Dual-Modality Microbeads To Improve Identification Of Disease Biomarkers Created By Scientists

Analyzing human blood for a very low virus concentration or a sample of water for a bioterrorism agent has always been a time-consuming and difficult process. Researchers at the Georgia Institute of Technology and Emory University have developed an easier and faster method to detect these types of target molecules in liquid samples using highly porous, micron-sized, silica beads.

The researchers developed a technique to simultaneously or sequentially add optical and magnetic nanoparticles into the beads. Adding magnetic nanoparticles allows the use of a magnetic field to attract and easily remove the beads from a liquid sample.

“These nanoparticles enter the pores of the microbeads so quickly and so completely — essentially more than 99 percent of the nanoparticles go into the pores of the beads,” explained Shuming Nie, the head researcher on the project and the Wallace H. Coulter Distinguished Chair in Biomedical Engineering and director of Emory-Georgia Tech Nanotechnology Center.

The beads are mixed in a liquid such as urine. Viruses, proteins or other biomarkers are captured on the bead surface. After the beads are removed from the liquid, optical imaging is used to determine the concentration of a specific protein or virus in the liquid sample based on the number of proteins or viruses attached to the surface of the beads.

Tushar Sathe, a graduate student in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, described the process of creating these novel beads and their clinical applications at SPIE Photonics West in San Jose, California. The work was also published in Analytical Chemistry.

The technology involves embedding fluorescent quantum dots and magnetic iron oxide nanoparticles inside the beads to create dual-modality magneto-optical beads. Nie and Sathe synthesize the quantum dots in different colors by varying their size, giving the beads a unique optical signature. Having different color beads allows the researchers to detect several target molecules at the same time in the same liquid sample.

“We use the quantum dots to create a set of beads that are unique and can be distinguished from each other. It’s similar to bar-coding — once you barcode the beads and put them in the urine or blood sample, you can remove them and decode what proteins or viruses have attached to individual beads based on their spectral signature,” explained Sathe.

The process of creating these beads is quite simple, according to Sathe. The surface of the beads contains a long-chain carbon molecule that makes the beads hydrophobic, meaning they repel water. The beads are dissolved in butanol and washed several times. Then the beads are counted and optical and magnetic nanocrystals are added to the suspension either simultaneously or sequentially.

After 15-20 minutes, the butanol is removed to get rid of any remaining nanoparticles that didn’t get incorporated into the beads and the beads are washed with ethanol. Then the beads are coated with a polymer that creates a hydrophilic surface on the beads. This allows the beads to be functionalized by adding antibodies or DNA molecules to the surface that will capture the target molecules.

These beads are dual-function — both optical and magnetic — but according to Sathe, more functions can be added to the beads. “Adding them is as easy as adding the nanoparticles into the solution. You just have to make sure the nanoparticle surface is hydrophobic so that it interacts with the beads,” said Sathe.

The primary biomedical applications for this new technology will be to detect cancer and neurological diseases by identifying certain molecules present in human blood or urine that indicate specific diseases, according to Nie, who is also professor of biomedical engineering, chemistry, materials science & engineering, and hematology and oncology at Emory University and the Georgia Institute of Technology.

“Some of the biomarkers for Alzheimer’s disease have very low concentrations in the blood so you need highly sensitive techniques that can find a specific molecule to diagnose this disease,” explained Nie. “Our technique could also be used to monitor therapeutic response. For example, if the viral level decreases in samples taken at later dates, then we know the drug is probably working.”

This new technology allows the researchers to analyze very low concentrations of target molecules. “Instead of analyzing a liter of sample where the concentration could be very dilute and you might not see the target molecule you’re looking for, you can let the beads capture the molecules on their surface, remove them from the liquid, and then just measure the number of molecules attached to the beads,” said Nie.

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This ongoing research is funded by the National Cancer Institute, the Department of Energy’s Genomes to Life (GTL) Program, the Department of Defense and the Georgia Cancer Coalition, a public-private partnership established by the Georgia General Assembly in 2001.

Contact: John Toon
Georgia Institute of Technology Research News

Successful Development Of Prototype Assays

International medical diagnostics company Panbio Limited has announced that it had developed two prototype immunoassays using their proprietary panDA Homogeneous Assay technology.

Panbio’s prototype panDA Homogeneous Assays are able to specifically and accurately detect and differentiate IgG antibodies induced by infection with Herpes Simplex Virus (HSV) 1 and HSV 2 in validated serum samples.

Commenting on the achievement of this milestone, Panbio Acting CEO, Dr Stuart Hazell said, “This is clear evidence that the panDA Homogeneous Assay technology is capable of differentiating similar analytes with high specificity, which is an area where other homogeneous immunoassay platforms typically flounder. Successfully demonstrating that the key components of the system and the analyte interact specifically and generate a clear signal represents an important breakthrough.”

The announcement marks the achievement of a key milestone in developing the panDA Homogeneous Immunoassay technology. “We have achieved the first functional prototype assays based on Panbio’s proprietary panDA Homogeneous Assay technology within the timeframe previously indicated to the market,” said Panbio Chairman, Maj Gen (Ret) Peter Arnison.

Key advances achieved in the development of the prototype panDA Homogenous Assays include:

• Sensitive and specific detection of a type specific antibody, IgG, induced by specific infection with either HSV 1 or HSV 2, with little or no cross reactivity between analytes.

• Performance data obtained using a true homogeneous immunoassay format. A serum sample is added to a master reagent mix, which if positive produces a colorimetric signal that may be detected shortly thereafter.

• Results that are comparable with those obtained by testing with the market leading kits using the current ELISA technology.

• Generation of performance data by in-house testing of a panel of 150 samples.

• The assay system uses B-Lactamase enzyme fragments that have been successfully engineered to be resistant to B-Lactamase inhibitors as announced in October 2006.

The technology represents a potentially great advance in medical and veterinary diagnostics. Reduced diagnostic test processing times down to as little as 10 minutes are possible, down from up to three hours using current technology. Quicker diagnosis will benefit patients, physicians and clinical laboratory customers.

Furthermore, the technology allows immunoassays to be performed in fewer steps, heavily reducing the complexity of performing the assays by instrument or by manual operation, hence reducing costs and the potential for operator error.

Given the extraordinary simplicity of the assay procedure, the potential applications for the technology in the clinical laboratory are diverse.

“One of the advantages of panDA Homogeneous Assay technology is that they don’t necessarily need to be performed on a highly complex and expensive instrument,” said Panbio Acting CEO, Dr Stuart Hazell.

“Assays using this technology could be run on many existing laboratory instruments, including open instrument platforms such as automated ELISA instruments and closed instrument platforms such as clinical chemistry analysers.

“The assays could also be run in hand held point-of-care (POC) testing devices allowing diagnosis of a broad range of conditions at the bedside.

“By exploiting panDA Homogeneous Assay technology you could envisage clinical laboratories where a single instrument is capable of performing immunoassays, clinical chemistry assays and assays for critical biomarkers.”

The achievement of this milestone does not mean that the project is accomplished. The team will now be focusing on developing other prototype assays to further prove the performance of the technology, expanding the assay technology’s performance and producing the first batch of assays to be used for independent clinical trials. These and other matters will be critical developments undertaken in 2007.

A number of further technical developments are required to deliver a robust commercial assay system. Thus, there remains both technical and commercial risk associated with this technology.

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Panbio is an international diagnostics company headquartered in Brisbane, Australia. With operations in Brisbane and Columbia, Maryland U.S.A., the company develops, manufactures and markets diagnostic tests to a worldwide customer base. Panbio products are used in the diagnosis of over 30 disease states. The company is recognised as a world leader in tests used in the diagnosis of flaviviruses and other arthropod-borne viruses.

Contact: Dr Stuart Hazell
Research Australia

Moscow Bird Flu From A Single Market

According to the Russian Agriculture Ministry, the Moscow bird flu outbreak was traced to a market southwest of the city. The market is now closed, the Ministry told AP, while scientists try to find out where the four dead birds came from.

Although H5N1 is suspected, further laboratory tests need to confirm this. It will be the first H5N1 bird flu outbreak in the Moscow area if tests results come back positive. Whether of not H5N1 has been confirmed is slightly confusing at the moment – some officials say tests have come back positive while others deny this. While a Ministry spokesman, Alexei Alexeyenko, has confirmed H5N1 was present in two places, Valery Sitnikox, Moscow’s Chief Veterinary Inspector, say we won’t know about the lab test results until Monday, February 19th.

Valery Sitnikox said authorities in the central Moscow region have implemented all measures to stem the spread of bird flu. “The situation is under control – the veterinary service is in control of everything. Measures to vaccinate birds will begin tomorrow.” He added that current measures will make sure further outbreaks can be prevented. He is extremely hopeful that the current chain of events have been stopped – the market where the infected birds were brought to has been shut down.

Nobody knows where the infected birds came from. Authorities stressed that this outbreak poses no threat to human health.

Scientists fear that the H5N1 bird flu virus strain, the most virulent one, will eventually mutate and become easily human transmissible. This has not happened yet. It is extremely difficult for birds to infect humans, and even harder for a human to infect another human.

It is believed that one of the ways H5N1 could mutate would be by infecting a person who is sick with the normal human flu virus. The bird flu virus would then have the opportunity to exchange genetic information with the bird flu virus and acquire its ability to spread easily from human-to-human (become easily human transmissible). If this happened, we could be facing a serious, global flu pandemic.

If we can keep the number of outbreaks among birds down to a minimum, then the number of humans becoming infected is also low – giving the bird flu virus fewer opportunities to mutate.

Written by: Christian Nordqvist
Editor: Medical News Today

1st International Study Group For New ‘Movement’ Discipline

Movement ecology is on the move, with the world’s first international research group on this topic having begun its work this fall at the Hebrew University of Jerusalem’s Institute for Advanced Studies

Movement ecology is a developing academic pursuit, combining expertise in a variety of fields, including biology, ecology, botany, environmental science, physics, mathematics, virology and others.

It has been largely developed by a Hebrew University of Jerusalem researcher, Prof. Ran Nathan, who heads the Movement Ecology Laboratory in the Department of Evolution, Systematics and Ecology at the university’s Alexander Silberman Institute of Life Sciences.. It involves the study of how plant and animal matter travels from one place to another, sometimes for great distances and in highly surprising ways.

The research group now at work at the Hebrew University’s Institute for Advanced Studies was convened at the initiative and under the leadership of Prof. Nathan and includes participants from the University of California at Berkeley, the University of California at Davis, Princeton University, Stony Brook University and Rutgers University, all from the U.S.; the Spanish Research Council; and from the Hebrew University, Ben-Gurion University of the Negev and the Technion – Israel Institute of Technology.

Prof. Nathan emphasizes that organism movement research is central to the understanding of how ecological systems work and has important implications for human life. A comprehensive understanding of movement as a process will help to conserve biodiversity, adapt to changes produced by global warming, and cope with environmental threats such as infectious diseases, invasive alien species, agricultural pests and the spread of allergens.

The field of movement ecology and Prof. Nathan were given a large boost of recognition in a recent special issue of Science magazine on migration and dispersal. The issue included an article by Prof. Ran Nathan on his specialty of long-distance dispersal of plants.

In addition, the same issue contained a news article which largely focused on the work of Nathan and his students, as well as others in the U.S., Britain and Australia, focusing on dispersal of both plants and animals.

The article noted that researchers have sought, for centuries, “to understand when, why and how various species crawl, swim, fly, float or hoof it to new locales. That work has led to maps of migration routes and details about dispersals.”

“But,” the article quoted Prof. Nathan as saying, “few biologists have tried to fit those data into a big picture of movement in general.” Now, said the article, through the new discipline called movement ecology, Nathan and others “are beginning to derive testable hypotheses about the mobile behaviors of animals, microbes and even the seeds of plants. Their goal is to join empirical work to theories and to build models that fill in gaps in our understanding of movement — be it over millimeters or continents or by groups of individuals – in the natural world.”

Last year, Nathan was chosen as the winner of the Hebrew University President’s Prize for the Outstanding Young Researcher for his pioneering work on seed dispersal. In May this year he was awarded the prestigious Wilhelm Bessel Research Award from the Humboldt Foundation of Germany.

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Contact: Jerry Barach
The Hebrew University of Jerusalem

China Biopharmaceuticals Holdings Completes All Clinical Trials Of Desloratadine For Hay Fever

China Biopharmaceuticals Holdings, Inc. (OTC Bulletin Board: CHBP), a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

CHBP President and Chief Operating Officer Lufan An said, “We are pleased to have completed all the required clinical trials for Desloratadine for the SFDA’s review. We hope to have the SFDA’s approval to manufacture and market this drug by the end of 2007. If we are granted production approval, CHBP will be one of only four pharmaceutical companies producing Desloratadine tablets in China through 2010. This is the latest accomplishment of our R&D team which has submitted 15 drug applications to the SFDA during this calendar year.”

In a separate release, CHBP also announced today that it is one of only three companies that received authorization from the SFDA to initiate clinical trials to evaluate the safety and efficacy of Sofalcone for the treatment of digestive ulcers. CHBP also stated that the trials will be conducted in six hospitals throughout China and are expected to be completed within one year.

About China Biopharmaceuticals Holdings

China Biopharmaceuticals Holdings, Inc (CHBP) is a research driven pharmaceutical company dedicated to the discovery, development, manufacturing and marketing of small and large molecule pharmaceutical products, including medicines, vaccines, and active pharmaceutical ingredients for various categories of diseases. CHBP’s product portfolio includes 260 drugs already approved for manufacturing and marketing by the Chinese State Food and Drug Administration (SFDA). CHBP also has submitted 15 drug applications to the SFDA for its review during the calendar year of 2006. CHBP is a U.S.-listed public company with operating subsidiaries and senior management based in China. For further information, please visit our website at http://www.cbioinc.com.

Safe Harbor Statement

The statements contained herein that are not historical facts are “forward looking statements” within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, our statements regarding the potential growth of the markets are examples of such forward- looking statements. The forward-looking statements include risks and uncertainties, including but not limited to, general economic conditions and regulatory developments, not within our control. The factors discussed herein and expressed from time to time in our filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed or implied by such statements. The forward looking statements are made only as of the date of this filing, and we undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

China Biopharmaceuticals Holdings, Inc.
http://www.cbioinc.com

Diet May Help Prevent Allergies And Asthma

A recent publication from the Global Allergy and Asthma European Network (GA2LEN) (1) provides new insights into the role that diet may play in the development of allergies, especially in children. The work suggests that the significant changes in European diets over the past 20-40 years may have contributed to the increased incidence of allergic diseases in both children and adults seen over this period. Members of the nutrition work package responsible for the report consider that its findings are just the beginning of GA2LEN’s potential role in greater understanding of this complex area.

The prevalence of allergic diseases has increased dramatically over the past few decades, especially in children. One child in three is allergic today and one in two people in Europe are likely to be suffering from at least one allergy by 2015. It is generally agreed that a combination of heredity and environmental factors is responsible for the development of the allergy and asthma. However, the evolution of these diseases has been far too rapid for genetics to be the sole explanation. Among the wide range of environmental factors under discussion, changes in the European diet in the last 20-40 years are considered to be a possible explanation. Indeed, the way in which children are fed early in life may have a direct effect on the subsequent development of asthma and allergies, according to a recent publication from the Global Allergy and Asthma European Network (GA2LEN). (1)

In a paper entitled “Nutrition and allergic disease”, published this year in Clinical and Experimental Allergy Reviews, 12 European experts working together in the GA2LEN nutrition work package present the evidence and define fertile topics for future research. (2) The work package team is led by Professor Philip C Calder, Institute of Human Nutrition, University of Southampton. (3)

Key findings: breastfeeding, early diet and probiotics

The three main areas producing key findings are breastfeeding, intake of certain nutrients, and probiotics. (4)

Exclusive breastfeeding, that is providing the infant with no other liquid or food other than breast milk, is believed to be effective in reducing subsequent development of allergies. It appears that exclusive breastfeeding for four months helps protect the child from cow’s milk protein allergy until 18 months, reduces the likelihood of dermatitis (skin allergy) until three years, and reduces the risk of recurrent wheeze (or asthma) until six years’ of age. However, the longer term effects of breast feeding on allergic outcomes are not known and require investigation.

The protective effect of four months of exclusive breastfeeding is important for all children but it is especially valuable for those at high risk of developing allergies. Children are at high risk of developing allergies if one or both parents are affected by allergic disease. If it is not possible for the high-risk child to be breastfed, hypoallergenic formula combined with avoidance of solid foods for 4-6 months offers an alternative source of protection. The studies show that hypoallergenic formula helps prevent cows’ milk protein allergy developing before the age of five years and offers protection against atopic dermatitis (eczema or other skin allergy) until the age of four years.

A second major area of importance appears to be the components of the diet. For example, antioxidants in the diet, such as vitamin C, vitamin E and selenium coming mainly from fruit and vegetables, may have a protective effect. Furthermore, different fats found in milk, butter, vegetable oils and fish may have different effects on development of allergies and asthma. Although it is difficult to find clear-cut evidence, it appears that reducing sodium intake, increasing magnesium intake, eating apples and other fruit and vegetables, and avoiding margarine might help some asthmatics. However much of the research conducted to date has not been systematic in its approach and this makes the drawing of hard conclusions very difficult.

The role of probiotics and prebiotics in the diet is promising. Living organisms such as probiotics appear to protect against the development of allergies by producing changes in the bacteria in the gut that stimulate the immune system. A double blind, placebo-controlled study has recently shown that probiotics can help reduce the risk of atopic disease. This is an important area for future research.

Meeting the challenge

The review highlighted several areas in nutrition and diet that appear to be fruitful for future research in allergic disease, and therefore for future disease control. In particular, it has highlighted gaps in relation to specific effects of maternal and infant nutrition on allergy and asthma in later life. Patients, health professionals and policy makers alike would benefit from such research and from more large-scale studies on diet and allergy. Key focuses should be identification of dietary patterns or factors likely to be involved in altering risk of development of allergies and asthma, and developing the evidence base about whether supplementation with specific fats or probiotics could contribute both to the protection and treatment of allergic diseases. The studies required will need to be large and to be well planned, designed and executed. They are likely to require cross-country collaboration.

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Notes:

1. GA2LEN – the Global Allergy and Asthma European Network is a “Network of Excellence” funded by the European Union 6th Research Framework Programme. It consists of 26 research centres spread throughout Europe, as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patients Associations (EFA).

2. The 72-page peer-reviewed paper entitled “Nutrition and allergic disease” is published in Clinical and Experimental Allergy Reviews 6: 117-188, 2006 Blackwell Publishing Ltd.

3. The article represents the work of Workpackage 2.1 of GA2LEN. Correspondence should be addressed to the workpackage leader, P. C. Calder, BSc, PhD, DPhil, Professor of Nutritional Immunology, Institute of Nutrition, University of Southampton, UK.

4. The full list of indicators comprises: Sodium and potassium, magnesium, lipids including fatty acids in milk, butter, vegetable oils and fish, antioxidants, including fruit and vegetable intake, flavonoids and flavonoid-rich foods, Vitamin C, Vitamin E, b-Carotene, Vitamin A, selenium, zinc and copper, and probiotics and prebiotics.

Contacts:

P.C. Calder
Institute of Human Nutrition
School of Medicine
University of Southampton
Bassett Crescent East
Southampton SO16 7PX
UK.

GA2LEN Dissemination
Avenue Brugmann 151
B-1190 Brussels
Noelie Auvergne

For further information please visit:
GA2LEN And
University of Southampton

Update On Salmonella Outbreak And Peter Pan Peanut Butter And Great Value Peanut Butter

FDA advised consumers not to eat any Peter Pan peanut butter purchased since May 2006 and not to eat Great Value peanut butter with a product code beginning with “2111″ purchased since May 2006 because of risk of contamination with Salmonella Tennessee. Salmonella is a bacterium that causes foodborne illness, and “Tennessee” is a type of Salmonella. All Peter Pan peanut butter purchased since May 2006 is affected; only those jars of Great Value peanut butter purchased since May 2006 with a product code beginning with “2111″ are affected. Although Great Value peanut butter with the specified product code has not been linked by CDC to the cases of Salmonella Tennessee infection, the product is manufactured in the same plant as Peter Pan peanut butter and, thus, is believed to be at similar risk of contamination. Great Value peanut butter made by manufacturers other than ConAgra is not affected.

Number of Cases and State Locations:

The Centers for Disease Control and Prevention (CDC) has identified 290 people from 39 states who have gotten sick from Salmonella Tennessee, the Salmonella type associated with this outbreak. Forty six (46) patients are known to have been hospitalized and there have been no reported deaths.

The 39 states with reported illness are: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia.

Advice to Consumers:

FDA continues to advise consumers not to eat any Peter Pan peanut butter purchased since May 2006. FDA also continues to advise consumers not to eat any Great Value peanut butter purchased since May 2006 with product codes beginning with the numbers “2111″ on the jar lid. All such products should be thrown out. If consumers cannot find a number on the jar lid or are unsure, the safest thing to do is to discard the product.

Individuals who have recently eaten the affected Peter Pan and Great Value peanut butter and who have experienced any symptoms of Salmonella infection should contact their health care provider immediately. Symptoms include fever, diarrhea and abdominal cramps. For persons in poor health or with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

Anyone who has a jar of the affected peanut butter and who has become ill also should report that they have a jar to state or local health authorities. Individuals who have eaten the affected peanut butter within the last week and who do not feel sick most likely will not get sick. However, persons who begin to have any of the symptoms outlined above should see a health care professional.

FDA Actions To-Date:

On February 13, 2007, FDA was notified by CDC and state health departments of data showing an outbreak of Salmonella Tennessee infection in people who reported having eaten certain jars of Peter Pan peanut butter. Since that time, FDA has been conducting an active investigation of Peter Pan and Great Value peanut butter made by ConAgra in the same facility.

On February 13, FDA contacted ConAgra officials. On February 14, ConAgra agreed to initiate a product recall.

On February 14, FDA took the following actions:

– Notified the public of the findings related to the Salmonella outbreak and advised consumers not to eat peanut butter from jars with a certain product code.

– Notified its counterpart agencies in Canada and Mexico, the World Health Organizations’ INFOSAN Food Safety reporting program and the food safety authority at the European Commission.

– Sent a team of microbiologists and experienced field investigators to begin its inspection of ConAgra’s manufacturing plant in Georgia. The inspection will include collecting environmental, raw ingredient and product samples, and reviewing manufacturing and quality assurance records.

Next Steps:

– FDA laboratory personnel will analyze samples collected from the manufacturing plant.

– FDA will conduct a thorough inspection and assess its own inspectors’ observations of the manufacturing plant for any necessary follow up actions. If international distribution is documented, FDA will inform and work with its counterpart agencies in those countries.

– FDA will continue to work closely with CDC and state health authorities to track any additional cases of Salmonella Tennessee illness.

– FDA will continue to work with ConAgra and inspect records to determine the distribution of the recalled product both within the United States and overseas.

– FDA will continue to provide regular updates to the public as this investigation unfolds.

Recall Status and For More Information:

ConAgra is recalling all Peter Pan peanut butter and all Great Value peanut butter beginning with product code 2111 that already was distributed. The company also is destroying all affected products in its possession. The company has stopped production and is working to identify the cause of the contamination. ConAgra has advised consumers to destroy all Peter Pan peanut butter and any Great Value peanut butter beginning with product code 2111.

For more information see: press releases and questions and answers.

— Photos: Peter Pan and Great Value Peanut Butter

— FDA’s Pilot Program to Better Educate Consumers about Recalled Food Products

http://www.fda.gov

Are We Spending Too Much On HIV?

Billions of pounds are being spent on the fight against AIDS in developing countries. In this week’s BMJ, two experts go head to head over whether we are spending too much.

HIV is receiving relatively too much money, with much of it used inefficiently and sometimes counterproductively, argues Roger England, Chairman of Health Systems Workshop.

Data show that 21% of health aid was allocated to HIV in 2004, up from 8% in 2000. It could now exceed a quarter. Yet HIV constitutes only 5% of the burden of disease in low and middle income countries as measured by disability adjusted life years lost (DALYs). It causes 2.8 million deaths a year worldwide – fewer than the number of stillbirths, and much less than half the number of infant deaths. More deaths are attributable to diabetes than to HIV.

Furthermore, HIV interventions are not cost effective enough to justify this disproportionate spending, he writes. Much HIV money could be spent with more certain benefits on, for example, bed nets, immunisation, or family planning. Money is also wasted in areas that reflect the interests of those on the AIDS industry payroll more than evidence.

He believes that the money could be more effective if used to strengthen public health systems rather than focusing on disease-specific programmes.

AIDS is widely acknowledged as a public health crisis and current spending is woefully inadequate, argue Paul de Lay and colleagues at the Joint United Nations Programme on HIV and AIDS (UNAIDS).

Resources currently pledged are only half of what is needed for a comprehensive response. For instance, in 2006, $9bn was available for the AIDS response but the real need was estimated at $15bn. Poor coordination between different stakeholders in affected countries also impedes effective spending. This is compounded by weak institutions and regulatory policies, poor governance, and in some cases corruption.

They argue that the response to AIDS needs to be seen in the context of international commitments to the millennium development goals, which also call for progress across many other developmental priorities. HIV threatens many of these goals, especially those related to poverty and health.

The cost of inaction against AIDS is huge, far greater than for any other public health crisis, they say. Current costs are so high because of the inadequacy of previous investments, but they will be higher tomorrow if we continue to underinvest.

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Contact: Emma Dickinson
BMJ-British Medical Journal

Continuous Infusion Of Hydrocortisone Reduces Hyperglyaemia In Patients With Septic Shock

Changing how critically ill patients are treated with hydrocortisone could reduce hyperglycemia. The results of a randomized controlled clinical trial, published in the journal Critical Care, lead researchers to recommend using continuous infusion of low-dose hydrocortisone in patients with sepsis, rather than bolus injections. The study shows that continuous infusion of low-dose hydrocortisone minimizes hyperglycaemic episodes, serious adverse events that can lead to insulin dependency. The researchers also found that continuous infusion reduced nurses’ workload.

Low dose hydrocortisone treatment is widely used as a treatment for patients suffering from septic shock. However, hydrocortisone stimulates glucose production in the liver and other tissues and may induce high blood glucose levels, or hyperglycaemia. Preventing hyperglycaemia has previously been shown to improve the survival of critically ill patients.

Pekka Loisa of the Päijät-Häme Hospital in Finland, and colleagues from hospitals throughout Finland carried out the trial involving 48 patients in four intensive care units (ICUs) between July 2005 and April 2006. One group of 24 patients received the hydrocortisone treatment by continuous infusion of 200mg/day. The bolus therapy group of 24 patients received the same overall dose, but the hydrocortisone was administered intravenously in 50mg doses every six hours. Loisa et al. compared blood glucose levels, insulin requirements and the nursing workload for the two groups. Hydrocortisone treatment lasted five days in both groups.

Loisa et al. found that the mean blood glucose levels were similar in both groups, but the number of hyperglycaemic episodes was higher in the group receiving bolus therapy. For patients undergoing bolus therapy, the insulin infusion rate had to be changed more often to maintain normal blood glucose levels, adding to nurses’ workload. The researchers stress that normal blood glucose levels can be achieved successfully using both methods. However, strict normoglycemia is more easily achieved with continuous hydrocortisone infusion.

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Article:

Effect of hydrocortisone treatment modality on glycemic control in patients with septic shock. A prospective randomized trial Pekka Loisa, Ilkka Parviainen, Jyrki Tenhunen, Seppo Hovilehto and Esko Ruokonen Critical Care 2007 (in press)

Contact: Grace Baynes
BioMed Central

Value Of Data From HIV Testing/counseling Centers Questioned

Use of data from voluntary HIV counselling and testing clinics for HIV surveillance in Africa is not appropriate, according to a Viewpoint in this week’s issue of The Lancet.

The rapid expansion of antiretroviral treatment for HIV-infected adults, which has been helped by various international initiatives* has demanded a scale-up of voluntary HIV counselling and testing services. Increases in clinic coverage, the obligation to fulfil donor-driven requirements of programme monitoring and assessment, and the desire to measure the effect of HIV-related interventions on the evolution of the epidemic, have led to suggestions to use data from these clinics for HIV and behavioural surveillance.

Gabriel Mwaluko (Tanzania Netherlands Project to Support HIV/AIDS control, Mwanza, Tanzania) and colleagues believe that this use of these data is not appropriate and argue that the data are inherently biased, and their collection could compromise the function of the clinics. How data for HIV prevalence from these clinics should be interpreted is not clear as they are influenced by the self-selection of patients who come forward for testing as well as by the underlying prevalence of HIV in the population – both are likely to change with time, and thus estimations of prevalence and trends are likely to be biased.

Furthermore, the authors state that the collection of data from different types of counselling and testing services to obtain national estimates presents problems – patients referred from medical wards to a testing centre within a hospital are different from those in a walk-in centre located in the community, who are different again from women accessing counselling via services for the prevention of mother-to-child transmission of HIV.

According to the authors, obtaining detailed data on client sexual behaviour could help assessment of the biases in HIV-prevalence, but the need for detailed structured questions about sexual behaviour does not conform with the ethos of the voluntary counselling and testing interview, and data collected when the client is emotionally stressed are notoriously unreliable. The authors state that this data would be better obtained by a community based inquiry – such as Demographic and Health Surveys that have been undertaken in many African countries – which inquire about testing history and sexual behaviour, and would not overburden voluntary counselling and testing services.

The authors conclude: “In view of the problems inherent in both obtaining and interpreting surveillance data from voluntary HIV counselling and testing centres, prudence should be exercised before extensions to routine data collections by providers of HIV counselling and testing services are recommended…what is needed in many countries is the implementation of well-designed but simple data-collection devices to ensure that useful and meaningful data are obtained and that duplication is eliminated.”

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Miss Alison Wringe, London School of Hygiene and Tropical Medicine, UK.

*Such as WHO’s 3 by 5 strategy, the Global Fund to fight AIDS, Tuberculosis and Malaria, and the President’s Emergency Plan for AIDs Relief.

Contact: Joe Santangelo
Lancet