(Complimentary Newsletter from Target Health Inc.)
[Home]
[Target e*CRO] [Target
e*CRF] [Publications] [Press
Release] [Advisors] [FDA
Process] [Advertising]
27 February 2006
I.
WHAT'S NEW?
Visit
to China
II. QUIZ
(Fill In The Blanks)
Pathogen
Transmission, Global Warming, Species Extinction
III.
HISTORY OF MEDICINE
Cesarean
Section
IV. MICROBIOLOGY
Bacterial Infection in Coronary Heart Disease
V. NEUROLOGY
New Possible Treatments for Parkinson's Disease
VI. EPIDEMIOLOGY
Snowboarders and Skiers Should Wear Helmets
VII. PSYCHOSOMATIC MEDICINE
A Placebo Versus Placebo Analysis
VIII. FDA
New Drug Approval For Candida Infections
IX. Target Health Inc.
Visit to China
Target Health Inc. is
pleased to announce that Dr. Jules Mitchel and Dr. Tai Xie (Brightech
International), have completed a successful day trip to China. The goal of the
trip was to explore potential collaborations within China and to evaluate the
use of Target e*CRF® for both domestic and international
studies performed in China/Asia. The trip was an eye-opener and clearly the Asian
market is rapidly growing. For more information, please contact Dr.
Jules T. Mitchel.
Pathogen Transmission,
Global Warming, Species Extinction
A study
published in the journal Nature, finds compelling evidence that global climate
change created favorable conditions for a pathogenic 1) ___ in Central and
South America. That fungus, in turn, has led to widespread extinctions of
harlequin 2) ___. This is a key example of unanticipated and complex impacts
from 3) ___ change. The Central and South American crisis is an amphibian alarm
call, but also a harbinger of much greater 4) ___ disruption. There is a
complex relationship between global warming and major extinction of 5) ___. The
powerful synergy between 6) ___ transmission and climate change should give us
cause for concern about 7) ___ health in a warmer world. Global change is
occurring at an unprecedented 8) ___. Therefore, we should expect many other
host taxa, from ants to zebras, to be confronted with similar challenges.
Answers: 1) fungus; 2)
frogs; 3) climate; 4) biological; 5) species; 6) pathogen; 7) human; 8) pace
Cesarean Section
The Cesarean section operation
did not derive its name from the fact that Julius Caesar was supposedly born in
this manner. It was called Cesarean because the Roman, or Cesarean, law
demanded that when a pregnant woman died, her body could not be buried until
the child had been removed. The law also stipulated that a Cesarean section
could not be performed on a living pregnant woman until the tenth month of
gestation. Ancient physicians were unable to save the life of the mother in
such cases, thus the procedure was rarely performed. We know from ancient sources
that Julius Caesar could not have been born by Cesarean section, because his
mother, Aurelia, lived to be an adviser to her grown son.
Bacterial Infection in
Coronary Heart Disease
Bacterial
infection has been discussed for many years as a potential etiologic factor in
the pathophysiology of coronary heart disease (CHD). As a result, a study
published in Circulation (2006;113:929-937), was performed to systematically
explore the presence, frequency, and diversity of bacteria molecular
phylogenies in atherosclerotic lesions in patients with CHD. The study
investigated 16S rDNA signatures in atherosclerotic tissue obtained through
catheter-based atherectomy of 1) 38 patients with CHD, 2) control material from
postmortem patients (n=15), and 3) heart-beating organ donors (n=11). Results
showed the presence of bacterial DNA in all CHD patients by conserved PCR but
not in control material or in any of the normal/unaffected coronary arteries.
Presence of bacteria in atherosclerotic lesions was confirmed by fluorescence
in situ hybridization. A high overall bacterial diversity of >50 different
species, among them Staphylococcus species, Proteus vulgaris, Klebsiella
pneumoniae, and Streptococcus species, was demonstrated in >1500
clones from a combined library and confirmed by denaturating gradient gel
analysis. Mean bacterial diversity in atheromas was high, with a score of
12.33±3.81 (range, 5 to 22). A specific PCR detected Chlamydia species in 51.5%
of CHD patients. According to the authors, detection of a broad variety of
molecular signatures in all CHD specimens suggests that diverse bacterial
colonization may be more important than a single pathogen. The authors added
that although the study results do not allow for the conclusion that bacteria
are the causative agent in the etiopathogenesis of CHD, bacterial agents could
have secondarily colonized atheromatous lesions and could act as an additional
factor accelerating disease progression.
Snowboarders and Skiers
Should Wear Helmets
In contrast to
bicycling, there is no policy of mandatory helmet use for recreational alpine
skiers and snowboarders. Although using a helmet is assumed to reduce the risk
of head injuries in alpine sports, this effect has been questioned. As a
result, a study published in the Journal of the American Medical Association
(2006;295:919-9240) was performed to determine the effect of wearing a helmet
on the risk of head injury among skiers and snowboarders. The investigation was
a case-control study at 8 major Norwegian alpine resorts during the 2002 winter
season. Study participants included 3,277 injured skiers and snowboarders
reported by the ski patrol and 2,992 non-injured controls who were interviewed
on Wednesdays and Saturdays. The controls comprised every 10th person entering
the bottom main ski lift at each resort during peak hours. The number of
participants interviewed corresponded with each resort's anticipated injury
count based on earlier years. Injury type, helmet use, and other risk factors
(age, gender, nationality, skill level, equipment used, ski school attendance,
rented or own equipment) were recorded. A multivariate logistic regression
analysis was used to assess the relationship between individual risk factors (including
helmet wear) and risk of head injury by comparing skiers with head injuries
with uninjured controls, as well as to skiers with injuries other than head
injuries. Head injuries accounted for 578 injuries (17.6%). Using a helmet was
associated with a 60% reduction in the risk for head injury when comparing
skiers with head injuries with uninjured controls. The effect was slightly
reduced when skiers with other injuries were used as controls. For the 147
potentially severe head injuries, those who were referred to an emergency
physician or for hospital treatment, the adjusted OR was 0.43. The risk for
head injury was higher among snowboarders than for alpine skiers (adjusted OR,
1.53). The authors concluded that wearing a helmet is associated with reduced
risk of head injury among snowboarders and alpine skiers.
New Possible Treatments for
Parkinson's Disease
Parkinson's disease is a
degenerative disorder of the brain in which patients may develop progressive
tremor, slowness of movements, and stiffness of muscles. It affects
approximately 1% of Americans over the age of 65. Although certain drugs, such
as levodopa, can reduce the symptoms of Parkinson's, no treatment has been
shown to slow the progressive deterioration in function. The National Institute
of Neurological Disorders and Stroke (NINDS) of the NIH has organized a
nationwide multi-center effort called NET-PD (Neuroprotection Exploratory
Trials in Parkinson's Disease), a randomized, double-blind futility trial, to
study compounds that may slow the clinical decline of Parkinson's disease.
Study results with minocycline and creatine are available online and will be
published in the March 14, 2006 issue of Neurology. To be included in the
study, patients were identified who were in the very early phase of their
disease such that they did not yet need medications typically used to treat
their Parkinson's symptoms. Patients were then randomly assigned to receive
minocycline, 200 mg per day; creatine, 10 grams per day; or placebo. The study
participants were followed for 12 months. In terms of safety, although neither
agent caused major side effects, minocycline was not as well tolerated. In
terms of efficacy, both creatine and minocycline appeared to modify the disease
features as measured by a decline in the clinical signs of Parkinson's disease.
However, it is important to note that the study was not designed nor intended
to determine whether creatine or minocycline was effective as a treatment for
Parkinson's and that further studies are needed.
A Placebo Versus Placebo
Analysis
According to an
article published in the British Medical Journal (2006;332:391-397), a study
was performed to investigate whether a sham device (a validated sham
acupuncture needle), has a greater placebo effect than an inert pill in
patients with persistent arm pain. The study was a single blind randomized
controlled trial created from the two week placebo run-in periods for two
nested trials that compared acupuncture and amitriptyline with their respective
placebo controls. Comparison of participants who remained on placebo continued
beyond the run-in period to the end of the study. Study participants included
270 adults with arm pain due to repetitive use that had lasted at least three
months despite treatment and who scored >3 on a 10 point pain scale.
Treatments were 1) acupuncture using the sham device twice a week for six
weeks, or 2) placebo pill once a day for eight weeks. The main outcome measures
were arm pain measured on a 10 point pain scale. Secondary outcomes were
symptoms measured by the Levine symptom severity scale, function measured by
Pransky's upper extremity function scale, and grip strength. Results showed
that pain decreased during the two week placebo run-in period in both the sham
device and placebo pill groups, but changes were not different between the
groups (-0.14). Changes in severity scores for arm symptoms and grip strength
were similar between groups, but arm function improved more in the placebo pill
group (2.0; P = 0.04). Longitudinal regression analyses that followed
participants throughout the treatment period showed significantly greater
downward slopes per week on the 10 point arm pain scale in the sham device
group than in the placebo pill group (-0.33 vs. -0.15; P = 0.0001) and on the
symptom severity scale (-0.07 vs. -0.05; P = 0.02). Differences were not
significant, however, on the function scale or for grip strength. Reported
adverse effects were different in the two groups. It was concluded that the
sham device had greater effects than the placebo pill on self reported pain and
severity of symptoms over the entire course of treatment but not during the two
week placebo run in. The authors added that the placebo effects seem to be
malleable and depend on the behaviors embedded in medical rituals.
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.
New Drug Approval For Candida
Infections
The FDA approved
Eraxis™ (anidulafungin) to treat certain infections caused by Candida, a yeast-like
fungus that can cause serious infections in hospitalized patients or patients
with compromised immune systems. Eraxis is an antifungal drug that is
administered intravenously, and is used to treat Candida infections in the
esophagus (candidiasis), blood stream (candidemia), and other forms of Candida
infections, including abdominal abscesses and peritonitis (inflammation of the
lining of the abdominal cavity). Eraxis was generally well tolerated in
clinical studies. The most commonly reported adverse events were mild diarrhea,
mild elevations in laboratory tests of liver enzymes, and headache. Some
patients experienced infusion-related reactions, most of which were mild. In a
few patients with significant underlying medical conditions who were on multiple
concomitant medications, there were reports of serious hepatic abnormalities.
Eraxis is manufactured by Pfizer Inc.
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.
261 Madison Avenue
24th Floor
New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
Target Health
Ad
www.targethealth.com
Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved