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10 April 2006
I.
WHAT'S NEW?
Annual
DIA Meeting
II. QUIZ
(Fill In The Blanks)
Stunning
Medical Milestone
III.
HISTORY OF MEDICINE
Erasmus
and the Patient-Doctor Relationship
IV. BASIC RESEARCH
Blind Mice Recover Visual Responses Using Protein From Green Algae
V. MICROBIOLOGY
Pneumococcal Conjugate Vaccine Works
VI. METABOLIC DISEASE
Magnesium Intake and Metabolic Syndrome
VII. FDA
Booz Allen Hamilton Hired to Evaluate Post Marketing Study
Commitments
VIII. Target Health Inc.
Annual DIA
Meeting
Target Health is pleased
to announce that it will again have a booth at the DIA Annual Meeting which is
being held this year in Philadelphia. Dr. Mitchel will be speaking on Data
Standards and Web Trials. Please let us know if you will be attending. For more information, please contact Dr.
Jules T. Mitchel.
Stunning Medical Milestone
The world's
first organ grown in a laboratory has been successfully implanted in 1) ___,
heralding a breakthrough medical event. A team at Wake Forest University School
of Medicine, led the trial, a vital step towards the goal of replacing damaged
organs. The regenerative medical techniques can now be used to generate
functional and durable 2) ___. Regenerative medicine may one day be a solution
to the shortage of donor organs for those needing transplants. Rejection
is too risky using genetically engineered pig organs; also there’s the
risk of transmitting animal viruses to humans. For the study, 7 patients, given
new bladders grown from their own 3) __, now have functioning 4) ___, but with
none of the ill effects when conventional techniques are used. A whole organ
grown in the lab, has never been tested in a human, before. This stunning
development, marks a new frontier in the search for replacement body parts,
because the number of organ donors available has declined as a result of
improved road safety and fewer accidents. Scientists behind the breakthrough
are now trying to grow other organs and 5) ___. Instead of relying on organs
from other bodies, doctors are investigating ways of 6) ___ specially grown
replacements by farming human tissue. The medical team continues to grow 20
tissues and organs, including blood vessels and 7) ___, in the laboratory. In
the trial, the seven patients, all aged between four and 19, had engineered
bladders grown from their own cells so there was no risk of 8) ___. A tiny
sample of cells was taken from each patient's bladder by 9) ___ and grown on a
biodegradeable "scaffold". Elastic, smooth 10) ___ cells were grown
on the outside, with 11) ___ cells forming the bladder lining on the inside.
After seven to eight weeks in the laboratory, the fully grown bladder was
transplanted and stitched to the patient's existing bladder to create an
enlarged organ. After up to seven years of follow-up, the new bladders still
functioned well and did not have the side-effects such as kidney 12) ___
formation associated with conventional repair with intestinal tissue. All the
patients were born with a congenital defect, spina bifida, which is associated
with poor bladders. Scientists have already grown human skin, cartilage, bone
and liver outside the 13) __. Heart valves have been grown and
transplanted into animals with human trials due to start soon.
Answers: 1) humans; 2)
bladders; 3) cells; 4) organs; 5) tissues; 6) harvesting; 7) hearts; 8)
rejection; 9) biopsy; 10) muscle; 11) epithelial; 12) stone; 13) body
Erasmus and the
Patient-Doctor Relationship
Desiderius Erasmus set out his
views on medical ethics just over 500 years ago. Applying the characteristic
approach of Renaissance Humanism, he drew upon a variety of classical sources
to develop his own account of the the physician’s obligation to his/her
patient. Of particular interest is Erasmus's attention to the patient's duties
as well as the physician's. By treating this reciprocal relationship as a
friendship between “unequals”, Erasmus was able to maintain the nobility of the
medical art and at the same time deal with the culturally sensitive issue of
paying for medical treatment. The use of physician-patient reciprocity as a
principle of medical ethics has until recently been considered a novel feature
of nineteenth-century medical codes. As Erasmus's treatment of physician-patient
reciprocity arose from a classical conception of friendship, there may be
grounds for reconsidering the role of friendship in other discourses on medical
ethics from the Renaissance to the nineteenth century.
Blind Mice Recover Visual
Responses Using Protein From Green Algae
Vision normally
begins when rods and cones, also called photoreceptors, respond to light and
send signals through the retina and the optic nerve to the visual cortex of the
brain, where visual images are formed. Unfortunately, photoreceptors degenerate
and die in some genetic diseases, such as retinitis pigmentosa (RP). In RP,
humans go progressively blind because with the loss of rods and cones there is
no signal sent to the brain. According to an article published in Neuron
(2006;50:23-33), it has been shown that nerve cells that normally are not light
sensitive in the retinas of blind mice, can respond to light when a green algae
protein called channelrhodopsin-2 (ChR2) is inserted into the cell membranes. The
mouse model used in the study was genetically bred to lose rods and cones, and
is similar to RP in humans. The study results raise the intriguing possibility
that visual function might be restored by conveying light-sensitive properties
to other surviving cells in the retina after the rods and cones have died. For
the study, a gene-transfer approach was used to introduce the light-absorbing
protein ChR2 into the mouse retinal cells that survived after the rods and
cones had died. Results showed that the signals reached the visual cortex in a
majority of the ChR2-treated mice and that light sensitivity persisted for at
least six months. While the mice probably did not regain usable vision, it was
suggested that with a number of technical improvements, this may be possible.
According to the authors, in addition to RP, there are many forms of retinal
degenerative eye diseases that possibly could be treated with gene-based
therapies by expressing ChR2 in other types of retinal cells. The authors added
that it would be interesting in future studies to modify the light sensitivity
and/or wavelength selectivity of ChR2, or use similar microbial proteins, to
produce diverse light-sensitive channels to improve outcomes for the possible
restoration of normal vision.
Pneumococcal Conjugate
Vaccine Works
Five of seven
serotypes in the pneumococcal conjugate vaccine, introduced for infants in the
United States in 2000, are responsible for most penicillin-resistant
infections. As a result, a study published in the New England Journal of
Medicine (2006;354:1455-1463) was performed to examine the effect of this
vaccine on invasive disease caused by resistant strains. For the study,
laboratory-based data from Active Bacterial Core surveillance was used to
measure disease caused by antibiotic-nonsusceptible pneumococci from 1996
through 2004. Cases of invasive disease, defined as disease caused by
pneumococci isolated from a normally sterile site, were identified in eight
surveillance areas. Isolates underwent serotyping and susceptibility testing.
Results showed that rates of invasive disease caused by
penicillin-nonsusceptible strains and strains not susceptible to multiple
antibiotics peaked in 1999 and decreased by 2004, from 6.3 to 2.7 cases per
100,000 and from 4.1 to 1.7 cases per 100,000, respectively. Among children
under two years of age, disease caused by penicillin-nonsusceptible strains
decreased from 70.3 to 13.1 cases per 100,000. Among persons 65 years of age or
older, disease caused by penicillin-nonsusceptible strains decreased from 16.4
to 8.4 cases per 100,000. Rates of resistant disease caused by vaccine
serotypes fell 87%. An increase was seen in disease caused by serotype 19A, a
serotype not included in the vaccine (from 2.0 to 8.3 per 100,000 among
children under two years of age). It was concluded that the rate of
antibiotic-resistant invasive pneumococcal infections decreased in young
children and older persons after the introduction of the conjugate vaccine, and
that .there was an increase in infections caused by serotypes not included in
the vaccine.
Magnesium Intake and
Metabolic Syndrome
Studies have suggested that
magnesium intake may be inversely related to risk of hypertension and type 2
diabetes mellitus and that higher intake of magnesium may decrease blood
triglycerides and increase high-density lipoprotein (HDL) cholesterol levels.
However, the longitudinal association of magnesium intake and incidence of
metabolic syndrome has not been investigated. As a result, a study published in
Circulation (2006;113:1675-1682), prospectively examined the relations between
magnesium intake and incident metabolic syndrome and its components among 4,637
Americans, aged 18 to 30 years, who were free from metabolic syndrome and
diabetes at baseline. Metabolic syndrome was diagnosed according to the
National Cholesterol Education Program/Adult Treatment Panel III definition.
Diet was assessed by an interviewer-administered quantitative food frequency
questionnaire, and magnesium intake was derived from the nutrient database
developed by the Minnesota Nutrition Coordinating Center. During the 15 years
of follow-up, 608 incident cases of the metabolic syndrome were identified.
Magnesium intake was inversely associated with incidence of metabolic syndrome
after adjustment for major lifestyle and dietary variables and baseline status
of each component of the metabolic syndrome. Compared with those in the lowest
quartile of magnesium intake, multivariable-adjusted hazard ratio of metabolic
syndrome for participants in the highest quartile was 0.69 (P for trend
<0.01). The inverse associations were not materially modified by gender and
race. Magnesium intake was also inversely related to individual component of
the metabolic syndrome and fasting insulin levels. It was concluded that the
findings suggest that young adults with higher magnesium intake have lower risk
of development of metabolic syndrome.
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.
Booz Allen Hamilton Hired to Evaluate
Post Marketing Study Commitments
Postmarketing
study commitments (PMCs), also called Phase 4 commitments, are studies
conducted after FDA has approved a product for marketing that a sponsor is
required, or has agreed, to conduct. These studies play a vital role in helping
to complete the medical community’s knowledge concerning the best use of a
product because these PMCs are intended to further define the safety, efficacy,
or optimal use of a product. The FDA has awarded a contract to Booz Allen
Hamilton to conduct a thorough evaluation of the postmarketing study commitment
process for collecting medical information. The goal of this in-depth
examination is greater internal consistency across the medical Centers at FDA
for requiring, requesting, facilitating, and reviewing postmarketing study
commitments. FDA fully intends to work with sponsors to make sure these
important commitments are properly focused, properly designed, and ultimately
completed in an appropriate time frame to be of value to practitioners and
patients. Over the next year Booz Allen Hamilton will examine in-depth the
agency’s internal processes regarding PMCs and make recommendations regarding
ways to improve our PMC processes and practices. This assessment should ultimately
lead to greater internal consistency across FDA’s medical product Centers, as
the Centers require, request, facilitate, and review postmarketing study
commitments for human drugs, biologic products, and medical devices. By
strengthening the process for postmarketing study commitments, FDA is
continuing to improve its regulation of new medical products by using the best
management approaches, the best information technology, and the best quality
systems and review processes. The evaluation is scheduled to begin in April and
is expected to take approximately 12 months to complete.
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
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Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved