The High Percentages Of Depression Have Been Greatly Exaggerated

According to widely reported community-based research, almost half the U.S. population suffers from depression. But research by two sociologists indicates that percentage is greatly exaggerated or is a misrepresentation.



The extraordinarily high rates of untreated mental illness reported by community studies are false, say Allan V. Horwitz, a sociology professor in the Institute of Health at Rutgers University, and Jerome Wakefield, a professor in the School of Social Work at New York University. Community studies rely on standard, closed-format questions about symptoms with no context provided to differentiate between reactions to normal life stress (i.e., a death, a romantic break up, work or school stress) and pathological conditions that indicate clinical mental illness.



"These numbers are largely a product of survey methodologies that, by nature, overstate the number of people with mental illness." Reporting the findings in Contexts magazine (Winter 2006), published by the American Sociological Association, the authors state, "Moreover, because people experiencing normal reactions to stressful events are less likely than the truly disordered to seek medical attention, such questions are bound to inflate estimates of the rate of untreated disorder."



In the past, diagnoses relied on treatment studies, but it became apparent that the number of treated patients understated the problem for a variety of reasons such as lack of access to treatment and reluctance to seek appropriate help. Today tightly structured questions are used in community studies to allow researchers to better diagnose a population.



The problem is that the criteria used in the community surveys are not necessarily valid for diagnosing mental disorders. One reason for this is that people self-select when seeking treatment and use their judgment to decide if their feelings exceed normal responses to stressful events. Second, clinicians make contextual judgments when they diagnose patients because some depressive symptoms might occur as a normal response to a loss of a job or a marriage unraveling. In surveys, interviewers are forbidden to judge the validity of a response or discuss the intent of a question. In addition, the duration criteria of community surveys only require that symptoms last at least two weeks, causing transient and self-correcting problems to be counted as disorders.



"In contrast to clinical settings," say Horwitz and Wakefield, "symptom-based diagnoses in community studies consider everyone who reports enough symptoms as having the mental disorder of depression. Symptoms that would not require treatment may nevertheless qualify as a disorder in a community survey."



"Community surveys could more adequately separate normal responses to stressful situations from mental disorders by including questions about the context in which symptoms develop and persist," say Horwitz and Wakefield. The decision not to include contextual criteria in community surveys, they speculate, might have to do not only with efficiency and practicality but also with resistance to change by groups that benefit from high rates of mental health problems.



There are a number of reasons that these high rates are perpetuated. One is that political support is more likely for an agency devoted to preventing and treating a widespread disease such as the National Institute of Mental Health. Another reason is that pharmaceutical companies capitalize on these survey findings to broaden their markets. The explosive growth in sales of antidepressants may indicate its effectiveness. Lastly, advocacy groups lay claim to the prevalence of mental disorders. They equate the millions of people that surveys identify with disorders with the serious mental disorders in order to reduce the social distance between the mentally disordered and others, thereby lowering the stigma. This may only hinder the truly disabled by shifting resources from where it is truly needed.







Contexts magazine, a peer-reviewed publication, seeks to apply new knowledge, stimulate fresh thinking, and disseminate important information produced by sociologists. It received the "Best Sociology Journal of 2002" award from the Association of American Publishers, Scholarly Publishing Division and was named "One of the Best New Magazines of 2002" by Library Journal.



The American Sociological Association, founded in 1905, is a non-profit membership association dedicated to serving sociologists in their work, advancing sociology as a science and profession, and promoting the contributions and use of sociology to society.



Contact: Johanna Olexy

pubinfoasanet

American Sociological Association

Depression intensifies from one generation to the next - Columbia study shows

20-year study at Columbia University Medical Center is first to highlight increased risk of depression across three
generations -


NEW YORK, NY, January 10, 2005 - Nearly 60 percent of children whose parents and grandparents suffered from depression have a
psychiatric disorder before they reach their early teens, according to a new study by researchers at Columbia University
Medical Center (CUMC) and the New York State Psychiatric Institute (NYSPI). This is more than double the number of children
(approx. 28 percent) who develop such disorders with no family history of depression.


The study, published in the January issue of the Archives of General Psychiatry, is the first to follow three generations of
high-risk families and has taken more than two decades to complete. The CUMC/NYSPI research team began studying 47 first
generation family members in 1982; then interviewed 86 of their children several times as they grew into adulthood. The team
has collected data from 161 members of the third generation, whose average age is 12.


Results found that most of the prepubescent grandchildren with a two-generation history of depression developed anxiety
disorders that developed into depression as they aged into adolescence. This trend was also found when the researchers
previously followed the children's parents through adolescence and adulthood.


"We have shown that the risk of depression is carried through several generations and that it intensifies as more generations
are affected," said the study's lead author, Myrna Weissman, Ph.D., Professor of psychiatry and epidemiology at Columbia
University Medical Center and Chief of the Department of Clinical & Genetic Epidemiology at New York State Psychiatric
Institute. "Children with a two-generation family history of depression develop anxiety disorders earlier than other children
and tend to experience more impairment." Other investigators involved included Priya Wickramaratne, Ph.D. and Virginia
Warner, MPH.


Previous studies have shown that the children of a depressed parent are at greater risk of mood and anxiety disorders, but
the Columbia study is the first to illustrate how the risk intensifies across three generations.


"Children of parents and grandparents with depression are at extremely high risk for mood and anxiety disorders even when
they're very young," Dr. Weissman says. "They should be considered for treatment if they develop anxiety disorders, or at
least monitored very closely."


Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, medical
education, and health care. The medical center trains future leaders in health care and includes the dedicated work of many
physicians, scientists, nurses, dentists, and other health professionals at the College of Physicians & Surgeons, the School
of Dental & Oral Surgery, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the
Graduate School of Arts and Sciences, and allied research centers and institutions. With a strong history of some of the most
important advances and discoveries in health care, its researchers are leading the development of novel therapies and
advances to address a wide range of health conditions.


Contact: Craig LeMoult

cel2113columbia

Columbia University College of Physicians and Surgeons

Lexapro(R) Demonstrated Significance On Prospectively Defined Efficacy Parameter And Was Better Tolerated Than Cymbalta(R) In Treatment Of Depression

Forest Laboratories, Inc.,
(NYSE: FRX) today announced the results of a new study demonstrating that
Lexapro (escitalopram oxalate) provided a greater reduction in MADRS
scores, (p=0.040), utilizing an LOCF approach and was better tolerated than
Cymbalta (duloxetine), based on the percentage of patients discontinuing
treatment due to adverse events, in the treatment of patients with moderate
to severe major depressive disorder (MDD).



Dr. Arif Kahn, Medical Director of Northwest Clinical Research Center
and investigator in this study said, "These findings add to a number of
studies that demonstrate the clinical value of Lexapro in the treatment of
depression."



Study details



Patients (aged 18-80 years) with DSM-IV diagnosed MDD as determined by
a Montgomery-Asberg Depression Rating Scale (MADRS) score of 26 or greater
were randomized to eight weeks of double-blind treatment with Lexapro 10-20
mg/day (dose fixed at 10 mg/day for the first four weeks with optional
up-titration to 20 mg/day thereafter) or Cymbalta 60 mg/day. Dosing of the
two antidepressants was consistent with information in the FDA-approved
package inserts of both drugs. The primary, prospectively-defined, efficacy
endpoint was the change from baseline at week eight in the MADRS total
score, using the last observation carried forward (LOCF) approach. At the
start of the study, 137 patients were enrolled in the Lexapro arm of the
study and 133 in the Cymbalta arm.



At the end of the eight-week study, Lexapro patients demonstrated
greater improvement than Cymbalta patients in total MADRS score (LSMD,
least squared mean difference, -2.42 [95% CI: -4.73, -0.11]; p=0.040). The
proportion of patients responding to Lexapro treatment, as determined by a
50 percent improvement in MADRS total score, also was greater when compared
to patients in the Cymbalta group (68 percent vs 52 percent, p=0.011;
LOCF). Remission rates were 44 percent in the Lexapro group and 38 percent
in the Cymbalta group, as determined by a total MADRS score of 10 or less,
this difference was not significant. The rate of improvement on the MADRS
was similar between the groups when an observed cases analysis was
conducted. In addition, there was no difference seen between the group on a
number of measures of relief of somatic and pain-related symptoms.



More patients in the Lexapro group completed eight weeks of treatment
than patients in the Cymbalta group (87 percent vs 69 percent, p=0.001),
and fewer patients receiving Lexapro discontinued treatment due to adverse
events compared to patients receiving Cymbalta (2 percent vs 13 percent,
p=0.001).
















About Lexapro



Lexapro is a selective serotonin reuptake inhibitor (SSRI) that has
been prescribed for more than 14 million adult patients in the United
States.



Lexapro was approved by the U.S. Food and Drug Administration in August
2002 for both the initial and maintenance treatment of major depressive
disorder (MDD) in adults, and in December 2003 for the treatment of
Generalized Anxiety Disorder (GAD) in adults.



The most common adverse events reported with Lexapro (reported at rates
of approximately 5 percent or greater and 2 times or more the incidence
seen in the placebo group) were nausea, insomnia, ejaculation disorder,
somnolence, increased sweating, fatigue, decreased libido, and anorgasmia.
Lexapro is contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs), pimozide, or in patients with a hypersensitivity to escitalopram
oxalate or any of the ingredients in Lexapro.



As with other SSRIs, caution is indicated in the coadministration of
tricyclic antidepressants (TCAs) with Lexapro. As with other psychotropic
drugs that interfere with serotonin reuptake, patients should be cautioned
regarding the risk of bleeding associated with the concomitant use of
Lexapro with NSAIDs, aspirin, or other drugs that affect coagulation.



Patients with major depressive disorder, both adult and pediatric, may
experience worsening of their depression and/or the emergence of suicidal
ideation and behavior (suicidality), whether or not they are taking
antidepressant medications, and this risk may persist until significant
remission occurs.



Although no causal role for such behaviors has been established,
patients being treated with antidepressants should be observed closely for
clinical worsening and suicidality, especially at the beginning of a course
of drug therapy, or at the time of dose changes, either increases or
decreases. Families and caregivers should be advised of the need for close
observation and communication with the prescriber. Lexapro is not approved
for use in pediatric patients.



Forest Laboratories licenses Lexapro from H. Lundbeck A/S, the Danish
pharmaceutical firm that developed escitalopram and citalopram.



About Forest Laboratories and Its Products



Forest Laboratories (frx) is a US-based pharmaceutical company
dedicated to identifying, developing, and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the internal and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar
HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotenisn receptor
blocker and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R) (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.


-- Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck
KGaA, Darmstadt, Germany.



Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
the Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for
the periods ended June 30 and September 30, 2006.


Forest Laboratories, Inc.

frx/


View drug information on Benicar; Campral; Cymbalta.

Teenage depression can be enduring, but is more often short-lived

Teenage depression is widespread and can become a life-long illness, but is more often transitory, said UCLA Psychology
Professor Constance Hammen, who will discuss her research at an invited address May 27 at the American Psychological
Society's annual convention in Los Angeles.


"Adolescent depression can be as high as 20 percent or higher," said Hammen, who has studied depression for more than 30
years. "While these numbers are alarming, and depression can be impairing, most of the depressions will be short-lived and
most of these kids will not go on to have further depression.


"Many things can make teenagers depressed, but in about 60 percent of the cases, the depression does not foretell future
depression. Of those who have adolescent depression, perhaps 40 percent will have recurring depression, and many of those
will likely be life-long."


Hammen has been conducting a long-term study over the last 10 years of 800 families with children now in their 20s, along
with Patricia Brennan from Emory University in Atlanta. The subjects are among 7,000 families in Australia who have been
studied since the children were five years old by researchers from the University of Queensland.


About half of the children in the current study who showed depression by age 15 had recurring depression by age 20, and those
who did have a distinctive profile, Hammen and Brennan found. Their preliminary analysis indicates the adolescents who showed
depression by age 15 and again between 15 and 20 also had anxiety disorders and poor social relationships such as fewer
friends or more conflict in their relationships.


"We have found that the risk for recurring depression occurs in the kids who had early depression and social difficulties,"
Hammen said. "Kids depressed by 15 who function normally in social relationships did not go on to have depression by 20. Poor
social functioning by age 15, such as not having stable friendships, looks like a risk factor for recurring depression.



"The kids with depression at both 15 and 20 have a very high rate before age 15 of fears, phobias, anxiety, and panic
reactions," she said. "In many cases, they were showing anxious, fearful and distressed symptoms as early as age five."



Twenty percent of the children of depressed mothers developed depression by age 15, a rate of depression twice as high as
that of the children of non-depressed mothers.


Girls were more than twice as likely as boys to show depression at both ages 15 and 20, Hammen said.


Parents commonly do not see depression in their children, she said.


"Parents often don't pick up on inner despair or distress, and notice depression mainly as irritability or loss of enjoyment
of activities their kids used to enjoy," Hammen said. "If it goes on for a month, I think the parent should pay more
attention and not just dismiss the behavior as part of adolescence."















"Most of the time when children are depressed, there's something wrong in their lives, and the situation that's causing the
depression needs to be addressed," Hammen said. "Kids often get depressed because bad things happen to them that they don't
have the coping skills to deal with."


Women are especially at increased risk for depression from stress factors, particularly interpersonal stress, such as poor
relationships marked by as conflicts.


"Most depression, particularly for women, is triggered by negative social connections, such as relationship problems,
arguments, break-ups, and not having close friends," Hammen said.


Interpersonal stress plays a large role in women's depression, Hammen has found.


Not all depression is alike, Hammen said, noting it can be mild or severe, a single episode or recurring.


Major episodes of depression last for at least two weeks, with impairment in performing daily activities, and a combination
of symptoms such as a depressed mood, loss of enjoyment in previously pleasurable activities, changes in appetite, changes in
sleep patterns, loss of motivation and energy, difficulty concentrating, and negative thoughts about themselves and the
future, including suicidal thoughts.


People who are depressed often select themselves into stressful environments, or contribute to such environments through
difficult relationships with romantic partners or families, that may result in chronic or recurring depression for
themselves, Hammen said.


Hammen has studied depression in adolescents and adults, and has studied children of depressed mothers. Depressed mothers
often themselves had mothers who were depressed. Her research is funded by the National Institute of Mental Health.


"By age 15, the children of depressed mothers had a higher risk of depression, but the risk for depression is not just from
genetics," Hammen said. "The risk is from a cascade of events that occur in depressed families, environmental and
psychological factors that are the determinants of whether the kids become depressed.


"If the mother is depressed and had stressful family factors like a bad marriage, then the child is more likely to have
social and interpersonal problems and more likely to have stressful life events associated with depression."


In the Australia study, Hammen is testing whether it makes a difference when in the child's life the mother was depressed and
whether the mother's depression was severe or mild. Mild depression does not have much impact on the child unless it is
chronic, she said.


Hammen and Brennan plan to study the link between maternal depression and youth depression, as well as interpersonal problems
such as domestic violence and early pregnancy.


Hammen has debunked myths about depression, including this one:


"A lot of people think depression stems from a weakness in character, and that you should just keep a stiff upper lip,"
Hammen said. "It's a myth. People cannot simply will depression away. It can be a serious impairment, and may require
treatment. It's not a weakness of will."


Contact: Stuart Wolpert

stuartwcollege.ucla

310-206-0511

University of California - Los Angeles

Getting A Job Promotion Is Bad For Mental Health & Stops You Visiting The Doctor

New research by economics and psychology researchers at the University of
Warwick has found that promotion on average produces 10% more mental strain and
gives up to 20% less time to visit the Doctors.



In a research paper entitled "Do People Become Healthier after Being Promoted"
Chris Boyce and Professor Andrew Oswald of the University of Warwick questioned
why people with higher job status seem to have better health. A long-held
assumption by researchers is that an improvement to a person's job status,
through a promotion, will directly result in better health due to an increased
sense of life control and self-worth.



The researchers tested this.?  They drew upon the British Household Panel Survey
data set, collected annually between 1991 and 2005, with information on
approximately 1000 individual promotions.?  They found no evidence of improved
physical health after promotion - nor that self-assessed feelings of health
declined.



What they did find, however, was significantly greater mental strain.?  After a
job promotion, there was on average a 10% decrease in people's mental health
measured in a standardized way across the British population.?  Intriguingly,
those promoted at work also reported on average a 20% fall in their visits to a
Doctor following their promotion.?  On first sight this drop in Doctor visits
does not match the lack of change in the reported health of promoted
individuals. But the increased stress levels of promoted workers may provide an
explanation -- part of the stress on?  promoted people may be more constraints on
their time and they simply have less time to visit a doctor.



University of Warwick researcher Chris Boyce said:



"Getting a promotion at work is not as great as many people think.?  Our research
finds that the mental health of managers typically deteriorates after a job
promotion, and in a way that goes beyond merely a short-term change.?  There are
no indications of any health improvements for promoted people other than reduced
attendance at GP surgeries, which may itself be something to worry about rather
than celebrate."



The research will be presented at the Royal Economic Society's conference later
this month.?  The research paper can be found here.



Source

Peter Dunn, Press and Media Relations Manager

Communications Office, University House,

University of Warwick, Coventry, CV4 8UW, United Kingdom

Nearly 5 Percent Of The US Population Suffers From Persistent Depression Or Anxiety

Though effective treatments are available for individuals suffering from chronic depression and anxiety, very little is known about how often these treatments are used or how prevalent these conditions are among the nation's general population.



But in a first-of-its-kind study, UCLA researchers have developed estimates for both the prevalence of chronic psychiatric illness in the general population and how often individuals suffering from such illnesses receive appropriate treatment.



In the study, published in the December issue of the peer-reviewed journal Psychiatric Services and currently available online, researchers found that approximately 4.7 percent of the nation's population suffers from persistent depression or anxiety disorders, with a minority of those afflicted receiving adequate medication or counseling.



"From a policy perspective, this study indicates that we have to do much better in terms of helping people in the population and clinicians in primary care," said lead author Dr. Alexander S. Young, a UCLA professor of psychiatry and director of health services for the Department of Veterans Affairs Desert Pacific Mental Illness Research, Education and Clinical Center (MIRECC). "We need to understand that psychiatric disorders are treatable with psychotherapy and/or medication. Patients would benefit if we improved linkages between primary care and specialty mental health care so that patients are referred and accept referrals to mental health specialists, especially when they are chronically ill.



"Also, we have to improve insurance arrangements so that they encourage more intensive treatment in people who remain ill," he said.



The study was based on data from Healthcare for Communities, a nationally representative household survey of adults in the United States. The researchers analyzed responses from 1,642 adults with major depression or anxiety disorders. These surveys, conducted in 1997 and 1998, with follow-ups approximately two-and-a-half years later, assessed diagnosis, quality of life, treatment satisfaction, medical conditions, suicidal thoughts, insurance, and the use of medications and counseling.



At follow-up, the researchers found that 59 percent of the individuals no longer met the criteria for having a psychiatric disorder. But to their surprise, they found that among those who remained ill, there were only modest increases in medication use and no statistically significant increase in the use of counseling for their disorders - measures that are known to significantly improve outcomes, especially when used in combination. Among this subgroup:
87 percent had a chronic, co-morbid medical disorder.















In the prior year, 88 percent had seen a primary care practitioner, but only 22 percent had consulted a mental health specialist.


In the two-and-a-half years between baseline and follow-up, use of medication rose from 21 percent to 29 percent, and use of counseling fell from 23 percent to 19 percent.


Only 12 percent with persistent illness were getting both medication and counseling (the appropriate treatment in this situation).


51 percent had suicidal thoughts at follow-up.


Men and those with less education received less treatment.

"Persistent depressive and anxiety disorders are remarkably common in the U.S. population and are associated with substantial morbidity. There are significant problems with the quality of care received by this population, and these problems persist over time," the researchers concluded. "In the population with persistent depressive and anxiety disorders, increasing the rate of appropriate care from its current low level could result in substantial improvement in individuals' lives."







In addition to Young, study authors included Ruth Klap, Ph.D., of the Health Services Research Center at UCLA; Rebecca Shoai, M.P.H., M.S.W., affiliated with MIRECC; and Kenneth B. Wells, M.D., M.P.H., of the UCLA Department of Psychiatry and the RAND Corp.



The Robert Wood Johnson Foundation funded the study, with additional support from the National Institute of Mental Health and the U.S. Department of Veterans Affairs.



The UCLA Department of Psychiatry and Biobehavioral Sciences within the David Geffen School of Medicine is home to faculty who are experts in the origins of and treatments for disorders of complex human behavior. The department is part of the Semel Institute for Neuroscience and Human Behavior at UCLA, a world-leading interdisciplinary research and education institute devoted to the understanding of complex human behavior and the causes and consequences of neuropsychiatric disorders.

University seeks recruits for Parkinson's Disease study

Researchers at the University of Edinburgh are seeking people with Parkinson's Disease (PD) to help them better
understand how mood-- particularly depression-- affects their symptoms. The study will investigate the way depression impacts
on the thinking processes of those with PD, and look at how this mood disorder can be treated.


Research psychologist Anthoula Lioni said: " Depression is very common in people with PD and we believe that their problems
with elaborate thinking processes -- for example, how the brain processes abstract thought and controls inappropriate
actions--may be due to major depression.


"Previous research has shown that PD patients with major depression show significant decline in their thinking processes
after a one-year period, compared with PD patients with minor, or no depression. If we can identify and treat depression, it
may prevent or delay the appearance of these thinking process symptoms.


The team, based at the Royal Edinburgh Hospital in Edinburgh, seeks 20 people over the age of 45, fluent in English, to take
part in the study. Participants will be asked to complete a questionnaire and carry out a short ability test. Information
given to researchers will be kept confidential and only used for research purposes. Those interested in finding out more
should contact Anthoula Lioni on 44-131-537-6282 or 44-131-662-1692, or email a.lionisms.ed.ac.uk


Contact: Linda Menzies

Linda.Menziesed.ac.uk

44-131-650-6382

University of Edinburgh

Prozac: Not Just For Depression

Prozac is regularly prescribed to ease the emotional pain of patients who are being treated for cancer. But can this common anti-depressant help to fight cancer itself?



Dr. Dan Peer of the Department of Cell Research and Immunology at Tel Aviv University is proving that it can. A study he and his colleagues recently completed validates that Prozac (chemical name fluoxetine) dramatically enhances the effectiveness of a widely used anti-cancer drug.



"The good news is that the medical community won't have to wait - Prozac can be used for this purpose right away," says Dr. Peer, noting that doctors in the U.S. already prescribe it to treat depression in chemotherapy patients.



Fighting Drug Resistance in Colon Cancer Patients



"Prozac is a very interesting non-specific blocker of cancer resistance," says Dr. Peer, whose study focused on colon cancer and the anti-cancer drug doxorubicin.



In their laboratory experiments, the Tel Aviv University scientists led by graduate student Mirit Argov together with Prof. Rimona Margalit, found that Prozac enhanced doxorubicin's efficacy more than 1,000%. Prozac, in effect, worked to block the cancer drug from leaving the interior of the cancer cell and poisoning the healthy non-cancerous cells that surrounded it.



