REG-Lilly (Eli) & Co: Lilly's Response to a NEJM Article
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Date: Jan. 18, 2008 For Release: Immediately Refer to: (317) 651-3710 David J. Shaffer (317) 651-9116 Tammy Hull (317) 276-5046 Angela Sekston In response toa New England Journal of Medicine article published yesterday and subsequent media coverage,Eli Lilly and Company issued the following statement: INDIANAPOLIS - Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials. The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac - the NEJM article didn't identify a single Prozac study as unpublished - but it also likely created a strong false impression with readers that Lilly suppresses data. Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results - whether favorable or unfavorable to a Lilly medicine - in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products. In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004. In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice - first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004. The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data. We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it - more than once - in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times … if only they had called and asked. About Prozac PROZAC is available by prescription only. A rash can be a sign of a serious medical condition. See your doctor immediately if you develop a rash while taking PROZAC. Also, you should not take PROZAC at the same time as or within 2 weeks if stopping a type of antidepressant medication known as an MAO inhibitor. Don't take MAO inhibitors for at least 5 weeks after stopping PROZAC. Thioridazine should not be administered with PROZAC or within a minimum of 5 weeks after PROZAC has been discontinued. Prozac® Weekly™, PROZAC, generic versions of PROZAC, and Sarafem® contain the same active ingredient, fluoxetine hydrochloride. Some people experience side effects like nausea, difficulty sleeping, drowsiness, anxiety, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning. Most of these tend to go away within a few weeks of starting treatment and, in most cases, aren't serious enough to cause people to stop taking PROZAC. You should also talk to your doctor if you are pregnant or are nursing. In addition, you, your family and other caregivers should be aware of the following information: Depression, as a disease, can be associated with periods when the symptoms can worsen and thoughts of suicide can emerge. Patients and their families should watch for these as well as for anxiety, agitation, panic, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or over excitement and hyperactivity. Call the doctor if any of these are severe or occur suddenly. Be especially observant at the initiation of antidepressant drug therapy and when there is a change in dose. Tell your doctor if you have ever been told you had Bipolar Disorder ("Manic Depression") or have had a "manic" or "psychotic" episode. For more information, including full Prescribing Information, please visit www.prozac.com, or call 1-800-LillyRX. Prozac® is a registered trademark of Eli Lilly and Company. Prozac®Weekly™ is a trademark of Eli Lilly and Company. Sarafem® is a registered trademark of Warner Chilcott, Inc. About Cymbalta Important Safety Information Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder and manage diabetic peripheral neuropathic pain. Antidepressants can increase suicidal thoughts and behaviors in children, adolescents and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over. Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril® (thioridazine) or have uncontrolled glaucoma. Patients should speak with their doctor about any medical conditions they may have, including liver or kidney problems or glaucoma. Patients should tell their doctor about all of their medicines, including those for migraine to avoid a potentially life-threatening condition, and NSAIDs, aspirin or blood thinners due to an increased risk of bleeding. They also should talk to their doctor about their alcohol consumption. Patients should consult with their doctor before stopping Cymbalta or changing the dose and if they are pregnant or nursing. Patients taking Cymbalta may experience dizziness or fainting upon standing. The most common side effects of Cymbalta include nausea, dry mouth, sleepiness and constipation. This is not a complete list of side effects. For full Patient Information, visit www.cymbalta.com. For full Prescribing Information, including Boxed Warning, visit http://www.cymbalta.com/. About Lilly Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. # # # Prozac® (fluoxetine hydrochloride, Dista) Cymbalta® (duloxetine hydrochloride) C-LLY Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U.S.A. www.lilly.com - 4 - END
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