Since the recent wellpublicized case of a female Hofstra University student who recanted rape allegations against five men, the question of how often “women falsely cry rape … has been flying around the Internet,” Slate columnists Emily Bazelon and Rachael Larimore write. They ask, “[I]snt the rate of false rape charges an empirical question, with a specific answer that isnt vulnerable to ideological twisting? Yes and no.”

According to Bazelon and Larimore, while some of the research on the frequency of false rape accusations is “careful, … much of it is questionable.” A majority of the “good” studies indicate a rate of about 8% to 10%, the columnists write, though they note that the research “isnt quite definitive enough to stamp out the far higher estimates.” In addition, “even if we go by the lower numbers, theres the question of interpretation,” they add. Bazelon and Larimore ask, “If one in 10 charges of rape is made up, is that a dangerously high rate or an acceptably low one?” Based on figures from the Bureau of Justice Statistics that show about 200,000 rapes in 2008, “we could be looking at as many as 20,000 false accusations,” they write.

Bazelon and Larimore examine several studies and legal articles on the subject, starting with a 1952 Yale Law Journal article that took a suspicious view of rape survivors. They also cite Susan Brownmillers 1975 book “Against Our Will Men, Women and Rape,” which said only 2% of rape accusations are false. Brownmiller cited findings by female police officers in a New York City rape squad. However, the “problem” with her figure is that although they have been “widely repeated, … no one has ever tracked down its source,” Bazelon and Larimore write. They also examine a 2006 Columbia Law Journal article by Philip Rumney that surveyed research “at the other end of the spectrum,” including studies purporting false rape allegations from 40% to as high as 90%. Bazelon and Larimore examine a group of U.S., British, Canadian and New Zealand studies indicating a rate of 8% to 10%.

Although the available research makes it difficult to know how common false rape allegations are, “[w]hat is clear … are two problems that are the flip side of the same coin,” Bazelon and Larimore write. They add, “False charges of rape are an absolute nightmare for the men caught in their net. And the specter of madeup allegations is a real problem for law enforcement which means they are also a problem for women who are telling the truth.” Therefore, the issue of false rape accusation is “a problem that a mens rights movement shouldnt trump up” and “one that feminists cant dismiss,” they conclude (Bazelon/Larimore, Slate, 10/1).

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.

Millions of African families could be saved from destitution thanks to a muchneeded vaccine that is being massproduced in a drive to protect cattle against a deadly parasite.

East Coast fever is a ticktransmitted disease that kills one cow every 30 seconds with one million a year dying of the disease.

Calves are particularly susceptible to the disease. In herds kept by the pastoral Maasai people, for example, the disease kills from 20 to over 50 per cent of all unvaccinated calves. This makes it difficult and often impossible for the herders to plan for the future, to improve their livestock enterprises and thus to raise their standard of living.

An experimental vaccine against East Coast fever was first developed more than 30 years ago. This has been followed by work to allow the vaccine to be produced on a large scale, with major funding from the UK Department for International Development (DFID) and others.

East Coast Fever puts the lives of more than 25 million cattle at risk in the 11 countries where the disease is now endemic, and endangers a further 10 million animals in new regions such as southern Sudan, where the disease has been spreading at a rate of more than 30 kilometres a year. The vaccine could save the 11 affected countries at least £175 million a year.

The immunization procedure called “infectionandtreatment” because the animals are infected with whole parasites while being treated with antibiotics to stop development of disease has proved highly effective. However, initial stocks produced in the 1990s recently ran low.

The International Livestock Research Institute (ILRI), at the request of the Africa Union/Interafrican Bureau for Animal Resources and chief veterinary officers in affected countries, produced one million doses of vaccine to fill this gap. However, for the longer term it is critical that sustainable commercial systems for vaccine production, distribution and delivery are established.

With UK£16.5 million provided by DFID and the Bill & Melinda Gates Foundation, the charity GALVmed is fostering innovative commercial means to do just this, beginning with the registration and commercial distribution and delivery of this new batch of the vaccine. This will ensure that the vaccine is made available, accessible and affordable to livestock keepers who need it most and to scale up its production for the future.