In animal models, a mild doxorubicin-fluoxetine treatment combination slowed down tumor progression significantly. These results suggest that pairing Prozac with chemotherapeutic drugs to curb drug resistance warrants further clinical study, says Dr. Peer. His research was just published in Cancer Letters, and his suggestions are now listed as recommendations in the latest version of Cancer Encyclopedia.



Working Backward to Make Great Advances



"Working with a major drug developer, we have validated Prozac's potential, and now Tel Aviv University can lead a humanitarian effort to save lives around the globe," he says.



Since it is very hard to protect this patent since any clinician can prescribe Prozac, it is impossible for Tel Aviv University to commercialize its research, says Dr. Peer. Instead, he suggests that researchers join forces internationally to implement retrospective studies of all the types of cancer treatment in which Prozac was prescribed. And further clinical experiments to validate the use of Prozac with chemotherapy is also needed, he stresses.



"The next step is to take the files of chemo patients and determine whether they received Prozac for their depression," says Dr. Peer. "This will streamline the understanding in the scientific community of whether, how and for which cancer-fighting drugs Prozac can be an effective partner. It will also give us invaluable information on how to design new drugs."



Dr. Peer's Tel Aviv University lab is also developing several new drug delivery nanotechnologies to bring novel therapeutics into breast, blood, pancreatic and brain cancers. A recent technological breakthrough to reprogram immune cells involved in ulcerative colitis and Crohn's disease was reported in Science earlier this year and it is the basis of a new platform technology developed in his group.







American Friends of Tel Aviv University (aftau/) supports Israel's leading and most comprehensive center of higher learning. In independent rankings, TAU's innovations and discoveries are cited more often by the global scientific community than all but 20 other universities worldwide.



Internationally recognized for the scope and groundbreaking nature of its research programs, Tel Aviv University consistently produces work with profound implications for the future.

Depression Can Increase Risk of Repeat Heart Disease in Heart Attack Patients

Depression can double the risk of death or repeat heart disease in heart attack patients, according to two reviews of
more than 40 studies that examine the link between depression and heart disease. The reviews are published in the journal
Psychosomatic Medicine.


In the first analysis of 22 studies, patients who were depressed after their heart attacks had a twofold increase in the risk
of dying or suffering a new heart problem two years after their heart attack, according to Joost van Melle, M.D., and
colleagues of University Hospital Groningen in the Netherlands.


In the second analysis of 20 studies by J?rgen Barth, Ph.D., of University of Freiburg in Germany and colleagues, the
researchers concluded that depressed patients were twice as likely to die within two years after their first heart disease
episode compared with non-depressed patients.


According to van Melle, post-heart attack depression is common, affecting nearly 20 percent of all heart attack patients.



The two research teams found that the relationship between depression and a higher risk of death and disease stayed
consistent despite a variety of ways to measure depression.


The finding "may have important clinical implications for the identification of post-heart attack patients with poor
prognosis, because questionnaires are easier, faster and cheaper than psychiatric interviews," van Melle says.


In their study, van Melle and colleagues also noticed a stronger link between depression and higher risk of death in studies
published before 1992.


"It may be possible that improvements in cardiac care for hospitalized and rehabilitating heart attack patients are
responsible for this finding, but this would need further research," van Melle says.


Both research teams also say they are unsure exactly how depression relates to poor health and greater risk of death in these
patients.


"It must be taken into account that sicker patients may have an increased risk to become depressed and subsequently have a
worse cardiovascular prognosis. In other words, it is possible that the observed risk is in reality caused by poor cardiac
function," van Melle says.


The van Melle study was supported by the Netherlands Heart Foundation.


By Becky Ham, Science Writer Health Behavior News Service


FOR MORE INFORMATION:

Health Behavior News Service: (202) 387-2829 or hbns.


Center for the Advancement of Health

Contact: Ira R. Allen

Vice President of Public Affairs

202.387.2829

presscfah

FDA Approves New Extended Release Pain Medication

FDA Works with Sponsor to Develop an Effective Plan to Reduce Inappropriate Use


The Food and Drug Administration (FDA) announced today the approval of Palladone (hydromorphone hydrochloride) capsules for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time.


Palladone is an extended-release formulation that comes in 12, 16, 24, and 32 milligram (mg.) capsules. This drug should only be used in patients who are already receiving opioid therapy and who require a total daily dose of at least 12 mg. of oral hydromorphone or its equivalent. Palladone offers a therapeutic choice for opioid-tolerant patients who might otherwise be candidates for other opioids and who do not achieve satisfactory therapeutic results with these other products.


The active ingredient in Palladone, hydromorphone, is currently a Scheduled II controlled substance, which is the highest level of control for drugs with a recognized medical use. Based on the risks associated with the drug, including the potential for abuse of Palladone, FDA has worked with the sponsor to develop a comprehensive risk management program (RMP).


The RMP was designed with three potential risk situations identified. These are the risks posed by improper dosing, indication, or patient selection; the risk posed by accidental pediatric exposure to the drug; and the risk posed by abuse or diversion of Palladone Capsules.


As a controlled substance in Schedule II of the Controlled Substances Act (CSA), Palladone also comes under the jurisdiction of the Drug Enforcement Administration (DEA), which administers the CSA. Schedule II drugs are subject to manufacturing quotas set by DEA with input on medical need from FDA, distribution tracking, import and export controls, registration of prescribers and dispensers, and written prescriptions without refills.


In addition to the protection afforded patients through the status of Palladone as a controlled substance, the RMP includes provisions for clear and appropriate labeling, and appropriate education of healthcare professionals, patients, and caregivers. In addition, the sponsor has committed to offer appropriate training to sales representatives. To guard against the inappropriate use of the drug, the RMP also establishes a multifaceted program for monitoring and surveillance of abuse. If abuse, misuse, and diversion occur the program includes an array of interventions.


As part of the RMP, a Medication Guide (FDA-approved patient information which is required to be dispensed with each prescription) has been written for patients prescribed Palladone. FDA requires a Medication Guide only when one or more of the following circumstances exists: (1) the drug is one for which patient labeling could help prevent serious adverse effects; (2) the drug is one that has serious risks of which patients should be made aware because information concerning the risks could affect patients' decision to use, or continue to use the drug; and (3) the drug is important to health and patient adherence to directions for use is crucial to the drug's effectiveness. In addition, the physician labeling for Palladone contains a "black box" warning.















FDA is also part of a larger initiative to reduce diversion and abuse of prescription drugs. On March 1, 2004, the Office of National Drug Control Policy was joined by the Surgeon General, the DEA Administrator, and the FDA Commissioner to announce the National Drug Control Strategy . The strategy emphasized new collaborative efforts at the federal, state, and local levels to prevent and reduce diversion and abuse of prescription drugs. This strategy focused on three core tactics: (1) Business Outreach and Consumer Protection, (2) Investigation and Enforcement, and (3) Protecting Safe and Effective Use of Medications. During the approval process for Palladone, FDA incorporated many of the elements of this strategy as exhibited by inclusion of the "black box" warnings on the labeling, the Medication Guide, and the implementation of a RMP.


In addition to the potential for abuse and addiction, respiratory depression is the chief potential risk associated with Palladone, if not properly dosed. Respiratory depression is manifested by a reduced urge to breathe and a decreased rate of respiration, often referred to as "shallow" breathing, and can result in severe effects or fatalities. The risk of respiratory depression is greater in patients not used to taking opiates, and in elderly or debilitated patients.


Palladone must be swallowed whole because chewing, dissolving, or crushing the contents of the capsules leads to the rapid absorption of a potentially fatal dose.


Other common side effects include nausea, vomiting, dry mouth, dizziness, urinary retention, and constipation.


Palladone is manufactured and distributed by Purdue Pharma L.P., located in Stamford, Conn.


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