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Chinese Government Reports Abortion Statistics
Chinese state media on Thursday reported that women in the country have about 13 million abortions annually, the AP/Houston Chronicle reports. According to the China Daily newspaper, the actual number likely is much higher because the 13 million includes abortions performed in hospitals but not unreported procedures performed in rural clinics. Most of the abortions were among single young women who experts say know little about contraception. The paper also said that about 10 million pills for medical abortion are sold annually in the country. China imposed strict population controls in the 1970s that prohibit most couples from having more than one child. For married women, sterilization and the use of intrauterine devices are widely promoted and subsidized. However, Chinese policies typically do not address the needs of unmarried women, even as national attitudes have become more accepting of sex outside of marriage, the AP/Chronicle reports. According to the newspaper, about 62% of the abortions were among unmarried women ages 20 to 29. The Chinese report called the number of abortions "an unfortunate situation" but did not indicate whether the procedures are increasing or decreasing from year to year. National Population and Family Planning Commission official Wu Shangchun is quoted in the report as saying that almost half of the women seeking abortion had used no form of contraception. Wu also said that reducing abortions is a national challenge that requires significant effort. Peking University professor Li Ying said that sex education in China must be improved at the university level and that Chinese parents must do more to teach children about sex (AP/Houston Chronicle, 7/30).
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Reform Editorials Examine Rationed Care, Taxing Health Benefits
Wall Street Journal: A recent decision by CMS to end Medicare coverage of virtual colonoscopies is "a preview of how health care will be rationed when Democrats" create "a new "universal" health insurance entitlement for the middle class," a Journal editorial states. According to the editorial, the prospects of such a health system are "playing out in miniature in Medicare" where CMS has decided that offering an alternative to the traditional colonoscopy is "too pricey." The editorial states that the situation features "precisely the sort of complexity that the Democrats would prefer to ignore as they try to restructure health care" and use comparative effectiveness research to determine what works best for the majority of patients. According to the editorial, "The problem is that what "works best" isn"t the same for everyone." It continues that CMS "made the hard-and-fast choice that it was cheaper to cut [virtual colonoscopies] ... for all beneficiaries. If some patients are worse off, well, too bad." The editorial concludes that the situation is "merely a preview of the life-and-death decisions that will be determined by politics" if Democrats enact their ideal system (Wall Street Journal, 5/19).
News of the day
Quintiles Consulting Outlines Methods For Re-Balancing Drug Development Risks
Quintiles Consulting released the first in a three-part series of white papers addressing how best to navigate risk in drug development. The first paper, "On the Re-Balancing of Risk to Transform Cost and Productivity in Drug Development," focuses on operational risk. It is available for download at http://www.quintiles.com/consulting.
Sexual Health

Trinam(R) Phase III Study Enrols First Patient

Ark Therapeutics Group plc ("Ark" or the "Company") announces that the first patient has been enrolled into the US Phase III study for Trinam®. Trinam® is Ark"s novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. The product is an adenovirus-mediated VEGF D gene delivered with a novel biodegradeable local delivery device (EG001). The Phase III study is a US multi-centre, randomised, controlled trial, in which the efficacy and safety of Trinam® will be investigated in patients with end-stage renal disease (ESRD) requiring vascular access for haemodialysis. Patients with ESRD will be randomised to receive either Trinam® in addition to standard care or standard care alone at the time of surgical placement of a synthetic PTFE graft for vascular access. Primary Unassisted Patency (time to any first intervention) will be the primary regulatory endpoint. Overall patency and a number of other important pre-defined clinical endpoints will also be measured. The safety of the trial will be assessed by an independent Data and Safety Monitoring Board (DSMB) against a pre-specified set of stopping rules defined during the Special Protocol Assessment (SPA). The DSMB will also undertake a blinded "sizing" analysis after 150 patients have been enrolled to determine the final trial size. This type of adaptive design assists groundbreaking drugs to ensure robust efficacy data are available to satisfy regulatory requirements as approval standards evolve. Results from a Phase II open-label, non-randomised, standard-care controlled trial of Trinam®, reported in March 2007, indicated that the access grafts of patients given Trinam® remained functional for dialysis, on average, up to three times longer than in untreated controls. Trinam® was well tolerated with no quantifiable systemic distribution of the product found and no serious side effects were exhibited other than those consistent with the nature of the operation and underlying condition. Trinam® was awarded Fast Track Status by the FDA earlier this month and has been granted Orphan Drug Status in both the US and Europe. US regulatory review for the product comes under the responsibility of the Centre for Biologics Evaluation and Research (CBER), the specialist biologics division of the FDA. Dr David Eckland, Research and Development Director of Ark, commented: "We are very pleased to commence enrolment into the Phase III study for Trinam® which follows the Fast Track Status gained from the FDA earlier this month. There is a significant unmet therapeutic need in this indication and today"s news brings us a step closer to gaining approval for a product which we believe will transform the prognosis for many patients suffering from kidney failure." Dr Nigel Parker, CEO of Ark, added: "First patient enrolment is a significant milestone for this very important gene-based medicine and reflects the good progress we continue to make at Ark. Our whole portfolio is growing in strength and we look forward to announcing details of Trinam®"s continued progress in due course." Trinam® Trinam® is a combination of a vascular endothelial growth factor gene in an adenoviral vector (Ad-VEGF-D) and Ark"s biodegradable local delivery collagen collar device (EG001). At the end of the access graft surgery procedure, the collar is fitted around the outside of the vein/graft join. The Ad-VEGF-D solution, which reduces the likelihood of blood clots and intimal hyperplasia, is then injected into the space between the wall of the collar and the blood vessel. This unique method of administration of the gene localises its delivery to the target tissue site, maximising efficacy, avoiding systemic distribution and thus minimising the potential for side effects. Ark Therapeutics Group plc


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