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30 January 2006
I.
WHAT'S NEW?
Employment
Opportunities
II. QUIZ
(Fill In The Blanks)
Psychosomatic
Medicine
III.
HISTORY OF MEDICINE
James
Marion Sims, Father of Gynecology
IV. ONCOLOGY
Light Exposure, Melatonin and Risk of Tumors
V. WOMENS HEALTH
Congestive Heart Failure and Rheumatoid Arthritis
VI. PUBLIC HEALTH
Lung Cancer Risk and Ethic Origin
VII. EPIDEMIOLOGY
Cell Phone Use and Brain Cancer Risk
VIII. FDA
New Draft Guidance - GMP Requirements For Phase 1 Studies
IX. Target Health Inc.
Employment
Opportunities
Target Health is
looking for Data Managers preferably with SAS skills and Sr. CRAs with Clinical
Operations experience, who want to work in New York City. Please fax (only)
resumes to 212-681-2105. For more information about Target Health, please
contact Dr.
Jules T. Mitchel.
Psychosomatic
Medicine
The following is
based on recent studies published in the Journal of the American College of
Cardiology and in the Archives of Internal Medicine. New research suggests that
employees who see their 1) ___ as unfair may be at significantly greater 2) ___
for heart disease. A study of 6,000 British male office workers over a
four-year period, found that employees who felt their supervisors treated them
3) ___, had a 30% lower risk of heart disease, which is the leading cause of 4)
___ in the industrialized world. Put another way, caustic, abrasive, and
overbearing bosses just might be taking years off their employees' lives. A
recent study, however, found that high stress levels or 5) ___, because of work,
run parallel to traditional risk factors like high 6) ___ and 7) ___. For
cardiologists, who don't typically get mixed up in psychology, the study points
to growing evidence that the 8) ___ can have a lot to do with the heart.
Consider a "killer boss" right at the top of the list of causes.
Answers: 1) bosses; 2)
risk; 3.) fairly; 4. death; 5) depression; 6) cholesterol; 7) smoking; 8) head
or mind
James Marion Sims, Father
of Gynecology
James Marion Sims is
recognized throughout the world as the founder of the field of gynecology. Dr.
Sims' unparalleled successes placed him in demand as far afield as the royal
houses of Europe. He counted among his patients Napoleon III's Empress Eugenie
of France, Scotland's Duchess of Hamilton and the Empress of Austria. Early in
his career, Sims quickly discovered the need for new techniques and thought as
medical textbooks had remained unchanged for a hundred years. Sims blazed a
career of original operations and techniques seldom equaled in medical history.
In 1845, Sims established the first woman's hospital in history in Montgomery,
Alabama. Later, in New York, he established the Woman's Hospital, which became
the forerunner and pattern for similar institutions around the world. Dr. Sims
practiced for several years in Paris and London and accepted invitations to
perform his unique operations. Several European governments honored him with
their highest awards. New York claims Sims as its own by virtue of his work and
death there. South Carolina claims him by reason of his birth in Lancaster,
S.C., but Alabama was the scene of Sims' early work and his initial successes
that were to spring him into an honored spot in medical annals.
Light Exposure, Melatonin
and Risk of Tumors
Melatonin
exerts a strong influence on the body's circadian rhythm. As a controller of
the internal “biological clock,” melatonin regulates sleep/wake cycles, body
temperature, endocrine functions, and a number of disease processes including
heart attack, stroke and asthma. Previous research has shown that artificial
light suppresses the brain's production of melatonin. Evidence is now emerging
that disruption of one's circadian clock is also associated with cancer in
humans. Mechanistically, melatonin interferes with a tumor's ability to use
linoleic acid, an essential fatty acid, as a growth signal. Under experimental
conditions, linoleic acid causes tumor metabolism and growth activity to shut
down. According to an article published in Cancer Research (December 1, 2005),
a study in laboratory mice showed that nighttime exposure to artificial light
stimulates the growth of human breast tumors. The study also showed that
extended periods of nighttime darkness greatly slowed the growth of these
tumors. According to the authors, these results might explain why female night
shift workers have been reported to have a higher rate of breast cancer, and
why there is an epidemic rise in breast cancer incidence in industrialized
countries like the United States. Interestingly, the risk of developing breast
cancer is about five times higher in industrialized nations than it is in
underdeveloped countries. To test the melatonin hypothesis, human breast cancer
cells were injected into laboratory mice. Once these cells developed into
cancerous tumors, the tumors were implanted into female rats where they could
continue to grow and develop. Blood samples were also taken from 12 healthy,
premenopausal volunteers collected under three different conditions: during the
daytime, during the nighttime following 2 hours of complete darkness, and
during the nighttime following 90 minutes of exposure to bright fluorescent
light. These blood samples were then pumped directly through the developing
tumors. Results showed that the melatonin-rich blood, collected from subjects
while in total darkness, severely slowed the growth of the tumors. In contrast,
tests with the melatonin-depleted blood from light-exposed subjects stimulated
tumor growth. According to the authors, if the link between light
exposure and cancer risk can be confirmed, it could have an immediate impact on
the production and use of artificial lighting in the industrialized world. This
might include lighting with a wavelength and intensity that does not disrupt
melatonin levels and internal timekeeping. Day workers who spend their time
indoors would also benefit from lighting that better mimics sunlight. Companies
that employ shift workers could introduce lighting that better allows workers
to see without disrupting their circadian and melatonin rhythms.
Diabetes and Urinary
Incontinence in Women
Nearly 21 million people in
the US a shocking 7% of the population, have diabetes. Diabetes is the most
common cause of blindness, kidney failure, and amputations in adults and a
major cause of heart disease and stroke. Type 2 diabetes accounts for up to 95%
of all diabetes cases. The prevalence of type 2 diabetes has risen dramatically
in the last 30 years, due mostly to the upsurge in obesity. In addition, about
40% of U.S. adults ages 40 to 74, 41 million people, have prediabetes, which
raises the risk of developing type 2 diabetes and cardiovascular disease. In
addition, more than 13 million people in the United States, mostly middle-aged
and older women, experience loss of bladder control. Overweight women and those
with type 2 diabetes have a 50- to 70-percent increased risk of incontinence.
According to an article published in the February issue of Diabetes Care,
losing a modest amount of weight through dietary changes and increased physical
activity, reduces the occurrence of urinary incontinence (UI) in women with
prediabetes. Prediabetes is a condition in which blood glucose levels are
higher than normal but not yet diabetic. The study results come out of the Diabetes Prevention
Program (DPP), a landmark clinical study funded by the National Institutes
of Health (NIH). Launched in 1995. The DPP's main results were announced in
2001 and reported in 2002. The main results showed that losing 5 to 7% of
weight through diet and a consistent increase in physical activity (e.g.,
walking 5 days a week 30 minutes a day) reduced the onset of type 2 diabetes by
58%, and treatment with metformin lowered the chances of developing diabetes by
31%. The 3,234 overweight people with higher-than-normal blood glucose levels
participating in the DPP study, were randomly assigned to one of three
approaches to prevent type 2 diabetes: 1) dietary changes and increased
physical activity aimed at a 7% weight loss; 2) treatment with the oral
diabetes drug metformin; or 3) placebo. The last two groups were also given
standard medical advice about diet and weight loss. For the women in the current
analysis, 660 were randomly assigned to intensive lifestyle changes, 636 to
metformin treatment, and 661 to placebo. The average age was 50 years old, with
an average body mass index of 35 (e.g., a 5' 4" woman weighing 204
pounds). Results showed that women who implemented intensive lifestyle changes,
and lost 5 to 7% of their weight, had fewer episodes of weekly incontinence
compared to those in the metformin or placebo groups (38% vs. 48% vs. 46%,
respectively.) According to the authors, a 200-pound woman who loses 10 to 15
pounds not only lowers the risk of developing type 2 diabetes but also improves
bladder control. Weight loss was particularly effective in reducing episodes of
stress incontinence which manifests itself by leakage of small amounts of urine
during physical movement, such as coughing, sneezing, and exercising. Stress
incontinence results, in large part, from a weakening of the pelvic floor
muscles that support the bladder. Though all the factors contributing to stress
incontinence are not fully understand, it is linked to obesity, diabetes, and
other conditions, such as pregnancy, all of which increase pressure on the
pelvic floor. In the DPP participants, weight loss did not alleviate urge
incontinence, defined as leakage of urine at unexpected times. Urge
incontinence is more closely linked to overactive nerves that control the
bladder, sometimes triggering inappropriate contractions. In the National
Health and Nutrition Examination Survey 2001-2002 sample, one out of three
women with diabetes or prediabetic glucose levels reported weekly or more
frequent episodes of UI. Some studies have reported that increased physical
activity worsens incontinence, but DPP participants randomly assigned to
lifestyle changes, who typically chose walking as their physical activity, did
not have increased problems with incontinence.
Lung Cancer Risk and Ethic
Origin
It has been observed that there is remarkable variation in the incidence of
lung cancer among ethnic and racial groups in the United States. As a result, a
study published in the New England Journal of Medicine (2006;354:333-342), was
performed to investigate the differences in the risk of lung cancer associated
with cigarette smoking among 183,813 African-American, Japanese-American,
Latino, Native Hawaiian, and white men and women. The analysis included 1,979
cases of incident lung cancer identified prospectively, over an eight-year
period, in subjects participating in the Multiethnic Cohort Study. Results
showed that the risk of lung cancer among ethnic and racial groups was affected
by the number of cigarettes smoked per day. Among participants who smoked no
more than 30 cigarettes per day, African Americans and Native Hawaiians had
significantly greater risks of lung cancer than did the other groups. Among
those who smoked no more than 10 as well as for those who smoked 11 to 20
cigarettes per day, as compared with African Americans, relative risks ranged
from 0.21 to 0.39 (P<0.001) among Japanese Americans and Latinos, and from
0.45 to 0.57 (P<0.001) among whites. However, at levels exceeding 30
cigarettes per day, these differences were not significant. Differences in risk
associated with smoking were observed among both men and women and for all
histologic types of lung cancer. According to the authors, among cigarette
smokers, African Americans and Native Hawaiians are more susceptible to lung
cancer than whites, Japanese Americans, and Latinos.
Cell Phone Use and Brain
Cancer Risk
Everybody is worried about
the risk of brain cancer by being on the cell phone for too long. As a result,
a study, published online in the British Medical Journal (20 January 2006), was
performed to investigate the risk of glioma in adults in relation to mobile
phone use. The investigation was a population based case-control study, in the
UK, with collection of personal interview data. The 966 study participants were
aged 18 to 69 years diagnosed with a glioma from 1 December 2000 to 29 February
2004, and 1,716 controls randomly selected from general practitioner lists. The
main outcome measures were odds ratios for risk of glioma in relation to mobile
phone use. Results showed that the overall odds ratio for regular phone use was
0.94 (95% confidence interval 0.78 to 1.13). There was no relationship of
glioma risk and 1) time since first cellphone use, 2) lifetime years of use,
and cumulative number of calls and hours of use. A significant excess risk for
reported phone use ipsilateral (same side) to the tumor (1.24, 1.02 to 1.52)
was paralleled by a significant reduction in risk (0.75, 0.61 to 0.93) for
contralateral use. According to the authors, the use of a mobile phone, either
in the short or medium term, is not associated with an increased risk of
glioma. This is consistent with most but not all published studies. The authors
added that complementary positive and negative risks associated with
ipsilateral and contralateral use of the phone in relation to the side of the
tumor, might be due to subject recall bias.
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.
New Draft Guidance - GMP Requirements
For Phase 1 Studies
The FDA has issued a new draft guidance, entitled “INDs -
Approaches to Complying with CGMP During Phase 1”, dated January 2006. This
draft guidance is intended to assist persons producing drug and biological
products for investigational use during phase 1 development (21 CFR 312.21(a))
in complying with relevant current good manufacturing practice as required by §
501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Controls for producing an investigational new drug for use in a phase 1 study
are primarily aimed at ensuring subject safety. The FDA’s position is that
applying quality control (QC) principles to the production of investigational
products (i.e., interpreting and implementing CGMPs consistent with good
scientific methodology) will facilitate the initiation of investigational
studies in humans and protect study subjects. When finalized, this guidance
will replace the 1991 Guideline on the Preparation of Investigational New Drug
Products (Human and Animal) for the production of IND products for phase 1
clinical trials. This guidance is being issued concurrently with a direct final
rule (and companion proposed rule), which specifies that the particular
requirements in Part 211 (21 CFR 211) need not be met for most investigational
drugs manufactured for use during phase 1 development. Instead, the Agency
recommends the approaches outlined in this guidance for complying with § 501(a)(2)(B)
of the FD&C Act. In terms of policy, FDA's guidance documents, including
this guidance, do not establish legally enforceable responsibilities. Instead,
guidances describe the Agency's current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word “should” in Agency guidances means
that something is suggested or recommended, but not required.
For a copy of the guidance, or to find out 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.
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New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
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Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved