(Complimentary Newsletter from Target Health Inc.)
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2 January 2006
I.
WHAT'S NEW?
Happy
New Year
II. QUIZ
(Fill In The Blanks)
Medical
Terminology - Can You Identify These?
III.
HISTORY OF MEDICINE
Birth
Control in the Ancient World
IV. INFECTIOUS DISEASE
TB - Mechanism of Drug Resistance Identified - Good for Drug
Development
V. OPHTHALMOLOGY
Dietary Antioxidants and Risk of Age-Associated Macular Degeneration
VI. NEUROLOGY
A Study in Twins Assesses Role of Genetics in Dementia
VII. ENDOCRINOLOGY
Intensive Treatment of Type-1 Diabetes Reduces Cardiovascular
Events
VIII. FDA
Health Claims For Barley Approved
IX. Target Health Inc.
Happy New Year
A Happy New Year greeting to
all of our readers. May the New Year bring the world closer.
For more information about Target Health, please contact Dr.
Jules T. Mitchel.
Medical
Terminology - Can You Identify These?
1) GERD __ __ __; 2) IBS __ __
__; 3) AAOS __ __ __ __; 4) Hematuria __ __ __ __ ; 5) BPD __ __ __; 6) MAM __
__ __; 7) Quinsy __ __; 8) Round Window __ __ __ __ __ __; 9) Zebra
__ __ __; 10) Johnny __ __.
Answers: 1) Gastroesophageal
reflux disease; 2) Irritable bowel syndrome; 3) American Academy of Orthopaedic
Surgeons; 4) Blood in the urine; 5) Borderline personality disorder; 6) Menstrually
associated migraine; 7) Peritonsillar abscess [old word]; 8) Membrane
separating middle and inner ear; 9) Unlikely diagnostic possibility; 10)
Hospital gown
Birth Control in
the Ancient World
Women in the ancient world
practiced birth control with little interference from religious or political
authorities. A precise knowledge of plants which could either block conception
or cause abortion was resident in the oral culture of herbalists and midwives.
One of the most common contraceptive agents used in the ancient Mediterranean
world was silphium, which grew exclusively in the country of Cyrene in North
Africa. Since Cyrene was the sole exporter of the plant, it became the city’s
official symbol on its coinage and it remained the city’s primary source of
income until the first century BCE. Other plants used in classical times as
contraceptives or abortafacients included pennyroyal, artemisia, myrrh, and
rue. In Aristophanes’s comedy Peace, first performed in 421 BCE, Hermes provides
Trigaius with a female companion. Trigaius wonders if the woman might become
pregnant. “Not if you add a dose of pennyroyal,” advises Hermes. Pennyroyal
grows in the wild and would have been readily available to ancient women.
Recent studies show that pennyroyal contains a substance called pulegone that
terminates pregnancy in humans and animals.
TB - Mechanism of Drug
Resistance Identified - Good for Drug Development
Scientists from
the National Institute of Allergy and Infectious Diseases (NIAID), have
determined how a promising drug candidate attacks the bacterium that causes
tuberculosis (TB). The article, published online in the Proceedings of the
National Academy of Sciences (2005; DOI: 10.1073/pnas.0508392102), may help to
optimize the development of PA-824, which targets Mycobacterium tuberculosis
"M. tb." PA-824, now in early stage clinical trials, holds promise
for shortening the TB treatment regimen, which is currently cumbersome and
lengthy. In preclinical testing, PA-824 showed evidence of being effective
against both actively dividing and slow-growing "M. tb", giving rise
to hope that the compound may be useful in treating both active and latent TB.
Interestingly, PA-824 must be chemically activated in the bacterium before it
exerts its anti-tubercular effect. In order to identify the precise protein
that binds PA-824, "M. tb" mutants were found which resisted the
killing power of PA-824. It was confirmed, based on previous research, that
resistance usually occurs when "M. tb" lacks components called FGD1
and F420, neither of which interacts directly with the drug. Next, the team
screened for PA-824-resistant "M. tb" that retained sensitivity to a
close relative of PA-824. Within this subgroup of PA-824-resistant bacteria,
the team identified those mutant strains with FGD1 and F420. The investigators
reasoned that resistance to PA-824 in mutants possessing FGD1 and F420 must be
due to a mutation in the "M. tb" protein that directly interacts with
PA-824. But determining exactly which of "M. tb"'s thousands of
proteins was changed in these mutants proved difficult. Conventional genetic
techniques for comparing normal and mutant strains of "M. tb" failed,
so the team turned to a specially modified microarray-based technique, called
comparative genome sequencing, developed by NimbleGen Systems, Inc. (Madison,
WI). Using this technique, which effectively re-sequences the entire genome of
the bacterium, the protein altered in the PA-824-resistant mutant strains of
"M. tb" was quickly pinpointed. In the past, such a complete genome
comparison might have taken many months of work; now it took just days. The
scientists found a total of four PA-824-resistant mutant strains: two lacked
the newly described "M. tb" protein altogether, while the remaining
two mutants evidently acquired resistance to PA-824 through a mutation that
made the protein unable to bind to the drug. With the discovery of the specific
protein that interacts with PA-824, there is now a lot of information which can
used to produce improved PA-824 relatives and accelerate the pace of new TB
drug development.
Dietary
Antioxidants and Risk of Age-Associated Macular Degeneration
Age-related macular degeneration
(AMD) is the most prevalent cause of irreversible blindness in developed
countries. Recently, high-dose supplementation with beta carotene, vitamins C
and E, and zinc was shown to slow the progression of AMD. As a result, a study,
published in the Journal of the American Medical Association
(2005;294:3101-3107), was performed to investigate whether regular dietary
intake of antioxidants is associated with a lower risk of incident AMD. For the
study, dietary intake was assessed at baseline using a semiquantitative food
frequency questionnaire. Incident AMD was determined by grading fundus color
transparencies, in a masked way, according to the International Classification
and Grading System. Study subjects were aged 55 years or older in a middle-class
suburb of Rotterdam, the Netherlands. Of 5,836 persons at risk of AMD at
baseline, 4,765 had reliable dietary data and 4,170 participated in the
follow-up. The main outcome measure was incident AMD, defined as soft distinct
drusen with pigment alterations, indistinct or reticular drusen, geographic
atrophy, or choroidal neovascularization. Drusen are tiny, white hyaline
deposits on Bruch's membrane (of the retinal pigment epithelium). Drusen are
common after age 60 and sometimes an early sign of macular degeneration.
Results showed that incident AMD occurred in 560 participants after a mean
follow-up of 8.0 years (range, 0.3-13.9 years). Dietary intake of both vitamin
E and zinc was inversely associated with incident AMD. The hazard ratio (HR)
per standard deviation increase of intake for vitamin E was 0.92 and for zinc
was 0.91. An above-median intake of all 4 nutrients, beta carotene, vitamin C,
vitamin E, and zinc, was associated with a 35% reduced risk of AMD. The authors
concluded that n this study, a high dietary intake of beta carotene, vitamins C
and E, and zinc was associated with a substantially reduced risk of AMD in
people over the age of 55.
A Study in Twins Assesses
Role of Genetics in Dementia
According to a study published
in the Journal of Geriatric Psychiatry and Neurology (2005;18:202-207), on
average, twins of people who have been diagnosed with dementia score lower on
cognitive tests than do the twins of people without dementia. The study, which
included more than 100 Swedish twins age 65 and older, also found that, on
average, identical twins of people with dementia have poorer cognitive skills
than do fraternal (non-identical) twins of people with dementia. This study
result suggested that these differences in thinking skills reflect a genetic
risk for dementia. However, the authors emphasized that cognitive changes and
elevated genetic risk, do not always predict that twins, or siblings of people
with dementia, will eventually develop dementia. The study included 112 members
of the Swedish Twin Registry who were at least 65 years old in 1998. Of the
study participants, 23 were identical twins and 62 were fraternal twins, whose
co-twins had dementia but who did not have dementia themselves. A comparison
group included 27 non-demented twins whose co-twins did not have dementia. The
comparison group was similar to the other participants in terms of age, gender,
and level of education. As part of the study, participants took a series of
neuropsychological tests that assessed their attention, memory, verbal recall,
verbal fluency, ability to copy simple drawings, comprehension, and other
cognitive skills. Results showed that both monozygotic and dizygotic
nondemented co-twins of dementia cases scored significantly lower than normal
control twins on 5 of 10 cognitive tests. Moreover, monozygotic co-twins of
dementia cases had a generally lower score profile than dizygotic co-twins of
dementia cases did. These findings showed that being at greater genetic risk
for dementia is reflected in cognitive performance even in the absence of a
diagnosis of dementia. The findings also suggested that the twins of people
with dementia are at higher risk for developing dementia in the future,
although they had already lived without dementia for an average of nearly 8
years beyond their co-twins' dementia onset. The authors added that while there
may be a genetic risk for dementia, it is important to recognize that not
everyone with a genetic risk factor will develop dementia.
Intensive Treatment of
Type-1 Diabetes Reduces Cardiovascular Events
Nearly 21
million people in the U.S. 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. At least 65% of people with diabetes will die from a heart
attack or stroke, yet two out of every three people with diabetes are unaware
of their increased risk. Type-1 diabetes accounts for 5 to 10% of diagnosed
cases of diabetes in the U.S. This form of diabetes usually strikes children
and young adults, who need three or more insulin injections a day or treatment
with an insulin pump to maintain the level of blood glucose control shown to
prevent or delay long-term complications. Most people with type-1 diabetes who
are treated with conventional glucose control, as it was defined before the
Diabetes Control and Complications Trial (DCCT), develop one or more
complications, including damage to the heart and blood vessels, eyes, nerves,
and kidneys. Today, such complications are much less likely to occur if
patients begin intensive treatment promptly after the onset of diabetes.
Intensive diabetes therapy aimed at achieving near normoglycemia reduces the
risk of microvascular and neurologic complications of type-1 diabetes. A study,
published in the New England Journal of Medicine (2005;353:2643-26530), was
performed to see whether the use of intensive therapy as compared with
conventional therapy during the DCCT affected the long-term incidence of cardiovascular
disease. Cardiovascular disease, defined as nonfatal myocardial infarction,
stroke, death from cardiovascular disease, confirmed angina, or the need for
coronary-artery revascularization, was assessed with standardized measures and
classified by an independent committee. The DCCT randomly assigned 1,441
patients with type-1 diabetes to intensive or conventional therapy, treating
them for a mean of 6.5 years. At the time of the study, conventional treatment
consisted of one or two insulin injections a day with daily urine or blood
glucose testing. Participants randomly assigned to intensive treatment were
asked to keep glucose levels as close to normal as possible. That meant trying
to keep hemoglobin A1c (HbA1c) readings at 6% or less with at least three
insulin injections a day or an insulin pump, guided by frequent self-monitoring
of blood glucose. HbA1c reflects average blood glucose over the past 2 to 3
months. Results showed that during the mean 17 years of follow-up, intensive
treatment reduced the risk of any cardiovascular disease event by 42% (P=0.02)
and the risk of nonfatal myocardial infarction, stroke, or death from
cardiovascular disease by 57% (P=0.02). The decrease in glycosylated hemoglobin
values during the DCCT was significantly associated with most of the positive
effects of intensive treatment on the risk of cardiovascular disease.
Microalbuminuria and albuminuria were associated with a significant increase in
the risk of cardiovascular disease, but differences between treatment groups
remained significant (P < 0.05) even after adjusting for these factors.
According to the authors, intensive diabetes therapy has long-term beneficial
effects on the risk of cardiovascular disease in patients with type-1 diabetes.
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.
Health Claims For Barley Approved
Chronic Heart Disease (CHD) is the cause of almost 500,000
deaths annually. Risk factors for CHD include high total cholesterol levels and
high levels of low density lipoprotein (LDL) cholesterol. Based on scientific
evidence shows that adding barley to one's diet can contribute to lowering
serum cholesterol, and as part of its continuing initiative to provide
Americans with the information they need to make healthy nutritional choices
about foods and dietary supplements, the FDA announced that whole grain barley
and barley-containing products are allowed to claim that they reduce the risk
of coronary heart disease (CHD). Consumers can expect to see whole barley and
dry milled barley products such as flakes, grits, flour, meal, and barley meal
bearing the health claim. An example of the health claim that may be used is:
"Soluble fiber from foods such as [name of food], as part of a diet low in
saturated fat and cholesterol, may reduce the risk of heart disease. A serving
of [provide the name of the food] supplies [provide amount] grams of the
soluble fiber necessary per day to have this effect." FDA is authorizing
food manufacturers to immediately use the health claim for barley and the reduced
risk of coronary heart disease through the issuance of an interim final rule.
To qualify for the health claim, the barley-containing foods must provide at
least 0.75 grams of soluble fiber per serving of the food. FDA will accept
public comments on the interim final rule, published in the Federal Register,
for 75 days. Comments may be submitted to Docket No. 2004P-0512.
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.
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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