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10 July 2006
I.
WHAT'S NEW?
Target e*CRF®
II. QUIZ (Fill
In The Blanks)
Tomatoes
Used To Attack Human Diseases
III.
HISTORY OF MEDICINE
Thomas Vicary, Barber-Surgeon
IV. PUBLIC HEALTH
Health Effects of Obesity
V. NEUROLOGY
Risk Factors For Stroke
VI. RHEUMATOLOGY
Increased Cardiovascular Risk in Patients With
RA
VII. INFECTIOUS DISEASE
New Treatment For Childhood Rotavirus
VIII. FDA
New Biologic Treatment Approved for Wet Age-Related Macular Degeneration
IX. Target Health Inc.
Target
e*CRF®
By September, Target
Health will be releasing the next version of Target e*CRF®. This version will
allow companies to configure an Internet-based clinical trial within days and
with full documentation. The skill set required is a CRA and a data
manager. You will be able to do "more with less" and it
will be less expensive than paper CRF trials. For more information, please contact Dr.
Jules T. Mitchel.
Tomatoes Used To Attack
Human Diseases
The US Department of
Agricultural Research Service, is collaborating with the Siberian Institute of
Plant Physiology and Biochemistry to create affordable 1) ___ for HIV and the
hepatitis B virus (HBV) that could be easily grown and processed in the
countries where they are most needed.. Genetically 2) ___ tomatoes, containing
edible vaccine are to be used to challenge two of the world’s most lethal
viruses. The researchers used a particular soil bacterium to shuttle a 3) ___
combination of HIV and HBV DNA fragments into tomato plants. These included
fragments of genes for various HIV 4) ___ and the gene for an HBV protein
called HBV surface antigen. The tomato plants then 5) ___ the proteins and,
like the oral 6) ___ vaccine, when the tomatoes were eaten, these proteins
prompted the body to create antibodies against the viruses. Mice fed a solution
containing the tomatoes in powdered form, developed high levels of 7) ___ in
their blood to both viruses. Equally important, the researchers found
antibodies on mucosal surfaces, where the viruses can gain entry to the body through
contact areas where protection is greatly needed. If the tomato-based vaccines
work in humans they could be given in tablet form, since giving people the
tomatoes directly, would make it difficult to control how much protein they
received. This form of vaccine wouldn’t need to be refrigerated or to be
injected, eliminating 8) ___ risks, a big advantage in poorer countries. An
oral vaccine would be inexpensive and relatively easy to make and to
administer. These results were presented at a meeting of the International
Society for Infectious Diseases in
ANSWERS: 1) vaccines; 2)
modified; 3) synthetic; 4) proteins; 5) manufactured; 6) polio; 7) antibodies;
8) infection
Thomas Vicary,
Barber-Surgeon
An Act of Parliament in 1540
uniting the barbers and surgeons to form the Barber-Surgeons' Company
represented an important foundation towards better surgery in
Health Effects of Obesity
Obesity, typically measured as body mass index of
30 or higher, has 3 subclasses: obesity 1 (30-34.9); obesity 2 (35-39.9); and
extreme obesity (> 40). Extreme obesity is increasing particularly
rapidly in the
Risk Factors For Stroke
According to an
article published in the journal Stroke (2006;37:1663-1667), a study was
performed to estimate the predictive value of risk factors for stroke measured
in midlife over follow-up extending through 28 years. The study was based on
results from a cohort of 7,457 men 47 to 55 years of age and free of stroke at
baseline year 1970. Risk of stroke was analyzed for the entire period and for
periods 0 to 15, 16 to 21, and 22 to 28 years of follow-up using age-adjusted
and multiple Cox regression analyses. Results showed that age, diabetes, and
high blood pressure were independently associated with increased risk of stroke
for the entire 28 years and for each of the periods. Previous transient
ischemic attacks, atrial fibrillation, history of chest pain, smoking, and
psychological stress were independently related to stroke for the entire
follow-up period and also during the first 1 or 2 successive periods. Family
history of stroke or of coronary disease carried no independent prognostic
information, nor did serum cholesterol. Elevated body mass index predicted
stroke during the later part of the follow-up and so did (almost) low physical
activity during leisure time, together with antihypertensive medication at
baseline. According to the authors, high blood pressure and diabetes retain
their importance as stroke risk factors also over an extended follow-up into
old age, while a family history of cardiovascular disease was not significantly
related to outcome. Transient ischemic attacks, atrial fibrillation, stress,
smoking, and a history of chest pain were associated with outcome only for the
first or the first 2 periods. High body mass index and antihypertensive
medication at baseline emerged as risk factors in the second and third decades.
Increased Cardiovascular
Risk in Patients With RA
It is well known that among
patients with rheumatoid arthritis (RA), cardiovascular mortality is increased
compared with the rate among unaffected peers. As a result, a study published
in Arthritis & Rheumatism (2006;54:2061-2068), was
performed to compare 30-day mortality rates following a first acute
cardiovascular event (myocardial infarction or stroke) between RA patients and
the general population. For the study, all cases of a first acute cardiovascular
event between July 1, 2001 and November 30, 2003 in
New Treatment For Childhood
Rotavirus
Rotavirus, a leading cause
of world-wide morbidity and mortality due to diarrhea in children younger than
5 years, has no effective treatment. As a result, a study published in The
Lancet (2006;368:124-129), was performed to assess the
activity of nitazoxanide, a broad-spectrum anti-infective drug, against
rotavirus a clinical trial in pediatric patients hospitalized with severe
rotavirus diarrhea. The study was a randomized double-blind placebo-controlled
trial in 50 children with severe rotavirus diarrhea admitted to the Cairo
University Children's Hospital between June 15 and Aug 23, 2005. Thirty eight
(38) children aged 5 months to 7 years (median age 11 months) with rotavirus as
the sole identified cause of gastroenteritis were enrolled in the clinical
study. Patients were randomly assigned either 7•5 mg/kg nitazoxanide as an oral
suspension or placebo twice a day for 3 days, and all remained in hospital for
7 days after start of treatment. The primary endpoint was time from first dose
to resolution of illness, and analysis was by modified intention-to-treat.
Survival analysis showed that the median time to resolution of illness was 31
hours (range 22–73) for the nitazoxanide-treated group compared with 75 hours
(51–124) for the placebo group (p=0•0137). No significant adverse events were
reported. According to the authors, a 3-day course of nitazoxanide
significantly reduced the duration of rotavirus disease in hospitalized
pediatric patients. The authors added that these results are encouraging, and
might lead us to think about new approaches to managing rotavirus disease in
children.
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 Biologic Treatment
Approved for Wet Age-Related Macular Degeneration
Age-related
macular degeneration (AMD) is a retinal disease causing severe and irreversible
vision loss, and is a major cause of blindness in individuals older than 55
years. Untreated, the majority of eyes affected with wet AMD may become
functionally impaired. Wet AMD, which accounts for 10% of all AMD, is
responsible for 80% of the associated vision loss. The vision loss in wet AMD
is caused by the growth of abnormal leaky blood vessels that eventually damage
the area of the eye responsible for central vision. The FDA has approved Lucentis
(ranibizumab injection; Genentech) for the treatment of patients with
neovascular (wet) age-related macular degeneration (AMD). Lucentis is designed
to block new blood vessel growth and leakiness, which ultimately lead to
disease progression and such vision loss. Lucentis is the first treatment
which, when dosed monthly, can maintain the vision of more than 90% of patients
with this type of AMD. Lucentis is a new molecular entity (NME), meaning it
contains an active substance that has never before been approved for marketing
in any form in the
For a copy of the guidance
or 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 full-time 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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Dr. Jules T. Mitchel,
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Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved