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3 April 2006
I.
WHAT'S NEW?
BIO-IT
World
II. QUIZ
(Fill In The Blanks)
Mental
Gains In Neck Artery Treatment
III.
HISTORY OF MEDICINE
Origins of
Anorexia Nervosa
IV. PSYCHIATRY
Treatment of Maternal Depression and the Impact on the Child
V. OPHTHALMOLOGY
Azithromycin Works in Trichiasis
VI. INFECTIOUS DISEASE
New Bird Flu Vaccine
VII. EPIDEMIOLOGY
Long Term Mortality Data for Smokers
VIII. FDA
Tacrolimus (Prograf) Approved for Heart Transplantation
IX. Target Health Inc.
Bio-IT
World
Target Health is pleased
to announce that Dr. Jules Mitchel will be chairing a session at the BIO-IT World
meeting in Boston this week. The 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. Hands-on clinical trial experience will be
presented. Co-presenters include colleagues from Regeneron Pharmaceuticals,
Infacare Pharmaceuticals, and Averion Inc. For more information, please contact Dr.
Jules T. Mitchel.
Mental Gains In Neck Artery
Treatment
A minimally
invasive procedure to reduce risk of 1) ___, by clearing plaque from neck
arteries, had unexpected gains in 2) ___ and mental skills. The procedure,
known as 3) ___ stenting, may allow many elderly people to continue to live
independently and has been developed as an alternative to painful neck 4) ___.
The procedure relies on tiny devices maneuvered through the circulatory system
to the carotid arteries in the neck from a small incision in the thigh. A
balloon is inflated to push the plaque into the vessel wall and then a metal
mesh scaffold, or stent, is implanted to keep the 5) ___ open. While stenting
typically improves blood flow to the 6) ___, it also unleashes a temporary
shower of 7) ___ that can disrupt brain functions, occasionally causing fatal
strokes or other serious harm. The team enrolled 100 patients over the last two
years to look at whether using a 8) ___ to catch most of the debris during the
procedure would reduce the disruptions so patients suffered no mental
impairment. The new data show reduced stroke risks without damaging mental
abilities and suggests that the benefits from the increased blood flow enabled
patients, taking memory tests, and executive function tests, to do better after
the procedure than before. Some reported that colors were brighter. The gains
were particularly striking for patients who had not yet suffered 9) ___ or
other symptoms of brain impairment but whose arteries were more than 90% 10)
___.
Answers: 1) stroke; 2)
memory; 3) carotid; 4) surgery; 5) artery; 6) brain; 7) microdebris 8) filter;
9) ministrokes; 10) blocked
Origins of Anorexia Nervosa
Examples of self-starvation
appeared in the Hellenistic era. Holy anorexics abused their bodies, rejected
marriage and sought religious asylum. Historically, Richard Morton is generally
credited with the first medical description of anorexia nervosa in 1689. The
condition then paled into obscurity until the 19th century when Louis-Victor
Marce (1828-1864) described a patient in 1859. In 1873, Ernest Charles Lasegue,
a student friend of Claude Bernard, and a favorite pupil of Trousseau
wrote about a patient who refused food over a prolonged period. On October
24, 1873, at a meeting of the Clinical Society of London, Sir William Gull
named the disease Anorexia Nervosa (Apepsia Hysterica, Anorexia Hysterica).
Treatment of Maternal
Depression and the Impact on the Child
Children of
depressed parents have high rates of anxiety, disruptive, and depressive
disorders that begin early, and often continue into adulthood, and are
impairing. As a result, a study published in the Journal of the American
Medical Association (2006;295:1389-1398) was performed to determine whether
effective treatment with medication of women with major depression is
associated with reduction of symptoms and diagnoses in their children. For the
study, children of depressed mothers, who were being treated (with medication)
as part of the multicenter Sequenced Treatment Alternatives to Relieve
Depression (STAR*D) trial, were assessed by a team of evaluators not involved
in the maternal treatment. The study population included 151 mother-child pairs
in 8 primary care and 11 psychiatric outpatient clinics across 7 regional centers
in the United States. The children were between 7 to 17 years of age. The main
outcome measures were child diagnoses based on the Kiddie Schedule for
Affective Disorders and Schizophrenia; child symptoms based on the Child
Behavior Checklist; and child functioning based on the Child Global Assessment
Scale. Study results showed that remission of maternal depression after 3
months of medication treatment was significantly associated with reductions in
the children's diagnoses and symptoms. There was an overall 11% decrease in
rates of diagnoses in children of mothers whose depression remitted, compared
with an approximate 8% increase in rates of diagnoses in children of mothers
whose depression did not. Of the children with a diagnosis at baseline, remission
was reported in 33% of those whose mothers' depression remitted compared with
only a 12% remission rate among children of mothers whose depression did not
remit. All children of mothers whose depression remitted after treatment and
who themselves had no baseline diagnosis for depression remained free of
psychiatric diagnoses at 3 months, whereas 17% of the children whose mothers
remained depressed acquired a diagnosis. Findings were similar using child
symptoms as an outcome. Greater level of maternal response was associated with
fewer current diagnoses and symptoms in the children, and a maternal response
of at least 50% was required to detect an improvement in the child. It was
concluded that remission of maternal depression has a positive effect on both mothers
and their children, whereas mothers who remain depressed may increase the rates
of their children's disorders. These findings support the importance of
vigorous treatment for depressed mothers in primary care or psychiatric clinics
and suggest the utility of evaluating the children, especially children whose
mothers continue to be depressed.
Azithromycin Works in
Trichiasis
Trichiasis is a
condition in which the eyelid turns inward and eyelashes rub against the eye,
resulting in corneal scarring and loss of vision. Trichiasis affects 11 million
people worldwide and results from trachoma, an eye infection that is the
leading preventable cause of blindness in the world. Trachoma infection caused
by Chlamydia trachomatis, which is spread through contact with flies and
other insects, clothing or household items that harbor the bacterium, or
infected people. Trachoma occurs in poor, overcrowded communities that have
little access to clean water, waste treatment facilities, or health care. These
communities are located mainly in Africa, the Middle East, Asia, Australia and
some areas of Latin America. While trachoma is rare in the United States,
certain populations marked by poverty, crowded living conditions, and/or poor
hygiene are at higher risk for this illness. According to a report published in
the Archives of Ophthalmology (2006;124:309-314), a study was performed to
determine if postoperative treatment with azithromycin compared with topical
tetracycline reduces recurrence up to 1 year. The study was a randomized,
single-masked, clinical trial conducted in Ethiopia. More than 77% of the
patients were women, who have four times the rate of trichiasis than men. Women
often contract trachoma repeatedly by taking care of infected children. A total
of 1,452 patients with trichiasis were randomized 1:1:1 to the following 3
arms: single-dose (1 g) oral azithromycin alone, single-dose azithromycin for
household members (20 mg/kg up to 1 g) plus the patient, or topical
tetracycline (twice per day for 6 weeks). Results showed that the combined
azithromycin groups had significantly fewer recurrences, 6.9 of 100
person-years overall, compared with topical tetracycline, 10.3 of 100
person-years (P = .047). There was no additional reduction in the
treatment arm that also treated household members, 8.1 of 100 person-years,
compared with treating the surgical patients alone, 5.8 of 100 person-years
(P = .19). It was concluded that in trachoma-endemic areas, one dose
of azithromycin, taken post-surgery, reduced postoperative trichiasis
recurrence rates by one third compared with topical tetracycline.
New Bird Flu Vaccine
Influenza A (H5N1) viruses
could cause a severe worldwide epidemic, with high attack rates, large numbers
of deaths and hospitalizations, and wide disruption. Effective vaccines against
these viruses in humans are urgently needed. A study of a new vaccine was
recently reported in the New England of Medicine (2006;354:1343-1351). The
investigation was a multicenter, double-blind two-stage study involving 451
healthy adults 18 to 64 years of age. Subjects were randomly assigned in a
2:2:2:2:1 ratio to receive two intramuscular doses of a subvirion influenza A
(H5N1) vaccine of 90, 45, 15, or 7.5 µg of hemagglutinin antigen or placebo,
and followed for 56 days. Serum samples obtained before each vaccination and
again 28 days after the second vaccination were tested for H5 antibody by
microneutralization and hemagglutination inhibition. Results showed that the
frequency of a serum antibody response was highest among subjects receiving
doses of 45 µg or 90 µg. Among those who received two doses of 90 µg,
neutralization antibody titers reached 1:40 or greater in 54%, and
hemagglutination-inhibition titers reached 1:40 or greater in 58%.
Neutralization titers of 1:40 or greater were seen in 43%, 22%, and 9% of the
subjects receiving two doses of 45, 15, and 7.5 µg, respectively. Mild pain at
the injection site was the most common adverse event for all doses of vaccine.
No responses were seen in placebo recipients. It was concluded that a two-dose
regimen of 90 µg of subvirion influenza A (H5N1) vaccine generates neutralizing
antibody responses typically associated with protection against influenza, and
that a conventional subvirion H5 influenza vaccine may be effective in
preventing influenza A (H5N1) disease in humans.
Long Term Mortality Data
for Smokers
The vast
scientific literature on smoking and health contains few large studies with
direct estimates of long-term mortality by smoking habits. Data have been
lacking, particularly for women. As a result, a study published in the Annals
of Internal Medicine (2006;144:381-389) was performed to study the effects of
smoking and causes of death. The investigation was a population-based cohort
study of 24,505 women and 25,034 men who were born between 1925 and 1941 in
Norway. For the study, information on smoking habits was initially collected
between 1974 and 1978. Smoking status was also assessed about 5 years and 10
years after the first examination. Death during 1974 to 2000 was studied by
using death certificate information. Results showed that during follow-up,
2,333 women and 4,680 men died in middle age. Among women and men, 9% and 14%
of never-smokers, respectively, and 26% and 41% of continuing heavy smokers (>
20 cigarettes per day), respectively, died in middle age. Years of life lost
among heavy smokers between 40 and 70 years of age were 1.4 years in women and
2.7 years in men, compared with never smokers. Rates of smoking-associated lung
cancer were similar in women and men, while lower cardiovascular mortality
rates in women explained most of the difference in smoking-associated all-cause
mortality between men and women. It was concluded that continuing smoking
strongly increased and smoking cessation decreased the risk for death between
40 and 70 years of age for both women and men. Interestingly, despite similar
rates for lung cancer death, women who smoked had lower mortality rates in
middle age than men with similar smoking histories due to fewer cardiovascular
deaths in women.
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.
Tacrolimus (Prograf) Approved for Heart
Transplantation
The FDA has
approved Prograf (tacrolimus), a drug that suppresses the body's immune
reaction, for the prevention of graft rejection in the recipients of heart
transplants. Prograf capsules and Prograf for injection, the first products
approved in the US for heart transplantation in eight years, had been
previously approved for the prevention of graft rejection in the recipients of
liver and kidney transplants. Prograf inhibits T-lymphocyte activation similar
to cyclosporine, another immunosuppressant used to prevent transplant
rejection. Thus Prograf offers an alternative to cyclosporine for use in
certain combination immunosuppressive regimens in liver, kidney and heart
transplantation. The safety and effectiveness of Prograf-based and
cyclosporine-based immunosuppression in heart transplantation were compared in
two trials, one of which was conducted in Europe and one in the U.S. In the
European trial, the survival of patients and grafts 18 months after the
transplantation in the Prograf group (91.7%) was similar to the cyclosporine
group (89.8%). In a U.S. study, patient and graft survival at 12 months after
transplantation in the Prograf group (93.5%) was similar to the cyclosporine
group (86.1%). The use of Prograf is associated with increased risk or
neurotoxicity, renal function impairment, infection, and post-transplant
diabetes mellitus. Like most combination immunosuppressive regimens used in
solid organ transplantation, the use of Prograf-based combination
immunosuppression is associated with an increased risk of malignancies, notably
of non-melanoma skin cancers. Prograf is manufactured by Astellas Pharma US,
Inc. in Deerfield, Illinois.
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