(Complimentary Newsletter from Target Health Inc.)
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20 March 2006
I.
WHAT'S NEW?
DIA Meeting
- Electronic Health Record and Electronic Data Capture (EDC)
Bio-IT
World Meeting - lnternet-Based Clinical Trials
II. QUIZ
(Fill In The Blanks)
Repairing
Brain Damage: Just One More 21st Century Miracle
III.
HISTORY OF MEDICINE
Wilder
Penfield - Creator of the Sensory Map
IV. BASIC SCIENCE
Is There a Link Between Smoking and Alcoholism? - Ask the
Rats
V. PUBLIC HEALTH
Fine Particle Air Pollution and Risk to the Elderly
VI. OPHTHALMOLOGY
Genetic Basis of Age-Related Macular Degeneration
VII. PEDIATRICS
LDH as a Predictor of Severity of Sickle Cell Disease
VIII. FDA
Predictive Safety Testing Consortium
IX. Target Health Inc.
DIA Meeting
- Electronic Health Record and Electronic Data Capture (EDC)
Target Health Inc. is
pleased to announce that Dr. Jules Mitchel will be presenting at the DIA
Meeting entitled "R&D
Meets Health IT," on March 28, 2006, in Philadelphia. The meeting is
being held in parallel with DIA's 21st Annual Clinical Data Management
Meeting. The presentation topic is "The Preparation and Promise of
EHR Integration - an EDC Perspective".
Bio-IT World Meeting - lnternet-Based Clinical Trials
Target Health
is pleased to announce that Dr. Jules Mitchel will chair a session at the
annual meeting of Bio-IT
World in Boston, April 3-5, 2006. The session topic is "Internet-Based
Clinical Trials - How To Work Together For the Common Good From the
Perspectives of the Sponsor, Clinical Site, CRO and EDC Vendor".
Please let us know if you will be attending. For more information, please
contact Dr.
Jules T. Mitchel.
Repairing Brain Damage:
Just One More 21st Century Miracle
The new science
of brain repair is a reality. While it is difficult to get drugs, to target
just one region of the brain, electrical devices can now do this. Doctors are
now using tiny 1) ___ devices to help mend compromised brains, not only those
injured by diseases such as 2) ___. Neurologists at several hospitals have just
started a major clinical 3) ___ of a promising implant that may repair brain
damage caused by 4) ___. Last year, the FDA approved a vagus nerve 5) ___ to
treat serious 6) ___. Vagus nerve stimulation is a 90-minute out-patient
procedure which targets those key areas of the brain responsible for
depression. At a neuroscience meeting last year, scientists showcased a
brand-new implant that allows a quadriplegic to control a remote robotic arm
with, literally, the 7) ___. It's all being pushed by tremendous advances in
brain 8) ___, allowing doctors to target tiny areas, and with computer 9) ___
to control them. Our understanding of targets has changed. Since the brain is
an electrical organ, there is no more efficient way of getting it to act, than
by using a tiny electrical 10) ___.
Answers: 1) electrical;
2) Parkinson’s; 3) trial; 4) stroke; 5) stimulator; 6) depression; 7) mind; 8)
mapping; 9) chips; 10) current
Wilder Penfield - Creator
of the Sensory Map
The sensory map in humans was
originally charted by the Canadian neurosurgeon Wilder Penfield in the 1930s.
Before operating on patients who suffered from epilepsy, Penfield stimulated
different parts of their brains with electrodes to locate the cells that set
off their attacks. He could do this while the patients were awake, since the
brain does not feel what is happening to it. In this way, Penfield soon learned
exactly where each part of the body that was touched or moved was represented
in the brain. He then showed it in his famous "homunculus" cartoons
of the somatosensory and motor areas. The brain's map of the body extends along
a vertical strip of cerebral cortex near the center of the skull. The cortex-a
large, deeply wrinkled sheet of neurons, or nerve cells, on the surface of the
brain's two hemispheres-governs all our sensations, movements, and thoughts.
Is There a Link Between
Smoking and Alcoholism? - Ask the Rats
It is well known
that people who smoke are more likely to drink alcohol than non-smokers.
Similarly, smoking is three times more common in people with alcoholism than in
the general population. Since previous studies have also determined that
genetics plays an important role in both alcohol and nicotine addictions, it
has been hypothesized that the same gene or genes may influence the co-abuse of
these substances. According to an article published in the Journal of
Neuroscience (2006;26:1872-1879), vulnerability to both alcohol and nicotine
abuse may be influenced by the same genetic factor. For the study, two genetically
distinct kinds of rat, one an innately heavy-drinking strain bred to prefer
alcohol ("P" rats), the other strain bred to not prefer alcohol
("NP" rats), learned to give themselves nicotine injections by
pressing a lever. Results showed that P rats preferred twice as much nicotine
as NP rats. According to the authors, the findings suggest that the genetic
factor underlying the high alcohol consumption seen in P rats may also
contribute to their affinity for nicotine. In the study, the P rats' affinity for
nicotine was demonstrated before the animals were ever exposed to alcohol. P
rats were also found to be more vulnerable to nicotine relapse than NP rats. In
one of the experiments, nicotine was withheld from the rats until their lever
pressing occurred infrequently. Then, both P and NP rats were given a single
nicotine injection. P rats, but not NP rats, resumed pressing the lever
previously associated with nicotine infusions. The study also showed that the P
rats' apparent genetic vulnerability to alcohol and nicotine did not appear to
extend to other drugs of abuse. When P and NP rats learned to press a lever to
receive cocaine, each group took about the same amount of that drug. According
to the authors, the lack of a difference in cocaine self-administration
indicates that the difference between P and NP rats in nicotine
self-administration is not due to a general "reward deficit" in NP
rats.
Fine Particle Air Pollution
and Risk to the Elderly
Fine particle
air pollution (PM2.5), consists of microscopic particles of dust and soot <
2.5 microns in diameter, which is about 30x smaller than the width of a human
hair. These tiny particles primarily come from motor vehicle exhaust, power
plant emissions, and other operations that involve the burning of fossil fuels.
Fine particles can travel deep into the respiratory tract, reducing lung
function and worsening conditions such as asthma and bronchitis. Evidence on
the health risks associated with short-term exposure to fine particles is limited.
As a result, a study published in the Journal of the American Medical
Association (2006;295:1127-1134), was conducted to estimate risks of
cardiovascular and respiratory hospital admissions associated with short-term
exposure to PM2.5 in the elderly. For the study, data were derived from a
national database comprising daily time-series data daily for 1999 through 2002
on hospital admission rates (constructed from the Medicare National Claims
History Files) for cardiovascular and respiratory outcomes as well as general
injuries. In addition, ambient PM2.5 levels, and temperature and dew-point
temperature was collected for 204 US urban counties (population >200,000)
with 11.5 million Medicare enrollees (aged >65 years) living an average of
5.9 miles from a PM2.5 monitor. The main outcome measures were daily counts
hospital admissions for the primary diagnoses of cerebrovascular, peripheral,
and ischemic heart diseases, heart rhythm, heart failure, chronic obstructive
pulmonary disease, and respiratory infection. Hospitalization for general
injuries was used as the control outcome. Results showed that here was a
short-term increase in hospital admission rates associated with PM2.5 for all
of the health outcomes except injuries. The largest association was for heart
failure, which had a 1.28% increase in risk per 10-µg/m3 increase in
same-day PM2.5. Study participants over 75 years of age experienced even
greater increases in admissions for heart problems and chronic obstructive
pulmonary disease than those between 65 and 74. Cardiovascular risks tended to
be higher in counties located in the Eastern region of the US, which included
the Northeast, the Southeast, the Midwest, and the South. The authors concluded
that short-term exposure to PM2.5 increases the risk for hospital admission for
cardiovascular and respiratory diseases and the results provide a strong
rationale for setting a national air quality standard.
Genetic Basis of
Age-Related Macular Degeneration
According to an article
published online in Nature Genetics (March 5, 2006), it has been shown that
variations in certain genes involved in fighting infection can successfully
predict the risk of developing age-related macular degeneration (AMD). AMD is
the leading cause of blindness in white Americans over the age of 60. AMD blurs
or destroys sharp, central vision. Approximately 7.3 million Americans have
intermediate stages of AMD with a high risk of increasing vision loss, while
1.8 million are visually impaired. There is no known cure for AMD. Two genetic
variants that protect against developing this disease were also identified. The
genes analyzed in the study -- Complement Factor B (BF) and Complement
Component 2 (C2) -- contain the instructions to make proteins that activate the
body's immune defense against microbial infections. These defense responses are
part of a system called the complement pathways. These pathways involve
numerous proteins in the blood that work in association with the body's immune
cells and antibodies to destroy bacteria, viruses or fungi invading the body.
Some complement proteins can stimulate inflammation, the redness and swelling
that result in tissues when they are infected. Previous studies have shown that
genetic variations in complement pathway genes can cause a dysfunction in the
inflammatory response that plays a central role in the pathology of AMD. For
the study, approximately 900 patients with AMD and 400 unaffected individuals
were screened for genetic variants in the BF and C2 genes. Data analysis
revealed that specific variants in each gene were associated with AMD. One
genetic variant conferred an increased risk for AMD, while two genetic variants
showed protection against developing this disease. These results, where then
analyzed looking at associations AMD and genetic variants of Complement Factor
H. Complement Factor H is a gene than contains the instructions to make a
protein that inhibits the complement system. Results showed that 56% of the
unaffected individuals had a variant that conferred protection to AMD while 74%
of those with AMD had no protective variants. According to the authors, these
studies confirm that AMD has a strong genetic component supports the
development of screening tests for risk of developing AMD, which would allow
earlier treatment.
LDH as a Predictor of
Severity of Sickle Cell Disease
Sickle cell
disease is a hereditary blood disorder that is most prevalent in blacks. An
abnormal type of hemoglobin inside the red blood cells distorts their shape and
interferes with blood flow. Pulmonary hypertension is prevalent in adult
patients with sickle cell disease and is strongly associated with early
mortality and markers of hemolysis, in particular, serum lactate dehydrogenase
(LDH). LDH is found throughout the body, especially in red blood cells, the
heart, liver, lungs and muscle. A blood test measuring LDH levels is readily
available and commonly used to determine tissue damage due to a variety of
causes. According to an article published in the journal Blood
(2006;107:2279-2285), LDH levels may help determine whether a patient has a
high risk of developing certain serious complications associated with sickle
cell disease. For the study, LDH levels were measured in 213 adults with sickle
cell disease. Patients were then categorized as having low, medium or high
levels. The frequency of several complications of the disease was then
determined in the three LDH groups. Results showed that patients in the highest
LDH group were more likely to experience three circulatory problems: pulmonary
hypertension, leg ulcerations, and persistent and priapism. Pulmonary
hypertension was detected in 61% of patients with high LDH compared to 15% of
patients in the lowest LDH group. Thirty-nine percent of people with high LDH
reported leg ulcerations and 60% reported priapism at some point in time.
Patients with high LDH levels had a nearly four-fold increased risk of early
death compared to patients with lower LDH levels. The study also found that
high LDH levels may help to explain why pulmonary hypertension develops in
sickle cell disease. High levels of LDH appear to indirectly indicate that two
other proteins, hemoglobin and arginase, have broken out of red blood cells.
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.
Predictive Safety Testing Consortium
The FDA and The Critical Path Institute (C-Path) today
announced the formation of the Predictive Safety Testing Consortium between
C-Path and five of America’s largest pharmaceutical companies. The goal of the
consortium is to share internally developed laboratory methods to predict
the safety of new treatments before they are tested in humans. The FDA, while
not a member of the Partnership, will assist it in an advisory capacity. This
unprecedented sharing of potential early indicators of clinical safety may
streamline the cost and time of preclinical drug safety evaluation and better
inform the use of “personalized medicine”.
The Predictive Safety Testing Consortium will enable pharmaceutical companies
to share knowledge and resources. This will allow the companies to determine
which of the lab tests that they have developed individually should be
recommended by the FDA to screen drugs and better understand the potential side
effects before the drugs enter clinical testing in humans. Companies will share
the details of the methods that each has developed for specific kinds of tests
and then agree to test another’s method to determine if it is reproducible. The
results of the comparison will be collected and summarized by C-Path for
submission to the FDA. Those methods that the FDA finds to be reliable and
reproducible will form the basis for agency-issued guidelines about which
safety tests should be used in the drug development process. The information
provided by the eight Members of the Consortium – Bristol-Myers Squibb Company,
GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research &
Development, LLC, Merck and Co., Inc., Novartis Pharmaceutical Corporation, Pfizer,
Inc., Roche Palo Alto, LLC, Schering Plough Research Institute, a division of
Schering Corporation and SRI International (participating in Consortium as a
founding partner of C-Path) --is expected to help energize drug development by
making it more predictable and efficient, and less prone to failure.
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
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Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved