix for unapproved usage.
Zyprexa (Olanzapine) is known as an atypical antipsychotic It's mechanism of action is thought to be that it increases levels of serotonin and dopamine. It's chemical name is thienobenzodiazepine although is not a benzo like valium.One of it's well known major side effects is weight gain which is why it is sometimes favored for those with eating disorders (which would be an off label use)
Doctors are at liberty prescribe drugs 'off label' like Zyprexa which is only FDA approved for schizophrenia and bipolar.They can give it or just about any drug for conditions other than what the drug was tested for.The doctors don't realize that Zyprexa is very addictive once a dependence has been built up and withdrawal is wicked.
I took it 1996-2000 for PTSD and it was worthless for my symptoms and gave me diabetes with an A1C of 13.9 normal blood sugar is 4
I had to get off it and it took me two months of horrible insomnia,I did not sleep for weeks.
So,be warned Zyprexa IS addictive,I think worst than nicotine and don't go off it unless you do so gradually under a doctor's care.
I am a whole lot better now,except for the diabetes and wishing every one a cheerful holiday season coming up.
Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect.
The issue is that Zyprexa is indicated for less than 1% of the population and it IS the most dangerous of all it's anti-psychotic cousins.
Zyprexa was PUSHED by Lilly "viva zyprexa" on a ton of non-symptomatic patients at up to $10.00 a pill to further their own greed
Point of fact here,it is Eli Lilly who boast in over 80 major news/press releases on how they have "settled" their zyprexa claims for $1.2 billion.
A) this payout is an admission of guilt? What would you call it if not that?
B) they in fact have NOT settled (past tense) and have paid out no where near $1.2 billion
Just up on the google Eli Lilly zyprexa news wire on how a Texas law firm is expected to PROFIT $90 million on litigation.
Why are lawyers on both sides getting fat off of mental patients?
Zyprexa was promoted indiscriminately {Viva Zyprexa} with much glamour as an 'anti-psychotic' panacea cure-all for patients with psychological trauma and other issues.There is only a narrow range of patients with schizophrenia accompanied by delusional hallucinations or for agitated manic patients who are FDA approved for good reason.
All zyprexa does for the rest of us patients is make you unproductive and sleep a lot.
The drug was 'tainted' in that warnings about dangerous side effects were withheld.It was Eli Lilly that manufactured,promoted and exaggerated the efficacy of it's defective zyprexa product.
Lilly has boasted of a whopping $1.2 billion zyprexa settlement injury fund way back,has given over $100 million of that to their lawyer buds and stonewalled true victims like myself.
I paid for the zyprexa out of my own pocket at $250 month co-pay X 4 years it didn't work as they promised and gave me diabetes now I want my money back.
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[ In 2005, about $10 billion was spent overall on second-generation antipsychotics,represented the most costly group provided by Medicaid at $3 billion ]
Federal Court Rejects Lilly's Preemption Argument in Utah Zyprexa case
FYI
On Sept. 4, a federal court in Utah ruled against Eli Lilly which sought to
absolve itself of Zyprexa liability.
The State of Utah sued Eli Lily alleging that the State had paid for
inappropriate,
unnecessary and unauthorized off-label use of Zyprexa, and that it was
entitled to relief
including the future costs of care for Medicaid recipients allegedly harmed
by the drug.
Lilly invoked FDA's Preemption Rule which claims sole jurisdiction over drug
safety issues.
This gift to the pharmaceutical industry was crafted by FDA's chief counsel,
Daniel Troy,
before he went back to a law firm representing pharmaceutical companies.
In effect, FDA preemption would deny citizens the right to seek relief for
preventable harm
caused by manufacturers' failure to warn about serious adverse effects
linked to their
FDA-approved prescription drugs.
The court rejected Lilly's effort to remove the case from state court
jurisdiction
underscoring the court's "presumption against preemption." In an almost
conclusory fashion,
the Utah district court cited the following precedents:
1. Supreme Court Justice Scalia’s bon mot in Alexander v. Sandoval, 532 U.S.
275, 291 (2001), that “[a]gencies may play the sorcerer's apprentice but not
the sorcerer himself.”
(In Sandoval, Scalia was referring to agencies’ power to create a federal
cause of action;
here, the same metaphor is applied to agencies’ power to preempt state law.)
2. An earlier district court opinion from Louisiana which rejected FDA's
assertion of preemption:
“To take such drastic action based solely on a preamble inserted at the
eleventh hour and drafted by an agency without the express or implied
authority to abolish such remedies is Draconian and unacceptable.”
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