IN THE NEWS

“Bacterial conjunctivitis is a common condition that affects people of all ages,” said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days.

Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older.

Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye.

Besivance is made by Bausch & Lomb, Rochester, N.Y.

Source: Press Release

The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic. The device is the first of its type.

Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement.

The Scandinavian Total Ankle Replacement (STAR) System is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. Fusion surgery involves cementing the shin bone (tibia) – the thicker of the two bones in the lower leg – to the talus bone in the ankle. The procedure stabilizes the ankle, but significantly decreases the ability to move the foot up and down.

“This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”

The FDA has already cleared several fixed-bearing ankle devices, which are also options to fusion surgery. In fixed-bearing ankle system, the articulating surface is molded, locked or attached to one of its metallic components.

For two years, researchers followed a subgroup of a 224-patient clinical study and found that the STAR system demonstrated similar rates of adverse events, surgical interventions and major complications as fusion surgery.

As a condition of FDA approval, the company will evaluate the safety and effectiveness of the device during the next eight years.

The STAR Ankle is owned by Small Bone Innovations Inc. of Morrisville, Pa.

Source: FDA Press Release

A new partnership allows users to access online grant making resources via one user ID and password.

The National Science Foundation (NSF) recently joined the InCommon Federation to provide NSF's research and education community simpler and easier access to online services.

Principal investigators and sponsored projects office officials from InCommon member institutions will soon be able to access NSF's online services such as Research.gov and FastLane using their unique IDs and passwords from their home institutions.

NSF's membership in InCommon will give users access to single sign-on technology, developed under an NSF grant, which allows researchers at member institutions to securely exchange online information and access web-based resources with one ID and password.

InCommon Federation doubled in size during the last two years, now serving 146 organizations, including higher education institutions, U.S. government research labs and agencies, and commercial partners. InCommon reaches more than 3 million people in these organizations.

NSF plans to first allow participants from the more than 100 member universities to access a partnership of federal research-oriented grant making agencies at Research.gov and NSF's site for submitting and reviewing proposals, FastLane. For a list of participants, see http://www.incommonfederation.org/participants/.

Research.gov, a modernization of FastLane, is a new web portal providing a broad range of information and grants management services for multiple federal agencies. FastLane is an interactive, real-time system used to conduct NSF business over the Internet that has been used for more than 14 years by 250,000 researchers, students, faculty and other research professionals to manage their grants and proposals.

"NSF is always pleased to see important results come from NSF supported projects," said George Strawn, NSF's chief information officer. "In this case, where our Middleware program has contributed to the emergence of InCommon, we're particularly pleased because the relationships between NSF and its academic partners will be both simplified and made more secure by our joint collaboration."

Streamlined access to federal research systems is a priority long desired by the research community, and through its membership in InCommon, NSF hopes to help meet the need.

-NSF-

View a VIDEO interview with David Waltz of Columbia University.

http://www.nsf.gov/news/news_videos.jsp?cntn_id=114512&media_id=64872&org=NSF 

April 2, 2009--As science fiction plot lines go, the unintended consequences of yielding tasks too complicated or dangerous for human hands to computers and robots is a popular one. Yet real life scientists are increasingly doing just that, creating automated systems and devices that can not only help collect, organize and analyze scientific data, but that are also able to intelligently and independently draw up new hypotheses and approaches to research based on the data they receive.

In a perspectives piece in tomorrow's edition of the journal Science, David Waltz of the Center for Computational Learning Systems at Columbia University and Bruce G. Buchanan of the computer science department at the University of Pittsburgh discuss this brave new world of scientific research and its implications for the way science is conducted. They see this all as a promising trend, but caution that researchers need to consider what tasks are best suited for automation and which should be left to the human mind.

Waltz and Buchanan point out that computer-aided automation has been a part of scientific research for decades, from simple programs that plotted ballistic arcs to databases that held and organized scientific data. All of these systems, however, required a "human in the loop" to shape the research, examine the results and determine how to apply the outcome to future endeavors.

Now the frontiers of automation can now make the human scientist seem obsolete. Waltz and Buchanan write that, "it is possible for one computer program ... to conduct a continuously looping procedure that starts with a question, carries out experiments to answer the question, evaluates the results, and reformulates new questions."

The authors argue that these new systems are arriving just when they are needed the most. As sensors and other instruments get more capable and complex, the scientific world is drowning in data, and having computer-based assistants who can actively sift through the data may be the only way to make sense of it all.

According to Waltz and Buchanan, the prospect of automating science also brings up a number of questions that need to be considered as these new technologies become widely adopted and deployed, e.g., how we determine what to automate, what should be left to human intervention, and how this newly automated research will affect the results and the scientific process. It is also possible, Waltz and Buchanan suggest, that these new tools will generate even more data to be considered, and will therefore contribute to one of the problems they are meant to solve.

Moving forward, the authors suggest that the best approach is to think of these tools as intelligent assistants that can do different types of tasks associated with scientific research. Scientists can then determine which assistants are the best choice for different aspects of their research.

So, does employing these automated assistants mean that students studying science should consider another major? The authors say no, indicating that for all of their capabilities, automated science systems will not do to researchers what robots have done to autoworkers--but they will change how scientists do their jobs.

Said Walter, "Regardless of specialty--biology, physics, chemistry, etc.--scientists may need to add knowledge and skills in artificial intelligence, machine learning, and knowledge representation."

-NSF-

March 30, 2009--The National Science Foundation (NSF) announced a nearly $50 million partnership with the Bill & Melinda Gates Foundation to support innovative, solutions to critical agricultural challenges in developing countries. Each organization will provide $24 million over five years to support a competitive awards program for science research projects that address drought, pests, disease and other serious problems facing small farmers and their families who rely on their crops for their food and income.

The award program will be called BREAD--Basic Research to Enable Agricultural Development--and will support a competitive award program for science research projects that develop innovative approaches and technologies to boost agricultural productivity in developing countries.

"This partnership enables NSF to seek breakthroughs and advances by funding international scientific partnerships aimed at addressing global farming problems such as drought, diseases, poor soil quality, the need for improved germplasm and for new technologies and production practices appropriate to small-scale farmers," said James Collins, NSF assistant director for biological sciences. "We are delighted to collaborate with the Bill & Melinda Gates Foundation, who have shown real commitment and leadership in addressing the challenges facing farmers in developing countries, and in identifying researchers in these countries who might collaborate in these research efforts."

The NSF will manage the program using its peer-review process in consultation with the Gates Foundation. NSF funds will be used to support research carried out in eligible U.S. academic institutions, such as non-profit research organizations, including museums, research laboratories and professional societies. The Bill & Melinda Gates Foundation's funds will be used to support eligible international partners via sub-awards from the U.S. awardees.

"This partnership with NSF is an exciting opportunity to tap into the most innovative, transformative ideas the global scientific community can offer", said Rob Horsch, deputy director of the agricultural development initiative at the Bill & Melinda Gates Foundation. "We believe the time is right to increase our investments in scientific research with the potential to create new pathways out of poverty for the millions of smallholder farmers in the developing world who support their families on less than $1U.S. a day."

BREAD Program solicitations will be non-prescriptive, inviting a broad scope of applications. A solicitation for funding proposals under the BREAD program will be available in early June on the BREAD Web site, which will be accessible through http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5338&org=BIO. The site will include more details about the program, such as a Dear Colleague letter from Collins and information about outreach workshops that will be webcast.

"This is a unique opportunity to promote international collaborations among scientists from the U.S. and those in developed and developing world countries. We aim to challenge members of the global scientific community to come together to think about how their own areas of research expertise might be applied to the myriad of problems facing global agriculture today," said Deborah Delmer, the newly appointed BREAD program director at NSF.

"What's truly special about the BREAD program is that it allows NSF to be involved in international research in a new way," said Jane Silverthorne, deputy director for NSF's biological infrastructure division. "The partnership is a great marriage between NSF's peer review process and the Gates Foundation's knowledge of the global science marketplace."

This funding program is part of the Gates Foundation's Agricultural Development initiative, which is working with a wide range of partners in sub-Saharan Africa and South Asia to provide millions of small farmers in the developing world with tools and opportunities to boost their yields, increase their incomes, and build better lives for themselves and their families. The foundation is working to strengthen the entire agricultural value chain-from seeds and soil to farm management and market access--so that progress against hunger and poverty is sustainable over the long term.

Zoology professor Elena Litchman, with MSU colleague Christopher Klausmeier and Kohei Yoshiyama of the University of Tokyo, explored how nutrient limitation affects the evolution of the size of diatoms in different environments. Their findings underscore potential consequences for aquatic food webs and climate shifts.

“They are globally important since they ‘fix’ a significant amount of carbon,” Litchman explained of the single-cell diatoms. “When they die in the ocean, they sink to the bottom carrying the carbon from the atmosphere with them. They perform a tremendous service to the environment.”

Carbon dioxide buildup, due to a significant extent to burning fossil fuels and deforestation, is identified as the leading cause of climate change. Carbon dioxide is at its highest level in at least 650,000 years and rising, according to The National Academies, and only half of the CO2 produced now can be absorbed by plant life.

Litchman analyzed data from lakes and oceans across the United States, Europe and Asia and found a striking difference between the size of diatoms in freshwater and in marine environments. In oceans, diatoms grow to be 10 times larger on average than in freshwater and have a wider range of sizes.

One factor that affects growth is nutrient availability, Litchman said.  The research shows that limitations by nitrogen and phosphorus exert different selective pressures on cell size.   The availability of these nutrients depends on the mixing of water from greater depths. Using a mathematical model, Litchman and her colleagues found that when those nutrients are constantly limited and mixing is shallow, smaller diatoms thrive.

But when nitrate comes and goes, as often happens in roiling oceans, diatoms evolve larger to store nutrients for lean times. Deep mixing also benefits large diatoms. Depending on how intermittent the nitrate supply is and how deep the ocean mixes, there can be a wide range of diatom sizes. Size matters for the creatures that eat them and also for carbon sequestration, as large diatoms are more likely to sink when they die.

Changing climate could alter the mixing depths and delivery of nutrients to diatoms and their subsequent sizes with a cascade of consequences, Litchman said.

 “On a global scale, increased ocean temperatures could make the ocean more stratified,” she explained. “This would cause less mixing and create stronger nutrient limitation and less frequent nutrient pulses. A change like this would select for different sizes of diatoms. If smaller sized diatoms dominate, then carbon sequestration becomes less efficient and there may be more CO2 remaining in the atmosphere, which would exacerbate global warming.”

Litchman and colleagues’ research was supported by the National Science Foundation and the J.S. McDonnell Foundation. Their findings were published Feb. 24 in the Proceedings of the National Academy of Sciences.

Michigan State University has been advancing knowledge and transforming lives through innovative teaching, research and outreach for more than 150 years. MSU is known internationally as a major public university with global reach and extraordinary impact. Its 17 degree-granting colleges attract scholars worldwide who are interested in combining education with practical problem solving.

For instance, imagine typing in “Who starred in the film Casablanca?” The search engine would respond with “Humphrey Bogart and Ingrid Bergman.”

Not impressed?

Try asking a more nuanced question, such as “What do Americans think of universal health care?” A search engine will create a report indicating trends in opinion based on what has been posted to the Web.

Search engines may eventually be used to conduct polling and even help sort fact from fiction, said Meng, who is helping to make such possibilities a reality, both through his research and as president of a company called Webscalers.

The way Meng sees it, big search engines such as Google and Yahoo are fundamentally flawed. The Web has two parts: the surface Web and the deep Web. The surface Web is made up of perhaps 60 billion pages. The deep Web, at some 900 billion pages, is about 15 times larger.

Google, which relies on a “crawler” to examine pages and catalog them for future searches, can search about 20 billion pages. Web crawlers follow links to reach pages and often miss content that isn’t linked to any other page or is in some way “hidden.”

Meng, along with researchers at the University of Illinois at Chicago and the University of Louisiana at Lafayette, has helped pioneer large-scale metasearch-engine technology that harnesses the power of small search engines to come up with results that are more accurate and more complete.

“Most of the pages on the deep Web aren’t directly ‘crawlable.’ We want to connect to small search engines and reach the deep Web,” he said. “That’s the idea. Many people have the misconception that Google can search everything, and if it’s not there it doesn’t exist. But we should be able to retrieve many times more than what Google can search.”

Not only can a metasearch engine probe deeper, it can also offer the latest information.

“In principle,” Meng said, “small guys are much better able to maintain the freshness of their data. Google has a program to ‘crawl’ all over the world. Depending on when the crawler has last visited your server, there’s a delay of days or weeks before a new page will show up in that search. We can get fresher results.”

The concept is not new. In fact, the first metasearch engine was built in 1994.

“The big difference between our technology and the ones pursued by other people is that most of the other technologies do the metasearching on top of a small number of general-purpose search engines, such as Yahoo, Google or MSN,” Meng explained. “We have a completely different perspective. We want to build large-scale metasearch engines on top of many small search engines.”

The Web has millions of search engines at businesses, universities, newspapers and other organizations. Since 1997, and with continued funding from the National Science Foundation, Meng and his collaborators have found ways to run queries across multiple search engines and sort through the results.

Webscalers is based in the Start-Up Suite at Binghamton University’s Innovative Technologies Complex, which is home to several young companies that have their roots in faculty inventions.

“If the Web keeps on growing, a company like Google may run out of resources to crawl all of those pages,” said Vijay V. Raghavan, vice president of Webscalers and a faculty member at the University of Louisiana at Lafayette. “We won’t have that problem. We will scale much better.”

Webscalers’ technology could be useful for large organizations with many divisions. For example, Webscalers has developed a prototype that would allow a search of all 64 campuses in the State University of New York system as well as SUNY’s central administration.

“People can use it to find collaborators,” Meng said. “It could also help prospective students find programs they’re interested in.”

The technology could be adapted to large companies or even the government, Meng said.

Challenges for large-scale metasearch engines include determining which search engines are the best for a given query, automating the interaction with search engines as well as organizing the search results.

Meng hopes to build a grand metasearch engine one day that would integrate all of the 1 million small search engines into a single system. “There are still a lot of significant challenges in creating a system of such magnitude,” he said, “but I am optimistic that such a metasearch engine can be built.”

Try out the concept online

Webscalers has already launched several metasearch products:

·  The first is a news metasearch engine called AllinOneNews. Available at www.allinonenews.com , it connects to 1,800 news sources in 200 countries. That’s the largest metasearch engine in the world.

·  Webscalers also offers MySearchView, a system that allows any user to create his or her own metasearch engine just by checking off a few options at www.mysearchview.com .

 For more on Binghamton University research, visit http://research.binghamton.edu/

Chief Executive Officer of Brisbane based biotechnology company Acuvax Ltd, Dr William Ardrey, said its American affiliate company, Hawaii Biotech Ltd, had posted stunning results in phase one trials of the West Nile Virus vaccine.

This was terrific news for researchers working around the clock to develop the similar Dengue vaccine. “This gives a green light for the Dengue program to advance,” Dr Ardrey said. “Dengue is a major challenge for Australia and building on good results with this related program helps us accelerate our Dengue program. Because they are related viruses, we hoped for good phase one trial results from the simpler West Nile Virus vaccine. We can roll straight into the Dengue program now. We have a solid foundation to move forward with Dengue.”

Twenty four patients were involved in the West Nile Virus study, which checked safety and antibody development in healthy volunteers. None of those involved suffered any serious side effects. “In this case, one hundred per cent of patients responded as we wanted them to,” Dr Ardrey said. “I have not seen trial results this good. Acuvax and our colleagues in Hawaii have done this properly. This is a coup for Acuvax and a coup for the sector. Our shareholders should be happy because we are backing and investing in drugs that actually work.”

The West Nile Virus vaccine will now be tested on children, the elderly and immuno-compromised patients. Dr Ardrey said if phase two and three trials produced similar results, the West Nile Virus vaccine could be commercially available “reasonably soon”.

The West Nile Virus is spread by exposure to infected mosquitoes. In severe cases it is fatal, with sufferers developing encephalitis.

 Source: Acuvax Press release

Genzyme Corporation announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Synvisc-One™ (hylan G-F 20), a product intended for the relief of pain associated with osteoarthritis (OA) of the knee. Synvisc-One is the only single-injection viscosupplement approved for the treatment of OA knee pain in the United States. This therapy has the potential to redefine the market for viscosupplementation products by extending the benefits of this therapeutic approach to a broader set of patients and reducing the total cost and burden of multiple injections.

“In just one visit to the doctor’s office, patients suffering from osteoarthritis may experience clinically significant pain relief for up to six months and for some patients this pain relief could potentially translate into a delay in the need for a total knee replacement,” said Jack M. Bert, M.D., president of the Arthroscopy Association of North America and adjunct clinical professor at the University of Minnesota School of Medicine. “This single injection regimen will provide greater physician and patient convenience.”

Synvisc-One is administered through a single intra-articular injection. It is an alternative treatment regimen to Genzyme’s Synvisc® (hylan G-F 20), a three-injection viscosupplement approved in the United States in 1997 and in use worldwide for more than 16 years. Synvisc-One contains the same material and total treatment volume as Synvisc but provides the 6 mL of hylan G-F 20 in a single injection. Viscosupplementation is a procedure in which hyaluronic acid or a derivative such as hylan G-F 20 is injected into the knee joint to replace synovial fluid that typically becomes degraded in patients with osteoarthritis. In synovial fluid, hyaluronic acid relieves pain and improves the knee joint’s natural shock absorbing abilities.

“Synvisc-One is an important therapy for OA of the knee because it delivers long-term pain relief through a single injection without the systemic side effects that can be caused by steroids and anti-inflammatory medication,” said Ann Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme Corp. that manufactures and markets Synvisc. “We expect that the approval of Synvisc-One will be a significant growth driver for the Synvisc franchise.”

Synvisc-One is also approved in the European Union and a number of Asian and Latin American countries. Nearly 10,000 patients have been treated with Synvisc-One since it was first approved last year. Genzyme will begin making Synvisc-One available immediately. For full prescribing information please visit www.synvisc.com.

About Synvisc-One

Synvisc-One™ (hylan G-F 20) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

Synvisc-One is contraindicated in patients with known hypersensitivity to hyaluronan products or patients with infections in or around the target knee. Use caution when injecting Synvisc-One in patients allergic to avian proteins, feathers, or egg products; who have evidence of venous or lymphatic stasis in the leg to be treated; or who have severe inflammation in the knee to be treated.

The most commonly reported related local adverse events were transient, mild-to-moderate arthralgia, arthritis, arthropathy, injection site pain and joint effusion. No serious adverse events have been reported in knees injected with Synvisc-One. Repeat treatment did not affect the safety profile. In the pivotal clinical trial, there was one related systemic event of syncope. The most common systemic side effects irrespective of relationship to Synvisc-One were headache, back pain, nasopharyngitis and influenza. Systemic adverse event profiles were similar between patients in the Synvisc-One and Saline Control groups. Side effects such as rash have been reported rarely in association with Synvisc.

Patients should be advised to avoid strenuous or prolonged weight-bearing activities for approximately 48 hours after treatment. Aspiration of any effusion prior to injection is highly recommended. Strict adherence to aseptic technique must be followed to avoid joint infection. The safety and effectiveness of Synvisc-One have not been established in children or in pregnant or lactating women. It is unknown whether Synvisc-One is excreted in human milk.

About Genzyme

 One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.

Researchers were able to greatly increase the stability of these two proteins (AcPh and Cdc42). The findings have implications for stabilizing many other types of proteins.

Proteins are widely viewed as a promising alternative to synthetic chemicals in everything from medications to hand lotion. The naturally occurring molecules have been shown to be more efficient and effective than many of the most sophisticated chemical compounds on the market. But outside the controlled confines of the lab bench, proteins quickly change structure, causing irreversible damage to their functionality and often safety.

Scientists are now searching for ways to increase the stability of proteins. In new research published Feb. 5 in the online Early Edition of the Proceedings of the National Academy of Sciences (PNAS), Rensselaer Senior Constellation Professor George Makhatadze and his colleagues detail a targeted strategy to substantially increase the thermodynamic stability of nearly any protein, while preserving its unique function. Their redesign technique creates proteins that remain stable at temperatures 10 degrees Celsius higher than normal.

To achieve these results, the researchers used high-powered computers to create new and improved versions of two human enzymes. The enzymes are  specific types of protein. The two enzymes in the study vary widely in size and functionality, yet both showed substantial increases in stability without loss of function in the body. This supports the idea that the stability of many other proteins could also be greatly stabilized, according to Makhatadze. The researchers are now looking to use the technique to improve that stability of specific proteins with strong industrial and drug development applications.

They developed a computational approach that altered the proteins’ structure and tested it for increased stability. “Our experimental validation of computational results is actually motivated by Thomas Edison, who wrote, ‘Until man duplicates a blade of grass, nature will laugh at his so-called scientific knowledge,’” Makhatadze said.

“There are several viable approaches to optimize proteins,” Makhatadze added. “Many researchers seek to optimize the protein by changing all types of physical interactions within the computer model at once. Instead, we felt that if we could understand one interaction, we could then use it to our advantage to build on the algorithm and then experimentally prove that that property really exists in the real protein system.”

The interaction the researchers focused on was the surface charge of the protein. The investigation of the importance of protein surface structure is a growing area of research within the field. In fact, a 2006 paper in the journal Biochemistry, published by Makhatadze supporting the importance of protein surface structure on stability, was the one of the top five most cited and downloaded papers from the journal that year.

In addition to important potential industrial applications, Makhatadze also believes the research sheds some light on the evolution of proteins. The researchers compared the mutations that they made within the proteins in order to optimize the protein’s performance with the mutations naturally occurring in the proteins from the evolutionary distant organisms.  Instead of seeing more mutations along with increased performance as with most evolutionary adaptations, the researchers saw that less frequent mutations resulted in a more stable protein. “This suggests that the stability of proteins might not be evolutionarily important,” he said.  “It appears that as soon as the protein is able to function in given conditions and is stable at a given temperature, anything above that is not really necessary.”

The research was fully funded by the National Science Foundation (NSF). Makhatadze was assisted in his research by post-doctoral researcher Mayank Patel, graduate student Jiajing Liu, NMR Core Director Scott McCallum, and Assistant Professor of Biology Chunyu Wang, all of Rensselaer, as well as former graduate student Alexey Gribenko, who is currently a member of the faculty at the University of Texas Medical Branch. In addition, the structure of one the proteins used in the study, acylphosphatase (AcPh), was actually solved at Rensselaer using the sophisticated nuclear magnetic resonance (NMR) core within the Center for Biotechnology and Interdisciplinary Studies (CBIS).

Source: Rensselaer Polytechnic Institute Press Release

Health, United States: 2008 is the 32nd annual edition of the report prepared by CDC′s National Center for Health Statistics, and includes a compilation of health data from a number of sources within the federal government and in the private sector. The report uses the most current data available at the time of publication.

This year′s edition features a special section on adults aged 18 to 29, a group making many life choices including decisions about education, marriage, childbearing, and health behaviors such as tobacco and alcohol use, which will affect both their future economic and health status.

Highlights of the report:

• Obesity rates have tripled among young adults in the past three decades, from 8 percent in 1971-1974 to 24 percent in 2005-2006.
• In 2006, 29 percent of young men were current cigarette smokers, compared to 21 percent of young adult women. Between 1997 and 2006, the percentage of women 18–29 years of age who currently smoked cigarettes declined nearly 20 percent. Current smoking did not decline significantly among young men.
• In 2005, unintentional injuries or accidents, homicide, and suicide accounted for 70 percent of deaths among young adults 18–29 years of age. Three-quarters of the 47,000 deaths in this age group occurred among young men. Young adults also have the highest rate of injury-related emergency department visits of all age groups.
• In 1999–2004, almost 9 percent of adults aged 20–29 reported having major depression, generalized anxiety disorder, or panic disorder in the past 12 months.
• In 2006, adults aged 20–24 were more likely to be uninsured (34 percent) than those aged 18–19 (21 percent) and 25–29 (29 percent).
• In 2004–2006, 17 percent of adults aged 18–29 reported needing but not receiving one or more of the following services in the past year because they could not afford them: medical care, prescription medicines, mental health care, or eyeglasses.

The full report contains 151 data tables in addition to the special feature on young adults. The tables cover the spectrum of health topics, serving as a comprehensive snapshot of the nation′s health. Other highlights:

• In 2006, American men could expect to live 3.6 years longer, and women 1.9 years longer, than they did in 1990. Death rates from heart disease, stroke and cancer have continued to decline in recent years.
• Sixty-five percent of men and 80 percent of women aged 75 and older reported having high blood pressure or were taking high blood pressure medication in 2003–2006, compared to about 36 percent of adults aged 45–54.
• The proportion of the population with high cholesterol levels has been dropping, in large part due to increased use of cholesterol-lowering drugs. In 2003–2006, 16 percent of adults had high cholesterol. Women aged 55 and over were much more likely to have high cholesterol than their male counterparts.
• Approximately 25 percent of adults aged 60 and over had diabetes in 2003-2006.
• Obesity rates do not appear to be increasing as rapidly as they did in past decades, but remain high, with over a third of adults age 20 and over considered to be obese in 2005–2006.

The full report is available at www.cdc.gov/nchs.

People with congenital fibrinogen deficiency are unable to make sufficient amounts of fibrinogen, which plays an important role in blood coagulation by helping to form blood clots and prevent bleeding. Fibrinogen is manufactured in the liver and circulates in the blood plasma in a normal concentration of 250-400 mg/dL.

"This product offers much-needed treatment for the small number of patients with congenital fibrinogen deficiency," said Jesse Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "If bleeding occurs in the brain or other organs and is left untreated, it may lead to blood loss, organ damage and death.”

Fibrinogen deficiency affects only 150 to 300 people in the United States and is usually diagnosed at birth when newborns bleed from their umbilical cord site. Children with the defect need to curtail activities because of risk of bleeding from minor trauma.

RiaSTAP is an intravenous fibrinogen concentrate made from the plasma of healthy human blood donors. The product is indicated for patients who have no fibrinogen or low levels of the substance, an abnormality known as afibrinogenemia, or for those patients whose fibrinogen levels are below 50 mg/dL, an abnormality known as hypofibrinogenemia. The product is not indicated for patients with dysfibrinogenemia, who may have normal fibrinogen levels but defective fibrinogen function. Patients such as these are at risk for both bleeding and clotting complications.

The licensing of RiaSTAP was supported by a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 mg/kg of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness, a surrogate marker likely to predict clinical benefit. Fever and headache were the most common adverse reactions.

Clinical benefit will be further verified in a postmarketing study which will include both afibrinogenemic and hypofibrinogenemic patients.

Orphan drugs are drugs or biologics intended for use in a rare disease or condition. Manufacturers are qualified to receive certain government benefits in exchange for developing such products. RiaSTAP [Fibrinogen Concentrate (Human)] was developed under the FDA’s accelerated approval regulations.

The drug is manufactured by CSL Behring, Marburg, Germany.

http://www.fda.gov/bbs/topics/NEWS/2009/NEW01948.html 

In light of the current financial situation in California, the board meeting began with a discussion of funding scenarios through 2010. At this time CIRM can fund all existing commitments through September of 2009.

The governing board chose not to approve immediate funding for the Bridges to Stem Cell Research and Research Training Program II grants due to the State’s current inability to sell bonds on the public market. Instead, they voted on the grants they would like to see funded when the financial situation resolves. That decision will depend on the board’s sense that the organization has sufficient funds and that the grants are consistent with the CIRM’s priorities at that time.

The 11 tentatively approved grants in the Bridges to Stem Cell Research program will provide $17.5 million to building future stem cell research workforce. These grants fund efforts to engage undergraduate and masters level students in stem cell research. The programs will provide comprehensive lecture and laboratory courses, facilitate internship placement, and advise and mentor students on research progress and career opportunities. The graduates of these programs will have the expertise needed to staff California’s expanding stem cell research laboratories in both industry and academic organizations.

In a letter, Senator Gloria Romero and Senate President pro Tempore Darrel Steinberg congratulated CIRM on the Bridges to Stem Cell Research Awards, citing recent reports from BayBio and  from the California Public Policy Institute forecasting a widespread shortage of college-educated and technically trained workers to meet industry demands. “An educated and properly trained workforce is essential if our state is to retain its premier position and fully realize the medical and economic benefits from this emerging industry,” they wrote.

“Training young people is critical to our mission of developing new therapies,” said Robert Klein, chairman of the CIRM governing board. “As California’s stem cell industry continues to grow the state will face a critical shortage for biomedical laboratory workers trained in state-of-the-art techniques required by stem cell research labs. People who graduate from our Bridges programs will be ready to fill these positions and help California industry and academic labs maintain momentum in their search for cures.”

The board also approved 15 Research Training Program II awards worth $40.6 million to fund graduate students, postdoctoral scholars and clinical fellows working in stem cell research labs. These grants follow the 16 given out in the first round of CIRM funding in 2006. Those grants are due to expire this year.

To accommodate the different sizes of the stem cell research programs throughout California, the Training grants support three types of programs.

• Type 1 Comprehensive training programs support up to 16 pre-doctoral, post-doctoral and clinical

fellows.

• Type 2 Intermediate training programs support up to ten students at two of the education levels.

• Type 3 Specialized training programs support up to six trainees at one or two levels of education.

 “These trainees are our future stem cell scientists,” said Alan Trounson, President of CIRM. “With these awards we are establishing a strong next generation of researchers and physician scientists to continue developing new stem cell-based therapies.”

In addition to the Bridges and Training grants, the board considered additional Tools &

Technologies grants carried over from the previous meeting. The board voted against funding any ofthese grants beyond the 23 approved in December.

Other ICOC business

The board also discussed the CIRM loan program, which will fund the translation of basic research into therapy development programs, potentially including early phase human trials. These loans will provide a mechanism for the funds to be recycled, thereby creating a recurring funding source to reach a broader medical portfolio and to accommodate the larger scale funding requirements of human trials.

The board voted that all successful industry applications to the Disease Team Awards would be funded through the loan program rather than through grants. This policy will allow funding for a greater number of these critical awards.

The following grants were approved at today’s meeting, pending a future decision by the Governing Board to moving forward with funding:

Bridges to Stem Cell Research

Application Number Institution Budget

TB1-01175 California Polytechnic State University, San Luis Obispo $1,396,509

TB1-01176 California State Polytechnic University,Pomona $1,436,797

TB1-01177 California State University, ChannelIslands $1,733,406

TB1-01182 California State University, Long Beach $1,337,700

TB1-01184 California State University, Sacramento $1,321,440

TB1-01186 California State University, San Marcos $1,732,164

TB1-01190 Humboldt State University $1,616,363

TB1-01192 Pasadena City College $1,727,991

TB1-01193 San Diego State University $1,716,030

TB1-01194 San Francisco State University $1,713,558

TB1-01195 San Jose State University $1,733,760

Total $17,465,718

Research Training Program II

ApplicationBudget

TG2-01150 3 City of Hope $1,212,732

TG2-01151 3 University of California, Santa Barbara $1,202,913

TG2-01152 1 University of California, Irvine $3,339,332

TG2-01153 1 University of California, San Francisco $3,899,912

TG2-01154 1 University of California, San Diego $3,886,191

TG2-01157 2 University of California, Santa Cruz $2,257,012

TG2-01158 3 The Salk Institute for Biological Studies $1,507,613

TG2-01159 1 Stanford University $3,930,000

TG2-01160 2 The J. David Gladstone Institutes $2,517,888

TG2-01162 3 Burnham Institute for Medical Research $1,390,599

TG2-01163 1 University of California, Davis $3,623,004

TG2-01164 1 University of California, Berkeley $3,371,686

TG2-01165 2 Scripps Research Institute $1,997,328

TG2-01168 2 Children’s Hospital Los Angeles $2,518,227

TG2-01169 1 University of California, Los Angeles $3,930,000

Total $40,584,437

About CIRM

CIRM was established in early 2005 with the passage of Proposition 71, the California StemCell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 253 research and facility grants totaling more than $635 million, making CIRM the largest source of funding for human embryonic stem cell research in the world. For more information, please visit www.cirm.ca.gov.

Venlo, The Netherlands -- Jan. 27, 2009 - An integrated laboratory system for sample fixation, stabilization and purification is now available from PreAnalytiX GmbH. With the PAXgene Tissue System, researchers can for the first time perform histology, immunohistochemistry and stabilized RNA, miRNA, and DNA extractions from one sample without worrying about a compromised workflow.

Research laboratories working with human and animal tissue are faced with the challenge of conducting a variety of analyses on limited sample materials.  The recognized standard for preserving tissue morphology is FFPE (formalin fixation/paraffin embedding).  However, while this method provides excellent results for morphological studies, it does not preserve biomolecules.  As a result, the DNA, RNA and miRNA molecules degrade, preventing the complete analysis required.  This is a necessity for applications such as case-controlled and population-based clinical studies, facilitating biomarker discovery and, ultimately, the development of diagnostics and therapeutics.

"Researchers say they need a system that not only fixes the tissue but prevents degradation of the biomolecules needed for molecular analysis," says Marie McCluskey, Global Product Manager for Pre-analytical Systems at QIAGEN.  "The PAXgene Tissue System combines tissue fixation with nucleic acid stabilization, enabling researchers to get the most information from samples.  For example, a biopsy sample can be assessed by a pathologist for morphology, then the same sample can be used for molecular analysis as well.  The stabilized nucleic acids make it possible for researchers to get optimal morphology and molecular results from one sample."

The PAXgene Tissue system has two components - a tissue container and tissue kits.  The dual-chambered container is pre-filled with two reagents: PAXgene Tissue Fix for fast penetration and fixation, and PAXgene Tissue Stabilizer for storage and transport.  The fixation process uses a standard histocasette with a fixative that is an alternative to formalin and is stopped by transferring the sample into the stabilizer.  Fixation time is standardized at 2-4 hours.  The sample is stable in the PAXgene Tissue Stabilizer for transport and storage prior to processing.  Tissue can then be paraffin embedded and processed in pathology workflows.  After tissue has been stabilized in PAXgene tissue containers (and optionally paraffin embedded), RNA, miRNA and DNA can be purified using the PAXgene tissue kits. 

"We are pleased to be able to bring the PAXgene Tissue System to the market," says Peer Schatz, CEO of QIAGEN.  "We believe that the technology represents a true breakthrough and that it brings a very powerful solution to a great, previously unmet need. The primary users of this product will be pathologists, oncologists, pharma companies and biobanks.  These professionals and organizations rely on us to help them maximize the use of their precious samples in research to make improvements in life possible."

The PAXgene Tissue System from PreAnalytiX is the newest addition sold in QIAGEN's suite of tissue management technologies.  The suite includes integrated products that standardize all steps of the workflow, starting with archived or prospectively collected tissues and ending with data analysis. This ensures comparability and reproducibility of data from laboratory to laboratory.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.

NEW YORK---Pfizer's Geodon (ziprasidone HCl) was an effective and generally well-tolerated adjunctive treatment to mood stabilizers for the maintenance treatment of bipolar disorder, according to a new study presented earlier this week at the European Psychiatric Association's European Congress of Psychiatry. Ziprasidone is available in Europe and other markets under the trade name Zeldox.

“Patients with bipolar disorder taking a mood stabilizer often have breakthrough mood episodes," said study author Eduard Vieta, M.D., Ph.D., Professor of Psychiatry, University of Barcelona, Spain. "These results demonstrate that ziprasidone was an effective adjunctive treatment for bipolar disorder over the long-term."

Bipolar disorder is a serious psychiatric disorder estimated to affect nearly 6 million Americans and nearly 30 million people worldwide. Pfizer filed an application with the U.S. Food and Drug Administration (FDA) for an adjunctive bipolar maintenance indication for Geodon based on the results of this study.

The study, presented at ESA January 25, demonstrated the efficacy and safety profile of Geodon over the long-term, having met the primary endpoint of time to intervention for a mood episode. Over the course of six months of treatment, significantly fewer patients (19.7 percent) taking Geodon plus a mood stabilizer (lithium or valproic acid) required intervention for a mood episode, compared to patients taking placebo plus a mood stabilizer (32.4 percent).

Geodon was generally well-tolerated with fewer patients in the Geodon group (12.6 percent) discontinuing due to adverse events compared to the placebo group (14.3 percent).

About the Study

This was a six-month, randomized, placebo-controlled, double-blind trial of Geodon plus a mood stabilizer in patients with bipolar disorder. The trial consisted of two phases: an open-label stabilization period of 2.5 months to four months, followed by a six-month, double-blind maintenance period. In the stabilization period, patients were given open-label Geodon (80-160 mg daily, dosed with food), in addition to lithium (0.6 - 1.2 mEq/L) or valproic acid (50-125 μg/ml) after the mood stabilizer had been maintained at therapeutic serum concentration for at least two weeks. Patients who achieved stability for eight consecutive weeks on this regimen were randomized into the second phase where they either continued receiving Geodon plus a mood stabilizer or were transitioned to placebo plus a mood stabilizer in order to evaluate efficacy and safety for an additional six months.

A total of 586 patients diagnosed with an acute manic or mixed episode of bipolar disorder entered the open-label stabilization period. Of those randomized into the double-blind period, 127 patients received Geodon and 112 patients received placebo.

Among treatment-emergent adverse events occurring in the six-month double-blind maintenance treatment phase, tremor was the only event occurring more frequently in the Geodon group (6.3 percent) than in the placebo group (3.6 percent). Adverse events occurring in more than 10 percent of patients in the open-label phase included sedation, somnolence, tremor, and insomnia.

About Geodon

Geodon is an atypical antipsychotic indicated in the United States for the management of symptoms of schizophrenia and acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features. In the EU, Zeldox is indicated for the treatment of schizophrenia and is indicated for the treatment of manic or mixed episodes of moderate severity in bipolar disorder. With more than seven years of experience, ziprasidone is available in 77 countries. It is widely accepted on hospital, Medicaid, national Veterans Administration and managed-care formularies.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Ziprasidone is not approved for the treatment of elderly patients with dementia-related psychosis.

Ziprasidone is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs. Ziprasidone has a greater capacity to prolong the QTc interval than several antipsychotics. In some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia. In many cases this would lead to the conclusion that other drugs should be tried first.

As with all antipsychotic medications, a rare and potentially fatal condition known as neuroleptic malignant syndrome has been reported with ziprasidone. Neuroleptic malignant syndrome can cause hyperprexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation, treatment, and monitoring are recommended.

Prescribing should be consistent with the need to minimize tardive dyskinesia, a potentially irreversible dose-and duration-dependent syndrome. If signs and symptoms appear, discontinuation should be considered since tardive dyskinesia may remit partially or completely.

Hyperglycemia-related adverse events, sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with ziprasidone, and it is not known if ziprasidone is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.

Precautions include the risk of rash, orthostatic hypotension, and seizures.

In short-term schizophrenia trials, the most commonly observed adverse events associated with ziprasidone at an incidence of more than 5 percent and at least twice the rate of placebo were somnolence and respiratory tract infection.

The most common adverse events associated with ziprasidone in bipolar mania were somnolence, extrapyramidal symptoms, dizziness, akathisia, and abnormal vision.

Please see full prescribing information available at www.Geodon.com

Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this.

“Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.

Prostate cancer is one of the most commonly diagnosed cancers in the United States. In 2004, the most recent year for which statistics are currently available, nearly 190,000 men were diagnosed with prostate cancer and 29,000 men died from the cancer.

Several treatment options exist for different stages of prostate cancer including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors. The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.

In fact, nearly all of the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.

The most frequently reported adverse reactions in the clinical study included injection site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.

Degarelix is manufactured for Ferring Pharmaceuticals Inc., Parsippany, N.J., by Rentschler Biotechnologie Gmbh, Laupheim, Germany.

Source: FDA Press Release

GIST is a fairly rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which helps to control the movement of food and liquid through the stomach and intestines.

Gleevec, first approved by the FDA in 2001, is one of the first drugs in a class of agents that block cellular communications that result in tumor growth

"Approval of Gleevec offers health care professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses."

About 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States. Because symptoms of GIST are no different than other GI complaints such as nausea and vomiting, the cancer is difficult to detect early. Patients initially undergo surgery to remove the tumor but GIST commonly recurs. Gleevec is intended to be given to patients following surgery to help prevent tumor recurrence.

The efficacy of Gleevec was established in a clinical trial in which patients received either Gleevec or a placebo for one year after surgical removal of the tumor. The optimal treatment duration is not known.

There were significantly fewer recurrences of GIST in patients receiving Gleevec than in patients who did not. The most frequently reported adverse reactions were diarrhea, fatigue, nausea, swelling of the feet, decreased red blood cell counts, rash, vomiting and abdominal pain.

Gleevec is manufactured by Novartis AG, Basel, Switzerland.

The U.S. Food and Drug Administration approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.

Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body.

"This MRA contrast imaging agent provides clinicians with a much clearer scan of blood vessels, compared to MRA without contrast, even in vessels that are difficult to scan because they twist and turn in the body," said John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, FDA.

When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 percent to 30 percent of the time. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure that may result in injury to vessel walls, blood clots, allergic reactions and potential kidney damage. Vasovist is injected into a peripheral vein and no artery is punctured, thus the potential risks are fewer.

The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture.

The safety and efficacy of Vasovist was established in two clinical studies of patients with known or suspected aortoiliac disease --- plaque buildup in the arteries going to the legs. In the studies, patients underwent MRA with and without Vasovist and their scans were compared to standard X-ray pictures using contrast. MRA with Vasovist detected more arterial disease than MRA performed without Vasovist and the pictures were of improved technical quality.

The primary safety risks for Vasovist are allergic reactions and n ephrogenic systemic fibrosis, a rare syndrome that involves the thickening of the skin, joints, eyes and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist. The warning can be found here:

http://www.fda.gov/cder/drug/InfoSheets/HCP/gcca_200705.htm

Vasovist Injection is manufactured by EPIX Pharmaceuticals Inc., Lexington , Mass.

Source: FDA Press Release

Hundreds of wounded people, including women, children and elderly, lie in hospitals that already lack basic supplies. Over the past two days, violence and military activities in Gaza have killed around 330 people and left 900 injured, according to latest reports.

The inability of the hospitals to cope with a problem of this magnitude, if the situation continues unchanged, will result in a surge in preventable deaths from complications due to trauma. Civilians are paying the price for the prolonged blockade. As a top priority, the shortages of essential and life-saving medicines needs to be abated without delay. The current escalation of the violence only compounds the health situation and unnecessarily exacerbates the fragile status of the civilians caught up in this conflict.

WHO has secured, in collaboration with several Member States, the dispatch of medical kits to cover surgical and trauma interventions. WHO is following up with the Palestinian and Israeli authorities to ensure that health relief supplies, including the medical kits already on hand, reach those who need them.

Negotiations with the Israelis are ongoing to guarantee the passage of urgent medical supplies today. WHO is also coordinating with other UN agencies, donors and nongovernmental organizations to ensure aid arrives to those most in need. The functioning of hospitals and access to health services is critical in order to respond to the mass casualties.

WHO reiterates its call for the immediate discontinuation of the current violence and the removal of blockades so that much-needed food, water, fuel, medicines and other humanitarian aid can reach those in need.

The approval of Apidra® for pediatric use is based upon FDA review of a 26-week, phase III, open-label, active control study of Apidra® in comparison with insulin lispro, in 572 children and adolescents (4 years and older) with type 1 diabetes.

Apidra® has a rapid onset and short duration of action and should normally be used in

combination with a longer-acting or basal insulin. Apidra® can also be used in insulin infusion pump therapy for blood sugar control.

About the Study

The approval of Apidra® for pediatric use is based upon a 26-week, phase III, open-label, active control study of Apidra® in comparison with insulin lispro in 572 children and adolescents (4 –17 years of age) with type 1 diabetes. Study patients received insulin glulisine or lispro 0-15 minutes premeal. These patients received concomitant treatment with insulin glargine once daily or NPH twice daily as basal insulin. The majority of the patients received insulin glargine as part of their basal-prandial regimen (69.7% and 72% in the Apidra® and insulin lispro treated groups, respectively).

The study compared the efficacy of Apidra® to insulin lispro in terms of change in glycohemoglobin (HBA1c), which is the amount of sugar bound to hemoglobin in the blood. The change in HBA1c from baseline to endpoint for Apidra® and insulin lispro were similar. The mean HBA1c change in the Apidra® population was +0.10% (± 0.08) and +0.16% (± 0.07) in the lispro group. The difference between the two treatments for this measure was -0.06%, or almost zero, with a 95% confidence interval of (-0.24; 0.12). HbA1c at baseline was 8.20% (±1.05) in the glulisine group and 8.17% (±1.02) in the lispro group; HbA1c at endpoint was 8.31% (±1.37) in the glulisine group and 8.37% (±1.32) in the lispro group. Postprandial glycemic control, as assessed by the self-monitored blood glucose values and blood glucose excursions, was similar in both treatment groups at endpoint.

The rate of new cases of diagnosed diabetes rose by more than 90 percent among adults over the last 10 years, according to a study by the Centers for Disease Control and Prevention (CDC).

The data, published in CDC′s Morbidity and Mortality Weekly Report, show that in the past decade, the incidence (new cases) of diagnosed diabetes has increased from 4.8 per 1,000 people during 1995-1997 to 9.1 per 1,000 in 2005-2007 in 33 states.

“This dramatic increase in the number of people with diabetes highlights the increasing burden of diabetes across the country,” says lead author Karen Kirtland, Ph.D., a data analyst with CDC′s Division of Diabetes Translation. “This study demonstrates that we must continue to promote effective diabetes prevention efforts that include lifestyle interventions for people at risk for diabetes. Changes such as weight loss combined with moderate physical activity are important steps that individuals can take to reduce their risk for developing diabetes.”

The study used data from CDC′s Behavioral Risk Factor Surveillance System, and provides incidence rates of diabetes for 43 states and two U.S. territories. Only 33 states had data for both time periods, but 43 states collected data in 2005-2007.

State-specific, age-adjusted estimates of new cases of diabetes ranged from 5 per 1,000 people in Minnesota to 12.7 per 1,000 in West Virginia. The number of news cases was highest in Puerto Rico at 12.8 per 1,000. States with the highest age-adjusted incidence were predominately Southern states: Alabama, Florida, Georgia, Kentucky, Louisiana, South Carolina, Tennessee, Texas and West Virginia.

“This report documents the geographic distribution of new cases of diabetes and is consistent with previous studies showing an increase in new diabetes cases,” said Kirtland. “We must step up efforts to prevent and control diabetes, particularly in the Southern U.S. region where we see higher rates of diabetes, obesity and physical inactivity.”

CDC, through its Division of Diabetes Translation, funds diabetes prevention and control programs in all 50 states, including the District of Columbia, and seven U.S. territories and island jurisdictions. The National Diabetes Education Program, co-sponsored by CDC and the National Institutes of Health, provides diabetes education to improve treatment for people with diabetes, promote early diagnosis and prevent or delay the onset of diabetes.

For more information about diabetes, visit www.cdc.gov/diabetes. The MMWR report is available at www.cdc.gov/mmwr.

Observations and measurements at the scale of DNA are tricky. The distance between the rungs in DNA's ladder (or base pairs), for example, was thought to be barely over 3 millionths of a millimeter, or 3.4 Å (angstroms). And this ladder has been typically assumed to be very rigid.

But now a team of Stanford scientists, supported in part by the National Science Foundation, have used a novel molecular ruler to cast doubts on this picture. Using this molecular ruler, they marked each end of a snippet of DNA with electron-dense gold nanocrystals. These markers scattered X-rays directed at the sample differently than the rest of the molecules, and allowed for a more precise calculation.

The observations led the Stanford team to discover that DNA is much softer than previously thought. Variation--both compression and stretching--was observed.

Most surprisingly, the team found that if a base pair had compressed, the base pairs in at least the next two turns of the double helix were more likely to be compressed as well.

These observations have important ramifications for biologists looking at proteins binding to DNA, such as transcription factors regulating gene expression. Because this study has shown regions of DNA affecting the behavior of neighboring regions, it could mean that proteins binding to the DNA could communicate across greater molecular distances than previously thought.

The National Science Foundation (NSF) has made 20 new awards totaling $57.3 million during the 11th year of its Plant Genome Research Program (PGRP).

These awards, which cover two to five years and range from $350,000 to $6.8 million, support research and tool development to further knowledge of genome structure and function. They will leverage sequence and functional genomics resources to increase understanding of gene function and interactions between genomes and the environment in economically important crop plants such as corn, soybean, wheat and rice.

"Plant biologists continue to make significant conceptual and theoretical advances in our understanding of basic biological processes using plants," said James Collins, NSF assistant director for biological sciences. "It is clear that 21st century biology has become increasingly quantitative and interdisciplinary. The latest projects funded through the PGRP reflect this shift and will integrate innovative, cutting edge research with the training of the next generation of plant scientists at both research universities and small teaching colleges and universities."

The new awards, made to 45 institutions in 28 states, include international groups of scientists from Asia, Australia, Europe and South America.

First-time recipients of PGRP awards include California State University-Long Beach, Case Western Reserve University, North Carolina Central University, University of Minnesota-Duluth, University of Southern California and Western Illinois University.

A wealth of genomics tools and sequence resources developed over the past 11 years of the PGRP continues to enable exciting, new comparative approaches to uncover gene networks that regulate plant development and growth in changing environments.

Projects include:

Research led by the University of Southern California to study how Medicago truncatula, a small legume, and associated soil bacteria co-adapt to high salinity conditions. This project will be done in collaboration with scientists in Tunisia and France.

Research led by the University of Minnesota, Duluth to identify the molecular mechanisms of nectar synthesis and secretion in the Brassicaceae, an agriculturally important family of flowering plants.

An interdisciplinary effort led by Pennsylvania State University to define the regulation of maize shoot growth and development by the plant hormone auxin.

A multi-institutional effort led by the University of California, Davis to develop genomics resources that will support the physical mapping of wheat chromosomes; this project will complement ongoing national and international efforts to sequence the wheat genome.

Research led by the University of Georgia to generate populations of mutant plants that will advance our understanding of the functions of agronomically important genes in soybean.

This year's awards were selected from a pool of outstanding proposals, many of which leveraged data and other resources previously produced with PGRP funding. The outstanding quality of these proposals testifies to the PGRP's success in enabling innovative research.

The PGRP, which was established in 1998 as part of the coordinated National Plant Genome Initiative by the Interagency Working Group on Plant Genomes of the National Science and Technology Council, works to advance the understanding of the structure and function of genomes of plants of economic importance.

-NSF-

The National Science Foundation (NSF) is an independent federal agency that supports fundamental research and education across all fields of science and engineering, with an annual budget of $6.06 billion. NSF funds reach all 50 states through grants to over 1,900 universities and institutions. Each year, NSF receives about 45,000 competitive requests for funding, and makes over 11,500 new funding awards. NSF also awards over $400 million in professional and service contracts yearly.

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The U.S. Food and Drug Administration announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.

"These cooperative agreements support and enhance local food protection efforts consistent with our Food Protection Plan," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The grants represent an important step in the FDA’s continued efforts to integrate and improve the effectiveness of food safety systems at the federal, state and local levels."

Prevention: Ruminant Feed Ban Support Program

The cooperative agreements for the Ruminant Feed Ban Support Program further enhance the infrastructure of state, territorial, and tribal animal feed safety and bovine spongiform encephalopathy (BSE) prevention programs. Under these cooperative agreements, state, territory, and tribal governments will enhance their feed/BSE safety programs to increase the ability to locate and visit companies involved in the manufacture, distribution, and transportation of animal feed as well as operations feeding ruminant animals, and to verify their compliance with the BSE/ruminant feed ban. Funds may also be used to conduct educational outreach activities and to develop materials needed to further enhance the industries' knowledge of and compliance with the BSE/ruminant feed ban. The awards were up to $250,000 and the states receiving them were Iowa, Mississippi, North Carolina and Washington.

Intervention: Food Safety and Security Monitoring

The grants for Food Safety and Security Monitoring provide funding to Food Emergency Response Network chemistry laboratories, laboratories essential to intervention efforts. The grants may be used for facility upgrades, training in current food testing methodologies, and increased laboratory sample analysis capacity, among other activities. In the event of a large-scale chemical terrorism event affecting food or food products, the recipient may be required to perform selected chemical analyses of food samples collected by the FDA or provided by other government agencies through the FDA. The states receiving these grants were Colorado, California and Ohio and were given up to $350,000.

Intervention: Innovative Food Defense

The Innovative Food Defense grants will generate novel solutions and outreach to address gaps in, or provide enhancement to, food defense nationwide -- for example, implementing the food defense programs in food establishments called the Assure, Look, Employees, Reports, and Threat or ALERT, and Employees Follow, Inspect, Recognize, Secure, and Tell or FIRST. Each recipient was awarded up to $40,000. The funded counties were Riverside County Dept. of Environmental Health (California) and Multnomah County Department of Health (Ore.). The funded states were Pennsylvania and South Carolina.

Response: Rapid Response Teams

The first-ever Rapid Response Team (RRT) cooperative agreement will develop, implement, exercise and integrate an all-hazards food and food-borne illness response capability to more rapidly react to potential threats to our food supply. The RRT, which is designed to operate in conjunction with other food and feed agencies within state programs, other state RRTs, FDA district offices, and state emergency operations centers, is another tool to enhance response capabilities.

The RRTs will respond to all food hazard incidents in the farm-to-table continuum of food production and delivery by using incident command structure response protocols, a formalized crisis management system. Each recipient was awarded up to $500,000 to exercise its response team, conduct a program assessment, purchase additional equipment and supplies, fund personnel, train, and share information and data as appropriate. The funded states were North Carolina, Massachusetts, California, Michigan, Florida and Minnesota.

Food Protection Plan

http://www.fda.gov/oc/initiatives/advance/food/plan.html

http://www.fda.gov/oc/initiatives/advance/food.html

Source: FDA Press Release

At a regular meeting of the Independent Citizens’ Oversight Committee (ICOC), the 29 member governing board of the California Institute for Regenerative Medicine (CIRM), the state stem cell agency, the members voted to accept a policy for loaning money to for-profit and not-for-profit organizations, an integral part of CIRM’s effort to strengthen California’s biotechnology industry and create collateral economic benefits such as high-paying jobs and increased tax revenues.

The goal of a loan program is to fund the translation of research into research tools, medical diagnostics and devices, and therapeutic products. These loans will be targeted at the funding gaps in product development that will serve to leverage participation by follow-on investors, such as venture capital and other capital markets, and result in more products that enter the market.

Robert Klein, chairman of the ICOC, said the proposed loan program is critical for expanding the funds available for translating discoveries into therapies. “These loans will help ensure that stem cell researchers have the funding for technologies they need to take their basic research to patients. We’re pleased that the loans will have additional economic benefits for California, and will bring funds back to CIRM to reinvest in more stem cell research,” he said.

About CIRM

CIRM was established in early 2005 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 229 research and facility grants totaling more than $614 million, making CIRM the largest source of funding for human embryonic stem cell research in the world. For more information, please visit www.cirm.ca.gov.

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

The FDA's paper, "An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in the FDA's spontaneous adverse event reporting system," documents that during the course of long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. From this data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis (ALS) in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," said Dr. Avigan.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, Chief of the Division of Epidemiology, Stanford University School of Medicine, and colleagues at the Division of Research, Kaiser Permanente. Results from this study should be available within 6-9 months. FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins. For a copy of the analysis, visit: Colman E, Szarfman A, Wyeth J, et al. An evaluation of a data mining signal for amyotrophiclateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system. Pharmacoepidemiol Drug Saf 2008; DOI: 10.1002/pds.1643; http://www3.interscience.wiley.com/journal/121395851/abstract.

Source: FDA Press Release

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01892.html

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years. The contract is the cornerstone of the FDA’s Information Technology for the 21st Century (ICT21) bioinformatics initiative, an extensive IT modernization program encompassing data management, data warehousing, IT infrastructure and IT security.

"This contract sets the stage for the FDA to have IT to acquire, analyze and act on data critical for import protection, food protection and medical product safety plans," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "We are creating a high-tech, efficient, data management system designed to meet the needs of those who must accomplish our mission -- protecting and promoting the health of the American public."

The contracts, with a minimum value of $25,000 in orders per contractor, were awarded to: Buccaneer, of Warrenton, Va.; Computer Sciences Corporation, Rockville, Md.; Dynanet, of Elkridge, Md.; Electronic Data Systems, Herndon, Va.; General Dynamics, Fairfax, Va.; Human Touch, McLean, Va.; IDL-Pragmatics, Vienna, Va.; Interactive Technology Solutions, Silver Spring, Md.; Telesis, Rockville, Md.; and Unisys, Reston, Va.

The ten contractors will compete for data information technology task orders through this contract. The FDA has awarded three task orders under the ICT 21 contract for the design and migration of all systems applications to two new data centers, which will be the cornerstone of the FDA IT infrastructure and bioinformatics modernization for the next decade. The three task orders were awarded to:

--IT Solutions (Task Order 1 - funded initially at $3,000,000) provides the design and implementation as well as migration of existing FDA applications to the newly configured White Oak Data Center, which will support all FDA test and development applications.

--Buccaneer (Task Order 2 - funded initially at $3,000,000) provides the operations and maintenance of the White Oak Data Center.

--EDS (Task Order 3 - funded initially at $12,000,000) provides the design, implementation, migration and operations and maintenance of existing FDA applications to a Contractor Owned Contractor Operated hosted data center for FDA production operations.

All FDA software applications and hosting operations will transition to the new data centers over a two-year period. The resulting enhanced computing power and greater responsiveness will provide the FDA with the tools it needs to ensure that all products reaching the American public are safer and more effective.

Source: FDA Press Release

"AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "It is an example of how advancements in science and technology are leading to new medical care diagnostics."

AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patient's blood sample.

Specifically the test measures gene expression—or how DNA transcribes its genetic instructions to RNA, the nucleic acid that translates and carries out those instructions—of 20 different genes, resulting in a score that indicates whether a heart transplant patient is unlikely to be rejecting the new organ.

Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.

Following a heart transplant, physicians regularly monitor patients for transplant rejection, a significant risk to patient survival. Rejection occurs when the patient's immune system fails to accept the new organ and begins to attack it. Successful heart transplants depend on a balanced immune system response—a response that is suppressed enough to accept the new organ but strong enough to protect the patient from infections.

Clinicians often rely on heart biopsy to gauge whether a patient is rejecting the transplanted heart. However, biopsies are difficult to perform and can be risky for the patient.

According to the National Heart, Lung and Blood Institute, half of all possible rejections happen during the first six weeks after surgery and 25 percent of patients have signs of possible rejection at least once during the first year following a transplant.

XDx Inc. developed AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S. heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study.

According to the American Heart Association, there were more than 2,000 heart transplants performed in the United States during 2006.

AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.

XDx Inc. is located in Brisbane, Calif.

Source: FDA Press Release

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01877.html

An international team of researchers has identified just 200 positions within the curves of the DNA helix that they believe capture much of the genetic diversity in European Americans, a population with one of the most diverse and complex historic origins on Earth. Their findings narrow the search for the elusive ancestral clues known as single nucleotide polymorphisms, or SNPs, that cause disease and account for the minute variations in the European American population.

“With this study, we looked at a very large population to determine how each individual could be stratified based on his or her  DNA,” said Petros Drineas, assistant professor of computer science at Rensselaer Polytechnic Institute and one of the two lead authors of the study. The researchers can now begin to analyze each SNP to understand the possible biological significance of those genetic, ancestral differences.

The research, which was published in the July 2008 edition of PLoS Genetics, is the first to isolate genetic ancestral clues based on a method that is purely computational, requiring no previous personal history. The other lead author of the study is Peristera Paschou of the Democritus University of Thrace in Greece.

The researchers plan to use the data to determine if any of the approximately 200 ancestry informative SNPs that they have identified change the way the body develops. “We want to see if the SNPs tied to a specific ancestry hold any biological significance to populations of different origins. We want to see if the SNPs that we isolated are related to natural selection and adaptation, for example to the weather conditions of different regions,” Drineas said. To help do so, the research team will move from the computer lab to the biology lab for further study.

In addition, the researchers hope that their findings will help narrow down the search for those SNPs that cause disease, according to Drineas.

Our genes are being increasingly linked to our susceptibility to certain diseases. Today, scientists are on the prowl to isolate and understand these “weakest links” in our DNA. With the discovery of each tiny SNP that is linked to specific diseases, researchers come closer to understanding our predisposition to certain diseases, as well as to developing cures.

However, SNPs linked to disease account for only a minuscule fraction of the estimated 10 million SNPs found in the human genome. Scientists have made great strides to narrow down the genetic playfield to just the genetic variations that cause disease, but other minor genetic variations like ancestry are only recently being accounted for. With this study, researchers will be able to quickly and inexpensively identify the genes linked to ancestry and unrelated to disease, and remove many of them from contention as causes of disease, thus greatly narrowing the search.

With this method, the researchers did not need prior information from the participants regarding their ancestry, which is required for most current genetic population studies. “Because this method is purely computational and leverages linear algebraic methods such as Principal Components Analysis, without the use of information on self-reported ancestry, we were able to treat the data as a black box,” Drineas said. Drineas does note that such self-reporting in genetics studies remains a fairly accurate and important way to trace ancestry, but is often difficult in populations as varied as European Americans.

The European American population was chosen because its genetic background, reflecting its historic origins, is among the most complex on the planet, requiring fine resolution characterization of the genetic code in order to define genetic structure, according to Drineas.

The researchers analyzed 1,521 individuals for more than 300,000 SNPs across the entire genome. The data were made available by the National Institute of Neurological Disorders and Stroke (NINDS) as well as the CAP (Cholesterol and Pharmacogenetics) and PRINCE (Pravastatin Inflammation/CRP Evaluation) studies. The team used linear algebra to find patterns in the highly diverse data. When the data sets were analyzed using the proposed algorithms, these patterns pointed to SNPs shared between groups from the same ancestral background.

“Much of the genetic variation was found to stretch between two ‘points’ – what we speculate is the Northern European to Southern European ancestry axis,” according to Drineas and Paschou. Importantly, their study removes any redundant SNPs uncovered during the modeling process, better targeting the most informative SNPs and reducing genotyping cost.

Drineas and Paschou were assisted in the research by Rensselaer graduate student Jamey Lewis; Caroline M. Nievergelt of the Scripps Research Institute and the University of California at San Diego; Deborah A. Nickerson and Joshua D. Smith of the University of Washington; Paul M. Ridker and Daniel I. Chasman of Brigham and Women’s Hospital; Ronald M. Krauss of the Children’s Hospital of Oakland Research Institute; and Elad Ziv of the University of California San Francisco.

The research was funded in part by a National Science Foundation (NSF) CAREER award to Drineas and a grant from the National Institutes of Health (NIH).

Source: Rensselaer Polytechnic Institute Press Release

For public health, the complexity of cancer control has increased enormously following the shift of the disease burden from wealthy to less affluent countries. Cancer causes around 7.9 million deaths worldwide each year. Of these deaths, more than 72% are now occurring in low- and middle-income countries. This is a shocking statistic, with huge implications for human suffering, health systems, health budgets, and the drive to reduce poverty.

Today, cancer touches every country in the world, sometimes in deeply disturbing ways. The time is right to make cancer control a development priority.

Diseases like cancer are a leading cause of so-called catastrophic health expenditure. This is especially true in low- and middle-income countries, where most people rely on out-of-pocket payments for health care. WHO estimates that catastrophic payments for health care push an estimated 100 million people below the poverty line each year. For cancer, out-of-pocket payment is a double-edged sword. It discourages people from seeking treatment early, when the chances of cure are greatest. And it deepens household and community poverty.

Health systems in developing countries can usually cope with the intermittent emergencies caused by infectious diseases. The patient either survives or dies. In contrast, the demands of chronic care can push a fragile health system to the breaking point. First-rate interventions – and the money to buy them – will have little impact in the absence of systems for their delivery.

For cancer control in low- and middle-income countries, breakthroughs do not come in the form of spectacular new drugs for cure. True breakthroughs come when research shows how existing tools can be adapted to work well in resource-poor settings.

Unfortunately, virtually no country in the world is doing enough to prevent cancer. Tobacco control is the world’s best opportunity to prevent cancer on a grand scale.

Developing countries are now face-to-face with problems that affluent countries confronted decades ago. Policies were devised. Lessons were learned. Clinical advances raced ahead. Incidence rates for some cancers dropped, while survival rates dramatically improved. These experiences need to be shared as urgently as possible. We are not starting from scratch. Screening programmes, diagnostic tests, and treatments are costly. But with the shift in the cancer burden, a nation’s resource level can no longer be viewed as a barrier to cancer control.

There is too much at stake – for health and economic development, for equity and social justice, for human suffering, and for the dignity of human life.

Source: WHO Press Release

CIRM applauds the creativity and value in the research reported and shares the excitement in the promise it might hold. However, it emphatically refutes assertions by opponents of embryonic stem cell research that this new study proves embryonic stem cell research is not necessary. In fact, the Harvard study poignantly points out the value of embryonic stem cell research.

Asked if his new findings eliminate the need for work with hESC and iPS cells, the lead Harvard researcher, Doug Melton, said: "This is a point I want to stress: We are continuing to do research using human embryonic stem cells and iPS cells. We would not be where we are today without having worked with human embryonic stem cells. These unique cells provide a window into human development, and disease development, that is needed if we are to make further progress in understanding and treating chronic diseases. They remain the key to long-term progress in regenerative medicine.”

The research reported in Nature is a major advance but it has significant limitations. It can be considered a type of gene therapy and has many of the same limitations and concerns that have been identified in the field of gene therapy. The genes that reprogrammed the cells were carried into the cells by adenoviruses, which have caused severe immune reactions in gene therapy. The mice in this study were immune compromised mice, so that complication was not seen in this model, but to-date has proven difficult to overcome in humans.

The cells that were reprogrammed in this study were relatively similar to insulin producing cells already; they and insulin producing cells both develop from a common precursor cell. For many diseases for which stem cell therapy holds out hope of major therapeutic advances, such similar neighboring cells may not exist or may not respond in a similar manner.

Melton’s work was clearly fostered by knowledge gained from embryonic stem cell research and from the reprogramming of skin cells to by embryonic-like stem cells, so called induced Pluripotent Stem Cells (iPS). The paper is an eloquent example of value in, and critical need for, pursuing all avenues of regenerative medicine. The knowledge gained by being able to watch cells mature from the embryonic state to functional neurons, pancreatic cells, or heart muscle will accelerate all efforts to find cures for the Parkinson’s patients, diabetics, and heart failure victims that so desperately need those cells functioning well.

About CIRM

CIRM was established in early 2005 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. To date, the CIRM governing board has approved 229 research and facility grants totaling more than $614 million, making CIRM the largest source of funding for human embryonic stem cell research in the world. For more information, please visit www.cirm.ca.gov.

The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database.

It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

"The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, which oversees medical diagnostics. "In the past, scientists have classified different types of cancers based on the organs in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells."

The Pathwork Tissue of Origin test is the second in vitro diagnostic multivariate index assay (IVDMIA) device to be cleared by the FDA. In July 2007, the FDA issued a draft guidance document to address premarket pathways and postmarket requirements for IVDMIAs. IVDMIA tests combine the values of multiple variables to yield a single, patient-specific result.

Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.

Microarray technology can simultaneously measure gene expression levels of large numbers of genes. Small DNA fragments are placed or arrayed on a slide and then RNA, which has been extracted from the tumor tissue and labeled with a fluorescent marker, is spread over this "microarray."

Since RNA binds to its complementary DNA strand, how much binding occurs indicates how active the gene being evaluated is. This can be determined by putting the array under a scanning microscope and measuring the intensity of the fluorescent light at each point on the array.

Pathwork’s proprietary software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types.

The Pathwork Tissue of Origin test has been found to provide patterns that confirm existing tissue of origin of the 15 common tumor types using standard clinical and pathological information. This accuracy of this test is similar to that achieved by expert pathologists using current standards of practice.

PathChip, the gene expression array used in the Pathwork Tissue of Origin test, is custom-designed for Pathwork Diagnostics of Sunnyvale, Calif., by Affymetrix Inc., of Santa Clara, Calif. PathChip is the first custom Affymetrix gene expression array to be cleared for diagnostic use.

Source: FDA Press Release

--Tongue Drive is inherently wireless and touch-free because it relies on a tiny magnetic tracer attached to the tongue with no power consumption--

Researchers have developed an experimental tongue-based system that may allow individuals with debilitating disabilities to control wheelchairs, computers and other devices with relative ease and no sophistication.

Because the tongue is directly connected to the brain via cranial nerves, it usually remains mobile when other body parts lose function to disease or accidents. That mobility underlies the new system, which may one day provide greater flexibility and simplicity to individuals who would otherwise use sip-and-puff controls or brain implants.

Electrical engineer Maysam Ghovanloo developed the Tongue Drive system in collaboration with graduate student Xueliang Huo and presented the findings June 29 at the 2008 Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) Annual Conference in Washington, D.C.

"Tongue Drive is inherently wireless and touch-free because it relies on a tiny magnetic tracer attached to the tongue with no power consumption," said Ghovanloo. "Tongue movements are also fast, accurate and do not require much thinking, concentration or effort."

Developed with funding from the National Science Foundation and additional support from the Christopher and Dana Reeve Foundation, the technology is already showing speed and flexibility that rivals or surpasses other technologies.

For further details regarding the Tongue Drive, see the Georgia Tech press release at: http://gtresearchnews.gatech.edu/newsrelease/tongue-drive.htm.

In three states – Alabama, Mississippi, and Tennessee – the prevalence of self-reported obesity among adults age 18 or older was above 30 percent. Colorado had the lowest obesity prevalence at 18.7 percent. Obesity is defined as a body mass index (BMI) of 30 or above. BMI is calculated using height and weight. For example, a 5-foot, 9-inch adult who weighs 203 pounds would have a BMI of 30, thus putting this person into the obese category.

The data were derived from CDC′s Behavioral Risk Factor Surveillance System, a state-based telephone survey that collects information from adults aged 18 years and older. For this survey more than 350,000 adults are interviewed each year, making BRFSS the largest telephone health survey in the world. BMI was calculated based on this self-reported information.

“The epidemic of adult obesity continues to rise in the United States indicating that we need to step up our efforts at the national, state and local levels,” said Dr. William Dietz, director of CDC's Division of Nutrition, Physical Activity, and Obesity. “We need to encourage people to eat more fruits and vegetables, engage in more physical activity and reduce the consumption of high calorie foods and sugar sweetened beverages in order to maintain a healthy weight.”

The study found that obesity is more prominent in the South, where 27 percent of respondents were classified as obese. The percentage of obese adults was 25.3 in the Midwest, 23.3 percent in the Northeast, and 22.1 percent in the West.

By age, the prevalence of obesity ranged from 19.1 percent for men and women aged 19-29 years to 31.7 and 30.2 percent, respectively, for men and women aged 50-59 years.

“Obesity is a major risk factor for a number of chronic diseases such as type 2 diabetes, heart disease and stroke. These diseases can be very costly for states and the country as a whole,” said Deb Galuska, associate director for science for CDC′s Division of Nutrition, Physical Activity and Obesity.

For more information on obesity trends, including an animated map, visit http://www.cdc.gov/nccdphp/dnpa/obesity/trend/maps

NEW YORK -- Michael Bloomberg and Bill Gates today announced joint efforts to combat the global tobacco epidemic. A combined investment of $500 million will help governments in developing countries implement proven policies and increase funding for tobacco control. Unless urgent action is taken, as many as one billion people this century—more than two-thirds in the developing world—could die from tobacco-caused illnesses. Paula Johns, executive director of Brazil's Alliance for the Control of Tobacco Use, and broadcast journalist Charlie Rose joined Bloomberg and Gates for the announcement.

Bloomberg's Initiative to Reduce Tobacco Use, which was established in 2005 and includes a $125 million commitment, will be extended with a new $250 million, four-year commitment. This brings Bloomberg's total commitment to date to more than $375 million.

The Bill & Melinda Gates Foundation announced that it will invest $125 million over five years to fight the tobacco epidemic, including a $24 million grant to the Bloomberg Initiative. In addition to the grant to Bloomberg, the Gates Foundation will support complementary efforts to reduce high rates of tobacco use in countries such as China and India, as well as to help prevent the tobacco epidemic from taking root in Africa.

The Bloomberg Initiative supports projects that increase tobacco tax, change the image of tobacco, protect nonsmokers from exposure to other people's smoke and help people quit. The Initiative supports the public sector's efforts to educate and advocate for change, and a rigorous tobacco use and policy monitoring system. The Gates Foundation funding to Bloomberg will accelerate implementation of the MPOWER package of proven tobacco control strategies and build economic evidence to support tobacco control over the next two years.

"When I announced this initiative, I said that I hoped others would step forward," said Bloomberg. "I'm delighted Bill and Melinda Gates are supporting one of the most important public health efforts of our time. Our commitments will help governments confront the tobacco epidemic by implementing the proven MPOWER package. This means assuring well-staffed tobacco control programs, raising tobacco taxes, running hard-hitting public information campaigns, creating comprehensive smoke-free public places and banning tobacco advertising."

"Tobacco-caused diseases have emerged as one of the greatest health challenges facing developing countries," said Bill Gates, co-chair of the Gates Foundation. "The good news is, we know what it takes to save millions of lives, and where efforts exist, they are working. We are pleased to join with Mayor Bloomberg, who has made the fight against tobacco a priority in New York City and around the world."

Bloomberg and Gates called on government and business leaders to make the fight against tobacco a higher priority by increasing resources for tobacco control and implementing proven policies to reduce tobacco use. According to the World Health Organization, 3.9 billion people live in low-and-middle-income countries that spend less than $20 million dollars per year combined on tobacco control. Today, these same countries collect more than $66 billion in tobacco taxes.

When New York City went smoke-free in 2002, only one state and no countries were smoke-free. Today many states and countries are smoke-free. Success stories in tobacco control are emerging from around the globe: 

24 states (including New York and Washington states) and the District of Columbia now have laws in effect that require 100% smoke free restaurants and bars.

Uruguay, UK, France, New Zealand, Italy and Ireland are all smoke-free.

Cities such as Mexico City, Mexico; Abuja, Nigeria; Beijing, China; and other Olympic cities are implementing smoke-free laws and regulations.

Uruguay, Turkey and other countries are implementing the comprehensive tobacco control policies of the MPOWER package.

Egypt has recently raised its tobacco tax.

Brazil and other countries are using graphic pictorial warnings on cigarette packs to warn the public about the dangers of smoking.

The Philippines has enacted a ban on tobacco advertising in all forms of mass media.

Earlier this year, Bloomberg and World Health Organization Director-General Margaret Chan released the U.N.'s evidence-based MPOWER package to help governments adopt the most effective measures to counter tobacco use. Although MPOWER has been proven to rapidly decrease tobacco use and save lives in New York City and elsewhere, less than 5 percent of the world's population is covered by any of the MPOWER interventions.

The six components of the MPOWER package are:

Monitor tobacco use and the policies to prevent it

Protect people from tobacco smoke

Offer people help to quit tobacco use

Warn about the dangers of tobacco

Enforce bans on tobacco advertising, promotion and sponsorship

Raise taxes on tobacco

"Bill and I want to highlight the enormity of this problem and catalyze a global movement of governments and civil society to stop the tobacco epidemic," said Bloomberg. "We challenge governments to show leadership by implementing tobacco control measures, as an increasing number are doing, and to increase funding for these efforts."

Tobacco Background

There are more than 1 billion smokers in the world today (more than 1 in 4 adults), and tobacco kills more people than any other single agent.

 Smoking kills half of smokers unless they quit, and many more are disabled by tobacco. Those killed by tobacco lose on average 10-15 years of life. Second-hand smoke causes lung disease, cancer, low birth weight and increased infant death as well as other problems in those exposed.

 More than 5 million people are killed by tobacco each year – more than AIDS, tuberculosis and malaria combined. In this century, unless urgent action is taken tobacco could kill more than 1 billion people. More than 80 percent of the world’s tobacco-related deaths will be in low- and middle-income countries by 2030. The poorest households in Bangladesh spend almost 10 times as much on tobacco as on education.

 Medical costs from smoking impoverish more than 50 million people in China; with 350 million smokers – a third of the world’s total – China suffers about a million deaths from tobacco each year.

Indonesians spend on average 2.5 times more on tobacco than on education, and 3.2 times more on tobacco than on health. Traditionally viewed as unacceptable practice, smoking among Indonesian women is now seen as modern and trendy, especially in large cities.

India's toll of premature, tobacco-related deaths is expected to rise from 700,000 annually to 930,000 by the year 2010, with bidis currently accounting for 77 percent of the market for smoked tobacco. Studies indicate that bidi smokers are five to six times more likely to develop lung cancer than nonsmokers.

The effectiveness of tobacco control interventions is well established by rigorous scientific studies; implementing proven programs can reduce smoking rates where they are high and prevent an increase where rates are low.

About the Bloomberg Initiative

The Bloomberg Initiative to Reduce Tobacco Use supports public sector and civil society efforts to implement proven strategies in tobacco control in low- and middle-income countries, particularly China, India, Indonesia, Russian Federation and Bangladesh.The Bloomberg Initiative supports training programs, journalism workshops, in-country development of mass media public education campaigns, capacity building and global monitoring through a WHO report on country-specific tobacco control policies and a population-based, house-to-house adult survey of tobacco use prevalence.

One aspect of the Bloomberg Initiative is to provide tobacco control funds to low- and middle-income countries through a competitive grants program (http://www.tobaccocontrolgrants.org/ ); more than 125 grants have been awarded in 36 countries.

 The Bloomberg Initiative to Reduce Tobacco Use is implemented though five partner organizations: the Campaign for Tobacco Free Kids, the Centers for Disease Control and Prevention Foundation, the Johns Hopkins Bloomberg School of Public Health, the World Health Organization and the World Lung Foundation.

Tobacco Control in New York City

 New York City's tobacco control program has included raising the tobacco tax, making virtually all workplaces smoke-free, running hard-hitting public education campaigns, helping smokers quit and rigorously monitoring smoking rates and program results. For the 10 years before New York City's program was implemented, there was no decrease in smoking rates. Between 2002 and 2007, under Bloomberg's leadership, New York City's comprehensive program reduced adult smoking by 300,000 smokers, from 21.6% to 16.9%, preventing 100,000 deaths in years to come. Teen smoking decreased from 17.6 percent in 2001 to 8.5 percent in 2007, a level nearly two-thirds lower than the latest available national teen smoking rate.

Bill & Melinda Gates Foundation

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Patty Stonesifer and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

About Mozobil

Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006

Important Clinical Role

Mozobil is designed to mobilize stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for a patient with certain types of cancers to receive a successful transplant. Specifically, patients with non-Hodgkin’s and Hodgkin’s lymphomas and multiple myeloma often receive high-dose chemotherapy, a process that destroys bone marrow. A stem cell transplant is required to replenish blood-forming bone marrow cells destroyed by high-dose chemotherapy. Stem cells differentiate into the mature red blood cells, white blood cells, and platelets that a healthy person needs.

Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs, called growth factors, to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are easier to collect in preparation for a transplant.

In order for the transplant to take place, a minimum number of approximately 2 million cells per kilogram of body weight must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible.

Genzyme conducted two phase 3 studies that confirmed the potential of Mozobil to effectively and predictably prepare lymphoma and multiple myeloma patients for an autologous transplant. Both studies successfully met primary and secondary endpoints. Patients who received Mozobil in conjunction with a growth factor achieved more rapid and effective mobilization of stem cells in preparation for autologous transplant than patients treated with growth factor alone. In addition, more patients treated with Mozobil plus a growth factor achieved a composite endpoint of optimal stem cell collection and successful transplantation, compared to patients mobilized with placebo plus a growth factor. Mozobil was well tolerated in both trials, with the most common adverse events being gastrointestinal effects and injection site reactions.

“There is a lot of excitement among treating physicians about Mozobil,” said Mark Goldberg, M.D., senior vice president of clinical research at Genzyme. “The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients.”

More than 900 patients have received Mozobil through a compassionate use program in the United States, and similar compassionate use programs have recently begun in Europe.

Commercialization Plans

Genzyme plans to launch Mozobil in the U.S. and Europe in 2009. Upon commercial launch, Mozobil will be marketed and sold by Genzyme’s existing Transplant sales force, which has a commercial presence in more than 55 countries worldwide. In addition, the company will leverage its Oncology business and clinical infrastructure.

Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin’s and non-Hodgkin’s lymphoma, and other conditions in markets where Genzyme has a commercial infrastructure, including the United States, Europe, Latin America and the Asian Pacific countries. Genzyme believes that over time, Mozobil will be used in the majority of these procedures, and peak sales of the product in the transplant setting are expected to reach $400 million annually.

In addition to the patient benefit, Mozobil also may offer significant economic benefits for transplant centers. Mozobil has the potential to decrease the number of apheresis days and provide transplant centers with more predictable and efficient use of the apheresis center, while reducing the number of patients who may fail to mobilize sufficient numbers of cells and therefore require a second mobilization procedure.

Additional Therapeutic Opportunities

Numerous Genzyme and investigator-sponsored trials are planned or underway to study Mozobil’s use in other settings such as allogeneic hematopoietic stem cell transplants. Genzyme is also studying the use of Mozobil to improve the efficacy of chemotherapy and/or immunotherapy in various types of hematologic malignancies such as chronic lymphocytic leukemia and acute myelogenous leukemia, and is pursuing preclinical work to explore the role that Mozobil may play in cord blood transplantation, solid organ transplantation, cardiovascular disease, renal ischemic disease, and a variety of additional types of solid tumor malignancies.

“We’re just beginning to unlock the potential of Mozobil,” said Joseph Lobacki, senior vice president of the Transplant business unit at Genzyme.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme® and AnorMED® are registered trademarks of Genzyme Corporation or its subsidiaries. Mozobil™ is an unregistered trademark of Genzyme Corporation or its subsidiaries. All rights reserved.

Source: Genzyme Press Release

The Sentinel System will enable FDA to query multiple, existing data sources, such as electronic health record systems and medical claims databases, for information about medical products. The system will enable FDA to query data sources at remote locations, consistent with strong privacy and security safeguards.  Data sources will continue to be maintained by their owners.

This historic new system will strengthen FDA's ability to monitor the performance of a product throughout its entire life cycle, thus enhancing the protection and promotion of public health. Such a system could also ultimately facilitate data mining and other research-related activities.

As envisioned, the Sentinel System can be achieved with minimal transfer of data, using tools and processes that will ensure the protection of patient information.

http://www.fda.gov/oc/initiatives/advance/reports/report0508.html

MDR-TB is a form of TB that responds poorly to standard treatment because of resistance to the first-line drugs isoniazid and rifampicin. At present it is estimated that only 2% of MDR-TB cases worldwide are being diagnosed and treated appropriately, mainly because of inadequate laboratory services. The initiatives announced today should increase that proportion at least seven-fold over the next four years, to 15% or more.

"I am delighted that this initiative will improve both the technology needed to diagnose TB quickly, and increase the availability of drugs to treat highly resistant TB," said British Prime Minister Gordon Brown, who helped launch the Stop TB Partnership's Global Plan to Stop TB in 2006 and whose government is a founding member of UNITAID. "The UK is committed to stopping TB around the world, from our funding of TB prevention programmes in poor countries, to our support of cutting edge research to develop new drugs."

In developing countries most TB patients are tested for MDR-TB only after they fail to respond to standard treatments. Even then, it takes two months or more to confirm the diagnosis. Patients have to wait for the test results before they can receive life-saving second-line drugs. During this period, they can spread the multidrug-resistant disease to others. Often the patients die before results are known, especially if they are HIV-infected in addition to having MDR-TB.

The initiative comes just one week after WHO recommended "line probe assays" for rapid MDR-TB diagnosis worldwide. This policy change was driven by data from recent studies, including a large field trial -- conducted by FIND together with South Africa's Medical Research Council and National Health Laboratory Services -- which produced evidence for the reliability and feasibility of using line probe assays under routine conditions.

"Five months ago, WHO renewed its call to make MDR-TB an urgent public health priority," said WHO Director-General Dr Margaret Chan, "and today we have evidence to guide our response. Based on that evidence, we are launching these promising initiatives."

Two projects

The new initiative consists of two projects. The first, made possible through US$ 26.1 million in funding from UNITAID, will introduce a molecular method to diagnose MDR-TB that until now was used exclusively in research settings. These rapid, new molecular tests, known as line probe assays, produce an answer in less than two days.

Over the next four years -- as lab staff are trained, lab facilities enhanced and new equipment delivered -- 16 countries will begin using rapid methods to diagnose MDR-TB, including the molecular tests. The countries will receive the tests through the Stop TB Partnership's Global Drug Facility, which provides countries with both drugs and diagnostic supplies.

As part of the project, WHO's Global Laboratory Initiative and FIND will help countries prepare for installation and use of the new rapid diagnostic tests, ensuring necessary technical standards for biosafety and the capacity to accurately perform DNA-based tests. One country, Lesotho, is already equipped to start using these tests; Ethiopia is expected to be ready by the end of 2008. The tests will be phased in during 2009-2011 in the remaining 14 countries.

Under a second, complementary agreement with UNITAID for US$ 33.7 million, the Global Drug Facility will boost the supply of drugs needed to treat MDR-TB in 54 countries, including those receiving the new diagnostic tests. This project is also expected to achieve price reductions of up to 20% for second-line anti-TB drugs by 2010. All the countries receiving this assistance have met WHO's technical standards for managing MDR-TB and already have treatment programmes in place. Some will use grants from the Global Fund against AIDS, Tuberculosis and Malaria to purchase the drugs.

"Through the US$ 60-million support provided by UNITAID, these projects are expected to produce significant results in diagnosing and treating patients as well as reducing drug prices and the costs of diagnosis. These efforts illustrate the way in which innovative financing can be deployed for health and development," said Philippe Douste-Blazy, Chairman of UNITAID's Executive Board.

Source: WHO Press Release

Diabetes now affects nearly 24 million people in the United States, an increase of more than 3 million in approximately two years, according to new 2007 prevalence data estimates released today by the Centers for Disease Control and Prevention (CDC). This means that nearly 8 percent of the U.S. population has diabetes.

In addition to the 24 million with diabetes, another 57 million people are estimated to have pre-diabetes, a condition that puts people at increased risk for diabetes. Among people with diabetes, those who do not know they have the disease decreased from 30 percent to 25 percent over a two-year period.

“These new estimates have both good news and bad news,” said Dr. Ann Albright, director of the CDC Division of Diabetes Translation. “It is concerning to know that we have more people developing diabetes, and these data are a reminder of the importance of increasing awareness of this condition, especially among people who are at high risk. On the other hand, it is good to see that more people are aware that they have diabetes. That is an indication that our efforts to increase awareness are working, and more importantly, that more people are better prepared to manage this disease and its complications.”

Diabetes is a disease associated with high levels of blood glucose resulting from defects in insulin production that causes sugar to build up in the body. It is the seventh leading cause of death in the country and can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations.

Among adults, diabetes increased in both men and women and in all age groups, but still disproportionately affects the elderly. Almost 25 percent of the population 60 years and older had diabetes in 2007. And, as in previous years, disparities exist among ethnic groups and minority populations including Native Americans, blacks and Hispanics. After adjusting for population age differences between the groups, the rate of diagnosed diabetes was highest among Native Americans and Alaska Natives (16.5 percent). This was followed by blacks (11.8 percent) and Hispanics (10.4 percent), which includes rates for Puerto Ricans (12.6 percent), Mexican Americans (11.9 percent), and Cubans (8.2 percent). By comparison, the rate for Asian Americans was 7.5 percent with whites at 6.6 percent.

The data are an update of diabetes prevalence estimates last reported two years ago and now published in the 2007 National Diabetes Fact Sheet developed by CDC in collaboration with multiple agencies under the U.S. Department of Health and Human Services and other federal agencies.

CDC also is releasing estimates of diagnosed diabetes for all counties in the United States. Derived from the agency's Behavioral Risk Factor Surveillance Survey (BRFSS) and census data, the estimates provide a clearer picture of areas within states that have higher diabetes rates. Nationally, the data indicate increased diabetes rates in areas of the Southeast and Appalachia that have traditionally been recognized as being at higher risk for many chronic diseases, including heart disease and stroke.

“These data are an important step in identifying the places in a state that have the greatest number of people affected by diabetes,” said Dr.Albright. “If states know which communities or areas have more people with diabetes, they can use that information to target their efforts or tailor them to meet the needs of specific communities.”

CDC, through its Division of Diabetes Translation, funds diabetes prevention and control programs in all 50 states, as well as the District of Columbia and eight U.S. territories and island jurisdictions. The National Diabetes Education Program, co-sponsored by CDC and the National Institutes of Health (NIH), provides diabetes education to improve the treatment and outcomes for people with diabetes, promote early diagnosis, and prevent or delay the onset of diabetes.

For more information on diabetes, please visit www.cdc.gov/diabetes . To access the National Diabetes Fact Sheet and county-level estimates of diagnosed diabetes, click on the "data and trends" link at the left.

Source: CDC Press Release

"We're learning more about the complexities of the illness that is chronic fatigue syndrome," said William C. Reeves, M.D., Chief of the Chronic Fatigue Syndrome Research Program at CDC. "Launching this research study with Emory will help us draw a clearer picture of how CFS affects people that ultimately could lead to more effective treatment of patients with CFS."

Each designated participant will spend three days at Emory University Hospital General Clinical Research Center (GCRC). Participants will undergo repeated blood draws and salivary sampling in addition to computerized testing and functional Magnetic Resonance Imaging (fMRI) of the brain. The study is planned to be completed within a year.

CFS, a condition characterized by fatigue, memory problems, and pain, may be more widespread than once thought. Experts estimate that between one and four million people in the United States may suffer from CFS. Unfortunately, an estimated 80 percent of all CFS patients have not yet been diagnosed by a medical provider.

The CDC-Emory study is designed to evaluate mechanisms of the illness with an emphasis on alterations in the regulation of hormones and the immune system as well as alterations in the brain circuits involved in cognitive function and mental fatigue. The molecular and genetic aspects of these alterations will also be explored.

"We believe this research will lead us to a better understanding of the causes of CFS, both from a psychological and biological standpoint," says Andrew Miller, M.D., Timmie Professor of Psychiatry and Behavioral Sciences at Emory and Emory principal investigator of the study. "We believe that this study will open doors that may lead us to better ways of diagnosing and treating CFS in the future."

CFS – The Larger Public Health Impact

It is estimated that only half of CFS patients have sought medical attention and fewer than one in five have been diagnosed and treated. This is a particular source of concern since early treatment could be associated with a significantly higher rate of recovery. Often, patients may report symptoms like being frequently exhausted, or having difficulty sleeping and concentrating, which may be linked to many other causes.

Dr. Reeves said, "CFS is often difficult to diagnose and physicians rely on patients reporting symptoms to identify the illness. There is no disease specific laboratory test for CFS, and the diagnosis is often made through a process of eliminating other causes that may explain the patients' signs and symptoms."

CFS occurs most frequently in women ages 40-60, but affects all races, sexes, and age groups, and can be as disabling as multiple sclerosis and chronic obstructive pulmonary disease. The condition can also take a tremendous personal and social toll on patients and their families, with a quarter of those affected by CFS either unemployed or on disability assistance.

"Our economic impact studies show that a family in which someone has CFS could forego up to $20,000 a year in annual earnings and wages, and that a quarter of them are either on disability or out of work following the illness," explains Reeves. "It is a serious public health problem."

If you think you or someone you know might be suffering from CFS, consult a health care professional to learn more about options that are available for you. For more information on CFS, visit www.cdc.gov/cfs.

Milestones of Previous CFS Studies

• CDC estimates that 2.5% of Georgians ages 18-59 years suffer from chronic fatigue syndrome. This represents a six- to ten-fold higher prevalence than previous estimates from other areas. More…

• CDC estimates that the average family in which a member suffers from CFS foregoes $20,000 in annual earnings and wages, nearly half the median US household income. More…

• CDC studies reveal that early life stress and accumulated lifetime stress are strongly and significantly associated with CFS. The current study at Emory Hospital will further clarify these findings. More…

• CDC research reveals that abnormally low morning concentrations of the hormone cortisol may be correlated with more severe fatigue in CFS patients, especially in women. More…

• CDC research has demonstrated that multiple types of early childhood trauma are important risk factors for CFS. More…

• CDC has conducted numerous studies to better understand the symptoms which would be included in the definition of chronic fatigue syndrome. Ultimately, this research has provided a formal case definition for CFS and provides clinicians a guide for diagnosing patients.  

 Additional Information

CDC has a comprehensive provider education program that includes outreach nationally at conferences, grand rounds, and through on-line continuing education. This outreach is aimed at aiding providers in the diagnosis, management, and treatment of CFS.

CDC purposely attempts to publish research on CFS in open-access journals to aid the public, patients, and providers in obtaining the most up-to-date information on this illness. For more information on the studies being conducted by CDC on chronic fatigue syndrome and the resulting research, please see the CFS website: http://www.cdc.gov/cfs/cfsresearch.htm.

Source: CDC Press Release

Prostate cancer is the leading cause of cancer death in men in the U.S., with more than 230,000 cases diagnosed annually.

LabCorp licensed the methylation technology from Veridex in 2007. Veridex licensed this technology from OncoMethylome Sciences, S.A. (OMS).

About Veridex

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. For additional information, please visit http://www.veridex.com.

Biodiesel requires good-quality raw materials. Today, this usually means using rapeseed and soy, which are also used in the manufacture of food products. Now Danish researchers will develop a new technology to replace the chemical production of biodiesel with an enzymatic process that will reduce concerns about biodiesel, both for the environment and the supplies of food.

The Danish National Advanced Technology Foundation has granted DKK 15 million towards research in biodiesel over the next 3.5 years.

The leader of the project, Per Munk Nielsen from Novozymes A/S, says, ”The chemical process demands raw materials of high quality that can often also be used as food. With a process based on enzymes we will be able to use raw materials of poorer quality, such as animal fats, recycled restaurant oils, and waste products, all materials that cannot be used as food.

”We will also deliver processes that reduce the CO₂ contribution, so that in 3.5 years we will have a technology that is well documented as more environmentally friendly. The plan to document the research results includes a pilot-scale plant that will be ready at the end of the 3.5 year grant period,” Per Munk Nielsen adds.

Emmelev A/S, one of the participating companies, already produces biodiesel and sees great possibilities for the project.

"With the new enzymatic process we will be able to use many more different raw materials than we can use today, being mainly rapeseed and soy. We will be able to use waste oils that today are simply thrown away. We will produce only the main products and no by-products,” says Morten Simonsen, Sales Director at Emmelev A/S.

The five partners in the research project are three Danish research institutes, located at the Technical University of Denmark and Aarhus University, and two Danish companies, Novozymes A/S in Bagsvaerd and Emmelev A/S in Otterup.

SEATTLE -- In recognition of its groundbreaking work to prevent debilitating blindness and provide affordable, world-class eye care to the poor, the Aravind Eye Care System, based in Tamil Nadu, India, has won the 2008 Gates Award for Global Health. The $1 million Gates Award—the world's largest prize for international health—honors extraordinary efforts to improve health in developing countries.

Founded by Dr. G. Venkataswamy in 1976, Aravind has saved millions of people in India from debilitating blindness. Cataracts account for more than half the cases of blindness in India. In the past year, Aravind provided out-patient care to approximately 2.4 million patients and performed more than 280,000 surgeries. Thanks in part to Aravind's efforts, the estimated number of blind people in India fell from 8.9 million in 1990 to 6.7 million in 2002, a decline of 25%.

William H. Gates Sr., co-chair of the Bill & Melinda Gates Foundation, will present the award on May 29 at the Global Health Council's 35th Annual International Conference in Washington, DC.

"Being blind in a rural village in the developing world leaves a person in darkness and dependence, often unable to earn a living or assist in the duties of their household," said Mr. Gates. "Aravind has given sight to millions of men, women, and children, enabling them to participate fully in the lives of their families and communities."

Since 1976, Aravind has grown from a rented house with 11 beds to a thriving network of hospitals and satellite clinics that provide eye exams and surgeries, train health care professionals, conduct research, and manufacture eye care products.

Outreach teams from Aravind hospitals coordinate with local leaders and service groups across India to organize "eye camps" that provide free exams. Since 2004, Aravind has used high-speed broadband access to link these camps directly to on-call doctors in central hospitals. The doctors can diagnose and refer patients in real time, ensuring that only those who require surgery make the journey to the hospital.

"All people have a right to sight," said Dr. Perumalsamy Namperumalsamy, chairman of Aravind. "We hope that this award will encourage others to develop creative, sustainable solutions to blindness and other global health challenges."

Aravind's innovative business model enables it to provide the same high-quality care to every patient, regardless of their ability to pay, without charitable contributions. The organization enlists local businesses to sponsor eye care hospitals, and subsidizes care for the poor through fees from paying patients and global sales of eye care products.

"Ensuring that the world's poorest people can access essential health care is an ongoing challenge in global health," said Dr. Nils Daulaire, president of the Global Health Council. "Aravind has demonstrated that there are ways to do good and commit to providing the highest quality services while utilizing the latest technologies and scientific advances."

About the Gates Award for Global Health

The Gates Award for Global Health was established by Bill and Melinda Gates in 2000 to recognize exemplary work in international health. The Global Health Council coordinates the selection process for and presentation of the Gates Award at its Annual International Conference.

Previous recipients of the Gates Award include Thailand's Population and Community Development Association for its innovative work in family planning and HIV prevention (2007); the Carter Center, for its pioneering work to fight neglected diseases (2006); the African Medical and Research Foundation, for improving health in some of Africa's poorest communities (2005); the Bangladesh Rural Advancement Committee, for community-based health programs (2004); the Brazilian National AIDS Program, for its integrated approach to HIV prevention and treatment (2003); the Rotary Foundation of Rotary International, for contributions to polio eradication (2002); and the ICDDR,B Center for Health and Population Research, for the discovery of a diarrhea therapy that has saved millions of lives (2001).

Bill & Melinda Gates Foundation

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, the foundation is led by CEO Patty Stonesifer and co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

WASHINGTON, March 14—A team of researchers in Bedford, Mass. has developed a way of examining brain tissue with near-infrared light to detect signs of Alzheimer's disease.

In the March 15 issue of the journal Optics Letters, published by the Optical Society of America, the team describes how they used optical technology to examine tissue samples taken from different autopsies and correctly identified which samples came from people who had Alzheimer's disease, which currently afflicts some 4.5 million Americans and is the most common cause of dementia among older people in the United States.

"We're primarily interested in finding a way of diagnosing and monitoring Alzheimer's disease during life," says U.S. Department of Veterans Affairs Research Scientist Eugene Hanlon. "We think this technique has a lot of potential for detecting the disease early on."

The new technique developed by Hanlon and his collaborators at Harvard Medical School/Beth Israel Deaconess Medical Center and Boston University can detect alterations to the optical properties of the brain that occur as the tissue undergoes microscopic changes due to Alzheimer's—sometimes far in advance of clinical symptoms. The technique is now being tested for its effectiveness at diagnosing Alzheimer's disease in living people.

For several years, Hanlon and his colleagues have looked at the possibility of analyzing the brain with near-infrared light, which has the advantage of being able to safely penetrate the skull and pass harmlessly through the brain.  Inside the head, some of the infrared light scatters, however, and how the light scatters can tell researchers about the condition of the brain.

In their paper, the team reports observing an optical effect due to the presence of microscopic features of Alzheimer's. Amyloid plaques, one of the telltale signs of Alzheimer's disease, scatter light differently from normal brain tissue. What Hanlon and his colleagues showed was that as the microscopic plaques accumulate, the optical properties of the brain change. The team found that this change is detectable and that their technique could quantify differences between in-vitro samples and correctly identify signs of Alzheimer's.

This technique will be a boon to medicine if it is able to detect microscopic changes that can be related to disease progression. While techniques like MRI are good at identifying the gross anatomical features associated with Alzheimer's, they cannot detect more microscopic changes.

Although Alzheimer's disease is one of the leading causes of death in the United States, claiming tens of thousands of American lives a year, there is no definitive way to diagnose it—at least not while someone is alive. After someone with Alzheimer's dies, pathologists can perform an autopsy and examine slices of the brain under the microscope, looking for the same signs that Alois Alzheimer first recognized when he identified the disease more than a century ago. Finding accumulations of amyloid plaques in the brain substance and tangle-like proteins in nerve cells is the only way to confirm with certainty that someone had Alzheimer's while they were alive.

Since there is no way to safely examine the brains of living people this way, doctors currently diagnose Alzheimer's disease using other methods. They rely on reviewing medical histories, administering physical exams, and taking into account the results of a battery of neuropsychological assessments that measure cognitive performance. A positive diagnosis is made when all other possible causes have been eliminated, but even under the best of circumstances, these diagnoses can be incorrect 10 percent of the time or more.

Accurate, early detection of Alzheimer's could save many lives. While there is no cure for the disease, clinically proven treatments can slow its progress—especially if they are administered early on. Moreover, being able to follow the disease progression over time would greatly enhance the ability of researchers and pharmaceutical companies to find new and improved drugs and treatment strategies for people at all stages of the disease.

A current rich area of research seeks to get information about what is going on in the brain without actually looking at the tissue. Some scientists, for instance, look at whether proteins and other biomarkers in the blood or spinal fluid indicate disease progression. Others try to image the brain with established techniques like MRI or PET scans. Optical methods, like the one used by the Bedford researchers, are an emerging approach to imaging.

The research was funded by the U.S. Department of Veterans Affairs, the National Science Foundation, and a New Concept Award from the Center for Integration of Medicine & Innovative Technology.

Paper: "Scattering Differentiates Alzheimer Disease In Vitro," by Eugene B. Hanlon et al., Optics Letters, Vol. 33, No. 6, March 15, pp. 624-26, abstract at http://www.opticsinfobase.org/abstract.cfm?URI=ol-33-6-624 .

About OSA

Uniting more than 70,000 professionals from 134 countries, the Optical Society of America (OSA) brings together the global optics community through its programs and initiatives. Since 1916 OSA has worked to advance the common interests of the field, providing educational resources to the scientists, engineers and business leaders who work in the field by promoting the science of light and the advanced technologies made possible by optics and photonics. OSA publications, events, technical groups and programs foster optics knowledge and scientific collaboration among all those with an interest in optics and photonics. For more information, visit www.osa.org.

The new findings were announced March 18 at a Tahoe scientific conference by three lake experts from the Tahoe Environmental Research Center at UC Davis -- Director Geoffrey Schladow, Associate Director John Reuter and postdoctoral researcher Goloka Sahoo."What we expect is that deep mixing of Lake Tahoe's water layers will become less frequent, even non-existent, depleting the bottom waters of oxygen. This will result in major, permanent disruption to the entire lake food web," Schladow said. "This is not unheard of," he continued. "Anoxia (oxygen depletion) occurs annually in most lakes and reservoirs in California in the summer. But Tahoe has always been special. It's been above and beyond such things.

"A permanently stratified Lake Tahoe becomes just like any other lake or pond. It is no longer this unique, effervescent jewel, the finest example of nature's grandeur." Schladow said research is ongoing to determine if lowered global greenhouse-gas emissions would significantly slow the lake's decline, or even prevent it.

UC Davis researchers are in their 50th year of teasing apart the intertwining threads of biology, chemistry and physics that determine what Lake Tahoe looks like and what organisms live in it.One of their chief objectives has been to understand the clarity-clouding effects of pollution from population growth and development, so that policymakers can devise solutions. Then, in December 2004, they reported that the lake was showing a new influence: Its water was warming up, probably because of global climate change.

The new study combined 40 years of weather data in the basin with mathematical models of global climate to create likely scenarios of future climate conditions at Lake Tahoe. Using those scenarios, the team employed a lake physics model to see how various combinations of probable air temperatures, cloudiness and wind speed would affect the mixing of water layers in the lake.

Currently, Lake Tahoe water mixes, on average, every four years. The deepest mixing typically occurs in late February. This winter -- a particularly cold and snowy one -- Lake Tahoe experienced mixing throughout its entire 1,644-foot depth.

This mixing has profound ecological and water-quality impacts. Deep mixing moves nutrients from the lake bottom to the water surface, where they promote the growth of algae. And it takes oxygen from the surface and distributes it throughout the lake, which supports aquatic life.The new study showed that, if global greenhouse-gas emissions continue at current levels, mixing could become less frequent and less deep -- even stop altogether as soon as 2019.

Schladow said that was quite a shock. "While we expected that the lake would mix less in the future, learning that we may be only a decade or two from the complete shutdown of deep mixing was very surprising."If mixing shuts down, then no new oxygen gets to the bottom of the lake, and creatures that need it, such as lake trout, will have a large part of their range excluded," Schladow said.

Equally worrying, he said, is the likelihood that when the oxygen is gone, phosphorus that is currently locked up in the lake-floor sediments will get released. This phosphorus will eventually reach the lake's surface, where it will fuel algal growth. Algae blooms can cause many problems, including reduced lake clarity, unpleasant odors and bad-tasting drinking water.

The climatic changes that are expected to affect Lake Tahoe are also impacting lakes around the world. These widespread concerns have been the topic of a science workshop at the Tahoe Environmental Research Center that runs through March 25. Researchers from Japan, New Zealand, Chile and the United States will discuss strategies to pool and analyze data from many of the lakes in the Pacific Rim region. Their goal is to learn more about the security of drinking-water supplies and the ecological sustainability of these lake systems.

About the Tahoe Environmental Research Center at UC Davis

The Tahoe Environmental Research Center conducts and supports multidisciplinary research, education and public outreach on lake systems and their contributing watersheds and airsheds. Lake systems encompass the physical, biogeochemical and human environments, and the interactions between them. The center is committed to providing objective scientific input to support the restoration and long-term sustainability of the Lake Tahoe Basin. It is a program of the John Muir Institute of the Environment at UC Davis.

The enzyme also promotes nerve plasticity, which potentially means that remaining undamaged nerve fibers have an increased likelihood of making new connections that could bypass the area of damage. It may also encourage the remaining undamaged nerve fibers to work more effectively.

Spinal injuries are difficult to treat because the body cannot repair damage to the brain or spinal cord. We are very hopeful that at last we may be able to offer paralyzed patients a treatment to improve their condition  In preliminary tests, the researchers have shown that combining chondroitinase with rehabilitation produces better results than using either technique alone.  What often happens in a clinical setting is that you don't get to see the results you would have liked  However, trials have yet to begin in patients.

Lead researcher Professor James Fawcett said: "It is rare to find that a spinal cord is completely severed, generally there are still some nerve fibers that are undamaged. "Chondroitinase offers us hope in two ways; firstly it allows some nerve fibers to regenerate and secondly it enables other nerves to take on the role of those fibers that cannot be repaired.

"Along with rehabilitation we are very hopeful that at last we may be able to offer paralyzed patients a treatment to improve their condition." Dr Yolande Harley, of the charity Action Medical Research which funded the work, said: "This is incredibly exciting, ground-breaking work, which will give new hope to people with recent spinal injuries."

Medical advances mean that spinal injuries have ceased to be the terminal conditions that they often once were, but they still had a huge impact on quality of life.

The study, published in Science, is the most important since a first gene was identified in 1993.

MND involves the progressive wasting of the muscles - while usually leaving the mind unaffected. Stephen Hawking, who has lived for 35 years with MND, is an exception. This new information will be a springboard to greater understanding of the processes that cause motor neurons to die. The protein has long been known to accumulate abnormally in MND patients, but it had been thought this was an innocent by-product of the disease.

Now, says Professor Chris Shaw, who led the research, it is clear that this protein is "directly toxic" to motor neurons. While the inherited form of the disease this mutation causes is extremely rare - accounting for just 1% of MND cases - researchers can use their findings to give animals the disease and investigate how it develops. "It is a new biological tool to understand the disease and develop treatments," says Professor Shaw. "It is another part of the jigsaw, but there are still, admittedly, a lot of pieces missing."

The first part of that jigsaw was uncovered in 1993, when researchers found the gene mutation SOD1 was responsible for one form of MND. Experts say this finding improved understanding, although it has yet to impact significantly on treatment.

This new information will be a springboard to greater understanding of the processes that cause motor neurons to die. It is through such understanding that we will develop the treatment strategies to defeat this devastating disease.

'It is a Noah's Ark for our biological heritage,' Norwegian Prime Minister Jens Stoltenberg said of the Norway-funded vault that cost 50 million kroner (9.3 million dollars) to build.

The vault is located about one kilometer away from the airport serving Longyearbyen, the main settlement on Svalbard, an archipelago off northern Norway some 1,000 kilometers from the North Pole. Arctic temperatures, permafrost and stable geological conditions were decisive factors in the choice of Svalbard.

The seed bank is to serve as a safety net and store copies of seeds from other seed banks and collections worldwide. Capacity is estimated at 4.5 million samples - some 2 billion seeds. The seeds will be stored at -18 degrees Celsius. Should there be a power failure, the permafrost of -4 degrees will keep temperatures below freezing, organizers said.

Deposits have been made from gene banks including the International Rice Research Institute (IRRI) in the Philippines and the International Maize and Wheat Improvement Centre (CIMMYT) in Mexico. The Rome-based Global Crop Diversity Trust has provided funds for the transport of the seeds that are stored in vacuum-sealed aluminium bags packed in special boxes. Cary Fowler, Executive Director of the Trust, said 'crop diversity will soon prove to be our most potent and indispensable resource for addressing climate change, water and energy supply constraints, and for meeting the food needs of a growing population.'

The vault would likely be accessed only a few times a year, mainly to deposit new samples.

Stoltenberg and Maathai carried the first box of seeds into the vault. Maathai founded the Kenya-based Green Belt Movement which has planted millions of trees across Africa and she was the first environmentalist to win the Nobel Peace Prize.

'We now understand that along with international movements to save endangered species and the rainforests of the world, it is just as important for us to conserve the diversity of the world's crops for future generations,' Maathai said.

Other dignitaries present followed suit, including Jose Manuel Barroso, head of the European Commission, and Jacques Diouf, Director-General of the UN Food and Agriculture Organization (FAO).

Dogs have 13 different blood types; the preferred donor type is dog erythrocyte antigen 1.1 negative.

The UC Davis veterinary hospital currently is limiting its community blood collection to dogs because the tests necessary for screening the health of cats are too expensive. The hospital will continue to keep its on-campus colony of blood donor cats. In addition to providing blood products for dog transfusions, the teaching hospital annually carries out 400 to 500 transfusions for cats, pigs, horses, cows, sheep and goats. The new animal blood bank will store regular blood products for all of these species. It also will store umbilical cord blood for future use and will process adult stem cells from horse patients, which can be used to treat ligament, tendon or joint injuries and promote healing of some fractures.

Until today, the hospital has obtained blood for its canine patients from a group of about 30 blood-donor dogs that live for a few years at the hospital and then are adopted out. Now, as the blood-donor program develops, those dogs are being matched with good homes.

 Approximately 1,200 pet dogs and canine law-enforcement officers will be screened during the coming year to develop a group of 200 to 400 regular donors. Although dogs are capable of donating blood monthly, the regular donors will probably come in two to three times per year. The donor program and its new UC Davis Animal Blood Bank are housed in the campus's William R. Pritchard Veterinary Medical Teaching Hospital. It is the largest such program west of the Mississippi.

"Each year, the teaching hospital provides 200 to 300 transfusions for dogs to treat conditions ranging from surgical complications to kidney failure," said Dr. Sean Owens, the blood bank's medical director and head of the veterinary hospital's Transfusion Medicine Section. "This new donor program will allow us to develop a large, reliable source of blood products for our patients, without maintaining a colony of donor dogs here at the hospital."

 Until today, the hospital has obtained blood for its canine patients from a group of about 30 blood-donor dogs that live for a few years at the hospital and then are adopted out. Now, as the blood-donor program develops, those dogs are being matched with good homes.

(Members of the public who might be interested in adopting a retired canine blood donor can obtain more information about the dogs by e-mailing caninebloodbank@gmail.com )

Donor dogs for the new program must be 1 to 8 years old, weigh at least 55 pounds and have never been pregnant or had puppies. To make regular donation practical, the dogs and their owners must live within 100 miles of UC Davis.

The animal's first visit to the blood bank will last for about one hour. During that appointment, each dog will be given a health check and screened for infectious diseases, and a unit of blood (about one pint) will be collected. If any health problems are detected, the owner will be advised to follow up with the dog's regular veterinarian. If cleared for further donation, the animal will return in two to three months for a half-hour donation visit. The initial health check, which includes veterinary services valued at $300, will be free, as will all subsequent donation visits.

Eventually, the program plans to establish a mobile blood bank that could be taken to dog shows and other canine events to make donating more convenient for dogs and their owners.Dog owners interested in learning more about the blood donor program or scheduling a health-screening appointment for their dog should contact the Veterinary Medical Teaching Hospital at (530) 752-1393, ext. 421.

Jan 2008-An international research consortium announced the 1000 Genomes Project, an ambitious effort that will involve sequencing the genomes of at least a thousand people from around the world to create the most detailed and medically useful picture to date of human genetic variation. The project will receive major support from the Wellcome Trust Sanger Institute in Hinxton, England, the Beijing Genomics Institute,Shenzhen (BGI Shenzhen) in China and the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH).

Drawing on the expertise of multidisciplinary research teams, the 1000 Genomes Project will develop a new map of the human genome that will provide a view of biomedically relevant DNA variations at a resolution unmatched by current resources. As with other major human genome reference projects, data from the 1000 Genomes Project will be made swiftly available to the worldwide scientific community through freely accessible public databases.

“The 1000 Genomes Project will examine the human genome at a level of detail that no one has done before,” said Richard Durbin, Ph.D., of the Wellcome Trust Sanger Institute, who is co-chair of the consortium. “Such a project would have been unthinkable only two years ago. Today, thanks to amazing strides in sequencing technology, bioinformatics and population genomics, it is now within our grasp. So we are moving forward to build a tool that will greatly expand and further accelerate efforts to find more of the genetic factors involved in human health and disease.”

Any two humans are more than 99 percent the same at the genetic level. However, it is important to understand the small fraction of genetic material that varies among people because it can help explain individual differences in susceptibility to disease, response to drugs or reaction to environmental factors. Variation in the human genome is organized into local neighborhoods called haplotypes, which are stretches of DNA usually inherited as intact blocks of information.

Recently developed catalogs of human genetic variation, such as the HapMap, have proved valuable in human genetic research. Using the HapMap and related resources, researchers already have discovered more than 100 regions of the genome containing genetic variants that are associated with risk of common human diseases such as diabetes, coronary artery disease, prostate and breast cancer, rheumatoid arthritis, inflammatory bowel disease and age-related macular degeneration.

However, because existing maps are not extremely detailed, researchers often must follow those studies with costly and time-consuming DNA sequencing to help pinpoint the precise causative variants. The new map would enable researchers to more quickly zero in on disease-related genetic variants, speeding efforts to use genetic information to develop new strategies for diagnosing, treating and preventing common diseases.

The scientific goals of the 1000 Genomes Project are to produce a catalog of variants that are present at 1 percent or greater frequency in the human population across most of the genome, and down to 0.5 percent or lower within genes. This will likely entail sequencing the genomes of at least 1,000 people. These people will be anonymous and will not have any medical information collected on them, because the project is developing a basic resource to provide information on genetic variation. The catalog that is developed will be used by researchers in many future studies of people with particular diseases.

“This new project will increase the sensitivity of disease discovery efforts across the genome five-fold and within gene regions at least 10-fold,” said NHGRI Director Francis S. Collins, M.D., Ph.D. “Our existing databases do a reasonably good job of cataloging variations found in at least 10 percent of a population. By harnessing the power of new sequencing technologies and novel computational methods, we hope to give biomedical researchers a genome-wide map of variation down to the 1 percent level. This will change the way we carry out studies of genetic disease.”

With current approaches, researchers can search for two types of genetic variants related to disease. The first type is very rare genetic variants that have a severe effect, such as the variants responsible for causing cystic fibrosis and Huntington’s disease. To find these rare variants, which typically affect fewer than one in 1,000 people, researchers often must spend years on studies involving affected families. However, most common diseases, such as diabetes and heart disease, are influenced by more common genetic variants. Most of these common variants have weak effects, perhaps increasing risk of a common condition by 25 percent or less. Recently, using a new approach known as a genome-wide association study, researchers have been able to search for these common variants.

“Between these two types of genetic variants — very rare and fairly common — we have a significant gap in our knowledge. The 1000 Genomes Project is designed to fillthat gap, which we anticipate will contain many important variants that are relevant to human health and disease,” said David Altshuler, M.D., Ph.D., of Massachusetts General Hospital in Boston and the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University in Cambridge, Mass., who is the consortium’s co-chair and was a leader of the HapMap Consortium.

One use of the new catalog will be to follow up genome-wide association studies. Investigators who find that a part of the genome is associated with a disease will be able to look it up in the catalog, and find almost all variants in that region. They will then be able to conduct functional studies to see whether any of the catalogued variants directly contribute to the disease.

The 1000 Genomes Project builds on the human haplotype map developed by the International HapMap Project. The new map will provide genomic context surrounding the HapMap’s genetic variants, giving researchers important clues to which variants might be causal, including more precise information on where to search for causal variants.

Going a major step beyond the HapMap, the 1000 Genomes Project will map not only the single-letter differences in people’s DNA, called single nucleotide polymorphisms (SNPs), but also will produce a high-resolution map of larger differences in genome structure called structural variants. Structural variants are rearrangements, deletions or duplications of segments of the human genome. The importance of these variants has become increasingly clear with surveys completed in the past 18 months that show these differences in genome structure may play a role in susceptibility to certain conditions, such as mental retardation and autism.

In addition to accelerating the search for genetic variants involved in susceptibility to common diseases, the map produced by the 1000 Genomes Project will provide a deeper understanding of human genetic variation and open the door to many other new findings of significance to both medicine and basic human biology.The sequencing work will be carried out at the Sanger Institute, BGI Shenzhen and NHGRI’s Large-Scale Sequencing Network, which includes the Broad Institute of MIT and Harvard; the Washington University Genome Sequencing Center at the Washington University School of Medicine in St. Louis; and the Human Genome Sequencing Center at the Baylor College of Medicine in Houston. The consortium may add other participants over time.

The project depends on large-scale implementation of several new sequencing platforms. Using standard DNA sequencing technologies, the effort would likely cost more than $500 million. However, leaders of the 1000 Genomes Project expect the costs to be far lower – in the range of $30 million to $50 million – because of the project’s pioneering efforts to use new sequencing technologies in the most efficient and cost-effective manner.

In the first phase of the 1000 Genomes Project, lasting about a year, researchers will conduct three pilots. The results of the pilots will be used to decide how to most efficiently and cost effectively produce the project’s detailed map of human genetic variation.

The first pilot will involve sequencing the genomes of two nuclear families (both parents and an adult child) at deep coverage that averages 20 passes of each genome. This will provide a comprehensive dataset from six people that will help the project figure out how to identify variants using the new sequencing platforms, and serve as a basis for comparison for other parts of the effort.

The second pilot will involve sequencing the genomes of 180 people at low coverage that averages two passes of each genome. This will test the ability to use low coverage data from new sequencing platforms to identify sequence variants and to put them in their genomic context.

The third pilot will involve sequencing the coding regions, called exons, of about 1,000 genes in about 1,000 people. This is aimed at exploring how best to obtain an even more detailed catalog in the approximately 2 percent of the genome that is comprised of protein-coding genes.

During its two-year production phase, the 1000 Genomes Project will deliver sequence data at an average rate of about 8.2 billion bases per day, the equivalent of more than two human genomes every 24 hours. The volume of data – and the interpretation of those data – will pose a major challenge for leading experts in the fields of bioinformatics and statistical genetics.

“This project will examine the human genome in a detail that has never been attempted – the scale is immense. At 6 trillion DNA bases, the 1000 Genomes Project will generate 60-fold more sequence data over its three-year course than have been deposited into public DNA databases over the past 25 years,” said Gil McVean, Ph.D., of the University of Oxford in England, one of the co-chairs of the consortium’s analysis group. “In fact, when up and running at full speed, this project will generate more sequence in two days than was added to public databases for all of the past year.”

The 1000 Genomes Project will use samples from volunteer donors who gave informed consent for their DNA to be analyzed and placed in public databases. NHGRI and its partners will follow the extensive and careful ethical procedures established for previous projects. As was the case for the International HapMap Project and Human Genome Project, the 1000 Genomes Project will have an expert working group devoted to examining the ethical, legal and social issues related to its research.

The first thousand samples for the 1000 Genomes Project will come from those used for the HapMap and from additional samples in the extended HapMap set, which used the same collection processes. No medical or personal identifying information was obtained from the donors, and the samples are labeled only by the population from which they were collected. The donors’ anonymity was enhanced by recruiting more donors than were actually used. Similar processes will be used for collecting additional samples for the 1000 Genomes Project.

Among the populations whose DNA will be sequenced in the 1000 Genomes Project are: Yoruba in Ibadan, Nigeria; Japanese in Tokyo; Chinese in Beijing; Utah residents with ancestry from northern and western Europe; Luhya in Webuye, Kenya; Maasai in Kinyawa, Kenya; Toscani in Italy; Gujarati Indians in Houston; Chinese in metropolitan Denver; people of Mexican ancestry in Los Angeles; and people of African ancestry in the southwestern United States.

“This project reinforces our commitment to transform genomic information into tools that medical research can use to understand common disease,” said Jun Wang, Ph.D., associate director of BGI Shenzhen, whose laboratory will participate in the 1000 Genomes Project and which also took part in the HapMap Project. “It will benefit all nations by creating a valuable resource for researchers around the globe.” The detailed map of human genetic variation will be used by many researchers seeking to relate genetic variation to particular diseases. In turn, such research will lay the groundwork for the personal genomics era of medicine, in which people routinely will have their genomes sequenced to predict their individual risks of disease and response to drugs.

The data generated by the 1000 Genomes Project will be held by and distributed from the European Bioinformatics Institute (EBI) and the National Center for Biotechnology Information (NCBI), which is part of NIH. There will also be a mirror site for data access at BGI Shenzhen. In addition to a catalog of variants, the data will include information about surrounding variation that can speed identification of the most important variants.

To learn more about the 1000 Genomes Project as the effort develops, and to read "A Workshop to Plan a Deep Catalog of Human Genetic Variation", which summarizes the meeting that laid the groundwork for the project, go to www.1000genomes.org .

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Experts said it was vital for research into life-threatening diseases. Two centers, King's College London and Newcastle University, will now be able to begin their work under one-year research license.  Any other centers wishing to do similar work will have to apply to the HFEA for permission, which will make a decision on a case by case basis.

Scientists want to create hybrid embryos by merging human cells with animal eggs in a bid to extract stem cells. The embryos would then be destroyed within 14 days. The cells form the basic building blocks of the body and have the potential to become any tissue, making them essential for research. At the moment, scientists have to rely on human eggs left over from fertility treatment, but they are in short supply and are not always good quality.

Critics say they are repulsed by the idea and there must be no creation of an animal-human hybrid. They say it is tampering with nature and is unethical. It is already illegal to implant human-animal embryos in the womb or bring them to term.

Dr Stephen Minger and colleagues at King's College London want to create hybrids to study diseases known to have genetic causes - such as Alzheimer's disease, spinal muscular atrophy and Parkinson's disease.

And Lyle Armstrong's team at Newcastle University are hoping to use the technique to help understand how stem cells develop into different tissues in the body.  In the distant future this information may lead to scientists to be able to grow new tissues in the laboratory.

Dr Armstrong said: "Now that we have the license we can start work as soon as possible.

"We have already done a lot of the work by transferring animal cells into cow eggs so we hope to make rapid progress."

John Smeaton, national director of the Society for the Protection of Unborn Children (SPUC), said: "The HFEA decision represents a disastrous setback for human dignity in Britain. "The deliberate blurring of the boundaries between humans and other species is wrong and strikes at the heart of what makes us human."

Cancer cells use many complex processes when they break away from their tumor and spread to other areas of the body. The Mena protein is found in excessive amounts in tumors and was already known to help cancer cells move away from a tumor and spread around the body to form secondary cancers - one of the main obstacles in treating cancer.

Study leader Dr Michael Way said Tes was not as well studied but in many tumors it is absent. Using a range of techniques, including X-ray crystallography, which can be used to determine the 3-dimensional structure of a molecule, Dr Way and his colleagues found that Tes attached itself to Mena in such a way it could no longer bind with other proteins.

Without being able to interact with its normal binding partners, Mena was no longer able to help the cancer cells migrate from the tumor. Dr Way said if researchers could design a drug to block Mena in the same way as Tes, it would potentially be a way to stop the spread of cancer once a tumor had formed.

Looking at the structure gives us clues in designing drugs which mimic the interaction with Tes and prevent cells from migrating, although that's a long way away. He said Mena was a very small part of the spread of cancer cells, but that was one of the control mechanisms that goes wrong.

Cancer cells use many complex processes when they break away from their tumor and spread to other areas of the body. Understanding these mechanisms and increasing our knowledge about this protein can hopefully help us to develop more effective cancer treatments in the future."

Researchers have already managed to make wider blood vessels from scratch, but the formation of the tiny diameter capillaries needed to create a blood supply within other tissues and organs is far more challenging.

The US scientists claim to have made progress towards this, using a "nanoscale" template into which stem cells called endothelial progenitor cells are placed. The cells detected the grooves and elongated themselves along them, aligning themselves in the same direction.

Adding a gel made of growth factors allowed the cells to grow outwards, forming a series of tiny tubes running parallel to each other.

While these tubes are not yet ready to be put inside a human body, the researchers say they are "very excited" by their potential. It provides a new way to create nano-based systems which we hope will provide a novel way to some day engineer tissues in the human body.

The team now plans to develop capillary tubes which can be inserted into animals to see if they work properly. The inability to create working small blood vessels in the laboratory was one of the major obstacles to efforts to create replacement organs outside the body.

Aside from the hope of creating replacement tissues and organs for patients, the work could help scientists understand how to tackle unwanted blood vessel growth, such as that found in tumors.

Par-4 was originally discovered in the early 1990s working inside human prostate cancers, and is believed to have a role in "programmed cell death", the body's own system for rooting out and destroying damaged or faulty cells.

The Kentucky team used an existing mouse breed known to be more vulnerable to cancers to test whether Par-4 could be used to fight them. They introduced the gene to mouse eggs, and it was active in both the resulting pups - and their own offspring.

The mice with active Par-4 did not develop cancers, and lived slightly longer than those without the gene.

Dr Vivek Rangnekar, who led the research, said that the gene offered a potential way, unlike most other cancer treatments, of destroying cancer cells without harming normal cells. "When a cancer patient goes to the clinic, they undergo chemotherapy or radiation and there are potential side effects associated with these treatments. "We are thinking of this as a holistic approach that not only would get rid of the tumor, but not harm the organism as a whole."

He said that much more research would be needed, however, before a human treatment could be launched. Although at an early stage, research like this allows us to understand more about the faulty genes involved in cancer and throws open new avenues to explore for cancer treatment.

It's important to remember that this work has only been done using genetically engineered mice, and more research is needed before we'll know if it can be translated to humans.

Most patients with advanced disease respond to chemotherapy, but more than 70% die from a recurrence of the cancer within five years of diagnosis. Details of the study appear in Proceedings of the National Academy of Sciences.

The vaccine contains an ovarian cancer protein fragment coupled with a molecule known to induce immune response. It targets a protein produced in a high proportion of ovarian cancer cells, but not in healthy cells. The researchers tested it in women with epithelial ovarian cancer, a cancer type that originates in the covering of the ovaries. They said although their study was designed as a phase one clinical trial - a preliminary study - it had produced "encouraging" results.

The vaccine induced the immune system to produce antibodies, and to mobilize specialized T cells which were able to target cancer cells producing the key protein. The researchers detected vaccine-induced immune cells in patients up to 12 months after immunization, suggesting a long-lasting effect.

Any research that could lead to improved survival for people with ovarian cancer, and cancer vaccines has exciting potential. This early trial shows encouraging results but it's important to remember that much larger studies will be needed before we know for sure whether the vaccine is safe and effective.

The study is published  in the Proceedings of the National Academy of Sciences.  This study shows the possibility of non-invasive methods that can help the millions who have this chronic disease. The researchers used a chemical analysis technique developed to test for air pollution.

Methyl nitrate concentrations were as much as 10 times higher in children with type 1 diabetes when they were in a hyperglycaemic state, than when their blood sugar levels were normal. Researcher Dr Pietro Galassetti said breath analysis had already shown promise as a diagnostic tool for ulcers and cystic fibrosis. While no clinical breath test exists yet for diabetes, this study shows the possibility of non-invasive methods that can help the millions who have this chronic disease.

It is thought that methyl nitrate is a by-product of the damage caused to the body's tissues when blood sugar levels are too high.

Currently children with diabetes need to prick their fingers around four times a day to check their blood glucose levels. Nevertheless, this study was only conducted on 10 children and the research is still at an early stage. More research will be needed to prove that breath-analysis testing can be an effective way of monitoring blood glucose (sugar) levels for people with diabetes.

The study, by a US and German team, appears in the journal Cell Metabolism. The researchers, from Harvard University and the University of Leipzig, analyzed 196 people.

In contrast, the same genes were only 12 times more active in obese people with a preponderance of fat lying just under the skin. The researchers believe that measuring RBP4 would potentially be an effective way to assess body fat, and that treatment to cut levels of the protein might also have health benefits.

In previous work, they showed that cutting RBP4 levels in obese mice helped the animals to make better use of the hormone insulin - and thus reduce their risk of diabetes. They also showed that measures to improve insulin sensitivity in human subjects resulted in a drop in RPB4 levels. The only known function of RBP4 is to carry vitamin A in the blood.

Researcher Dr Matthias Blüher said: "We believe that in the near future, measurements of RBP4 serum concentrations might serve as a novel biomarker for visceral obesity and increased risk for type 2 diabetes and other adverse outcomes of visceral obesity. "In addition, pharmacological interventions that reduce RBP4 levels might be a new approach in the treatment of metabolic syndrome and visceral obesity."

A waist measurement of 37 inches (94cm) or more for men, and 31.5 inches (80cm) or more for a woman is considered to raise the risk. For men of South Asian origin a waist measurement of 35 inches (89cm) or more is considered a risk.

The finding may help to explain why people with a condition called spinocerebellar ataxia progressively lose co-ordination and movement. Humans have four genes responsible for the production of beta spectrin protein.  The entire functioning of the nervous system depends on these wire-like axons between nerve cells

Recent studies have shown that people with a condition called spinocerebellar ataxia type 5, a neurodegenerative disease that develops between the ages of 10 and 68, have a mutation in one of the genes. It was previously thought that the mutation in this protein meant cells could not communicate properly because the necessary proteins would not be anchored in place.

But research by Professor Michael Bastiani and colleagues at the University of Utah suggests that a mutation in or absence of the protein causes long nerve fibres (axons) to lose their flexibility and break. When nematode worms were bred without beta spectrin their nerve axons died over time and caused paralysis. In worm embryos only 3% of nerve cells were broken or defective but that grew to 60% by the time the worms were a day old, suggesting the protein is not responsible for initial growth of nerve cells but for preventing breakage later on.

Nerve function

Professor Bastiani said the team found it "incredible" that the one protein was responsible for preventing nerves breaking in your whole body. The entire functioning of the nervous system depends on these wire-like axons between nerve cells. He added that when the worms were paralyzed by a second mutation the nerve axons did not break because the worms were not moving around. What was surprising was in the past, it's always been embedded in the literature that the thing that provides the strength and flexibility was the neurofilaments. This research is  proposing a completely different model.

There are thought to be more than 20 types of hereditary spinocerebellar ataxia, for which there is no treatment and commonly results in people needing a wheelchair. The gene for spinocerebellar ataxia type 5 has been discovered in 11 generations of US President Abraham Lincoln's family and it is thought it may have afflicted Lincoln himself although it did not become apparent before he was assassinated at the age of 56.

It seems that inherited ataxias that are dominant are due to gene repeats that that leads to an extra long string on the protein causing cell damage.This is a completely different mechanism.

The Johns Hopkins University study appears in Proceedings of the National Academy of Sciences. Animal models of schizophrenia have been hard to design since many different causes underlie this disease. However, the Johns Hopkins team were able to take advantage of the recent discovery of a major risk factor for the disease.

Scientists pinpointed a key gene - dubbed DISC 1 - which makes a protein that helps nerve cells assume their proper positions in the brain. The Johns Hopkins team generated mice that make an incomplete, shortened form of the DISC 1 protein in addition to the regular type. The short form of the protein attaches to the full-length one, disrupting its normal duties. As these mice matured, they became more agitated when placed in an open field, had trouble finding hidden food, and did not swim as long as regular mice - behaviors that echo the hyperactivity, smell defects and apathy observed in schizophrenia patients.

Magnetic resonance imaging (MRI) also revealed characteristic defects in brain structure, including enlarged lateral ventricles, a region that circulates the spinal fluid and helps protect against physical trauma. Researcher Professor Akira Sawa said the defects in these mice were not as severe as those typically seen in people with schizophrenia, because more than one gene is required to trigger the clinical disease. However, this mouse model will help us fill many gaps in schizophrenia research and can be used  to explore how external factors like stress or viruses may worsen symptoms. The animals can also be bred with other strains of genetically engineered mice to try to pinpoint additional schizophrenia genes.

The goal is trying to identify a strategy that may cure schizophrenia. Schizophrenia is a complex human condition in which genes play just one important part.

The research is published in the New England Journal of Medicine and Nature Genetics.

The finding will not lead directly to new tests or treatments, as experts say as many as 100 more genes may play a role in MS.

The joint project used the latest genome-scanning technology to look at the genetic make-up of thousands of MS patients, looking for signs of tiny genetic differences which might mean a greater risk of developing the illness. It concluded that people carrying either of two genetic variants, called IL7R-alpha and IL2R-alpha, had an increased risk of between 20% and 30%.

 These discoveries  are the first of many, and after three decades finding nothing, we would expect to find many more of these genes over the next few years. It is only once many more "MS genes" are revealed, that scientists would then be able to identify people carrying large numbers of them and examine what other factors might be triggering their illness.

Both of the genes identified by the research are known to have a role in the body's immune responses. MS is caused when the immune system wrongly attacks the sheaths surrounding the nerves, destroying them and the body's ability to send signals along them. This leads to muscle weakness, difficulties with balance and speech and vision problems.

The Harvard Center for Neurodegeneration and Repair was one of several US universities and research institutes which worked together on the project. Adrian Ivinson, its director, said: "This study illustrates the power of collaboration - individually, none of us could have completed a study of this scale and complexity."

Dr Lee Dunster, head of research and information at the MS Society, welcomed the publication of the studies in the journals Nature Genetics and the New England Journal of Medicine He said: "One of the great unknowns about MS is what causes it and this looks like a welcome breakthrough in getting to grips with the genetics behind the disease.

"People with MS often worry about what caused it, and particularly whether it will affect their children, so a better understanding of the role of certain genes is good news.

"These latest findings will be of great interest to researchers trying to develop future treatments."

It surprised the team that the stem cells - rather than replacing the damaged cells as anticipated - actually worked to protect them, preventing further deterioration. But while the monkeys fared well in the initial months of the trial, four months in they started once again to show the symptoms of the disease.

Further trials are needed to establish whether similar results are seen in people who have Parkinson's.  The researchers speculate this may be to do with the monkeys beginning to reject foreign tissue, and suggested that further research would need to be done suppressing their immune systems. These results are from a very early stage pre-clinical trial using an animal model of Parkinson's.  

More than four million people worldwide are estimated to suffer from Parkinson's disease, making it the most common brain degenerative disease after Alzheimer's disease. It is a disease of the nervous system that generally affects both men and women who are more than 40 years old. It is associated with trembling of the arms and legs, stiffness and rigidity of the muscles and slowness of movement. The progressive decline brought on by the condition is caused by a loss of brain cells which produce a chemical called dopamine.

Stem cells are seen as providing one of the major avenues of hope for a cure. Dr Stephen Minger, Director of King's Stem Cell Biology Laboratory, said he welcomed any research which took the search for a cure further but similarly cautioned against great hopes. The body's "master cells", stem cells are created shortly after conception. They have the capacity to turn into any kind of tissue in the body.

Cancer Research UK scientists led an international team of experts in the world's first large-scale "whole genome search" for breast cancer genes. Hundreds of genes may be linked to breast cancer. By studying the genetic material researchers found five culprit DNA regions housing new four genes, FGFR2, TNRC9, MAP3K1 and LSP1.

They sifted through the DNA of nearly 50,000 women, half of them breast cancer patients and half healthy.

It is hoped their discovery, published in Nature journal, will lead to more genes being identified, and better testing to identify women most at risk.

Disease prevention

If more genes were identified it may help prevent the disease because people who were at "particularly high risk of the disease" could be identified.

Overall, inherited cases make up between 5 and 10% of all breast cancer cases. "Lifestyle factors" such as smoking and environmental factors are believed to account for the rest.

 It is likely many more cancer predisposing genes will be identified using similar approaches in the next few months

The new genes identified are far more common in the population than the well-known BRCA1 and BRAC2, but carry a lower risk.

Between 50% and 85% of women with BRCA1 or BRCA2 will develop breast cancer in their lifetime.

In comparison, about 14% of women with one of the new genes would develop breast cancer.

This relatively small increased risk makes genetic testing for the four new genes - FGFR2, TNRC9, MAP3K1 and LSP1 - unsuitable, say the researchers.

But as more of these "low risk" genes are found, it may be possible to design tests for a combination of genes, they say.

'Risk banding'

Currently, doctors only test for four genes, BRCA1, BRCA2, TP53 and PTEN, as these are associated with high risks of developing cancer.

They believe there are hundreds more breast cancer genes to be found.

Leading cancer specialist Professor Karol Sikora said: "It's likely many more cancer predisposing genes will be identified using similar approaches in the next few months.

"By risk banding women we will be able to target screening programs far more effectively as well as developing tailored prevention strategies just for those most likely to get cancer.

"I suspect that in the next three years it will be possible to separate a group of women into those that have a very high chance of getting breast cancer, those that have a very low chance and those that are in the middle.

"So all our screening programs will be targeted for the very high risk and therefore be much more efficient."

Hundreds more genes

Lead author Professor Bruce Ponder, Director of Cancer Research UK's Cambridge Research Institute at the University of Cambridge, added: "At the moment we don't know how these genes interact with each other or with lifestyle factors, each of which might increase the risk.

"We'll continue to search for more genes, but we'll also focus on unraveling this information so that we're ready to offer advice to women who may carry one or more of these faulty genes in the future."

The whole genome analysis technique used by the researchers enabled them to study all the significant pieces of DNA code they wanted in one go, taking just a few hours.

The researchers, writing in the Lancet, said HRT increased the risk of ovarian, breast and womb cancers. Government experts said current advice would not change and women should be on HRT for the shortest possible time.

Previous results from the Million Women Study, published in 2003, showed use of combined HRT doubles the risk of breast cancer. This study, along with our previous research, clearly demonstrates the cancer risks of taking HRT

The findings prompted recommendations that women weigh up the risks and benefits of HRT and take the smallest possible dose for the shortest possible time. The new analysis of 948,576 postmenopausal women showed a 20% increased risk of developing and dying from ovarian cancer in HRT users, compared with those who had never used the treatment.

This translates to one extra case of ovarian cancer for every 2,500 women taking HRT and one extra death from ovarian cancer in every 3,300 users. The increased risk was the same for all types of HRT.

Risk of ovarian cancer in women taking HRT returned to normal within a few years of stopping treatment.

Lead researcher, Professor Valerie Beral - director of Cancer Research UK's epidemiology unit at the University of Oxford - said: "The results of this study are worrying because they show that, not only does HRT increase the risk of getting ovarian cancer, it also increases a woman's risk of dying of ovarian cancer.

"This study, along with our previous research, clearly demonstrates the cancer risks of taking HRT."

The team said overall ovarian, breast and womb (endometrial) cancer accounted for 40% of all cancers diagnosed in UK women and that the total incidence of the three is 63% higher in those taking HRT.

In the UK the number of HRT users fell from two million in 2002 to one million in 2005, according to data from the General Practice Research Database.

A spokesman for the Medicines and Healthcare products Regulatory Agency said the new data was being studied by an expert group but the advice was unlikely to change, and HRT remained an effective treatment for the short-term relief of menopausal symptoms in the majority of women.

He added that any woman on HRT who is concerned should discuss her need to continue treatment with her doctor.

At present, there is no specific regulation on food products from cloned animals for consumption in the EU.

Last year, the US Food and Drug Administration (FDA) concluded that products from cloned animals were safe.

It has put that draft ruling out for consultation, but it is widely expected that the FDA will give the go-ahead to the sale of food products made through animal cloning later this year.

In the light of this, the European Commission wrote to the EFSA, asking them "to advise on food safety, animal health, animal welfare and environmental implications of cloned animals... their offspring, and of products obtained from these animals".

It added: "According to experts, animal cloning... is on the verge of widespread commercial use and expected to spread within the global food chain before 2010.

 "Food derived, in particular from traditionally produced offspring of cloned animals, might therefore be available to consumers in the future."

The EFSA has said its scientific committee will lead the research. The commission has asked for the watchdog to provide its scientific conclusions within the next six months.

It has also asked the European Group of Ethics to look into the ethics of cloning.

Commercial cloning is already an issue for some European countries; a calf grown from an embryo taken from a cloned cow was recently born on a British farm.

At the time, the UK's environment department said no health and welfare rules had been broken, but its food watchdog said more discussions were needed to assess legal requirements relating to offspring of cloned animals.