Lilly Trained Sales Force to Ignore Drug's Risks

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http://www.bloomberg.com/apps/news?pid=20601103 & sid=aNURtByTt7Yk & refer=us#BLOOMBERG NEWSLilly Trained Sales Force to Ignore Drug's RisksBy Margaret Cronin Fisk and LopattoJuly 31 (Bloomberg) -- Eli Lilly & Co. trained its sales force to downplayrisks for Zyprexa and encourage doctors to prescribe the drug beyondapproved uses for schizophrenia and bipolar disorder, according to courtdocuments.Lilly's research showed some patients on Zyprexa gained as much as 80 poundsand that the incidence of high blood sugar at diabetes levels was 3.5 timeshigher than for placebos, according to documents filed in a lawsuit broughtby the state of Alaska. Before those findings, doctors already saw a``logical link between weight gain and diabetes,'' an instruction sheetadvised the sales force in 2002.``We believe it is essential to weaken this link to neutralize thediabetes/hyperglycemia issue,'' the company said in the sales document,which was provided for the Alaska case. ``Neutralizing any concern from ourcustomers will be essential to the future growth of Zyprexa in themarketplace.''Zyprexa became the company's top-selling drug, with $4.76 billion in saleslast year -- about a quarter of Lilly's revenue. Company salesrepresentatives disputed or ignored the risks and pursued primary-care andnursing-home doctors as well as psychiatrists, according to documents in theAlaska case that were released July 29 after Bloomberg News filed a motionto unseal them.Lilly agreed to pay $15 million to settle the Alaska suit in March. Thecompany has paid about $1.2 billion to resolve claims brought by more than31,000 patients who said they weren't adequately warned Zyprexa could causeweight gain, diabetes or inflammation of the pancreas, Lilly spokeswomanMarni Lemons said July 8.FAILURE TO WARNLilly faces suits by nine other states alleging failure to warn and impropermarketing, separate consumer-protection investigations in about 30 otherstates and an investigation of off-label marketing by the U.S. Attorney inPhiladelphia, the company said May 6 in a regulatory filing.Lilly doesn't engage in improper marketing and hasn't downplayed the risks,spokeswoman Tarra Ryker said in an e-mailed statement. The lawsuit documents``are a tiny fraction of the more than 20 million pages'' provided by Lilly,Ryker said. ``They do not accurately portray our company strategy or ouroverall conduct.''Lilly fell as much as 1 percent in the initial minutes of trading to $46.85and was down 5 cents to $47.36 at 10:10 a.m. in New York Stock Exchangecomposite trading.Pushed SalesLilly pushed Zyprexa sales to primary care physicians and doctors in nursinghomes for patients who weren't diagnosed with schizophrenia or bipolardisorder, according to complaints filed by Montana and Mississippi.Most documents and depositions were acquired by plaintiffs' lawyers inconsolidated Zyprexa litigation before U.S. District Judge Jack Weinstein inNew York. Alaska's lawyers, who were provided the material, acquiredadditional evidence before trial.The unsealed documents showed that about 550 sales representatives weregreeted at an October 2000 meeting with a ``Viva Zyprexa'' version of theElvis Presley song, ``Viva Las Vegas,'' touting the ``many wonderfulindications'' for the drug.There were only two indications for the drug at the time, Mike Bandick,director of marketplace management for the Zyprexa product team, testifiedin a June 2006 deposition. This didn't mean the team was pushing salesbeyond the approved uses, he said. ``I assume this had more to do withgetting the right number of syllables into that line,'' referring to song'slyrics.Zyprexa's ``attributes line up so beautifully in the elderly,'' Alan Breier,then-team manager for the drug, told the group. ``The need for bettertreatment in Alzheimer's and other elderly conditions is so paramount and sokey,'' Breier said, according to a recording provided for the Alaskalawsuit.CEO QUESTIONEDZyprexa wasn't approved for use with Alzheimer's or for elderly conditions,Sidney Taurel, the current chairman of Lilly's board and then-chiefexecutive officer, said under questioning by Alaska's lawyers in September.Breier wasn't encouraging improper sales, Taurel said.``He's talking about the characteristics of the molecule which might make ita good agent for Alzheimer's,'' Taurel testified. ``He was not giving theminstructions as to what to do the next day in the field.''Sales representatives were advised to focus on symptoms, not diagnoses, whendealing with primary care physicians or PCPs, according to the Alaskadocuments.``The doctor's thinking that he does not see a schizophrenic or bipolarpatient,'' Bandick said in a December 2000 internal e- mail to the marketingdepartment. ``But he probably does see patients with symptoms of behavior,mood and thought disturbances,'' he wrote. ``Even if the doctor does nothave diagnosis, he should treat anyway.''NOT APPROVEDZyprexa wasn't approved for such indications at the time, Bandick said inhis June 2006 deposition. ``I did not intend for the sales force to promoteunder mood, thought and behavioral disturbances,'' he testified.Lilly's sales representatives encouraged doctors to prescribe for such uses,according to call notes produced in the Alaska suit. In a July 2002 note,sales representative Thea Jung described her meeting with a doctor inAnchorage this way: ``Dr. B said she misunderstood and thought Z was justfor bipolar or schizophrenia and was really excited to hear that it wasapplicable to her practice for `complicated mood.'''Talking to patients about symptoms ``is an important and necessary piece ofthe dialogue between physicians and sales representatives,'' Lilly's Rykersaid.ADDED WARNINGLilly added a warning to its packaging in October 2007 saying that more thanhalf of patients in 13 studies gained an average of 12 pounds after takingthe drug for less than a year. It said Zyprexa was more associated withhigher blood sugar levels, a risk factor for diabetes, than similarmedications.Before the October 2007 label change, Lilly didn't instruct its sales forceto say Zyprexa's diabetes rates were higher, former marketing director Noesges said in a January deposition.``We will NOT proactively address the diabetes concern,'' the Zyprexa salesforce was advised in 2002, the documents show. ``The competition wins if weare distracted into talking about diabetes.''The case is Alaska v. Eli Lilly and Co., 3AN-06-05630 CI, Alaska SuperiorCourt, Anchorage District.To contact the reporters on this story: Margaret Cronin Fisk in Southfield,Michigan, at mcfisk@...; Lopatto in New York atelopatto@....Last Updated: July 31, 2008 10:28 EDT