MinTankesmie

Skjulte dokumenter om alvorlige bivirkninger

Skjulte dokumenter om alvorlige bivirkninger
aftenposten.no 13.10.2008
Legemiddelprodusent godtok rekordforlik i USA. Mange nordmenn bruker medisinen.

Et skred av pasientklager mot legemiddelkonsernet Eli Lilli førte til at selskapet ble saksøkt av 33 amerikanske stater. (...)

Søksmålet gikk blant annet ut på ulovlig markedsføring og for å ha solgt preparatet til pasienter som ikke trengte det, skriver Helsebiblioteket.no.

Nå har Eli Lilly akseptert å betale 62 millioner dollar i erstatning for å skjult dokumentasjon om alvorlig bivirkningsfare ved bruk av legemiddelet Zyprexa, og for å ha oppfordret leger til å skrive ut legemiddelet til personer som ikke trengte det. Selskapet må også frigi alle forskningsresultater om Zyprexa. (...)

Hyppigst rapportert er bivirkninger i nervesystemet, som svimmelhet, kramper og parkinsonlignende symptomer sier Kvande.

Interne dokumenter viser at Eli Lilly satset aggressivt på å få Zyprexa inn på markeder legemiddelet ikke er godkjent for, blant annet til medisinering av eldre pasienter med demens, ifølge the New York Times. (...)

Zyprexa er heller ikke godkjent til bruk på unge under 18 år. Studier på pasienter viste flere uønskede reaksjoner, blant annet vektøkning og forandringer i stoffskiftet.

En intern epost tyder imidlertid på at selskapet vil overtale helsepersonell til å behandle ungdommer med legemiddelet, skriver avisen. (...)

I begynnelsen av oktober varslet Eli Lilly at Zyprexa vil bli merket med advarsel om risiko for vektøkning, økt blodsukker, forhøyet kolestrolverdi og andre stoffskifteproblemer.

Til nå har selskapet hevdet at Zyprexa ikke avviker fra andre tilsvarende preparater når det gjelder bivirkninger. (...)

(Anm: Antipsykotika (psykofarmaka etc.) (mintankesmie.no).)

Skjulte bivirkningsfare
nettavisen.no 12.10.2008
MÅ BETALE: Legemiddelet som Eli Lilly har solgt viser seg å være risikofyllt og dyre for selskapet.

Legemiddelkonsernet Eli Lilly er dømt til å betale 62 millioner dollar i erstatning for å ha skjult risiko for alvorlige bivirkninger av legemiddelet Zyprexa.

Dommen fra USA omfatter også tvilsom markedsføring og salg av preparatet til pasienter på feil indikasjon. (...)

Mange hevder blant annet de har utviklet diabetes som følge av Zyprexa. Resultatet er at 33 stater saksøkte Eli Lilly blant annet for ulovlig markedsføring, og for å ha solgt preparatet til pasienter som ikke trengte det. (...)

Hemliga papper om Zyprexa blir offentliga
lakemedelsvarlden.se 9.9.2008
Företaget Eli Lilly är föremål för en omfattande utredning i USA. Det handlar om det antipsykotiska läkemedlet Zyprexa och allvarliga biverkningar som företaget anklagas för att ha dolt.

Rättsligt Det är en federal domare i Brooklyn som i fredags beslöt att offentliggöra hemligstämplade dokument om storsäljaren Zyprexa (olanzapin).

Bakgrunden är att ett antal försäkringsbolag, pensionsfondsbolag och fackföreningar har krävt Eli Lilly på stora skadestånd på grund av biverkningar av Zyprexa som företaget dolt. (...)

Diverse artikler

Patentudløb på Zyprexa (olanzapin)
irf.dk 3.10.2011 (Institut for Rationel Farmakoterapi (IRF)
Skal olanzapin nu være førstevalg?

Mandag d. 3. oktober ser hele 8 nye generiske olanzapin-præparater dagens lys.

Zyprexa (olanzapin) er, med en omsætning på kr. 266 mio. i 2010, det til dato mest solgte antipsykotikum i Danmark - skarpt efterfulgt af Seroquel (quetiapin), der omsatte for kr. 265 mio.

Patentudløb på olanzapin betyder, at der kan opnås et årligt besparelsespotentiale på optil kr. 200 mio. - alene ved at skifte til billigste generika (baseret på priser per 3.10.2011).

I dag koster billigste parallelimporterede pakning af Zyprexa 20 mg kr. 53,91 per tablet. Til sammenligning koster det billigste generika nu kr. 2,04 per tablet. Forskellen svarer til en årlig besparelse på godt kr. 19.000 bare for en enkelt patient. For lavere doser (2,5-10 mg) er besparelsen mellem 6.400 og 8.400 kr. I 2010 blev godt 17.000 patienter behandlet med Zyprexa.

Olanzapin er nu, sammen med risperidon, det billigste valg, men er de også det bedste valg? (...)

Lilly enjoys good quarter ahead of Zyprexa patent expiries
pharmatimes.com 22.7.2011
Eli Lilly has posted a 11% decline in earnings for the second quarter, but sales were up 9%, thanks again to the performances of the antidepressant/fibromyalgia blockbuster Cymbalta and the lung cancer drug Alimta.

Net income was $1.20 billion, hit by higher marketing and administrative expenses, plus costs associated with the company’s recently-announced diabetes collaboration with Boehringer Ingelheim. Sales came in at $6.25 billion.

Revenues from Cymbalta (duloxetine) were up 16% to $1.00 billion, while the cancer drug Alimta (pemetrexed) increased 11% to $613.4 million. Lilly’s best-selling drug continues to be the antipsychotic Zyprexa (olanzapine), which had turnover of $1.40 billion, up 12%. (...)

FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns (Meddelelse fra FDA om legemiddelsikkerhet: Oppdatert preparatomtale for antipsykotika ved bruk under svangerskap og risiko for unormale muskelbevegelser og seponeringsymptomer hos nyfødte.)
fda.gov 22.2.2011
Safety Announcement (Sikkerhetsmeddelelse)
(...) The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder, and have been shown to improve daily functioning in individuals with these disorders. Common brand names for antipsychotic drugs include Haldol, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, and Invega (see List of Antipsychotic Drugs below). (...)

Summary Box: Key drugs boost Lilly 2Q performance
forbes.com 22.7.2010
SECOND-QUARTER NUMBERS: Indianapolis drugmaker Eli Lilly and Co. earned $1.35 billion, or $1.22 per share. That's up from $1.16 billion, or $1.06 per share, in the same period last year. Revenue rose 9 percent to $5.75 billion. (...)

KEY FACTORS: Revenue growth from top-selling drugs like the antipsychotic Zyprexa and the antidepressant Cymbalta helped Lilly overcome pricing cuts in Europe and a $70-million hit from the U.S. health care reform law. (...)

Caution on Zyprexa in Adolescents
fda.gov (April 2010 April 2010)
The FDA is recommending that healthcare professionals use caution when considering Zyprexa (olanzapine) for treating adolescents 13 to 17 years old for schizophrenia and bipolar disorder.

Physicians, patients and caregivers should understand that adolescents may experience weight gain and hyperlipidemia with Zyprexa. In fact, they have a greater risk of these effects than adults. They are likely to gain more weight than adults and have greater increases in total cholesterol, LDL cholesterol, triglycerides, prolactin, and hepatic transaminase levels. Adolescents are also more likely to experience sedation than adults. Clinicians should take these effects into account when deciding on antipsychotic medications for adolescents, and they may want to consider trying other drugs first.

If Zyprexa is prescribed for adolescents, it should be part of a comprehensive treatment program that often includes psychological, educational and social components. It is also important to note that Zyprexa has not been approved for patients under the age of 13. (...)

Zyprexa (olanzapine) tablet, orally disintegrating tablets and IM injection
fda.gov 18.2.2010
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

WARNINGS
Hyperprolactinemia
As with other drugs that antagonize dopamine D2 receptors, olanzapine elevates prolactin levels, and the elevation persists during chronic administration. Hyperprolactinemia may suppress hypothalamic GnRH...

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated...

In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults...
In placebo-controlled olanzapine monotherapy studies in adolescent patients (up to 6 weeks) with schizophrenia or bipolar I disorder (manic or mixed episodes), changes from normal to high in prolactin concentrations... (...)

(Anm: hyperprolaktinemi; for rikeleg danning av prolaktin skuldast oftast større eller mangfaldige små svulstar i hypofysen (sjå prolaktinom), stress, visse medikament eller hypotalamussjukdom, kan hos kvinna gi mjølkerenning og menstruasjonsskiplingar, hos menn vert det gjerne veik kjønnshelse med sviktande libido, dårleg reisning og endra sædavgang. EN hyperprolactinemia. Kilde: Norsk medisinsk ordbok.)

FDA Advises Caution in Olanzapine Use in Teens
Clinical Psychiatry News 2009;38(1):1 (January 2010)
The approval of olanzapine for two pediatric indications—the treatment of schizophrenia and of manic or mixed episodes associated with bipolar I disorder in adolescents aged 13 to 17 years—comes with a precaution.

The Food and Drug Administration is advising clinicians to consider the increased potential for weight gain associated with the antipsychotic in adolescents, compared with adults.

Olanzapine (Zyprexa) was approved in December for the two indications based on two short-term studies—one, a 6-week trial of 107 adolescents with schizophrenia; the other, a 3-week study of 161 adolescent inpatients and outpatients with manic or mixed episodesassociated with bipolar I disorder.

The indications section of the revised label for both bipolar I disorder and schizophrenia includes the following statement: “When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases, this may lead them to consider prescribing other drugs first in adolescents.” (...)

Utah AG says state gets $24M in Zyprexa settlement
forbes.com 11.11.2009 (Associated Press)
SALT LAKE CITY -- Utah Attorney General Mark Shurtleff says the state has agreed to a $24 million civil settlement with Eli Lilly & Co. over claims the drug maker engaged in off-label marketing of the anti-psychotic drug Zyprexa.

Shurtleff's office said Wednesday that it conducted a nearly four-year investigation of the drugmaker from Indianapolis.

Shurtleff says Zyprexa is approved for treatment of schizophrenia and bipolar disorder. But he says Lilly's sales force illegally promoted Zyprexa for uses not approved by the Food and Drug Administration such as dementia, Alzheimer's, agitation and depression. (...)

Lilly Paid Doctors to Prescribe Zyprexa, Notes Show (Update2) (Lilly betalte leger for å forskrive Zyprexa, ifølge notater)
bloomberg.com 8.9.2009
Sept. 8 (Bloomberg) -- Eli Lilly & Co. paid doctors in South Carolina for participating in a speakers’ program in exchange for prescribing the antipsychotic Zyprexa, and used golf bets to get more patients on the drug, according to notes by sales representatives.

During a golf game, one doctor agreed to start new patients on Zyprexa for each time a sales representative parred, or put the ball in a hole within a predetermined number of strokes, according to the notes.

“I got four pars out of nine holes,” Lilly salesman Vince Sullivan said in a February 2002 note. “I said I wanted my four new patients.” (...)

Lilly resolved a marketing investigation over Zyprexa in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states. South Carolina opted not to join that settlement. (...)

(Anm: Antipsykotika. (mintankesmie.no).)

Psykisk syge får nej til erstatning
politiken.dk 24.5.2009
To danskere har fået erstatning for bivirkninger ved den mest udbredte medicin mod skizofreni. I USA er tallet 30.000.

Det mest solgte lægemiddel til danskere med skizofreni har været centrum for et gigantisk retsopgør i USA de senere år, hvor producenten har udbetalt erstatning til 30.000 amerikanere for potentielt dødelige bivirkninger ved medicinen Zyprexa.

Herhjemme har blot to patienter fået erstatning for bivirkninger ved præcis samme lægemiddel.

»USA har en helt anden tradition for retssager om bivirkninger ved lægemidler. Det kan være forklaringen på, at der har været så mange erstatningssager derovre og så få i Danmark«, siger overlæge Anders Fink-Jensen, der er formand for Dansk Psykiatrisk Selskab og klinikchef på Rigshospitalets psykiatriske afdeling. (...)

Patientforsikringen oplyser, at den i perioden 2003-2009 har modtaget 18 klager fra enkeltpersoner over bivirkninger ved Zyprexa. Det svarer til tre klager om året i gennemsnit.

De har blandt andet klaget over, at de er blevet overvægtige af Zyprexa. 16 sager er afgjort, og i langt de fleste får klagerne at vide, at de ikke er berettiget til erstatning. Kun to patienter har fået medhold.

Trods sagerne i USA ser Lægemiddelstyrelsen ingen grund til at mistænke Zyprexa for at være farlig.

»Vores vurdering af effekt og sikkerhed bygger ikke på retssager i et andet land. De bygger på forskningsresultater og indberettede bivirkninger fra Danmark og resten af Europa«, siger overlæge Doris Stenver fra Lægemiddelstyrelsen. (...)

(Anm: Antipsykotika. (mintankesmie.no).)

Eli Lilly to Continue Schizophrenia Drug Program In Spite Of "Inconclusive" Study Results
pharmpro.com (1.4.2009)
INDIANAPOLIS (AP) — Eli Lilly & Co. said Sunday it will continue developing a potential schizophrenia treatment and considered recent midstage study results "inconclusive" after the drug candidate was no more effective than placebo. (...)

The company plans to start another midstage clinical trial on mGlu2/3.

Leerink Swann analyst Seamus Fernandez called the results a "serious blow" to Eli Lilly's pipeline.

"We believe any additional studies (with the drug candidate) should be viewed as exploring the mGlu2/3 mechanism, but the agent should not move forward into Phase III studies due to safety concerns," he said, in a note to investors. (...)

Eli Lilly to continue schizophrenia drug program
forbes.com 30.3.2009 (Associated Press)
Eli Lilly & Co. said Sunday it will continue developing a potential schizophrenia treatment and considered recent midstage study results "inconclusive" after the treatment candidate was found to be no more effective than placebo. (...)

In all 669 patients enrolled and 393 completed the study. None of the four doses of MGlu2/3 were more effective than placebo.

Eli Lilly also said the already approved anti-psychotic Zyprexa was no more effective than placebo when given in 15-milligram doses, once-daily. Zyprexa has previously proved more effective than placebo.

The company plans to start another midstage clinical trial on mGlu2/3. (...)

Lilly's Zyprexa/Prozac Combo Approved for Depression
pharmexec.findpharma.com 25.3.2009
Eli Lilly, on Monday, received approval to market its bipolar disorder treatment Symbyax—a combination of the antipsychotic Zyprexa and the antidepressant Prozac—to patients suffering from treatment-resistant depression (TRD). Symbyax becomes the first drug approved for TRD.

Symbyax was approved as a bipolar treatment in 2003, and Lilly has been trying diligently to expand its indications to patients with that haven’t responded to traditional drug therapies.

“We define treatment-resistant depression patients as people who fail to respond to at least two different anti-depressants in their current episode of depression,” said Sara Corya, medical director at Eli Lilly. “You can imagine, that a patient at that stage is thinking that nothing is going to work for them. Those are the folks that we feel will be appropriate for Symbyax.” (...)

Keeping us safe from drug reps
philly.com 27.1.2009
Eli Lilly and its "off-label marketing" of Zyprexa is not the only case of drug firms risking patients' health and lives. (...)

Lilly Looks Beyond Loss To Prasugrel
forbes.com 29.1.2009
Charges have sunk the company to a loss in the last two quarters, but hope is on the horizon.

Eli Lilly posted its second consecutive quarterly loss as Zyprexa sales continued to weaken and the acquisition of ImClone weighed heavy on its balance sheet. But investors are looking to next week, when Lilly may find out if it can fill its coffers with a new blockbuster. (...)

The fourth quarter was Lilly's second consecutive loss. It posted a loss in the third quarter due to a $1.4 billion charge related to a Zyprexa settlement. (See "Lilly Admits $1.4 Billion Zyprexa Mistake.") The Indianapolis-based company admitted guilt in a misdemeanor violation of the Food, Drug and Cosmetic Act for its improper marketing of Zyprexa to elderly patients with dementia during the period of September 1999 to March 2001. While Lilly did not admit guilt in the civil investigation related to these charges, it agreed to pay a total of $1.4 billion in settlements, and entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. (...)

Lilly Admits $1.4 Billion Zyprexa Mistake
forbes.com 30.1.2009
The big pharmaceutical firm pays out for its past marketing missteps.

Eli Lilly was the picture of remorse on Thursday, when the pharmaceutical company admitted to the improper marketing of its antipsychotic drug Zyprexa, agreeing to pay more than $1.4 billion in settlements.

The Indianapolis-based company admitted guilt in a misdemeanor violation of the Food, Drug and Cosmetic Act for its improper marketing of Zyprexa to elderly patients with dementia during the period of September 1999 to March 2001. (...)

Lilly nears $1.4B Zyprexa agreement, report says
forbes.com 14.1.2009
Drugmaker Eli Lilly and Co. is close to agreeing to a $1.4 billion settlement related to a government investigation into the marketing of its top seller Zyprexa, according to a New York Times report.

The Times reported Wednesday on its Web site that an agreement could be reached as soon as Thursday. (...)

But the Times reported in late 2006 that confidential documents show Lilly downplayed the drug's risks and marketed it for unapproved uses.

Lawsuits have made similar claims, accusing Lilly of pushing doctors to prescribe Zyprexa for "off-label" conditions like Alzheimer's disease. Doctors are free to prescribe drugs for unapproved uses, but pharmaceutical companies are prohibited from marketing them for those uses. (...)

Lilly Said to Be Near $1.4 Billion U.S.
Settlement
nytimes.com 14.1.2009
Eli Lilly, the drug company, is expected to agree as soon as Thursday to pay $1.4 billion to settle criminal and civil charges that it illegally marketed its blockbuster antipsychotic drug Zyprexa for unauthorized use in patients particularly vulnerable to its risky side effects. (...)

FDA not prepared to approve long-acting Zyprexa just yet
pharmatimes.com 8.1.2009
Eli Lilly has suffered a setback with the news that US regulators have delayed a decision on whether to approve a long-acting version of the blockbuster schizophrenia drug Zyprexa.

Lilly said that it has received a complete response letter from the US Food and Drug Administration (FDA) for Zyprexa (olanzapine) long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. The firm noted that the agency does not require any additional clinical trials for the continued review of the New Drug Application. (...)

Minnesota becomes latest to sue Lilly over Zyprexa
forbes.com 3.11.2008
INDIANAPOLIS - Minnesota has joined a long line of states aiming to wrangle money from Eli Lilly and Co. with a lawsuit over the drugmaker's top seller, the anti-psychotic Zyprexa.

The state attorney general's office filed a complaint in federal court last week echoing claims of other lawsuits that say Lilly downplayed the drug's side effects and marketed it for uses not approved by federal regulators.

Lilly has spent more than $1.1 billion since 2005 to settle product liability claims regarding the drug, which brought in more than $4.7 billion in revenue last year. It announced last month a $62 million settlement with 32 states and Washington, D.C., over Zyprexa marketing practices. (...)

Eli Lilly boosts adjusted 2008 profit forecast
forbes.com 23.10.2008 (Associated Press)
NEW YORK - Drugmaker Eli Lilly and Co. raised its adjusted profit forecast Thursday, although its results will include a large legal charge.

Eli Lilly (nyse: LLY - news - people) said it expects adjusted earnings between $3.97 and $4.02 per share in 2008, up from $3.85 to $4 per share. That excludes a charge of $1.48 billion, or $1.33 per share, which Lilly expects to pay to resolve an investigation into the market of its biggest-selling drug, the anti-psychotic Zyprexa. (...)

Lilly takes $1.4 B charge related to investigation
forbes.com 21.10.2008 (Associated Press)
INDIANAPOLIS - Drug maker Eli Lilly and Co. says it will take a $1.42 billion charge in the third quarter related to an investigation into marketing practices for the anti-psychotic Zyprexa.

The company says it is in advanced discussions to settle the investigation.
The investigation was led led by the U.S. Attorney's Office for the Eastern District of Pennsylvania. Lilly says the U.S. attorney's office launched its investigation in 2004.

The charge amounts to $1.29 per share. (...)

Eli Lilly settles Zyprexa inquiries in 32 states (Eli Lilly betaler etter Zyprexa-granskninger i 32 stater)
forbes.com 7.10.2008
NEW YORK - Eli Lilly & Co. said Tuesday it will pay $62 million to resolve investigations into the marketing and promotion of its antipsychotic drug Zyprexa in 32 states and Washington, D.C.

The payments will be divided between the states that were investigating the company, and Lilly said it will take a related charge of 4 cents per share in the third quarter. Zyprexa, the company's top-selling drug with 2007 sales of $4.8 billion, will continue to be available through Medicare programs in all states, and Lilly said there was no finding it had broken any laws.

The company also agreed to provide the states' attorneys general with information about the compensation it paid to health care professionals who received more than $100 per year for promotional speaking or consulting regarding Zyprexa, and agreed to other promotional terms. (...)

Lilly paid $15 million to settle a lawsuit with the state of Alaska in March, and since 2005, the company says it has settled approximately 31,000 individual product liability suits related to the drug's side effects. Those side effects include neuroleptic malignant syndrome and hyperglycemia. (...)

Psykofarmaka till dementa under lupp
lakemedelsvarlden.se 10.9.2008
Läkemedelsverket kommer inom de kommande veckorna presentera en ny vägledning kring hur antipsykotiska läkemedel ska användas, eller inte användas, hos dementa. Dokumentet är ett resultat av en workshop i våras. (...)

Judge to Unseal Documents on the Eli Lilly Drug Zyprexa
nytimes.com 5.9.2008
A federal judge in Brooklyn decided on Friday to unseal confidential materials about Eli Lilly’s top-selling antipsychotic drug Zyprexa, citing “the health of hundreds of thousands of people” and “fundamental questions” about the way drugs are approved for new uses.

The decision by Judge Jack B. Weinstein of Federal District Court came as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions that want Lilly to repay them billions of dollars they spent on the drug. They contend that Lilly hid the side effects of the drug and marketed it for unapproved uses. (...)

Some drugs risky for seniors, FDA says (Noen legemidler er risikable for eldre, ifølge FDA)
seattletimes.nwsource.com 17.6.2008
The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia... (...)

The FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly's Zyprexa and Johnson & Johnson's Risperdal.

FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side effects, such as tremors. (...)

New schizophrenia drugs no better, Dutch team find (Nye schizofreni-legemidler ikke bedre, ifølge Nederlandske forskere)
reuters.com 29.3.2008
LONDON (Reuters) - Costly new antipsychotic drugs are not significantly better than cheaper older ones at treating a first episode of schizophrenia, Dutch researchers said on Friday.

The finding adds to controversy about the benefits of second-generation products like AstraZeneca Plc's Seroquel and Eli Lilly and Co's Zyprexa, which were introduced in the 1990s and are now multibillion-dollar sellers. (...)

Lilly agrees to $15 million payout to settle Alaskan Zyprexa case
pharmatimes.com 26.3.2008
26 March 2008
US drug giant Eli Lilly has agreed to pay the state of Alaska $15 million to settle claims that its Medicaid programme was not adequately warned over potential side effects from the use of its antipsychotic Zyprexa. (...)

Lilly Settles Alaska Suit Over Zyprexa
forbes.com 26.3.2008
NEW YORK - Eli Lilly and Co. and Alaska announced a $15 million settlement Wednesday in the state's lawsuit over the use of the drug Zyprexa in its Medicaid program.

The deal ensures that Alaska will be treated as well as any other state that may settle with Lilly over similar claims involving the drug, which is used to treat schizophrenia and bipolar disorder.

The agreement included no admission of wrongdoing by Lilly. (...)

Side-Effect Concerns Derail Schizophrenia -Drug Approval (Bekymringer for sideeffekter forpurrer godkjenning av schizofreni-legemiddel)
Psychiatr News 2008;43(6):19 (March 21) (© 2008 American Psychiatric Association)
The FDA issues a not-approvable letter for long-acting olanzapine injection for schizophrenia treatment out of concerns about an unpredictable, and potentially serious, side effect. (...)

Of the 24 patients who had cases of excessive sedation, 20 were hospitalized or visited an emergency department. Five reported temporary loss of consciousness, including three who could not be aroused for a period of time. One of these patients was clinically diagnosed with coma, and another with "symptoms consistent with coma." Two patients were intubated. All patients recovered, and 12 continued to receive additional olanzapine pamoate injections, company representatives said. (...)

(Anm: olanzapine; omsettes under handelsnavnet Zyprexa.)

Eli Lilly E-Mail Discussed Unapproved Use of Drug
nytimes.com 15.3.2008
ANCHORAGE — John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators. (...)

API patients on Zyprexa got diabetes, official says
adn.com 13.3.2008
TRIAL: Medical director testifies risks weren't fully known. (...)

Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies (Lilly ventet for lenge med advarsel om schizofreni-legemiddel, ifølge leges vitnesbyrd)
nytimes.com 8.3.2008
ANCHORAGE — Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes.

Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes.

Lilly setter "profitt foran forbrukerens anliggende", sa Dr. Gueriguian på slutten av sitt fire timers vitnemål. (...) (Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony.)

State: No Alerts on Zyprexa Side Effects
forbes.com 6.3.2008
ANCHORAGE, ALASKA - Eli Lilly and Co. failed to adequately warn doctors and patients of dangerous side effects associated with its drug Zyprexa, an attorney for Alaska said Wednesday in opening arguments in the state's lawsuit against the drug maker.

Lilly did not adequately disclose that using the drug, prescribed to treat schizophrenia and bipolar disorder, could lead to severe obesity, elevated blood sugar and diabetes, lawyer Scott Allen said.

"If they put a warning on this product, their sales would fall," Allen said. "They would lose money. People would choose another drug, and they decided not to disclose what they knew." (...)

FDA Wants More Info on Zyprexa Injection (FDA ønsker mer info på Zyprexa-injeksjon)
forbes.com 28.2.2008
INDIANAPOLIS - The Food and Drug Adminstration won't approve Eli Lilly and Co.'s Zyprexa long-acting injection for adult schizophrenia until the company produces more information about the risks and cause of the excessive sedation seen in certain patients, Eli Lilly said Thursday. (...)

FDA panel supports long-acting Zyprexa
pharmatimes.com 7.2.2008
A US Food and Drug Administration Advisory Committee has supported the approval of a long-acting form of Eli Lilly’s antipsychotic Zyprexa, despite concerns over excessive sedation side effects in some patients. (...)

FDA staff cite safety concern with Lilly drug
reuters.com 4.2.2008
WASHINGTON (Reuters) - Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's blockbuster Zyprexa schizophrenia drug, U.S. drug reviewers said in an analysis released on Monday. (...)

Lilly in Settlement Talks With U.S.
nytimes.com 30.1.2008
Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments. (...)

Zyprexa: Suicide can be a Side Effect of Drugs
lawyersandsettlements.com 10.1.2008
Washington, DC: The news is getting harder and harder to ignore. More drugs are being linked to an increased risk of violence and suicide. While some people would argue that, at least in the case of Zyprexa, it is the underlying condition of the patient that increases the risk of suicide, there are more drugs being linked to this risk, making it more difficult to deny that medications can cause people to commit suicidal acts. (...)

FDA to Meet on Long-Lasting Zyprexa
forbes.com 8.1.2008
WASHINGTON - The Food and Drug Administration has scheduled a meeting next month to review the safety and effectiveness of a long-acting version of Eli Lilly & Co.'s schizophrenia drug. (...)

FDA said it is particularly concerned about incidents of severe drowsiness among patients tested with the new formulation.

Zyprexa is currently available in pill form to treat schizophrenia and bipolar disorder. Sales grew 6 percent to $1.67 billion in the final quarter of last year.

Shares of Eli Lilly & Co. rose $1.03 to $55.57 in morning trading Tuesday. (...)

A risky drug may get wider market
sptimes.com 16.12.2007
The FDA may approve Zyprexa for kids, despite its significant side effects in adult use

It sounds like a cosmic, FDA joke:

The Food and Drug Administration approves the antipsychotic drug Zyprexa to treat adults with schizophrenia or bipolar disorder. It becomes a market wonder, a bestseller. But the side effects turn out to be dangerous; some patients develop diabetes.

Some 30,000 people sue the manufacturer, Eli Lilly. The pharmaceutical giant shells out more than $1-billion to settle the cases.

Here comes the punch line:

Though studies show that kids are even more susceptible to Zyprexa's dangerous side effects, now Lilly wants the government's seal of approval for adolescents to use it. And the FDA is about to say yes. (...)

Eli Lilly Putting Zyprexa Patients At Risk of Suicide
lawyersandsettlements.com 25.11.2007
Rockville, MD: Now we know there is a corelleation between Zyprexa and suicide, people who may not have realized that their suicidal thoughts were related to Zyprexa, now understand that they may not have been in control of their thoughts and actions at all. Unfortunately, some patients, including youth, have committed suicide while taking this medication and even though their families can file lawsuits against Eli Lilly, nothing will bring these victims back.

One website, [psychdrugdangers.com] makes available the FDA's Adverse Event Reporting System. The website claims to have a listing of Adverse Event Reports made "between 2004 and 2006 where the listed psychiatric drug was identified as the Primary Suspect Drug responsible for causing these reactions." If this website is accurate, the number of suicides and suicide attempts by people who were taking Zyprexa is alarming and is not something that should not be ignored. (...)

Doctor Who Leaked Documents Will Pay $100,000 to Lilly
nytimes.com 30.10.2007
A doctor who leaked confidential materials about Eli Lilly’s antipsychotic drug Zyprexa agreed yesterday to settle a legal dispute with Lilly over the documents. (...)

Dr. Egilman acknowledged that Lilly had a different view of the safety of its schizophrenia drug Zyprexa than was portrayed in the documents. He did not admit that he accepted Lilly’s view that Zyprexa was safe. (...)

Läkemedel kan orsaka ”livsstilssjukdomar”
lakemedelsvarlden.se 22.10.2007
(...) Stephan Rössner nämnde särskilt psykofarmaka som orsak till övervikt. Han berättade att han möter unga flickor som tagits in för graviditetspsykos och kommer ut botade från sina psykiska besvär men 30 kilo tyngre. (...)

Givetvis ska patienter som verkligen lider av schizofreni få dessa läkemedel, men problemet är att preparaten ibland förskrivs utanför indikation och alldeles för lättvindigt. I Uppdrag Granskning framgick att Zyprexa (ett av de psykofarmaka som orsakar mest viktuppgång) försäljs för omkring 250 miljoner kronor varje år i Sverige. Detta fast läkemedlet enbart är godkänt för behandling av schizofreni och bipolär sjukdom. (...)

Patients Come Forward With Zyprexa Suicide Complaints
lawyersandsettlements.com 20.10.2007
Boise, ID: Since LawyersandSettlements began posting about the link between [Zyprexa and suicide], we have received many emails from frustrated patients who say taking Zyprexa completely altered their personality and resulted in suicide attempts. We have also heard from family members of patients who committed suicide. These family members all say that their loved ones changed drastically for the worse after they started taking Zyprexa. (...)

Studies have also shown that Zyprexa is more expensive, but not more effective, than older drugs that were used to treat schizophrenia. Furthermore, a study published in the November 2007 issue of the Journal of Affective Disorders found an increase in suicidal behavior in bipolar patients who took antipsychotic medications. (...)

Lilly Adds Strong Warning Label to Zyprexa, a Schizophrenia Drug
nytimes.com 13.10.2007
Eli Lilly yesterday 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. (...)

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 period. (...)

Ms. Lemons also noted that older antipsychotic medicines also have severe side effects, including a tendency to cause facial tics.

The new warnings may add to the controversy surrounding Zyprexa, which is by far Lilly’s best-selling drug. (...)

Internal Lilly documents disclosed by The New York Times last December indicated that Lilly was aware of Zyprexa’s tendency to cause weight gain and blood sugar changes by the late 1990s but played down the risks. (...)

Lilly has spent $1.2 billion since 2004 to settle lawsuits from 28,500 people who claimed they developed diabetes or heart problems after taking the drug. At least 1,200 more lawsuits are still pending. (...)

Zyprexa To Win FDA Approval For Teens
pharmalot.com 26.9.2007
September 26th, 2007 7:39 am By Ed Silverman
That’s right. And it’s likely to occur because a senior FDA official overruled his colleagues. A three-member FDA team of medical reviewers initially urged rejecting Zyprexa for pediatric use because of inconsistent data from studies in US and Russian teens, Bloomberg News reports. But in an April 29 memo posted on the FDA’s Web site (look here), Thomas Laughren, head of the agency’s psychiatry division, wrote that the drug’s benefits in some studies outweighed the reviewers’ concerns.

Zyprexa, with $4.4 billion in global sales in 2006, is Lilly’s biggest seller and the biggest among five antipsychotics. But the teen market is important to Lilly, because Zyprexa’s market share has slipped as 86 percent of psychiatrists are writing fewer scrips due to side effects - weight gain and diabetes. Johnson & Johnson’s Risperdal last month became the only drug in the class cleared for pediatric use though docs have long prescribed the pills to children.

A growing number of states, meanwhile, are suing Lilly over improperly marketing Zyprexa. Their argument - downplaying or hiding side effect data while state Medicaid programs fork over big money for the med. (...)

Lilly's Zyprexa Poised for Approval for U.S. Teens (Update3)
bloomberg.com 26.9.2007
Sept. 26 (Bloomberg) -- Eli Lilly & Co.'s best-selling schizophrenia drug Zyprexa is poised to get U.S. approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues. (...)

Almost 44 percent of teenagers taking Zyprexa gained more than 7 percent of their body weight, compared with 7 percent of those on placebos, according to Laughren. Levels of fats, blood sugar and the hormone prolactin increased in patients taking Zyprexa, while dropping in placebo patients.

"A 7 percent increase in body weight in a young patient in such a short time may predispose people to diabetes and create a cardiac burden as the heart is forced to work harder,'' Klotz said."

Ark.: Lawsuit Over Drug Marketing
forbes.com 24.9.2007
LITTLE ROCK - A Houston-based private law firm will pursue a suit seeking millions of dollars for Arkansas' Medicaid program from Eli Lilly and Co. and two other drug companies accused of improperly marketing anti-psychosis drugs.
Attorney General Dustin McDaniel has told state legislators that the suit would seek recovery of money paid by the state's Medicaid program for anti-psychosis drugs prescribed for uses not approved by federal regulators or indicated in labeling. (...)

Zyprexa Linked to Suicide Risk
lawyersandsettlements.com 17.9.2007
Houston, TX: Zyprexa, an atypical antipsychotic drug, has been linked to an increased risk of suicide acts. Clinical trials for Zyprexa have found that patients taking the drug are more likely to commit suicide than patients on any other antipsychotic medication. Lawsuits are now being filed against the maker of Zyprexa, alleging the company knew about the risk of suicidality but failed to warn physicians or the public about that risk.

Patients taking Zyprexa have reported increased adverse reactions to the drug, including agitation, sleep disturbances and akathisia (a condition that involves inner restlessness, agitation and emotional trauma). Akathisia has been linked to suicide and homicide and is a common adverse side effect of antipsychotic drugs. In fact, both sleep disturbances and akathisia are precursors to suicide.

Dr. David Healy, a Professor of Psychiatry at the University of North Wales, noted, "The studies in adults with Zyprexa that Lilly submitted to the FDA demonstrate, as far as I can establish, a higher death rate on Zyprexa than on any other antipsychotic ever recorded."

Lawsuits have been filed against Eli Lilly & Company, makers of Zyprexa, alleging that the antipsychotic has caused people to commit, or attempt to commit, suicide. One such case, known as Ebel vs. Eli Lilly & Company, was filed in Texas. (...)

Eli Lilly Settles Zyprexa Lawsuit; Attempts to Shift Blame to Legal Advertising
newsinferno.com 19.6.2007
Eli Lilly, the makers of Zyprexa announced it had settled another 900 lawsuits against its anti-psychotic medication Zyprexa, on that very same day Eli Lilly was claiming that legal advertisements where hurting patients. The company asserts that a recent study showed that patients using Zyprexa were more likely to abruptly stop taking it once they were exposed to legal advertising highlighting its harmful side effects. The study, which Eli Lilly paid for, surveyed only 402 patients – a small number considering that an estimated 2 million people may be using Zyprexa. (...)

Eli Lilly: Drug Ads Influencing Patients
forbes.com 13.6.2007
Eli Lilly and Co., 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. (...)

Lilly Settles Zyprexa Lawsuits (Lilly inngår forlik i Zyprexa-søksmål)
forbes.com 12.6.2007
Eli Lilly and Co. settled an additional 900 product liability lawsuits involving its top-selling drug, the anti-psychotic Zyprexa.

The Indianapolis-based drug maker declined to release the settlement amount. But spokeswoman Marni Lemons said Tuesday it would have no material impact on the company's financial statements.

Lilly has settled roughly 28,500 product liability claims involving Zyprexa over the past two years. In June 2005, the company settled 8,000 claims for $690 million. This past January, it settled more than 18,000 for roughly $500 million. (...)

U.S. Wonders if Drug Data Was Accurate (Amerikanske myndigheter stiller spørsmål om legemiddeldata var korrekte)
nytimes.com 25.4.2007
The Food and Drug Administration is examining whether Eli Lilly & Company provided it with accurate data about the side effects of the antipsychotic drug Zyprexa, a potent medicine that has been linked to weight gain and diabetes.

Zyprexa is Lilly’s top-selling drug, with $4 billion in annual sales.

The F.D.A. has questions about a Lilly document from February 2000 in which the company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug.

That document was not submitted to the agency. But a few months later, Lilly provided data to the F.D.A. that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not.
The F.D.A. confirmed its inquiry in response to questions from The New York Times. The agency said it had not yet decided whether to take any action against Lilly. (...)

Medisiner kan utløse ulvehunger
bladet.psykiskhelse.no 28.3.2007
Vanlige medisiner mot alvorlige psykiske lidelser kan gi økt appetitt, kraftig vektøkning og diabetes. – Jeg synes problemet med vektøkning blant psykisk syke er blitt større de siste årene, sier fagkonsulent Svein Einarsbøl i Asker kommune. (...)

De vanligste medisinene mot alvorlige psykiske lidelser kan medføre en stadig sultfølelse og dermed kraftig vektøkning. Noen medisiner gir også økt risiko for type 2 diabetes. Særlig er dette en bivirkning av noen av de nye legemidlene mot psykose, de såkalte atypiske antipsykotiske legemidlene. Denne vektøkningen kommer på toppen av de vanlige livsstilsproblemene som «annenhver nordmann» sliter med. De som har psykiske lidelser, kan derfor få dobbel belastning. (...)

Senator Probes Eli Lilly Drug Promotion (Senator gransker Eli Lillys markedsføring av legemiddel)
forbes.com 5.4.2007
Republican Sen. Charles Grassley has requested documents from Eli Lilly in the wake of lawsuits alleging the company downplayed risks and wrongly promoted its top-selling drug Zyprexa.

In a letter released late Wednesday, the Iowa lawmaker asks Lilly to provide "e-mails, letters, reports" and other internal documents relating to Zyprexa, which is approved to treat schizophrenia and bipolar disorder. Grassley is the ranking member of the Senate Finance Committee.

Indiana-based Lilly said Thursday it will cooperate with the request from the Iowa lawmaker. (...)

(Anm: Sen. Chuck Grassley. GRASSLEY SEEKS MARKETING AND SAFETY DOCUMENTS FROM MAJOR DRUG MAKER. grassley.senate.gov 4.4.2007.)

New York Times Examines Eli Lilly Program Aimed at Reducing Unnecessary Medicaid Prescriptions for Antipsychotic Drug Zyprexa
kaisernetwork.org 23.3.2007
The New York Times on Friday examined an Eli Lilly program that offers state Medicaid programs assistance in monitoring physicians' prescribing practices for Zyprexa, a treatment for schizophrenia and bipolar disorder that is the single largest drug cost in state Medicaid budgets. Under the program, which Lilly has implemented in two dozen states since 2003, the company pays New York-based Comprehensive NeuroScience an undisclosed amount to monitor physicians' prescribing practices. (...)

In Some States, Maker Oversees Use of Its Drug
nytimes.com 23.3.2007
Many states, looking to rein in the cost of expensive antipsychotic drugs like Zyprexa, have turned to an unusual ally for help — the very company that sells the drug.

At more than $300 for a monthly prescription, Zyprexa, which is used to treat schizophrenia and bipolar disorder, is the single biggest drug cost for state Medicaid budgets.

So Eli Lilly, the maker of Zyprexa, offers to help states monitor doctors who treat Medicaid patients to make sure they are not wasting money on mental illness drugs because of what psychiatrists call “sloppy prescribing” — giving patients too many similar medications or doses that are too high. Twenty states use Lilly’s free service. (...)

Lilly wins court case to get leaked Zyprexa documents back
pharmatimes.com 15.2.2007
Eli Lilly's battle to defend its actions concerning Zyprexa has taken yet another turn with the news that a US federal judge has ordered several individuals to orders return confidential papers leaked to the media about the blockbuster antipsychotic.

(…) Whistleblower slams FDA over handling of Zyprexa
Lilly may have won a victory over Zyprexa in the courts but the drug found itself once again at the centre of attention in the US Congress. Dr David Graham, the US Food and Drug Administration official who caused a stir over the last couple of years by criticising the agency's handling of Merck & Co's withdrawn painkiller Vioxx (rofecoxib), told a congressional hearing that the FDA acted far too slowly in changing the label on Zyprexa to include the weight gain/diabetes risk. The famous whistleblower also told the hearing that other antipsychotic medications also warrant closer scrutiny. (...)

Judge Rules Drug Documents Must Be Returned to Eli Lilly
nytimes.com 14.2.2007
A federal district judge in Brooklyn ruled yesterday that confidential marketing materials belonging to Eli Lilly & Company about its top-selling anti-psychotic drug Zyprexa must be returned to the company by a doctor and a lawyer who, the judge said, engaged in a scheme to leak them to the news media. (...)

Researchers discover why antipsychotics cause weight gain
pharmatimes.com 15.2.2007
Scientists at a prestigious US medical institute believe that they have uncovered the reasons why antipsychotic drugs cause patients to gain so much weight that they often develop life-threatening complications such as diabetes and heart disease.

Professor Solomon Snyder of the Johns Hopkins School of Medicine and one of the authors of the study, which will be published online next week at the Proceedings of the National Academy of Sciences, said: "We have now connected a whole class of antipsychotics to natural brain chemicals that trigger appetite." (...)

Eli Lilly Profit Falls But Still Beats Expectations
forbes.com 31.1.2007
Cash-draining litigation and plant closings drove down Eli Lilly’s fourth-quarter profit, but plenty of pill poppers still sought out the drug-maker’s products and helped the company beat expectations. (...)

Ny ekonomisk uppgörelse kring Zyprexa
Läkemedelsvärlden 2006(1-2) (FEBRUARI 2007)
Arton tusen personer får dela på femhundra miljoner dollar. Det blev resultatet i den senaste uppgörelsen mellan läkemedelsföretaget Eli Lilly och patienter som behandlats med Zyprexa. (...)

Lilly investigated in US over the marketing of olanzapine (Lilly granskes i USA grunnet sin markedsføring av olanzapine (Zyprexa))
BMJ 2007;334:171 (27 January) (British Medical Journal)
The multinational drug company Eli Lilly faces the threat of lawsuits from US state governments over alleged illegal practices in the marketing of its drug olanzapine (Zyprexa), which is used to treat schizophrenia and bipolar disorder.

The company has already agreed to settle more than 18 000 outstanding product liability claims that relate to the drug in the United States for an undisclosed sum. (...)

The states are investigating claims that the company concealed data that show serious risk of side effects including weight gain, hyperglycaemia, and diabetes. (...)

Eli Lilly was concerned by Zyprexa side-effects from 1998 (Eli Lillys var bekymret over bivirkninger ved Zyprexa siden 1998)
business.timesonline.co.uk 23.1.2007
Eli Lilly, the American pharmaceutical giant that has consistently denied any link between Zyprexa, its antipsychotic drug, and diabetes, was concerned about the side-effects of the drug as early as 1998, according to documents seen by The Times. (...)

States Study Marketing of Lilly Pill (Stater gransker markedsføring av Lilly-pille)
nytimes.com 20.1.2007
Stepping up government investigations into Eli Lilly’s marketing of its best-selling drug Zyprexa, state prosecutors in Illinois and Vermont have demanded that the company turn over information about the way it promoted the medication.

On Thursday, lawyers from the consumer protection division of the Illinois attorney general’s office demanded that Lilly hand over marketing materials, e-mail messages, and other documents with information about promotion of Zyprexa. Vermont investigators issued a similar order yesterday morning.
The orders are the civil equivalents of criminal subpoenas, according to Deborah Hagan, the chief of the Illinois consumer protection division. (...)

Documents Borne by Winds of Free Speech
heraldtribune.com 15.1.2007
(...) It is a messy plot that pits Eli Lilly, the pharmaceutical giant at the center of several articles in The New York Times suggesting that the company tried to hide or play down the health risks of its leading antipsychotic drug, Zyprexa, and lawyers representing various individuals, organizations and Web sites — all arguing that their online speech has been gagged. (...)

Drug company seeks to suppress internal memos (Legemiddelfirma forsøker å hemmeligholde interne notater)
BMJ 2007;334:59 (13 January) (British medical Journal)
The drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet. (...)

DRUG MAKER SETTLES 18,000 ZYPREXA CLAIMS
INDYSTAR.COM 5.1.2007
Lilly's top moneymaker has also been a big headache
Indy-based firm will have paid more than $1 billion to resolve suits over antipsychotic medication

Facing the prospect of lengthy trials and unfavorable publicity, Eli Lilly and Co. on Thursday put behind it thousands more legal claims over its best-selling drug, Zyprexa. (...)

Lilly Settles With 18,000 Over Zyprexa
nytimes.com 5.1.2007
Eli Lilly agreed yesterday to pay up to $500 million to settle 18,000 lawsuits from people who claimed they had developed diabetes or other diseases after taking Zyprexa, Lilly’s drug for schizophrenia and bipolar disorder. (...)

Criminal Prosecution of Lilly Sought Over Zyprexa (Lilly best tiltalt for Zyprexa)
by Evelyn Pringle
opednews.com 4.1.2007
California Attorney, Ted Chabasinski, is calling for the criminal prosecution of Eli Lilly executives for hiding the adverse effects of Zyprexa, based in part on articles last month in the New York Times which quote internal company documents that revealed that Lilly knew about the adverse effects for a decade but kept the information hidden. (...)

Mother Wonders if Psychosis Drug Helped Kill Son
ytimes.com 4.1.2006
At first, the psychiatric drug Zyprexa may have saved John Eric Kauffman’s life, rescuing him from his hallucinations and other symptoms of acute psychosis. (...)

For many patients, the side effects of Zyprexa are severe. (...)

Exactly how many people have died as a result of Zyprexa’s side effects, and whether Lilly adequately disclosed those risks, are central issues in the thousands of product-liability lawsuits pending against the company, and in state and federal investigations. (...)

Eli Lilly now faces federal and state investigations about the way it marketed Zyprexa. Last week — after articles in The Times about the Zyprexa documents — Australian drug regulators ordered Lilly to provide more information about what it knew, and when, about Zyprexa’s side effects. (...)

Eli Lilly to Settle More Zyprexa Suits
forbes.com 4.1.2006
Drug maker Eli Lilly and Co. said Thursday it will settle more liability lawsuits for its anti-psychotic medication Zyprexa for less than $500 million.
The settlement covers more than 18,000 claims that the company did not adequately warn patients taking the medication of a heightened diabetes risk. The company did not disclose the exact dollar amount of the new settlement. About 1,200 claims are still outstanding.

In June 2005, Lilly settled more than 8,000 similar claims for a little less than $700 million.

Lilly will record a settlement charge in the fourth quarter. Analysts surveyed by Thomson Financial expect fourth-quarter earnings per share of 82 cents. (...)

New York Times kräver kongressförhör om Zyprexa
Läkemedelsvärlden 2006(12) (Desember)
Efter avslöjanden i en rad artiklar kräver New York Times på ledarplats att kongressförhör ska inledas med anledning av företaget Lillys marknadsföring av schizofreniläkemedlet olanzapin (Zyprexa). (...)

Court Orders Lawyer to Return Documents About an Eli Lilly Drug
nytimes.com 20.12.2006
A federal court in Brooklyn overseeing product liability lawsuits against Eli Lilly’s best-selling drug Zyprexa has ordered the lawyer who provided company documents to The New York Times and other organizations and individuals to return the documents. (...)

Eli Lilly Said to Play Down Risk of Top Pill (Eli Lilly hevdes å ha tonet ned risiko for bestselgende pille)
nytimes.com 17.12.2006 (New York Times)
The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

Dokumenter overlevert Times av advokat som representerer pasienter, viser at lederne i Lilly holdt tilbake informasjon for leger om Zyprexas link til fedme og tilbøyelighet til å øke blodsukker - begge kjente for risikofaktorer for diabetes. (The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.)

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug. (...)

Documents suggest Lilly concealed drug's risks (Dokumenter tyder på at Lilly hemmeligholdt risiko ved legemiddel)
seattletimes.nwsource.com 17.12.2006
The drug maker Eli Lilly has engaged in a 10-year effort to downplay the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mails among top company managers. (...)

Lilly has consistently denied such a link and did so again Friday in a written response to questions about the documents. The company defended Zyprexa's safety and said the documents had been taken out of context. (...)

Lillys dementi saknar tyngd”
Läkemedelsvärlden (November 2005)
DEBATT
Inte oväntat bemöter Eli Lilly min kommentar om Zyprexa i Nils Bergeås intervju (LMV 11/05), men insändaren gör också ett anmärkningsvärt påstående. Jag refererade till dokumentation om allvarliga biverkningar undanhållna av det amerikanska huvudkontoret, som en advokat (också läkare) tagit del av i ett rättsfall. Jag har svårt att tro att det svenska kontoret haft tillgång till hemliga dokument från USA.

Dementin fran Eli Lilly Sweden AB saknar tyngd eftersom den inte bekräftat att anställda på dotterbolaget är insatta i frågan.

Mörkning av negativ information om marknadsförda läkemedel är tyvärr vanlig. Sanningen kommer oftast inte fram förrän fallen går till domstol. Endast i undantagsfall diskuteras de i medicinska tidskrifter. Vi rapporterade till exempel om Bayer och cerivastatin (Lipobay) förra året (1).

En stor jämförande studie av Zyprexa och andra atypiska antipsykotika vid schizofreni (CATIE, 2005) rapporterade nyligen att tre av fyra patienter avbröt behandlingen i förtid, främst på grund av bristande effekt eller biverkningar. För Zyprexa avbröts behandlingen i 64 procent av fallen. Detta ger inget kraftfullt stöd för Zyprexas "effekt och säkerhet"!

Mest häpnadsväckande för mig i Eli Lillys inlägg är påståendet att Zyprexa är "ett läkemedel som räddar liv". Var finns dokumentationen för att Zyprexa förbättrar överlevnaden? Kanske något för NBL att ta ställning till.

Jag välkomnar Läkemedelsindustriföreningens agerande. Dess kursändring är det första steget mot bättre öppenhet rörande läkemedelsbiverkningar och säkerhetsutvärdering. Tyvärr är erfarenheten att frivilliga åtaganden oftast är relativt effektlösa. Vad som saknas, det andra steget, är att brott mot dessa principer får allvarliga konsekvenser – indragning av läkemedel, höga böter och i värsta fall fängelse.

I USA finns för närvarande lagförslag i kongressen som omfattar dessa typer av straff. Om Lif och dess systerorganisationer i Europa är ovilliga att ta det andra steget, är risken att deras agerande faller under rubriken "lip service".

Curt Furberg
Professor, Wake Forest University, USA

”Lilly döljer negativ information om Zyprexa”
Läkemedelsvärlden (November 2005)
Curt Furberg kräver större ärlighet från läkemedelsindustrin

Enligt Curt Furberg försvinner läkemedelsföretagens etiska tänkande så fort ett läkemedel blir storsäljare – då har man inte råd att vara öppna med negativa studieresultat och biverkningsrapporter. Företagen lovar också rutinmässigt inför godkännanden att genomföra uppföljningsstudier – som sedan sällan blir av. (...)

– Det jag reagerar på är att många tror att det här bara gäller Merck och Vioxx. Men det enda nya här är att vi fått en öppen diskussion i media efter indragningen. Men det finns i själva verket värre exempel, exempelvis Zyprexa.

– Det stora problemet är att industrin känner till biverkningar som inte rapporteras till FDA, inte till läkarkåren, inte till patienterna. (...)

– Det jag reagerar på är att många tror att det här bara gäller Merck och Vioxx. Men det enda nya här är att vi fått en öppen diskussion i media efter indragningen. Men det finns i själva verket värre exempel, exempelvis Zyprexa.

– Det stora problemet är att industrin känner till biverkningar som inte rapporteras till FDA, inte till läkarkåren, inte till patienterna.

Hur vet du det?

– Jag har suttit som expertvittne i flera rättsfall. Då släpps all intern dokumentation så att vittnena kan ta del av den. Det har bland annat gällt i rättegångar om cerivastatin (Lipobay) som försvann från marknaden, och Warner Lamberts diabetesmedel troglitazon (Rezulin), där interna dokument tidigt visat att läkemedlen hade fler biverkningar än vad alla utomstående visste.

Menar du att Zyprexa kan bli ”nästa Vioxx”?

– Allvarliga former av diabetes och kraftig viktökning har rapporterats. Ett rättsfall var på gång med Zyprexa och jag blev inkopplad, fick ta del av information och talade med en advokat. Han, som var erfaren av liknande fall, berättade att ”det här är värre än allt annat jag sett, det finns ingen chans att företaget kan låta det här gå till domstol, då offentliggörs allting. De måste gå med på en uppgörelse i godo.”

– Så blev det också. Man jobbar konsekvent med sådana uppgörelser i USA.

– Problemet är att företagen inte har råd att vara öppna när läkemedel kommit ut på marknaden och säljer mycket. Man undanhåller data. Min förhoppning är att företagen under trycket av böter, rättsfall och nya lagar tvingas vara mer öppna.

– Det som är skrämmande är att så länge böterna är lägre än inkomsterna vill man ha kvar ett läkemedel på marknaden. Med ett sådant resonemang ser man inget människovärde.

– Så har åtminstone inte MSD resonerat. Man drog visserligen på Vioxx-beslutet men när studien kom agerade man föredömligt på en gång. Man hade viss intern dokumentation, och kanske borde man dragit in Vioxx tidigare, men det är alltid lätt att säga i efterhand. Merck är alltså inte på något sätt värre än de andra företagen, vilket man kan tro av debatten, kanske till och med tvärtom.

Lilly replikerar: "Felaktigt och oansvarigt om Zyprexa"
Läkemedelsvärlden (November 2005)

Svidande kritik mot Lilly måste bemötas
Lederartikkel. Nils Bergeå, t f chefredaktör
Läkemedelsvärlden (Novemger 2005)
SE ÄVEN ADDENDUM (20051104) NEDANFÖR LEDARTEXTEN

Efter Vioxx-indragningen har läkemedelsindustrins rykte slagit alla bottenrekord. Det gäller inte minst i USA, och situationen är till stor del självförvållad.
Den mest relevanta kritiken mot företagen handlar om mörkning av studieresultat och biverkningsrapporter, ovilja att genomföra uppföljningsstudier som man utfäst sig att verkställa, olika former av studiemygel och publikationsbias till förmån för ”fördelaktiga” studieresultat. Detta har parats med ett i många fall osunt förhållningssätt till kunderna, läkarkåren.

Det tycks vara en bister sanning att företagen, som i fallet med Vioxx, inte ansett sig ha råd att vara öppna om säkerhetsproblem när ett läkemedel blivit en storsäljare. Det nya efter Vioxx är att den amerikanska allmänheten börjat förstå det.

Enligt professor Curt Furberg, som intervjuas i detta nummer, är Zyprexa ett väl så flagrant aktuellt exempel. Lilly vet betydligt mer än vad som är allmänt känt om läkemedlets koppling till allvarliga metabola biverkningar och diabetes, menar han. Uppgörelser med drabbade patienter betingar i tysthet skyhöga belopp i USA, men än så länge är dessa summor lägre än intäkterna och läkemedlet måste därför hållas kvar på marknaden, hävdar Furberg. (...)

Curt Furbergs kritik mot Lilly om Zyprexa, se länk i högermarginalen här intill, är stenhård. Jag har sedan jag genomförde intervjun med honom även tagit del av Lillys syn på saken, och företagets bild av verkligheten är inte oväntat en helt annan.

Är det Furberg gett uttryck för korrekt är det skrämmande och ett tecken på att industrins rörelse mot ökad öppenhet inte kommit så långt som man kan önska. För patienternas skull är förhoppningsvis Lillys version den som bäst överensstämmer med verkligheten. Lilly har gått i första ledet i en föredömlig utveckling mot ökad transparens, och det agerande Curt Furberg beskriver vore helt oförenligt med detta.

I alla händelser lär antagligen ord stå mot ord i frågan om Zyprexa, vilket riskerar leda till en infekterad ordväxling i Läkemedelsvärldens spalter. Lilly har nu replikerat – se länk i högermarginalen – och Curt Furberg har sagt sig vilja föra meningsskiftet vidare.

Kommentar till Lillys replik från Läkemedelsvärlden
Läkemedelsvärlden (November 2005)

Replik från Lif: "Vi menar vad vi säger"
Läkemedelsvärlden (November 2005)

Lilly Profit Rises on Sales of Newer Drugs
New York Times 20.10.2005
INDIANAPOLIS, Oct. 20 (AP) - Eli Lilly & Company said Thursday that its third-quarter profit rose 5 percent on strong sales of newer drugs and diabetes products, which helped offset lackluster growth of its anti-psychotic drug Zyprexa.

Net income grew to $794.4 million, or 73 cents a share, from $755.2 million, or 69 cents a share, a year earlier. Revenue rose 10 percent, to $3.60 billion from $3.28 billion, led by a 13 percent increase in sales of diabetes products to $652.8 million. (...)

Sales of Zyprexa rose 1 percent to $1.04 billion. Zyprexa sales fell 10 percent in the United States but rose 14 percent overseas.

Sales of Lilly's treatment for attention deficit disorder, Strattera, fell 14 percent, to $140.9 million from a year ago. In late September, Lilly announced it was adding a warning to the medication to alert patients that it could cause suicidal thoughts in children taking the drug.

Shares of Lilly, which is based in Indianapolis, fell 35 cents, to close at $51.25.

Study Finds No Best Schizophrenia Drug
Los Angeles Times 19.9.2005
— The nation's leading schizophrenia drug doesn't work much better than an older, far cheaper medicine, says a major government study that found no clear winner in comparing treatments for the devastating mental illness.

The biggest surprise: An overlooked generic drug called perphenazine -- around since the 1950s but seldom used -- proved as effective as all but one of a class of newer treatments called atypical antipsychotics that make up 90 percent of schizophrenia-related prescriptions today. (...)

Government study information: http://www.nimh.nih.gov/healthinformation/catie.cfm

Leading schizophrenia drug no better than older, cheaper kind
USA TODAY 19.9.2005
— The nation's leading schizophrenia treatment doesn't work much better than an older, far cheaper drug, says a government study that is the most comprehensive comparison of therapies for the 3.2 million Americans with the devastating mental illness. (...)

Those taking Eli Lilly & Co.'s Zyprexa did slightly better, staying on the medicine longer before switching and thus experiencing slightly fewer hospitalizations, researchers reported Monday.

However, Zyprexa was far more likely than leading competitors to cause some troubling side effects: severe weight gain associated with high cholesterol, high blood sugar and even Type 2 diabetes.

The big surprise was that older generic drug perphenazine was just as effective as Zyprexa's main competitors — Seroquel, Risperdal and Geodon — and Zyprexa's advantage was modest, the study found.

That is a striking finding, considering that the newer drugs cost more than 10 times as much as perphenazine, used since the 1950s.

"It's simply playing to the bias of jurors ... a certain perception that there are too many lawsuits and that it's causing society problems," Higbee said.

Lilly to pay nearly $700M to settle Zyprexa claims (Lilly betaler nærmere 700 millioner dollar for å forlike krav)
USA TODAY 10.6.2005
INDIANAPOLIS (AP) - Eli Lilly & Co. endret sin preparatomtale for å advare publikum om at deres antipsykotika legemiddel kunne utsette pasienter for risiko for å utvikle diabetes. (Eli Lilly & Co. changed its labels to warn people that its anti-psychosis drug Zyprexa could put patients more at risk for developing diabetes.)

But the warning came after 8,000 people claimed the labels before September 2003 did not tell them of the risk. The company now is prepared to pay nearly $700 million to those people as part of a settlement announced Thursday.

The Indianapolis-based company plans to establish the settlement fund, which will affect its second-quarter earnings. The company said it plans to take a pretax charge of at least $700 million for the fund and to cover other claims not in the agreement.

When the settlement is finalized, it will resolve the majority of Zyprexa claims pending in the United States, according to a Lilly news release Thursday.

However, the agreement only involves people who filed claims arguing that they developed diabetes-related conditions from using Zyprexa, which is used to treat schizophrenia and bipolar disorder. Lilly said it is prepared to continue its "vigorous defense" of the drug in the remaining cases.

"While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors," Lilly Chairman and CEO Sidney Taurel said in the statement.

Most of the lawsuits claimed that before September 2003, the information on Zyprexa labels regarding the risk of hyperglycemia and diabetes was not adequately displayed. Hyperglycemia is a condition in which the blood has elevated sugar levels, typical in diabetics.

In September 2003, the FDA required label changes for all atypical anti-psychotic drugs to warn against the risk.

Christopher Seeger, a member of the plaintiffs' steering committee, said the group was pleased with the agreement.

"The patient population to which this drug is given has difficult medical histories," Seeger said. "Protracted litigation was in no one's interest."

In April, Lilly said worldwide sales of Zyprexa fell 5% to $1.04 billion. Sales in the United States fell 17% to $517.4 million because competing drugs are reducing demand for Zyprexa, the company said. U.S. sales of the treatment for schizophrenia and other disorders brought in $2.4 billion for Lilly last year. The drug had worldwide sales of $4.4 billion in 2004.

However, Lilly prevented further erosion of the still lucrative U.S. franchise for the drug when a federal judge in April upheld its patent giving its exclusive U.S. rights until 2011. The case could still face appeals.

Lilly to settle for up to $690M
indystar.com 10.6.2005
Deal may resolve 8,000 Zyprexa claims
Eli Lilly and Co. said Thursday it will pay up to $690 million to settle legal claims by about 8,000 patients alleging they were harmed by the antipsychotic Zyprexa, Lilly's top-selling drug.

The proposed settlement comes six months before the first trial in a rash of Zyprexa lawsuits is scheduled to begin in federal court in New York.

The Indianapolis drug maker said it's not admitting in the agreement that its star drug caused the diabetes-related injuries alleged by claimants, many of whom are schizophrenia patients. The drug also is approved to treat manic depression.

"While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors," said Lilly President Sidney Taurel in a statement.

The agreement in principle covers about 75 percent of the filed or pending claims that Lilly knows about in the Zyprexa litigation, the company said. The final wording of the deal has to be approved by both sides.

"This takes the lion's share of the risk to the company off the table," said a Lilly executive vice president, John Lechleiter.

He said the settlement would remove a major distraction to Lilly and allow it to devote more time and resources to marketing Zyprexa.

A New York plaintiff's attorney, Jerrold Parker, said: "It's really remarkable to arrive at a settlement of this magnitude so early" in the litigation process. The proposed settlement comes before federal Judge Jack Weinstein has ruled on whether the hundreds of lawsuits being consolidated in his court in New York can be combined as a class action.

Parker said a team of trial attorneys from 12 firms, including some of the best-known product litigators in the nation, "were able to demonstrate to Lilly extremely early in the litigation there were certain possibilities they had to face up to. They (Lilly) realized their exposure and decided to live up to the consequences."

Parker estimated about $500 million of the settlement money will go to patients, after subtracting nearly $200 million for attorney fees and costs of claims administration.

Patients would be compensated in large part on the extent of their alleged injuries, although guidelines have not been drawn up, Parker said.

"There's a range of injuries here, from a little weight gain to death," he said.

If $500 million were split equally among the 8,000 patients, the average payout would come to $62,500. Claimants would be allowed to opt out of the agreement and individually pursue their claims. (...)

Lilly said it would take a $700 million charge against earnings in the current quarter to cover the cost of the settlement.

The company said it will continue to fight in court any new Zyprexa lawsuits that are filed.

Many of those who have sued Lilly allege the company failed to warn patients and doctors of Zyprexa's link to diabetes, possibly caused by a side effect of weight gain.

While Zyprexa was launched on the U.S. market in 1996, Lilly did not add a significant warning about the risk of diabetes and hyperglycemia to the drug's label until September 2003. That warning was required by the Food and Drug Administration for all antipsychotics in Zyprexa's class.

Lilly has maintained that its drug is not to blame for diabetes-related problems. Lechleiter said schizophrenia patients are prone to weight gain and also suffer a fourfold greater incidence of diabetes than the general population.

The agreement also would result in the dismissal of claims against physicians and other health care professionals named as co-defendants, Lilly said.

Zyprexa, which is taken in pill form, became Lilly's best-selling drug after Prozac lost U.S. patent protection in 2001. Last year Zyprexa generated almost a third, or $4.4 billion, of Lilly's total sales of $13.86 billion.

In part because of the litigation and charges that the drug caused diabetes, Zyprexa's U.S. sales have been slowing.

Lilly's settlement was announced after the markets closed. Lilly shares closed Thursday at $57.07, down 30 cents.

Zyprexa Trial in Schizophrenia 'Prodome' Yields Only Hints
medpagetoday.com 3.5.2006
(...) NEW HAVEN, Conn., May 3 — A two-year study of Zyprexa (olanzapine) in patients thought to have early signs of schizophrenia had mixed results, researchers reported.

On one hand, daily Zyprexa appeared to blunt symptoms and delay the onset of full-blown schizophrenia, according to Thomas McGlashan, M.D., of Yale and colleagues in the multicenter Prevention Through Risk Identification, Management, and Education (PRIME) project.

On the other hand, patients taking Zyprexa had large weight gains and the dropout rate in the study was so high that no definitive conclusions about the efficacy of the drug could be drawn, the researchers reported in the May issue of the American Journal of Psychiatry. (...)

(Anm: Randomized, Double-Blind Trial of Olanzapine Versus Placebo in Patients Prodromally Symptomatic for Psychosis. Am J Psych 2006; 163:790-799.)