Popular Articles

FDA Reviewing Preliminary Safety Information On Asthma Drug Xolair
The U.S. Food and Drug Administration announced that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.
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Bill Fuels Debate Over Universal Screening For Postpartum Depression
A bill (HR 20, S 324) in Congress that would mandate funding for research, services and public education related to postpartum depression has sparked debate over whether all women should be screened for the condition, Time reports. The Melanie Blocker-Stokes Postpartum Depression Research and Care Act, also known as the Mothers Act, passed the House and is before the Senate. The bill does not specifically include funding for PPD testing, though an earlier version did; regardless, critics say it would still lead to greater screening. According to Time, the issue at the center of the debate is whether PPD screening identifies actual cases "or simply contribute[s] to the potentially dangerous medicalization of motherhood." Ingrid Johnston-Robledo, director of women"s studies at the State University of New York, said that experts on both sides of the debate agree about increased support for women. "The problem with women"s reproductive health issues is that they tend to be ignored or exaggerated," Johnston-Robledo said. She added, "We need to find a way to come down in the middle: acknowledge women"s depression but not assume that all women who struggle with the transition to motherhood are depressed."Critics of the bill argue that mental health screenings are notorious for giving false positives. They also contend that increased testing is a bid by pharmaceutical companies to sell more medication to women who do not need it. Some psychologists argue that universal PPD screening would be misdirected because the greatest risk factor for the condition is previous depression, not giving birth. Paula Caplan, a clinical and research psychologist, said, "(We) should be addressing the social factors causing women to be upset after they give birth, not locating the problem within the women."Some proponents of PPD screening say it is not supposed to be used as a diagnostic tool but as a way to identify which patients require further evaluation. According to Time, studies suggest that PPD affects as many as one out of seven women who have recently given birth and that leaving it untreated exposes women and their infants to unwarranted risk. Katherine Wisner, a psychiatrist at the University of Pittsburgh Medical Center, said, "Postpartum depression is not a benign, uncommon thing." She added, "We screen all infants for (the genetic disorder) phenylketonuria, which is extremely rare. Why don"t we screen women for this?" (Elton, Time, 7/20).
News of the day
Experts Say Slant Toward Male Births Among Asian-American Families Reflects Sex Selection Practices
Research indicating distorted ratios of male to female births among U.S. residents of Chinese, Indian and Korean descent could reflect those families" openness to sex-selection techniques, according to some demographers, the New York Times reports. Historically, male births in the U.S. have led female births by a ratio of 1.05 to 1. A study published last year in Proceedings of the National Academy of Sciences examined 2000 census data and found that among Chinese-, Indian- and Korean-American families, if the first child was a girl, the likelihood that the second child was a boy increased to 1.17 to 1. In addition, if the first two children were girls, the chance that the third was a boy was 1.51 to 1, or about 50% greater than normal. In a study published this year, Jason Abrevaya of the University of Texas examined census data and birth records through 2004, finding that the incidence of boys as third children among immigrant Chinese parents in New York was 558 of every 1,000 births, significantly higher than the national average of 515. Many experts were surprised at the evidence that the cultural preference for sons among some Asian cultures has carried over to immigrants in the U.S., the Times reports. Studies have not demonstrated a slanted proportion of male births among Japanese immigrants, according to the Times. According to demography experts, the deviation toward male births among some Asian-American immigrants reflects both a cultural preference for boys and an increased tendency for families to seek out sex-selection techniques such as in vitro fertilization, sperm sorting or abortion. Some clinics that offer IVF or sperm sorting to select for sex market their services to Asian-American families through advertisements in Indian- and Chinese-language newspapers. In 2001, criticism arose within the Indian-American community about clinics targeting that population, and some community newspapers and magazines expressed regret for publishing advertisements that critics said were perpetuating a misogynistic practice. Joyce Moy, executive director of the Asian American/Asian Research Institute of the City University of New York, said that younger Chinese immigrants have adopted the family values that are common in China -- such as the tradition of elders depending on their sons for support -- even though some of the reasons behind those customs are less relevant in the U.S. Experts say that the preference for male children may fade with further assimilation, the Times reports.In China, sex selection typically is achieved through abortion of female fetuses. Although doctors say the practice also occurs in the U.S., few families discuss it, the Times reports. Lisa Eng, a Hong Kong-born gynecologist who practices in New York City"s Chinatown and Brooklyn, said that she attempts to discourage couples who prefer boys from having abortions. "If it"s going to be a third [child], they"re pretty determined to have a boy," she said, adding, "If it"s a boy, they keep it. If it"s a girl, they"ll abort" (Roberts, New York Times, 6/15).
Medical Devices

