DOV 21,947 Demonstrates Significant Body Weight And BMI Reductions In Drug Compliant Subjects In Phase Ib Clinical Study

DOV Pharmaceutical,
Inc. ("DOV", or the "Company") (OTCBB and Pink Sheets: DOVP) announced additional Phase Ib results for DOV 21,947, its lead triple reuptake inhibitor ("TRIP") for the treatment of depression and obesity. A preliminary analysis of the study results demonstrated that DOV 21,947 was
safe and well tolerated at the doses examined, and produced a statistically
significant reduction in plasma triglyceride levels, as described more
fully below. Further analyses of these data demonstrate that DOV 21,947
significantly reduces body weight and Body Mass Index ("BMI") in
drug compliant subjects compared to placebo. The Company intends to
initiate a Phase II study of DOV 21,947 for the treatment of depression in
the first quarter of 2008.



This double-blind, placebo-controlled Phase Ib study enrolled 46 male
and female volunteers. Following a one-week placebo run-in, subjects
received either escalating daily doses of 50 mg, 100 mg and 150 mg of DOV
21,947 (31 subjects) or placebo (15 subjects), for a total of eight weeks.
Those subjects with detectable blood levels of DOV 21,947 or its principal
metabolite during at least three of four bimonthly visits (approximately
70% of the drug-treated subjects) were classified as drug compliant.



At the end of this eight-week study, the mean difference in body weight
change from baseline between the drug-compliant and placebo groups was 4.6
pounds (p








"The delay in the initiation of the Phase II study of DOV 21,947 to the
first quarter of 2008 has enabled us to further evaluate the protocol
design to ensure that we are capturing potential effects of DOV 21,947's
effects on body weight and appropriately capture drug-compliance in our
analyses. This delay, along with other cost containment measures, also
serves to provide us with sufficient capital through April 2008 as we
explore our financing and collaborative options," said Barbara Duncan,
Chief Executive Officer of DOV. The double-blind, Phase II study now
scheduled for initiation in the first quarter of 2008 will compare up to
100 mg per day of DOV 21,947 versus placebo in approximately 200 patients
with major depressive disorder over a six-week treatment period. The
Company expects the results from this Phase II study to be available at the
end of 2008.



About DOV 21,947



Clinical research indicates that co-administrating drugs that, in
combination, inhibit reuptake of the three neurotransmitters most closely
linked to depression - serotonin, norepinephrine and dopamine - can produce
greater overall efficacy than currently marketed antidepressants. This
novel combination of properties in a single antidepressant could provide a
breakthrough in the treatment of depression. DOV 21,947, a TRIP, is
structurally related to DOV 216,303. In a Phase II clinical trial with DOV
216,303 for the treatment of depression, patients who completed two weeks
of treatment in both the DOV 216,303 and citalopram groups demonstrated
reductions from baseline (p

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Archimedes Pharma Announces Ground Breaking Phase III Data Showing NasalFent To Be Superior To The Standard Of Care For Breakthrough Cancer Pain

Archimedes Pharma Limited, the UK based, pan-European
specialty pharmaceutical company, announces new positive headline
phase
III results for NasalFent(R), the Company's innovative and highly
differentiated fentanyl citrate nasal spray, developed for the rapid
relief
of breakthrough cancer pain. The ground breaking phase III study compared
NasalFent to immediate release morphine sulphate, the most commonly
prescribed medicine for breakthrough cancer pain.





Breakthrough cancer pain affects up to 95% of all cancer
patients and is characterised by sudden, unpredictable episodes of intense
pain that occur despite background pain medication. This pain is rapid in
onset, often reaching maximum intensity in 5 minutes with a duration of
30-60
minutes.





NasalFent met the primary efficacy endpoint in the phase III
study 044. Patients treated with NasalFent showed a statistically
significant
improvement in Pain Intensity Difference within 15 minutes (PID15)
compared
to immediate release morphine sulphate (p < 0.04), meaning a greater
reduction in pain.





NasalFent is the only one of the new generation of fentanyl
products to have demonstrated statistically significant improvements over
immediate release morphine sulphate. Significantly better improvements in
pain scores for NasalFent versus immediate release morphine sulphate were
seen at all subsequent time points indicating that superiority of
NasalFent
was maintained for 60 minutes after dosing.





NasalFent showed both consistent effectiveness and high
acceptability; 94% of patients completed the double-blind part of the
study
and 70% of patients elected to continue therapy with NasalFent in the long
term Phase III safety study.





Professor Marie Fallon, St Columba's Hospice Chair of
Palliative Medicine, University of Edinburgh, Edinburgh Cancer Research
Centre (CRUK) Western General Hospital Edinburgh, UK stated: "These data
are
hugely exciting. This is the first time a simple-to-use fentanyl product
has
been shown to be superior to the standard treatment for breakthrough
cancer
pain. NasalFent offers the prospect of greatly improving the management of
this distressing and common complication of cancer".





Study 044 was conducted in all major western European
countries and in India, involving 35 expert investigational sites. A total
of
135 patients were screened and 110 (82%) entered the open dose titration
phase. 84 (76%) patients participated in the double-blind,
placebo-controlled
portion of the study. It is planned that data from study 044 will be
presented at scientific meetings later in 2009.





Richard de Souza, CEO of Archimedes, commented, "We are
delighted with these results from another innovative study of NasalFent in
what is the largest and most comprehensive clinical programme for any
breakthrough cancer pain product. These data clearly show that NasalFent
is
superior to the benchmark product for this condition and fully supports
the
results from study 043 which demonstrate that NasalFent offers pain relief
within 5 minutes of dosing and is highly acceptable to patients. Data from
our third phase III study, 045, a long-term safety study, including over
500
patients, will be available shortly."


















Phase III data on NasalFent confirming best-in-class profile
to be presented at major scientific congresses





Data from the phase III study 043 on NasalFent are to be
presented at the American Pain Society (APS) on 7 and 8 May by Professor
Allen Burton, Professor and Chair at the University of Texas and MD
Anderson
Cancer Centre in Houston, Texas, and at the European Association of
Palliative Care (EAPC) on 9 and 10 May by Dr Russell Portenoy, Chairman,
Department of Pain Medicine and Palliative Care, Beth Israel Medical
Center,
New York and Dr Donald Taylor, Medical Director and Anesthesiologist,
Georgia
Center for Cancer Pain Management & Palliative Medicine, Georgia.





Results covering both primary and secondary outcomes show
statistical superiority for NasalFent over placebo and provide robust
evidence for NasalFent as the first product to have demonstrated both
rapid
onset of pain relief within five minutes of dosing, and early clinically
meaningful pain relief within 10 minutes of dosing. Use of rescue
medication
was low confirming that NasalFent was also consistently effective.
Additional
data presented showed that NasalFent produced highly significant
improvements
across a range of pain assessments. Nasal tolerability was excellent and
side
effects were generally mild to moderate in intensity and importantly were
typical of fentanyl use in this patient population.





Professor Allen Burton, Professor and Chair at the University
of Texas and MD Anderson Cancer Centre in Houston, Texas, who participated
in
the study and is presenting the data at the APS, said: "Breakthrough
cancer
pain is a significant clinical issue and these data illustrate the
potential
for NasalFent to offer ultra-rapid, consistent pain relief to the many
patients who suffer from this unpredictable and extremely debilitating
pain."










NasalFent





NasalFent is an innovative and highly differentiated aqueous
fentanyl citrate nasal spray utilising Archimedes' proprietary PecSys(TM)
technology. NasalFent has a low viscosity and is easily delivered in a low
volume of 100mcl using a conventional nasal spray pump. The pump produces
a
fine mist of similarly sized spray droplets which are deposited into the
front of the nostril. The calcium ions present in nasal mucosal fluid
cause
the pectin to form a thin gel layer resulting in modulated drug
absorption,
allowing rapid but controlled absorption into the systemic circulation and
an
increased duration of action. PecSys technology avoids problems associated
with simple solutions used as nasal sprays such as supratherapeutic levels
of
drugs and dripping or swallowing of drug solution. NasalFent is in
development for rapid relief of breakthrough cancer pain.





Breakthrough cancer pain affects up to 95% of all cancer
patients and is characterised by sudden, unpredictable episodes of intense
pain typically lasting 30-60 minutes and which occur despite background
opioid pain medication. Initial Phase III data illustrates that NasalFent
has
a potential best-in-class profile among fentanyl products for breakthrough
cancer pain and is the first product to demonstrate onset of pain relief
within five minutes of dosing. NasalFent will be filed for regulatory
approvals from Q2 2009 and is targeted for launch from mid-2010.


Source
Archimedes Pharma Limited

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British Doctors To Scale Everest For Intensive Care Breakthrough

What's the similarity between high altitude climbing and intensive care? A great deal, according to a team of extreme athletes who also happen to be qualified physicians and scientists. Next spring, they will conduct experiments at high altitude and at Everest's summit - such as blood oxygen readings and brain function tests - that will be brought back ultimately to the bedsides of critically ill patients.



Many in the team are based at the Institute of Human Health and Performance at University College London and are members of the Centre for Aviation, Space and Extreme Environment Medicine, (CASE Medicine) where the team leader, Dr Mike Grocott and his fellow medics conceived the idea for the 'world first' expedition.



Expedition research leader, Dr Hugh Montgomery, who today (June 6) talks at the Knowledge Two conference at The Institute of Electrical Engineers, London said, "At the 8,850m summit of Everest, there's so little oxygen getting into the lungs that the body quickly starts shutting down and mountaineers risk slipping into a coma. These extreme conditions mimic what it's like for patients in intensive care and studying the human body in this environment will teach us invaluable lessons in the science of survival.



"One in six Britons will spend time in an Intensive Care Unit and, shocking as it may sound, statistics show that up to three in ten people admitted do not pull through, causing devastation to families.



"We know that mountaineers survive on low oxygen levels that would take the lives of intensive care patients in a matter of minutes. Our Everest ascent will involve creating the world's highest medical laboratory, taking field science to a new level."



Dr Montgomery's genetic work has identified a gene associated with improved performance at high altitude and subsequently demonstrated that the same gene was associated with improved outcome in a variety of conditions found on intensive care units, including the severe lung disease, Acute Respiratory Distress Syndrome (ARDS).



Peak practice



While any Everest expedition has risks, the team of climbers have a wealth of extreme sports experience at their disposal. Dr Montgomery, aged 45 from Southampton is a qualified skydiver who also dived in the Solent to help raise Henry VIII's sunken Mary Rose. Climbing leader Dr Sundeep Dhillon, aged 36 from London in 1998 became the youngest person in the world to conquer the Seven Summits. Dr Kevin Fong, aged 35 from London specialises in the medical conditions experienced by astronauts while Dr Denny Levett, aged 35 from Kent is a qualified Divemaster. Dr Levett is married to the expedition leader, Dr Mike Grocott, aged 40, from Manchester.



Dr Grocott lectures in high altitude physiology and is a Consultant Intensive Care Physician.



He said, "If we chose to, we could simulate our experiments in a special laboratory but this would in fact cost a lot more than going to Everest and the results would be no more accurate.



"Low oxygen levels (hypoxia) in the blood and cells are a critical factor in Intensive Care patients. The summit of Everest is by extraordinary coincidence exactly at the limit of human tolerance for hypoxia. For many years, doctors and scientists believed that it would be impossible to climb Everest without supplementary oxygen. In 1978 Reinhold Messner proved them wrong and since then more than 100 individuals have ascended the mountain without supplemental oxygen. It is clear that were the mountain even a few meters higher this would be impossible. The summit of Everest is a wonderful natural laboratory for the study of the effects of critical hypoxia in humans."



The physicians hope that their findings will result in better intensive care recovery rates throughout Britain and the rest of the world plus increased quality of life for people with conditions ranging from Cystic Fibrosis to severe infections and lung disease.



xtreme-everest

case.ucl.ac




The team, that is currently seeking sponsors, leaves for Everest in March 2007. They will climb the South Col route.



Extensive trials are being conducted in advance of the Everest expedition. In July they will train in the Alps and in September will become further prepared on Cho Oyu, the world's sixth highest peak.



Dr Mike Grocott is also a co-director for CASE - the Centre for Aviation, Space and Extreme Environment Medicine based at the Institute of Human Health and Performance, Ground Floor, Charterhouse Building, Archway Campus, Highgate Hill, London N19 5LW, Tel: +44 (0)20 7323 9911, email: infoxtreme-everest

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Fight Off Aches & Pains This Winter With Extra Vitamin D

It's no wonder many people feel achy and sore, and sometimes tired and depressed, during winter months they're often not getting enough vitamin D. The body makes vitamin D from the sun's ultraviolet rays, so it's known as the sunshine vitamin, but this source is in short supply throughout late fall and winter.


According to an extensive review of clinical research in a report from Pain Treatment Topics (Pain-Topics), inadequate vitamin D has been linked to a long list of painful maladies, including bone and joint pain, muscle aches, fibromyalgia syndrome, rheumatic disorders, osteoarthritis, and other complaints. Lack of vitamin D also has been implicated in the mood disturbances of chronic fatigue syndrome and seasonal affective disorder, or SAD, which are more common during winter.


Author of the report and editor of Pain Treatment Topics, Stewart B. Leavitt, MA, PhD, notes that for many people sunshine is not an ample source of vitamin D during most of the year and the few foods containing the vitamin do not provide enough of it. "In our review of 22 clinical research studies persons with various pain and fatigue syndromes almost always lacked vitamin D, especially during winter months. When sufficient vitamin D supplementation was provided, the aches, pains, weakness, and related problems in most sufferers either vanished or were at least helped to a significant degree."


The report mentions the following important points:


-- Vitamin D is a complex nutrient that actually functions as a hormone to benefit numerous body tissues and organs, including bones, muscles, and nerves.


-- A surprising majority of persons in many parts of the world, including the United States, do not get enough vitamin D from sunshine or foods.


-- The currently recommended adequate intake of vitamin D up to 400 IU per day in children and 600 IU per day in adults is outdated and too low. According to the research, most children and adults need at least 1000 IU per day, and persons with bone or muscle aches and pains could benefit from 2000 IU or more per day of supplemental vitamin D3 (also called cholecalciferol), especially during winter months.


-- Vitamin D supplements are generally safe if taken as directed. They interact with very few drugs or other agents, and are usually not harmful unless very high daily doses such as, 50,000 IU or more are taken for an extended period of time.


-- Vitamin D supplements are easy to take, usually have no side effects, and typically cost as little as 7 to 10 cents per day.


Besides the comprehensive Research Report (50-pages, 170 references) -- titled "Vitamin D A Neglected 'Analgesic' for Chronic Musculoskeletal Pain" -- there is available a shorter Practitioner Briefing (7-pages) that summarizes the report and provides guidance for healthcare providers. Additionally, a special Patient Brochure (6-pages) explains what vitamin D is, how it works, and how it can help in relieving aches and pains.


All 3 documents are available for free access at:
pain-topics/vitamind


In conclusion, Leavitt stresses that vitamin D should not be viewed as a cure for all pain conditions, and it is not necessarily a replacement for other pain-relief treatments. "While further research would be helpful," he says, "extra vitamin D should be considered for all persons in late fall or early winter, and especially for those who have developed aches and pains, or fatigue and mood disorders."


