(Complimentary Newsletter from Target Health Inc.)
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11 December 2006
I.
WHAT'S NEW?
II.
QUIZ - (Fill In The Blanks)
Honey Bees vs. Computer Chips
III. HISTORY OF MEDICINE
Mental Illness
IV. ONCOLOGY
Serendipity May Lead to Melanoma Treatment
V. NEUROLOGY
Stroke-Risk
and Lipid Intake
VI. OPHTHALMOLOGY
Cell Transplantation in Severe Ocular
Surface Disease
VII. PEDIATRICS
Women
With Biliopancreatic Bypass Surgery Have
VIII. REGULATORY AFFAIRS
E. coli Outbreak - Time For Science-Based Regulations
IX.
In celebration of the upcoming holiday season, Target Health's employees will
all be taking a well-earned respite during December 25, 2006 and January 1,
2007, inclusive. There was a lot energy used this year and it is time to recharge
batteries. Next year should be quite special at Target Health as companies
begin to use 3 new software products: Target e*CRF® Version 3, Target Document®
and Target Encoder™.
For more information, please
contact Dr.
Jules T. Mitchel.
II. QUIZ (Fill In The Blanks)
Honey Bees vs. Computer
Chips
Bomb-sniffing bees are at the
heart of a promising new technology that could soon help fight terrorism and
sniff out humans with 1) ___. A new detection device that harnesses the common
honeybee's extraordinary sense of 2) ___, effectively signals the presence of
explosives. Bees can detect explosives at the parts per-trillion level, which
in some cases is better than the currently available electronic and instrumental
methods. Scientists have long known that bees, like 3) ___, could be trained to
react to specific smells. A "bee box" has been developed, that with
the help of small cameras, and recognition 4) ___, allows humans to observe the
bees' reactions to the smells they're trained to detect. This extraordinary
capability has been harnessed, and put in a box, with technology which extracts
a signal. Bees send that signal with their 5) ___, or tongue. Bees given sugar
water or nectar, will automatically stick its proboscis out. Scientists can
exploit this reflex by first giving the bee a whiff of explosive, followed by a
reward of sugar water. After three or four of these training rounds, the bee
will stick its tongue out at the smell of explosives, in anticipation of the
sugar water. This is 6) ___ training, called associative learning. Scientists
harness individual bees with small straps and stick three of them into a
shoe-box-size device, which is attached to a laptop computer. A camera in the
box, and recognition software, allow the user to know when the bees are
sticking their tongues out. Instead of developing a circuit or a 7) ___ that
detects something, the bees do the job better. Thousands of experiments on
individual bees have successfully detected a simulated suicide bomber, a
simulated IED and a car bomb. The technology has proven effective and offers
advantages over current detection strategies, including bomb sniffing dogs.
Bees are more discreet, inexpensive to maintain and can be trained quickly,
within hours; whereas, dogs take a 8) ___... This technology has many
non-security applications like using bees to search for overripe or underripe fruit, or in the medical industry to sniff out
cancer.
ANSWERS: 1) cancer; 2) smell;
3) dogs; 4) software; 5) proboscis; 6) Pavlovian;
7) chip; 8) month
III. HISTORY OF MEDICINE
Mental Illness
In the Middle Ages, the social and physical exclusion of lepers
represented the lowest cultural rung. With the gradual disappearance of
leprosy, madness came to occupy this excluded position, the outcasts of society . First published in the 15th century, The Ship of Fools, is a literary version of one such exclusionary
practice, the practice of sending mad people away in ships. However, during the
Renaissance, madness was regarded as an all-abundant
phenomena, because humans could not come close to the Reason of God. In
Cervantes' Don Quixote, all humans are ridiculous, weak to desires and
dissimulation. Therefore, the insane, understood as those who have come too
close to God's Reason, were accepted in the middle of society. It is not before
the 17th century, in a movement which social historian Michael Foucault
famously describes as the Great Confinement, that those
"unreasonable" of the population systematically were locked away and
institutionalized. In the 18th century, madness came to be seen as the obverse
(counterpart) of Reason, i.e., as having lost what made them human and
having become animal-like and therefore treated as such. It is not before 19th
century that madness became mental illness that should be cured, e.g.
Freud.
Serendipity May Lead to
Melanoma Treatment
While
investigating a fungus known to cause an infection in people with AIDS, an
unexpected discovery was made for a potential strategy for treating metastatic melanoma, one of the deadliest forms of skin
cancer. The treatment approach, which involves combining an antibody with
radiation, has since been further developed and is expected to enter
early-stage human clinical studies in 2007. Pain Therapeutics, Inc., a San
Francisco-based biopharmaceutical company, licensed the radiolabeled
monoclonal antibody technology from the Albert Einstein College of Medicine.
The investigation started when researchers began to study the biology of the
skin pigment melanin to better understand why its synthesis plays a role in the
process whereby certain yeast-like fungi, specifically Cryptococcus neoformans, cause disease in some people. C. neoformans can cause cryptococcosis,
a potentially fatal fungal infection that can lead to inflammation of the brain
and death in people with AIDS and other immunocompromised
individuals. The team created an infection-fighting (monoclonal) antibody that
binds to melanin, based on scientific evidence suggesting that, when melanin is
synthesized, it causes the immune system to react in a way that might create
antibodies to fend off C. neoformans
infection. Based on this finding, it was theorized that melanomas might contain
melanin that would allow the monoclonal antibody to deliver radiation to tumor
cells. In a study published in the Proceedings of the National Academy of
Sciences (2004;101:14865-14870), the C. neoformans monoclonal antibodies were combined with
radiation to create radiolabeled antibodies. They
then tested these radiolabeled antibodies in mice to
determine their effectiveness in attacking melanoma tumors. Initially, the mice
had melanoma tumors ranging from 0.6 to 1.0 centimeters (cm) in diameter. After
receiving a single dose of the radiolabeled
antibodies, tumor growth was completely inhibited and near total tumor
regression occurred in those animals with smaller tumors (0.6 to 0.7 cm in
diameter). Further, the treated mice showed no signs of kidney or other organ
damage and none died during the 30-day study. Conversely, tumors continued to
aggressively grow in the untreated control group and by day 20, all but one of
the eight untreated mice had died. According to the American Cancer Society,
melanoma accounts for approximately 5% of all skin cancers but causes roughly
75% of all skin cancer-related deaths.
Stroke-Risk and Lipid Intake
Since the impact
of lipometabolic and glucometabolic
disturbances on stroke incidence remains to be characterized, a study,
published in Stroke. (2006;37:2898-2903), was performed to investigate the
relationship of a comprehensive panel of baseline lipometabolic
and glucometabolic variables to incident fatal and
nonfatal stroke or transient ischemic attack (TIA), and stroke subtypes. The investigation
was a community-based prospective study of 2,313 middle-aged men invited to a
health survey beginning at age 50. Results showed that during a follow-up of up
to 32 years, 421 study participants developed stroke or TIA. In Cox
proportional hazards analyses adjusting for treatment with cardiovascular drugs
at baseline, one-standard deviation increases in body mass index, systolic and
diastolic blood pressures, serum proinsulin, and
lipoprotein(a) were associated with 11 to 35% increased risk for subsequent
stroke/TIA. Electrocardiographic left ventricular
hypertrophy and smoking were also associated with a higher risk for stroke/TIA.
Essentially the same variables were related to brain infarction/TIA. Higher
proportions of palmitic (16:0), palmitoleic
(16:1), and oleic acid (18:1) in cholesterol esters were associated with an
increased risk, whereas a higher proportion of linoleic
acid (18:2 n-6) was protective against stroke/TIA. Foods high in linoleic acid include flaxseed, canola and soybean oils, as
well as flaxseed and walnuts. Foods high in palmitic,
palmitoleic, and oleic acid include palm oil, macademia nuts, and Trisun oil,
respectively. Further, essentially the same pattern was observed after
adjusting all models for hypertension, diabetes, the metabolic syndrome, serum
cholesterol, atrial fibrillation, cardiovascular
disease, smoking, and physical activity. According to the authors, indices of
an unhealthy dietary fat intake and a high serum lipoprotein (a) level
predicted fatal and nonfatal stroke/TIA independently of established risk
factors.
Cell Transplantation in
Severe Ocular Surface Disease
According to an article
published in Archives of Ophthalmology (2006;124:1543-1551), a study was
performed to evaluate the use of autologous serum
(AS)-derived cultivated oral epithelial transplants for the treatment of severe
ocular surface disease. For the study, AS was used from 10 patients with severe
ocular surface disease and total limbal stem cell
deficiency to develop autologous cultivated oral
epithelial equivalents. These equivalents were compared with epithelial
equivalents derived from conventional fetal bovine serum–supplemented medium.
Surgery involved removal of the corneal pannus and
surrounding diseased tissue and transplantation of the AS-derived epithelial
equivalents. The oral equivalents were analyzed by review of histologic and immunohistochemical
findings. Results showed that oral epithelial sheets cultivated in
Women With Biliopancreatic Bypass Surgery Have Normal Weight Children
According to an article
published in Pediatrics (2006;118:e1644-e1649), a study was performed to
compare the prevalence of obesity in children born to obese mothers with
substantial weight loss after biliopancreatic bypass
surgery with the same-age siblings who were born before maternal surgery and
with current population standards. The study compared 172 children who were
aged 2 to 18 years and born to 113 obese mothers (BMI: 31 ± 9 kg/m2) with substantial
weight loss after biliopancreatic bypass surgery,
with 45 same-age siblings who were born before maternal surgery (mothers’ BMI:
48 ± 8 kg/m2) and with current population standards. Results showed that after
maternal surgery, the prevalence of obesity in the offspring decreased by 52%
and severe obesity by 45.1%, with no increase in the prevalence of underweight.
Among children of both genders who were aged 6 to 18 years of age and born
after maternal surgery, the prevalence of overweight was reduced to population
levels. According to the authors, contrary to outcomes after intrauterine
under- and overnutrition, the prevalence of
overweight and obesity in children of mothers with large voluntary postsurgical weight loss was similar to that in the general
population, with no increase in underweight. The results demonstrate the
importance of potentially modifiable epigenetic factors in the cause of
obesity.
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.
E. coli Outbreak - Time For
Science-Based Regulations
The U.S. Centers
for Disease Control and Prevention (CDC) has reported at least 62 probable or
confirmed cases of illness in six states associated with the outbreak of E.
coli O157 infection in consumers, associated with eating food from Taco Bell
restaurants in six states. In the vast majority of the cases, individuals
reported having eaten at a Taco Bell restaurant within seven days before onset
of illness. A significant percentage of cases resulted in hospitalization. The
FDA continues to investigate an ongoing outbreak. FDA is collaborating with
state and local health officials, the CDC, the firm, suppliers and distributors
to determine the cause of the sicknesses and prevent additional infections. As
noted by CDC, FDA expects additional cases to be identified in the coming days.
To date, no data implicates or rules out any specific food item served at the
Taco Bell restaurants. FDA has obtained samples of all non-meat items served in
the restaurants that could carry the pathogen. These include cilantro, cheddar
cheese, blended cheese, green onions, yellow onions, tomatoes and lettuce. The
samples are being tested at FDA and at state laboratories. Infection with E.
coli O157 causes diarrhea, often bloody. Although most healthy adults can
recover completely within a week, some people can develop hemolytic uremic syndrome (HUS), a form of kidney failure. HUS is
most likely to occur in young children and the elderly. The condition can lead
to serious kidney damage and even death. Consumers who are concerned that they
may have contracted E. coli O157 infection should notify their local health
department and contact their physician or health care provider to seek medical
attention as needed. On December 6, Taco Bell Corp. announced it was
voluntarily removing green onions from its restaurants nationwide after
preliminary testing by the firm indicated the possible presence of E. coli
O157:H7 in samples of the product. Tests to confirm that preliminary finding continue
but have not yet been completed. In the interim, FDA continues to investigate
the possibility that other food items served at the restaurants are the source
of the pathogen. FDA also is working with Taco Bell Corp. and its suppliers and
distributors to obtain information on sources and distribution of products, to
aid in tracing back any products identified as contaminated with the pathogen.
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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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