Neupro(R), The Only Transdermal Patch For Restless Legs Syndrome, Now Available In The UK

The only transdermal patch in the UK for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults was launched by UCB. Applied once-a-day, Neupro® (rotigotine transdermal patch) allows for continuous drug delivery to provide stable drug levels in the bloodstream 24 hours a day and improves symptom control day and night. RLS may present itself as a 24 hour condition with symptoms frequently occurring during periods of rest, such as during sleep, or inactivity during the day, like long car journeys.RLS is thought to affect between three and 10 per cent of the population to some extent, causing sensations such as tingling or prickling sensations, burning, tugging and creeping. If left untreated, in some patients RLS can cause exhaustion and negatively impact quality of life. The goal of treatment for idiopathic RLS is symptom remission. Clinical trials, evaluating the efficacy and safety of rotigotine over a six month period in almost 1000 patients with RLS showed significant and clinically relevant improvements in RLS symptoms compared with placebo and that the treatment was generally well tolerated. "The most common adverse drug reactions reported in RLS patients treated with rotigotine were nausea, application site reactions, fatigue and headache. "The symptoms of Restless Legs Syndrome can have a significant impact on quality of life for many people, often affecting sleep, job performance and social activities. People with severe symptoms may require lifelong treatment," said Professor Ray Chaudhuri, Consultant Neurologist, University College Hospital. "The clinical trial data show that rotigotine provides us with a new and effective option for tackling this debilitating condition." Supporting Clinical Data In a clinical trial of 458 patients with moderate to severe RLS, rotigotine (1mg/24h, 2mg/24h and 3mg/24h) proved more efficacious than placebo in relieving symptoms in patients over a six month treatment period. The primary efficacy outcomes were the absolute change from baseline to the end of six month maintenance period in IRLS sum scores and in the clinical global impressions (CGI) item 1 score. Efficacy analyses were done on 112 patients in the 1 mg group, 109 in the 2 mg group, 112 in the 3 mg group, and 114 in the placebo group. Mean change in IRLS sum score from baseline at the end of the maintenance phase was -13òˆ™7 (SE 0òˆ™9) in the 1 mg group, -16òˆ™2 (0òˆ™9) in the 2 mg group, -16òˆ™8 (0òˆ™9) in the 3 mg group, and -8òˆ™6 (0òˆ™9) in the placebo group (pIRLS Scale The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a ten-item scale developed and validated by The International Restless Legs Syndrome Study Group and considered to be a useful scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. It is administered by clinicians and includes questions related to the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence and impact of RLS on activities of daily living and mood. The total IRLS score ranges from 0 (no symptoms) to 40 (very severe symptoms). A score of >20 indicates severe RLS. CGI Scale The Clinical Global Impressions (CGI) scale is a well-established tool which measures the general severity of an illness, clinical improvement or efficacy of treatment parameters. It is widely used in clinical research and clinical trials across various therapeutic areas and assesses response to treatment on a patient"s overall condition. About Neupro® in Europe The launch of Neupro® follows the granting of a European licence for the symptomatic treatment of moderate to severe idiopathic RLS in adults in September 2008. Neupro® is approved in Europe for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults, and for the treatment of the signs and symptoms of early-stage idiopathic Parkinson"s disease, as monotherapy or in combination with levodopa over the course of the disease through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occurs. UCB


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