OnTarget (January 8, 2007)
I. WHAT'S NEW?
Published Study Used Target e*CRF® For Data
Management
II. QUIZ - (Fill In The Blanks)
Nanoparticles Destroy Prostate
Cancer
III. HISTORY OF MEDICINE
Roman Medicine
IV. PUBLIC HEALTH
Educating Patients
V. INFECTIOUS DISEASE
Salmonella, You and Your Pets
VI. GENETICS
Molecular
Basis of Cleft Palate - Don't Smoke
VII. RHEUMATOLOGY
Is There
a Genetic Basis for Osteoarthritis?
VIII. REGULATORY AFFAIRS
Fat Dogs Now Have a Pill and it is "Not For Human Use"
IX.
TARGET
HEALTH
I.
WHAT'S NEW
EDC at
Target Health - Published Study Used Target e*CRF® For Data Management
Target Health is pleased to announce that a published study (see Educating
Patients below), authored by Pamella D. Thomas, MD,
MPH; and Robert Miceli, PhD, and sponsored by
Pfizer, used Target e*CRF® for data collection and data managment. Target Health also monitored the study, performed
the statistical analyses and wrote the study report.
Target Health has been doing EDC since 1999 and has performed over 100 studies
all over the world. Version 3.1 of Target e*CRF® is being released on
January 31, 2007. You do not need to be a programmer to create, manage, deploy,
and archive an Internet-based clinical trial. It will be the most
user friendly and cost effective system out there. Target e*CRF® was built as in internal tool for Target Health with
collaboration with a client.
For more
information, please contact Dr.
Jules T. Mitchel.
II. QUIZ (Fill In The Blanks)
Nanoparticles Destroy Prostate Cancer
Here's one battle with cancer,
where 1) ___ is losing dramatically. Researchers at MIT and Harvard have
custom-designed nanoparticles that hone in on
prostate cancer 2) ___ and deliver doses of targeted 3) ___. In trials with
mice, which were given 4) ___ prostate cancer, a single injection of these nanoparticles completely eradicated 5) ___ in five out of
seven animals, and significantly reducing tumor size in the other two. The work
may be replicable for treatments of breast and 6) ___ cancer, as well. These
cancer-killers, will soon be in human clinical trials.
ANSWERS: 1) cancer; 2)
cells; 3) chemotherapy; 4) human; 5) tumors; 6) pancreatic
III. HISTORY OF MEDICINE
Roman Medicine
Like modern
medical practice, Ancient Roman medicine was split among different specialties,
such as internists, ophthalmologists, and urologists. All surgical tasks were
only preformed by appropriate specialists. Surgeons used practically the same
tools as American doctors did, only one hundred years ago. An Ancient Roman
doctor1s tool kit would include forceps, scalpels, catheters, and even
arrow-extractors. Similarly, Ancient Roman surgeons had a wide range of
painkillers and sedatives to help in surgery, including extracts of opium
poppies (morphine) and of henbane seeds (scopolamine). There is little doubt
that the many folk remedies used throughout the
Roman
Empire
were tested in battle by Roman physicians on wounded and
ailing soldiers, doctors who sifted through and found the treatments and
methods with the most useful effects. edited by Alex Hays.
IV. PUBLIC HEALTH
Educating Patients - Study Used Target e*CRF® For Data Management
According to an
article published in the American Journal of Managed Care (2006;12:SP33-SP39),
a study was performed to evaluate the effect of an educational intervention
program on clinical outcomes and on compliance with medical therapy in patients
with type 2 diabetes mellitus (DM), hypertension, or both. The study was a
six-month randomized unblinded study. For the study,
352 patients were screened, and 347 were randomized to the intervention group
(education through the Know Your Health [KYH] program [n = 174]) or to the
control group (usual care [n = 173]). Evaluation of the effectiveness of the
KYH program was based on the cohort of patients who were not at their
therapeutic goal at baseline (124 in the intervention group and 115 in the
control group). The primary research interests were to assess patient
acceptance of the KYH materials and to compare the clinical outcomes of the
intervention group with those of the control group. Results showed that after 6
months of being in the program, significantly more patients in the intervention
group than in the control group were at goal (44.2% vs 29.2%, P = .046). Among patients with hypertension, reductions in the mean
diastolic blood pressure were significantly greater in the intervention group
compared with the control group at month 6 (–6.7 vs –3.6 mm Hg, P = .04). The groups did not differ significantly on other primary
end points (percentage of patients with DM who were at goal, change from
baseline glycosylated hemoglobin level, and change in Morisky score). According to the authors,
participation in the KYH educational program during a 6-month period, improved
clinical outcomes in patients with type 2 DM or hypertension. The KYH materials
were well received and were considered informative and easily comprehensible by
patients who completed the program.
V. INFECTIOUS DISEASE
Salmonella, You and Your Pets
An estimated 1.4
million salmonella infections occur annually in the
United States
. The majority of
these infections are foodborne, but many are acquired
by contact with animals. In August 2004, isolates of Salmonella enterica serotype Typhimurium,
which were indistinguishable from one another by pulsed-field gel
electrophoresis (PFGE), were obtained from eight hamsters from a
Minnesota
pet
distributor. A study published in the New England Journal of Medicine (2007;356:21-28), was recently conducted to determine whether
human cases of salmonella could be linked to this rodent-borne strain. For the
study, in order to identify cases of human infection with S. enterica serotype Typhimurium potentially related to pet rodents, salmonella PFGE patterns were reviewed
which were submitted to the National Molecular Subtyping Network for Foodborne Disease Surveillance. Patients
with isolates matching the hamster strain were interviewed about exposure to
pet rodents. Implicated rodents were traced to pet stores, distributors, and
breeders. The study identified matching S. enterica serotype Typhimurium isolates from 28 patients in
whom the onset of illness occurred between December 2003 and September 2004. Of
22 patients (or in the case of children, their parents) interviewed, 13
patients (59%) in 10 states reported exposure to pet hamsters, mice, or rats,
and 2 (9%) had secondary infections. The median age of the 15 patients with
primary or secondary rodent exposure was 16 years, and 6 patients (40%) were
hospitalized. Thirteen associated pet stores supplied by seven distributors
were identified in 10 states. No single source of the rodents was identified.
The outbreak strain of S. enterica serotype Typhimurium was cultured from a patient's pet mouse and
from seven hamsters from pet stores. Closely related S. enterica serotype Typhimurium isolates were cultured from
rodent cages and reusable transport containers at a pet distributor. Human,
rodent, and environmental isolates were resistant to ampicillin, chloramphenicol, streptomycin, sulfisoxazole,
and tetracycline. According to the authors, pet rodents probably are an underrecognized source of human salmonella infection.
VI. GENETICS
Molecular Basis of Cleft
Palate - Don't Smoke
In the
US
, about one
in every 750 babies is born with isolated, also called nonsyndromic,
cleft lip and/or palate. The condition is correctable but typically requires
several surgeries. Families often undergo tremendous emotional and economic
hardship during the process, and children frequently require many other
services, including complex dental care and speech therapy. According to an
article published in the American Journal of Human Genetics (2007;80:76-90),
women who smoke during pregnancy and carry a fetus whose DNA lacks both copies
of a gene involved in detoxifying cigarette smoke, substantially increase their
baby's chances of being born with a cleft lip and/or palate. According to the
authors, about a quarter of babies of European ancestry and possibly up to 60%
of those of Asian ancestry lack both copies of the gene called GSTT1. Based on
the data, it was calculated that if a pregnant woman smokes 15 cigarettes or
more per day, the chances of her GSTT1-lacking fetus developing a cleft
increase nearly 20 fold. Globally, about 12 million women each year smoke
through their pregnancies. According to the authors, parents who are
considering having a child and need added motivation for the mother to quit
smoking might one day be tested to determine their GSTT1 status. Because the
fetus inherits its genes from both mother and father, the test would determine
the likelihood of the baby developing without the GSTT1 gene to detoxify the
cigarette smoke. For the study, a list of 16 genes of interest were assembled,
each of which encode proteins that plug into various pathways in the body involved
in detoxifying dangerous chemicals. These genes were picked since previously
they showed evidence either of being directly involved in cigarette smoke
toxicity or were major players in general toxicity management in people. The
authors then turned to their existing database of kids with clefts, their
parents, and siblings. In all, 5,000 DNA samples were analyzed, including 1,244
from children born with clefts. Importantly, families in
Denmark
and
Iowa
provided the opportunity to
independently confirm the findings in two distinct populations. Results showed
that the mother provides the toxic environmental exposure, which then can be
greatly amplified by the genetics of the fetus to produce the cleft. This marks
the first time a gene-environment interaction in clefting has been documented at a molecular level.
VII. RHEUMATOLOGY
Is There a
Genetic Basis for Osteoarthritis?
According to an article
published in Arthritis &Rheumatism (2006; 56:137-146), a study was
performed to assess whether the association of genetic polymorphisms with
osteoarthritis (OA) in other populations could be replicated in a large, multicenter, mixed-gender, case-control study of clinical
knee OA. For the study, genetic polymorphisms in OA candidate genes were
genotyped in 298 men and 305 women, ages 50-86 years, and in 300 male and 299
female control subjects matched for age and ethnicity. All of the study
subjects had a diagnosis of knee OA as assessed clinically and radiographically. Allele and haplotype frequencies for 5 genes (ASPN, CALM1, COL2A1, COMP, and FRZB), previously
tested for association with hip and/or knee OA, were compared between patients
and control subjects. Results showed that the same FRZB 2-marker
single-nucleotide polymorphism (SNP) haplotype,
associated with hip OA in other populations of Caucasian women, was shown to
increase the risk of knee OA among the women (but not the men) (odds ratio [OR]
2.87, P < 0.04). The CALM1 SNP, which affects the risk of hip OA in Japanese
individuals, was not shown to be associated with susceptibility to OA in men or
women. COL2A1 haplotypes were demonstrated to be
associated with a decreased risk of knee OA in men (OR 0.68, P < 0.005) but
not in women. COMP haplotypes that were associated
with susceptibility to knee OA were different in men and women (P < 0.014
and P < 0.032, respectively). A meta-analysis of these data and those from
previously published reports indicated a strong association between the FRZB
G324 allele (P < 0.0003) and suggested that an ASPN allele is protective
against the risk of knee OA in Caucasians (P < 0.02). According to the
authors, the results indicate that genetic polymorphisms affecting knee OA vary
between populations (Japanese versus Caucasian) and gender and indicate a role
for ASPN, COMP, FRZB, and COL2A1 in Caucasians.
VIII. REGULATORY AFFAIRS
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.
Fat Dogs Now Have a Pill and
it is "Not For Human Use"
Veterinarians
generally define a dog that weighs 20% more than its ideal weight as obese. Surveys
have found that approximately 5% of dogs in the
United States
are obese, and
another 20-30% are overweight. The FDA has announced
the approval of Slentrol (dirlotapide),
a prescription drug for the management of obesity in dogs. Slentrol reduces appetite and fat absorption to produce weight loss. Slentrol is a new chemical entity, called a selective microsomal triglyceride transfer protein inhibitor, which blocks the assembly and release
of lipoproteins into the bloodstream. The mechanism for producing weight loss
is not completely understood, but seems to result from reduced fat absorption
and a satiety signal from lipid-filled cells lining the intestine. The drug is
given to the dog in varying amounts over the course of the treatment. The dog
is given an initial dose for the first 14 days. After that, the veterinarian is
to assess the dog's progress at monthly intervals, adjusting the dose depending
on the dog's weight loss. After the dog has achieved the goal weight, the
drug's manufacturer recommends continued use of the drug during a three-month
period, while the veterinarian and dog owner establish the optimal level of
food intake and physical activity needed to maintain the dog's weight. Adverse
reactions associated with treatment with Slentrol include
vomiting, loose stools, diarrhea, lethargy and loss of appetite. To discourage
human use, the label of Slentrol includes the
standard warning, "Not for use in humans. Keep this and all drugs out of
reach of children," and cites adverse reactions associated with human use,
including abdominal distention, abdominal pain, diarrhea, flatulence, headache,
nausea and vomiting. Slentrol is manufactured by
Pfizer Inc.,
New York
,
N.Y.
For more information about
our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
IX. TARGET HEALTH
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.
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
