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6 February 2006
I.
WHAT'S NEW?
Target
Health Speaking at DIA Meeting on Electronic Health Records and Clinical Trials
II. QUIZ
(Fill In The Blanks)
Biohazard
or Needed Research?
III.
HISTORY OF MEDICINE
William
Beaumont and Early Studies of Gastric Secretion
IV. WOMEN'S HEALTH
Risk of Heart Disease Differs in Women From Men
V. BASIC SCIENCE
Biomarker For Depression
VI. PSYCHIATRY
Multiple Drug Therapy For Schizophrenia
VII. ONCOLOGY
Adjuvant Radiation Therapy in Endometrial Adenocarcinoma
VIII. FDA
Vaccine For Rotavirus Approved
IX. Target Health Inc.
Target
Health Speaking at DIA Meeting on Electronic Health Records and Clinical Trials
Target Health Inc. is
pleased to announce that Dr. Jules T. Mitchel will be presenting a talk
entitled, “Integrating EHR with EDC” at a DIA meeting being held in
collaboration with the Healthcare Information and Management Society (HIMSS).
The meeting, entitled “Research and Development Meets Health Information
Technology: Using Electronic Health Records to Streamline Clinical Trial
Operations,” is being held on March 26 - 29, 2006 at the Philadelphia Marriott
Downtown, and will take place in parallel with DIA’s annual meeting on Clinical
Data Management. For more information, please contact Dr.
Jules T. Mitchel.
Biohazard or Needed
Research?
The world’s
deadliest 1) ___ are moving to Boston because Boston University won final
federal approval from the NIH for a controversial plan to build a research
laboratory in the city's South End that would handle some of the world's most
2) ___ and exotic germs. This world-class lab will be a part of a national
group of facilities that will study 3) ___ diseases such as 4) ___ and the West
Nile virus. University officials said the lab will be safe and will
provide needed research into contagious illnesses and the risk they might pose
in the hands of 5) ___. Opponents have criticized the decision to build the lab
in a densely populated 6) ___ neighborhood. A controversy escalated in
2004, when three workers at another BU lab became sick after they were exposed
to a highly infectious strain of 7) ___, or rabbit fever. They recovered.
Construction is scheduled to begin this month and should be complete by 8) ___.
The university estimates the new lab will create more than 650 permanent jobs
and contribute nearly 9) ___ to the local economy over the next 20 years.
Answers: 1) germs;
2) dangerous; 3) infectious; 4) Ebola; 5) bioterrorists; 6) urban; 7)
tularemia; 8) 2008; 9) $3 billion
William Beaumont and Early Studies
of Gastric Secretion
As a young army surgeon
stationed on Mackinac Island in Michigan, William Beaumont (1785-1853) was
asked to treat a shotgun wound. The patient, Alexis St. Martin, survived but
was left with a permanent opening into his stomach from the outside. Over the
next few years, Dr. Beaumont used this crude fistula to sample gastric
secretions. He identified hydrochloric acid as the principal agent in gastric
juice and recognized its digestive and bacteriostatic functions. Moreover, many
of his conclusions about the regulation of secretion and motility remain valid
to this day.
Risk of Heart Disease
Differs in Women From Men
Much of our
understanding of the underpinnings of heart disease and heart attack, and the basis
for our standard methods of diagnosis and treatment, are the result of research
conducted in men. Through clinical experience, many critical questions have
arisen about how the disease may manifest differently in women, and how
diagnostic techniques may need to be used differently in order to prevent more
heart attacks and save lives. According to findings from the Women's Ischemia
Syndrome Evaluation (WISE) study, published in the Journal of the American
Academy of Cardiology (2006;47:S4-S20), in as many as 3 million U.S. women with
coronary heart disease, in contrast to men, cholesterol plaque may not build up
into major blockages, but instead spreads evenly throughout the artery wall.
Diagnostic coronary angiography incorrectly concludes “low risk” because
results show "clear" arteries (no blockages). However, many of these
women have a high risk for heart attack. In women with this condition, called
coronary microvascular syndrome, plaque accumulates in very small arteries of
the heart, causing narrowing, reduced oxygen flow to the heart, and pain that
can be similar to that of people with blocked arteries. Unfortunately, the
plaque does not show up in standard diagnostic tests. As a result, many women
go undiagnosed. The WISE program was developed 1) to evaluate diagnostic
approaches for ischemic heart disease detection in women; 2) to better
understand the ways in which heart disease develops in women including the
significance of ischemia without coronary blockages in women; and 3) to
evaluate the influence of hormones on ischemic heart disease development and
diagnosis. According to the authors, too often women are tested again and
again, go untreated, and still have high risk for heart attacks and that it is
time for a change.
Biomarker For Depression
According to an article
published in Psychosomatic Medicine (2006;68:1-7), a study was performed to
understand the pathophysiological effects of depression by examining group
differences in serum levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG), a
biomarker of oxidative damage. The study population consisted of 169
participants, 84 of which met diagnostic criteria for clinical depression. The
85 participants in the comparison group were matched on age, gender, and
ethnicity to the depressed group. 8-OHdG was measured by enzyme-linked
immunosorbent assay. Results showed that after adjusting for age, gender,
race/ethnicity, years of education, daily smoking, average number of alcoholic
drinks per week, average amount of physical activity per week, and body mass
index, participants in the depressed group had significantly higher levels of
oxidative DNA damage compared with participants in the control group. Pairwise
comparisons showed that participants with major depression had significantly
higher levels of 8-OHdG than control subjects and marginally higher levels of
8-OHdG compared with those with minor depression. Furthermore, participants
with recurrent episodes of depression had more oxidative damage than
participants with single episodes, who in turn had more damage than healthy
control subjects. Finally, participants with recurrent episodes of major
depression had more DNA damage than other depressed participants, who in turn
had more damage than healthy control subjects. The authors concluded that the
findings suggest that increased oxidative damage may represent a common
pathophysiological mechanism, whereby depressed individuals become vulnerable
to comorbid medical illness.
Multiple Drug Therapy For
Schizophrenia
The treatment of schizophrenia with multiple antipsychotic drugs is common, but
the benefits and risks are not known. As a result, a study published in the New
England Journal of Medicine (2005;354:472-482), was performed to evaluate
patients with schizophrenia who were poor responders to clozapine and then
subsequently treated with risperidone. For the study, patients who were poor
responders to clozapine were randomly assigned to receive eight weeks of daily
augmentation with 3 mg of risperidone or with placebo. This course of treatment
was followed by an optional 18 weeks of augmentation with risperidone. The
primary outcome was reduction in the total score for severity of symptoms on
the Positive and Negative Syndrome Scale (PANSS). The secondary outcomes
included cognitive functioning. For the study, a total of 68 patients were
randomly assigned to treatment. In the double-blind phase, the mean total score
for the severity of symptoms decreased from baseline to eight weeks in both the
risperidone and the placebo groups. There was no statistically significant
difference in symptomatic benefit between augmentation with risperidone and
placebo: 9 of 34 patients receiving placebo and 6 of 34 receiving risperidone
responded to treatment (P=0.38). The mean difference in the change in PANSS
scores from baseline to eight weeks between those receiving risperidone and
those receiving placebo was 0.1 (95% confidence interval, –7.3 to 7.0). The
verbal working-memory index showed a small decline in the risperidone group and
a small improvement in the placebo group (P=0.02 for the comparison between the
two groups in the change from baseline). The increase in fasting blood glucose
levels was mildly greater in the risperidone group than in the placebo group
(16.2 vs. 1.8 mg per deciliter [0.90 vs. 0.10 mmol per liter], P=0.04). The
incidence and severity of other side effects did not differ between the two
groups. According to the authors, the addition of risperidone to clozapine did
not improve symptoms in patients with severe schizophrenia.
Adjuvant Radiation Therapy
in Endometrial Adenocarcinoma
The benefit of adjuvant
radiation therapy (RT) in stage I endometrial adenocarcinoma remains
controversial despite several phase 3 trials. As a result, a study published in
the Journal of the American Medical Association (2006;295:389-397), was
performed to evaluate the frequency and effect of adjuvant RT on overall and
relative survival within a large US population database. The investigation was
retrospective analysis of data from the Surveillance, Epidemiology, and End
Results program of the US National Cancer Institute from January 1, 1988, to
December 31, 2001. A total of 21,249 patients with American Joint Committee on
Cancer stage IA-C node-negative endometrial adenocarcinoma were evaluated. The
main outcome measures were overall survival curves using the Kaplan-Meier
method adjusted for age. Relative survival was performed to assess the effects
of age, race, stage, grade, whether nodes were examined, and whether adjuvant
RT was administered. Of 21,249 women, 4,080 received adjuvant RT (19.2%) while
17,169 did not (80.8%). The mean age at diagnosis was 63.2 years (range, 14-99
years). Results showed that adjuvant RT significantly improved overall survival
for patients with stage IC/grade 1 (P<.001) and stage IC/grades 3 and 4
(P<.001). Cox proportional hazards regression analysis revealed a
statistically detectable association of adjuvant RT with improved relative
survival in patients with stage IC/grade 1 and stage IC/grades 3 and 4 (hazard
ratio [HR], 0.44; P<.001; and HR, 0.72; P = .009; respectively). A separate
analysis of those patients with a surgical lymph node examination at the time
of total abdominal hysterectomy and bilateral salpingo-oophorectomy revealed
similar estimates (HR, 0.59; P = .01; and HR, 0.73; P = .02; respectively).
According to the authors, results of the study clearly reveals a statistically
significant association between improved overall and relative survival and
adjuvant RT in stage IC disease (grades 1 and 3-4), and that future work is
needed to continue to delineate clinical and biological factors, which can
guide treatment decisions and account for disparities in outcome between varied
subsets of patients.
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.
Vaccine For Rotavirus Approved
Infection with rotavirus is a leading cause of severe diarrhea in
infants and young children in the world. While death is rare from a rotavirus
infection in the US, there are approximately 55,000 annual hospitalizations.
However, in developing countries, rotavirus gastroenteritis has been estimated
to cause up to several hundred thousand deaths annually. This week, the FDA
announced the approval of RotaTeq™ (Merck), the first live, oral, vaccine for
use in preventing rotavirus gastroenteritis in infants. For the approval,
approximately 72,000 healthy infants were studied all over the world in
randomized placebo-controlled studies for safety. Of these infants, almost
7,000 from the United States and Finland were also studied for effectiveness.
Compared to placebo, RotaTeq™ prevented 74% of all rotavirus gastroenteritis
cases and 98% of the severe cases. In addition, RotaTeq™ prevented
approximately 96% of hospitalizations due to rotavirus gastroenteritis. In
1998, FDA approved a different live vaccine against rotavirus that was later
withdrawn from the market because of its association with an increased risk of
intussusception, a rare, life-threatening type of blockage or twisting of the
intestine. Intussusception occurs spontaneously in approximately 1 in 2,000
healthy young infants and children per year, but occurred at an increased rate
during the first week or two following vaccination with the previous rotavirus
vaccine. In the safety analysis, RotaTeq™ was not associated with an increased
risk of intussusception when compared to placebo. In addition, RotaTeq™ was not
associated with an increased risk of other serious adverse events when compared
to placebo. Merck has committed to conducting a post-licensure study of
approximately 44,000 children. CDC will also conduct a large study designed to
rapidly detect any association of intussusception with RotaTeq™ through its
Vaccine Safety Datalink Program, which evaluates vaccine safety in approximately
80,000 U.S. infants every year. In addition, for the first three years of
licensure, Merck will report cases of intussusception and all serious and
unexpected adverse events to FDA within 15 days of receiving them, and all
other side effects on a monthly basis. RotaTeq™ is a liquid vaccine that is
given by mouth in three doses, between the ages of 6 and 32 weeks.
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.
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
©2006 Target Health Inc. All rights reserved