International Development Minister Mike Foster said “Some 1.3 billion of the worlds poorest people rely on livestock for their livelihoods. Many Africans depend on the health of their cattle for milk, meat and as their only hard asset for trade and investment. A smallholder dairy farmer can take years to recover economically from the death of a single milking cow. Thats why its vital that every possible step is taken to ensure that these essential vaccine doses are sustainably produced, tested and made available to the people who need them.

“DFID is supporting GALVmed to explore ways of transferring the production and distribution of the vaccine into the private sector through local manufacturers and distributors. This is extremely important in making the vaccine affordable, accessible and crucially sustainable.”

GALVmed CEO Steve Sloan said “Funded by DFID and the Bill & Melinda Gates Foundation, GALVmed is working to protect livestock and the livelihoods of their owners. Thanks to the highly effective East Coast fever vaccine developed over many years by researchers working in East Africa and then refined and mass produced by ILRI, cattle invaluable to pastoralists such as the Maasai as well as smallholder dairy farmers are being protected.

“The survival of cattle for the millions who live on tiny margins has a direct effect on quality of life and the dignity of choice and selfdetermination. Collaborating with ILRI and partners in the developing world, including governments and veterinary distributors and those from the private sector, GALVmed is working to embed the vaccine through registration in East African countries and to scale up its production so that it remains accessible to poor people.

“This pioneering registration effort aims to ensure that the vaccine is approved and monitored by affected nations and enables local firms to sell and distribute it, embedding its sustainability. Registration in Malawi is already complete, with significant progress in Tanzania, Kenya and Uganda.”

ILRI veterinary scientist Henry Kiara, who has conducted research on the live vaccine for 20 years, explains that ILRI is “looking forward to commercialising the production, distribution and delivery of the vaccine to the smallholder and emerging dairy producers as well as livestock herders” in this region of Africa. “Now that all the building blocks are in place, thanks to past investments by DFID and others”, he says, “we are excited to be at a stage where this vaccine can take off.”

Over the past several years, the field logistics involved in mass vaccinations of cattle with the infectionandtreatment method have been greatly improved, due largely to the work of a private Company called VetAgro Tanzania Ltd, working with Maasai cattle herders in northern Tanzania. Sustainability underpins GALVmeds approach and the charity is working with developing world partners to ensure that the vaccine is available to those who need it most, bringing public and private partners together.

Source
Christopher Kiggell

Intercept Pharmaceuticals, Inc., has announced that its firstinclass farnesoid X receptor (FXR) agonist INT747 has met the primary endpoint of improved insulin sensitization in a 6 week double blind, placebo controlled trial in type 2 diabetic patients with nonalcoholic fatty liver disease (NAFLD).

By employing a euglycemic insulin clamp procedure, the study demonstrated that a single oral daily dose of INT747 statistically significantly improved glucose disposal rate, consistent with improved hepatic and peripheral insulin sensitivity. Furthermore, patients treated with INT747 demonstrated statistically significant weight loss and improved biochemical markers of liver function. The compound was well tolerated at the doses tested, with side effects similar to placebo.

Intercepts Chief Medical Officer, David Shapiro, MD, commented, “INT747 therapy generated several clinically meaningful signals in this first proof of concept study, validating the mechanism of action of FXR activation that we and other groups have described preclinically.” Dr. Shapiro is presenting the results of the trial on Friday, Oct. 2, in a plenary session at the European Association for the Study of Diabetes (EASD) annual meeting.

Insulin resistance is an important driver of liver fibrosis, the progressive scarring that can lead to cirrhosis. Based on INT747s ability to improve insulin sensitivity and other important parameters of liver function in this patient population, Intercept is planning to initiate a Phase II trial in patients with nonalcoholic steatohepatitis (NASH) in 2010. There are an estimated 5 million or more NASH patients in the United States alone with no effective therapeutics currently available.

About Intercept Pharmaceuticals

Intercept is a clinical stage biopharmaceutical company focused on discovering and developing small molecule drugs for the treatment of chronic fibrotic and metabolic diseases. The companys most advanced programs are focused on the development of modified bile acids that are selective for FXR, a nuclear receptor, and TGR5, a G proteincoupled receptor. Intercepts lead drug candidate, the FXR agonist INT747, is currently being advanced for chronic liver disease indications. The companys next candidate in the pipeline, INT777, is a selective TGR5 agonist being advanced to an IND, projected for the second quarter of 2010.

Accuray Incorporated (Nasdaq ARAY), a global leader in the field of radiosurgery, announced today publication of results from a study of early stage prostate cancer patients treated with CyberKnife Radiosurgery. The study demonstrated that erectile function was preserved in 81 percent of patients at a median followup of two years. Published rates of erectile function preservation at two years for other commonly used prostate cancer treatments, such as open surgery and conventional radiation therapy, range from 5070 percent.

This study of 112 patients, led by a team of two radiation oncologists, a urologist and a physicist, achieved 97 percent sustained PSA response at two years, with urinary and rectal side effect profiles comparable to conventional radiation therapy. CyberKnife prostate radiosurgery is a noninvasive, outpatient treatment that is typically completed in a single week, making it more convenient for patients than six to eight weeks of conventional radiation therapy or an invasive surgical treatment that requires patients to have general anesthesia and an overnight hospital stay.

“The CyberKnifes ability to track and correct for movement of the prostate allowed us to focus our radiation dose on the prostate and spare surrounding tissues, like the nerves, resulting in erectile function preservation in a majority of our patients,” said David M. Spellberg, M.D. “These data are encouraging for the millions of men diagnosed with prostate cancer looking for a noninvasive therapy that will preserve their quality of life.”

“I was looking for a treatment that offered the best chance for a complete cure, but at the same time, it was extremely important to me to avoid the complications impotence, incontinence and bowel problems that commonly result from prostate cancer treatment,” said study participant and retired Orthopedic Surgeon Scott Silver, M.D. “I am pleased to report three and a half years posttreatment, I remain cancerfree with my quality of life 100 percent intact.”

About the CyberKnife® Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the worlds only robotic radiosurgery system designed to treat tumors anywhere in the body noninvasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in realtime throughout the treatment. This enables the CyberKnife System to deliver highdose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames. Treatments are completed in five or fewer outpatient visits and patients can typically return to normal activities immediately following treatment.

About Accuray

Accuray Incorporated (Nasdaq ARAY), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a nonsurgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 70,000 patients worldwide and currently 176 systems have been installed in leading hospitals in the Americas, Europe and Asia.

Safe Harbor Statement

The foregoing may contain certain forwardlooking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release, as to system utilization, clinical studies, patient and clinician acceptance, and performance of products are forwardlooking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forwardlooking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or managements good faith belief as of that time with respect to future events. You should not put undue reliance on any forwardlooking statements. Important factors that could cause actual performance and results to differ materially from the forwardlooking statements we make include clinical results, commercialization of products; market acceptance of products; competing products; and other risks detailed from time to time under the heading “Risk Factors” in our report on Form 10K for the 2009 fiscal year and our other filings with the Securities and Exchange Commission. The Companys actual results of operations may differ significantly from those contemplated by such forwardlooking statements as a result of these and other factors. We assume no obligation to update forwardlooking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forwardlooking information, except to the extent required by applicable securities laws.

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, provided a clinical development update for Perceiva, the companys proprietary ocular sirolimus product. The company has completed patient enrollment in four ongoing Phase 2 clinical trials of Perceiva and plans to announce data from these studies in the first half of 2010. All four studies are being conducted at investigational sites in the United States. These studies, which are evaluating Perceiva as a treatment for diabetic macular edema (DME), neovascular (wet) agerelated macular degeneration (wet AMD) and dry eye syndrome, are part of MacuSights broad Phase 2 Perceiva clinical program which spans five major ocular disease indications.

“The completion of enrollment in these important clinical trials, which was achieved rapidly and, in some cases, ahead of our study timelines, represents a key milestone in our Phase 2 clinical program. Based on promising data from our two Phase 1 studies, as well as Perceivas broad biological activity relevant to multiple ocular diseases, we elected to undertake this large Phase 2 program targeting five major ophthalmic disease markets,” stated David A. Weber, Ph.D., president and chief executive officer of MacuSight. “We are excited by the progress that is being made with our ongoing clinical work and look forward to presenting the results early next year.”

Perceiva Phase 2 Clinical Program Overview

MacuSights DME study, known as the DIAMOND trial, has completed enrollment of 131 patients at 39 investigational sites. This randomized, doseranging, placebocontrolled study consists of four treatment arms (three different doses and placebo) administered by a minimally invasive subconjunctival injection. Patients enrolled in this trial are administered Perceiva at baseline and again at three months. The primary endpoints for the trial are visual and anatomical improvements measured at six months, three months following the second administration of Perceiva.

Additionally, the company is conducting two studies in patients with wet AMD. The first trial, which is a monotherapy study in newly diagnosed patients not previously treated for the disease, is intended to demonstrate Perceivas biological activity in wet AMD. MacuSight has completed enrollment of 20 patients in this singlesite, openlabel, parallel study. Patients enrolled in this redose trial are administered Perceiva by either subconjunctival injection or the traditional, more invasive intravitreal injection at baseline, again at two months and a final time at four months. The primary endpoints for the trial are changes in visual acuity and retinal thickness measured at six months.

MacuSights second wet AMD study, known as the EMERALD trial, is designed to evaluate the therapeutic potential of Perceiva in combination with Lucentis® in patients with wet AMD. The company has completed enrollment of 62 previously treated wet AMD patients at 28 investigational sites. Patients in this randomized, doseranging, placebocontrolled study are being administered Perceiva via subconjunctival injection, along with Lucentis, at baseline and again at two months. Roches Lucentis is currently approved by the United States Food and Drug Administration for the treatment of wet AMD. The primary endpoints of this combination trial are changes in visual acuity and retinal thickness measured at four months.

“In conducting these two complementary studies in wet AMD, MacuSight is taking a comprehensive approach to assessing the therapeutic potential of Perceiva in this disease,” stated Pravin U. Dugel, M.D., managing partner, Retinal Consultants of Arizona, Phoenix, AZ, clinical instructor, vitreoretinal diseases and surgery, department of ophthalmology, University of Arizona, and a lead investigator of both wet AMD studies. “While evaluating the biological activity of the product on its own is important, there is a rapidly advancing belief in the ophthalmology community that the future of wet AMD treatment lies in combination therapy. Furthermore, there is a critical need for safe and effective wet AMD treatment alternatives that have less frequent administration requirements. This product may possess the potential to address these needs.”

MacuSights fourth Phase 2 trial, in which the company is using Perceiva to evaluate the potential role for sirolimus in the treatment of dry eye syndrome, has successfully enrolled 143 patients at four investigational sites. For this trial, MacuSight worked with Ora, Inc., a leading global clinical research organization located in Andover, MA. As part of this randomized, doseranging, placebocontrolled study, patients receive a single subconjunctival injection of Perceiva at baseline. Investigators will evaluate signs and symptoms of dry eye over a period of 28 days following a single injection.

“In addition to these four separate studies that we are overseeing at MacuSight, our Perceiva Phase 2 program includes three trials sponsored by the National Eye Institute of the National Institutes of Health, as well as individual investigators,” added Joel Naor, M.D., chief medical officer of MacuSight. “The NEI is conducting studies of Perceiva in DME, dry AMD and anterior uveitis. A separate investigatorsponsored trial in posterior uveitis is also currently enrolling patients. As a result of this extensive clinical development program, more than 500 patients across five major posterior and anterior segment ocular indications will have been dosed with Perceiva by the time the Phase 2 program is complete. This scope is virtually unprecedented for a Phase 2 program in the area of ocular drug development.”

