Lilly Reaches Zyprexa Agreement With Seven States (Update2)

Eli Lilly & Co. agreed to settle, on confidential terms, lawsuits filed by seven states alleging the company improperly marketed its antipsychotic drug Zyprexa, a court-appointed official said.

“All of the states have essentially settled for the same” non-monetary arrangements, said Michael Rozen, special master appointed by the court to help settlement negotiations. The money terms, which weren’t disclosed, “have fallen roughly in line,” he said at a hearing today in federal court in Brooklyn, New York.

Lawyers told U.S. District Judge Jack B. Weinstein, who is overseeing the cases, that finishing the settlements may be delayed while the parties determine how much money the U.S. government plans to claim in compensation for federal dollars spent on Zyprexa through state Medicaid programs.

If completed and approved in court, the settlements would leave four suits filed by states pending against Lilly.

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Cymbalta's waning patent and generic rivals soon could threaten Lilly's sales

Eli Lilly has enjoyed a wave of success with antidepressants, but analysts say such expertise must now bring new revenue growth.

Eli Lilly and Co. built a large part of its fortune selling medications for gloom, anxiety and withdrawal.

Now the question is: Can the Indianapolis drug maker keep riding the antidepressant wave? Can it find its next Prozac, its next Cymbalta?

Use of antidepressants in the U.S. doubled from 1996 to 2005, as more people sought out treatment and the stigma of depression has fallen, according to a study published in the August issue of the Archives of General Psychiatry. All told, about 10 percent of Americans, or 27 million people, were prescribed an antidepressant in 2005, up sharply from 13 million people a decade earlier.

"There's a huge increase in the recognition of depression and its symptoms," said Dr. Jim Martinez, an Indianapolis psychiatrist and adviser to Lilly. "And I think we've seen a growing improvement in public attitudes around seeking care for this disease."

But in recent years, the market has faced growing headwinds. Industry sales from antidepressants dipped nearly 14 percent in the past four years, even as the number of prescriptions dispensed for the pills has continued to climb. Medco Health Solutions, a huge pharmacy company that studies drug trends, is forecasting that use of antidepressants is likely to grow slowly over the next three years.

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AP IMPACT: Drugmakers' push boosts 'murky' ailment

Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all.

Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.

That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.

Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.

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Bitter Pill

Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza

In June 1992, not long after the place closed down, a Harvard-trained psychologist named Sergio Pirrotta walked out of Danvers State Hospital for the last time. The psychiatric facility, at this late date, was a baggy old thing, rectangled into a field just north of Boston; whole wings were barely occupied, and vandals had already begun to rip out the mantelpieces and furniture. The hospital had been slowly, incrementally shutting down for a decade, and the patients that remained were the hardest cases, mostly schizophrenics and those with disorders too dense and weird to classify. But now, as Pirrotta took a walk around the campus, even those patients were gone: released into the larger world to fend for themselves or bused to hospitals where the staffs had little psychiatric training.

Pirrotta had come to Danvers in the mid-1970s to rehabilitate children whom the courts had declared insane. Back then the place was overpopulated, the halls packed with madmen who would wander around smoking cigarettes, leering and lunging at the kids. In those days, the drugs used to treat mental illness were crude and ugly things. Thorazine was the best, and it made you into a ghouled and lifeless ogre — your face seized up involuntarily, you kept shuffling around, you were an emotional drone. But gradually the medications got a little bit better, the pharmacology more precise. First there was haloperidol, similar to Thorazine but with less-vivid side effects. Then clozapine, which had at first seemed a wonder drug, before it turned out to trigger a potentially fatal immune deficiency in two cases out of a hundred.

READ MORE @ ROLLING STONE

Lilly to Pay Biggest Fine Ever to End Zyprexa Probe (Update7)

Eli Lilly & Co. will plead guilty to a charge of promoting its antipsychotic drug Zyprexa for unapproved uses and pay $1.42 billion, including the largest criminal fine ever imposed by the U.S. on an individual company.

The company admitted its marketing of Zyprexa was illegal in a civil and criminal settlement announced jointly today in a statement by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will also submit to U.S. monitoring against future lawbreaking.

Lilly resolved federal and state probes into how it marketed the drug and will make its guilty plea in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis- based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act.

“Eli Lilly completely ignored the law” and made “hundred of millions of dollars” from its illegal promotion of Zyprexa, Magid said at a press conference in Philadelphia today. “We’re holding a company responsible for putting thousands and thousands of patients at risk.”

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Lilly Will Take $1.42 Billion Charge in Zyprexa Probe (Update1)

Eli Lilly & Co. said it is having ``advanced discussions'' to settle investigations by U.S. and state authorities over marketing the antipsychotic Zyprexa and will take a $1.42 billion charge in the third quarter.

The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.

Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.

``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.

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Judge OKs Zyprexa Class Action, Unseals Documents

A federal judge has granted class action status to a Zyprexa lawsuit that claimed Eli Lilly hid the drug’s serious side effects. The decision by Judge Jack B. Weinstein of Federal District Court in Brooklyn also unseals confidential documents relating to the antipsychotic medication. Eli Lily

The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.

The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.

READ MORE @ NEWS INFERNO

Lilly May Need Stronger U.S. Warning on Zyprexa Label (Update4)

Eli Lilly & Co.'s current label warning on health risks linked to its antipsychotic Zyprexa may not be strong enough, according to court documents.

Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It also says Zyprexa is more ``associated'' with higher blood- sugar levels -- a risk factor for diabetes -- than similar medications.

The warning, approved by the U.S. Food and Drug Administration, may need to be adjusted to link Zyprexa more directly to higher blood sugar and diabetes, according to a letter to the Indianapolis-based drugmaker from the agency. The document was produced for a lawsuit by the state of Alaska claiming the company withheld information on risks of Zyprexa, Lilly's top-selling drug with sales of $4.76 billion last year.

``We anticipate that additional labeling changes will be necessary when we have reviewed the results of the additional analyses that we have requested,'' FDA administrator Tom Laughren wrote to Lilly in an Aug. 28 letter.

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Statement from Eli Lilly and Company: Response to Today's New York Times Article, 'Lilly E-Mail Discussed Off-Label Drug Use'

See Friday, March 14, 2008 post.
Eli Lilly and Company today called the assertions in a New York Times online article 'flat out wrong.' The Times report in question focused on the State of Alaska v. Eli Lilly and Company trial that is underway and attempted to interpret a 2003 email from John C. Lechleiter, Ph.D., currently Lilly's president and chief operating officer. About this email and the Times report, the company makes the following statement:

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A Chilly Court: Alaska Attacks Lilly Over Zyprexa

This is the Zyprexa trial we’re talking about. The state, you may recall, sued Lilly in 2006, alleging the drugmaker failed to warn of weight gain and diabetes caused by Zyprexa, and wants Lilly to cover treatment costs of Medicaid patients who suffered serious health problems.

The civil suit is being closely watched by state and federal prosecutors investigating the drugmaker, because this is the first lawsuit filed by a state against Lilly to make it to trial. The outcome - and even the evidence - could, therefore, influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general. An unfavorable verdict could also prompt other states to file lawsuits, although eight others already have done so. (By the way, if you want to read the controversial Zyprexa documents, visit Furious Seasons).

For its part, Lilly argues the state has two irreconcilable positions - at the same time Alaska is suing the drugmaker, the state continues to seek court orders to force mental patients to take the very drug it says is harmful. These are the slides Lilly’s lawyers used in court.

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SCIENTISTS who develop drugs are familiar with disappointment — brilliant theories that don’t pan out or promising compounds derailed by unexpected side effects. They are accustomed to small steps and wrong turns, to failure after failure — until, in a moment, with hard work, brainpower and a lot of luck, all those little failures turn into one big success.

For Darryle D. Schoepp, that moment came one evening in October 2006, while he was seated at his desk in Indianapolis.

At the time, he was overseeing early-stage neuroscience research at Eli Lilly & Company and colleagues had just given him the results from a human trial of a new schizophrenia drug that worked differently than all other treatments. From the start, their work had been a long shot. Schizophrenia is notoriously difficult to treat, and Lilly’s drug — known only as LY2140023 — relied on a promising but unproved theory about how to combat the disorder.

When Dr. Schoepp saw the results, he leapt up in excitement. The drug had reduced schizophrenic symptoms, validating the efforts of hundreds of scientists, inside and outside of Lilly, who had labored together for almost two decades trying to unravel the disorder’s biological underpinnings.

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Lilly Adds Label Warnings for Mental Illness Drug

Eli Lilly today added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing the drug’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.

For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.

Lilly previously argued that Zyprexa had not been proven to cause high blood sugar at a more frequent rate than its competitors.

Concern about Zyprexa’s side effects has been increasing since at least 2004, and Zyprexa’s prescriptions and market share have fallen sharply over the same period. As a result, the new warnings may have only a moderate impact among doctors and patients, said S. Nassir Ghaemi, director of the Bipolar Disorder Research Program at Emory University.

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Lilly's Schizophrenia Drug Targets Different Brain Chemicals

Eli Lilly and Co.'s experimental schizophrenia drug, which may replace its top-selling Zyprexa, was just as effective without causing patients to gain weight, according to a study.

Unlike other schizophrenia medicines on the market, the new compound doesn't target dopamine, a chemical that functions within the brain's reward system. It affects glutamate, involved in learning and memory. The study showed the new drug candidate to be as effective as Zyprexa in reducing symptoms such as hallucinations and social withdrawal.

The new drug candidate, dubbed LY2140023, would be the first for the disorder affecting glutamates, a company official said. Zyprexa, with $4.3 billion in 2006 sales, now faces competition from less expensive copies in Canada and Germany, the Indianapolis-based company said on June 8. The drug's U.S. patent expires in 2011.

``Discovering an antipsychotic drug that doesn't work through dopamine is the holy grail of drug development,'' said Gerald Marek, Lilly's chief scientific officer of psychiatric disorders, in an Aug. 30 telephone interview. ``It looks like we've hit upon a target that will ultimately do this.''

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Lilly Posts Ends Strong Numbers With Cialis, Cymbalta

Eli announced its second quarter results, reporting sales were up 20 percent, worldwide. Eli Lilly reported Q2 sales reached $4.63 billion, with volume up 11 percent, led by the antidepressant drug Cymbalta and the erectile dysfunction drug Cialis.

In January, Eli Lilly acquired Cialis' maker, ICOS Corp. for $2.3 billion. The second quarter return is the first full period incorporating Cialis profits into Eli Lilly's numbers. The take-over kicked marketing and administrative expenses up 23 percent to $1.52 billion.

"We are very pleased to have delivered another quarter of strong financial results," CEO Sidney Taurel said. "Our accelerated, double-digit sales growth in this quarter was fueled by increased volume, driven by several products launched this decade, most notably Cymbalta."

Lilly May Face More Zyprexa Lawsuits After FDA Letter (Update2)

Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators.

The U.S. Food and Drug Administration told Lilly in March it would delay the approval of Symbyax for hard-to-treat depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac.

The FDA's request, in a letter to Lilly obtained by Bloomberg, may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.

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Anti-depressants weaken elderly bones

Two studies published add to growing evidence the most popular class of drugs taken to treat depression may contribute to fragile bones in elderly people.

The research focused on a class of antidepressant drugs called selective serotonin reuptake inhibitors. Millions of people, including many elderly, take these drugs, known as SSRIs, which include Eli Lilly's Prozac, known generically as fluoxetine.

Two teams of researchers found that older men and women taking SSRIs had more bone loss than those not taking the drugs, which account for more than 60 percent of U.S. antidepressant drug prescriptions. A drop in bone mass can lead to osteoporosis and bone fractures.

A team led by Dr. Susan Diem of the University of Minnesota tracked 2,722 women, average age 78, including 198 SSRI users. They measured their bone mineral density five years apart

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Eli Lilly: Drug ads influencing patients

Eli Lilly, which has faced thousands of lawsuits over its anti-psychotic Zyprexa, says lawyers' ads about the drug are prompting some patients to stop taking mental illness medications when they shouldn't.

The advertising blitz "presents yet another barrier for patients who suffer from severe mental illness" and increases the risks that people will not get the care they need, said Carole Puls, a spokeswoman for the Indianapolis-based drug maker.

Lilly released the results of a company-funded survey that asked 402 psychiatrists who treat patients with bipolar disorder or schizophrenia to complete an online questionnaire. More than half of the participating psychiatrists said they believed their patients who stopped medication or reduced the dosage did so after seeing lawyers' advertisements about anti-psychotic drugs.

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Eli Lilly: Lawyers' Ads Are Hurting Patients - Law.com

Big Headache for Big Pharma

For pharmaceutical giant Eli Lilly, death and injury are just a cost of doing business. When Zyprexa, Lilly’s drug to treat schizophrenia and bipolar disorder, hit the marketplace in 1996, it was hailed as an “atypical” – a “safe, gentle psychotropic,” more effective than older drugs like Thorazine and Trilafon, without the dangerous side effects. Sales skyrocketed. The hype soon gave way to reality, as Lilly faced waves of lawsuits by patients suffering from diabetes, massive weight gain, pancreatitis and cardiac problems. Lilly responded with the cozy arrangement that worked with Prozac, another blockbuster plagued with problems: quietly settle suits out of court, with proceedings sealed and secret under a gag order. Anything embarrassing – or illegal – that Lilly is doing behind closed doors would remain hidden from public view.

By - Will Hall co-founder of the Freedom Center, and a member of the Icarus Project.

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Behind The Curtain: Lilly Discloses Grants

In a long overdue move, Lilly today will release a report detailing the grant money given to non-profit groups and educational institutions. In this year's first quarter, for instance, the drugmaker gave $11.8 million to universities, foundations devoted to disease research and awareness, and companies that are in the continuing education business.

For instance, the largest single grant was $825,000 to Massachusetts General Hospital's psychiatry department for a year-long educational program with more than 150,000 registrants. And the National Alliance for the Mentally Ill, an advocacy group for patients, received $544,500. Of that, $450,000 went to fund a project called "Campaign for the Mind of America."

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Puzzle of antipsychotic drug weight gain solved

Researchers said on Monday they have pinpointed the reason some drugs used to treat mental illnesses like schizophrenia cause patients to gain a lot of weight, raising hope for developing drugs without this side effect.

Antipsychotic medications such as Zyprexa, made by Eli Lilly and Co., increase the activity of an enzyme called AMPK in cells in the part of the brain that regulates eating behavior, according to research in mice led by scientists at Johns Hopkins University in Baltimore.

READ MORE @ Reuters