(Complimentary Newsletter from Target Health Inc.)
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20 February 2006
I.
WHAT'S NEW?
Leigh
Ren, Associate Director of Biostatistics
II. QUIZ
(Fill In The Blanks)
LifeStraw
- Fantastic New Global Patented Product
III.
HISTORY OF MEDICINE
Dr. James
Lind and Scurvy
IV. EPIDEMIOLOGY
Spousal Death
V. ONCOLOGY
New Compound For the Treatment of Liver Cancer
VI. METABOLISM
New Drug For Obesity
VII. CARDIOLOGY
Reducing the Lifetime Risk of Atherosclerotic Cardiovascular
Disease
VIII. FDA
NCI and FDA Collaborate
IX. Target Health Inc.
Leigh Ren, Associate Director of Biostatistics
Target Health Inc. is
pleased to announce that Leigh Ren, MS (Columbia), has returned to Target
Health as Associate Director of Biostatistics. Leigh left Target Health about a
year ago and realized that there is no Community like the Target Health
Community. Another employee will be coming back on March 1 (to be announced) as
a Clinical Project Manager. Close to 50% of our employees have been with the
company for more than 5 years and we have one of the best employee retention in
the CRO industry. For more information, please contact Dr.
Jules T. Mitchel.
LifeStraw - Fantastic New
Global Patented Product
What is the most
precious liquid on earth? If you said 1) ___, you would be wrong. It's water.
Even though more than 2) ___% of the earth's surface is covered in water, many
parts of the world suffer from a persistent and crippling 3) ___ of potable
drinking water. The LifeStraw hopes to change all that. The 10-inch-long,
1-inch-in-diameter device is made by Vestergaard Frandsen S.A. of Lausanne,
Switzerland, out of a patented 4) ___ that kills bacteria on contact. Its
filters remove bacteria, such as 5) ___ and 6) ___, from surface water in 7)
___ and lakes. Reusable and affordable, at $3 to $4 each, the LifeStraw has the
potential to not only reduce the outbreak of 8) ___ but also to improve living
standards and 9) ___ in many of the 10) ___ poorest regions.
Answers: 1) oil; 2)
70%; 3) shortage; 4) resin; 5) salmonella; 6) staphylococcus; 7) rivers; 8)
disease 9) sanitation; 10) world's
Dr. James Lind and Scurvy
James Lind wrote in his
Treatise of the Scurvy: "On the 20th of May, 1747, I took twelve patients
in the scurvy on board the Salisbury at sea. Their cases were as similar as I
could have them." Thus began his description of his classic therapeutic
experiment on sailors with the scurvy in which various, then proposed remedies,
were tested as antiscorbutics. His experiment provided clear evidence of the
curative value of oranges and lemons and was also the first example of a
controlled clinical nutrition study using human subjects. James Lind was born
in Edinburgh, Scotland, the son of a merchant. At age 15 he was apprenticed to
a physician and in 1739 passed the examination for surgeon's mate in the Royal
Navy. A year after his famous experiment he retired from the Navy, obtained a
medical degree, and entered private practice. Ten years later he became
physician at the Royal Naval Hospital at Portsmouth.
Spousal Death
There is a strong
perception that the illness of a spouse can affect the health of a caregiving
partner. As a result, a study published in the New England Journal of Medicine
(2006;354:719-730), was performed to examine the association between the
hospitalization of a spouse and a partner's risk of death among elderly people.
The study evaluated hospitalizations and deaths during 9 years of follow-up in
518,240 couples who were enrolled in Medicare in 1993. Overall, 383,480
husbands (74%) and 347,269 wives (67%) were hospitalized at least once, and
252,557 husbands (49%) and 156,004 wives (30%) died. Mortality after the
hospitalization of a spouse varied according to the spouse's diagnosis. Among
men, 6.4% died within a year after a spouse's hospitalization for colon cancer,
6.9% after a spouse's hospitalization for stroke, 7.5% after a spouse's
hospitalization for psychiatric disease, and 8.6% after a spouse's
hospitalization for dementia. Among women, 3.0% died within a year after a
spouse's hospitalization for colon cancer, 3.7% after a spouse's
hospitalization for stroke, 5.7% after a spouse's hospitalization for
psychiatric disease, and 5.0% after a spouse's hospitalization for dementia.
The risk of death for men was not significantly higher after a spouse's hospitalization
for colon cancer but was higher after hospitalization for stroke (1.06),
congestive heart failure (1.12), hip fracture (1.15), psychiatric disease
(1.19), or dementia (1.22). For women, the various risks of death after a
spouse's hospitalization were similar. Overall, for men, the risk of death
associated with a spouse's hospitalization was 22% of that associated with a
spouse's death; for women, the risk was 16% of that associated with death.
According to the authors, among elderly people hospitalization of a spouse is
associated with an increased risk of death, and the effect of the illness of a
spouse varies among diagnoses. Such interpersonal health effects have clinical
and policy implications for the care of patients and their families.
New Compound For the
Treatment of Liver Cancer
According to
an article published in Cancer Research (2006 66:2488-2494), a new compound,
called CDDO-Im, has been identified that protects against the development of
liver cancer in laboratory animals. The compound appears to stimulate the
enzymes that remove toxic substances from the cells, thereby increasing the
cells' resistance to cancer-causing toxins. The compound's effectiveness at
very low doses suggests it may have similar cancer-fighting properties in
humans. CDDO-Im may be particularly effective in preventing cancers with a
strong inflammatory component, such as liver, colon, prostate and gastric
cancers, and that the compound could eventually play a preventive role in a
wide range of other illnesses such as neurodegenerative disease, asthma and
emphysema. CDDO-Im belongs to a class of cancer-fighting compounds called
triterpenoids. It is a synthetic compound derived from oleanolic acid, a
naturally occurring substance found in plants all over the world. Research with
other oleanolic derivatives showed marked anti-tumor activity in both animals
and humans. To test the effectiveness of CDDO-Im, laboratory rats were treated
with either 0.1, 0.3, 1.0, 3.0 or 10 micromole doses of CDDO-Im. Two days after
treatment, the rats were treated with aflatoxin, a naturally occurring toxin
that causes liver cancer in animals. Evaluation of the rat livers showed that
the lowest concentration of CDDO-Im led to an 85% reduction in pre-cancerous
lesions, abnormal growths that have a greater likelihood of developing into
actual cancers. According to the authors, CDDO-Im activates a protein called
Nrf2 that plays a central role in protecting the cells against the toxic
effects of environmental agents. Nrf2 directs certain genes to stimulate the
cell's defense mechanisms. It also stimulates key enzymes that can detoxify
harmful agents like aflatoxin and remove them from the cell. Like other
compounds derived from oleanolic acid, CDDO-Im also has strong anti-inflammatory
properties that make it ideally suited to the prevention of certain cancers.
When cells become inflamed, they can produce reactive molecules called free
radicals that can damage DNA and promote cancer development. CDDO-Im may also
inhibit cancer formation by interfering with this inflammatory process.
New Drug For Obesity
According to an article
published in the Journal of the American Medical Association
(2006;295:761-775), a 2-year study was performed to compare the efficacy and
safety of rimonabant, in conjunction with diet and exercise, for sustained
changes in weight and cardiometabolic risk factors. Rimonabant is a selective
cannabinoid-1 receptor blocker. The investigation was a randomized,
double-blind, placebo-controlled trial of 3,045 obese or overweight subjects.
After a 4-week single-blind placebo [plus diet] run-in period, patients were
randomized to receive placebo, 5 mg/day of rimonabant, or 20 mg/day of
rimonabant for 1 year. Rimonabant-treated patients were rerandomized to receive
placebo or continued to receive the same rimonabant dose while the placebo
group continued to receive placebo during year 2. The main outcome measures
were body weight change over year 1 and prevention of weight regain during year
2. Additional efficacy measures included changes in waist circumference, plasma
lipid levels, and other cardiometabolic risk factors. At year 1, the completion
rate was 309 (51%) patients in the placebo group, 620 (51%) patients in the 5
mg of rimonabant group, and 673 (55%) patients in the 20 mg of rimonabant
group. Compared with the placebo group, the 20 mg of rimonabant group produced
greater mean (SEM) reductions in weight (-6.3 vs. -1.6 kg; P<.001), waist
circumference (-6.1vs. -2.5 cm; P<.001), and level of triglycerides (-5.3
vs. 7.9%; P<.001) and a greater increase in level of high-density
lipoprotein cholesterol (12.6 vs. 5.4; P<.001). Patients who were switched
from the 20 mg of rimonabant group to the placebo group during year 2
experienced weight regain while those who continued to receive 20 mg of
rimonabant maintained their weight loss and favorable changes in
cardiometabolic risk factors. Rimonabant was generally well tolerated; the most
common drug-related adverse event was nausea (11.2% for the 20 mg of rimonabant
group vs. 5.8% for the placebo group). According to the authors, treatment with
20 mg/d of rimonabant plus diet for 2 years promoted modest but sustained
reductions in weight and waist circumference and favorable changes in
cardiometabolic risk factors.
Reducing the Lifetime Risk
of Atherosclerotic Cardiovascular Disease
Lifetime
risk for atherosclerotic cardiovascular disease (CVD) has not previously been
estimated, and the effect of risk factor burden on lifetime risk is unknown. As
a result, a study published in Circulation (2006;113:791-798), was performed to
look at lifetime risks to 95 years of age. The study included all Framingham
Heart Study participants who were free of CVD (myocardial infarction, coronary
insufficiency, angina, stroke, claudication) at 50 years of age. Lifetime risks
to 95 years of age were estimated for men and women, with death free of CVD as
a competing event. The study participants (3,564 men and 4,362 women) were
followed for 111,777 person-years. During the study, 1,757 participants had CVD
events and 1641 died free of CVD. At 50 years of age, lifetime risks were 51.7%
for men and 39.2% for women, with median survivals of 30 and 36 years,
respectively. With more adverse levels of single risk factors, lifetime risks
increased and median survivals decreased. Compared with participants with >2
major risk factors, those with optimal levels had substantially lower lifetime
risks (5.2% versus 68.9% in men, 8.2% versus 50.2% in women) and markedly
longer median survivals (>39 versus 28 years in men, >39 versus 31 years
in women). According to the authors, the absence of established risk factors at
50 years of age is associated with very low lifetime risk for CVD with markedly
longer survival. The authors added that these results should promote efforts
aimed at preventing development of risk factors in young individuals. Given the
high lifetime risks and lower survival in those with intermediate or high risk
factor burden at 50 years of age, these data may be useful in communicating
risks and supporting intensive preventive therapy.
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.
NCI and FDA Collaborate
Biomarkers are
biologic indicators of disease or therapeutic effects, which can be measured
through dynamic imaging tests, as well as tests on blood, tissue and other
biologic samples. This week, the FDA and the National Cancer Institute (NCI),
announced the Oncology Biomarker Qualification Initiative (OBQI), The OBQI is
an agreement to collaborate on improving the development of cancer therapies
and the outcomes for cancer patients through biomarker development and
evaluation. The collaboration will develop scientific understanding of how
biomarkers can be used to assess the impact of therapies and better match
therapies to patients. For instance, OBQI will address questions such as how
particular biomarkers can be used to:
- Assess after one or two treatments if a patient's tumor is
responding to treatment
- Determine more definitively if a tumor is dying, even if it is not
shrinking
- Identify which cancer patients are at high risk of their tumor
coming back after therapy
- Determine if a patient's tumor is likely to respond at all to a
specific treatment
- Efficiently evaluate whether an investigational therapy is
effective for tumor treatment.
The goal of OBQI
is to validate particular biomarkers so that they can be used to evaluate new,
promising technologies in a manner that will shorten clinical trials, reduce
the time and resources spent during the drug development process, improve the
linkage between drug approval and drug coverage, and increase the safety and
appropriateness of drug choices for cancer patients. Under the OBQI, biomarker
research will be focused in four key areas:
- Standardizing and evaluating imaging technologies to see in more
detail how treatments are working
- Developing scientific bases for diagnostic assays to enable
personalized treatments
- Instituting new trial designs to utilize biomarkers, and
- Pooling data to ensure that key lessons are shared from one trial
to another.
Rather than
waiting weeks to months to determine if a specific drug works for a patient,
biomarkers could be used to monitor real-time treatment responses. The first
OBQI project to be implemented will serve to validate and standardize the use
of Fluorodeoxyglucose - Positron Emission Tomography (FDG-PET) scanning. PET
scans are used to characterize biochemical changes in a cancer. Under the
collaboration, researchers will use FDG-PET imaging technology in trials of
patients being treated for non-Hodgkin's lymphoma, to determine if FDG-PET is a
predictor of tumor response. Data resulting from this type of evidence-based
study will help both FDA and CMS work with drug developers based on a common
understanding of the roles of these types of assessments.
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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Phone: (212) 681-2100; Fax (212) 681-2105
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Ms Joyce Hays, CEO
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