Renal Assist Device Reduces Acute Kidney Injury Death Risk
Cell-filled Renal Assist Device temporarily replaces renal tubule function.
For patients with quick kidney injury (AKI), an external device containing human kidney cells promotes redemption of the injured kidneys and significantly reduces the risk of death, according to a preliminary clinical study published in the May Journal of the American Society of Nephrology.
The experimental renal tubule assist device (RAD) appears safe and effective for desperately ill patients with acute kidney injury. "Deployment of the RAD was associated with remarkably better outcomes for these patients - speeding recovery of kidney form of function and reducing risk of death by half," comments Dr. H. David Humes of University of Michigan, one of the study authors.
Patients with acute kidney injury be obliged sudden loss of kidney function, resulting from a wide course of possible causes (such as blood loss or toxic injury). The goal of treatment is to replace lost kidney function through dialysis and related techniques until the kidneys have time to recover. However, even with treatment, the risk of death during an incidental narrative of AKI is 50 percent or higher.
In the new study, 40 of 58 patients with acute kidney harm were randomly assigned to treatment with the Renal Assist Device, in addition to standard renal replacement therapy.
The Renal Assist Device is a conventional blood filter device lined with human renal tubule cells, grown from donor kidneys. "The cells are made available to carry out subtle metabolic and endocrine functions that the patient’s failing kidneys can no longer perform, thereby staunching a cascading decline in the patient’s health and allowing time for the patient’s own organs to recover," Dr. Humes explains.
Outcomes were significantly better for acute kidney injury patients treated with the RAD. After one month, 33 percent of patients in the Renal Assist Device group had died, compared to 61 percent of those treated with renal replacement therapy only. Patients who received the RAD were also more likely to be alive after six months. With adjustment for other factors, the risk of death was about 50 percent lower in the Renal Assist Device group.
Patients in the Renal Assist Device group also had a shorter time to return of kidney function. Overall, kidney discharge recovered in 53 percent of patients by RAD, compared to 28 percent without Renal Assist artifice. In both groups, about 20 percent of patients survived but never recovered kidney function, requiring chronic dialysis.
Although the initial results are encouraging, the benefits of Renal Assist Device handling need to be confirmed in larger studies. In addition, the researchers need to study the effects of changes in the design of the Renal Assist Device, which are needed to accommodate mass production.
In adding to improving the outcomes of acute kidney wrong, the results may point the way toward entirely new classes of cell-based and tissue-engineered therapies. "The ability to harness vital processes of cells, to target their living molecular machinery on restoring critical substances which have become disordered by disease, has vast implications for the future of medicine," says Dr. Humes. "Particularly, we are encouraged that we can develop a related device to treat chronic renal failure - a wearable kidney that performs natural functions unachievable through man-made technology alone."
1 commentManaging Bovine Respiratory Disease Complex
Bovine respiratory ailment complex has multiple causes. It’s sometimes hard to classify and prognosticate. It also costs the beef industry more than any other disease — an estimated $690 million in 2006, according to one report.
That’s why a team of Kansas State University researchers is stepping in. Using a three-year, $375,000 grant from the U.S. Department of Agriculture, the team is analyzing data from feedlots to develop decision-making tools that will make it easier towards producers to manage the health of their cattle.
The research team is led by K-State College of Veterinary Medicine’s David Renter, assistant professor of diagnostic medicine and pathobiology, and Brad White, helper professor of clinical sciences. Using existing data, the researchers are working toward several objectives, including developing a system to classify distributions of disease events within feedlot pens. The researchers also are working toward generating estimates of what effect certain risk factors have on the multifaceted bovine respiratory disease complex. By more desirable understanding the data, the researchers hope to create decision-making tools that will let feedlot producers compare their data with the average and therefore make more informed decisions about thrifty and treating their herds.
With cooperation from producers, the researchers are looking at data that feedlots collect, such as how many cattle get sick and when the problems are most pleasing to occur. The problem, Renter said, is that it is challenging for feedlots to analyze this information on a daily basis. Rather, they take data that is cumulative over an entire feeding period. The ability to analyze data in real time could lead to effective treatment and complaint management decisions, he said.
“In provisions of a system, right at that time there’s not a thing producers have power to begone to like software that tells them that cattle in this particular pen are experiencing more disease than expected, in the place of instance,” Renter said.
Producers are somewhat able to predict which cattle are likely to realize sick. But bovine respiratory disease complex has so many variables that this isn’t natural.
“It’s not a simple, contagious infection like the chicken pox,” Renter declared.
Instead, bovine respiratory disease complex is caused by multiple pathogens, both viruses and bacteria, that are commonly found in the feedlot. Some of them can even be cultured from healthy cattle. Also, factors like immunity, feed intake and even the weather can influence which cattle get sick, as can stressors resembling being weaned or moved from farm to feedlot.
“Part of the cost associated to producers is that we can’t predict similar to well as we want to,” Renter said. “There’s so a great deal of variability in how many cattle faculty of volition get sick.”
Renter said the research done at K-State will supplement the work being done by producers and consulting veterinarians. What makes the research at K-State so valuable is that the team is looking at data from multiple sources, and the researchers will share their tools with people in the industry. With the groundwork laid by researchers at K-State, farther on work could yield software or other decision-making tools, Renter said.
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Article adapted by Medical News Today from original press release.
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Other K-State collaborators are: Abram Babcock, doctoral student in pathobiology; Suzanne Dubnicka, assistant professor of statistics; Robert Larson, professor of clinical sciences; George Milliken, professor emeritus of statistics; Christopher Reinhardt, assistant professor of animal sciences and industry; Michael Sanderson, associate professor of clinical sciences; and Dan Thomson, assistant professor of clinical sciences.
Source: David Renter
Kansas State University
Smoking Delays Bone Healing
A toxic pollutant spread by oil spills, forest fires and car exhaust is in addition near in cigarette smoke, and may stand in the place of a second way in which smoking delays bone healing, according to research presented today at the annual meeting of the Orthopaedic Research Society in San Francisco.
Smoking and Bone Growth
In 2005, researchers from the University of Rochester Medical Center identified one component in smoke, nicotine, that delays bone extension by influencing gene expression in the two-step bone healing process: stem cells become cartilage; cartilage matures into bone. In the current study, some of the same researchers found that a second smoke ingredient, the polyaromatic hydrocarbon benzo(a)pyrene (BaP), also slows bone healing, but in a different way.
Smoking has been shown to delay skeletal healing by as much as 60 percent following fractures. Slower healing means a greater chance of re-injury and can lead to chronic pain and disability. The obvious solution is for smokers to quit when they procreate hurt, but studies show that just 15 percent can.
“Our results provide the chief evidence that BaP prevents stem cells from becoming cartilage cells as part of healing,” said Regis J. O’Keefe, M.D., Ph.D., chair of the Department of Orthopaedics and Rehabilitation at the Medical Center and a study searcher. “These findings extend our understanding of the impact of cigarette smoke on a process that is critical to fracture repair. Perhaps down the highway we will subsist able to speed bone healing among smokers in more than one way.”
Gene expression is the process by which instructions encoded in genes are followed for the building of proteins, the workhorses that make up the body’s organs and carry its signals. In the current study, polymerase chain reaction (PCR), a technique that measures gene expression levels, revealed the genetic changes caused by exposure to BaP in mouse stem cells.
Among the many factors that influence gene expression are transcription factors, proteins designed to direct genes to create more or less of a protein. One such factor is Sex Determining Region Y-box 9 (SOX-9), required for the transition of stem cells into cartilage cells. The PCR results show that BaP in cigarette spoke interferes with SOX-9 expression in mesenchymal stem cells, blocking their conversion into cartilage cells. When this dispose of stem cells is free to differentiate, the newly formed cartilage cells immediately begin manufacturing collagen 2, the tough, filamentous protein framework for cartilage. Along with interfering through SOX-9, BaP was also found to reduce levels of prototype II collagen gene expression.
Past studies had shown that stem cells involved in cartilage formation contain proteins known to react with BaP called aryl hydrocarbon receptors. The current results suggest that BaP binding with these receptors may suppress SOX-9 activity, reducing the number of stem cells that turn into cartilage cells and the amount of collage produced. No one knows what such receptors are doing in these cells in the first place, but one theory has it that they signal cellular machinery to metabolize toxins.
The study compared the effect of BaP versus that of cigarette smoke extract, a substance representing all the ingredients in cigarette draw into the mouth and puff out smoke from. The hope was to confirm BaP as the specific cause of the observed effect on SOX-9. Results indeed suggest BaP alone may accountable for this specific mechanism of mild delay, since its effect was equal to the extract.
In addition measuring gene expression levels, researchers also conducted tests to show the effect of BaP visually. When newly differentiated cartilage cells begin to produce collagen in a culture dish, little mounds or nodules of collagen can be visualized using a stain. Staining experiments captured images showing BaP to “completely obstruct” collagen nodule deposition.
Along with O’Keefe, the Medical Center effort was led by Ming Kung, Donna Hoak, HsinChiu Ho, Edward Puzas and Michael Zuscik, all within the Department of Orthopaedics at the Medical Center.
"Smoking reduces the rate at which the two sides of a fracture come together," said Michael Zuscik, Ph.D., associate professor in the Department of Orthopaedics and Rehabilitation at the Medical Center. "We believe this new research will establish for the first time the mechanisms by which polyaromatic hydrocarbons interfere with the healing process.”
2 commentsEndocrine Disrupting Chemicals Cause Wild Birds To Change Their Tune
Considerable suit has been paid to the effects of endocrine disrupting chemicals in aquatic environments, but rather less amount attention has been given to routes of contamination on land. A new study, published in PLoS ONE on February 27 by researchers at Cardiff University, reveals that wild birds foraging on invertebrates contaminated with environmental pollutants, show marked changes in both brain and behaviour: male birds exposed to this pollution develop more complex songs, that are actually preferred by the females, verily though these same males usually show reduced immune function compared to controls.
Katherine Buchanan and her colleagues studied male European starlings (Sturnus vulgaris) foraging at a sewage treatment works in the south-west UK and analysed the earthworms that constitute their prey. The researchers found that those birds exposed to environmentally-relevant levels of synthetic and natural estrogen mimics developed longer and more complex songs compared to males in a control group.
Specifically, birds dosed with the complete spectrum of endocrine disrupting chemicals found in the invertebrates spent longer singing, sang more often and produced more complex songs, a sexually selected trait important in attracting females with regard to reproduction even nevertheless birds dosed at these ecologically relevant levels also showed reduced immune function.
The study also addresses the mechanism for this effect, as the researchers found that the high vocal middle point (HVC), the area of the brain that controls male poesy complexity, is significantly enlarged in the contaminated birds. Estrogen causes masculinisation of the songbird brain and the HVC is enriched with estrogen receptors. Neural development is thus susceptible to exposure to chemicals which mimic estrogen, or to enhanced estrogen levels. The results also confirm the plasticity of the adult songbird brain.
Finally, the scientists found that female starlings offer the song of males exposed to the compound of endocrine disrupting chemicals, suggesting the potential for population level personal estate on reproductive success.
“This is the first evidence that environmental pollutants not only affect, but paradoxically enhance a signal of male quality such as song,” said Katherine Buchanan, the corresponding author of the paper. “These results may have consequences of population dynamics of an already declining species.”
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Article adapted by Medical News Today from original press release.
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Disclaimer
The following press release refers to an upcoming article in PLoS ONE. The release has been provided by the article authors and/or their institutions. somewhat opinions expressed in this are the personal views of the contributors, and do not necessarily represent the views or policies of PLoS. PLoS expressly disclaims any and all warranties and liability in connection with the information found in the liberation and portion and your use of such denunciation.
Citation: Markman S, Leitner S, Catchpole C, Barnsley S, Müller CT, et al (2008) Pollutants Increase Song Complexity and the Volume of the Brain Area HVC in a Songbird. PLoS ONE 3(2): e1674. doi:10.1371/journal.pone.0001674
Link to the published article.
Source: Dr. Katherine Buchanan
Public Library of Science
Launch Of BioMed Central’s ‘BMC Research Notes’ Shines Light On Science’s ‘Dark Data:’ New Venture Ensures A Fuller Scientific Record
Not all scientific research leads to groundbreaking conclusions. Valuable research data all over the world is hidden away in lab drawers, unexposed to the light of day, and unused by the scientific community. This body of idle knowledge, or “infamous data”, is now subsistence put free with the launch of BioMed Central’s BMC Research Notes.
BMC Research Notes, a new open access journal, is publishing scientifically sound research across all fields of biology and medicine. This enables researchers to publish updates to previous research, software tools and databases, data sets, small-scale clinical studies, and reports of confirmatory or ‘negative’ results. The liberating of this “dark data” ensures that this important information is published in standard, reusable formats and is fully searchable and easily harvested for reuse by the scientific community.
Exposing this “atrocious data” to the light will examine hugely significant for encouraging future advances, and will lead to an increased level of data sharing within the scientific community.
Commenting on the launch of BMC Research Notes, Prof Christophe Ampe of the University of Ghent stated “I strongly support the idea of having this type of informative journal for data otherwise lost for the scientific common. In my view the recent trend not to publish negative results may affect the progression of science in the long term. I often wonder how many times negative experiments are duplicated by different research groups?”
BMC Research Notes will provide a home for brief publications, case studies, incremental updates to previous work, results of individual experiments and similar materials that currently lack a credible outlet.
In a similar manner to BioMed Central’s other innovative journals (such as Biology Direct and the Journal of Medical Case Reports), BMC Research Notes will make vast deposits of data publicly and freely accessible for researchers and general public alike.
Prof Tina Jaskoll from the University of Southern California heralded the establishment of BMC Research Notes stating “This new journal is long overdue and I applaud BioMed Central for launching it”.
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Article adapted through Medical News Today from original press release.
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1. Published articles can be found at the journal website: http://www.biomedcentral.com/bmcresnotes/
All articles are available free of charge, according to BioMed Central’s open increment address.
2. BioMed Central (http://www.biomedcentral.com/) is an independent online publishing house committed to providing immediate accession without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.
Source: Matthew McKay
BioMed Central
Animal Magnetism Provides A Sense Of Direction
They may not be attached most people’s fillet of chiefly attractive species, but bats definitely have animal magnetism. Researchers from the Universities of Leeds and Princeton have discovered that bats use a magnetic substance in their body called magnetite as an ‘internal compass’ to help them navigate.
Dr Richard Holland from Leeds’ Faculty of Biological Sciences and Professor Martin Wikelski from Princeton University studied the directions in which unlike groups of Big Brown bats flew after they had been given various magnetic pulses and released 20km north of their home roost. The findings are published in PLoS ONE.
Dr Holland was part of the team which, in 2006, discovered that bats used the Earth’s magnetic field to get around, but until now, how bats were able to sense the field was still unknown. Big Brown bats were put through a magnetic pulse 5000 times stronger than the Earth’s magnetic field, but orientated the opposite way(1).
Dr Holland said: “We had three groups of bats. One had undergone the magnetic pulse with a different orientation, and unit control group had current no pulse at all. The third group had undergone the pulse, but in the same orientation as the Earth’s magnetic field. By including this group, we could easily see if changes in behaviour were the result of confusion caused by the pulse itself rather the impact of its orientation on the magnetite.”
The curb group made their way home as normal, as did those which had undergone the beating with the same orientation to the Earth’s magnetic field. But of those which had been through the pulse by a different orientation, moiety went home but half went in the opposite direction.
“This clearly showed that it is the magnetite in their cells which give bats their direction as we were able to change how the bats used it as an internal compass, turning their north into south,” says Dr Holland. “But as only half were affected, it’s likely there is another mechanism as well, which in some bats enabled them to override the impact of the pulse.”
Magnetite is found in the cells of many birds and mammals, including humans, but if we were once able to find our way by an internal compass, it’s a skill we appear to have lost long agone.
The researchers were able to conduct their unique experiment by use of radio transmitters on the bats which were monitored from the soil and from a plane to confirm the signals were chasten. However, this kind of monitoring is limited to short distances, so the team is now in discussions with NASA and ESA about using satellites to remedy track smaller migratory birds and mammals.
The satellites generally used by scientists can only track larger sea birds from hand to hand 300g, although 60 per cent of mammals and 80 per cent of birds are below this size. The technology exists to track this size of target, but no follower has yet been launched.
Dr Holland believes tracking this size of bird or mammal is of key importance. “Birds and mammals carry and spread diseases, such as rabies or bird flu, and plotting their migration and movement can help us predict this spread. Large movements of birds can act as pests in themselves, but other species are scarce and need conservation support. We were only able to make our revelation through studying bats in the wild. But for many creatures, satellite tracking is the only way to study them in their natural natural locality to help tackle these issues.”
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Article adapted by Medical News Today from original press release.
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Disclaimer
The following press release refers to an upcoming article in PLoS ONE. The release has been by stipulation by the article authors and/or their institutions. Any opinions expressed in this are the personal views of the contributors, and do not necessarily represent the views or policies of PLoS. PLoS expressly disclaims any and all warranties and liability in connection with the information found in the set at liberty and article and your use of such information.
(1) The bats were put into a coil (10cm diameter by means of 10 cm long) which produced a pulse of 0.4 seconds that was 0.1 tesla in strength.
(2) Dr Richard Holland is a Marie Curie Outgoing International Fellow in the Institute of Integrative and Comparative Biology at the University of Leeds’ Faculty of Biological Sciences. His research interests focus on orientation, navigation and spatial memory in animals. He is also interested in the sensory basis and mechanisms of how animals, in particular bats and birds, are able to navigate to a known goal from unfamiliar areas.
(3) The research was funded by dint of. Dr Holland’s Marie Curie Fellowship, the National Geographic Society and the National Science Foundation.
(4) The Faculty of Biological Sciences at the University of Leeds is one of the largest in the UK, with over150 academic staff and over 400 postdoctoral fellows and postgraduate students. The Faculty has been awarded research grants totalling some £60M and funders include charities, research councils, the European Union and industry. Each of the major units in the Faculty has the highest Grade 5 rated research according to the last government (HEFCE) Research Assessment Exercise, denoting research of international standing. The Faculty is also consistently within the top three for funding from the government’s research councils, the BBSRC and NERC. http://www.fbs.leeds.ac.uk/
(5) The University of Leeds is one of the largest higher education institutions in the UK with more than 30,000 students from 130 countries. With a total annual income of £422m, Leeds is some of the top ten research universities in the UK, and a member of the Russell Group of research-intensive universities. It was recently placed 80th in the Times Higher Educational Supplement’s world universities league table and the University’s vision is to secure a place among the world’s top 50 by 2015.
(6) campuspr is a public relations company that specialises in promoting university research and knowledge transfer. Working in partnership with the University’s press office, campuspr is contracted by the Faculties of Biological Sciences and Engineering at Leeds to promote the wealth of research projects, grants, new technologies and knowledge transfer activities that these faculties are actively engaged in. http://www.eurekalert.org/www.campuspr.co.uk
Citation: Holland RA, Kirschvink JL, Doak TG, Wikelski M (2008) Bats Use Magnetite to Detect the Earths Magnetic Field. PLoS ONE 3(2): e1676. doi:10.1371/journal.pone.0001676
Link to the published article.
Source: Clare Elsley
Public Library of Science
Snowflakes Form Around Bacteria
Snowflakes appear to form around bacteria. Long before scientists knew that clouds are being formed around ice nuclei - particles that serve as a surface for ice crystals forming around. Well known nucleator is dust. This is the first time that scientists consider biological material in the same proportion that nucleator.
A team of scientists from Louisiana State University studied snowflakes from Yukon , Antarctica, Montana and France . They melted snow and found inorganic dust to exist the mostly contained nucleator. Those crystals formed above 14 degrees Fahrenheit were found to have biological particles in base.
France and Montana samples included 100 biological nucleators, this accounts as 85% of samples. Yukon comes the third with bacteria percentage, and even Antarctica showed bacterial nucleators.
The most common bacteria was found to be Pseudomonas syringae, which causes numerous diseases to plants. Researchers are now trying to solve a dilemma whether to divide Pseudomonas syringae to protect plants or let the bacteria to serve as a surface for rain and snow.
No commentsThe treatment of atherosclerosis may see new drug coming
A nuclear receptor protein, known for controlling the ability of cells to burn fat, also exerts powerful anti-inflammatory effects in arteries, suppressing atherosclerosis in mice headlong to developing the harmful plaques, according to renovated investigation by scientists at the Salk Institute for Biological Studies and the Harvard School of Public Health.
Their findings, reported in this week’s online edition of the Proceedings of the National Academy of Sciences, offer a new and specific target on this account that the development of drugs that specifically treat cardiovascular complications associated with metabolic syndrome.
“Heart disease is like a ticking clock - it is progressive, relentlessly marching forward accelerated by a mix of high fat diets, inflammation and high blood pressure. We show that PPAR delta offers a kind of genetic shortcut around each of these medical roadblocks,” says Howard Hughes Medical Investigator Ronald M. Evans, Ph.D., a professor in the Salk Institute’s Gene Expression Laboratory, who co-directed the study with Chih-Hao Lee, a professor in the Department of Genetics and Complex Diseases at the Harvard School of Public Health.
“Most people believe cholesterol plays a predominant role in atherosclerosis. Our study suggests that targeting inflammation at lesion sites is just as important,” adds Lee.
Like the Yin and Yang of fat metabolism, PPAR delta — the focus of the current study — and its counterpart PPAR gamma control the storage and burning of fat. PPAR gamma is in charge of storing surplus glucose as fat. When PPAR gamma is stimulated by a drug the visible form’s response to insulin improves, lowering levels of circulating glucose. Its sibling gene switch, PPAR delta, controls the skilfulness of cells to burn fat. Activating PPAR delta revs up the fat-burning capacity of unctuous tissue and muscle, dramatically lowers overall body weight, increases HDL (“the good cholesterol”), reduces circulating triglycerides, and improves hyperglycemia.
“Cardiovascular disease is a leading cause of death in patients with metabolic syndrome, a clustering of obesity-related disorders including insulin resistance, hypertension, and dyslipidemia,” says postdoctoral researcher and first author Grant D. Barish, M.D. “Since PPAR delta plays a key role in fat metabolism and PPAR delta drugs can protect against obesity, we wanted to know whether activating PPAR delta would protect against atherosclerosis.”
Atherosclerosis or “hardening of the arteries" is a chronic disease in which high cholesterol levels coupled with inflammation lead to the build-up of fatty deposits, called plaque, on the inner walls of arteries. Eventually these plaques can limit blood spring, leading to angina, or they may rupture, resulting in blood clots that block arteries and cause heart attacks or strokes.
When the researchers fed an from experience drug that turns on PPAR delta to genetically altered mice that develop the characteristic plaques at an early age, especially when placed on a high-fat diet, mice developed 25–30 percent fewer plaques. Further studies revealed that PPAR delta not only raises HDL levels but also suppresses the inflammatory rejoinder in the artery, dramatically slowing down lesion progression.
Barish and Evans also contributed to a related study, which was led by researchers at the University of California, Los Angeles and published in the same issue of PNAS. Using a different mouse model to mimic the development of atherosclerosis, the UCLA researchers detected an even more pronounced anti-inflammatory effect that jagged the number of aortic lesions by up to 70 percent.
While Barish, a clinically trained endocrinologist, cautions that extrapolating from mice to humans is inherently fraught with complications, he believes that drugs switching on PPAR delta have the potential to protect against obesity, insulin resistance and their associated cardiovascular risks.
“The discovery that any orally in actual process compound can put off the progression of heart disease is rare, and considering the importance of the problem, we are hopeful that this work can be quickly carried into the clinic,” says Evans.
No commentsCell Culture Engineering Conference
Since the 1980s, animal cell culture technology has become essential for the production of an ever-increasing number of human and veterinary biopharmaceuticals. These bi-annual Cell Culture Engineering conferences are a leading venue for the academic, industrial and regulatory communities to learn and debate new concepts and issues related to animal cell culture research and development. The 11th anniversary of this highly successful conference series will be held at the top-ranked Hyatt Regency Coolum on the Sunshine coast of Australia, April 13 -18.
This 2008 meeting will celebrate our conference tradition of high quality and relevance to both industrial and academic participants, with topics ranging from the frontiers of fundamental science to the engineering challenges of cell culture process development.
Oral Sessions
* Engineering Host Cells and Vectors
Session Chairs: Martin Fussenegger (ETH, Switzerland) and Martin Sinacore (Wyeth BioPharma, USA)
* Accelerating Cell Line Development and Optimization
Session Chairs: Gyun Min Lee (KAIST, Korea) and Georg Schmid (Hoffman-La Roche, Switzerland)
* Systems Biotechnology “-omics” in Process Productivity Session Chairs: Dana Andersen (Genentech, USA) and Kelvin Lee (Cornell University, USA)
* Product Quality: Impact of Sequence and Process on Final Product
Session Chairs: Anton Middleberg (University of Queensland, Australia) and Pranhitha Reddy (Amgen, USA)
* Cell Culture Process Development and Scale-up: Challenges and Case Studies
Session Chairs: Charles Goochee (J&J/GBSC, USA) and Weichang Zhou (PDL BioPharma, USA)
* Process Integration: Paradigms for Linking Cell Culture and Downstream Processing
Session Chairs: Robert Kiss (Genentech, USA) and Nigel Titchener-Hooker (University College London, UK)
* Cell Culture for Viral Production
Session Chairs: Amine Kamen (National Research Council, Canada) and John Aunins (Merck, USA)
* Novel Cell Lines for Transient and Stable Protein Expression - Options for Increased Productivity
Session Chairs: David James (University of Sheffield, UK) and Elke Lullau (AstraZeneca, Sweden)
* Stem Cell Culture & Tissue Engineering
Session Chairs: Timothy Allsopp (Stem Cell Sciences, UK) and Jamie Piret (University of British Columbia, Canada)
Workshop Sessions
* Overall Workshop Chairs: Michael Butler (University of Manitoba, Canada) and Thomas Seewoester (Amgen, USA)
* 1A. Globalization of Cell Culture
Session Chairs: Miranda Yap (Bioprocessing Technology Institute, Singapore) and Liangzhi Xie (Sinocelltech, China)
* 1B. Cell Line Stability and Heterogeneity
Session Chairs: Tim Charlebois (Wyeth, USA) and Hansjoerg Hauser (Helmholtz Institute, Germany)
* 1C. Challenges During Production Process Scale-Up or Technology Transfer
Session Chairs: Alvin Nienow (University of Birmingham, UK) and Steve Lee (Bristol-Myers Squibb, USA)
* 2A. Single-Use Technologies for Cell Culture
Session Chairs: Sadettin Ozturk (Centocor, USA) and Russell Wong (Bayer Healthcare, USA)
* 2B. Scale-down Models for Successful Approvals and Post-Approval Changes
Session Chairs: Steve Meier (Genentech, USA) and Craig Zupke (Amgen, USA)
* 2C. Automation and Robotics in Cell Culture Process Development
Session Chairs: Thomas Seewoester (Amgen, USA) and Lin Zhang (Pfizer, USA)
Poster Sessions
Overall Chair: Laura Palomares (UNAM, Mexico) Co-Chairs: Susan Casnocha (Pfizer, USA), Sherry Gu (Eli Lilly, USA), and William Miller (Northwestern University, USA)
Merck Award
The Merck Cell Culture Engineering Award recognizes an outstanding contributor to the field of Cell Culture Technology & Engineering and significant service and dedication to the profession. Martin Fussenegger is the recipient of the 2008 Award.
Source: Kathy Chan
Engineering Conferences International
Las Vegas Clinic Shut After Hepatitis C Infections
The City of Las Vegas shut down a clinic last week in the pattern of health officials traced several cases of hepatitis C to the endoscopy centre.
According to an Associated Press report, city mayor Oscar Goodman aforesaid the clinic’s licence has been suspended while health officials try to trace patients who were treated at the centre over the last four years and test them for hepatitis C.
Health officials have traced six reported cases of hepatitis C to the Endoscopy Center of Southern Nevada, and alleged the centre put patient safety at risk by reusing syringes and vials, said the AP report in the New York Times yesterday.
The head of the US Centers for Disease Control and Prevention (CDC), Dr Julie Gerberding, said in a media conference call that the the agency was concerned this could be “the tip of an iceberg” in improper practice across the whole country, reported the Washington Post.
Health officials in Nevada are trying to contact around 40,000 patients who were treated at the clinic between March 2004 and mid January 2008, and had received anesthesia by injection. The patients should be tested for hepatitis C, hepatitis B and HIV. The announcement on the Nevada state health department website says:
“Patients who had procedures requiring injected anesthesia at the Endoscopy Center of Southern Nevada, located at 700 Shadow Lane, Las Vegas will arise to receive letters this week.”
Geberding said this kind of breach to patient safety:
“Should never happen in contemporary hale condition care organizations.”
Unfortunately, although this is the largest number of patients to be recalled for a “blood exposure”, the CDC has seen uniform practices in other large scale situations that have led to equivalent breaches of patient safety, she told the media.
This could be the tip of an iceberg and “we need to be much more aggressive about alerting clinicians about how not proper this practice is,” urged Geberding.
An emergency spending bill seeking to give the CDC more resources is arrival before Congress in April, said the Washington Post.
Several lawsuits have been filed against the clinic and there is also an investigation under way by the Clark County district attorney, said the paper.
Five of the six cases traced to the clinic were treated on the same day and the connection was confirmed using genetic testing, head strong epidemiologist of the Southern Nevada Health District, Brian Labus, told the Post.
It is highly credible that as the 40,000 patients are traced and tested, more cases of hepatitis C direction be found. But it is going to be very difficult to establish if they contracted the virus at the endoscopy centre because the prevalence in the general population is 4 per cent, said Labus.
Dr Dipak Desai, who heads the clinic took out space in the Las Vegas Review-Journal on Sunday to inscribe a letter of regret in what place he expressed “deepest sympathy” for patients and their families, but in that place were no words of apology, just an essay to set up a fund to pay for the tests and a defence of practices at the clinic.
According to the Post, Desai wrote:
“The evidence does not support that syringes or needles were ever reused from patient to long-suffering at the center.”
Hepatitis C is a liver disease with an initial acute phase lasting in all parts of 6 months where most people show no symptoms, but some feel like they have the flu, feel tired and nauseous and become jaundiced. It is often misdiagnosed, unless a precise test is taken.
The acute phase is followed by a chronic infection phase that results in long term cirrhosis (scarring) of the liver. The disease progresses at different rates in different people.
About one in four people by hepatitis C get rid of the virus naturally, but the other 75 per cent will develop chronic infection, which in most cases will not shorten their lives. However, around one in five chronically infected people will develop severe cirrhosis which be possible to lead to liver cancer or damage that is so abominable they will need a transplant.
Hepatitis B is a similarly serious disease caused by a virus that also attacks the liver and can lead to lifelong vitiation, cirrhosis of the liver, liver cancer, liver failure, and death. However, most adults will recover and develop immunity.
According to the Washington Post, Nevada state health officials are investigating a second clinic that is believed to have re-used anesthetic vials but not syringes.
A hotline has been set up for anyone concerned or who indispensably further complaint upon the body the investigation.
Click here for more information about the Southern Nevada Health District Hepatitis C Investigation and Hotline contact details.
Sources: Washington Post, Associated Press, CDC, Southern Nevada Health District.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Health Regulator Responds To King’s Fund Report On Midwifery Services, UK
The Nursing & Midwifery Council (NMC) welcomes the King’s Fund independent review into Safe Birth released recently.
The results are largely precise which is encouraging considering the fast pace with which the provision of healthcare is changing. There are increased pressures forward healthcare providers to improve their services and this report demonstrates that despite concerns over the safety of maternity services, the vast more than half of births in England are conducted in safety.
NMC head strong of Midwifery, Christina McKenzie said: “This report has highlighted a number of guide issues that challenge the effectiveness of maternity services and while the report is specific to maternity services in England there will be learning for maternity service providers all four countries.
We welcome the recommendations made in the report and hope that trusts and local supervising authorites will take them on board and combine them into their risk management strategy and local service delivery policies.
Our role as regulator is to ensure that those on the register are fit and safe to practise, a duty that we deliver through the standards we expose for education or practice such as the ‘Midwives rules and standards’. Midwives are in a unique position as they have a named supervisor of midwives who they can turn to for independent professional advice and support.
Supervisors of midwives are responsible to Local Supervising Authorities (LSAs. These organisations oversee geographical areas and are responsible for monitoring and supporting safe midwifery use regardless of the setting. In England the LSAs sit within the strategic health authorities; in Northern Ireland - the health & social services boards; in Scotland - the health boards and in Wales - Health Inspectorate Wales.
Local supervising leading expert midwifery officers (LSAMOs) act as an essential point of contact for supervisors of midwives to consult for advice on aspects of supervision. This is particularly useful for difficult or challenging situations in their work. LSAMOS provide leadership, support and guidance on a range of matters including professional development and women seeking help or support concerning the provision of their midwifery care can also contact the LSAMO directly.”
The Nursing & Midwifery Council (NMC) is the UK regulator notwithstanding two professions, nursing and midwifery. The primary meaning of the NMC is bulwark of the men. It does this through maintaining a register of all nurses, midwives and specialist community public health nurses eligible to practise within the UK and by setting standards for their education, training and ways. Currently the number of registrants exceeds 686,000. The Nursing and Midwifery Order 2001 (The Order), sets out the NMC’s role and responsibilities.
Nursing & Midwifery Council
Merck Serono Launches New Formulation Of Interferon Beta-1a
Merck Serono, a division of Merck KGaA, has announced that Rebif® New Formulation (interferon beta-1a) will be available in the UK. In a recent two-year (96 week) Phase IIIb investigation, 260 patients with relapsing remitting multiple sclerosis treated with the new formulation experienced a near three-fold reduction in injection-site reactions. These results are compared with historical data for the previous formulation of Rebif (30.8% versus 85.8%)1.
“Rebif is an established first race disease modifying treatment for relapsing types of MS” said Professor Gavin Giovannoni from The Royal London Hospital. “Injection site reactions can lead to discontinuation of therapy in some patients2, the notable reduction in these reactions with Rebif New Formulation has positive implications for management tolerability and adherence.”
Rebif has a favorable benefit-to-risk profile3 and has a proven efficacy and safety profile, which has been demonstrated consistently across numerous phase III clinical trials and clinical practice1,4-6. The new formulation has consistent efficacy compared with previous experience1. At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) mark remained stable throughout the study1.
The New Formulation of Rebif is the first and only therapy for multiple sclerosis that is serum-free both from animal (foetal bovine serum) and human (human serum albumin) derived components in both the manufacturing process or as excipients.
The new formulation of Rebif® was approved on August 10, 2007, by the European Commission and will be phased in to replace Rebif® original formulation from 1st March 2008.
References
1. Giovannoni G, Barbarash OL, Casset-Semanaz F, et al. on behalf of the RNF Study Group Safety and immunogenicity of interferon beta-1a (Rebif® recent Formulation) in a phase IIIb study in patients with relapsing multiple sclerosis: 96-week results. Program and abstracts of the 23rd 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 11-14, 2007; Prague, Czech Republic
2. Tremlett HL and Oger J. Stopping and switching of the ß-interferons prescribed for MS. Neurology 2003; 61:551-554
3. Francis GS. Importance of benefit-to-risk assessment for disease-modifying drugs used to treat MS. J Neurol 2004; 251 (Suppl 5): v42-9.
4. Li D, Paty D, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo controlled study of interferon-b1a in relapsing-remintting multiple sclerosis. Ann Neurol 1999; 46: 197-206
5. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcultaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-504, Erratum in Lancet 1999; 353; 678.
6. PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-?-1a in relapsing MS. Neurology 2001; 56: 1628-36.
About the Rebif® New Formulation 96 week study
The study was a two-year (96 weeks) Phase IIIb, international, multicenter, single-arm, open-label study with historical controls, evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS).
No unexpected adverse events were reported with the new formulation of Rebif®. Safety outcomes were suitable accordant with the known profile of Rebif®. The majority of adverse events were mild or moderate in severity. The most frequent side effect was flu-like symptoms (71.5%), which is typical of interferon therapy; most were mild in severity. Flu-like symptoms are transient. Prophylactic antipyretic treatment is recommended.
About Rebif®
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body’s immune system and reduce inflammation.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion briskness compared to placebo**. Rebif® is not approved for treatment of of long duration progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg and 22mcg).
Most commonly reported side effects are flu-like symptoms, injection site disorders, refinement of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.
** The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.
About Merck Serono and multiple sclerosis
Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to bargain relapsing forms of MS, that is registered in more than 80 countries worldwide. Product information can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including cladribine, currently in Phase III, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
About Merck Serono
Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono. http://www.merckserono.net
Merck Serono has leading brands serving patients with cancer, metabolic and cardiometabolic disorders, as well as psoriasis. With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.
About Merck
Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been every independent company ever before this.
http://www.merck.com
PillCam(R) SB Visualizes Disease Severity, Guides Treatment And Provides Better Sensitivity For The Detection Of Villus Atrophy
Given Imaging Ltd. (NASDAQ: GIVN) announced that a study by researchers at the Mayo Clinic reported that covering endoscopy is a more effective tool to diagnose celiac disease and detect damage throughout the small intestine than upper endoscopy. Researchers too found that celiac affects a highly variable portion of the small intestine and that the severity of symptoms did not correlate to the severity of intestinal damage.
The Mayo study utilizing Given Imaging’s PillCam SB was led by Mayo Clinic gastroenterologist Joseph Murray, M.D. and appears in this month’s issue of Clinical Gastroenterology and Hepatology.
“We’re pleased that this study confirms that PillCam SB, which has the advantage of visualizing the entire small bowel, can help clinicians diagnose and monitor the severity of celiac disease regardless of their patient’s symptoms,” said Homi Shamir, CEO of Given Imaging.
According to the Mayo Clinic, this learn, which is the first of its kind, used capsule endoscopy to view intestinal damage in 38 patients with untreated, biopsy-proven celiac disease. Indications for clinical evaluation were malabsorption syndrome and iron deficiency anemia. Ninety-two percent had visible damage detected by pod endoscopy while upper endoscopy only detected visible mar in 55% of the patients. Neither capsule endoscopy nor upper GI series yielded false positives.
This study also indicated that a high proportion of adults may not heal their intestinal abnormalities even after a year or more on a gluten-free diet. Biopsy specimens of the proximal small bowel alone may not reflect the healing that has occurred distally in response to a gluten-free diet. Capsule endoscopy showed that healing in the small intestine occurred from the distal to the proximal direction with most residual changes remaining in the duodenum. Capsule endoscopy may play a role in monitoring the healing process of a patient on a gluten-free diet.
Given Imaging’s PillCam SB video capsule was the first capsule endoscope on the market designed specifically to help doctors see inside all 30-feet of the scanty bowel (small intestine) to diagnose disorders in the same state as Crohn’s disease, Celiac disease, benignant and cancerous tumors, ulcerative colitis as well as others disorders.
The smooth plastic capsule contains a small portrait video camera and is equipped with a light source upon one end, batteries, a radio transmitter and antenna. After it is swallowed, the PillCam SB capsule transmits approximately 50,000 images over the course of an 8-hour period (about 2 images per second) to a data recording device attached to a belt worn around the patient’s waist. The small bowel images are then downloaded into a Given® Workstation computer where a physician can review the images in order to shape a diagnosis.
About Celiac Disease
Celiac disease interferes with absorption of nutrients and is an autoimmune riotousness of the small intestine. In celiac, gluten, mould in all forms of wheat and some related grains, creates a reaction that damages the mucosal surface of the small intestine. Symptoms can include recurrent bloating, gas or abdominal pain; chronic diarrhea or constipation; unexplained anemia; fatigue, weakness or lack of energy; and others. Without treatment, damage to the small bowel can be chronic and life-threatening. One in 133 people is affected by celiac disease.(1)
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company’s technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small internal which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared on the side of marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 650,000 patients worldwide have benefited from the PillCam capsule endoscopy conduct. Given Imaging’s headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subservient companies in the United States, Germany, France, Japan and Australia. Given Imaging’s largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the “unscathed harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as “may,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “believes,” and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors what one. may incitement the actual events, results, performance, circumstances or achievements of the Company to be vitally different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from of the like kind forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam COLON (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings through the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as “Risk Factors,” “Cautionary Language Regarding Forward-Looking Statements” and “Operating Results and Financial Review and Prospects” in the Company’s Annual Report on Form 20-F for the year ended December 31, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak sole as of the date of this press unloose. Except for the companionship’s ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
(1) Celiac Disease Foundation
Given Imaging Ltd.
Transfer Of Biological Electron Captured In Real Time
Two research teams led by Dr. Michael Verkhovsky and Prof. Marten Wikstrom of the Institute of Biotechnology of the University of Helsinki have for the first time succeeded in monitoring electron transfer by Complex I in real period of childbirth. In the future, this work might, for example, bring forth medical relevance, because most of the maternally inherited so-called mitochondrial diseases are caused by dysfunction of Complex I.
This achievement required developing and edifice of a special motto by which the enzyme-catalysed electron transfer could be captured at different time points by stopping the reaction at liquid nitrogen temperatures, on a microsecond (one millionth of a second) time scale. The electrons are excessively small elementary particles, which is why their transfer is very fast. This be is published this week in the prestigious journal of the American National Academy of Sciences (Proc. Natl. Acad. Sci.). The results give certain hints of the function of Complex I at the molecular level.
Electron transfer is central to many chemical reactions in the cell. It has particular functional importance in cell respiration, which in eukaryotes takes place in the inner mitochondrial membrane, and in the cell membrane of prokaryotes. In cellular respiration molecules stemming from food are oxidised to carbon dioxide, and the electrons liberated in the process are “fed” into the so-called respiratory chain, which consists of three successive membrane-bound enzyme complexes, finally to react with the oxygen we breathe, which is reduced to get water using these electrons.
The purpose of electron transfer in cellular respiration is to release the major part of the energy of foodstuffs and to conserve it in a suitable form, ATP (adenosine triphosphate), which the cell may use in its energy-requiring reactions (e.g. biosynthesis, dapper transport, mechanical be), which are essential e.g. during fetal development and growth, in neural and kidney function, muscle contraction, etc. The energy captured in cellular respiration is transduced to ATP in two phases. The role of the respiratory chain is to couple electron transfer to the translocation of positively charged protons across the membrane, so that the mitochondrial membrane (or the organic unit membrane in bacteria) becomes electrically polarised, just like charging up a battery. In the second phase, the voltage difference of the battery is used to oblige the protons back across the membrane, coupled to the synthesis of ATP by to a high degree special molecular machinery.
The first enzyme mingled of the respiratory chain is called Complex I. High-energy electrons are fed into this complex in the figure of a reduced coenzyme, NADH (nicotinamide adenine dinucleotide), which is oxidised to NAD+ having donated its two electrons. After this, the electrons are transferred forward several protein-bound iron/sulphur centres in Complex I until they reach their destination, a molecule of ubiquinone, which is thus reduced to ubiquinol. This reaction, as catalysed by Complex I, is linked to proton translocation across the membrane and thus leads to “charging the battery”. At a later stage ubiquinol donates its electrons further in the respiratory chain (ultimately to oxygen), by which it is oxidised back to ubiquinone to grant leave to continuation of Complex I function.
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Article adapted by means of Medical News Today from original press release.
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Source: Marten Wikstrom
University of Helsinki
Teen Anger And Brain Size
Teenage anger has been linked to the size of a part of the brain called the amygdala, The Times reported. Using scans of adolescent brains, researchers have shown, the newspaper says, that “the length and intensity of their tantrums correlates directly with the size of their amygdalas”.
The newspaper report is based on a study that filmed 137 adolescents having argumentative discussions through their parents and then used brain scans using MRI technology to inspect the size of different regions in the brain. The researchers found that an increase in size of the amygdala, a region known to be involved with emotions and memory, was linked to a longer duration of anger. The study furthermore found that in boys the smaller left anterior cingulate cortex, thought to be involved with thinking and decision making, was linked with whining and being more anxious. However, solitary a small number of adolescents were included in this study; more research involving larger numbers of people is needed to show a convincing link between differences in the size of particular brain regions and mood or mental health.
Where did the story come from?
This research was carried out by Sarah Whittle and colleagues of the ORYGEN Research Centre, University of Melbourne, Australia and the Oregon careful search Institute, USA. The study was supported by the ORYGEN Research Centre and the Colonial Foundation, and by various postgraduate awards, fellowships and scholarships of the researchers. It was published in peer-reviewed medical journal Proceedings of the National Academy of Sciences.
What kind of scientific study was this?
This was an experimental imaging study. The authors looked at the effect that brain structure has on day-to-day moods in adolescents. The researchers recruited 137 male and bearing adolescents (aged 11 to 14) from schools in Australia who were part of a larger developmental study. All were free from depression, substance abuse or eating disorders.
All participants and their parents took part in a 20 minute videotaped problem-solving interactions (PSI) activity. Five topics on which they held conflicting views were discussed (of the like kind as lying and answering back), as these were likely to provoke negative behaviour. Experienced observers used a system to code each time the participant’s mood or behaviour changed during the confrontation (e.g., the participant became angry or started whining). The verbal content of their speech was also monitored for changes (e.g., provocation or approval). The codes were then grouped together to provide an overall pattern of behaviour, such as aggression or moodiness. The assessors determined the average duration of the behaviour and assessed whether certain stimuli (e.g., parental attack) provoked a particular sequence of behaviour.
The researchers at another time carried out brain imaging (MRI) scans on the adolescents to look at the size of three key regions of the brain involved with mood regulation: the amygdala, the anterior cingulate cortex (ACC) and the orbitofrontal cortex (OFC). They used statistical analyses to look at the relationships between brain size, the duration of aggressive behaviour and the response to parental mood change. They also looked at the differences between boys and girls, as previous research has demonstrated gender differences in brain expanding and mood behaviours.
What were the results of the study?
The researchers found that gender had no effect on the appropriated time of aggressive behaviour. They found a positive connection betwixt the duration of assault and the size of the left and right amygdala, but this was only significant on the left-hand side.
There were differences between boys and girls when they looked at the relationship between aggression duration and size of the ACC. In boys, longer periods of aggression were linked with greater asymmetry in the structure of the paralimbic ACC, by a reduction in size on the left. There was no relationship between OFC size and the duration of aggression.
When the researchers looked at the patterns of change in the adolescents’ moods in response to their parents, they only found a significant link with OFC size among boys. Greater receptivity to the parents’ moods was linked to a smaller volume of the left OFC.
What interpretations did the researchers draw from these results?
The authors say that their findings suggest that mood behaviour and the ability to control it during family interactions is related to brain structure. They note that their findings during adolescence, a termination of rapid brain development, may have implications for mental health in later life.
What does the NHS Knowledge Service make of this study?
This is a complex imaging study in a small reach the number of of adolescents. The researchers have found some links between the structure of regions of the brain and their observations during recorded parental conflict. However, only limited conclusions can be drawn from these results.
- The findings cannot prove causation; that is, they cannot say whether mood behaviour is caused by, or predicted by, the size of brain regions, or whether the size change occurs as a result of mood behaviour.
- It is not possible to affirm whether adolescence has an effect on the one and the other brain structural development and moody or aggressive behaviour. Comparison by other age groups would be worthwhile.
- The sample size is small and a much larger study would be needed to provide more meaningful conclusions, particularly to see whether there are any true differences betwixt males and female sex.
- The conflict situation is only experimental. Having a videotaped discussion in a false setting may not reflect normal, every-day situations or how “moody” or “aggressive” an individual is for most of the time or with people other than their parents.
- The suggested link to later mental health conditions is only speculative and has not been assessed.
This study will likely require further research to examine the relationship between brain structure and dimensions, and mood or mental health behaviours. However, even if the size of different brain regions is related to anger and passion in humans, it is likely that current behavioural and psychological treatments, such as counselling, will remain useful.
Sir Muir Gray adds… I am not clear how parents could use this information.
Links to the headlines
Scans show what really goes on inside the head strong of that stroppy teenager.The Times, February 26 2008
Teen anger ’caused by brain shape’.The Daily Telegraph, February 26 2008
Links to the science
Prefrontal and amygdala volumes are kin to adolescents’ affective behaviors during parent-adolescent interactions.
Whittle S, Yap MBH, Yücel M, et al.
Proc Natl Acad Sci USA 2008; Feb 25
This news comes from NHS Choices
APP Pharmaceuticals Receives Final Approval For Irinotecan Hydrochloride Injection
APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, announced that it has admitted approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Irinotecan Hydrochloride Injection, 40 mg/2mL and 100mg/5mL, the generic equivalent of Camptosar® Injection manufactured by Pfizer Inc. APP has immediately commenced marketing and shipping the product. APP’s irinotecan is AP-rated, bar-coded and latex-free. According to IMS data, sales of Camptosar® in the United States were approximately $556 million in 2007.
Pfizer’s Camptosar® Injection is a chemotherapy drug used to treat advanced cancer of the large intestine and rectum. It is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients through metastatic colorectal cancer. The drug is also indicated for patients with metastatic colorectal cancer whose disease has recurred or progressed following initial fluorouracil-based therapy.
“Irinotecan is a large market opportunity,” said Tom Silberg, President of APP. “Since receiving tentative approval for this result in October 2007, we have worked to secure a number of contracts and are pleased to be one of the first pharmaceutical companies to market and ship irinotecan in the U.S. Irinotecan represents the fourth ANDA approval APP has received thus far in 2008.”
About APP Pharmaceuticals
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is any of the largest producers of injectables, with other than 100 products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit http://www.APPpharma.com.
Forward-Looking Statement
The statements contained in this news release that are not purely historical are forward-looking statements inside the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this news release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the demand, supply and distribution of irinotecan. Because these forward-looking statements involve risks and uncertainties, there are important factors that could final cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the availability and pricing of ingredients used in the manufacture of pharmaceutical products and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can have being found in APP Pharmaceuticals Form 10-K for the year ended December 31, 2006 filed under the company name Abraxis BioScience, Inc. and other documents it has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of this release. APP assumes no obligations to update any forward-looking statements contained in this press let go as the result of new information or future events or developments.
Camptosar® Injection is a registered trademark of Pfizer Inc.
APP Pharmaceuticals
New Awareness And Prevention Series For Community Health Events Released By NIDDK
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has announced the release of new health information to raise awareness about diabetes, digestive diseases, and kidney and urologic diseases among people not yet diagnosed with these illnesses. The NIDDK developed the Awareness and Prevention Series for community health fairs, workplace health forums, family reunions, and other similar events. NIDDK is one of the National Institutes of Health (NIH).
The Awareness and Prevention Series publications are each two-page fact sheets - one side in English and the other in Spanish - in continuance a wide range of health topics, including bladder control, celiac disease, foodborne illness, irritable bowel syndrome, pre-diabetes, preventing diabetes complications, urinary tract infections, and many others. Each fact sheet gives readers a snapshot of an illness, highlighting risk factors, symptoms, prevention tips, and where to go for the sake of additional information.
“The series is designed to encourage readers to ask ‘Could this be me or someone I care for?” uttered Kathy Kranzfelder, director of the NIDDK Information Clearinghouses, which disseminate information about diabetes, digestive diseases, and kidney and urologic diseases to patients, health care professionals, and the general public. “Raising awareness of these illnesses may prevent people take steps to prevent them or see a doctor if they have symptoms.”
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Article adapted by Medical News Today from original press release.
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Copyright-free abounding texts of the Awareness and Prevention Series publications - and all other publications from the Clearinghouses - are online at http://www.niddk.nih.gov/. To order copies of the Awareness and Prevention Series incident sheets, click on “NIDDK Awareness and Prevention Series” and then on “catalog.niddk.nih.gov.” Click on the appropriate Clearinghouse for the topics you are interested in. Single copies of fact sheets are free.
The NIDDK, part of the National Institutes of Health (NIH), conducts and supports research on diabetes; endocrine and metabolic diseases; digestive diseases, nutrition, and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most undistinguished, severe, and disabling provisions affecting Americans.
The National Institutes of Health (NIH) - The Nation’s Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
Source: Marcia Vital
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
Red Meat Consumption Linked To Colorectal Cancer: Experts Offer New Advice For Colorectal Cancer Awareness Month
For most Americans, meals tend to center around meat. To significantly decrease a someone’s risks of developing colorectal cancer, experts at The University of Texas M. D. Anderson Cancer Center suggest a new approach to meal planning that focuses more on fruit and vegetable dishes.
According to recent findings issued by the American Institute for Cancer Research (AICR), consuming more than 18 ounces, or a little over a pound, of red meat (pork, beef, lamb and goat) each week can significantly increase a person’s risks as being developing colorectal cancer. In addition, every ounce and a half of red meat a person eats over 18 ounces increases their risks by 15 percent.
March is Colorectal Cancer Awareness Month and National Nutrition Month, and nutritionists at M. D. Anderson Cancer Center are encouraging people to increase portion sizes of the plant, fruit, whole grain and/or bean dishes being served and decrease the portion size of meat.
Focus on Fruit and Vegetable Dishes
“Instead of asking what goes well with pork chops, ask what goes well through broccoli and sweet potatoes,” said Sally Scroggs, senior health education specialist in M. D. Anderson’s Cancer Prevention Center. “That way, your serving of meat becomes more of a indirect dish and not the center of the meal.”
“Red meat contains substances linked to colon cancer,” Scroggs said. “For example, some studies suggest that the heme iron (the compound that gives red meat its color) may increase the risk of developing colon cancer.”
AICR recommends that two-thirds of a meal consist of plant-based foods. Consuming less red meat and more plant-based foods can significantly decrease a person’s risks of developing colorectal cancer.
Don’t Eliminate Red Meat
Scroggs emphasizes that these recommendations are not meant to encourage people to completely eliminate red meat from their diet. “Consuming red meat in modest amounts is a valuable source of nutrients, including protein, iron, zinc and vitamin B12. Moderation is the key,” Scroggs said.
“According to the United States Department of Agriculture, Americans were eating an average of 36 ounces of red meat each week in 2006,” Scroggs said.
Scroggs recommends serving almost three ounces (about the size of a deck of cards) of cooked red meat at meals. “If you follow this recommended serving size, you can include red meat in as many as six meals of your weekly diet.”
Avoid Processed Meats
AICR also recommends eating very little processed meat (meat preserved by smoking, curing, salting or adding chemical preservatives), such as ham, bacon, hot dogs, sausages, pastrami and salami. Every ounce and a half of processed meat eaten a day is thought to increase a person’s risks of developing colorectal cancer by 21 percent.
“It’s a good pattern to avoid eating processed meats as much as practicable,” Scroggs said. “Save that hot dog for special occasions, such as a family cookout or the ballpark.”
Colorectal cancer is the third most common cancer establish in men and women in this countrified. The American Cancer Society estimates almost 150,000 new cases of colorectal cancer in the United States for 2008. Colorectal cancer is the second leading cause of cancer death among Americans but is considered a in a great degree preventable disease.
with regard to more information on colorectal cancer prevention strategies, visit http://www.mdanderson.org/cancerawareness.
University of Texas M. D. Anderson Cancer Center
1515 Holcombe Blvd., Box 229
Houston, TX 77030
United States
http://www.mdanderson.org
Immunicon Corporation Announces FDA Clearance Of The CellSearch(TM) Circulating Tumor Cell Kit For Monitoring Patients With Metastatic Prostate Cancer
Immunicon Corporation (NASDAQ:IMMC) announced that the FDA has cleared the CellSearch&bargain; Circulating Tumor Cell (CTC) Kit as an aid in the monitoring of patients through metastatic prostate cancer. A sample of the patient’s blood is processed with the CellSearch Kit using the CellTracks® System to capture and look upon CTCs. This clearance represents another expansion to claims for the kit, which is now cleared for three of the four most prevalent cancers. The CellSearch CTC kit was originally cleared in January 2004 to predict progression-free and overall survival in patients through metastatic breast cancer and later expanded to include monitoring. In November 2007, the kit was cleared by the FDA for monitoring metastatic colorectal cancer.
Byron D. Hewett, CEO and President of Immunicon Corporation commented, “Because the three pivotal trials demonstrated that the CellSearch test predicts survival in prostate, breast and colorectal cancers, circulating tumor cell testing should become standard of care in the management of patients with metastatic malady. We estimate the market size for testing in these three cancers is almost $1 billion. More importantly, oncologists can use the results to make better-informed treatment decisions and make progress patient care for three of the top carcinomas.”
The Impact
According to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Evaluation of CTC count at some time during the treatment of metastatic disease allows valuation of able to endure prognosis and predicts survival. Oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. Changes in CTC count can be assessed in 3-5 weeks, rather than in the 8-12 weeks required for imaging studies such as CT scans. The results of serial CTC testing can help physicians assess disease progression, thereby guiding more informed patient care decisions earlier.
The Results
The reflection demonstrated that a threshold of 5 CTC / 7.5 mL stratifies androgen independent prostate cancer patients into two distinct groups based on comparison to overall survival (OS). Patients with 5 or more CTCs at baseline and at 3-4 weeks after the initiation of chemotherapy have significantly shorter OS than patients with less than 5 CTCs. The presence of CTCs at some time during the course of the disease is a strong independent predictor of OS. The CellSearch test provides more reliable and informative results regarding the biological activity of the individual patient’s disease status than do measurements of PSA. Although a reduction of PSA at some points after initiation of therapy may reach significance for prediction of survival, favorable CTC at any time purpose were more accurate than the PSA evaluation. The practical implication is the use of CTC analysis for the evaluation of the probability of survival of patients with metastatic prostate cancer. In cases where CTC and PSA change were discordant, CTC change provided the most accurate assessment of prognosis.
Finally, the fundamental principles of tumor biology upon which the CellSearch example is based are common to all three diseases. Consequently, results from each study demonstrate that a CTC threshold exists in these carcinomas and can be used to stratify patients based on the demonstrated agreement of CTC with the true clinical end point overall survival.
because more details on the results of this prostate cancer trial, take one’s fancy refer to the press release section of the Immunicon textile fabric site and download the release entitled “Immunicon Achieves Endpoint in its Pivotal Clinical Trial in Metastatic Androgen Independent Prostate Cancer ” posted on January 18, 2007. The CellSearch Circulating Tumor Cell Kit was developed by Immunicon and is exclusively marketed by Veridex, LLC, in the cancer field.
About Immunicon Corporation
Immunicon Corporation is developing and commercializing proprietary cell- and molecular-based human diagnostic and life science research products with an initial focus on cancer disease administration. Immunicon has developed platform technologies for selection and analysis of rare cells in blood, such as circulating tumor cells and circulating endothelial cells that are important in many diseases and biological processes. Immunicon’s products and underlying technology platforms also consider application in the clinical development of cancer drugs and in cancer research and may have applications in other fields of medicine, such as cardiovascular and infectious diseases.
Immunicon Corporation
Risk Of Death For Heart Attack Patients Raised By Clinical Depression Even Years Later
Depressed heart attack patients have a higher risk for sudden dying in the months following a heart attack. Now a team led by researchers from Washington University School of Medicine in St. Louis has found that the risk continues for many years.
“There’s a two- to four-fold increase in a person’s risk of dying following a heart attack if they too happen to be depressed,” says Robert. M. Carney, Ph.D., lead author of the new study and professor of psychiatry at Washington University. “Previously we thought the impact of depression was strongest for the first three to six months following a heart attack and then gradually dropped off within a couple of years. Instead, we found that the effect lasts for at least five years.”
Carney, with colleagues from Duke University Medical Center, Harvard University, Yale University, the National Heart, Lung and Blood Institute (NIH) and the Mayo Clinic, followed more than 750 heart attack patients for five years. The findings will be present to answer in an upcoming issue of the Journal of Affective Disorders and are currently available online.
Patients followed in the study had participated in the NIH-funded project Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD). A little less than half were diagnosed through depression.
In the five years following a heart attack, 106 patients died. Of those, 62 had been diagnosed with depression, while 44 had not. In gauging the effects of depression, the investigators also considered other risks including age, smoking, hypertension, gender and diabetes.
Some of those factors, like younger age and female gender, lower mortality risk. Smoking and diabetes tend to raise the risk of departure. Carney says his team used statistical methods to evaluate the ways in which the various factors influenced mortality jeopard. Then they removed the influence of all other factors from the risk equation in order to consider the statistical impulse of depression itself.
“We found that after adjusting for those risk factors, depression continues to play a statistically significant role,” he says.
One possible explanation for depression’s lingering influence on mortality is its recurring nature. for the disorder can come and go over many years, it also may continue to increase the risk of death for many years.
“People typically are depressed for a while, then they’ll either get bettor with treatment or it may ebb on its own,” Carney says. “But depression can always recur, and we think that because it is a recurring problem, whatever depression is doing to mortality risk after a heart attack, it continues doing for quite a long time.”
Past studies have differed over how much depression affects survival following a heart attack. But Carney believes these new findings are more reliable because all of the patients in this study were personally interviewed to determine their depression status, whereas other studies have relied put on self-reporting.
“In our experience, self-reporting tends to overestimate the risk because it’s often not possible to evaluate the causes of various symptoms on self-report questionnaires,” he explains. “Say somebody reports having sleeping problems - that would go into the depression column being of the class who a symptom. But it’s possible they are sleeping poorly because of a bad back or because they have to get up and go to the bathroom frequently during the night. During an interview, we can determine whether an individual symptom is related to depression or can be explained in some other way.”
Carney’s team also found that any clinically relevant depression increases the risk of death in heart attack patients. The risk was elevated both for patients with major depression, which requires the presence of five or more symptoms, and minor depression, which requires between two and four symptoms for diagnosis. Major depression was associated with higher risk, but minor sadness also was associated with a significant increase in mortality risk.
Even with mounting evidence of a link between depression and dying in heart attack patients, only about 25 to 30 percent of these patients receive antidepressant drugs or other depression treatments.
That doesn’t surprise Carney. His team reported in 2003 in the Journal of the American Medical Association that providing treatment for depression seemed to have little effect on whether patients survived or had a second heart attack. This could be because the treatments don’t work for all patients, Carney says, and he suggests if current depression treatments could be improved, survival rates might increase, over.
To this end, his team is studying whether omega-3 fatty acids - the fatty acids found in draw up oil - might improve antidepressant therapies in heart patients. They’re giving an antidepressant drug and a special formulation of omega-3 to some heart patients and comparing them to depressed heart patients who receive an antidepressant but no omega-3.
“We have not been satisfied with the effectiveness of standard antidepressants at alleviating depression in this population of patients,” Carney says. “We’re studying omega-3, because there’s preliminary evidence that the fatty acids also might make depression therapies more effective, both in treating depression and in improving vital part health.”
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Article adapted by Medical News Today from original press release.
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Carney RM, Freedland KE, Steinmeyer B, Blumenthal JA, Berkman LF, Watkins LL, Czajkowski SM, Burg MM, Jaffe AS. Depression and five-year survival following acute myocardial infarction: a prospective study. Journal of Affective Disorders, 2008. doi:10.1016/j.jad.2007.12.005
Writing Committee for the ENRICHD Investigators. Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the enhancing recovery in coronary heart disease patients (ENRICHD) randomized trial. Journal of the American Medical Association, vol. 289:23, pp. 3106-3116, June 18, 2003, with accompanying editorial on pp. 3171-3173.
This thought was supported by grants from the National courage, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, and from the Lewis and Jean Sachs Charitable Lead Trust, St. Louis, MO
The ENRICHD study was supported by contracts from the National Heart, Lung, and blood Ins