(Complimentary Newsletter from Target Health Inc.)
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26 June 2006
I.
WHAT'S NEW?
DIA Meeting
II. QUIZ
(Fill In The Blanks)
Red Yeast
Rice: Nutraceutical or Pharmaceutical?
III.
HISTORY OF MEDICINE
Early
Medicine
IV. PUBLIC HEALTH
Serious Orthopedic Problems In Overweight Children
V. PSYCHIATRY
Intermittent Explosive Disorder
VI. ONCOLOGY
Genetic Deficiency in Adrenal Cancer
VII. INFECTIOUS DISEASE
Structured Treatment Interruption in HIV - Not a Good Idea
VIII. FDA
Hycamtin (topotecan hydrochloride) Plus Cisplatin Approved For
Cervical Cancer
IX. Target Health Inc.
DIA Meeting
Target Health want to
thank all of our friends and new colleagues who visited us at the annual DIA
meeting last week. We also welcome more than 100 new readers to ON TARGET. It
was a very successful meeting and one of the highlights of the week was the
reception Target Health hosted for the NY, NJ, Pennsylvania CDISC User Group.
After the meeting, our friends from
Red Yeast Rice: Nutraceutical
or Pharmaceutical?
The 1) ___ industry continues to grow as
people around the world become more aware of diet-disease links, rising health
care costs, and advances in nutrition and food technology. Red 2) ___ rice has
been used in 3) __ for centuries as a food and as a medicine. It is made by
fermenting rice with a type of red yeast, known as, Monascus purpureus.
Currently, red yeast rice is classified as a dietary supplement, however, there
are many who feel that it is actually an unregulated drug. There is ongoing
debate, about whether to change the status of red yeast rice to a prescription
drug, requiring greater regulation. In Chinese medicine, red yeast rice is used
to promote 4) __ circulation. It has been discovered that this natural product,
contains substances that are similar to prescription medications that lower 5)
___. It is also used as a natural food dye and preservative. The use overlap,
in traditional Chinese practice, is mirrored by a modern day controversy in the
Answers: 1) nutraceuticals;
2) yeast; 3) China; 4) blood; 5) cholesterol; 6) enzyme; 7) heart; 8) high; 9)
placebo
Early Medicine
Some Greek and Muslim
physicians believed that the moon and planets played an important part in good
health and this belief was continued in the Middle Ages. It was believed that
the human body and the planets were made up of the same four elements (earth,
fire, air and water). For the body to operate well, all four elements had to be
in harmony with no imbalances. It was believed that the Moon had the greatest
influence on fluids on Earth and that it was the Moon that had the ability to
affect positively or negatively the four elements in the body. Where the Moon
and planets were – and a knowledge of this - was considered important when
making a diagnosis and deciding on a course of treatment. Physicians needed to
know when to treat a patient and when not to. since the location of the planets
determined this. A so-called Zodiac Chart also determined when blood letting
should be done as it was believed by some that the Moon and planets determined
this as well.
Serious Orthopedic Problems
In Overweight Children
Few studies have
quantified the prevalence of weight-related orthopedic conditions in otherwise
healthy overweight children. The goal of the present study, published in
Pediatrics (2206:117:2167-2174), was to describe the musculoskeletal
consequences of pediatric overweight in a large pediatric cohort of children
that included severely overweight children. A total of 355 African American and
white Washington, D.C. area children and adolescents (227 overweight and 128
nonoverweight) took part in the study. Upon entering the study, the children
underwent a detailed physical examination and were questioned about whether
they had experienced any joint, bone or muscle-related problems. Study
participants were classified as overweight if they had a body mass index above
the 95th percentile for their height and weight. Youth were classified as
non-overweight if they had a body mass index above the 5th percentile and below
the 95th percentile. A questionnaire was designed to gauge the impact of weight
on quality of life, ranking on a 5-point scale whether statements about
impaired mobility applied to them. Such statements included: "I have
trouble using stairs," "I feel clumsy or awkward," and "I
have trouble getting up from chairs." The study also used a technique
known as Dual Energy X-Ray Absorptiometry (DXA) to detect any effects of
overweight on the feet, ankles and knees. Results showed that compared with
nonoverweight children, overweight children reported a greater prevalence of
fractures and musculoskeletal discomfort. The most common self-reported joint
complaint was knee pain, with 21.4% of overweight youth reporting knee pain and
16.7% of non-overweight youth reporting knee pain. The overweight youth were
also more likely to report impaired mobility than the non-overweight youth. DXA
scans showed that overweight youth were more likely to experience changes in
how the bones of the thigh and leg meet at their knees, than were
non-overweight youth. According to the authors, reported fractures,
musculoskeletal discomfort, impaired mobility, and lower extremity malalignment
are more prevalent in overweight than nonoverweight children and adolescents.
The authors added that because they affect the likelihood that children will
engage in physical activity, orthopedic difficulties may be part of the cycle
that perpetuates the accumulation of excess weight in children.
Intermittent Explosive
Disorder
Intermittent
explosive disorder (IED), is a little-known mental disorder, is marked by
episodes of unwarranted anger, causing bodily injury and property damage.
According to an article published in the Archives of General Psychiatry
(2006;63:669-678), IED is more common than previously thought. The study, was
based on data from the National Comorbidity Survey Replication, a nationally
representative, face-to-face household survey of 9,282
Genetic Deficiency in
Adrenal Cancer
Target Health is very
active managing a program in pancreatic cancer.
According to an article
published online in Nature Genetics (11 June 2006), it has been observed that a
rare tumor of the adrenal glands appears to result from a genetic deficiency of
an important enzyme. The enzyme is one of a class of enzymes involved in
halting a cell's response to hormones and appears to stop cells from dividing.
For the study, gene arrays were used to analyze the DNA of patients with a rare
tumor of the adrenal glands, known as micronodular adrenocortical hyperplasia.
Gene arrays were also used to analyze samples of the patients' tumors. Results
showed that four patients had mutant copies of a gene that contains the
information for phosphodiesterase 11A (PDE11A). Phosphodiesterases are a family
of enzymes involved in "switching off" a cell's response to hormones.
For a hormone to affect the cell, it must first bind to a molecule, or
receptor, on the cell's surface, analogous to how a key fits into a lock. This
action triggers the cell to produce substances known as cyclic nucleotides.
These function as "second messengers," often stimulating the cell to
begin an activity. In the case of adrenal cells, cyclic nucleotides, such as
cyclic AMP and cyclic GMP, may stimulate cell growth or other activities. Once
the activity ends, phosphodiesterases degrades the cyclic nucleotides, thereby
halting the cell's response to the hormone. Results showed that the tumors were
made up of cells that were deficient in the enzyme PDE11A, the enzyme which
halts cyclic nucleotide production in adrenal cells as well as in other kinds
of cells. Because they lacked PDE11A, the patients' adrenal cells had higher
levels of cyclic nucleotides. The gene for PDE11A contains the information
needed to make 4 slightly different forms of the enzyme. The form of the enzyme
that was mutated in the patients who took part in the study is found in large
amounts in normal adrenal glands and in even larger amounts in normal prostate
glands. Although the evidence associating the mutation in the gene for PDE11A
to the development of adrenal tumors was very strong, the study was not capable
of proving that the mutation actually caused the tumors.
Structured Treatment
Interruption in HIV - Not a Good Idea
Structured treatment
interruptions of highly-active antiretroviral therapy (HAART) might be
particularly relevant for sub-Saharan
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.
Hycamtin (topotecan
hydrochloride) Plus Cisplatin Approved For Cervical Cancer
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.
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Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved