ON TARGET
COMPLIMENTARY NEWS LETTER OF TARGET HEALTH® INC.
11 March 2007
I. WHAT'S NEW?
Partnering With CROs - Available
Software Tools
II. QUIZ - (Fill In The Blanks)
Transgenic Pigs and Brain Power
III. HISTORY OF MEDICINE
Maggot Therapy - Part 1
IV. EPIDEMIOLOGY
Atkins Diet Wins
V. INFECTIOUS DISEASE
Bird Flu - What Can We Learn From the 1918 Pandemic
VI. CARDIOLOGY
The
Jury is Still Out on Medicated Stents
VII. REGULATORY AFFAIRS
Tekturna
(Novartis) Approved for Treatment of Hypertension
VIII.
Partnering
With CROs - Available Software Tools
Target Health
has developed Internet-based software tools which will give competitive
advantages to CROs as well as Pharmaceutical and Device companies. Through
Target e*CRF®, we work collaboratively with many CROs. The following are
our software tools:
For more
information, please contact Dr.
Jules T. Mitchel.
Visit our Blog and Website.
II. QUIZ (Fill In
The Blanks)
Transgenic Pigs and Brain
Power
Pigs can be 1)
___ to produce large quantities of omega-3 fatty acids, found at high
concentrations in foods such as flax seeds and certain fish. Transgenic pork
containing omega-3s would avoid the potential problem of 2) ___ found in some
fish, and also circumvent fears about over-fishing. Omega-3s are still thought
to 3) ___ brain power. A team at Harvard Medical School in Boston used
4) techniques to produce piglets carrying a version of a gene from a
nematode 5) ___ that converts unhealthy omega-6 fatty acids into omega-3s. 6)
___ made up an average of 8% of the total fat in muscles of the six transgenic
pigs, compared with 1 to 2 per cent in normal pigs.
ANSWERS: 1) engineered;
2) mercury; 3) boost; 4) cloning; 5) worm; 6) Omega-3s
III. HISTORY
OF MEDICINE
Maggot Therapy -
Part 1
Maggot Debridement Therapy
(MDT), also known as larval therapy, is a type of biotherapy involving the
intentional introduction by a health care practitioner of live, disinfected
maggots (fly larvae) into the non-healing skin and soft tissue wound(s) of a
human or animal for the purpose of selectively cleaning out only the necrotic
(dead) tissue within a wound in order to promote wound healing. Written records
have documented that maggots have been used since antiquity as a safe and
effective wound treatment. There are reports of the successful use of maggots
for wound healing by Mayan Indians and aboriginal tribes in Australia. There
also have been reports of the use of maggot treatment in the Renaissance times.
During warfare, many military physicians observed that soldiers whose wounds
had become colonized with maggots experienced significantly less morbidity and
mortality than soldiers whose wounds had not become colonized. These physicians
included Napoleon’s surgeon general, Baron Larrey, who reported during France's
Egyptian campaign in Syria, 1829, that certain species of fly destroyed only
dead tissue and had a positive effect on wound healing. Dr. Joseph Jones, a
ranking Confederate medical officer during the American Civil War, is quoted as
follows, "I have frequently seen neglected wounds ... filled with maggots
... as far as my experience extends, these worms only destroy dead tissues, and
do not injure specifically the well parts." The first therapeutic use of
maggots is credited to a second Confederate medical officer Dr. J.F. Zacharias,
who reported during the American Civil War that, "Maggots ... in a single
day would clean a wound much better than any agents we had at our command ... I
am sure I saved many lives by their use. " He recorded a high survival
rate in patients he treated with maggots. Edited by Alex Hays
IV. EPIDEMIOLOGY
Atkins Diet Wins
Popular diets,
particularly those low in carbohydrates, have challenged current
recommendations advising a low-fat, high-carbohydrate diet for weight loss.
According to some, potential benefits and risks have not been tested
adequately. As a result, a study published in the Journal of the American
Medical Association (2007;297:969-977) was performed to compare 4 weight-loss
diets representing a spectrum of low to high carbohydrate intake for effects on
weight loss and related metabolic variables. The investigation was a 12-month
randomized trial conducted in the
V. INFECTIOUS DISEASE
Bird Flu - What Could We
Learn From the 1918 Pandemic
Highly
pathogenic H5N1 influenza viruses have primarily infected wild birds and
domestic poultry populations in dozens of countries, although at least 275
people have been infected and 167 have died. Concern that the H5N1 avian
influenza virus could trigger an influenza pandemic, past pandemics are being
looked at, including the 1918 "Spanish Flu," for insight into
pandemic planning. However, in a Journal of Infectious Diseases review article
published online (2007;DOI: 10.1086/511989), it was concluded that studies of
the 1918 influenza pandemic, which killed some 50 to 100 million people around
the globe, have so far raised more questions than they answer. According to
authors, a treasure trove of journal articles and other materials exist in many
languages that can be mined for novel information with practical applications
relevant to the threat of pandemic influenza. The review addresses several
topics, including the origins of the 1918 pandemic influenza virus, the excess
mortality of the pandemic, the predilection to kill the young and healthy, the
lower-than-expected mortality among the elderly, and the cyclicity of influenza
pandemics over the past 100 years. One of the great unsolved mysteries
surrounding the 1918 pandemic is why, unlike yearly influenza epidemics, in
which death rates are highest among infants, the elderly and those with chronic
health conditions, the 1918 influenza pandemic took its greatest toll on
healthy adults between the ages of 20 and 40. One possible explanation,
supported by recent studies in mice with a reconstructed version of the 1918
virus, is that an over-responsive immune system may release a "cytokine
storm," or excessive amount of immune system proteins that trigger
inflammation and harm the patient in the process. Of note, most deaths among
humans infected with the H5N1 avian influenza virus have occurred in
individuals under the age of 40. However, as the authors point out, it is not
yet known whether there is a higher percentage of young people in the affected
populations compared to older people, whether younger people are more
susceptible to infection or whether they have more exposure to infected birds.
According to the article, the H1N1 virus that caused the 1918 pandemic appears
to be avian in origin, but the host source of the 1918 virus has never been
identified. Furthermore, no major disease outbreaks among birds were documented
immediately before the 1918 pandemic. The authors suggest that an avian
influenza strain could have been hidden in an obscure ecological niche, and the
pandemic strain arose by the genetic adaptation of that avian virus to a new
human host. From the pathologist’s perspective, most pandemic deaths were
associated with either an aggressive bronchopneumonia, in which bacteria could
be cultivated from lung tissue at autopsy, or with a severe acute respiratory
distress-like syndrome (ARDS) characterized by blue-grey facial discoloration
and excessive fluid in the lungs. In neither case, is it known whether most
deaths were caused by a secondary bacterial infection or a primary viral
infection. The authors propose that the many excess deaths that occurred during
the 1918 influenza pandemic resulted from a disease process that began with a
severe acute viral infection that spread down the respiratory tree causing
severe tissue damage, which was often followed by secondary bacterial
invasion.
VI. CARDIOLOGY
The Jury is Still Out on
Medicated Stents
The long-term effects of
treatment with sirolimus-eluting stents, as compared with bare-metal stents,
have not been established. As a result, a meta-analysis, published in the New
England Journal of Medicine (2007;356:1030-1039) was performed on individual
data on 4,958 patients enrolled in 14 randomized trials, by comparing
sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1
to 58.9 months). The primary end point was death from any cause. Other outcomes
included stent thrombosis, the composite end point of death or myocardial
infarction, and the composite of death, myocardial infarction, or
reintervention. Results showed that the hazard’s ratio [HR] for the overall
risk of death of 1.03 and the combined HR of the risk of death or myocardial
infarction of 0.97 were not significantly different for patients receiving
sirolimus-eluting stents versus bare-metal stents. There was a significant
reduction in HR of the combined risk of death, myocardial infarction, or
reintervention of 0.43 associated with the use of sirolimus-eluting stents.
There was no significant difference in the overall risk of stent thrombosis
with sirolimus-eluting stents versus bare-metal stents. However, there was
evidence of a slight increase in the risk of stent thrombosis associated with
sirolimus-eluting stents after the first year. According to the authors, the
use of sirolimus-eluting stents does not have a significant effect on overall
long-term survival and survival free of myocardial infarction, as compared with
bare-metal stents. However, there is a sustained reduction in the need for
reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis
is at least as great as that seen with bare-metal stents.
VII. 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.
Tekturna (Novartis) Approved
for Treatment of Hypertension
The FDA has
announced the approval of Tekturna (aliskiren) tablets for the treatment of
high blood pressure, or hypertension. Hypertension affects an estimated 25% of
Americans and causes increased risk of stroke, heart attack, kidney failure,
heart failure and death. Tekturna, a new molecular entity (NME), is the first
high blood pressure drug approved by FDA that inhibits renin, a kidney enzyme
associated with the regulation of blood pressure. Tekturna acts at the
beginning of the blood pressure regulation process, while other available high
blood pressure medications act at later stages. The effectiveness of Tekturna
in lowering blood pressure has been demonstrated in six placebo-controlled
eight-week clinical trials, which studied more than 2,000 patients with mild to
moderate hypertension. The effect was maintained for up to one year. Tekturna
was effective across all demographic subgroups, but African American patients
tended to have smaller reductions in blood pressure than Caucasians and Asians,
as is generally true for drugs that affect the renin-angiotensin system. When
Tekturna was used in combination with hydrochlorothiazide, a diuretic, further
reductions in blood pressure were achieved. In terms of safety, Tekturna was
evaluated in more than 6,460 patients, including 1,740 who were treated longer
than six months, and more than 1,250 for over one year. Side effects were
usually mild and brief. The most common side effect experienced by patients was
diarrhea, reported by approximately 2% of patients on the higher of the two
approved doses, compared with approximately 1% on placebo. Rarely, patients
taking Tekturna developed an allergic reaction with swelling of the face, lips
or tongue and difficulty breathing, as has been seen with other drugs for high
blood pressure that act directly on the renin-angiotensin system. Tekturna and
other drugs that act directly on the renin-angiotensin system should not be
used during pregnancy because they can cause injury and even death to the
developing fetus. Tekturna is manufactured by Novartis Pharmaceuticals Corp.,
East Hanover, N.J.
VIII. TARGET HEALTH
TARGET HEALTH INC. (www.targethealth.com) is a
full service eCRO 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
Target
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Dr. Jules T. Mitchel,
President
Ms Joyce Hays, CEO
©2007 Target Health Inc. All rights reserved
