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Friday, April 30th, 2010
FDA starts infusion pump safety project
WASHINGTON - The U.S. Food and Drug Administration says it
is starting an initiative designed to address safety problems
associated with external infusion pumps. Infusion pumps are
devices that deliver fluids, including nutrients and medi-
cations, into a patient's body in a controlled manner. The
FDA said it has received more than 56,000 reports of "adverse
events" involving infusion pumps that have resulted in seri-
ous injuries and more than 500 deaths during the last five
years. Infusion pumps are widely used in hospitals, other
clinical settings, and in homes, the FDA said. The devices
allow a greater level of control, accuracy, and precision
in drug delivery, helping to reduce medication errors.
The federal agency said it wants to establish additional
premarket requirements for infusion pumps. The FDA also
announced a May public workshop on infusion pump design, as
well as a new Web page devoted to infusion pump safety.
Failures of infusion pumps have been observed across multiple
manufacturers and pump types. The FDA said many of the re-
ported problems appear to be related to deficiencies in de-
vice design and engineering. The FDA's public workshop will
be held May 25-26, during which participants will discuss
safety problems and ways to improve the design of infusion
pumps on the market or in development, to reduce malfunctions
and errors.
Stem cells may repair malformed bone
BETHESDA, Md. - A study led by the National Institutes of
Health has pinpointed the location of bone generating stem
cells in the spine, shins and other bones. A team of re-
searchers said the study involving mice also identified fac-
tors that control the stem cells' growth. "Identifying the
location of bone stem cells and some of the genetic triggers
that control their growth is an important step forward," said
Dr. Alan Guttmacher, acting director of the Eunice Kennedy
Shriver National Institute of Child Health and Human
Development -- the NIH institute where much of the research
took place. "Now, researchers can explore ways to harness
these cells so that ultimately they might be used to repair
damaged or malformed bone. Also, studies of this stem cell
population could yield insight into the formation of bone
tumors." The scientists said the study is the first to
identify the location of bone stem cells in the adult mouse
skeleton. The study included Kit Man Tsang, a graduate
student from the Chinese University of Hong Kong, NIH Dr. -
Constantine Stratakis and researchers from Johns Hopkins
University and Ohio State University. The findings appear
online in the Proceedings of the National Academy of Sci-
ences.
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Vitamin D improves elderly mobility
WINSTON-SALEM, N.C. - Elderly study participants with the
highest levels of vitamin D had better physical function and
mobility than others, U.S. researchers found. Dr. Denise
Houston of the Sticht Center on Aging at Wake Forest Univer-
sity and colleagues studied vitamin D status and physical
function in a group of relatively healthy seniors, mean age
75, in Memphis and Pittsburgh. The study tracked 2,788
seniors for four years and assessed vitamin D status by
analyzing each person's blood for 25-hydroxyvitamin D -- a
precursor activated vitamin D. The researchers looked at how
quickly each participant could walk a short distance about,
six yards, and rise from a chair five times, as well as bal-
ance tests. The study found physical function declined during
the study period, but it remained significantly higher among
those with the highest vitamin D levels at the beginning of
the study. However, Houston said it is possible those with
better physical function had higher vitamin D because they
were able to go outside more often and get the vitamin
through exposure to sunshine. The findings were presented at
the American Society for Nutrition at the Experimental Bio-
logy meeting in Anaheim, Calif.
New diabetic macular edema therapy found
BETHESDA, Md. - U.S. scientists say they've found a combi-
nation of eye injection and laser therapy has better outcomes
than laser treatment alone for diabetic macular edema. The
National Institutes of Health-supported study by the Diabetic
Retinopathy Clinical Research Network showed ranibizumab
(Lucentis) eye injections combined with laser treatment re-
sult in better vision than laser treatment alone for diabetes-
associated swelling of the retina. The researchers said
although laser treatment alone has been the standard care
for 25 years, nearly 50 percent of patients who received the
new treatment experienced substantial visual improvement
after one year, compared with 28 percent who received the
standard laser treatment. "These results indicate a treatment
breakthrough for saving the vision of people with diabetic
macular edema," said Dr. Neil Bressler, chief of the retina
division of the Wilmer Eye Institute at Johns Hopkins Uni-
versity. "Eye injections of ranibizumab with prompt or de-
ferred laser treatment should now be considered for patients
with characteristics similar to those in this clinical trial."
The researchers said diabetic retinopathy is the most common
cause of vision loss in working-age Americans. The condition
damages small blood vessels in the eye's retinal tissue. That
results in blood vessel leakage and causes swelling that can
lead to vision loss if left untreated. The study is reported
in the early online edition of the journal Ophthalmology.
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No evidence Alzheimer's prevention works
BETHESDA, Md. - U.S. medical investigators said Wednesday
there is no firm evidence any preventive measures for cog-
nitive decline or Alzheimer's disease are effective. An
independent panel convened by the National Institutes of
Health said many preventive measures including mental
stimulation, exercise and a variety of dietary supplements
have been studied over the years. But the experts said the
value of such strategies for delaying the onset or reducing
the severity of decline or disease has never been demon-
strated by rigorous studies. "Alzheimer's disease is a feared
and heart-breaking disease," said Dr. Martha Daviglus, the
panel's chairwoman and a professor of preventive medicine at
Northwestern University. "We wish we could tell people that
taking a pill or doing a puzzle every day would prevent this
terrible disease, but current evidence doesn't support this."
The panel's members said they found no evidence of even
moderate scientific support associating any dietary supple-
ment, prescription or non-prescription drug, diet, exercise
or social engagement with reduced risk of Alzheimer's disease.
The panel said evidence surrounding risk reduction for cog-
nitive decline is similarly limited, although low-grade
evidence shows weak associations between many lifestyle
choices and reduced risk of Alzheimer's disease and cognitive
decline. "These associations are examples of the classic
chicken or the egg quandary," Daviglus said. "Are people able
to stay mentally sharp over time because they are physically
active and socially engaged or are they simply more likely to
stay physically active and socially engaged because they are
mentally sharp?" Daviglus said. The panel included experts
in preventive medicine, geriatrics, internal medicine, neuro-
logy, neurological surgery, psychiatry, mental health, nutri-
tion, pharmacology, genetic medicine, nursing, health econ-
omics, health services research and family care-giving. The
report is available at:
http://www.ahrq.gov/downloads/pub/evidence/pdf/alzheimers/alzcog.pdf.
Phosphate in soda may accelerate aging
BOSTON - High levels of phosphates -- found in sodas and
processed food -- may accelerate signs of aging, U.S. re-
searchers suggest. The study, published in the journal of
the Federation of American Societies for Experimental
Biology, also finds high phosphate levels may increase the
prevalence and severity of chronic kidney disease and cardio-
vascular calcification and skin atrophy. "Humans need a
healthy diet and keeping the balance of phosphate in the diet
may be important for a healthy life and longevity," Dr. M. -
Shawkat Razzaque of the Harvard School of Dental Medicine
says in a statement. "Avoid phosphate toxicity and enjoy a
healthy life." Razzaque and a colleague examined the effects
of high phosphate levels in mice missing the gene klotho,
which when absent, causes mice to have toxic levels of
phosphate in their bodies. These mice lived from eight to 15
weeks. Mice fed a high phosphate diet also died within 15
weeks, while mice not fed a high phosphate diet lived for 20
weeks.
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