The Pain-Topics website, a project of Pain Treatment Topics, provides open and free access to noncommercial, evidence-based clinical news, information, research, and education on the causes and effective treatment of the many types of pain conditions. It is independently produced and currently supported by an unrestricted educational grant from Covidien/Mallinckrodt Inc., St. Louis, MO, a leading manufacturer of generic opioid analgesic products.


NOTE: Neither the author nor the sponsor has any financial interests in vitamin D products or the nutritional supplement field.


Pain Treatment Topics

Pain-Topics

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Breast Cancer Could Be Reduced And Existing Sufferers Helped By Drugs Like Aspirin

Anti-inflammatory drugs like aspirin may reduce breast cancer by up to 20 per cent, according to an extensive review carried out by experts at London's Guy's Hospital and published in the March issue of IJCP, the International Journal of Clinical Practice.



But they stress that further research is needed to determine the best type, dose and duration and whether the benefits of regularly using non-steroidal anti-inflammatory drugs (NSAIDs) outweigh the side effects, especially for high-risk groups.



"Our review of research published over the last 27 years suggests that, in addition to possible prevention, there may also be a role for NSAIDs in the treatment of women with established breast cancer" says Professor Ian Fentiman from the Hedley Atkins Breast Unit at the hospital, part of Guy's and St Thomas' NHS Foundation Trust.



"NSAID use could be combined with hormone therapy or used to relieve symptoms in the commonest cause of cancer-related deaths in women."



Professor Fentiman and Mr Avi Agrawal reviewed 21 studies covering more than 37,000 women published between 1980 and 2007.



Their review included 11 studies of women with breast cancer and ten studies that compared women who did and did not have the disease.



"The purpose of a review like this is to look at a wide range of published studies and see if it is possible to pull together all the findings and come to any overarching conclusions" explains Professor Fentiman. "This includes looking at any conflicting results and exploring how the studies were carried out.



"For example some of the studies we looked at as part of this review found no links between NSAIDs and reduced levels of breast cancer, while others suggested that taking NSAIDs can reduce the breast cancer risk by about a fifth.



"Having weighed up the findings from over 20 studies, we have concluded that NSAIDs may well offer significant protection against developing breast cancer in the first place and may provide a useful addition to the treatment currently available to women who already have the disease.



"Recent studies of NSAIDs use have shown about a 20 per cent risk reduction in the incidence of breast cancer, but this benefit may be confined to aspirin use alone and not other NSAIDs."



Previous studies have suggested that NSAIDs like aspirin and ibuprofen, which have traditionally been used as mainstream non-prescription analgesics, may provide protection against coronary heart disease and some malignancies, such as colorectal cancer.



But Professor Fentiman is urging caution until further research fully weighs up the pros and cons of using NSAIDs to prevent and treat breast cancer.



"Our review did not look at the potential side effects of using NSAIDs on a regular basis" stresses Professor Fentiman "These can include gastrointestinal bleeding and perforation which can carry a significant risk of ill health and death.



"It would be essential to take these negative effects into account before we could justify routinely using NSAIDs like aspirin to prevent breast cancer.



"More research is clearly needed and we are not advocating that women take these non prescription drugs routinely until the benefits and risks are clearer.



"But our findings clearly indicate that these popular over-the-counter drugs could, if used correctly, play an important role in preventing and treating breast cancer."



###



* NSAIDS and breast cancer: possible prevention and treatment strategy. Agrawal A and Fentiman I S. IJCP, the International Journal of Clinical Practice. 62.3, 444-449. (March 2008)



* IJCP, the International Journal of Clinical Practice was established in 1946 and is edited by Dr Graham Jackson from Guy's and St Thomas' NHS Foundation Trust, London, UK. It provides its global audience of clinicians with high-calibre clinical papers, including original data from clinical investigations, evidence-based analysis and discussions on the latest clinical topics. The journal is published by Blackwell Publishing Ltd, part of the international Blackwell Publishing group. blackwellpublishing/ijcp



* About Wiley-Blackwell. Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley's Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit blackwellpublishing/ or interscience.wiley/



Source: Annette Whibley


Blackwell Publishing Ltd.

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Blocking Stress-Related Cell Death Could Provide New Drug Development Target For Heart Attack, Stroke And Parkinson's

Scientists from the Florida campus of The Scripps Research Institute have uncovered a potentially important new therapeutic target that could prevent stress-related cell death, a characteristic of neurodegenerative diseases such as Parkinson's, as well as heart attack and stroke.



In the study, published recently in the journal ACS Chemical Biology, the scientists showed they could disrupt a specific interaction of a critical enzyme that would prevent cell death without harming other important enzyme functions.



The enzyme in question is c-jun-N-terminal kinase (JNK), pronounced "junk," which has been implicated in many processes in the body's response to stresses, such as oxidative stress, protein misfolding, and metabolic disorder. JNK also plays an important role in nerve cell survival and has become a target for drugs to treat neurodegenerative disorders such as Parkinson's disease.



In recent studies, JNK has been found to migrate to the mitochondria - the part of the cell that generates chemical energy and that is involved in cell growth and death. That migration, coupled with JNK activation, is associated with a number of serious health issues, including apoptosis or programmed cell death, liver damage, neuronal cell death, stroke and heart attack.



"Activated JNK migrates to the mitochondria in reaction to a stress signal," said Philip LoGrasso, professor in the Department of Molecular Therapeutics and senior director for drug discovery at Scripps Florida who led the study. "Once there, it amplifies the effects of reactive oxygen species that cause significant damage to the cell. We developed a small peptide that intervenes in JNK migration and blocks those harmful effects - specifically cell death."



LoGrasso noted that the team was able to block JNK mitochondrial interaction without harming any other important enzyme processes, such as JNK's impact on gene expression. These findings, LoGrasso said, suggest that this interaction could be exploited in the development of a new drug.



"The peptide we developed will never be a drug, but it is an important new investigative tool that we can use to selectively probe mitochondrial biology," he said. "Our hope is to produce a small molecule that can mimic the inhibitory effect of this peptide. If we can do that, we might be able to selectively inhibit JNK mitochondrial interaction and use it to treat a number of diseases."


Notes:


The first author of the study, "Selective Inhibition of Mitochondrial JNK Signaling Achieved Using Peptide Mimicry of the Sab Kinase Interacting Motif-1 (KIM1)," is Jeremy W. Chambers of Scripps Research. Other authors include Lisa Cherry, John D. Laughlin, and Mariana Figuera-Losada, also of Scripps Research.



The study was supported by National Institutes of Health and the Saul and Theresa Esman Foundation.



Source:

Mika Ono


Scripps Research Institute

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Coma, Vegetative State, Minimally Conscious State: Frequent Misdiagnoses And Inconsistent Standards In Europe Pose Ethical Problems

"Latest research raises important ethical issues concerning our care for patients with chronic consciousness disorders," said Professor Gustave Moonen (Liege, Belgium), past president of the European Neurological Society (ENS), at a press conference at the current ENS Congress. This major meeting in European neurology is gathering more than 2,900 experts from all over the world in Milan. "This is all the more important as studies have shown that more than a third of patients given an initial diagnosis of vegetative state or persistent vegetative state show minimal signs of consciousness under more detailed examination."


230,000 coma patients in Europe per year


The special challenge for neurologists and other professionals caring for coma patients will be just one of the topics under discussion at the congress in Milan. Modern medical progress leads to an increasing number of patients having survived injuries and illnesses but at the price of serious brain injuries. Experts estimate that there are around 230,000 coma patients in Europe each year and that around 30,000 remain in a persistent vegetative state. Many of the studies on coma and related issues are a result of the work done in Liege by the "Coma Science Group" headed by Professor Steven Laureys.


A particularly delicate issue: coma and other states of impaired consciousness are not always easy to differentiate, although the classification can have grave repercussions. Patients seldom remain longer than two to five weeks in a coma, a state of deep unconsciousness uninterrupted by exterior stimuli. The vegetative state is characterized by wakefulness without awareness. "In a chronic vegetative state of more than a year, medical guidelines consider the withdrawal of treatment such as artificial nutrition and hydration ethically justifiable," Prof. Moonen explains. "The minimally conscious state characterizes patients with more than reflex behavior, with an inconsistent but clearly discernible evidence of consciousness but a lack of interactive communication. There are no generally accepted standards for the care of these patients." European studies show varying standards for care and decision making involving passive assisted death.


In a current study being presented at the ENS Congress in Milan, Professors Moonen and Laureys and their team surveyed the attitudes of European doctors, paramedical professionals and non-medical professionals on end-of life decisions in these challenging patients. The investigation shows that that key questions are being evaluated with anything but uniformity. Some 65 % of all respondents considered it acceptable to stop artificial nutrition and hydration in patients in a chronic vegetative state, whereas only 29 % considered this measure justified in patients in chronically minimally conscious states. The majority (78%) of respondents considered that being in a permanent vegetative state is worse than death for the patient's family, but only 51 % think that it is worse than death for the patients themselves. Furthermore, half of the respondents (52 %) considered that being in a minimally conscious state is worse than a vegetative state for the patients. "There are quite different attitudes throughout Europe towards patients in a minimally conscious state and a vegetative state," Professor Moonen points out. "In light of the high rates of diagnostic error in these patients, the necessity for adapted standards of care for minimally conscious state as compared to vegetative state is warranted."


Children with "locked-in-syndrome"


Another new study being presented in Milan by the Coma Science Group identifies the particular problems entailed in the treatment of children with so-called "locked-in-syndrome" (LIS). Patients suffering this syndrome are fully conscious but are completely paralyzed and only able to communicate via small eye movements. "The development of intensive care has considerably increased the number of children surviving acute brainstem damage," Professor Moonen explains. "But LIS is still rare in children. As a result, the diagnosis is often missed or delayed." Researchers in Liege examined a series of five cases. "Two of the reported cases died, and three survived, one up to eleven years, remaining with a severely handicapped motricity but meaningful self-scored quality of life," Professor Laureys reports. "We also observed that most pediatric LIS patients show some motor recovery. Our reported and reviewed data stress the need for physicians to carefully interpret signs and symptoms of LIS." Results of this study are to appear in the journal "Pediatric Neurology".


Neural networks show significant differences between the vegetative state and brain death.


Still another study in Liege shows just how delicate the decision over life and death can be. Through magnetic resonance imaging, the connections among defined neuroanatomical networks in the brain were compared using healthy people, patients in a vegetative state and brain dead patients. "Our MRI data indeed showed not only significant remaining correlations between distant default network areas in a case of vegetative state. In the vegetative state patient, as in age-matched controls, anti-correlations could also be observed between specific cortical networks. Both correlations and anti-correlations were significantly reduced in vegetative state as compared to healthy persons. A similar approach in a brain dead patient did not show any such long-distance functional connectivity," Prof. Laureys explains. "Ongoing multi-centric studies are documenting the diagnostic and prognostic value of cerebral 'resting state' functional MRI studies in coma survivors." Results of this study are in press in the journal "Human Brain Mapping".



Source
European Neurological Society

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F.D.A. And Drug Makers Could Run Tighter Ship

The pharmaceutical industry could be wasting more than $50 billion a year in manufacturing costs alone, costs that could translate in to lower prices or greater research and development - according to findings of the largest empirical study ever performed of pharmaceutical manufacturing and the Food and Drug Administration monitoring policies. Jackson Nickerson, professor of organization and strategy at the Olin School of Business at Washington University in St. Louis, and Jeffrey Macher, assistant professor of strategy and economics at Georgetown University, jointly conducted the study, which received no funding from either the pharmaceutical industry or the F.D.A.


"We undertook the project to understand how the F.D.A. regulates and pharmaceutical manufacturers produce so we could see where there may be conflicts that inhibit advances in manufacturing," Nickerson said. "Our policy goal is to understand both sides of the coin so that we could contribute to improving the regulatory environment, thereby altering the pharmaceutical industry's incentives to maintain and in some cases enhance product quality, but for a much lower cost."


In their most recent findings, the researchers collected data from 42 manufacturing facilities owned by 19 manufacturers. They studied the company's performance in terms of cycle time, frequency of deviations, reasons for deviations, cycle time, yield, and rates of improvements in important manufacturing metrics,. Their analysis revealed five key outcomes that influence the pharmaceutical manufacturing performance metrics.


-- Information Technology. Companies that used IT to electronically and automatically report, track and resolve deviations; track people; and centrally store all data, uniformly displayed superior manufacturing performance compared to those without such IT.


-- Decision making. The lower down in the ranks that companies allow employees to make decisions, the higher the overall manufacturing performance. This is especially true when considering deviation management, lot failure, lot review and process valuation.
-- Outsourcing. Contract manufacturing generally although not always - have inferior manufacturing metrics.


-- Process analytic technology. The use of technology that measures the uniformity of a drug's content prior to the completion of the final product, corresponds to worse performance measures. The correlation doesn't imply causation, said Nickerson. In fact, process analytic technology may improve a drug's quality,. However, the FDA had been encouraging the industry to adopt use of the technology using the argument that it would improve overall performance. Nickerson said, this finding may cause the FDA to rethink their reasons for endorsing process analytic technology.


-- Size and range. The scale and scope of the manufacturing facility have a complex interplay with manufacturing performance. Depending on what aspect of manufacturing is being measured, scale and scope can either be a detriment or a benefit.


Nickerson said that some of the findings weren't necessarily surprising, but the study represents one of the first documentations of these phenomena.


The manufacturing project was completed about a year after Nickerson and Macher conducted a similar study that focused on the FDA's regulatory processes.


"Each study addresses a different side of the same coin. But in combination, we feel that we are now in a better position to comment on how to improve or change regulations so that the FDA and manufacturers focus on a risk-based environment," Macher said.


Although the report is primarily a benchmarking device, the research is already pointing to important observations that suggest specific areas of conflict and to the direction to take in future research. For example, the FDA study made it clear that individual regulators are not identical in how they inspect a facility.


"If there are differences in regulators and if regulatory agencies randomize who goes out and inspect facilities, then we believe that creates an incentive for manufacturers to be overly risk averse," Nickerson said. "Manufacturers want to insure themselves against any regulator that comes into inspect a facility, especially when adverse outcomes can impose substantial costs on the manufacturers. The net result is that because of the regulatory environment, companies have an incentive not to innovate in manufacturing processes that could lower cost or improve the manufacturing process."


The professors say that once they better understand the interplay between regulators and manufacturers, then they can make proposals on how to change regulatory policies so that firms do have in incentive to innovate manufacturing processes.


"Doing so could have dramatic impact on global healthcare," Macher said.


Washington University in St. Louis

One Brookings Dr., Campus Box 1070

St. Louis, MO 63130

United States

news-info.wustl.edu/

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First National Study To Examine Rock Climbing-Related Injuries

In the past decade the popularity of rock climbing has dramatically increased. It has been estimated that rock climbing is now enjoyed by more than 9 million people in the U.S. each year. A new study by researchers at the Center for Injury Research and Policy of the Research Institute at the Nationwide Children's Hospital found that as the popularity of the sport has escalated, so have the number of injuries. Study findings revealed a 63 percent increase in the number of patients that were treated in U.S. emergency departments for rock climbing-related injuries between 1990 and 2007.