Perceiva Phase 1 Clinical Results

MacuSight has completed two Phase 1 clinical trials of Perceiva in patients with DME and wet AMD. Findings from both studies, which included a total of 80 patients, demonstrated the product to be safe and welltolerated in all doses tested with two different routes of administration (minimally invasive subconjunctival injection, as well as traditional intravitreal injection). In addition, investigators from both studies noted improvements in visual acuity consistent with observed beneficial anatomical changes following a single administration of Perceiva. Importantly, these findings were consistent across both routes of administration. These promising results for Perceiva delivered with subconjunctival injection provide the first evidence for the potential of treating retinal disease without direct injection into the back of the eye.

About Perceiva

MacuSights lead product candidate, Perceiva, is a proprietary ocular formulation of sirolimus. As an mTOR inhibitor, sirolimus possesses a broad spectrum of therapeutic action which MacuSight recognized as potentially relevant to the treatment of ocular diseases, including the inhibition of inflammation, angiogenesis, vascular permeability, proliferation and fibrosis. Designed for minimally invasive, sustained, local administration, Perceiva may offer more comfort to patients and more convenience to physicians, while minimizing the risk of complications and adverse events. The product candidate is currently being evaluated in a broad Phase 2 clinical program for a number of major ocular disease indications.

About MacuSight

MacuSight is a privately held pharmaceutical company focused on developing proprietary ocular formulations of mTOR inhibitors, including sirolimus (rapamycin), for minimally invasive, sustained, local administration to treat a number of major sightthreatening diseases. The company is advancing a comprehensive Phase 2 clinical program for Perceiva, its proprietary ocular sirolimus product. This program spans across multiple major ophthalmic indications including diabetic macular edema (DME), wet agerelated macular degeneration (wet AMD), uveitis and dry agerelated macular degeneration (dry AMD). Additionally, as part of this Phase 2 program, the company is using Perceiva to evaluate the potential role for sirolimus in the treatment of dry eye syndrome (DES). With patient enrollment complete in four MacuSightsponsored Phase 2 studies, the company plans to announce data from these studies in the first half of 2010.

No major role for fish in the prevention of heart failure; only a possible beneficial effect in those with diabetes

The consumption of fish has no major role in the prevention of heart failure, according to results from a large prospective population study.(1) The study, which was started in 1990 and involved all men and women over the age of 55 living in a suburb of Rotterdam, found no difference in the risk of developing heart failure between those who did eat fish and those who didnt.

The study is published on 30 September in the October issue of the European Journal of Heart Failure.

“Scientists and health authorities are increasingly persuaded that the intake of fish even in small amounts will protect against the risk of fatal myocardial infarction,” said study investigator Dr Marianne Geleinjse from Wageningen University in the Netherlands. “However, there is no strong evidence that eating fish will protect against heart failure. One study has suggested that this might be so, but we could not confirm it in our cohort study of older Dutch people.”

Heart failure is by far todays single biggest reason for acute hospital admission. Around 30 million people in Europe have heart failure and its incidence is still increasing more cases are being identified, more people are living to an old age, and more are surviving a heart attack but with damage to the heart muscle. According to one study, the reported prevalence among those aged 6574 years is one in 35, and among the over85s one in seven.

According to background information to the study, the lifetime risk of developing heart failure is even higher estimated in men and women as one in four at age 40. The risks increase with age, and prognosis is poor; a previous report from the same Rotterdam Study has shown survival rates at one, two and five years of 89%, 79%, and 59%, representing an ageadjusted mortality rate twice that of those without heart failure.(2) The hazard ratio for sudden death was found to be almost five times higher.

With heart failure treatments often limited to palliative care, much rests on prevention; this latest report from the Rotterdam Study was to investigate whether intake of the longchain n3 polyunsaturated fatty acids (PUFAs) found in fish conferred protection against heart failure as they seem to do against coronary heart disease.(3)

The analysis comprised 5299 subjects (41% men, mean age 67.5 years) who were free from heart failure and for whom dietary data were available. During 11.4 years of followup, 669 subjects developed heart failure. Their habitual diet had been assessed at baseline (in a selfreported checklist and by expert interview), with subjects specifically asked to indicate the frequency, amount, and kind of fish they had eaten, either as a hot meal, on a sandwich, or between meals.

Results showed that the dietary intake of fish was not significantly related to heart failure incidence. This relative risk was measured according to five levels of fish consumption as reflected in intake of two long chain n3 PUFAs (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]), both of which have been shown to exert some cardiovascular benefit via antiinflammatory mechanisms, antiarrhythmic effects and/or a reduction in serum triglycerides, blood pressure, and heart rate.

The relative risk (RR) of heart failure in the top (highest) and bottom (lowest) quintile of EPA plus DHA intake was 0.89 (95% CI, 0.69.14) after adjustment for lifestyle and dietary factors, a nonsignificant finding.

Results were also estimated according to the weight of fish consumed; but even for a high daily fish consumption of more than 20 grams a day there appeared no added protection against heart failure. Incidence rates were the same in those who consumed no fish (incidence rate of 11 per 1000), moderate fish (median 9g per day, 12.3 per 1000) or high fish (9.9 per 1000). The relative risk of heart failure in the high intake groups was 0.96 (0.78.18) when compared with no intake.

Variations in risk were seen in various subgroups according to age, sex and body mass index (BMI), but once again the differences were not statistically significant. In diabetic subjects, however, an inverse association of EPA plus DHA intake with heart failure was observed (RR 0.58 (0.32.06) for top vs. bottom quartile), which was just of borderline statistical significance. Similarly, a high EPA plus DHA intake tended to be protective (but not statistically significant) in women (RR 0.75, 0.54.04), although not in men.

Commenting on the public health implications of the study Dr Geleijnse said “Many health authorities recommend two weekly servings of fish particularly fatty fish like salmon, mackerel and herring for the prevention of cardiovascular disease. Based on our data we would not change this advice, even though fish intake was not associated with the development of heart failure in our cohort. Fish intake in the Netherlands is extremely low on average less than one portion per week so maybe higher intakes are needed for any protection against heart failure.

“Apart from n3 fatty acids, fish also contains other healthy components such as vitamin D and selenium. Fish is a good source of protein and is more healthy than, for example, red meat.”

According to the authors this is only the second ever study to examine the relationship between PUFAs and the risk of heart failure; the other, over 12 years of followup among older adults, did find that consumption of tuna or other broiled or baked fish (but not fried fish) was associated with a lower incidence of heart failure.(4)

Notes Dijkstra C, Brouwer IA, Van Rooij FJA, et al. Intake of very long chain n3 fatty acids from fish and the incidence of heart failure the Rotterdam Study. Eur J Heart Fail 2009; doi10.1093/eurjhf/hfp126.

Mosterd A, Cost B, Hoes AW, et al. The prognosis of heart failure in the general population The Rotterdam Study. Eur Heart J 2001; 22 13181327.

There has been fairly consistent evidence that n3 PUFAs do have a protective effect against coronary heart disease since the first suggestions were made more than 30 years ago following studies in the Inuit people of Greeneland. More recently, a 2009 review in the Journal of the American College of Cardiology, whose evidence was based mainly on four randomised trials involving nearly 40,000 subjects, described the effect of n3 PUFAs in the prevention of cardiovascular disease as “of great promise”. The GISSIPrevenzione trial of 1999 established the potential of dietary n3 PUFAs for reducing mortality in patients after recent myocardial infarction. The effect on coronary heart disease mortality of n3 PUFAs as a supplement postinfarction is presently being studied in the Alpha Omega trial in the Netherlands.

Mozaffarian D, Bryson CL, Lemaitre RN, et al. Fish intake and risk of incident heart failure. J Am Coll Cardiol 2005; 45 2015. * The European Journal of Heart Failure is a journal of the European Society of Cardiology.* ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure simplify the definitions of new, transient and chronic disease. The 2008 ESC Guidelines can be seen in various formats, click here.

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Press Office

A study by researchers at The George Institute for International Health in Australia found that it is rare for patients presenting to PCPs with acute lower back pain to have previously undiagnosed serious diseases. The most common serious disease cause documented was vertebral fracture, with half of the cases identified at the time of initial consultation. Full findings appear in the October issue of Arthritis & Rheumatism, a journal published by WileyBlackwell on behalf of the American College of Rheumatology.

The World Health Organization (WHO) estimates that global prevalence of lower back pain could be as high as 42%. Pain occurring in the lower back interrupts daily routines such as work, school, or activities and is a chief cause of visits to primary care physicians (PCPs). According to The National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health (NIH), back pain is the second most common neurological ailment in the U.S. NINDS estimates Americans spend at least $50 billion each year due to low back pain, a leading contributor to missed work and jobrelated disability.

In this study a total of 170 general medical practitioners (Australian equivalent to PCP), physiotherapists, and chiropractors in the Sydney area were recruited. Between 2003 and 2005, the clinicians screened 3,184 patients with 1,172 presenting with acute low back pain. These patients were assessed for the presence of red flags for serious disease. The term “red flag” means danger and is used as a warning signal. In healthcare settings “red flag” clinical features, e.g. unexplained weight loss, are used by PCPs to screen for low back pain patients who are more likely to have a serious disease and so require more extensive diagnostic workup.

Patients 14 years and older, presenting for the first consultation of the current episode of acute low back pain were included in this study. Researchers monitored patients for 12 months after initial consultation to determine if fracture, infection, arthritis, or cancer was the cause of their lower back pain. The results showed that PCPs identified 5 of the 11 cases of previously undiagnosed serious illnesses during the initial consultation.

Researchers, led by Christopher Maher, Ph.D., noted 8 cases of vertebral fracture, the most common serious disease identified and the only disease for which researchers were able to create a diagnostic rule. The rule contained 4 variables female sex, age > 70 years, significant trauma (major in young patients, minor in elderly patients), and prolonged use of corticosteroids. When at least 1 of the “red flag” questions was positive, the likelihood ratio (for fracture) was 1.8; with at least 2 positive features, the ratio increased to 15.5 and with 3 positive features it increased to 218.3. “Our rule suggests that when any 3 of the 4 “red flags” are positive, the probability of vertebral fracture greatly increases (e.g., from 0.5% to 52%), said Professor Maher.

The study also uncovered there to be high falsepositive rates with some red flag questions. An approach where any positive red flag is acted upon would result in unnecessary referrals to specialists and needless investigation of patients. The authors propose, “A better approach would be to evaluate a combination of red flag questions that identify serious disease while reducing the number of falsepositive results.” The primary care setting plays a vital role in early detection of serious disease and the authors recommend further research into the diagnostic accuracy of red flags in lower back pain is needed.

Citation

“Prevalence of and Screening for Serious Spinal Pathology in Patients Presenting to Primary Care Settings With Acute Low Back Pain”
Nicholas Henschke, Christopher G. Maher, Kathryn M. Refshauge, Robert D. Herbert, Robert G. Cumming, Jane Bleasel, John York, Anurina Das, and James H. McAuley.

The rains are over, but the cleanup has only just begun as hundreds of American Red Cross staff and volunteers continue to help those affected by the devastating flooding which inundated the area last week.

For nearly 200 people, home is still a Red Cross shelter. Emergency Response Vehicles (ERVs) are in floodravaged neighborhoods providing meals, snacks, and cleanup supplies. Red Cross disaster assessment teams are surveying homes for damage, and caseworkers are working directly with individuals and families, providing assistance for food, clothing, shelter and healthrelated concerns, as well as directing people to other recovery resources.

In about two weeks time, the Red Cross has served more than 12,700 meals and 11,400 snacks, and provided more than 28,300 items such as bleach, comfort kits, bottled water and cleanup kits.

The Red Cross prepositions supplies and disaster equipment around the country to be able to rush relief services into affected areas when disaster strikes. Since 1997, members of the Red Cross Annual Disaster Giving Program (ADGP) have pledged donations in advance of major disasters to ensure the Red Cross has the ability to respond immediately when needed. This year, members have provided more than $20 million in funding for the Disaster Relief Fund.

ADGP members include Altria Group, Inc., American Express, AXA Foundation, ConAgra Foods, FedEx Corporation, GE Foundation, The Home Depot Foundation, John Deere Foundation, KimberlyClark Corporation, Merck & Co., Inc., Morgan Stanley, Nationwide Insurance Foundation, Raytheon, Ryder Charitable Foundation, State Farm, State Street Foundation, Target, The TJX Companies, Inc., UnitedHealthcare, and UPS.

“Thanks to the generosity of our Annual Disaster Giving Program members, we are able to mobilize human and material resources at a moments notice to provide lifesaving services,” said Jeffrey Towers, chief development officer at the American Red Cross. “These funds, coupled with the support of the American public, are critical during floods and enable the Red Cross to rush immediate relief to disaster victims before the first donation has been given.”

You can help people affected by disasters like the current floods by donating to the American Red Cross Disaster Relief Fund. On those rare occasions when donations exceed Red Cross expenses for a specific disaster, contributions are used to prepare for and serve victims of other disasters. Your gift enables the Red Cross to prepare for disasters and provide shelter, food, emotional support and other assistance to victims of all disasters. Call 1800REDCROSS (18007332767) or 18002577575 (Spanish). Contributions to the Disaster Relief Fund may be sent to your local American Red Cross chapter or to the American Red Cross, P.O. Box 37243, Washington, DC 20013. Internet users can make a secure online contribution by visiting redcross.org.

Source

A draft G20 communique revealed Friday that the group of countries “has called on the World Bank to work with donor agencies to create a multilateral trust fund to increase agricultural investment in poor countries,” Reuters reports. In July, the G8 launched a $20 billion agriculture initiative to help developing countries.

Leaders who are meeting in Pittsburgh called for the World Bank and regional development banks to review “capital needs … by the first half of 2010,” Reuters writes (Wroughton, 9/25).

Londons Times reports on a Wednesday evening dinner on the sidelines of the summit where “300 of the globes most influential women” came together to “tackle one of the most pressing but least noticed issues holding back global economic recovery maternal health.”

In a speech, “Sarah Brown, wife of the British Prime Minister, said … more than half a million women worldwide die each year from pregnancyrelated causes, most of them preventable. Millions more suffer injuries and develop lifelong disabilities,” the Times writes. Brown said that improvements in maternal health could promote economic growth “by ensuring that women remained alive to feed, vaccinate, educate and nurture the next generation, as well as make their own economic contribution,” according to the Times.

Brown also “called on world leaders at the G20 meeting in Pittsburgh … to put maternal health high on their agenda. This would help to ensure that the United Nations Millennium Development Goals outlined in 2000, which include reducing maternal deaths by 75 percent, could be achieved by 2015″ (Frean, 9/24).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

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The Society for Vascular Surgery® (SVS) and the American Podiatric Medical Association (APMA) announce formation of a strategic collaboration to help advance the care of patients with critical limb ischemia, especially in the diabetic population. The multidisciplinary team approach was outlined during a meeting between leaders of both associations in August.

The collaboration includes an agreement approved by the respective boards of SVS and APMA to identify clinical issues, questions important to both memberships, and to work together to find solutions that will benefit our patients. Specifically, in the August leadership meeting, it was agreed to

1. Appoint a group representing both organizations to write a joint statement on the multidisciplinary team approach to the care of diabetic foot

2. Produce a supplement on the care of the diabetic foot that will be jointly published in the Journal of Vascular Surgery® and the Journal of the American Podiatric Medical Association

3. Establish joint postgraduate courses to be held at the annual scientific meetings of both organizations

4. Collaborate on practice guidelines and reporting standards dealing with the care of diabetic foot

5. Collaborate on advocacy and public awareness efforts in areas of common interest

“Vascular surgeons and podiatrists have always worked together to provide the best care for patients with diabetic foot problems,” said Anton N. Sidawy, president, SVS. “We are pleased to formalize an alliance with APMA so that we can jointly work on the prevention and management of diabetic foot, which would positively impact the care of our patients. Our staffs will conduct public education programs to raise awareness and promote prevention.”

A Management of the Diabetic Foot session was a highlight at the SVS 2009 Vascular Annual Meeting®.

About the Society for Vascular Surgery®

The Society for Vascular Surgery (SVS) is a notforprofit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 3,000 vascular surgeons dedicated to the prevention and cure of vascular disease