In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Compan
19 January 2008 - 3:41AM
PR Newswire (US)
INDIANAPOLIS, Jan. 18 /PRNewswire-FirstCall/ -- 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identify a single Prozac study as unpublished -- but it also likely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"unpublished" have, in fact, been published in peer-reviewed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(R) Weekly(TM),
PROZAC, generic versions of PROZAC, and Sarafem(R) 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 http://www.prozac.com/, or call
1-800-LillyRX. Prozac(R) is a registered trademark of Eli Lilly and
Company. Prozac(R)Weekly(TM) is a trademark of Eli Lilly and
Company. Sarafem(R) 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(R)
(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 http://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 http://www.lilly.com/.
Prozac(R) (fluoxetine hydrochloride, Dista) Cymbalta(R) (duloxetine
hydrochloride) C-LLY (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://photoarchive.ap.org/ DATASOURCE: Eli Lilly and Company
CONTACT: David J. Shaffer, +1-317-651-3710, or Tammy Hull,
+1-317-651-9116, or Angela Sekston, +1-317-276-5046, all for Eli
Lilly and Company
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