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24 July 2006
I.
WHAT'S NEW?
Electronic Health Record (EHR) Meets EDC Conference
II. QUIZ (Fill
In The Blanks)
Alzheimer's
Patients May Get Skin Patch
III.
HISTORY OF MEDICINE
History of Opium
IV. GENETICS
Genetic Basis of Rare Dementias Identified
V. HEMATOLOGY
Blood Test For Sickle Cell Disease Predicts Outcome
VI. NEUROLOGY
Long-Term Risk Factors for Stroke
VII. OPHTHALMOLOGY
Inflammation and Age-Related Macular Degeneration (AMD)
VIII. FDA
Public Health Alert – Bogus Treatment of Lyme Disease
IX. Target Health Inc.
Electronic
Health Record (EHR) Meets EDC Conference
Target Health is pleased
to announce that Dr.
Alzheimer's Patients May
Get Skin Patch
Alzheimer's patients may soon
get the first skin patch to treat 1) ___ degeneration. This is a novel way to
deliver an old 2) __ drug so that it's easier to take. A patch might also work
better and would be appreciated by patients as well as caregivers. The patch,
which infuses the drug Exelon (Novartis) through patients' skin, headlines a
trio of innovative potential treatments unveiled Wednesday, July 19, 2006, at
an Alzheimer's meeting in Spain. About 4.5 million Americans have Alzheimer's,
a toll expected to reach a staggering 14 million by 2050 with the graying of
the population. It gradually robs sufferers of their 3) ___ and ability to care
for themselves, eventually killing them. There is no known 4) __ or prevention.
Today's drugs only temporarily treat 5) ___. Exelon does that by inhibiting the
breakdown of a brain chemical called acetylcholine, which is vital for nerve
cells to 6) ___ with each other. The longer acetylcholine sticks around, the
longer those cells can call up memories. It can be hard to get Alzheimer's
patients to swallow 7) ___, and oral Exelon can cause serious 8) ___ and
vomiting. Applied once a day, the new skin patch sends Exelon straight into the
9) ___, bypassing the 10) ___ tract in hopes of fewer side effects and a
consistent daylong dose. The Novartis-funded study of nearly 1,200 patients
compared taking 12 milligrams of Exelon a day by mouth to a low-dose patch -
equivalent to 9.5 mg of Exelon daily - or a high-dose patch, equivalent to 17.4
mg. And the high-dose patch users scored slightly better on cognition tests
than pill users, with similar side effects. That means the high-dose patch
could provide one more treatment option.
ANSWERS: 1) brain; 2) oral; 3)
memories; 4) cure; 5) symptoms; 6) communicate; 7) pills; 8) nausea; 9) bloodstream;
10) gastrointestinal
History of Opium
In 3400 BCE, the opium
poppy, opium thebaicum, was cultivated in
lower
Genetic Basis of Rare
Dementias Identified
Frontotemporal Dementias (FTD) encompasses a set of rare brain disorders
including Pick's Disease , Frontotemporal
Lobar Degeneration, Progressive Aphasia and Semantic Dementia. FTD affects the
frontal and temporal lobes of the brain. People with FTD may exhibit
uninhibited and socially inappropriate behavior, changes in personality and, in
late stages, loss of memory, motor skills and speech. There is no treatment.
While most cases of FTD are sporadic, an estimated 20 to 50% has a family
history of dementia. According to an article published online in the journal
Nature (July 16, 2006), genetic mutations have been discovered that cause a
form of familial frontotemporal dementia (FTD). The
finding provides clues to the underlying mechanism of this devastating disease
and may provide insight for future approaches to developing therapies. The
mutations are contained in a single gene that is responsible for a large
portion of inherited FTD. The discovery builds on a 1998 finding of mutations
in another gene that is responsible for a smaller proportion of inherited FTD
cases. Interestingly, both the gene found in 1998 and the newly found gene were found on the same region of chromosome 17. The
current discovery appears to explain all the remaining inherited FTD cases
linked to genes on chromosome 17 and may provide new insights into the causes
of the overall disease process. The investigators began looking for genetic
causes of FTD after a 1996 conference on the disorder. The conference
encouraged researchers to cooperate, rather than compete, to find the FTD gene.
At the start, all that was known was that the inherited changes were linked to
chromosome 17. Two years later, it was discovered that mutations in a
particular gene on chromosome 17 were responsible for a subset of inherited FTD
cases. That gene, called MAPT, contains instructions for a protein known as tau. However, there were many other families where FTD was
inherited but without mutations in the tau gene.
Further searching of chromosome 17 in the families without tau
mutations finally turned up another set of mutations in another gene, this one
containing instructions for the assembly of a protein known as progranulin. The progranulin, or
PGRN, gene, makes a growth factor protein that
stimulates cell division and motility during multiple processes including
embryonic development, wound repair and inflammation. In the FTD families, the progranulin mutations appear to cut short the assembly
process for the protein in brain nerve cells (neurons), and the lack of progranulin eventually causes neurons to die. Understanding
how the mutations of the two different genes on chromosome 17 cause neuronal
death might assist in understanding the different pathways that cause dementia.
The findings also suggest that PGRN may play a role in other neurodegenerative
diseases, such as ALS (Amyotrophic Lateral Sclerosis) or Lou Gehrig's disease.
Blood Test For Sickle Cell Disease Predicts Outcome
Sickle cell
disease affects about 1 in 600 blacks and 1 in 1,000 -1,400 Hispanic newborns
every year. Patients with this disease have abnormal hemoglobin molecules in
their red blood cells. The molecules damage the red cells, causing them to
stick to blood vessel walls and resulting in pain, organ damage, and anemia.
With the development of new treatments for the symptoms and complications of
sickle cell disease, patient survival has improved in recent years. Sickle cell
anemia is one of the most common genetic blood disorders in the
Long-Term Risk Factors for
Stroke
According to an article published
in the journal Stroke (2006;37:1663-1667), a study was performed to estimate
the predictive value of risk factors for stroke measured in midlife over
follow-up extending through 28 years. For the study, a cohort of 7,457 men 47
to 55 years of age and free of stroke at baseline year 1970 were examined. Risk
of stroke was analyzed for the entire period and for 0 to 15, 16 to 21, and 22
to 28 years of follow-up using age-adjusted and multiple Cox regression
analyses. Results showed that age, diabetes, and high blood pressure were
independently associated with increased risk of stroke for the entire 28 years
and for each of the periods. Previous transient ischemic attacks, atrial fibrillation, history of chest pain, smoking, and
psychological stress were independently related to stroke for the entire
follow-up period and also during the first 1 or 2 successive periods. Family
history of stroke or of coronary disease carried no independent prognostic
information, nor did serum cholesterol. Elevated body mass index predicted
stroke during the later part of the follow-up and so did (almost) low physical
activity during leisure time, together with antihypertensive medication at
baseline. The authors concluded that high blood pressure and diabetes retain
their importance as stroke risk factors also over an extended follow-up into
old age. A family history of cardiovascular disease was not significantly
related to outcome. Transient ischemic attacks, atrial
fibrillation, stress, smoking, and a history of chest pain were associated with
outcome only for the first or the first 2 periods. High body mass index and
antihypertensive medication at baseline emerged as risk factors in the second
and third decades.
Inflammation and
Age-Related Macular Degeneration (AMD)
The evidence that
inflammation is an important pathway in age-related macular degeneration (AMD)
is growing. Recent case-control studies demonstrated an association between the
complement factor H (CFH) gene, a regulator of complement, and AMD. As a
result, a study published in the Journal of the American Medical Association
(2006;296:301-309), was performed to assess the associations between the CFH
gene and AMD in the general population and to investigate the modifying effect
of smoking, serum inflammatory markers, and genetic variation of C-reactive
protein (CRP). The investigation was a population-based, prospective cohort
study of individuals aged 55 years or older in
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.
Public Health Alert – Bogus
Treatment of Lyme Disease
Bismacine,
also known as chromacine, is an injectable
product that has been used to treat Lyme disease. However, bismacine
is not approved for anything, including Lyme disease. Bismacine
is not a pharmaceutical but is mixed individually by druggists. It is
prescribed or administered by doctors of "alternative health" or by
people claiming to be medical doctors. The FDA has cautioned consumers and
health care providers not to use a bismacine. FDA is
investigating one report of a death and several reports of injury related to
the administration of bismacine. Bismacine
contains high amounts of bismuth, a heavy metal that is used in some
medications taken by mouth to treat Helicobacter pylori (a bacteria that
can cause stomach ulcers), but that is not approved in any form for use by
injection. On April 20, 2006, one person died as a result of treatment with bismacine, and on March 29, 2005, another person was
hospitalized after receiving a bismacine treatment.
Other individuals who have used or been administered this product have also
suffered serious adverse events. Possible effects of bismuth poisoning include
cardio-vascular collapse and kidney failure. Individuals who believe they have
suffered adverse events from receiving bismacine
should seek medical attention. FDA is evaluating the product suppliers and will
take additional action as appropriate.
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 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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Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
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