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Researchers from Boston University School of Medicine (BUSM) in collaboration with scientists at the University of Louisville and the University of Nice Sophia Antipolis in France, have identified the target antigen PLA2R in patients with idiopathic membranous nephropathy (kidney disease), which has implications for the diagnosis and treatment of this disease. These findings appear in the July 2 issue of the New England Journal of Medicine.

Idiopathic membranous nephropathy involves the thickening and dysfunction of the filtering parts of the kidneys called glomeruli. It is caused when antibodies attack the glomeruli causing large amounts of protein to leak into the urine. It is a relatively common cause of adultonset kidney disease that can progress over time to cause kidney failure. Until now, the diagnosis of membranous nephropathy required a kidney biopsy as there are no blood or urine tests to specifically distinguish membranous nephropathy from other causes of kidney disease. This is because up until now the protein that is the target of the circulating autoantibodies has never been identified.

To identify the target antigen in patients with this condition, the researchers used circulating antibodies from adults with this disease to detect normal glomerular proteins. Subsequent analysis with the use of mass spectrometry and confirmation with the use of proteinspecific reagents allowed for identification and characterization of the predominant protein detected by these circulating antibodies.

According to the researchers this discovery has important implications for both the diagnosis and treatment of membranous nephropathy. “Identifying the antigen will enable development of a simple blood test that could replace the need for a kidney biopsy and establish which patients are most likely to benefit from immunosuppressive treatment,” said senior author David Salant, MD, a professor of medicine at BUSM and chief of the renal section at Boston Medical Center.

“Our findings show that PLA2R is a major target antigen in idiopathic membranous nephropathy. Seventy percent of our patients with biopsyproven idiopathic membranous nephropathy had IgG antibodies that reacted with PLA2R, a constituent of normal human glomeruli,” he added.

Notes
Funding for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases, Amgen, the Halpin Foundation, Centre National de la Recherche Scientifique and Association pour la Recherche sur le Cancer, and the Department of Veterans Affairs.
Disclosures One author (Beck) reports receiving grant support from Amgen and having a patent pending for a diagnostic immunoassay to detect antiPLA2R antibodies in membranous nephropathy; another author (Lambeau) is holding patents related to the therapeutic use of secretory PLA2 proteins and their inhibitors; and another author (Salant) receives consulting fees from Questcor Pharmaceuticals, Cormedix, and DiObix and has a patent pending for a diagnostic immunoassay to detect antiPLA2R antibodies in membranous nephropathy.

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Michelle Roberts

MorphoSys AG (FSE MOR; Prime Standard Segment, TecDAX) and the University of Melbourne announced today an agreement to cooperate on investigating new therapeutic applications for MorphoSyss MOR103 program. MOR103, a HuCAL antibody against human GMCSF (Granulocyte macrophagecolony stimulating factor), is currently in development for the treatment of rheumatoid arthritis (RA). The collaboration announced today will focus on new therapeutic areas in which GMCSF has recently been implicated in asyet unpublished work of researchers at the University of Melbourne. As part of the expanded relationship, new patent applications have been filed, which are intended to broaden the patent position of the antiGMCSF approach.

Under the terms of the agreement, MorphoSys will fund research activities at the University of Melbourne in multiple new indications. The University of Melbourne will receive an upfront payment and will be entitled to research funding, clinical milestone and royalty payments. Further financial details were not disclosed.

“The University of Melbourne, and in particular the research group of Professor John Hamilton, has long been at the cutting edge of research on GMCSF. We are excited to be able to deepen our relationship with MorphoSys and help speed the transition of these laboratory insights into clinical applications for the benefit of patients”, said Dr Charlie Day, CEO of Melbourne Ventures, the technology commercialization company for the University of Melbourne.

“Researchers at the University of Melbourne have now generated evidence for the involvement of GMCSF in indications beyond those that were already known”, commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. “We look forward to working closely with them to explore the potential of targeting GMCSF in these additional indications, and expand still further the patent position around inhibitors of GMCSF. Meanwhile, development of our antiGMCSF antibody MOR103 in RA continues according to plan.”

In 2007, MorphoSys signed an agreement with the University of Melbourne, providing the company with an exclusive license to a patent family covering therapeutic uses of inhibitors of GMCSF. The claims of the patent are directed to methods of ameliorating the effects of inflammation by administering to a patient an antibody directed against GMCSF. In November 2008, the U.S. Patent & Trademark Office (USPTO) issued the patent U.S. Patent No. 7,455,836, covering key uses of antibodies against GMCSF. Human GMCSF is already implicated in a number of medical conditions.

Lyme disease in the U.S. is caused by the tickborne bacteria Borrelia burgdorferi and usually begins with a skin lesion, after which the bacteria spread throughout the body to the nervous system, heart or joints. About 60 percent of untreated individuals develop arthritis, which affects the knees in particular. Lyme disease usually responds well to antibiotic therapy, but in rare cases arthritis can persist for months or years after treatment, a rare condition known as antibioticrefractory Lyme arthritis. Joint fluid usually tests negative for B burgdorferi after treatment, indicating that joint inflammation may persist even after the bacteria has been eradicated.

Two genetic marker systems are used to correlate the variation of this bacterial strain with clinical outcomes OspC typing divides B burgdorferi strains into 21 types, while the ribosomal RNA intergenic spacer type (RST) system divides them into just three groups, with certain RST groups corresponding uniquely to specific OspC types.

A new study led by Allen Steere of Massachusetts General Hospital and Harvard Medical School analyzed joint fluid samples from 124 patients with Lyme arthritis who were seen over a 30year period. It identified B. burgdorferi strains in the joints of patients with Lyme arthritis and found that the genotype frequencies in joints reflected those in skin lesions. However, RST1 strains were the most frequent in patients with antibioticrefractory arthritis. The study was published in the July issue of Arthritis & Rheumatism.

The researchers were able to identify 10 of the 16 B burgdorferi OspC types found in the northeastern U.S. and all three RST types in the joint fluid of patients with Lyme arthritis. Although it was only possible to determine B burgdorferi phenotypes in 40 percent of the samples, the researchers feel confident that the distribution reflects what has been observed in the skin because they were able to identify numerous OspC and RST types, and the distribution was similar to what has been reported in previous studies of skin lesions.

One might presume that the association of RST1 strains with antibioticrefractory arthritis may reflect a greater ability of these strains to survive in the joint despite antibiotic therapy. However, this seems not to be the case. Rather, RST1 strains seem to induce a more marked immune response, which may set the stage for joint inflammation that persists after antibiotic therapy in genetically susceptible individuals.

“We hypothesize that RST1 strains are more virulent, leading to larger numbers of organisms in blood, and more inflammation in joints,” the authors state. They conclude that the results of this study “add to the emerging literature concerning the differential pathogenicity of strains of B burgdorferi.”

Article “Analysis of Borrelia burgdorferi Genotypes in Patients with Lyme Arthritis,” Kathryn L. Jones, Gail A. McHugh, Lisa J. Glickstein, Allen C. Steere, Arthritis & Rheumatism, July 2009.

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Sean Wagner

The July issue of European Urology, the official journal of the European Association of Urology, features an editorial by Lars Holmberg comparing the results from the European Randomised Study of Screening for Prostate Cancer (ERSPC) with the results from the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) In the editorial, Professor Holmberg writes that “The studies illustrate that the price to pay for 20% reduction in prostate cancer deaths is high; overdiagnosis and overtreatment are great problems. The answers lie in improving the PSA test or finding biomarkers that effectively separate aggressive cancers from slowgrowing ones. We identify some priorities in the discussion about PSA testing.”

Another article of interest in this issue is “Testosterone and Prostate Cancer Revisiting Old Paradigms” by H. Isbarn et al. The notion that pathologic prostate growth, benign or malignant, can be stimulated by androgens is a commonly held belief but one without scientific basis. In the article, Dr. Isbarn writes that, “We therefore conducted a Medline search to identify articles addressing the relationship between testosterone and the risk of prostate cancer development. Although large prospective studies addressing the longterm effect of testosterone treatment are needed to either refute or corroborate the hypothesis, the available literature strongly suggests that testosterone treatment neither increases the risk of prostate cancer diagnosis in normal men nor causes cancer recurrence in men who were successfully treated for prostate cancer.”

Next month, European Urology will publish the EAU position statement on screening for prostate cancer which takes into consideration the recent scientific information on randomised screening studies on prostate cancer (Schröder et al, NEJM 2009). The EAU adopts the conclusions of the ERSPC study and recognises the benefit of screening in terms of mortality reduction, as well as the adverse effects of overdiagnosis and overtreatment of prostate cancers which could be quantified for the first time in the setting of a randomised screening study.

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Lindy Brouwer

Massachusettsbased Catholic hospital system Caritas Christi Health Care on Friday ended its joint venture with the Missouribased health insurer Centene after Cardinal Sean OMalley of the Archdiocese of Boston insisted that the relationship linked Catholic hospitals too closely to abortion providers, the AP/San Francisco Chronicle reports (AP/San Francisco Chronicle, 6/27). Under the joint venture, Caritas and Centene created a new company, CeltiCare, which would have insured thousands of lowincome Massachusetts residents under Commonwealth Care, the states subsidized health care program.

Financially troubled Caritas, which was founded by the Archdiocese of Boston, said it will continue to participate as a provider in Commonwealth Care but will no longer be a coowner of the insurance venture with Centene. Caritas will provide care to patients covered by Centene, as it does for patients covered by other private insurers, but it will not provide any services that violate Catholic teachings, such as abortions or sterilizations.

In terminating the joint venture, the archdiocese hopes to appease criticism that Caritas would have profited from abortion and other services provided at nonCatholic medical centers, the Boston Globe reports. According to the archdiocese, OMalley sought the withdrawal after weeks of consultation with the churchaffiliated think tank National Catholic Bioethics Center, in response to harsh criticism from antiabortionrights groups for not blocking the agreement. The withdrawal is “a vindication of sorts” for OMalleys critics, who have argued that it would be wrong for Caritas to enter an agreement with a health insurer that covers abortion care, according to the Globe.

Andrea Miller, the executive director of NARAL ProChoice Massachusetts, said that Caritas involvement in the joint venture had raised concern from NARAL because of the Catholic Churchs opposition to abortion rights. She said that although Caritas has withdrawn from the venture, “[t]he question remains Will the involvement of Caritas Christi health providers negatively affect womens ability to get timely access to reproductive services, including birth control?” Miller added that NARAL hopes that state regulators “will continue due diligence to ensure that referrals and services are provided in a manner that does not delay access to reproductive health services” (Paulson/Lazar, Boston Globe, 6/27).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Southamptons teaching hospitals have been recognised by one of the UKs top medical organisations for leading the way in use of antibiotics in the fight against infection. The British Medical Association, the professional body for doctors and medical students, praised Southampton University Hospitals NHS Trusts development of clear and simple antimicrobial prescribing guidelines for staff.

Careful and restricted prescribing plays a key part in preventing bugs resistance to treatment, and the policy which is available in hard copy on all wards outlines simple measures to ensure infection medication is only given in the correct circumstances.

The guidance urges staff to closely document justifications for starting therapy, to administer antimicrobials orally wherever possible and regularly refer to consultant microbiologists for authorisation and advice.

SUHTs pharmacy department has also produced a pocket antibiotic booklet which is issued to all prescribers, as well as being available through the Trusts intranet site. The team works closely with the microbiologists to make sure the guidelines are followed.

Martin Stephens, associate medical director of clinical effectiveness and medicines, said “Our microbiology doctors and pharmacists have worked extremely hard on developing this policy to further enhance the fight against infection and we are delighted to have received national credit.”

SUHTs antimicrobial prescribing policy appears in the BMA Board of Sciences Tackling healthcare associated infections through effective policy action report, published this month.

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A new Auburn Universitydesigned, hightech pharmacy in Meridian, Miss., is the first of its kind and is a model facility that could be built in communities across the United States.

Auburn pharmacy professors Kenneth Barker and Betsy Flynn led a multidisciplinary team in designing the recently opened facility for Vital Care Inc., which will help pharmacists offer complex medications for inhome use, ones that are normally administered only in hospitals.

The twostory, 16,000squarefoot building is used for preparing, dispensing and administering the medications, while, at the same time, serving as a demonstration and teaching model for potential franchisees wishing to open a similar facility. Pharmacists may choose to duplicate the entire design for homeinfusion medications or individual function areas.

Home infusion is a growing trend among pharmacies through which medications are administered in homes by nurses, caregivers or patients themselves. This includes potent intravenous antibiotics, chemotherapy, cardiac medications and intravenous nutritional formulas.

“We conducted research to determine the best work flows and safety for this new pharmacy that offers such highlevel medication and treatments,” said Barker, director of the Center for Research on Pharmacy Operations and Designs in Auburns Harrison School of Pharmacy.

“Our pharmacy design program is unique in that we give much more attention to the functional programming phase than is normally given to the design of a commercial facility.”

Functional programming is the gathering of “evidencebased” information before any design work is considered. Barkers team uses trained observers, who are pharmacists and nurses, to observe various operational setups to determine the best floor and fixture layout for each job function. He says this works much better than the traditional use of questionnaires given only to those who will be occupying a proposed facility.

“We also insist on interviewing the top 15 or so people in an organization and passing along our recommendations before even meeting with architects,” Barker said.

The new building has a sterile preparation area, compounding area and a specialty pharmacy area for limiteddistribution medicines, such as those used in clinical trials. It also has four treatment suites for patients who need to receive treatments at the facility, rather than at home. Patients are able to receive treatment while having Internet access, listening to music or watching television on the suites audiovideo system.

The Auburn pharmacists worked on the project with professors Shea Tillman and Christopher Arnold of Auburns Department of Industrial Design; Meridian architect Robert Luke of Luke Peterson Kaye Architects; information technology consultant Brad Barker; and Paul Giles, vice president of R.C. Smith company which designs pharmacy fixtures.

Auburn alumni Johnny H. Bell, owner Vital Care Inc., and son Jonathan C. Bell, owner of the Vital Care franchise that serves Meridian and West Alabama, asked the Auburn professors to help design the facility.

“We now have a model facility to show pharmacists how they can provide home infusion service, especially in rural areas,” said the senior Bell, an alumnus of the Auburn School of Pharmacy. “We combined our staffs knowledge of hightechnology therapies and infusion pharmacy operations with the design and ergonomics knowledge of the Auburn design team.”

Bell founded Vital Care Inc. in 1986 and has expanded the company to 75 employees in Meridian and 140 franchisees in 18 states. In addition to assisting franchisees with their business startup, Vital Care conducts various business and clinical functions and it offers expertise about reimbursement from Medicaid, Medicare and private insurance companies. The company provides information about construction of medication preparation areas to comply with federal and state requirements. Also, its nurses travel to the franchisees area to train local nurses to work with homeinfusion patients.

The North Carolina Senate on Tuesday voted 2521 to approve a bill (S. 221) that would require public school systems in the state to offer a sex education curriculum that includes information on abstinence, contraceptives and sexually transmitted infections, the WinstonSalem Journal reports. Currently, only two public school systems in the state offer comprehensive sex education, with the rest teaching abstinenceonly curricula. Under the bill, parents would be able to have their children removed from the comprehensive portions of the program (Romoser, WinstonSalem Journal, 6/24). The bill would apply to students in seventh through ninth grade (AP/VirginianPilot, 6/23).

The bill includes several changes from an earlier version that was approved by the state House. The measure now returns to the House, where lawmakers will decide whether to approve the Senates changes (WinstonSalem Journal, 6/24).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

The U.S. Food and Drug Administration approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.

Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescriptiononly product for women ages 17 and under. Todays approval allows marketing of a prescriptiononly generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif.

President Obama is causing the “core culturewar battle” over sex education to “come full circle” by proposing to redirect funding for abstinenceonly sex education to a new Teen Pregnancy Prevention Initiative that “rejects an abstinenceonly approach,” Washington Times columnist Cheryl Wetzstein writes. According to Wetzstein, Obamas fiscal year 2010 budget plan “zeroed out” the Title V abstinenceonly sex education grant program, set to expire on June 30, and the CommunityBased Abstinence Education program.

Wetzstein continues that groups supporting comprehensive sex education have “loathed Title V from its inception” because of its “prohibition on teaching teens how to use birthcontrol products (i.e., no condom demonstrations) and its eightpoint definition that seemed utterly unrealistic to sex educators.” For example, Title Vs definition said that the “expected standard of human sexual activity” was a “mutually faithful, monogamous relationship in the context of marriage,” which Wetzstein says she has “heard many times, was insulting to gay youth who couldnt marry” and “insensitive to minority youth who grew up in neighborhoods where marriage was rare.”

Wetzstein asks, “What will happen to Title V?” She writes that opponents “are staying vigilant” and working to avoid “any lastminute, backdoor revivals of this program.” Groups that support abstinenceonly sex education are “working the phones, too,” Wetzstein reports. According to Wetzstein, Valerie Huber, executive director of the National Abstinence Education Association, noted that “[s]aving Title V will require some heavy lifting, but its expired before and been retroactively renewed.” Wetzstein concludes that “well soon see what happens with the new players in town” (Wetzstein, Washington Times, 6/23).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.