The study, published in the online issue of the American Journal of Preventive Medicine, found that over 40,000 patients were treated in U.S. emergency departments for rock climbing-related injuries between 1990 and 2007. The most common types of rock climbing-related injuries were fractures (29 percent) and sprains and strains (29 percent). Lower extremities were the most common region of the body to be injured (46 percent) while the ankle was the most common individual body part to be injured (19 percent). Climbers in the study ranged in age from 2 to 74 years, with an average age of 26 years. Climbers 20-39 years old accounted for the majority of the injuries (56 percent) while climbers 19 years and younger accounted for 30 percent. Climbers 40 years and older accounted for the remaining 14 percent. The study also found that women accounted for more than 28 percent of the injuries, a higher proportion than found in previous rock climbing studies.


Falls were the primary mechanism for injury with over three-quarters of the injuries occurring as the result of a fall. The severity of fall-related injuries correlated with the height of the fall. Patients who were injured after falling from a height over 20 feet were 10 times more likely to be hospitalized than patients who were injured falling from 20 feet or lower.


"We found that the climbers who fell from heights higher than 20 feet accounted for 70 percent of the patients there were hospitalized for a rock climbing-related injury," explained study author Lara McKenzie, PhD, principal investigator at the Center for Injury Research and Policy at Nationwide Children's Hospital and faculty member of The Ohio State University College of Medicine. "This trend, combined with the fact that rock climbers have a higher hospitalization rate than other sports and recreational injuries, demonstrates the need to increase injury prevention efforts for climbers."


Data for this study were collected from the National Electronic Injury Surveillance System (NEISS), which is operated by the U.S. Consumer Product Safety Commission. The NEISS dataset provides information on consumer product-related and sports and recreation-related injuries treated in hospital emergency departments across the country.


The Center for Injury Research and Policy (CIRP) in The Research Institute at Nationwide Children's Hospital works globally to reduce injury-related pediatric death and disabilities. With innovative research at its core, CIRP works to continually improve the scientific understanding of the epidemiology, biomechanics, prevention, acute treatment and rehabilitation of injuries. CIRP serves as a pioneer by translating cutting edge injury research into education, advocacy and advances in clinical care. In recognition of CIRP's valuable research, the Centers for Disease Control and Prevention (CDC) designated the Center for Injury Research and Policy as an Injury Control Research Center in 2008.


Source: Nationwide Children's Hospital

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Asterand Signs Partnership To Supply Drug Discovery Services To Japan

Asterand plc (LSE: ATD), the human
tissue research company, announced that it had entered into agreements with
Mitsui Corporation and Toyobo Co. Ltd., to offer drug discovery services to
the Japanese market. The agreement was signed during a visit to Detroit of
a high-level delegation from the two Japanese companies.


Asterand will supply Japanese drug discovery companies with biological
samples, data and research services covering a range of diseases, including
cancer, gastrointestinal, respiratory, metabolic disorders, inflammatory,
cardiovascular, as well as diseases of the Central Nervous System such as
Alzheimer's.


"The Japanese pharmaceutical market is a major developer of new drugs,"
says Randal Charlton, CEO of Asterand. "The use of human tissue in
preclinical research can shorten the drug development process. However,
Japanese drug research companies have limited access to high quality
samples and data and this creates an opportunity for Asterand. We can meet
the demand through our world bio-bank and our global network of hospitals
that provide ethically consented samples and data for approved research."


Mitsui is one of the largest corporations in the world and second
largest trading house in Japan. Toyobo is a market leader in Japan,
operating the largest contract manufacturing business for antibody drugs.
"They are powerful partners and we are honored to be working with them,"
says Charlton.


Under the agreement with the two companies, Asterand has been
guaranteed a minimum level of business. However, Charlton emphasizes that
Asterand and their partners are taking a long-term view of the Japanese
market where very high quality service is critical to success. "We expect
to grow revenues carefully and steadily over several years," he says.


"We will provide full scientific and technical support," adds Mike
Null, Asterand's Vice President of sales and marketing. This will include
scientific support from Asterand's research team, technical literature in
Japanese and a Japanese language web site, plus regular visits to support
the Toyobo sales team.


The agreement was signed in Detroit on July 5th, 2006 with a four-man
Japanese delegation consisting of Dr. Bunsei Kawakami, General Manager,
LifeScience Department, Mr. Hideyuki Komatsubara, Technical Manager,
LifeScience Department, Mr. Naoki Takahashi, Group Manager, Legal
Department of Toyobo Co. Ltd. and Mr. Kimihide Kondoh, Project Manager,
LifeScience Division of Mitsui Corporation.


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America May Learn From Quebec's Prescription Drug Plan

A new study published in The Milbank Quarterly finds a number of similarities between Canadian drug coverage and that of the United States, despite their publicized differences. Looking at Quebec's Prescription Drug Insurance Program and the United States' Medicare Prescription Drug, Improvement and Modernization Act (MMA), the study suggests that the older Canadian plan may provide valuable insights for American decision-makers.



The study examines the factors that led to the adoption of Quebec's drug policy in 1997 and of the MMA in 2003, finding that both programs were developed in response to popular discontent, pressure from the pharmaceutical industry, and the determination of the government of the day to leave its mark on history. Canadian and American policy-makers shared a goal of expanding prescription drug benefits to a greater part of the population while also controlling costs.



Led by Marie-Pascale Pomey of the University of Montreal, the study looks at some of the challenges that have faced the Quebec plan since its inception ten years ago, including the complexity of the regime, the heavy burden of users' contributions, and the lack of a comprehensive pharmaceutical policy. Some of these problems have already been experienced by the MMA, and others are predicted in its future. Canadian efforts to resolve these challenges, such as streamlining the various sources of financing of the program, adjusting terms of coverage to remove access barriers to the poor and developing innovative policies to regulate drug prices, may provide guidance to American policy-makers.



"With so much already achieved, cross-national policy learning may be one of the tools that will allow both programs to progress even further, so that Quebecers and Americans alike can enjoy the positive health benefits of prescription drug programs that balance the goals of equitable access, a healthy and innovative pharmaceutical industry, and cost containment," says Pomey.



###



This study is published in the September issue of The Milbank Quarterly.



Marie-Pascale Pomey, M.D., Ph.D., is an Assistant Professor in the Department of Health Administration at the University of Montreal. She can be reached for questions at umontreal.



The Milbank Quarterly publishes scholarly analysis of significant issues in population health and health policy. It presents original peer-reviewed primary research, research synthesis, policy analysis, and commentary. The Quarterly encourages contributors to explore in an international context the social, economic, and political determinants of health, the development of health policy and evidence of its effectiveness, and the methods and uses of evidence-based health research. For more information, please visit www.blackwell-synergy/loi/milq. The Milbank Quarterly has been published by the Milbank Memorial Fund since 1923. For more information, please visit milbank.



Source:

Sean Wagner

Blackwell Publishing Ltd.

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Containment Technologies Group, Inc. Introduces New Aseptic Hospital Isolator Technology

Containment Technologies Group,
Inc. announces a new advanced aseptic compounding isolator for
pharmacy-compounded sterile preparations. The Mobile Isolation
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About Containment Technologies Group, Inc.



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Cat Or Dog Might Be 'Purr-Fect' Holiday Gift For Seniors, Says Matrix Home Care Psychologist

When choosing a holiday gift for an older relative, consider a warm and fuzzy dog or a cat. A pet can provide companionship, open the door to neighborhood conversations and even improve a senior's physical health, according to Matrix Home Care psychologist Alexander Fiuza, PhD, as director of client services for Miami-Dade and Broward Counties.


"A dog or cat can be the 'purr-fect' gift for a senior," said Dr. Fiuza. "A pet offers a feeling of love and connection, which is very important to someone who is living alone or lacks companionship."


Taking care of a pet can also change an elderly person's lifestyle, opening the door to new daily activities, such as taking a dog for a walk or playing hide-and-seek with a cat. "Petting a cat or playing with a dog relaxes a human, as well as a pet," added Dr. Fiuza. "By helping to relieve those internal stresses, a pet can improve the quality of life for an elderly person."


Studies of nursing home residents found that seniors who were around pets smiled more often and were more alert than those who did not come into contact with animals. Holly Bedgio, RN, Matrix' director of clinical operations/risk management agrees with those findings. "I believe pets can be a real morale-booster to almost any senior," said Bedgio. "After I gave a small dog to her mother, who is living at home, I could see a real improvement in her attitude toward life."


Dr. Fiuza notes clinical research studies show that having a pet also can provide physical health benefits for the owner, such as lower blood pressure and reduced cholesterol levels. A three-year study of 5,741 people in Australia found that pet owners had lower blood pressure and triglyceride and cholesterol levels than did non-owners.


"A pet can be the ideal holiday gift," said Dr. Fiuza, "providing a loved one with companionship for many years."


Source

Matrix

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Clinician Led Management Can Fix The NHS, UK

Clinician led management can fix the NHS, argues a senior doctor in this week's BMJ. He calls on the government to let clinicians and managers plan and run their services free from political control.



Senior medical professionals are often branded as opponents of reform, writes David Flook, Consultant General Surgeon at the Royal Oldham Hospital. But most medical personnel support changes, they just oppose "the cynical, superficial reforms through which politicians have exploited the NHS."



For instance, he condemns the "fraudulent claims" by health ministers that initiatives such as the "two week wait rule" have contributed to the recent modest fall in cancer deaths, and argues that fast track referral prioritises the worried well at the expense of the target population.



And he questions how patients can make a meaningful "choice" of who treats them from the vast NHS array. Was not personal referral to consultants by a GP preferable to the current lottery?



Other examples of subtle misinformation abound, he writes. The reduction in accident and emergency waiting times achieved by one recent initiative is hailed as evidence of improved performance. But this overlooks the sometimes dangerous means by which this goal was achieved, such as the premature transfer of acutely ill patients to almost anywhere outside A&E.



For strategic planners, the evidence suggests that they recognise the problem but choose to cut corners in service provision and avoid any political upsets, he says. And the problem for NHS managers is that politicians have replaced doctors in priority setting. "Managers are now no more than foot soldiers implementing the latest vote-winning initiative and I have seen no evidence that management consultants do better at even greater costs," he writes.



Even good managers can only make the NHS safe and fair, if freed from political control and willing to prioritise in accordance with guidance from the staff who treat the patients, he concludes.


###


Contact: Emma Dickinson


BMJ-British Medical Journal

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Effectiveness Of Advance Directives Compromised By Legal Restrictions

Current legal restrictions significantly compromise the clinical effectiveness of advance directives, according to a study by researchers at the University of California, San Francisco.



Advance directives allow patients to designate health care decision-makers and specify health care preferences for future medical needs. However, "the legal requirements and restrictions necessary to execute a legally valid directive prohibit many individuals from effectively documenting their end-of-life wishes," said lead author Lesley S. Castillo, BA, a geriatrics research assistant in the UCSF Department of Medicine.



The authors suggest that advance directive law and advance care planning evolve from what they call a current "legal-transactional approach" into a "flexible, relationship-and communication-based model," in which any type of advance care planning tool or discussion, including advance directives, can help guide clinical care.



Currently, tension exists between advance directive law and what occurs in clinical practice, noted principal investigator Rebecca Sudore, MD, an assistant professor of medicine at UCSF. In the clinical setting, she said, "advance directives often are just one piece of information among many that are used as guidelines when determining a patient's wishes and health care preferences." Conversely, said Sudore, advance directive law "takes a much more rigid approach to advance care planning - one that is more akin to signing a will than having a conversation between physicians and family members."



Castillo and her co-authors list a number of legal barriers to the clinical effectiveness of advance directives, including requirements that certain legal terms be used, regardless of the patient's reading comprehension level or native language; restrictions on who may serve as a patient's health care agent or surrogate, such as anyone who works for a clinician including a case manager; and technical hurdles such as not allowing oral advance directives and requiring a witness's or notary signature for advance directives to be legally valid.



Other barriers include lack of reciprocity from state to state, lack of attention to religious, social and cultural preferences - for example, allowing family instead of an individual to serve as the surrogate, and encouraging documentation of specific death rituals.



"Vulnerable populations are most likely to be affected by these barriers," said Castillo. "These include patients with limited literacy levels and limited English proficiency, same-sex or domestic partners, and patients who are isolated and without friends."



To improve the clinical efficacy of advance directives, the researchers suggest doing away with mandatory legal language to improve readability; relaxing health care agent and surrogate limitations to expand the potential pool of medical decision-makers, including non-medical professionals who may be close to unbefriended adults; promoting universal acceptance of oral advance directives; and eliminating witness and notary requirements.



They also recommend that all states adopt nonrestrictive reciprocity laws for directives from other states, regardless of the location or type of advance care planning tool used, and urge that patients be allowed to document their religious, social, and cultural values and preferences for end-of-life care.


Notes:


The study, which surveys medical and legal literature from across the United States, appears in the January 18, 2010 issue of the Annals of Internal Medicine.



Co-authors include Brie A. Williams, MD, of UCSF; Sarah M. Hooper, JD, of UC Hastings College of Law; Charles P. Sabatino, JD, of the American Bar Association; and Lois A. Weithorn, PhD, JD, of UCHCL.



The research was supported by funds from a Pfizer Fellowship in Clear Health Communication, UC Hastings College of Law, and the Department of Veterans Affairs.



UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.



Source:

Elizabeth Fernandez

University of California - San Francisco

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Can Vitamins And Minerals Prevent Hearing Loss?

About 10 million
people in the United States alone -- from troops returning from war to
students with music blasting through headphones -- are suffering from
impairing noise-induced hearing loss.



The rising trend is something that researchers and physicians at the
University of Michigan Kresge Hearing Research Institute
(khri.med.umich.edu) are hoping to reverse, with a cocktail of
vitamins and the mineral magnesium that has shown promise as a possible way
to prevent hearing loss caused by loud noises. The nutrients were
successful in laboratory tests, and now researchers are testing whether
humans will benefit as well.



"The prevention of noise induced hearing loss is key," says Glenn E.
Green, M.D.
(www2.med.umich.edu/healthcenters/provider_profile.cfm?individual_id =112086), assistant professor of otolaryngology at the U-M Health System
and director of the U-M Children's Hearing Laboratory.



"When we can't prevent noise-induced hearing loss through screening
programs and use of hearing protection, then we really need to come up with
some way of protecting people who are still going to have noise exposure.
My hope is that this medication will give people a richer, fuller life."



The combination of vitamins A, C and E, plus magnesium, is given in
pill form to patients who are participating in the research. Developed at
the U-M Kresge Hearing Research Institute, the medication, called
AuraQuell, is designed to be taken before a person is exposed to loud
noises. In earlier testing at U-M on guinea pigs, the combination of the
four micronutrients blocked about 80 percent of the noise-induced hearing
impairment.



