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16 October 2006
I.
WHAT'S NEW?
Global
Clinical Trials At Target Health - Our Model
II. QUIZ - (Fill In The Blanks)
Scalpel-Free Obesity Surgery
III. HISTORY OF MEDICINE
Vicks VapoRub
IV. GENETICS
Genes
and Prostate Cancer - Why Racial Differences?
V. NEUROLOGY
Rat
Model of Alcoholism Shows Promise For Humans
VI. CARDIOLOGY
Lipitor Affects Atrial Fibrillation Post Cardiac
Surgery
VII.
DERMATOLOGY
Sunburn
Incidence in the
VIII. FDA
FDA Enforcement of "Illegally"
Marketed Drugs
IX.
Global
Clinical Trials At Target Health - Our Model
Target Health is involved with global studies through the use of Target e*CRF®.
We have done studies on every continent except
For more information about
Target Health, please contact Dr.
Jules T. Mitchel.
Scalpel-Free Obesity
Surgery
Obese individuals have a 50% to
100% increased risk of 1) ___ from all causes when compared with normal-weight
individuals. Total health care-related costs associated with overweight and
obesity are estimated to exceed $100 billion, a cost
comparable to the economic costs of cigarette smoking. The 2006 Obesity
Congress, sponsored by The Cleveland Clinic, this past week, presented new data
regarding scalpel-free obesity surgery. 2) ___ is fast becoming the most
important public health issue in the
ANSWERS: 1) death; 2) Obesity; 3) mouth; 4) incision;
5) robotic; 6) calorie; 7) public
III. HISTORY OF MEDICINE
Vicks VapoRub
Lunsford Richardson was born in
1854 on a farm near
Genes and Prostate Cancer -
Why Racial Differences?
According to the
National Cancer Institute, the annual incidence of prostate cancer among
African American men is 277 per 100,000 compared to 168 per 100,000 for white
men. The annual death rate from prostate cancer is 73 per 100,000 for African
American men compared to 30 per 100,000 for white men. Family history is the
most significant risk factor known for prostate cancer among all men, including
African Americans. According to an article published online in the journal The
Prostate (9 October 2006), using genetic markers, several regions of the human
genome have been identified that likely contain genes that, when altered,
increase the risk of developing prostate cancer. This study is the first
genome-wide linkage study of prostate cancer in African Americans. The study
was designed to identify genetic risk factors for prostate cancer and to help
determine if heredity plays a role in the disparity in prostate cancer rates
seen in African American men. The African American Hereditary Prostate Cancer
(AAHPC) study network recruited 77 African American extended families which
resulted in a total of 418 study participants. The families studied came from
Rat Model of Alcoholism Shows
Promise For Humans
Relapse to
uncontrolled drinking after periods of sobriety is a defining characteristic of
alcoholism and is often triggered by stress. According to a study published
online in the Early Edition of the Proceedings of the National Academy of
Sciences (2 October 2006), a new investigation in rats shows that a specific
receptor for a stress-response transmitter may play an important role in
stress-induced relapse. The study was designed to examine stress-induced
relapse in rats that were bred to have a greater-than-normal preference for alcohol.
These rats provide an excellent model for identifying genes involved in
stress-mediated relapse in that not only do they voluntarily consume large
amounts of alcohol, but they also display anxiety and depression-like traits.
These latter traits are characteristics that are common among human alcoholics
and which indicate a maladaptive response to stress. For the study, a series of
behavioral experiments confirmed that the alcohol-preferring rats were more
sensitive to stressful situations. For example, the rats explored a new
environment significantly less than did the normal rats, and also remained
immobile longer than normal rats did in the novel environment. Each group of
rats then learned that, by pressing a bar, they gained access to as much alcohol
as they cared to drink. Under these conditions, the alcohol-preferring rats
consume more than twice the amount of regular rats, and did so in order to
obtain the intoxicating effects of alcohol. This behavior was extinguished, or
unlearned, by a 15-day period during which bar-pressing yielded no alcohol,
thus allowing the alcohol-preferring rats to achieve a state of sobriety. The
investigators then assessed whether a stressful stimulus, such as a mild
electric foot shock, would induce the rats to again seek alcohol by resuming
the bar- pressing behavior. Results showed that alcohol-seeking was reinstated
in the alcohol-preferring rats by foot shocks of much lower intensity than
normal rats required. According to the authors, the resumption of alcohol-seeking
by alcohol-preferring rats under these conditions is analogous to
stress-induced relapse to drinking by human alcoholics. To determine if a
particular gene or genes might underlie the stress-induced drinking of the
alcohol-preferring rats, gene expression patterns were compared in the brains
of rats from each group. The search focused on several families of known
stress-related genes, including those associated with corticotropin-releasing
hormone (CRH), which influences behavioral responses to stress through a number
of different receptors. The study found that alcohol-preferring rats had higher
expression levels of Crhr1, a gene encoding the corticotropin-releasing
hormone receptor 1 (CRH-R1). Subsequent experiments showed that antalarmin, a compound that blocks CRH-R1, suppressed
alcohol drinking and completely blocked stress-induced reinstatement of
drinking in alcohol-preferring rats, but had no effect on normal rats. As a
result of these experiments, the NIH has begun to develop antalarmin
for human use. The authors concluded that the Crhr1 genotype and its expression
interact with environmental stress to reinstate alcohol-seeking behavior in
this animal model of excessive drinking, and that the data provide a functional
validation for antagonism at CRH-R1 receptors as a mechanism for novel
treatments aimed at relapse prevention in susceptible individuals.
Lipitor Affects Atrial
Fibrillation Post Cardiac Surgery
Atrial fibrillation (AF) after cardiac surgery
is associated with increased risk of complications, length of stay, and cost of
care. Observational evidence suggests that patients who have undergone previous
statin therapy have a lower incidence of
postoperative AF. As a result, a study published in Circulation (2006;114:1455-1461), was performed to test this observation in a
randomized, controlled clinical trial. For the study, 200 patients undergoing
elective cardiac surgery with cardiopulmonary bypass, but without previous statin treatment or history of AF, were enrolled. Patients
were randomized to atorvastatin (Lipitor;
40 mg/day, n=101) or placebo (n=99) starting 7 days before the operation. The
primary end point was incidence of postoperative AF; secondary end points were
length of hospitalization, 30-day major adverse cardiac and cerebrovascular
events, and postoperative C-reactive protein (CRP). Results showed that atorvastatin significantly reduced the incidence of AF
versus placebo (35% versus 57%, P=0.003). Accordingly, length of stay was
longer in the placebo versus atorvastatin arm
(6.9±1.4 versus 6.3±1.2 days, P=0.001). Peak CRP levels were lower in patients
without AF (P=0.01), irrespective of randomization assignment. Multivariable
analysis showed that atorvastatin treatment conferred
a 61% reduction in risk of AF (odds ratio 0.39; P=0.017), whereas high
postoperative CRP levels were associated with increased risk (odds ratio 2.0;
P=0.01). The incidence of major adverse cardiac and cerebrovascular
events at 30 days was similar in the 2 treatment groups. The authors concluded
that treatment with atorvastatin 40 mg/day, initiated
7 days before surgery, significantly reduced the incidence of postoperative AF
after elective cardiac surgery with cardiopulmonary bypass and shortens
hospital stay. The authors added that the study results may influence practice
patterns with regard to adjuvant pharmacological therapy before cardiac
surgery.
Sunburn
Incidence in the
It is well known that sunburn is a major
preventable risk factor for skin cancer. What is not known is how many people
in the
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 Enforcement of
"Illegally" Marketed Drugs
Before enactment of the
Federal Food, Drug and Cosmetic Act (FFDCA) of 1938, drugs could be marketed in
the
The FDA has issued a new
compliance policy guide (CPG) describing how it intends to exercise
enforcement discretion with regard to drugs marketed in the US that do not have
required FDA approval for marketing. The CPG applies to any drug required to
have FDA approval for marketing, including new drugs covered by the
Over-the-Counter (OTC) Drug Review, except for licensed biologics and
veterinary drugs. FDA estimates that, currently, perhaps as many as several
thousand drug products are marketed illegally. Once an illegally marketed
product is identified, taking enforcement action against the product would
typically involve one or more of the following: requesting voluntary
compliance; providing notice of action in a Federal Register notice; issuing an
untitled letter; issuing a Warning Letter; or initiating a seizure, injunction,
or other proceeding. In order to make the best use of scarce FDA resources, FDA
has prioritized enforcement efforts. In general, in recent years, FDA has
employed a risk-based enforcement approach with respect to marketed unapproved
drugs. This approach includes efforts to identify illegally marketed drugs,
prioritization of those drugs according to potential public health concerns or
other impacts on the public health, and subsequent regulatory follow-up. FDA is
not required to, and generally does not intend to, give special notice that a
drug product may be subject to enforcement action, unless FDA determines that
notice is necessary or appropriate to protect the public health. The issuance
of this guidance is intended to provide notice that any product that is being
marketed illegally is subject to FDA enforcement action at any time. The only
exception to this policy is, as set forth elsewhere, that generally products
subject to an ongoing DESI proceeding or ongoing OTC drug monograph proceeding
(i.e., an OTC product that is part of the OTC drug review for which an
effective final monograph is not yet in place) may remain on the market during
the pendency of that proceeding and any additional
period specifically provided in the proceeding (such as a delay in the
effective date of a final OTC drug monograph). However, once the relevant DESI
or OTC drug monograph proceeding is completed and any additional grace period specifically
provided in the proceeding has expired, all products that are not in compliance
with the conditions for marketing determined in that proceeding are subject to
enforcement action at any time without further notice (see, e.g., 21 CFR
310.6).
For a copy of the compliace guide and/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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Phone: (212) 681-2100; Fax (212) 681-2105
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Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved