Zyprexa News

 

Lilly reportedly in talks with feds Newspaper: $1B payment

-Indianaoplis Star

01/31/2008 - Eli Lilly and Co. could pay more than $1 billion to settle a criminal and civil investigation into the marketing of its antipsychotic drug Zyprexa, according to The New York Times, citing anonymous sources involved in the probe. The Indianapolis drugmaker's settlement talks with federal prosecutors also could lead it to plead guilty to a misdemeanor criminal charge, the story said. Lilly said in a statement that it disagrees with "many speculative statements" contained in the Times story. If a deal is reached, the fine would represent "the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines," the Times reported Wednesday on its Web site. The agreement would allow Lilly to continue selling Zyprexa to Medicaid and Medicare, two big government programs that are large customers for the drug. More significantly, the deal would represent another big step as Lilly tries to resolve myriad legal and financial issues surrounding Zyprexa, its top-selling product, with sales last year of $4.7 billion. For more than four years, Lilly has been battling claims that it improperly marketed Zyprexa for off-label uses -- including treatment of dementia, depression and autism -- without warning about its risks. The company has steadfastly denied it has broken laws or misled consumers. Lilly said Wednesday it is "committed to promoting our medications only for approved uses and consistent with all federal and state laws. We disagree with any allegations or suggestions to the contrary." Nevertheless, Lilly has paid more than $1 billion in recent years to settle claims from more than 25,000 patients who accused the company of underplaying the drug's side effects, including weight gain and elevated blood sugar. Les Funtleyder, a drug analyst at Miller Tabak & Co. in New York, said such a fine would be sizable for Lilly, but not debilitating. Lilly reported Tuesday it made profits of $2.9 billion last year on sales of $18.6 billion. "I would say $1 billion is a lot of money for any company, but to the extent it removes an overhang for the company and investors, it's probably a good thing to get it behind them," he said. Federal prosecutors have been investigating Lilly for its marketing of Zyprexa since 2004, and state attorneys general have been doing the same since 2005. Lilly also has spent money trying to reassure psychiatrists that the drug is safe to prescribe. Prescriptions have sagged for several years, although Lilly has raised its price to keep revenues stable. Several months ago, Lilly hired a medical-education company to design and mail a 14-page brochure to psychiatrists, pointing out that they have among the lowest number of malpractice claims of all medical specialists, and most claims against them are closed without payment. The company acknowledged it has received a grand jury subpoena from the U.S. attorney for the Eastern District of Pennsylvania, seeking documents related to Zyprexa. Lilly said it has provided a broad range of documents and information to investigators. "However, we have no intention of sharing those discussions with the news media, and it would be speculative and irresponsible for anyone to do so," Lilly said in a statement. The U.S. attorney's office in Philadelphia could not be reached for comment. Some longtime critics say the deal, if it comes about, would be a good first step. But David Oaks, director of MindFreedom International, an Oregon-based coalition of mental health groups, said he wishes the government would go even further, requiring Lilly to plead guilty to a felony. "Their behavior has been disgraceful," he said. Lilly has touted its transparency in recent years on a wide range of information, posting results of clinical tests on its Web site that show the safety and effectiveness of its drugs. The company also posts information each quarter on which groups, from patient-advocacy organizations to hospital researchers, receive millions of dollars worth of Lilly grant money. Last fall, Lilly and the government were close to a deal in which Lilly would have paid less than $1 billion to settle the marketing case, which at the time consisted only of a civil complaint, the Times reported. Then Justice Department lawyers in Washington pressed for a grand jury investigation to examine whether Lilly should be charged criminally for its promotional activities, the Times reported, citing people involved in the negotiations. A few days ago, facing the possibility of both civil and criminal charges, Lilly opened new discussions with the prosecutors in Philadelphia, the Times said. In October, Lilly said it was taking steps to beef up the drug's label to add stronger language concerning weight gain and elevated blood sugar. The company said it will display the information prominently in the warning section of the label, rather than lower, where it might be missed. Lilly also acknowledged, in a letter to doctors, that Zyprexa is more likely to raise blood-sugar levels than competing drugs.

If you are currently taking Zyprexa and have concerns about its safety, you should consult with your doctor regarding your treatment options. Under no circumstances should you discontinue taking any medication, including Zyprexa, without first consulting with your doctor. For Zyprexa legal information contact the Zyprexa Attorneys of Ennis & Ennis, P.A. by filling out our free Zyrpexa case evaluation form or by calling the toll-free number listed below.