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22May 2006
I.
WHAT'S NEW?
Asian
Clinical Trial Network
II. QUIZ
(Fill In The Blanks)
Human
Evolution More Blurred?
III.
HISTORY OF MEDICINE
Joseph
Plenck (1735-1807)
IV. CARDIOLOGY
Is There a Medical Risk Associated With Long-Haul Air Travel?
V. ONCOLOGY
New Technique to Culture Glioblastoma Cells
VI. RHEUMATOLOGY
COX-2 Inhibitors and Cardiovascular Risk - No Bias Here
VII. PEDIATRICS
Caffeine Treatment of Apnea of Prematurity
VIII. FDA
FDA Approves Teva's Drug For Parkinson's Disease
IX. Target Health Inc.
Asian
Clinical Trial Network
Target Health is pleased
to announce that Dr. Mitchel just returned from
Human Evolution More
Blurred?
A new, detailed
analysis of the humans and chimpanzees 1) ___, [Nature: 18 May 2006] suggests
that after the two lineages separated, they may have begun interbreeding. The
split between the human and chimpanzee lineages, a pivotal event in human 2)
___, may have occurred millions of years later than fossil bones suggest, and
the break may not have been as clean as humans might like. This analysis, sets
up a serious conflict between the date of the split as
indicated by fossil skulls, about 7 million years ago, and the much younger
date implied by genetic analysis, as late as 5.4 million years ago. The
conflict might be resolved, if it can be assumed there were two splits between
the human and chimp lineages, with the first being followed by interbreeding
between the two populations and then a second split. The earliest human-lineage
3) ___ remains, seem clearly to have been 4) ___, walking on two feet, but the
ancestors of chimps presumably walked on their two feet and the knuckles of
their hands, as do modern chimps. Hybrid populations often go extinct
because the males are 5) ___, so hybrid females may have mated with male chimps
to produce viable offspring. The human lineage finally re-emerged from this 6)
___ population, explaining the younger genetic dates, while the very early
fossils with human-like features may come from the earlier period before the
hybridization. The crucial events in early human evolution are hard to judge
dispassionately, because we like to have a more Victorian view of our genome,
and this study of 7) ___, reminds us that we are really animals and gives us a
more realistic look at our past. This study also draws on 8) __ sequences from
the gorilla, orangutan and macaque, to iron out ambiguities. A principal
finding is that the X chromosomes of humans and chimps appear to have diverged
about 1.2 million years more recently than the other chromosomes. There was a hybridization between the recently separated chimp and
human lineages. Although the genetics does not specify
whether it was the chimp or human lineage that emerged from the hybrid
population, the study favors the idea that it was the 9) ___ line.
Answers: 1) genomes; 2)
evolution; 3) fossil; 4) bipeds; 5) sterile; 6) hybrid; 7) interbreeding; 8)
DNA; 9) human
Joseph Plenck
(1735-1807)
Dr Joseph Plenck, the Viennese
protodermatologist was professor and secretary of the
Is There a Medical Risk
Associated With Long-Haul Air Travel?
The link between
long-haul air travel and venous thromboembolism is the subject of continuing
debate, and it remains unclear whether the reduced cabin pressure and oxygen
tension in the airplane cabin create an increased risk compared with seated
immobility at ground level. Journal of the American Medical Association (2006;295:2251-2261). As a result, a study published in the
Journal of the American Medical Association (2006;295:2251-2261),
was performed to determine whether hypobaric hypoxia, which may be encountered
during air travel, activates hemostasis. The investigation was a single-blind,
crossover study, performed in a hypobaric chamber, to assess the effect of an
8-hour seated exposure to hypobaric hypoxia on hemostasis in 73 healthy
volunteers. Study participants were screened for factor V Leiden G1691A and
prothrombin G20210A mutation and were excluded if they tested positive. Blood
was drawn before and after exposure to assess activation of hemostasis. For the
study, individuals were exposed alternately (>1 week apart) to hypobaric
hypoxia, similar to the conditions of reduced cabin pressure during commercial
air travel (equivalent to atmospheric pressure at an altitude of 2438 m), and
normobaric normoxia (control condition; equivalent to atmospheric conditions at
ground level, circa 70 m above sea level). The main outcome measures were
comparative changes in markers of coagulation activation, fibrinolysis,
platelet activation, and endothelial cell activation. Results showed that
changes were observed in some hemostatic markers during the normobaric
exposure, attributed to prolonged sitting and circadian variation. However,
there were no significant differences between the changes in the hypobaric and
the normobaric exposures. For example, the median difference in change between
the hypobaric and normobaric exposure was 0 ng/mL for
thrombin-antithrombin complex; –0.02 nmol/L for prothrombin fragment 1 +
2; 1.38 ng/mL for D-dimer; and –2.00% for endogenous thrombin potential.
According to the authors, the findings do not support the hypothesis that
hypobaric hypoxia, of the degree that might be encountered during long-haul air
travel, is associated with prothrombotic alterations in the hemostatic system
in healthy individuals at low risk of venous thromboembolism.
New Technique to Culture
Glioblastoma Cells
Gliomas are the
most common primary malignant tumors of the central nervous system in adults,
and primary brain tumors are now the leading cause of cancer-related deaths in
children. An estimated 18,820 new cases of brain cancer will be diagnosed in
the
COX-2 Inhibitors and
Cardiovascular Risk - No Bias Here
The following study was
funded by: Merck, Pfizer; the NIH; the Arthritis Foundation; and Engalitcheff
Arthritis Outcomes Initiative
Controversy persists regarding the cardiovascular risks of treatment with
selective cyclooxygenase 2 inhibitors (coxibs) and nonselective nonsteroidal
antiinflammatory drugs (NSAIDs). The following study, published in Arthritis
& Rheumatism (2006;54:1378-1389), was undertaken to examine, in a large
group of new users of coxibs and NSAIDs, the rate of cardiovascular events,
their time course, and whether baseline cardiovascular risk modified the rate
ratios (RRs) for future events. The study population included Medicare
beneficiaries who enrolled in a state-run prescription drug plan that fully
covered NSAIDs and coxibs without restriction. All study patients started use
of a coxib or NSAID after January 1, 1999. The primary composite end point was
a hospital admission for either myocardial infarction or ischemic stroke.
Predefined exposure groups included the 3 coxibs available in the
Caffeine Treatment of Apnea
of Prematurity
Caffeine, theobromine and
theophylline are chemical compounds with closely related structures and similar
pharmacological properties. They are all members of the class of compounds
known as methylxanthines which are mild stimulants. Methylxanthines have been
shown to reduce the frequency of apnea of prematurity and the need for
mechanical ventilation during the first seven days of therapy. According to an
article published in the New England Journal of Medicine (2006;354:2112-2121), a study was performed to see whether
methylxanthines would have short- and long-term benefits or risks in infants
with very low birth weight. For the study, 2,006 infants with birth weights of
500 to 1250 g during the first 10 days of life, were
randomly assigned to receive either caffeine or placebo, until drug therapy for
apnea of prematurity was no longer needed. Of 963 infants who were assigned to
caffeine and who remained alive at a postmenstrual age of 36 weeks, 350 (36%)
received supplemental oxygen compared with 447 of the 954 infants (47%)
assigned to placebo (P<0.001). Positive airway pressure was discontinued one
week earlier in the infants assigned to caffeine than in the infants in the
placebo group (P<0.001). Caffeine reduced weight gain temporarily. The mean
difference in weight gain between the group receiving caffeine and the group
receiving placebo was greatest after two weeks (mean difference, –23 g;
P<0.001). The rates of death, ultrasonographic signs of brain injury, and
necrotizing enterocolitis did not differ significantly between the two groups.
According to the authors, it can be concluded that caffeine therapy for apnea
of prematurity reduces the rate of bronchopulmonary dysplasia in infants with
very low birth weight.
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 Approves Teva's Drug For Parkinson's Disease
Parkinson's disease (PD) is a
chronic, progressive neurodegenerative condition caused by the destruction of
the brain cells that produce dopamine. As the level of this chemical declines,
messages from the brain telling the body how and when to move are delivered
more slowly, leaving a person incapable of initiating and controlling movements
in a normal way. The FDA has approved Azilect (rasagiline), a new molecular
entity, for the treatment of PD. The drug is a monoamine oxidase type--B
(MAO-B) inhibitor that blocks the breakdown of dopamine, sends information to the
parts of the brain that control movement and coordination. Azilect was approved
for use as an initial single drug therapy in early PD, and in combination with
levodopa in more advanced patients. Levodopa is a standard treatment for PD.
The safety and effectiveness of Azilect was demonstrated in three 18- to
26-week controlled clinical trials. One of the studies compared the effects of
Azilect with the effects of placebo in 404 patients with early Parkinson's.
Compared with patients on placebo, the condition of patients on Azilect showed
significantly less worsening on a rating scale that measures the ability to
perform mental and motor tasks as well as daily living activities. The other
two studies compared the effects of Azilect with placebo when taken together
with levodopa by over 1,100 patients with more advanced Parkinson's. In these
studies, patients using Azilect together with levodopa had significantly less
time per day with relatively poor function and mobility as compared with
patients on levodopa and placebo. In terms of side effects, Azilect may be
associated with hypertensive crisis if patients also consume tyramine-rich
foods, beverages (such as cheese and red wine) or dietary supplements or amines
contained in many cough/cold medications. Therefore, patients will need to
avoid these sources of tyramine and amines when taking Azilect. As with most
other medications for Parkinson's, Azilect has the potential to cause
involuntary movements (dyskinesias), hallucinations and lowered blood pressure.
These side effects are described in the product labeling. During development,
melanoma was diagnosed in a small number of patients treated with Azilect.
Although the FDA has concluded that the available data do not establish that
Azilect is associated with an increased risk for melanoma, it appears that
compared to the general population, patients with PD have an increased risk for
this form of skin cancer. In order to address the question of whether or not
Azilect itself increases such risk, the drug's manufacturer will perform a
Phase 4 (postmarket) study. The product labeling will recommend that patients
undergo periodic dermatologic examinations. Azilect is manufactured by Teva
Pharmaceutical Industries in Tel Aviv,
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 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.
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©2006 Target Health Inc. All rights reserved