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9 January 2006
I.
WHAT'S NEW?
Target
e*CRF™ Training
II. QUIZ
(Fill In The Blanks)
Sleep
Deprivation
III.
HISTORY OF MEDICINE
Concepts
of Health in the Middle Ages
IV. ONCOLOGY
Intraperitoneal Treatment Extends Life in Women With Ovarian
Cancer
V. NEUROLOGY
Biomarkers For Alzheimer's Disease - New Program Launched by the
NIH
VI. CARDIOLOGY
Depression and Risk of Coronary Heart Disease
VII. PREVENTATIVE MEDICINE
Statin Treatment Has No Effect on Cancer Incidence
VIII. FDA
FDA to Celebrate 100th Birthday
IX. Target Health Inc.
Target
e*CRF™ Training
Target Health is
providing complimentary training for Target e*CRF™ Version
3 on January 20 and 23. Target e*CRF™, is Target
Health's cost-effective, user-friendly Internet-based clinical trial
software. Target e*CRF™ has been used in over 75 protocols
with 2 NDA and 1 PMA approvals, with over 10 flawless FDA clinical site
pre-approval inspections. Training will take place at our offices on Madison
Avenue, and there are still a few slots available. Already, independent data
managers and statisticians as well as pharmaceutical industry personnel
have been trained. For more information about this program,
please contact Dr.
Jules T. Mitchel.
Sleep Deprivation
Sleep
deprivation can lead to daytime 1) ___ and interfere with the ability to pay 2)
___ and focus. Teeth grinding or 3) ___, can disrupt sleep and damage teeth and
4) ___. To prevent this, dentists recommend using a plastic mouth 5) ___. Deep
sleep or 6) ___wave, causes a decline in growth 7) ___, which can lead to 8)
___ gain. Lack of deep sleep also interferes with the 9) ___ ability to process
10) ___. Sleep debt is associated with a weakened 11) ___ system, which creates
more susceptibility to 12) ___. Too little sleep can raise blood 13) ___ and stress
levels, increasing risk of 14) ___ disease. Poor sleep can lead to a drop in
15) ___ response, which creates a difficulty in keeping blood 16) ___ levels
stable. These unstable levels can contribute to 17) ___ and obesity. 18) ___
may seem to help sleep; however, it can disrupt the normal sleep 19) ___,
during the second half of the 20) ___.
Answers: 1) fatigue; 2)
attention; 3) bruxism; 4) gums; 5) guard; 6) slow; 7) hormone; 8) weight; 9)
metabolic; 10) carbohydrates; 11) immune; 12) illness; 13) pressure; 14) heart;
15) insulin; 16) sugar; 17) diabetes; 18) alcohol; 19) pattern; 20) night
Concepts of Health in the
Middle Ages
As populations of medieval
towns and cities increased, hygienic conditions worsened, leading to a vast
array of health problems. Medical knowledge was limited and, despite the
efforts of medical practitioners and public and religious institutions to
institute regulations, medieval Europe did not have an adequate health care
system. Antibiotics weren't developed until the 1800s and it was almost
impossible to cure diseases without them. There were many myths and
superstitions about health and hygiene as there still are today. People
believed, for example, that disease was spread by bad odors. It was also
assumed that diseases of the body resulted from sins of the soul. Many people
sought relief from their ills through meditation, prayer, pilgrimages, and
other nonmedical methods. The body was viewed as a part of the universe, a
concept derived from the Greeks and Romans. Four humors, or body fluids, were
directly related to the four elements: fire=yellow bile or choler;
water=phlegm; earth=black bile; air=blood. These four humors had to be
balanced. Too much of one was thought to cause a change in personality--for
example, too much black bile could create melancholy.
Intraperitoneal Treatment
Extends Life in Women With Ovarian Cancer
An estimated
22,220 women in the US were diagnosed with ovarian cancer in 2005. It causes more
deaths in the US than any other cancer of the female reproductive system, with
an estimated 16,210 women dying from the disease in 2005. The most recent
statistics show that only 45% of women survive five years after being diagnosed
with ovarian cancer. The survival rate increases to 94% when the disease is
diagnosed before it has spread. However, women with ovarian cancer frequently
have no symptoms or only mild symptoms until the disease is advanced. As a
result, only 19% of all cases are detected at that early, localized stage.
Standard chemotherapy for newly diagnosed ovarian cancer is a platinum-taxane
combination given intravenously. However, for the present study, reported in
the New England Journal of Medicine (2006; 354:34-43), The Gynecologic Oncology
Group conducted a randomized, phase 3 trial that compared intravenous
paclitaxel plus cisplatin with intravenous paclitaxel plus intraperitoneal
cisplatin and paclitaxel in patients with stage III ovarian cancer. For the
study, patients with stage III ovarian carcinoma or primary peritoneal
carcinoma with no residual mass greater than 1.0 cm, were randomly assigned to
receive 135 mg of intravenous paclitaxel per square meter of body-surface area
over a 24-hour period followed by either 75 mg of intravenous cisplatin per
square meter on day 2 (intravenous-therapy group) or 100 mg of intraperitoneal
cisplatin per square meter on day 2 and 60 mg of intraperitoneal paclitaxel per
square meter on day 8 (intraperitoneal-therapy group). Treatment was given
every three weeks for six cycles. Quality of life was assessed. Results showed
that of the 429 randomized patients, 415 were eligible. Grade 3 and 4 pain,
fatigue, and hematologic, gastrointestinal, metabolic, and neurologic toxic
effects were more common in the intraperitoneal-therapy group than in the
intravenous-therapy group (P<0.001). Only 42% of the patients in the
intraperitoneal-therapy group completed six cycles of the assigned therapy.
However, the median duration of progression-free survival in the
intravenous-therapy and intraperitoneal-therapy groups was 18.3 and 23.8
months, respectively (P=0.05). The median duration of overall survival in the
intravenous-therapy and intraperitoneal-therapy groups was 49.7 and 65.6
months, respectively (P=0.03). Quality of life was significantly worse in the
intraperitoneal-therapy group before cycle 4 and three to six weeks after
treatment but not one year after treatment. According to the authors, as
compared with intravenous paclitaxel plus cisplatin, intravenous paclitaxel
plus intraperitoneal cisplatin and paclitaxel improves survival in patients
with optimally debulked stage III ovarian cancer.
Biomarkers For Alzheimer's
Disease - New Program Launched by the NIH
According a recent study, published
online in Annals of Neurology (21 December 2005), new biomarkers to detect
Alzheimer's disease (AD), before signs of memory loss appear, have been
identified. The study combined high-tech brain imaging with measurement of
beta-amyloid protein fragments in cerebrospinal fluid (CSF). Results showed
that greater amounts of beta-amyloid containing plaques in the brain were
associated with lower levels of a specific protein fragment, amyloid-beta 1-42,
in CSF. Amyloid-beta 1-42 is central to AD development and is a major component
of amyloid plaques in the brain. It is the buildup of brain amyloid, a hallmark
of the Alzheimer's brain, that influences the decrease in cell-to-cell
communication. The study included 24 people ages 48 to 83 years who were cognitively
normal or had very mild, mild, or moderate dementia. The study used positron
emission tomography (PET), a brain imaging technique, with a tracing substance
called Pittsburgh Compound B (PIB), to determine the amount of plaques in the
participants' brains. PIB travels through the bloodstream into the brain and
then binds to beta-amyloid containing plaques in the brain. PIB makes it
possible to see on PET images any areas of the brain with high concentrations
of plaques. Samples of study participants' CSF and blood plasma were analyzed
for levels of specific protein fragments, including two forms of beta-amyloid
and the protein tau. The seven participants whose PET scans showed PIB binding,
and therefore deposits of beta-amyloid containing plaques in the brain, had the
lowest levels of amyloid-beta 1-42 in their CSF. Those without PIB binding had
the highest levels of CSF amyloid-beta 1-42. No relationship was seen between
PIB binding and the other CSF or blood-plasma biomarkers studied, including
plasma amyloid-beta 1-42. Importantly, three of the participants had normal
cognitive evaluations but had high PIB binding and low CSF amyloid-beta 1-42,
suggesting the possibility that this combination of methods may be useful as
"antecedent" biomarkers of AD. This observation may identify the
presence of AD amyloid pathology before the development of cognitive
impairments. Alternatively, if these subjects never develop cognitive decline,
it is possible that plaque number is not always a predictor of the disease.
Although this study involved a very small sample, the findings suggest that
amyloid imaging and CSF beta-amyloid measures together may have utility as
biomarkers of AD before symptoms develop and as the disease progresses The
search for biomarkers to detect AD and to monitor disease progression was
accelerated recently when the NIA (National Institute of Aging), and other
organizations, launched the 5-year, $60 million Alzheimer's Disease
Neuroimaging Initiative. The initiative is the most comprehensive effort to
date to study and correlate neuroimaging and fluid biomarkers with the changes
associated with mild cognitive impairment and AD. It will examine whether
serial magnetic resonance imaging (MRI), PET, other biomarkers, and clinical
and neuropsychological assessment can be combined to assess mild cognitive
impairment and early AD progression.
Depression and Risk of
Coronary Heart Disease
Previous studies have shown
that patients with depression have higher rates of coronary heart disease (CHD)
than people in the general population. However, large-scale population-based
data on incidence rates of CHD in people with depression have not been
performed. As a result, a study published in the American Journal of
Preventative Medicine (2005;29:428-433), was performed to analyze whether
hospitalization for depression predicts CHD in men and women after accounting
for socioeconomic status and geographic region. For the study, data from the
family coronary heart disease database at the Karolinska Institute, Stockholm,
were used to identify all people in Sweden aged 25 to 64 at onset of depression
and aged 25 to 79 at onset of nonfatal CHD between 1987 to 2001. Standardized
incidence ratios (SIRs) of CHD among those with and without depression were compared.
Results showed that there were 1,767 cases of CHD among those with depression
during the study period. The risk of developing CHD was strongest for those
aged <40 (SIR = 2.17). The risk was attenuated with increasing age in both
men and women. However, people aged 70 to 79 at onset of depression did not
have an increased risk of CHD. According to the authors, even after accounting
for socioeconomic status and geographic region, depression was a clinically
significant risk factor for developing CHD, especially in men and women aged 25
to 50. The authors added that primary healthcare teams should make particular
efforts to identify young to middle-aged women and men who have depression,
especially in combination with other CHD risk factors.
Statin Treatment Has No
Effect on Cancer Incidence
Statins are
cholesterol-lowering drugs that have been shown in randomized controlled trials
to prevent cardiac events. Recent retrospective analyses have suggested that
statins also prevent cancer. As a result, a study published in the Journal of
the American Medical Association (2006;295:74-80), was performed to investigate
the effect of statin therapy on cancer incidence and cancer death. In addition,
the study analyzed the effect of statins on specific cancers and the effect of
statin lipophilicity or derivation. For the study, a systematic literature
search was performed using MEDLINE, EMBASE, CINAHL, Web of Science, CANCERLIT,
and the Cochrane Systematic Review Database through July 2005 using specific
search terms. A review of cardiology and cancer abstracts and manual review of
references was also performed. Twenty-seven of the 8,943 articles (n = 86,936
participants) initially identified met the inclusion criteria. These 27 studied
included 26 randomized controlled trials of statins, with a mean duration of
follow-up of at least 1 year, enrolling a minimum of 100 patients, and
reporting data on either cancer incidence (n = 20 studies) or cancer death (n =
22 studies). All data were independently extracted by 3 investigators using a
standardized data abstraction tool. Weighted averages were reported as odds
ratios (ORs) with 95% confidence intervals (CIs) using a random-effects model
(DerSimonian and Laird methods). Statistical heterogeneity scores were assessed
with the Q statistic. Results showed that, based on 6,662 incident cancers and
2,407 cancer deaths, statins did not reduce the incidence of cancer (OR, 1.02)
or cancer deaths (OR, 1.01) . No reductions were noted for any individual
cancer type. This null effect on cancer incidence persisted when only
hydrophilic, lipophilic, naturally derived, or synthetically derived statins
were evaluated. According to the authors, statins have a neutral effect on
cancer and cancer death risk in randomized controlled trials, and that no type
of cancer was affected by statin use and no subtype of statin affected the risk
of cancer.
TARGET HEALTH excels in
Regulatory Affairs and works closely with many of its clients performing all
FDA submissions. TARGET HEALTH receives daily updates of new developments at
FDA. Each week, highlights of what is going on at FDA are shared to assure that
new information is expeditiously made available.
FDA to Celebrate 100th Birthday
The FDA will celebrate its 100th anniversary in 2006. In
addition to a nation-wide program of commemorative events being held throughout
the year. The January-February 2006 issue of FDA's bimonthly publication, FDA
Consumer, traces the agency's history from the passage of pure food and drug
laws at the turn of the last century to the challenges posed today by
cutting-edge sciences such as genomic and proteomics, and new initiatives like
"personalized medicine." An online version of the magazine will be
available on January 15, 2006, at www.fda.gov/centennial/fdac.
FDA dates its origin to June 1906, when President Teddy Roosevelt signed the
Food and Drugs Act and entrusted implementation of this law to the Bureau of
Chemistry of the U.S. Department of Agriculture. The Bureau, the oldest U.S.
consumer protection office, eventually became the FDA, an agency of the
Department of Health and Human Services. Over the years, FDA has provided
Americans with increasingly comprehensive, science-based protections that
ensure the highest quality of products essential for health and survival.
Today, these products represent almost 25% of all consumer spending and include
80% of the national food supply and all human drugs, vaccines, medical devices,
tissues for transplantation, equipment that emits radiation, cosmetics, and
animal drugs and food.
For more information about our expertise in Regulatory Affairs,
please contact Dr. Jules T.
Mitchel or Dr. Glen Park.
TARGET HEALTH INC. (www.targethealth.com)
is a full service e*CRO with fulltime staff dedicated to all aspects of drug
and device development. Areas of expertise include Regulatory Affairs,
comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions,
execution of Clinical Trials, Project Management, Biostatistics and Data
Management, Web Trials, utilizing Target e*CRF™, our proprietary Internet-based
Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical
Advisory Dream Team (PADT) assists companies in strategic planning from Discovery
to Market Launch. Let us help you on your next project.
TARGET HEALTH INC.
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24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
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Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved