(Complimentary Newsletter from Target Health Inc.)
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27 March 2006
I.
WHAT'S NEW?
Two Employees
Return to Target Health
II. QUIZ
(Fill In The Blanks)
Merging
With Machines? Six Remarkable Examples
III.
HISTORY OF MEDICINE
Was Louis
XIV Infected with Parasites?
IV. NEUROLOGY
Is There a Genetic Basis For Violence?
V. RHEUMATOLOGY
Chronic RA and Risk of Lymphoma
VI. ALTERNATIVE MEDICINE
Acupressure and Low Back Pain
VII. CARDIOLOGY
ACAT Inhibitors Not Effective in Atherosclerosis and May Make it
Worse
VIII. FDA
New Device For The Detection of Cervical Cancer
IX. Target Health Inc.
Two
Employees Return to Target Health
Employee turnover is a
major problem in the pharmaceutical industry. In contrast to this trend, Target
Health is pleased to announce that Eva Jurewicz has returned as Clinical
Project Manager and Leigh Ren as Associate Director of Biostatistics. More than
50% of our employees have been with Target Health for more than 5 years and we
have been working with several of our clients for over 10 years. For
more information, please contact Dr. Jules T. Mitchel.
Merging With Machines? Six
Remarkable Examples
A German design
team has designed an internal cell phone, a microvibration 1) ___ and a
wireless low-frequency receiver that can be implanted in the 2) ___. The
vibrator acts as microphone and speaker, sending sound waves along the jawbone
to the 3) ___. A second device is being developed in the US to enhance memory.
A microchip will send signals from one healthy brain cell to another, bypassing
damaged 4) ___ that would otherwise block the message. This artificial
hippocampus may help Alzheimer’s patients regain the ability to form 5) ___.
Thirdly, the Bionic Ear Institute in Australia is building an implant for the
inner ear that will shock damaged 6) ___ back to health. A small pump showers
the nerves with stimulating chemicals while 7) ___ will excite the cells to
keep them alive. Next, a pacemaker, being developed in the US, is helping
test subjects lose 25 to 40% of their body fat. Its mild 8) ___ relax and
expand the upper part of the 9) ___, and the brain interprets the distended
stomach as feeling full. Usually when one ruptures or dislocates a spinal 10)
___disc, nearby vertebrae need to be fused to prevent them from rubbing against
each other. But now there’s the Charité, approved by the FDA. This device is a
disc of polyethylene and cobalt-chromium alloy that shifts and slides to allow
a full 21 degrees of motion. When doctors replace a knee, they remove the
anterior cruciate 11) ___, shifting the primary contact area from the inner
edge of the knee to the outer edge. The 3DKnee made by Encore Medical Corp. in
Austin, Texas, is the first to take this switch into account, so the knee feels
more natural and lasts 12) ___.
Answers: 1) device; 2)
tooth; 3) eardrum; 4) tissue; 5) memories; 6) nerves;
7) electrodes; 8) shocks; 9) stomach; 10) disc; 11) ligament; 12) longer
Was Louis XIV Infected with
Parasites?
Louis XIV, known as the Sun
King, came to the throne at the age of 5 and reigned for 72 years, from 1643 to
1715. In 1680, a chateau and surrounding lodges were built in Marly-le-Roi,
near Paris, to serve as a hunting residence for the king and his court.
Marly-le-Roi was razed during the French revolution, but archaeological
excavations revealed the site of several latrines. Examination of their
sedimented fecal remains showed that two nematode parasites--ascaris and
trichinella--were particularly widespread. Also found were many well preserved
taenia eggs. In some of the specimens, the characteristic hooks that allow
these tapeworms to fix themselves on the intestinal wall were still
distinguishable. Taeniasis was doubtless caused by the consumption of
insufficiently grilled meat, favored by the nobility. Another parasite that
infested the king's court was Fasciola hepatica, probably present in
watercress and dandelion. Records testify that watercress was fashionable and
was brought from Cailly, in Normandy, and from Orleans. To this day, Fasciola
hepatica parasitosis has not been eradicated in France.
Is There a Genetic Basis
For Violence?
According to an
article published online in the Proceedings of the National Academy of Sciences
(March 20, 2006), a study showed that a version of a gene previously linked to
impulsive violence in humans, appears to weaken brain circuits that regulate
impulses, emotional memory and thinking. Results showed that brain scans of
people with this version of the gene, especially males, tended to have
relatively smaller emotion-related brain structures, a hyperactive alarm center
and under-active impulse control circuitry. The gene is one of two common
versions that code for the enzyme monoamine oxydase-A (MAO-A), which breaks
down key mood-regulating chemical messengers, most notably serotonin. The
previously identified violence-related, or L, version, contains a different
number of repeating sequences in its genetic code than the other version (H),
likely resulting in lower enzyme activity and hence higher levels of serotonin.
This, in turn, influences how the brain gets wired during development. The
variations may have more impact on males because they have only one copy of
this X-chromosomal gene. Several previous studies had linked increased
serotonin during development with violence and the L version of MAO-A. For
example, an earlier study published in Science (2002;297:851-854) discovered
that the gene's effects depend on interactions with environmental hard knocks.
Men with L were more prone to impulsive violence, but only if they were abused
as children. For the present study of 97 subjects, it was found that those with
L showed reductions in gray matter (neurons and their connections) of about 8%
in brain structures of a mood-regulating circuit (cingulate cortex, amygdala)
among other areas. Volume of an area important for motivation and impulse
regulation (orbital frontal cortex) was increased by 14% in men only. The study
also looked at effects on brain activity using functional MRI (fMRI) scans.
While performing a task matching emotionally evocative pictures such as angry
and fearful faces, subjects with L showed higher activity in the fear hub
(amygdala). At the same time, decreased activity was observed in higher brain
areas that regulate the fear hub (cingulate, orbital frontal, and insular
cortices). While these changes were found in both men and women, two other
experiments revealed gene-related changes in men only. In a task which required
remembering emotionally negative information, men, but not women, with L had
increased reactivity in the fear (amygdala) and memory (hippocampus) hubs. Men
with L were also deficient during a task requiring them to inhibit a simple
motor response; they failed to activate a part of the brain (cingulate cortex)
important for inhibiting such behavioral impulses. This region was,
conspicuously, the cortex area that was most reduced in volume. According to
the authors, by itself, this gene is likely to contribute only a small amount
of risk in interaction with other genetic and psychosocial influences. But, by
studying its effects in a large sample of normal people, it may be possible to
see how this gene variant biases the brain toward impulsive, aggressive
behavior.
Chronic RA and Risk of
Lymphoma
Chronic
inflammatory conditions such as rheumatoid arthritis (RA) have been associated
with malignant lymphomas. As a result, a study published in Arthritis and
Rheumatism (2006;54:692-701), was undertaken to investigate which patients are
at highest risk, and whether antirheumatic treatment is hazardous or
protective. For the investigation, a matched case-control study was performed
with 378 consecutive Swedish RA patients in whom malignant lymphoma occurred
between 1964 and 1995 (from a population-based RA cohort of 74,651 RA
patients), and 378 controls. Information on disease characteristics and
treatment from onset of RA until lymphoma diagnosis was abstracted from medical
records. Lymphoma specimens were reclassified and tested for Epstein-Barr virus
(EBV). Results showed that the relative risks (odds ratio [OR] of lymphoma were
only modestly elevated up to the seventh decile of cumulative disease activity.
Thereafter, the relative risk increased dramatically (OR ninth decile 9.4, OR
tenth decile 61.6. Most lymphomas (48%) were of the diffuse large B cell type,
but other lymphoma subtypes also displayed an association with cumulative
disease activity. Standard nonbiologic treatments did not increase lymphoma
risk. EBV was present in 12% of lymphomas. According to the authors, the risk
of lymphoma is substantially increased in a subset of RA patients with very
severe disease. High inflammatory activity, rather than its treatment, is a
major risk determinant.
Acupressure and Low Back
Pain
According to an article published
in the British Medical Journal (2006;332:696-700), a study was performed to
evaluate the effectiveness of acupressure in terms of disability, pain scores,
and functional status. This randomized study included 129 patients with chronic
low back pain treated with acupressure or physical therapy for one month. The
main outcome measures were self-administered Chinese versions of standard
outcome measures for low back pain (primary outcome: Roland and Morris
disability questionnaire) at baseline, after treatment, and at six month
follow-up. Results showed that the mean total Roland and Morris disability
questionnaire score after treatment was significantly lower in the acupressure
group than in the physical therapy group regardless of the difference in absolute
score (- 3.8) or mean change from the baseline (- 4.64). Acupressure conferred
an 89% reduction in significant disability compared with physical therapy. The
improvement in disability score in the acupressure group compared with the
physical group remained at six month follow-up. Statistically significant
differences also occurred between the two groups for all six domains of the
core outcome, pain visual scale, and modified Oswestry disability questionnaire
after treatment and at six month follow-up. It was concluded that acupressure
was effective in reducing low back pain in terms of disability, pain scores,
and functional status for six months.
ACAT Inhibitors Not
Effective in Atherosclerosis and May Make it Worse
Target Health is
pleased to announce that this article is co-authored by one of our colleagues,
Laurent Kassalow.
The enzyme acyl–coenzyme
A:cholesterol acyltransferase (ACAT), esterifies cholesterol in a variety of
tissues. In some animal models, ACAT inhibitors have antiatherosclerotic
effects. As a result, a study published in the New England Journal of Medicine
(2006;354:1253-12630, was performed to evaluate the effect the ACAT inhibitor
pactimibe in patients coronary disease. For the study, intravascular ultrasonography
was performed in 408 patients with angiographically documented coronary
disease. All patients received usual care for secondary prevention, including
statins, if indicated. Patients were randomly assigned to receive the ACAT
inhibitor pactimibe (100 mg per day) or matching placebo. Ultrasonography was
repeated after 18 months to measure the progression of atherosclerosis. Results
showed that the progression of atherosclerosis, measured by the change in
percent atheroma volume, was similar in the pactimibe and placebo groups (0.69%
and 0.59%, respectively; P=0.77). In addition, both secondary efficacy
variables assessed by means of intravascular ultrasonography showed unfavorable
effects of pactimibe treatment. As compared with baseline values, the normalized
total atheroma volume showed significant regression in the placebo group (–5.6
mm3, P=0.001) but not in the pactimibe group (–1.3 mm3,
P=0.39; P=0.03 for the comparison between groups). The atheroma volume in the
most diseased 10-mm subsegment regressed by 3.2 mm3 in the placebo
group, as compared with a decrease of 1.3 mm3 in the pactimibe group
(P=0.01). The combined incidence of adverse cardiovascular outcomes was similar
in the two groups (P=0.53). It was concluded that for patients with coronary disease,
treatment with an ACAT inhibitor did not improve the primary efficacy variable
and adversely affected two major secondary efficacy measures assessed by
intravascular ultrasonography. The authors added that ACAT inhibition is not an
effective strategy for limiting atherosclerosis and may promote atherogenesis.
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 Device For The Detection of
Cervical Cancer
Cervical cancer
is one of the few highly preventable cancers. The early detection and removal
of pre-cancerous cervical lesions reduces the risk of developing invasive
cervical cancer. The FDA has approved a new imaging system that can help detect
a cervical cancer precursor. The LUMA Cervical Imaging System, manufactured by
MediSpectra, Inc. of Lexington, Mass., is intended to be used along with
colposcopy. Colposcopy is a high magnification evaluation of the cervix for
women who have recently had an abnormal Pap test. Study results showed that the
new device can detect additional cancer precursors missed by colposcopy. Of the
50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of
cervical pre-cancer and LUMA caught an additional 9 cases of cervical
pre-cancer that colposcopy had missed. The LUMA Cervical Imaging System shines
a light on the cervix and analyzes how different areas of the cervix respond to
this light. The LUMA Systems assigns a score to tiny areas of the cervix and
produces a color map that helps identify the biopsy sites. The colors and
patterns on the map help to distinguish between healthy tissue, and potentially
diseased tissue. The system works as follows: Colposcopy is performed to
identify areas on the cervix to biopsy. The LUMA image is then evaluated to see
whether or not there are additional areas of the cervix that should be
biopsied. Only after both the colposcopy and LUMA procedures are completed are
the biopsies performed. FDA's approval was based on data from 193 women who
underwent colposcopy, followed by LUMA. FDA's analysis showed that the device
is safe and effective and that, when used along with colposcopy, the LUMA
system will help detect additional cervical cancer precursors. Use of the LUMA
device is not a substitute for a thorough colposcopic exam.
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.
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©2006 Target Health Inc. All rights reserved