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28 August 2006
I.
WHAT'S NEW?
New Publication
- Applied Clinical Trials
II. QUIZ
(Fill In The Blanks)
Nocturnal
Asthma
III.
HISTORY OF MEDICINE
Cancer
Is Not A Modern Disease
IV. PUBLIC HEALTH
New Treatment For Smokers
V. OPHTHALMOLOGY
Contact Lens Users - Fusarium Keratitis Associated With Use Of
ReNu With MoistureLoc
VI. ONCOLOGY
Gene Expression In Hepatocellular Carcinoma Predicts Outcome
VII. NEUROLOGY
Autism Is A Global Brain Disorder
VIII. FDA
FDA Approves OTC Plan B For Women Over 18
IX. Target Health Inc.
New
Publication - Applied Clinical Trials
Target Health is pleased to announce the publication
of a new article in this month's Applied
Clinical Trials, entitled "Impact of Internet-based Clinical
Trials (IBCTs) on Clinical Trial Efficiency." The article is co-authored
with our colleagues Jens Langendorf and Silvana Cappi of Ferring
Pharmaceuticals (
Nocturnal Asthma
Asthma occurs primarily at 1)
___ (called nocturnal asthma) in as many as 75% of asthma patients. Attacks
often occur between 2 and 4 AM. Factors that might play a role in nocturnal
asthma may include, chemical and temperature changes in the body during the
night that increase inflammation and narrowing of the 2) __. Also contributing
to nocturnal asthma are, delayed allergic responses from exposure to 3) ___
during the day. Another factor is, the wearing off of inhaled 4) ___ toward the
early morning. One interesting contributor is an increase in 5) ___ reflux
(back up of stomach acid) that causes the airways to 6) ___. A likely other
cause of nocturnal asthma is 7) ___ drip that occurs during sleep. Final
contributions to nocturnal asthma are conditions relating to sleep, such as
sleep 8) ___, and sleeping on one's back. Some experts believe that nocturnal
asthma may actually be a unique form of asthma with its own specific biologic
mechanisms that occur only at night and which 9) ___ natural steroid hormones,
which block 10) ___.
ANSWERS: 1) night; 2) airways;
3) allergens; 4) medications; 5) acid; 6) narrow; 7) postnasal; 8) apnea;
9) reduce; 10) inflammation
III. HISTORY OF MEDICINE
Cancer Is Not A Modern Disease
Cancer is not a disease of our
modern industrialized age. The oldest description of human cancer was found in an Egyptian papyri written between 3000-1500 BCE, and
referred to tumors of the breast. The oldest specimen of a human cancer was
found in the remains of a female skull dating back to the Bronze Age (1900-1600
BCE). The mummified skeletal remains of Peruvian Incas, dating back 2400 years
ago, contained lesions suggestive of malignant melanoma, and cancer was found
in fossilized bones and manuscripts of ancient
New Treatment For Smokers
Varenicline tartrate
(Chantix, Pfizer), a novel, selective nicotinic receptor partial agonist, was
recently approved by FDA for smoking cessation. According to an article
published in the Archives of Intern Medicine (2006; 66:1561-1568), a study was
performed to evaluate the efficacy, tolerability, and safety of 3 varenicline
doses, versus Bupropion hydrochloride and placebo, for smoking cessation. The
investigation was a phase 2, multicenter, randomized, double-blind study of
healthy smokers (18-65 years old). Subjects were randomized to varenicline
tartrate, 0.3 mg once daily (n=128), 1.0 mg once daily (n=128), or 1.0 mg twice
daily (n=127), for 6 weeks plus placebo for 1 week; to 150-mg sustained-release
bupropion hydrochloride twice daily (n=128) for 7 weeks; or to placebo (n=127)
for 7 weeks. Results showed that during the treatment phase, the continuous
quit rates for any 4 weeks were significantly higher for varenicline tartrate,
1.0 mg twice daily (48.0%; P<.001) and 1.0 mg once daily (37.3%; P<.001),
than for placebo (17.1%). The bupropion rate was 33.3% (P=.002 vs placebo). The
carbon monoxide-confirmed continuous quit rates from week 4 to week 52 were
significantly higher in the varenicline tartrate, 1.0 mg twice daily, group
compared with the placebo group (14.4% vs 4.9%; P=.002). The bupropion rate was
6.3% (P=.60 vs placebo). Discontinuation owing to treatment-emergent adverse
events was 15.9% for bupropion, 11.2% to 14.3% for varenicline, and 9.8% for
placebo. No dose-related increases occurred in adverse events for varenicline.
It was concluded that varenicline tartrate demonstrated both short-term (1 mg
twice daily and 1 mg once daily) and long-term efficacy (1 mg twice daily) vs
placebo, and that varenicline was well tolerated and may provide a novel therapy
to aid smoking cessation.
Contact Lens Users - Fusarium
Keratitis Associated With Use Of ReNu With
MoistureLoc
Fusarium keratitis is a serious corneal
infection, most commonly associated with corneal injury. Beginning in March 2006,
the Centers for Disease Control and Prevention received multiple reports of Fusarium
keratitis among contact lens wearers. According to an article published in the
Journal of the American Medical Association (2006;296:953-963),
a study was performed to define the specific activities, contact lens hygiene
practices, or products associated with this outbreak. For the study, a
confirmed case of Fusarium keratitis was defined as keratitis with
illness onset after June 1, 2005, with no history of recent ocular trauma and a
corneal culture growing Fusarium species. Data were obtained by patient
and ophthalmologist interviews for case patients and neighborhood-matched
controls by trained personnel. Available Fusarium isolates from
patients' clinical and environmental specimens were genotyped by multilocus
sequence typing. Environmental sampling for Fusarium was also conducted
at a contact lens solution manufacturing plant. As of June 30, 2006, 164
confirmed case patients were identified in 33 states and 1
Gene Expression In Hepatocellular Carcinoma Predicts Outcome
Hepatocellular carcinoma (HCC) is
the most common liver cancer diagnosed in adults and has a high prevalence in
Asian and African populations. The rate of new HCC cases has been rising over
the past 10 years in the
Autism Is A Global Brain Disorder
People with autism tend to display
3 characteristic behaviors, which are the basis of the diagnosis of autism.
These behaviors involve difficulty interacting socially, problems with verbal
and non-verbal communications, and repetitive behaviors or narrow, obsessive
interests. Traditionally, those studying autism have concentrated on these
behavioral areas. Within the last 20 years, however, other aspects of thinking
and brain functioning have been studied in autism, and it has been discovered
that people with autism have difficulty in many other areas, including balance,
movement, memory, and visual perception skills. In the current study, published
in the August edition of Child Neuropsychology (2006:12:279-298), a
comprehensive array of neuropsychological tests was administered to a group of
children with autism. Results showed that autism affects the functioning of
virtually the entire brain, and is not limited to the brain areas involved with
social interactions, communication behaviors, and reasoning abilities, as had
been previously thought. The study also found that autism also affects a broad
array of skills and abilities, including those involved with sensory
perception, movement, and memory. The findings ,
strongly suggest that autism is a disorder in which the various parts of the
brain have difficulty working together to accomplish complex tasks. The study
was conducted by researchers in the Collaborative Program of Excellence in
Autism (CPEA), a research network funded by two components of the NIH, the
National Institute of Child Health and Human Development and the National
Institute on Deafness and Other Communication Disorders. For the study, 56
autistic children were tested, and their responses were compared to those of 56
children who did not have autism. The children with autism were classified as
having higher functioning autism -- an I.Q. of 80 or above, and the ability to
speak, read, and write. All of the children in the
study ranged in age from 8 to 15 years. The purpose of the test array was to
determine whether there were any patterns in mental functioning unique to
autism. Results showed that across the entire
series of tests, the children with autism performed as well as -- and in some
instances even better than -- the other children on measures of basic functioning.
Uniformly, however, children with autism had trouble with complex tasks. For
example, regarding visual and spatial skills, children with autism were very
good at finding small objects in a cluttered visual field (e.g. like
finding Waldo in the "Where's Waldo" picture books series). However,
when asked to perform a complex task, like telling the difference between the
faces of similar looking people, children with autism had great difficulty.
Although their memory for the detail in a story was phenomenal, the children
with autism had great difficulty comprehending the story. Many were highly
proficient at spelling and had a good command of grammar, but had difficulty
understanding complex figures of speech, like idioms and metaphors. Other complex
tasks were also difficult for children with autism, as the children with autism
either had poor handwriting, or wrote very slowly. Many had difficulty tying
their shoes and with using scissors. According to the authors, the major
implication of the study is that when seeking to understand autism,
investigators need to look for a cause or causes that affect multiple brain
areas, rather than limiting their search to brain areas dealing with the three
characteristic behaviors involving social interactions, communication, and
repetitive behaviors or obsessive interests. The authors added that the study
strongly suggests that autism is not primarily a disorder of social
interaction, but a global disorder affecting how the brain processes the
information it receives -- especially when the information becomes complicated.
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.
FDA Approves OTC Plan B For Women Over 18
The FDA has approved Plan B, a
contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and
older. Plan B is often referred to as emergency contraception or the
"morning after pill." Plan B contains levonorgestrel, an ingredient
used in prescription birth control pills, only in the case of Plan B, each
pill contains a higher dose and the product has a different dosing regimen. In
terms of dosing, the first tablet should be taken as soon as possible within 72
hours after possible contraceptive failure and the second tablet should be
taken 12 hours after the first dose. When used as directed, Plan B
effectively and safely prevents pregnancy. Plan B will remain available as a
prescription-only product for women age 17 and under. Duramed, a subsidiary of
Barr Pharmaceuticals and manufacturer of Plan B, will make Plan B available with
a rigorous labeling, packaging, education, distribution and monitoring program.
In the CARE (Convenient Access, Responsible Education) program Duramed commits
to:
- Provide consumers and healthcare professionals with labeling and
education about the appropriate use of prescription and OTC Plan B,
including an informational toll-free number for questions about Plan B;
FDA's action
concludes an extensive process that included obtaining expert advice from a
joint meeting of two FDA advisory committees and providing an opportunity for
public comment on issues regarding the scientific and policy questions
associated with the application to switch Plan B to OTC use. Duramed's
application raised novel issues regarding simultaneously marketing both
prescription and non-prescription Plan B for emergency contraception, but for
different populations, in a single package.
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.
TARGET HEALTH INC.
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Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved