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Universal HIV testing and immediate treatment could reduce but not eliminate HIV/AIDS epidemic

Implementing a program of universal HIV testing and immediate antiretroviral treatment (ART) for infected individuals could have a major impact on the HIV/AIDS epidemic in Washington, DC, but a new study finds that it would not halt the epidemic, something that a previous report had projected. In a paper that will appear in the August 15 issue of Clinical Infectious Diseases and has been released online, researchers find that the so-called "test-and-treat" strategy could reduce new HIV infections by 15 percent over the next five years while conferring large survival benefits to HIV-infected patients. "Test-and-treat will save lives, but it won't stop the HIV epidemic in its tracks all by itself," says Rochelle P. Walensky, MD, MPH, of the Massachusetts General Hospital (MGH) Division of Infectious Disease, who led the study." It is only a single new and important page in the HIV-prevention playbook." Test-and-treat has been the subject of widespread interest and controversy in the scientific community. In January 2009, WHO scientists published a report in The Lancet suggesting that a voluntary system of annual HIV testing of all adults, followed by immediate provision of ART for those testing positive, "could nearly stop transmission and drive HIV into an elimination phase." Inspired by these findings, researchers and public health officials have rushed to design and implement test-and-treat studies and interventions. The National Institute for Allergy and Infectious Diseases (NIAID) recently announced a two-year, $26.4 million partnership with the Washington, DC, Department of Health that includes a pilot study of the test-and-treat strategy. However, some experts have expressed concern that the assumptions underlying the WHO findings painted too optimistic a picture of the likely outcomes. The current study used epidemiologic data and results from HIV screening programs conducted in the U.S. capital to give a realistic picture of the likely impact of a test-and-treat effort in that city, which has one of the nation's largest rates of HIV infection. This contrasts with the WHO study which employed data from sub-Saharan Africa and assumed truly universal screening and treatment with optimal clinical outcomes. "The reality of HIV screening programs, even the best ones, is that many people are never reached for screening, some refuse screening or do not link to care, and many of those who are treated do not maintain viral suppression," notes Kenneth A. Freedberg, MD, MSc, of the MGH Department of Medicine, the report's senior author. The study finds that a test-and-treat program in Washington, DC, could extend life expectancy of HIV-infected patients -- currently projected at about 24 years after diagnosis -- another one to two years and could reduce the rate of new infections 15 percent over a five-year period. Survival and prevention impacts would be even greater with improvements in screening, linkage to treatment and retention in care -- improvements not yet reflected in the "best cases" reported by any U.S. program. Such optimistic but possibly achievable scenarios could extend survival to 29 years after HIV diagnosis and decrease new infections by as much as 50 percent over five years. "The benefits of expanded testing to persons with undiagnosed HIV infection are unquestioned," Walensky says. "Earlier detection and linkage to care saves lives; this alone is a reason for test-and-treat. But pinning all our hopes on the latest 'magic bullet,' underestimating the logistical obstacles, and forgetting that prevention requires an integrated package of strategies puts us at risk of falling into a trap we've seen before. Our analysis suggests that test-and-treat will likely be a very important addition to the treatment and prevention armamentarium, but the expectations for its impact should be realistic." Walensky and Freedberg are both associate professors of Medicine at Harvard Medical School. Additional co-authors of the Clinical Infectious Diseases report are Bethany Morris, Callie Scott, MSc, and Erin Rhode, MS, MGH Department of Medicine; A. David Paltiel, PhD, Yale School of Medicine; Elena Losina, PhD, Brigham and Women's Hospital; and George Seage, ScD, Harvard School of Public Health. The study was supported by grants from the NIAID, the National Institute of Mental Health and the Doris Duke Charitable Foundation. Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

Jul 9, 2010

Health

Biofuels sustainability: JRC designs methodology to calculate carbon stock changes

A key tool is the JRC's methodology to quantify changes to the amount of carbon in soils and biomass when land use changes as a result of biofuels production. This is an important factor in the sustainability assessment. The methodology follows the Intergovernmental Panel on Climate Change (IPCC) guidelines for national greenhouse gas inventories and is supported by comprehensive global data collected by the JRC. The methodology was the basis for the Commission decision on the guidelines for the calculation of land carbon stocks. The new system, adopted in June by the European Commission, encourages industry, governments and NGOs to set up voluntary certification schemes for all types of biofuels. It will help to ensure that all biofuels (including those imported into the EU) are sustainable and deliver high greenhouse gas (GHG) savings, at least 35% when compared to fossil fuels. It also excludes specific land categories, such as primary forests, wetlands, peatlands and areas with high diversity. The JRC provided extensive technical and scientific support to the Commission Directive and Communications. This included designing practical measures and procedures for calculating the GHG emissions of various options for producing biofuels and bioliquids. The accompanying global data layers on climate regions and soil types have also been developed by the JRC, following IPCC specifications. The standard methodology and the carbon stock coefficients together with the data layers will enable economic operators to determine what changes in land carbon stocks might arise from the conversion of land for biofuels production. The calculation of default values for GHG savings is a complex procedure, which must take into consideration a number of parameters such as the type of fertiliser or pesticide used when growing biofuels, the fuel used by agricultural vehicles (tractors) or the distance to the processing plant and users. Other JRC contributions included: Calculating the typical and default values for GHG savings (Annex V of the Directive 2009/28/EC "on the promotion of the use of energy from renewable sources"); Adapting and updating the list of pathways to technical and scientific progresses; Selecting the most scientifically appropriate data sources; Providing technical answers and support to third parties on the assessment of GHG emissions and on the values specified in the Directive. Background The package adopted on 10 June 2010 by the European Commission, in support of the 2009/28/EC Directive, provided for: Sustainable biofuel certificates: The Commission encourages industry, governments and NGOs to set up 'voluntary schemes' to certify biofuel sustainability and explains the standards these must meet to gain EU recognition. One of the main criteria is that they have independent auditors which check the whole production chain, from the farmer and the mill, via the trader, to the fuel supplier who delivers petrol or diesel to the filling station. The Communication sets standards requiring this auditing to be reliable and fraud-resistant. Protecting untouched nature: The Communication establishes that biofuels should not be made from raw materials from tropical forests or recently deforested areas, drained peatland, wetland or highly biodiverse areas. It also provides guidelines for the assessment, making clear for instance that the conversion of a forest to a palm oil plantation would fall foul of the sustainability requirements. The promotion of biofuels with high greenhouse gas savings: The Communication reiterates that EU countries have to meet binding national targets for renewable energy and that only those biofuels with high greenhouse gas savings count towards those targets. It also explains how to calculate those savings. Biofuels must deliver greenhouse gas savings of at least 35% compared to fossil fuels, rising to 50% in 2017 and to 60%, for biofuels from new plants, in 2018. About the JRC The mission of the Joint Research Centre is to provide customer-driven scientific and technical support for the conception, development, implementation and monitoring of EU policies. As a service of the European Commission, the JRC functions as a reference centre of science and technology for the Union. Close to the policy-making process, it serves the common interest of the Member States, while being independent of special interests, whether private or national. More information JRC biofuels thematic programme: http://re.jrc.ec.europa.eu/biof/ Thematic data layers (according to climatic zones and soil type): http://eusoils.jrc.ec.europa.eu/projects/RenewableEnergy/ Sustainability criteria for biofuels: http://ec.europa.eu/energy/renewables/biofuels/sustainability_criteria_en.htm Download Commission decision on guidelines for the calculation of land carbon stocks for the purpose of Annex V of Directive 2009/28/EC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:151:0019:0041:EN:PDF

Jul 9, 2010

Health

Extremely obese children have 40 percent higher risk of reflux disease of esophagus

July 9, 2010 (PASADENA, Calif.) -- Extremely obese children have a 40 percent higher risk of gastroesophageal reflux disease (GERD) and children who are moderately obese have a 30 percent higher risk of GERD compared to normal weight children, according to a Kaiser Permanente study published online in the International Journal of Pediatric Obesity. This large population-based study establishes an association between obesity and GERD in children, an association that has been previously reported in adults. GERD can lead to decreased quality of life, chronic respiratory conditions, and increased risk for cancer of the esophagus (the tube that carries food from the mouth to the stomach) if it persists through adulthood. Researchers used electronic health records to conduct a cross-sectional study of 690,321 children aged 2 -- 19 years who were members of the Kaiser Permanente Southern California integrated health plan in 2007 and 2008. About 8 to 25 percent of children in the U.S. may be affected by frequent symptoms of gastroesophageal reflux, depending upon their age and body mass index. GERD is a chronic condition in which the liquid content of the stomach flows up in to the esophagus. This can inflame and damage the lining of the esophagus. GERD may be responsible for an increased occurrence of coughs, asthma, and inflammation of the larynx. Left untreated, GERD may result in chronic esophageal inflammation and lasting damage to the esophagus. Cancer of the esophagus is the nation's fastest growing cancer and is expected to double in frequency in the next 20 years -- unlike most other cancers, which are decreasing in frequency. Researchers suspect this rise is due in part to the nation's obesity epidemic. "Childhood obesity, especially extreme childhood obesity, comes with a high risk for many serious health consequences such as diabetes, cardiovascular disease and cancer. The takeaway message of our study is that GERD now also is one of the conditions associated with childhood obesity" said study lead author Corinna Koebnick, PhD, a research scientist at the Kaiser Permanente Southern California's Department of Research and Evaluation in Pasadena, Calif.. "Beyond counseling for weight loss, obese children who report symptoms of GERD may need to be treated for the underlying reasons to help avoid persistence of GERD into adulthood and to prevent its complications. " "Even though some health conditions associated with extreme childhood obesity may not seem important early in life, they can be a significant burden for the patient and a link to other serious conditions later in life. We need to be aware of these links, search for obesity-related conditions and address childhood obesity as a family issue as early as possible," noted Dr. Koebnick. Previous research into the association between obesity and GERD was hospital-based instead of population-based, included mainly people with asthma, and did not address extreme childhood obesity. In this study, the percentile of the measure of a child's weight in relation to height for age was calculated according to the 2000 U.S. Centers for Disease Control and Prevention recommendation to assign a weight class (normal weight, overweight, moderate and extreme obesity). Children in the study had an average of 2.6 medical visits per year where height and weight were measured. This study is part of the Kaiser Permanente Southern California Children's Health Study, Kaiser Permanente's ongoing work to identify and treat childhood obesity through research and community programs. Results from the Children's Health Study published in the Journal of Pediatrics in March 2010, reported that extreme obesity is affecting more children at younger ages, with 12 percent of African American teenage girls, 11.2 percent of Hispanic teenage boys, 7.3 percent of boys and 5.5 percent of girls 2 -- 19 years of age now classified as extremely obese. In February 2010, Kaiser Permanente announced that it was a founding partner of the Partnership for a Healthier America (www.ahealthieramerica.org), a nonprofit, nonpartisan foundation created to catalyze and increase support around First Lady Michelle Obama's campaign to curb childhood obesity in a generation. Other study authors included: Darios Getahun, MD, Ning Smith, MS, and Steven J. Jacobsen, MD, PhD, from the Kaiser Permanente Department of Research and Evaluation in Pasadena, Calif.; Amy H. Porter, MD, from the Kaiser Permanente Baldwin Park Medical Center; and Jack K. Der-Sarkissian, MD, from the Kaiser Permanente Medical Center, Los Angeles. About the Kaiser Permanente Department of Research and Evaluation The Department of Research and Evaluation conducts high quality, innovative research into disease etiology, prevention, treatment and care delivery. Investigators conduct epidemiology, health sciences, and behavioral research as well as clinical trials. Areas of interest include diabetes and obesity, cancer, HIV/AIDS, cardiovascular disease, aging and cognition, pregnancy outcomes, women's and children's health, quality and safety, and pharmacoepidemiology. Located in Pasadena, Calif., the department focuses on translating research to practice quickly to benefit the health and lives of Kaiser Permanente Southern California members and the general population. Visit www.kp.org/research. About Kaiser Permanente Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.6 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter.

Jul 8, 2010

Health

Pfizer Hemophilia presents new data at the World Federation of Hemophilia 2010 Congress

BUENOS AIRES, ARGENTINA, July 9 -- Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia (WFH) 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia. These presentations follow Pfizer's recent announcement about the creation of a new research unit focused on rare diseases, including hemophilia. "We are very excited to present these data, which highlights the strength of our pipeline and our enduring commitment to provide recombinant products for the hemophilia community," says Brenda Cooperstone, M.D., vice president of clinical development and medical affairs for the Specialty Care Business Unit at Pfizer. "Our investigation of novel therapies for hemophilia treatment remains ongoing and we will continue to work closely with our partners -- including the World Federation of Hemophilia -- to help improve hemophilia care worldwide." Early Research with Factor Xa and VIIa Pfizer will present the results of a pre-clinical study in mice indicating that recombinant factor Xa therapy may provide a unique way to bypass deficiencies in the intrinsic pathway. Additional results from a preclinical study in mice suggest that a recombinant factor VIIa molecule with increased activity and duration of action may have the potential to improve inhibitor outcomes. Additional Hemophilia Research from Pfizer at WFH New model of antibody-induced hemophilia A for the assessment of bypass therapies An electronic documentation system in Haemophilia provides otherwise unavailable feedback for continuous quality control -- first results from the Haemoassist® system A prospective registry of European hemophilia B patients receiving BeneFIX® (nonacog alfa, recombinant human factor IX) for usual use Two-year interim results of a non-interventional trial to assess the safety and efficacy of treatment with recombinant factor IX Safety and efficacy of B-domain-deleted recombinant FVIII -- final results of a 10 year pharmacovigilance study Pfizer's Ongoing Commitment to the WFH and the Hemophilia Community Pfizer will make a contribution to WFH at the meeting in support of the Twinning Program, which aims to increase the level of diagnosis and care for people with hemophilia by pairing emerging treatment centers and patient organizations with more established centers and organizations around the world. Wyeth, now part of Pfizer, has acted as the exclusive corporate sponsor of the world-renowned program since 2001, which currently has 32 Twinning partnerships worldwide. Historically, there have been 149 Twinnings. Pfizer will also host the annual reception for the Twinning Program. About Hemophilia Hemophilia is a rare, inherited blood-clotting disorder characterized by spontaneous hemorrhages or prolonged bleeding. People with hemophilia are deficient in one of the key proteins -- factor VIII for hemophilia A or factor IX for hemophilia B -- that is needed for normal blood clotting. Most patients with hemophilia are dependent on replacement therapy. Indication for BeneFIX BeneFIX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including peri-operative management. BeneFIX is NOT indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X), hemophilia A patients with inhibitors to factor VIII, reversal of coumarin-induced anticoagulation, or bleeding due to low levels of liver-dependent coagulation factors. Important Safety Information for BeneFIX BeneFIX is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with the product should be discontinued, and emergency treatment should be sought. BeneFIX has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFIX administration by continuous infusion have not been established. Development of activity-neutralizing antibodies has been detected in patients receiving factor IX products. If expected plasma factor IX activity levels are not attained, or if patient presents with allergic reaction, or if bleeding is not controlled with an expected dose, an assay that measures factor IX inhibitor concentration should be performed. Patients may develop hypersensitivity to hamster (CHO) protein as BeneFIX contains trace amounts. The most common adverse reactions (>5%) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash. Please see full Prescribing Information for BeneFIX available at www.pfizer.com. Indication for ReFacto® ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown. Important Safety Information for ReFacto As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto. Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur. Please see full Prescribing Information for ReFacto available at www.pfizer.com. Pfizer Inc: Working together for a healthier world™ At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 9, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information regarding the Pfizer Hemophilia Franchise. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

Jul 8, 2010

Health

Revised standards for psychology services in jails, prisons, correctional facilities and agencies

Los Angeles, CA (July 8, 2010) Revised standards for psychology services in jails, prisons, correctional facilities, and agencies appear in the July special issue of the journal Criminal Justice and Behavior (published by SAGE). The three largest mental health institutions in the U.S. are not hospitals, but penal institutions: New York's Riker's Island, Chicago's Cook County Jail and the Los Angeles County Jail. Seriously mentally ill individuals compose about 15% of the over two-million individuals currently incarcerated in the U.S.. Unfortunately, many correctional systems lack resources to meet the constitutionally mandated needs of mentally ill individuals in their custody. The standards represent the International Association for Forensic and Correctional Psychology's (IACFP) second revision of psychology services standards in correctional settings, which were first published in 1980. They are the result of more than a year's effort by the IACFP's revision committee, chaired by Richard Althouse, Ph.D., president of the IACFP. "Offenders, mentally ill or not, entrusted to the custody of correctional facilities and agencies, benefit in a number of ways from the highest quality of rehabilitative and mental health services," writes Althouse in the introduction to the special issue. These benefits include helping to maintain institutional security, an increased likelihood of successful integration back into the community, and reduced likelihood of expensive civil litigation or other legal actions that can result from inadequate correctional mental health services. IACFP's revised standards provide information for both administrators and clinicians in areas relevant to providing optimal mental health services, including organizational policies and ethical principles, intake screening, staffing rations, mental health services, suicide prevention and intervention, records, research, and references. They can be read free for a limited time at http://cjb.sagepub.com/content/37/7/749.full.pdf+html. Criminal Justice and Behavior (CJB) is the official publication of the International Association for Correctional and Forensic Psychology (www.ia4cfp.org). CJB promotes scholarly evaluations of assessment, classification, prevention, intervention, and treatment programs to help the correctional professional develop successful programs based on sound and informative theoretical and research foundations. Publishing timely, well-conceived, and lively scholarship, CJB advances the knowledge and expertise of professionals and academics involved in forensic psychology, with a concentration on correctional psychology. http://cjb.sagepub.com SAGE is a leading international publisher of journals, books, and electronic media for academic, educational, and professional markets. Since 1965, SAGE has helped inform and educate a global community of scholars, practitioners, researchers, and students spanning a wide range of subject areas including business, humanities, social sciences, and science, technology, and medicine. A privately owned corporation, SAGE has principal offices in Los Angeles, London, New Delhi, Singapore and Washington DC. www.sagepublications.com

Jul 8, 2010

Health

Tip sheet for journalists: Equol, soy, menopause and bone health research published in Journal of Nutrition

The dietary supplement SE5-OH containing Natural S-equol, developed from soy, may be appropriate for women in menopause, based on results of recent clinical trials documenting its effectiveness and safety in relieving hot flushes and other symptoms of menopause. Nine articles on equol, soy, menopause, bone health and cancer research appear in a July 2010 supplement to the Journal of Nutrition and are summarized here. About SE5-OH containing Natural S-equol Soybeans contain a naturally occurring compound, the isoflavone called daidzein. Certain bacteria living within the human digestive tract can convert daidzein into S-equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman]. S-equol is thought to bind to the estrogen beta receptors, but further study is underway to confirm this hypothesis. Studies in Japan have documented an association in women between milder menopausal symptoms in those who naturally produce S-equol after eating soy compared to non-producers. The production of S-equol after soy consumption depends on the types of bacteria present in the large intestine and may be influenced by the amount of soy consumed. About 50 percent of Asians and 20 to 30 percent of North Americans and Europeans, who in general consume less soy than Asians, have the ability to produce equol. Pharmavite LLC, the makers of Nature Made® vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co., Ltd., is conducting and sponsoring clinical trials that examine the use of SE5-OH containing Natural S-equol in supplement form for the management of menopausal symptoms. JN Papers 1. Historical Overview of Soy and Isoflavone Research Messina reviews the past two decades of soy and isoflavone research, noting that largely because of research evaluating the anticancer effects of soyfoods sponsored by the US National Cancer Institute in the 1990s, interest in the role of soy and isoflavones in disease prevention greatly increased . Subsequently, isoflavones and soyfoods have been studied for their ability to lower cholesterol, their potential as alternatives to conventional hormone therapy, alleviate, as well as treat hot flashes and inhibit bone loss in postmenopausal women. "A Brief Historical Overview of the Past Two Decades of Soy and Isoflavone Research," Mark Messina, Ph.D., adjunct associate professor of nutrition at the Loma Linda University School of Public Health in California and of Nutrition Matters, Inc. in Port Townsend, Washington 2. Discovery and Chemistry of Equol The health benefits of soy-based diets may be greater in people who can produce S-equol after eating soy, than in non-producers. Equol exists in two mirror-image forms: S- equol and R-equol, but intestinal bacteria exclusively produce the S-equol from soy, which is known to have a select affinity for estrogen receptor beta. A man-made chemical process is needed to make R-equol, which binds more weakly with a preference for estrogen receptor alpha. Both forms of equol are of interest from a clinical and pharmacological perspective and are under development as nutraceutical and pharmacological agents. The authors state that wide range of biological activities these two equol forms possess warrants their investigation for the treatment of a number of hormone-related conditions involving conditions dependent on the female hormone estrogen and related to the male hormone androgen. "Equol: History, Chemistry and Formation," Kenneth D. R. Setchell, of Pathology and Laboratory Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center in Ohio, and Carlo Clerici of Clinica di Gastroenterologia ed Epatologia, at the Universita` degli Studi di Perugia University of Perugia in Italy 3. Biological Actions of Equol Equol exhibits a wide range of biological properties. This paper reviews previous research on how the body processes both equol forms, also called pharmacokinetics, and their biological actions. The authors note that if the theory that health benefits of soy-based diets are greater in equol-producers can be substantiated in studies, then for those adults who are unable to produce S-equol due to a lack of equol-producing bacteria in the intestine or some other factors, one option is to eat equol in the form of a nutraceutical. " Equol: Pharmacokinetics and Biological Actions," Kenneth D. R. Setchell, of Pathology and Laboratory Medicine, Department of Pediatrics, Cincinnati Children's Hospital Medical Center in Ohio, and Carlo Clerici of Clinica di Gastroenterologia ed Epatologia, at the Universita` degli Studi di Perugia University of Perugia in Italy 4. Equol Review by an Epidemiologist Lampe reviews the very limited body of a subset of research about equol, which includes animal studies involving S-equol, a mix of S- and R-equol or their "parental" compound, daidzein, and human epidemiologic studies of soy intake and equol production. "Emerging Research on Equol and Cancer," Johanna W. Lampe, of the Cancer Prevention Program, Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center in Seattle 5. Equol and Bone in Women and Mice Soybean isoflavones, including daidzein and genistein, can inhibit bone loss, depending on the dosage, according to a number of studies using animal model with osteoporosis, without causing notable effects on reproductive organs. Ishimi reports in this article data from a year-long study in postmenopausal Japanese women, in which 25 received a daily dose of daidzein and the isoflavone genistein , and 29 received a placebo. In the women in the isoflavone group who could produce S-equol, the percent change in bone loss at the total hip (a decrease of 0.46 percent) and at the hip intertrochanteric region (a decrease of 0.04 percent) was significantly lower (P< 0.05 for both) than that of the nonproducers (a decrease of 2.28 and 2.61, respectively.) Similarly the S-equol producers in the isoflavone group had significantly lower changes in their fat mass compared to nonproducers during the course of the study. The results suggest that using soy isoflavones to prevent bone loss and the accumulation of fat in women in early post-menopause may depend on an individual's equol-producing capacity. "Dietary Equol and Bone Metabolism in Postmenopausal Japanese Women and Osteoporotic Mice," Yoshiko Ishimi, of the National Institute of Health and Nutrition in Tokyo, Japan 6. Equol May Help to Reduce Bone Loss Estrogen produced in the body helps maintain dynamic bone with a high turnover rate. Menopause in women is associated with the body's stage when estrogen levels decrease. The reduction in production and circulating estrogen is associated with rapid bone loss. S-equol binds to estrogen receptor beta, in bone cells. A two-year randomized placebo-controlled trial that characterized postmenopausal women by their equol-producing status, showed that those who were equol producers had a 2.4 percent increase in the lumbar spine bone mineral density (BMD) compared with just 0.6 percent increase in the S-equol non-producers. Additional clinical studies have related women's equol producer status with changes in markers of bone turnover in response to treatments with soy isoflavones. "Equol, via Dietary Sources or Intestinal Production, May Ameliorate Estrogen Deficiency-Induced Bone Loss," Connie M. Weaver and LeeCole L. Legette, of the Department of Foods and Nutrition at Purdue University in Indiana 7. Cultural influences on assessing Menopausal Hot Flashes Hot flashes continue to be a troublesome problem for menopausal women the world over. After 50 years of research, Kronenberg reports that the specific cause and mechanism of hot flashes is still not understood, or how estrogen, the major pharmaceutical treatment, works to reduce hot flashes. Insights into the social and cultural complexities that may affect how and whether women report hot flashes and becoming more sophisticated in research tools, such as questionnaires, physiological monitors and brain imaging techniques, may yield more information. New aspects of hot flash research, including neuroimaging and the study of genetic differences, when combined with increasingly nuanced ways of asking questions of culturally distinct populations, provide challenges but rich complexity from which a better understanding of menopausal hot flashes will emerge. "Menopausal Hot Flashes: A Review of Physiology and Biosociocultural Perspective on Methods of Assessment," Fredi Kronenberg of the Clayman Institute for Gender Research at Stanford University 8. Equol Improves Menopausal Symptoms in Japanese Women Aso reports on three studies exploring the possible therapeutic role of the SE5-OH containing Natural S-equol supplement in treating menopausal symptoms in Japanese women. The studies indicated that a daily dose of 10 mg of SE5-OH containing Natural S-equol improved menopausal symptoms. In a confirmation study, menopausal women who were not equol producers who consumed 10 mg daily of the supplement for 12 weeks had significantly reduced severity and frequency of their hot flashes as well as a significant reduction in the severity of their neck or shoulder stiffness. The equol-ingesting group also showed trends of improvement in sweating and irritability. SE5-OH containing Natural S-equol appears to have a promising role as an alternative remedy in the management of women's menopausal symptoms. "Equol Improves Menopausal Symptoms in Japanese Women," Takeshi Aso, M.D., Ph.D., Professor Emeritus at the Tokyo Medical and Dental University in Japan. 9. Research Needs for Equol, Soy, and Menopause Research Barnes reported that research opportunities now exist to determine whether the effects of equol on menopausal symptoms, such as hot flashes, sleep disturbances, bone health, in equol producers can be extended to equol non-producers via supplements. It is recommended that future research be designed to avoid complications from differences of social culture, lifetime exposure to soy products, experimental techniques and other variables. "Cautions and Research Needs Identified at the Equol, Soy, and Menopause Research Leadership Conference," Stephen Barnes, Ph.D., of the Department of Pharmacology and Toxicology, and Helen Kim, PhD, director of 2-D Proteomics Laboratory, both at the University of Alabama at Birmingham. Making SE5-OH containing Natural S-equol Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. developed SE5-OH containing Natural S-equol, which is created under current Good Manufacturing Practices using the equol-producing lactic acid bacterial strain Lactococcus 20-92 in a proprietary fermentation process patented by the Otsuka Pharmaceutical Co., Ltd. This process converts daidzein to Natural S-equol, steadily increasing the concentration of Natural S-equol until reaching a maximum concentration at 72 to 96 hours and decreasing daidzein by 95 percent. Following fermentation, the SE5-OH ingredient undergoes a sterilization process using heat denaturation that deactivates the bacteria. The process is designed to produce a product rich in Natural S-equol that can be used as a nutraceutical ingredient. For more information on the research on Natural S-equol, please visit the website www.naturalequol.com. About Pharmavite LLC: For almost 40 years, Pharmavite has earned and maintained the trust of healthcare professionals, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. Nature Made® is the number one selling dietary supplement brand in the food, drug, club and mass channels. The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states. About Otsuka Pharmaceutical Co., Ltd.: Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US $11.7 billion*) in annual revenues in fiscal 2009. Visit Otsuka Pharmaceutical Co., Ltd. at www.otsuka-global.com.

Jul 8, 2010