Now, AuraQuell is being tested in a set of four multinational human
clinical trials: military trials in Sweden and Spain, an industrial trial
in Spain, and a trial involving students at the University of Florida who
listen to music at high volumes on their iPods and other PDAs, funded by
the National Institutes of Health (NIH). This is the first NIH-funded
clinical trial involving the prevention of noise-induced hearing loss.



"If we can even see 50 percent of the effectiveness in humans that we
saw in our animal trials, we will have an effective treatment that will
very significantly reduce noise-induced hearing impairment in humans. That
would be a remarkable dream," says co-lead researcher Josef M. Miller,
Ph.D. (khri.med.umich.edu/faculty/miller.php ), the Lynn and
Ruth Townsend Professor of Communication Disorders and director of the
Center for Hearing Disorders at the U-M Department of Otolaryngology's
Kresge Hearing Research Institute. Miller is leading the research along
with colleagues at Karolinska Institute, where Miller also has an
appointment; the University of Florida; and the University Castille de La
Mancha.
















Until a decade ago, it was thought that noise damaged hearing by
intense mechanical vibrations that destroyed the delicate structures of the
inner ear. There was no intervention to protect the inner ear other than
reducing then intensity of sound reaching it, such as ear plugs, which are
not always effective. It was then discovered that noise caused intense
metabolic activity in the inner ear and the production of molecules that
damage the inner ear cells; and that allowed the discovery of an
intervention to prevent these effects.



The laboratory research that led to a new understanding of the
mechanisms underlying noise induce hearing loss was funded by the NIH; the
preclinical translational research that led to the formulation of AuraQuell
as an effective preventative was funded by General Motors and the United
Auto Workers.



Miller notes that the military tests in the new study could be of
particular importance because of the high number of soldiers who develop
hearing loss in the line of duty, due to improvised explosive devices
(IEDs) and other noises.



Last year, he says, the Department of Defense spent approximately $1.5
billion in compensation for hearing impairment, and Veterans Affairs
hospitals spent close to $1 billion for clinical care and treatment of
hearing impairment. The most recent figures in a report by the Institute of
Medicine (iom.edu/CMS/3795/20024/29957.aspx) indicated that
one-third of returning soldiers fighting in Afghanistan and Iraq cannot be
redeployed specifically because of hearing impairment.



"Not only is it an enormous factor in quality of life for the
individual affected, in cost to society for health care and compensation,"
Miller says, "but it fundamentally compromises the effectiveness of our
military at this time." Miller has launched a U-M startup company called
OtoMedicine (otomedicine), which holds the license to
developed the vitamin-and-magnesium pill for human application.



Hearing loss commonly occurs, Green says, when loud noises trigger the
formation of molecules inside the ear and these molecules cause damage to
the hair cells of the inner ear. The cells then shut down and scar, and
they cannot grow back.



The U-M researchers discovered that this new combination of vitamins,
when mixed with magnesium, can prevent noise-induced damage to the ears by
blocking some of these complex cellular reactions. Read more about the
science of hearing loss, free radicals in hearing loss, and the science
behind the effectiveness of these nutrients, in this press release
(med.umich.edu/opm/newspage/2007/hearingloss.htm).



Disclosure: If and when revenues are generated by the vitamin and
magnesium formulation developed at U-M, the University and the developers
could benefit financially.



For more information, visit these Web sites:



Results of the U-M laboratory studies on noise-induced hearing loss:
www2.med.umich.edu/prmc/media/newsroom/details.cfm?ID=611



The Kresge Hearing Research Institute at the University of Michigan:
khri.med.umich.edu/about.php



Ear, nose and throat services at the University of Michigan:
www2.med.umich.edu/healthcenters/dsp_cliniclist_oto.cfm



What is noise-induced hearing loss?
nidcd.nih/health/hearing/noise.asp


University of Michigan Health System

med.umich.edu

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American Medical Association Sends Letter To President Obama And Congress Outlining Critical Elements Of Health Reform

As part of continued health-reform efforts, AMA President J. James Rohack, M.D. sent a letter to President Obama and members of Congress urging action on reforms that will benefit all Americans.



"Our elected leaders need to approach the health-reform debate with a renewed focus on what matters most - health coverage for all Americans as well as providing stability and security for Americans that currently are insured, including Medicare patients," said Dr. Rohack.



In his letter, Dr. Rohack outlines seven critical elements the AMA has identified as necessary to improve access to affordable, quality care and reduce unnecessary costs in the current system:



- Health-insurance coverage for all Americans


- Insurance market reforms that expand choice of affordable coverage and eliminate denials for pre-existing conditions


- Assurance that health-care decisions will remain in the hands of patients and their physicians, not insurance companies or government officials


- Investments and incentives for quality improvement, prevention and wellness initiatives


- Repeal of the Medicare physician payment formula that would trigger steep cuts and threaten seniors' access to care


- Implementation of medical liability reforms to reduce the cost of defensive medicine


- Streamlining and standardizing of insurance claims processing requirements to eliminate unnecessary costs and administrative burdens



"We have already seen physicians, patients and policymakers find common ground on ideas that offer real improvements," said Dr. Rohack. "The stage is now set for meaningful reform and we must seize it."



To read Dr. Rohack's full letter, please visit here.


To learn more about the AMA's vision for health-system reform, please visit hsreform.


Source

American Medical Association

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Asthma - Oxyphone Better Than A Tight-fitting Mask For Toddlers At Delivering Aerosolized Albuterol

Most children do not like the mask. It increases their fear in an already frightening situation. Anxiety, medication effects and the precipitating respiratory problem all combine to increase tachypnea and tachycardia. Stridor and wheezing will both increase in anxious children.


Children, especially 2-6 year olds, have the physical strength to make giving a nebulized treatment almost impossible without brute force. They are not likely to submit to our logic or parental threats. This physical restraint and increased crying creates increased stress on the child and more parental anxiety.


Crying changes several parameters of respiratory activity. The first is to prolong the expiratory phase which forces aerosol out of the mask dead space. The second is a shortened inspiratory phase. These factors combine to decrease droplet depostion to 25% in a crying child compared to that of normal respiration.
( Berlinski ) (Amirav)


A recent study has shown that using a mask for blow-by is less effective than blow-by with a corrugated tube (Geller 1) Geller also states "...blowby with an extension tube (but not with a mask) is an acceptable alternative to a close-fitting mask, especially if it prevents fussiness of the child." (Geller 1)


Blow-by is the way the majority of nebulizer treatments are given to this age group. This requires a Health Care Provider (HCP) to maintain continuous presence during the treatment. The parent, or many times another HCP must hold the child. The nebulizer output must blow at the child's mouth and nose to increase the local concentration of the medication. If the child moves, the HCP delivering the treatment must follow with the nebulizer. The effective breathable concentration drops dramatically while the HCP "catches up" with the child.


The Oxyphone is held to the child's ear. The mouthpiece directs the nebulized medication to the nose and mouth area in a process I call "facial flooding". Since the Oxyphone moves when the child moves, there is no loss in concentration at the oro-nasal region. Even if the child moves constantly, the "facial flooding" continues as long as the Oxyphone is held to the child's ear.


Most children enjoy their treatment with the Oxyphone. Generally they do not have to be held, thereby freeing up a member of the treatment team. The cooperative child can hold the Oxyphone and the parent can easily monitor the flow of medication by watching the mouthpiece. Gentle redirection can be accomplished as needed by either the parent or monitoring HCP.


Studies have shown that a nebulizer may function at less than 50% when held at an angle of 45 degrees. The Oxyphone has a built-in angle of 45 degrees to the vertical plane allowing it to be held upright while holding it like a phone. The rotating connector allows the Oxyphone to be used with the child laying on his side.


A quiet child will have an optimal respiratory pattern to inhale aerosolized medication. The Oxyphone can provide a calming effect because of the music and familiar shape. Studies are pending to quantify this effect.


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Cancer Prevention Tips By Age

Men who maintain a healthy body throughout life are often better able to fight off diseases like cancer. That's why experts at The University of Texas MD Anderson Cancer Center have created a guide with cancer prevention tips to help men at every stage of life.


"Practicing the healthy behaviors in our guide is important for all men, regardless of age," said Therese Bevers, M.D., medical director of MD Anderson's Cancer Prevention Center. "So take note of all of these tips even the ones directed toward men older or younger than you."


Your 20s: Avoid Alcohol and HPV


Sex, Vaccines and HPV: Most sexually active men will get the human papillomavirus (HPV). This sexually transmitted disease increases a man's chances of developing penile, anal and head and neck cancers. Men in their 20s can protect their body from this disease by getting the HPV vaccine.


Too Much Booze, You Lose: Men are more likely to be binge drinkers than women. And, research shows that drinking even a small amount of alcohol increases cancer risks. Men can play it safe by having no more than two alcoholic drinks per day.


Your 30s: Gain Muscle, Lose Stress


Put Some Muscle into It: Most men begin to lose muscle mass after age 30. Strength training can prevent muscle loss, build bone density and help the body burn calories faster to keep men at a healthy weight. And, maintaining a healthy weight can help men avoid diseases like cancer.


Take Time to Unwind: Increased responsibilities at home and work can bring increased stress. And, chronic stress affects almost every system in a man's body and wreaks havoc on its functioning, making it harder to fight off diseases like cancer. Men can help curb stress by doing breathing exercises and other relaxation-type activities like massage or yoga.


Your 40s: Fight the Battle of the Bulge


Avoid Weight Gain: As men get older, their metabolism decreases. This is especially true for men after age 40. Making healthy food choices and staying active every day can help men jumpstart their metabolism and keep off unwanted pounds that could raise their risk of cancer.


Your 50s and older: Get Screened


Schedule a Doctor's Visit: Cancer is more likely to show up in men age 50 and older. That's why the majority of cancer screening exams begin at this age. Finding and treating cancer as early as possible is one of the best ways to beat this disease.


And, in the case of prostate cancer (the most common cancer in men), treating the disease at an early stage means men may be less likely to experience long-term side effects like impotence.


Get annual check-ups


"Whether you're in your 20s, 40s or 60s, yearly check-ups are a must," said Bevers. "With the help of your doctor, you can create a personalized health plan to help you stay healthy for many years to come."


Bevers recommends men download this Screening Exams by Age checklist and take it to their next doctor's visit.

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Federal Pain Management Policy Reform Supported By National Physician Organization

Representing the interests of pain patients in light of federal pain management policy reform, leading pain expert and former President of the American Academy of Pain Medicine (AAPM) briefed congress on the National Pain Care Policy Act of 2007.



"The crisis of under-treated pain extends well beyond an issue of comfort for those who suffer. It is now a social issue with major economic and political ramifications," said AAPM representative, Scott M. Fishman, MD, in his Congressional briefing. Fishman is a past president of AAPM and a professor of anesthesiology and chief of the division of pain medicine at the University of California, Davis.



The National Pain Care Policy Act of 2007, also referred to as the Capps-Rogers bill, is strongly supported by the AAPM. The bill calls for a Congressional finding for improved pain care research, education, access, and care are national health care priorities and appropriates funding.



The Congressional briefing, "National Pain Policy: Tackling Barriers to Proper Pain Management," will help Congress better understand the immediate need for federal pain policy reform.



Co-sponsored by Representatives Michael Rogers (R-MI) and Lois Capps (D-CA), the Capps-Rogers bill provides for a number of actions considered necessary to delivering appropriate pain care. The bill permanently establishes the Pain Consortium office at the National Institute of Health (NIH). The office will convene an annual conference and coordinate pain research, training, and related activities across all NIH programs and institutes. The bill also authorizes an Institute of Medicine conference on pain care; pain care education and training programs based on best practices; and an educational outreach and public awareness program on pain management.



AAPM members, along with members from the other three physician organizations that comprise the Pain Care Coalition -- the American Pain Society, the American Headache Society, and the American Society of Anesthesiologists -- have helped to garnered support for the bill. Pain Care Coalition members met with potential supporters and their staffs and urged them to join the bill as co-sponsors. To date, a formal consensus statement has been signed by more than 100 organizations.



Millions of Americans suffer from acute or chronic pain every year and the effects of pain exact a tremendous cost on our country in health care costs, rehabilitation, and lost worker productivity as well as the emotional and financial burden it places on patients and their families. The costs of unrelieved pain can result in longer hospital stays, increased rates of rehospitalization, increased outpatient visits, and decreased ability to function fully leading to lost income and insurance coverage. As such, patient's unrelieved chronic pain problems often result in an inability to work and maintain health insurance. Reduced productivity due to pain costs employers somewhere between $60 and $100 billion annually, yet NIH spends only 1% of its funding on research focused primarily on pain.



###



For more information on pain, visit AAPM's website at painmed/patient/facts.html



Founded in 1983 as the American Academy of Algology, the American Academy of Pain Medicine (AAPM) has evolved as the primary organization for physicians practicing the specialty of Pain Medicine in the United States. As the practice of Pain Medicine has grown, a defined body of knowledge and scope of practice have emerged, and today, Pain Medicine is recognized as a discrete specialty by the American Medical Association (AMA). AAPM is the only comprehensive pain organization with representation in the AMA House of Delegates. For more information, visit painmed/.



Source: Amy Jenkins


American Academy of Pain Medicine

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Blood Signatures To Diagnose Infection

Coughing and wheezing patients could someday benefit from quicker, more accurate diagnosis and treatment for respiratory infections such as flu, through a simple blood test, according to scientists.


Dr. Aimee Zaas, presenting her work at the Society for General Microbiology's autumn meeting in Nottingham describes how simply looking at an individuals blood 'signature' can be used to quickly diagnose and treat ill patients and could even predict the onset of a pandemic.


The team, from the Duke Institute for Genome Sciences & Policy and Duke University Medical Center in the US, looked at the blood of otherwise healthy individuals who had been exposed to rhinovirus, respiratory syncytial virus or influenza. The team found each viral infection timulated the body to produce a very specific set of immune molecules that could be detected in the blood. Recording the distinct blood signatures for each virus in a database and matching them against blood samples from other ill patients pinpointed the cause of disease with more than 95% accuracy.


Respiratory infections, including colds and flu are a common reason for seeking medical help. As Dr. Zaas highlighted, "Current methods for accurate diagnosis are time and labour intensive and are not always accurate. This means GPs are sometimes overcautious and may prescribe antibiotics unnecessarily, for viral infections. During a pandemic, this has real consequences as there is an increased risk of spreading infection."


Dr. Zaas explained how her test works completely differently to current diagnostic tests as it analyses each individual's immune response to infection, rather than the actual micro-organism responsible. "We effectively look at the imprint in the blood that the virus makes, which is as individual as a signature," she said. "Not only is this much more accurate than traditional testing, it also works much faster as it can be done through a simple blood test."


This work was sponsored by the US Defense Department Advanced Research Projects Agency and is part of a large team effort. If developed further, the findings could be used in emergency departments and primary care clinics to diagnose respiratory viral illness. "This could allow patients quicker access to antiviral drugs, but could also give an accurate warning of an upcoming pandemic," explained Dr. Zaas.


Sources: Society for General Microbiology, AlphaGalileo Foundation.

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