DEERFIELD, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence]. Baxalta is seeking market authorization in Europe of OBIZUR for the treatment of bleeding episodes in adult patients with acquired hemophilia caused by antibodies to Factor VIII (FVIII), a very rare and potentially life-threatening acute bleeding disorder. Buy Nizoral (Ketoconazole) Following this positive opinion, the European Commission is expected to make a decision on the application later this year. Buy Kamagra Effervescent (Sildenafil Citrate) without prescription Upon approval in Europe, OBIZUR will be the first recombinant porcine FVIII treatment available for acquired hemophilia A, allowing physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments. “The marketing authorization anticipated later this year for OBIZUR will be an important milestone, offering patients with acquired hemophilia A in Europe a treatment option that transforms their care by allowing physicians to monitor treatment response,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. About Mircette (Desogestrel / Ethinyl estradiol) with free prescription “The positive support by the European regulators reflects the value this therapy can provide to patients, and supports Baxalta’s long-standing commitment to addressing unmet needs and reducing the global burden of bleeding disorders.” The CHMP positive opinion is based on a global, prospective, controlled, multi-center Phase II/III open-label clinical trial that examined the efficacy of OBIZUR in the treatment of serious bleeding episodes in adults with acquired hemophilia A (29 patients evaluated for safety, 28 evaluated for efficacy). About Dosan with free Rx All patients treated with OBIZUR (28/28) showed a positive response (bleeding stopped or reduced) and clinical improvement, with FVIII activity levels at least greater than 20 percent at 24 hours after the initial infusion. About Tadacip (Tadalafil) with no prescription Resolution of the initial bleeding episode was observed in 24 out of 28 (86 percent) of the patients treated with OBIZUR. Buy Water Bottles online Common adverse reactions observed in greater than five percent of patients in the clinical trial were development of inhibitors to porcine FVIII. OBIZUR is currently approved in the United States and is under regulatory review in Canada, Switzerland, Australia and Colombia. http://doctorconsult.wordpress.com OBIZUR was granted orphan-drug designation by the European Commission based on the classification of acquired hemophilia A as a rare disease and the potential for the treatment to address an important unmet medical need. About OBIZUR in Europe OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] is indicated for the treatment of bleeding episodes in adults with acquired haemophilia caused by antibodies to Factor VIII. OBIZUR is not indicated for the treatment of congenital hemophilia A or von Willebrand disease. Important Risk Information for OBIZUR CONTRAINDICATIONS OBIZUR should not be used in patients with known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients. WARNINGS & PRECAUTIONS Hypersensitivity Allergic type hypersensitivity reactions are possible with OBIZUR. The product contains trace amounts of hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. In case of shock, standard medical treatment for shock should be implemented. Development of inhibitory antibodies Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR. Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR. It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay. There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration. Therefore, OBIZUR must only be administered when considered clinically necessary. Extensive cutaneous purpura do not necessarily require treatment. OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells. Antibodies to baby hamster kidney cell protein were not detected in subjects either before or after exposure to OBIZUR. High and sustained Factor VIII activity in blood may predispose to thromboembolic events. Those with pre-existing cardiovascular disease and the elderly are at particular risk. If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered. Factor VIII activity determined by the chromogenic assay is generally lower than Factor VIII activity determined by the one-stage clotting assay. Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient. The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR. Sodium content Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution. To be taken into consideration by patients on a controlled sodium diet. Monitoring Laboratory Tests Monitor Factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering OBIZUR. Monitor Factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table for recommended target Factor VIII trough levels. The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate. ADVERSE REACTIONS Common adverse reactions observed in greater than 5% of subjects in the clinical trial were development of inhibitors to porcine factor VIII. About Acquired Hemophilia A Acquired hemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, typically affects older adults and occurs in both males and females1,2. In acquired hemophilia A, individuals typically experience subcutaneous, soft tissue, and post-surgical bleeding.2,3,4 The comorbidities in this typically elderly population also pose a particular challenge to treat serious bleeding episodes.1 About Baxalta Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide. Forward-Looking Statements This release includes forward-looking statements concerning OBIZUR, including expectations with regard to its potential impact on patients, related regulatory actions and commercial launch plans. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta s control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta s Registration Statement on Form 10 and other Securities and Exchange Commission filings, all of which are available on Baxalta s website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. REFERENCES 1.   Acquired Hemophilia: Revised Edition. World Federation of Hemophilia. 2012; No. 3: 1-5. Accessed on July 16, 2014. Available at: 1.wfh.org/publication/files/pdf-1186.pdf 2. Musial, J; Zdziarska, J. Acquired hemophilia A: an underdiagnosed, severe bleeding disorder. Department of Hematology, Jagiellonian University Medical College. 2nd Department of Medicine, Jagiellonian University Medical College. 2014. Accessed on July 16, 2014. Available at: pamw.pl/sites/default/files/PAMW%202014-04_Zdziarska.pdf 3. Franchini, M; Gandini, G; Paolantonio, T; Mariani, G. Acquired Hemophilia A; A Concise Review. American Journal of Hematology. 2005. No. 80: 55-63. Accessed on July 16, 2014. Available at: onlinelibrary.wiley.com/doi/10.1002/ajh.20390/pdf 4. Franchini, M; Mannucci, P. Acquired Hemophilia A: A 2013 Update. Department of Transfusion Medicine and Hematology, Carlo Poma Hospital, Mantova, Italy. 2013. Accessed on July 17, 2014. Available at: .ncbi.nlm.nih.gov/pubmed/24008306

Food container plastics linked to hypertension

Chemicals supposed to be safe replacements for harmful chemicals in plastics are linked to hypertension and insulin resistance, a precursor to diabetes, find scientists from NYU Langone Medical Center in New York City. Small rises in blood pressure were linked to the chemicals supposed to replace those previously found to be unsafe. The phthalate compounds in question - di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP) - are replacements for another chemical, di-2-ethylhexylphlatate (DEHP), which the same researchers proved in previous research to have similar adverse effects. The phthalates are meant to strengthen plastic wraps and processed food containers, among other household items. The two new pieces of research are published in the journals Hypertension and The Journal of Clinical Endocrinology and Metabolism. In the Hypertension study, for every 10-fold increase in the amount of phthalates consumed, there was a 1.1 millimeters of mercury (mmHg) increase in blood pressure. In the other study, one in three adolescents with the highest DINP levels had the highest insulin resistance, while for those with the lowest concentrations of the chemicals, only 1 in 4 had insulin resistance. Growing concerns over environmental chemicals and insulin resistance Study leader Dr. About Crixivan (Indinavir) with free Rx Leonardo Trasande, a professor at NYU Langone, says: "Our research adds to growing concerns that environmental chemicals might be independent contributors to insulin resistance, elevated blood pressure and other metabolic disorders." Prof. About Sinemet (Carbidopa-Levodopa) with no prescription Trasande would like the 1976 Toxic Substances Control Act updated: "Our study adds further concern for the need to test chemicals for toxicity prior to their broad and widespread use, which is not required under current federal law." Other research from Prof. Buy Breast Success () without prescription Trasande in 2013 confirmed a link between DEHP exposure and hypertension in Americans. About Cyklokapron with no Rx DEHP was used as a plasticizer but banned in Europe in 2004 - DINP and DIDP are designed to replace it. Buy Arava (Leflunomide) with free prescription Perhaps the safer alternatives lie in not using plastics at all. "Alternatives to DIDP and DINP include wax paper and aluminum wrap; indeed, a dietary intervention that introduced fresh foods that were not canned or packaged in plastic reduced phthalate metabolites substantially." Prof. Buy Progesterone Cream online Trasande adds that there are "safe and simple" steps that can limit exposure to phthalates, including: Do not microwave food in plastic containers or covered by plastic wrap Do not wash plastic food containers in the dishwasher, where plasticizers can leak out Avoid phthalates by avoiding plastic containers labeled with the numbers 3, 6 or 7 inside the recycle symbol. The results of the research come from blood and urine sample analysis of participants in the National Health and Nutrition Examination Survey (NHANES). Since 1999, NHANES has surveyed 5,000 volunteers annually about risk factors and diseases. http://asthmareview.wordpress.com As part of the NYU Langone investigation, blood and urine samples were analyzed from a diverse group of children and adolescents aged between 6 and 19 years. Blood and urine samples were collected once between 2008 and 2012, and the study volunteers blood pressure was similarly measured. Diet, physical activity, gender, race/ethnicity, income, and other factors independently associated with insulin resistance and hypertension were also factored into the researchers analysis. Written by Markus MacGill

More accurate prostate cancer diagnoses offered by sensor chip

Prostate cancer is one of the most deadly cancers for men, but current diagnosis methods using antibodies are not completely reliable. Buy Azulfidine (Sulfasalazine) with no Rx A new sensor chip could be the solution to the problem, however, making prostate cancer diagnosis more efficient and reliable according to the results of a recent study. About Vesicare (Solifenacin) without prescription Prostate cancer is the second most common cancer in American men, behind skin cancer. The study was conducted by researchers from the University of Birmingham in the UK and is published in Chemical Science. Buy Lanoxin (Digoxin) with no Rx Its findings demonstrate that the new technology could reduce the number of false readings that occur with traditional diagnosis methods. Study author Prof. About Combimist with free Rx Paula Mendes states that there are two key benefits to the new sensor chip: "Crucially for the patient, it gives a much more accurate reading and reduces the number of false-positive results. Casodex (Bicalutamide) with no prescription Furthermore, our technology is simple to produce and store, so could feasibly be kept on the shelf of a doctors surgery anywhere in the world. Buy Nettle online It can also be recycled for multiple uses without losing accuracy." According to the American Cancer Society (ACS), prostate cancer is the second leading cause of cancer death in American men, with around 1 in 38 dying as a result of the disease. http://pharmaceutical-journal.blogspot.com They estimate that around 220,800 new cases of prostate cancer will be diagnosed in the US over the course of 2015. Prostate cancer is normally diagnosed by tests relying on antibodies that are expensive to make and vulnerable to degeneration brought on by environmental changes. Crucially, however, they are known to give false-positive readings at a high rate. The researchers believe that their new sensor chip could improve prostate cancer diagnosis by avoiding these limitations. Created by a team of chemical engineers and chemists, the sensor chip works by identifying specific proteins bonded to carbohydrate chains known as glycoprotein molecules. These molecules perform many roles in different functions of the body, including the immune response. Due to their role in the immune response, glycoprotein molecules are frequently used by scientists as biomarkers for diseases, including prostate cancer. Previously, techniques for detecting glycoproteins have focused on the protein of the molecule. However, this part of the molecule does not always change when the body is affected by disease. Instead, the new chip is designed to focus on the carbohydrate part of the molecule that, in contrast, are subtly different in healthy and diseased patients. Chip technology could also be used to diagnose other diseases "Biomarkers such as glycoproteins are essential in diagnostics as they do not rely on symptoms perceived by the patient, which can be ambiguous or may not appear immediately," explains Prof. Mendes. "However, the changes in the biomarkers can be incredibly small and specific and so we need technology that can discriminate between these subtle differences - where antibodies are not able to." The new sensor chip has nano-cavities on its surface that fit the shape of the specific glycoprotein associated with prostate cancer. These nano-cavities are made with a cast, constructed by binding a custom-designed molecule to both a gold surface and the prostate cancer glycoprotein. The end of the custom-designed molecule that reacts with the glycoprotein contains a boron group. When these boron bonds are broken, a perfect cast is left behind. Prof. Mendes explains further: "It is essentially a lock, and the only key that will fit is the specific prostate cancer glycoprotein that we re looking for. Other glycoproteins might be the right size, but they won t be able to bind to the very specific arrangement of boron groups." The team hope that further investment and collaboration with commercial partners could lead to their novel technology becoming accessible for all and adapted for use in the treatment of other conditions. "We believe that this could be applicable to other diagnostic challenges," states co-author Dr. John Fossey. "Lots of diseases produce specific glycoproteins, so there are a number of possible avenues to improve the accuracy of our diagnoses." As with any cancer, reliable and quick diagnosis is vital for ensuring the best possible outcome for patients. This new technology could prove to be a difference maker not only in the treatment of prostate cancer but other dangerous diseases as well. Previously, Medical News Today reported on a study conducted by researchers from the University of Michigan in which a previously unidentified biomarker of prostate cancer was discovered that could potentially affect the diagnosis and treatment of the disease. Written by James McIntosh

Targeting gene-control molecule may heal chronic wounds

Wound healing is a complex process that progresses in stages and for which there are few targeted treatments for when it goes wrong. About Arcoxia (Etoricoxib) with free Rx Now, a new study has discovered how a small molecule that regulates gene expression plays a key role in progressing wounds through their healing stages. The researchers suggest the molecule they identified could be a new target for treating chronic wounds. Chronic wounds affect between 0.2 and 1% of people in developed countries and represent a growing health concern and cost to society. Current treatments concentrate on controllable factors such as clearing infections. Buy Viread (Tenofovir Disoproxil Fumarate) without prescription The researchers behind the new study note there is a pressing need for treatments that go further than this and target the wound healing process itself. The researchers suggest the molecule they identified - called miR-132 - could be a target for new treatments for wounds that are hard to treat. In the Journal of Clinical Investigation, they describe how they focused on two of the stages of wound healing: the inflammatory and the proliferative. Glucotrol Xl (Glipizide) During the inflammatory stage, immune cells clear away debris such as damaged and dead cells and bacteria. During the proliferative stage, skin cells multiply to grow new tissue. About Co-amoxiclav with free prescription The transition to this stage from the inflammatory stage is a critical one and can decide whether the wound heals successfully or not. miR-132 very active during inflammatory and peaks during proliferative stage Following on from previous work, the researchers investigated a group of molecules called microRNAs (abbreviated miRNAs) - small pieces of genetic code that do not hold instructions for making proteins, but regulate the genes that do. They collected skin biopsies from the edge of wounds and looked for changes in miRNA expression during the healing process. The team found that one miRNA in particular - called miR-132 - was very active during the inflammatory stage in a type of skin cell called epidermal keratinocytes, which form the outermost layer of the skin. Cialis Light Pack-30 () with no prescription They also noticed how the molecule peaked in the subsequent proliferative stage. During the inflammatory stage, miR-132 caused fewer immune cells to move to the wound. Buy Muscle Recovery online Conversely, a lack of miR-132 caused more immune cells to move to the wound and increase inflammation. During the proliferative stage, miR-132 promoted keratinocyte growth, while a lack of it held back cell growth and slowed wound healing. Principal investigator, Ning Xu Land en, an assistant professor in the department of medicine at Karolinska Institutet in Stockholm, Sweden, says: "Our results show that miR-132 is important during the transition from the inflammatory to the proliferative phase and therefore acts as a critical regulator of skin wound healing. Due to its pro-healing capacity, miR-132 may be an attractive therapeutic target for chronic skin wounds. http://futurepharmaceuticals.wordpress.com Our goal is to develop a microRNA-based treatment to promote healing." Meanwhile, another team is working on a way to use nanoparticles to hasten wound healing. A study that Medical News Today reported in March 2015, explains how the experimental therapy - which uses nanoparticles to deliver an enzyme blocker - cut wound healing time by 50% in mice. The researchers - from the Albert Einstein College of Medicine of Yeshiva University, Bronx, NY - hope their treatment will one day help patients with all kinds of wounds, from surgical incisions to diabetic ulcers. Written by Catharine Paddock PhD

Cystic fibrosis gene therapy trial offers hope of treatment

. http://md-opinion.blogspot.com he results of a trial provide the first proof of concept that non-viral gene therapy is safe and can benefit lung function in patients with cystic fibrosis, say investigators writing in The Lancet Respiratory Medicine. Trial participants receive the gene therapy by inhaling fat globules containing the corrective DNA. Nootropil (Piracetam) without prescription Image credit: Imperial College London The trial - run by the UK Cystic Fibrosis Gene Therapy Consortium - now needs to be followed by further studies to assess the optimum dose and treatment schedule, they add. The placebo-controlled, double-blind trial was carried out at two centers in the UK and recruited 136 cystic fibrosis patients over the age of 12. The patients received either monthly doses of the gene therapy or a placebo for 1 year. The trial tested a gene therapy where the patient inhales molecules of DNA wrapped in fat globules (liposomes) that deliver a correct copy of the gene into the cells in the lung lining. Cystic fibrosis is a condition where the lungs produce too much thick mucus, making breathing difficult and increasing the risk of infection. The disease is caused by a single faulty gene located on chromosome 7. Gene therapy shows significant but modest benefit After 1 year of treatment, compared with placebo, patients who received the gene therapy showed "a significant, albeit modest, benefit" in forced expiratory volume or FEV in 1 second (a measure of lung function), write the study investigators, who note that such a result indicates a "stabilization of lung function in the treatment group." They conclude the trial is the first to show that repeated doses of gene therapy can have a meaningful effect on cystic fibrosis and change lung function. However, they warn there is still some work to do before the treatment is ready for clinical use. Buy Allegra (Fexofenadine Hcl) without prescription The effectiveness needs to be improved and the correct dosing needs to be established. Lead author Eric Alton, a professor of gene therapy and respiratory medicine at Imperial College London, and consultant physician at Royal Brompton Hospital, is the coordinator of the Consortium. About Clarinex (Desloratadine) with no prescription He adds that the findings also showed there were no safety concerns about the therapy, and: "Whilst the effect was inconsistent, with some patients responding better than others, the results are encouraging, laying the groundwork for further trials, which we hope could improve the effect." "We are looking to undertake follow-up studies assessing higher, more frequent doses as well as combinations with other treatments," he adds. Step change in treatment of cystic fibrosis Prof. About Ciplacef with free Rx Alton explains that by focusing on the basic defect underlying the disease rather than just its symptoms, they aim to bring about a "step change" in the treatment of cystic fibrosis: "It has taken more than 20 years to get where we are now, and there is still some way to go. Buy Differin (Adapalene) with no Rx Eventually we hope gene therapy will push CF patients towards a normal life expectancy and improve their quality of life significantly." Funding for the trial came from a partnership between the Medical Research Council (MRC) and the National Institute for Health Research (NIHR). The Consortium is also developing a second therapy that uses a virus to deliver the corrective DNA to the lung cells. Buy Lomatium online First clinical trials are expected to start in 2016. Publication of the trial results follows other welcoming news that Medical News Today reported recently of a new drug combination that targets the most common genetic cause of the disease could extend the life of cystic fibrosis patients. The trial results showed that treatment with a combination of lumacaftor and ivacaftor led to a reduction in required hospital antibiotic courses, and other improvements. Written by Catharine Paddock PhD

As people age, they often encounter new health problems. Buy Viagra Capsules (Sildenafil Citrate) with free prescription One of the challenges for men and women growing older is how these changes are dealt with, including navigating the world of treatment options that are often available. Low testosterone can lead to erectile dysfunction, reduced sexual desire and infertility. When men get older, many notice significant differences in their sex drive, weight, emotion and energy levels. Buy Asacol (Mesalamine) without prescription These changes, often occurring when men reach their late 40s and early 50s, have prompted comparison with the female menopause. Sometimes these changes are attributed to reduced levels of testosterone - the male sex hormone produced predominantly by the testes. Tetracycline (Tetracycline Hydrochloride) with no Rx Men with reduced testosterone levels can experience benefits with testosterone therapy, with many physicians able to prescribe replacement testosterone in the form of injections, patches, pellets and gels. However, the use of testosterone therapy is fiercely debated - particularly when low testosterone levels are associated with age - with clinicians concerned about when treatment is appropriate and what its risks and benefits are. In this Spotlight feature, we have a look at circumstances that might warrant the use of testosterone therapy and investigate different viewpoints from both sides of the current debate. The male menopause One major aspect of the debate is how the drop in testosterone is discussed. Buy Chloramphenicol In many news stories, the terms "male menopause" and "andropause" are used on account of the fact that most of the symptoms associated with declining testosterone levels are similar to those caused by the female menopause. Low testosterone can lead to changes in sexual function, including reduced sexual desire, erectile dysfunction and fewer spontaneous erections. ED Trial Pack () with free Rx Other physical changes that can occur include increased body fat, decreased bone density and hot flashes. Emotional changes can also occur, such as a decrease in motivation and self-confidence, as can sleep disturbances such as insomnia. However, the timeframe over which these changes occur is a major difference between what is experienced by women and many men. Buy Lavender Oil online Whereas the female hormone levels fall over a short period of time, male testosterone levels typically decline gradually over a period of many years. Dr. http://mdreview.wordpress.com Abraham Morgentaler, an associate clinical professor of urology at Harvard Medical School in Boston, MA, told Medical News Today that the terms are problematic in that they set up a parallel with the female menopause that is obviously incorrect. However, he believes the terms do have some use. "On the other hand, what is valuable about these terms is that they convey to the public a condition that has strong similarities to something they already know, making it easier to understand," he explained. Testosterone levels decline in men as they grow old as part of the aging process, typically falling by around 1% each year after men enter their 30s. However, testosterone levels can also fall as part of a disease known as hypogonadism, caused by a problem with the testicles or pituitary gland. Central to the debate over using testosterone therapy to treat perceived symptoms of hypogonadism is whether or not observed biological changes are a result of a decline in hormone concentrations caused by reproductive system pathology or merely the result of aging (aging-related hypogonadism) or other conditions, such as thyroid problems and alcohol use. Testosterone therapy can reverse the effects of hypogonadism. However, the use of testosterone therapy in otherwise healthy men who are experiencing symptoms caused by reduced levels of testosterone is subject to passionate debate. "Unfortunately, passion clouds our ability to assess the evidence on testosterone objectively," warns Dr. Morgentaler in an article published on Medscape. Is testosterone therapy dangerous? Dr. Morgentaler believes that testosterone treatment can benefit patients reporting symptoms associated with reduced levels of testosterone even when there is no documented cause for hypogonadism, such as a pituitary tumor. "Deficiencies of hormones, such as testosterone, produce certain symptoms," he writes. "The effect is the same whether an underlying cause is identified or not. Imagine limiting antihypertensive therapy to the minority of men with known causes. This makes no sense." An argument for limiting testosterone therapy is a perceived risk of cardiovascular events among men receiving testosterone. Earlier this year, the US Food and Drug Administration (FDA) updated testosterone product labels to detail a possible increased risk of heart attacks and stroke. Supporters state that testosterone therapy is a proven effective treatment and that cardiovascular risks are overstated. The FDA recommend that physicians should only prescribe testosterone therapy for men with low testosterone levels caused by disorders of the testicles, pituitary gland or brain that cause hypogonadism. Prior to this announcement, however, Dr. Morgentaler and colleagues conducted a systematic review of available literature on testosterone and cardiovascular risks. They found only four studies reported negative concerns while many others suggested several positives, including reduced mortality, increased exercise capacity and improvement in cardiovascular risk factors such as fat mass. In summary, the researchers concluded that there is no convincing evidence of increased cardiovascular risks with testosterone therapy and, on the contrary, there could be a beneficial relationship between cardiovascular health and normal testosterone levels. "Although no large, long-term controlled studies have definitively determined risk, the weight of evidence right now strongly favors the [cardiovascular] benefits of having a normal serum testosterone concentration, whether achieved naturally or with testosterone therapy," Dr. Morgentaler writes. Overall, there is evidence demonstrating that testosterone therapy can improve symptoms - both sexual and nonsexual - in most men, and Dr. Morgentaler holds that general health may also be improved in symptomatic users. "Testosterone therapy is good medicine for the appropriate patient," he writes. "There is value in identifying men who are testosterone-deficient, and offering them a trial of treatment. For the good of men, it is high time to restore the primacy of science to the field of testosterone deficiency." This form of treatment is increasingly seen as valuable, by patients and clinicians alike. An estimated 2 million men in the US are currently being treated with testosterone, with the number of prescriptions rising steeply over the past decade. In an article originally published in the Journal of the American Geriatrics Society, Dr. Thomas Perls and David J. Handelsman, PhD, describe the increases in prescriptions in detail: "US pharmaceutical sales of testosterone increased from $324 million in 2002 to $2 billion in 2012, and the number of testosterone doses prescribed climbed from 100 million in 2007 to half a billion in 2012, not including the additional contributions from compounding pharmacies, Internet, and direct-to-patient clinic sales." Accusations of disease mongering Dr. Morgentaler states that the reasons for this rise are an increased awareness of testosterone deficiency among health care providers and assuaged fears around an early association between testosterone therapy and prostate cancer. Critics of testosterone therapy, however, believe that other forces are at work. In their paper, Dr. Perls and Prof. Handelsman state that 10- and 40-fold increases reported in the US and Canada are partly attributable to direct-to-consumer product advertising and lax consensus guidelines. "We join others who characterize the mass marketing of testosterone coupled with the permissive prescribing of testosterone for common, nonspecific, aging-related symptoms as disease mongering of declines in testosterone with advancing age," they write. Critics believe that guidelines incorporating nonspecific symptoms such as increased weariness have been drawn up to increase the scope of testosterone therapy. Dr. Perls, based in the Department of Medicine at Boston Medical Center, MA, told MNT that the evidence suggests that pharmaceutical marketing is the predominant reason that testosterone therapy has become as prevalent as it has, stating that aging-related hypogonadism did not exist as a condition to be diagnosed before 2000. "It emerged once the pharmaceutical companies and other doctor and Internet-based entrepreneurs sensed a big profit opportunity by greatly expanding the market for testosterone by making up a new disease consisting of a decreased testosterone level [...] combined with nonspecific common symptoms," he said. "Instead of the 0.5% of men previously noted by endocrinologists to have hypogonadism, there are now clinics and doctors claiming that 40-100% of men experience hypogonadism that merits testosterone replacement." Symptoms such as decreased sexual desire, depressed mood and decreased exertion tolerance can be the result of common problems such as obesity and smoking, which also cause a functional decline in testosterone. "Replacing testosterone in these cases is medically inappropriate and, rather, steps should be taken to treat the underlying cause," he said. In the example of obesity, more apt treatment methods include diet and exercise which do not carry the same risks as those identified by the FDA for testosterone therapy. Co-author Prof. Handelsman, of the ANZAC Research Institute at the University of Sydney in Australia, believes that, at present, we do not know enough about naturally declining testosterone levels to automatically classify them as a deficiency. Regarding cases of testosterone decline in men not associated with reproductive medical disorders, Prof. Handelsman told MNT: "In these situations lower circulating testosterone is not a deficiency at all. This thinking confuses a genuine deficiency state due to pathological reproductive system disorders with a normal functional, adaptive hypothalamic reaction to a systemic disease - which may be beneficial, neutral or harmful." Critics of the wide use of testosterone therapy believe that varying guidelines have been created that stretch the definition of hypogonadism to incorporate nonspecific age-related symptoms which in turn increase the scope of the treatment, making it easier for clinicians to prescribe. "Without demonstrated underlying reproductive system pathology, a set of common complaints plus or minus a low serum testosterone cannot constitute hypogonadism, " write the authors. The FDA currently require the demonstration of a pathological basis for growth hormone deficiency before a prescription for growth hormone can be dispensed. Dr. Perls and Prof. Handelsman believe that a similar demonstration of pathology should be required for the prescription of testosterone. The debate continues On the one hand, testosterone therapy is a form of treatment that can improve various symptoms experienced by some men as they grow older. On the other hand, testosterone therapy is a means to profit from disease mongering. For supporters of testosterone therapy like Dr. Morgentaler, the results speak for themselves. "Indeed," he writes "one only needs to treat five symptomatic men with low testosterone values to become convinced: two will thank the physician profusely for restoring their sexuality and vitality, another two will report solid benefits, and one will not respond." Prof. Handelsman believes that further research is needed. "That point requires proper evaluation, not wild guesswork by pharma or single-issue proponents who have vested interests in such drug promotion," he told MNT. Both sides of the debate present their own evidence and refute that of the opposition, putting the lay person who lacks expertise in a tricky position when it comes to making a judgment. The Mayo Clinic recommend discussing any signs and symptoms that could be attributed to a low testosterone level with a doctor. Being honest with health care providers, making healthy lifestyle choices and seeking help when feeling down are useful steps in tackling problems associated with aging and may help with any decision making about pursuing treatment. It is likely that the debate surrounding testosterone therapy and aging-related hypogonadism will continue into the near future. For any patients affected by these topics, it would appear best to keep an open mind and listen to both sides of the debate while further research is conducted. Written by James McIntosh

Cuba is the first country in the world to receive validation from the World Health Organization for wiping out mother-to-child transmission of HIV and syphilis. Cuba s achievement represents an important step toward an AIDS-free generation say the WHO. In the announcement on Tuesday, Dr. Ventolin (Albuterol (Salbutamol)) Margaret Chan, Director-General of the World Health Organization (WHO), describes the achievement as a "major victory" and an "important step" toward an AIDS-free generation. "Eliminating transmission of a virus is one of the greatest public health achievements possible," says Dr. About Cialis Sublingual (Tadalafil) with no Rx Chan. Michel Sidib e, Executive Director of UNAIDS says the achievements shows it is possible to end the AIDS epidemic and they now "expect Cuba to be the first of many countries coming forward to seek validation that they have ended their epidemics among children." Since 2010, WHO, the Pan American Health Organization (PAHO) and other partners have been working in Cuba and other countries in the Americas to put in place regional initiatives to eliminate mother-to-child transmission of HIV and syphilis. The initiatives ensure early access to prenatal care, and to HIV and syphilis testing for pregnant women and their partners. Buy Elocon (Mometasone) with no prescription Where pregnant women test positive, they and their babies receive prompt treatment, plus the babies are delivered by cesarean section and are not breastfed. Another feature of the initiative is that programs for HIV and sexually transmitted infections are offered as an integral part of mother and child health programs in equitable, accessible and universal health systems. For a country to be recognized as having eliminated mother-to-child transmission of HIV and syphilis, it must pass the validation process and criteria that WHO and their key partners issued in 2014. Careprost without Rx Validation by panel of international experts The validation process recognizes that no treatment is 100% effective in preventing mother-to-child-transmission, so it defines elimination as a "reduction of transmission to such a low level that it no longer constitutes a public health problem." In 2013, only two babies were born with HIV in Cuba, and only 5 babies were born with syphilis inherited from their mothers. To carry out the validation, a PAHO and WHO mission spent 5 days in Cuba in March 2015. Glucovance (Metformin/Glyburide) The mission included experts from several countries in the Americas, plus the Bahamas, Italy, Japan, the US and Zambia. Buy Hearing - Ears online They visited health centers, laboratories, and government offices across the island, interviewing health and other officials. http://anti-infectives-opinion.blogspot.com The validation process places great emphasis on services being offered free of coercion and in line with human rights. PAHO Director, Dr. Carissa F. Etienne, says: "Cuba s achievement today provides inspiration for other countries to advance towards elimination of mother-to-child transmission of HIV and syphilis." Every year around the world around 1.4 million HIV-infected women get pregnant. Without treatment, there is a 15-45% chance they will pass the virus to the baby in the womb, or during birth or breastfeeding. But that risk falls to just over 1% if mothers and their babies receive antiretrovirals during all the stages where infection can occur. Number of children born with HIV has halved According to WHO, the number of children globally born every year with HIV is now nearly half what it was in 2009, when it was around 400,000. Also, since 2009, the proportion of HIV-infected pregnant women in low- and middle-income countries who receive effective anti-HIV drugs to prevent passing it to their child has doubled. A WHO statement says: "Among the 22 countries which account for 90% of new HIV infections, 8 have already reduced new HIV infections among children by over 50% since 2009, based on 2013 data, and another four are close to this mark." Syphilis, which infects nearly 1 million pregnant women around the world every year, is cost-effective and easy to screen and treat during pregnancy. Doing so eliminates most of the complications of infection, which include miscarriage and stillbirth, plus death, low birthweight and serious infections of newborns. In 2012, syphilis affected 360,000 pregnancies through stillbirths, death of newborns, premature births and infected babies. Following a global campaign to eliminate mother-to-child syphilis in 2007, WHO estimate that by 2014, more than 40 countries were testing 95% or more of pregnant women in prenatal care for syphilis. Meanwhile, Medical News Today recently reported a study that suggests risk of HIV reduces with longer secondary education. For the study, the researchers focused on Botswana, the most HIV-affected country in the world, and where recent reforms have increased time spent in secondary education. Written by Catharine Paddock PhD

Cuba is the first country in the world to receive validation from the World Health Organization for wiping out mother-to-child transmission of HIV and syphilis. Cuba s achievement represents an important step toward an AIDS-free generation say the WHO. In the announcement on Tuesday, Dr. Ventolin (Albuterol (Salbutamol)) Margaret Chan, Director-General of the World Health Organization (WHO), describes the achievement as a "major victory" and an "important step" toward an AIDS-free generation. "Eliminating transmission of a virus is one of the greatest public health achievements possible," says Dr. About Cialis Sublingual (Tadalafil) with no Rx Chan. Michel Sidib e, Executive Director of UNAIDS says the achievements shows it is possible to end the AIDS epidemic and they now "expect Cuba to be the first of many countries coming forward to seek validation that they have ended their epidemics among children." Since 2010, WHO, the Pan American Health Organization (PAHO) and other partners have been working in Cuba and other countries in the Americas to put in place regional initiatives to eliminate mother-to-child transmission of HIV and syphilis. The initiatives ensure early access to prenatal care, and to HIV and syphilis testing for pregnant women and their partners. Buy Elocon (Mometasone) with no prescription Where pregnant women test positive, they and their babies receive prompt treatment, plus the babies are delivered by cesarean section and are not breastfed. Another feature of the initiative is that programs for HIV and sexually transmitted infections are offered as an integral part of mother and child health programs in equitable, accessible and universal health systems. For a country to be recognized as having eliminated mother-to-child transmission of HIV and syphilis, it must pass the validation process and criteria that WHO and their key partners issued in 2014. Careprost without Rx Validation by panel of international experts The validation process recognizes that no treatment is 100% effective in preventing mother-to-child-transmission, so it defines elimination as a "reduction of transmission to such a low level that it no longer constitutes a public health problem." In 2013, only two babies were born with HIV in Cuba, and only 5 babies were born with syphilis inherited from their mothers. To carry out the validation, a PAHO and WHO mission spent 5 days in Cuba in March 2015. Glucovance (Metformin/Glyburide) The mission included experts from several countries in the Americas, plus the Bahamas, Italy, Japan, the US and Zambia. Buy Hearing - Ears online They visited health centers, laboratories, and government offices across the island, interviewing health and other officials. http://anti-infectives-opinion.blogspot.com The validation process places great emphasis on services being offered free of coercion and in line with human rights. PAHO Director, Dr. Carissa F. Etienne, says: "Cuba s achievement today provides inspiration for other countries to advance towards elimination of mother-to-child transmission of HIV and syphilis." Every year around the world around 1.4 million HIV-infected women get pregnant. Without treatment, there is a 15-45% chance they will pass the virus to the baby in the womb, or during birth or breastfeeding. But that risk falls to just over 1% if mothers and their babies receive antiretrovirals during all the stages where infection can occur. Number of children born with HIV has halved According to WHO, the number of children globally born every year with HIV is now nearly half what it was in 2009, when it was around 400,000. Also, since 2009, the proportion of HIV-infected pregnant women in low- and middle-income countries who receive effective anti-HIV drugs to prevent passing it to their child has doubled. A WHO statement says: "Among the 22 countries which account for 90% of new HIV infections, 8 have already reduced new HIV infections among children by over 50% since 2009, based on 2013 data, and another four are close to this mark." Syphilis, which infects nearly 1 million pregnant women around the world every year, is cost-effective and easy to screen and treat during pregnancy. Doing so eliminates most of the complications of infection, which include miscarriage and stillbirth, plus death, low birthweight and serious infections of newborns. In 2012, syphilis affected 360,000 pregnancies through stillbirths, death of newborns, premature births and infected babies. Following a global campaign to eliminate mother-to-child syphilis in 2007, WHO estimate that by 2014, more than 40 countries were testing 95% or more of pregnant women in prenatal care for syphilis. Meanwhile, Medical News Today recently reported a study that suggests risk of HIV reduces with longer secondary education. For the study, the researchers focused on Botswana, the most HIV-affected country in the world, and where recent reforms have increased time spent in secondary education. Written by Catharine Paddock PhD

Brain scans could predict how effective OCD treatment will be

Doctors may be able to predict how people with obsessive-compulsive disorder will respond to therapy using a simple brain scan, according to the findings of a new study. Obsessive-compulsive disorder often causes people to perform certain rituals and behaviors repetitively to relieve anxiety. The study, published in Frontiers in Psychiatry, is the first to use brain connectivity to predict the progression of a condition after treatment, as well as being the first to assess the impact of cognitive behavioral therapy (CBT) on brain network connectivity. "The efficiency of brain network connectivity before treatment predicts the worsening of symptoms after treatment," states study author Jamie Feusner, an associate professor psychiatry at the University of California, Los Angeles (UCLA). Between 1-2% of the American population is estimated to have obsessive-compulsive disorder (OCD). About Pyridium (Phenazopyridine) with no prescription The disorder is characterized by frequent upsetting thoughts that patients will try to control through the repetition of certain rituals and behaviors. Not only can OCD be a profoundly distressing condition but it can also severely disrupt the everyday routines of those who experience it, adversely affecting the ability to learn, work or maintain relationships. CBT is frequently used as a form of treatment for OCD, teaching patients different ways of reacting to situations that cause distress without having obsessive thoughts or acting compulsively. Unfortunately, CBT is not effective for every patient. Buy Feldene (Piroxicam) with free prescription In fact, the authors of the study state that in an estimated 20% of patients, the symptoms of OCD eventually return after a course of CBT has finished. Understanding what factors help predict who will relapse after CBT has long been a goal for psychiatry researchers. Lasix (Furosemide) without Rx The new study, conducted by researchers at UCLA and colleagues, indicates that functional magnetic resonance imaging (fMRI) could help. For the study, the researchers examined the brains of 17 participants with OCD aged 21-50. Buy Bisoprolol without Rx Each participant received a 4-week course of CBT, and fMRI scans were taken of their brains both before and after the therapy. Lexapro (Escitalopram) with free Rx Over the following 12 months, doctors monitored their clinical symptoms. "We found that cognitive behavioral therapy itself results in more densely connected local brain networks, which likely reflects more efficient brain activity," says Feusner. Scans showing functional network efficiency found to predict OCD relapse The participants whose scans revealed more efficient brain connectivity before CBT fared worse during the follow-up period than those whose connectivity was less efficient before receiving therapy. In contrast, the severity of symptoms prior to CBT and how well the symptoms improved following CBT did not predict how well the participants would fare during the follow-up period. This clue to how patients will respond to CBT in the long term could prove to be beneficial to both doctors and patients in the future if the results can be confirmed in larger studies. "Cognitive-behavioral therapy is in many cases very effective, at least in the short term. Buy Fiber online But it is costly, time-consuming, difficult for patients and, in many areas, not available," Feusner explains. http://allegra-opinion.blogspot.com "Thus, if someone will end up having their symptoms return, it would be useful to know before they get treatment." For those who might find a 4-week course of CBT ineffective, Feusner is keen to point out that alternative forms of treatment exist. Anti-anxiety medications and antidepressants are commonly prescribed by doctors, and longer courses of CBT could be beneficial. The researchers now aim to validate their findings by conducting a study with a larger number of patients. While doing so, they will also look at other measures of brain function and structure in the hope of identifying further predictors of the clinical course of OCD post-treatment. "We are now starting to translate knowledge of the brain into useful information that in the future could be used by doctors and patients to make clinical decisions," Feusner concludes. "Although a brain scan may seem expensive, these scans only took about 15 minutes and thus the cost is not exceptionally high, particularly in comparison to medication or cognitive-behavioral therapy treatments, which over time can cost many thousands of dollars." Previously, Medical News Today reported on a study that found CBT used to reduce chronic tics in people with Tourette syndrome can also alter the functioning in specific areas of the patients brains. Written by James McIntosh