October 25, 2007 AIDS vaccine volunteers among recipients who may be at higher risk of contracting virus South African AIDS researchers have begun warning hundreds of volunteers that a highly touted experimental vaccine they received in recent months might make them more, not less, likely to contract HIV in the midst of one of the world's most rampant epidemics. The move stems from the discovery last month that an AIDS vaccine developed by Merck & Co. might have led to more infections than it averted among study subjects in the United States and other countries. Among those who received at least two doses of the vaccine, 19 contracted HIV compared with 11 of those given placebos. Researchers shut down the trial on the grounds that the vaccine was proving ineffective, but the surge in infection among vaccinated volunteers prompted intense scientific debate and anxiety among researchers. The failure of the Merck vaccine is the latest in a series of disappointing results for research projects aimed at curbing AIDS. Researchers in Soweto, Cape Town, Durban and two other sites began contacting South Africa's 801 trial participants on Tuesday, mainly by cellphone text message. The goal is to tell each one individually whether they had received a placebo or the vaccine, a process called "unblinding" the trial. Researchers are telling the roughly half who received the vaccine that it might have increased their risk of contracting HIV. Merck developed the vaccine in conjunction with the U.S. National Institutes of Health, and until September's announcement, researchers worldwide considered it the most promising candidate yet in a multibillion-dollar quest for an AIDS vaccine dating to the 1980s. Scientists crafted the vaccine by genetically altering a common virus to include elements of HIV. They hoped that it would trigger an immune response that would make recipients less likely to contract HIV, or at least delay the onset of full-blown AIDS. The vaccine could not have caused infection, researchers say, but it could have caused immunological changes that made it easier for the virus to take hold during a later exposure. The Merck vaccine trials took place in 15 cities in the United States, including Boston, Los Angeles and New York, and three in Canada. There also were sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those trials began in December 2004 and included 3,000 participants, mostly gay men. In South Africa -- where an estimated 5.5 million people are infected with HIV, more than in any other country -- the study used the same vaccine but was administered separately. The trial here started later, with the first injections this year, and had its own ethics oversight board. Most of the subjects were heterosexual. The ethics oversight board in the United States, which monitored the trial everywhere but in South Africa, has not decided whether to tell participants if they received the placebo or the vaccine, said Mark Feinberg, vice president for medical affairs and policy for Merck. Continuing research could be compromised, he said,if participants were told immediately whether they received the placebo or the vaccine. Vaccine researchers are scheduled to meet in Seattle on Nov. 7. He added that individual participants who want to know whether they received the vaccine will be told. Researchers also are counseling all study participants that the vaccine may have increased HIV risk for those who received it. Other AIDS studies also have had unexpected results. Trials of two vaginal microbicide gels to prevent HIV led to more infections among those using the products instead of placebos. A massive study in Zimbabwe of the ability of HIV counseling and testing to prevent the spread of the epidemic found more infections among those with expanded access to testing. For the complete story, see http://www.washingtonpost.com/wp-dyn/content/article/2007/10/24/AR2007102402514.html Drug eluting balloons show promise as a potential alternative to drug eluting stents used in the treatment of coronary artery disease Drug eluting balloons could offer a viable alternative to drug eluting stents (DES) in the treatment of coronary artery disease. Research results from two studies presented at the Late Breaking Trials sessions during the Cardiovascular Research Foundation’s (CRF) Nineteenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., support conducting further studies of the use of this potential therapeutic alternative. One of the studies marked the first direct comparison between DES and drug eluting balloons. Used to open atherosclerotic arteries, DES have come under intense scrutiny over the last several years, prompting the U.S. Food and Drug Administration (FDA) to form a special advisory board to investigate claims of complications. Recent studies have suggested that the polymer coating of these stents might be implicated in the reported complications. The “SeQuent Please” drug eluting balloon catheter from B. Braun Melsungen AG in Germany delivers drugs directly to the lesion during angioplasty. A pilot study published last year in the New England Journal of Medicine first shed light on this potential treatment option. In the PEPCAD II study, Dr. Martin Unverdorben (Rotenburg, Germany) directly compared “SeQuent Please” to another manufacturer’s DES in 131 patients over six months. The team evaluated restenosis, the re-closing or narrowing of the artery after a cardiac procedure, and the rate of major adverse cardiac events (MACE) such as heart attack, bypass, repeat stenosis, or death. Proving patients treated with the drug eluting balloons experienced only 3.7 percent restenosis and 4.8 percent MACE, as compared to patients with DES, wherein restenosis was 20.8 percent with 22.0 percent MACE rate. Further supporting these results, a separate study by Unverdorben evaluated the use of drug eluting balloons for the treatment of small vessel disease in 120 patients. PEPCAD I is the first study to investigate the use of drug eluting balloons in “native” lesions – those who have not already been treated by DES or bare metal stents. After six months, native lesions treated solely with “SeQuent Please” showed only a 5.5 percent binary restenosis rate and 6.1 percent MACE. These results compare quite favorably with previously published results using drug-eluting stents for the treatment of small vessel disease with 31.2 percent restenosis and 18.9 percent MACE. The development of “SeQuent Please” for the treatment of coronary artery disease is made possible through B. Braun Melsungen AG agreement with Charité Hospital in Berlin, Germany. The product features a unique matrix coating which is fully bioabsorbable and polymer-free, enhancing the drug transfer into vascular tissue. Hospitals adopt STERIS Advanced Room Sterilization Technology in the fight against ‘Superbugs’ STERIS Corporation announced it has received the first orders for its VaproSure Room Sterilizer from several U.S. hospitals. The VaproSure Room Sterilizer incorporates STERIS patented technologies and is the first product of its kind for the healthcare market. Since being introduced in June of this year, systems have been ordered by Wellmont Health System (VA, TN, KY) Lake Hospital System (OH), and the VA Boston Healthcare System (MA). These hospitals are demonstrating leadership in patient safety and infection control and will use their VaproSure Room Sterilizers to sterilize all the exposed surfaces in critical hospital rooms. As highlighted in recent national news media reports, the persistent spread of germs and infections in healthcare facilities is a significant challenge for patient safety and compromises the ability for hospitals to deliver economically efficient healthcare services. With the VaproSure Room Sterilizer, it is now possible to sterilize all of the exposed pre-cleaned surfaces within a sealed room. STERIS is the only company to offer a complete hygiene solution to hospitals as a way to enhance their infection control programs and improve the efficiency of their operations. The VaproSure Room Sterilizer utilizes Vaprox Sterilant (EPA Registration No. 58779-4) to create a dry sterilization vapor that inactivates the full spectrum of biological contaminates on dry, pre-cleaned, exposed, porous and non-porous surfaces within a sealed hospital room. The chemistry is recognized as sporicidal, bacteriacidal, fungicidal and virucidal. Additionally, the technology is environmentally friendly, reducing to water vapor and oxygen at the conclusion of the cycle. Steris Corporation wins U.S. EPA SmartWay Environmental Excellence award STERIS Corporation has received the U.S. Environmental Protection Agency’s SmartWay Transport Partnership Environmental Excellence Award for its leadership in conserving energy and lowering greenhouse gas emissions from its transportation and freight activities. The awards were announced earlier this week at the annual conference of the Council of Supply Chain Management Professionals in Philadelphia, PA. STERIS was officially recognized by the U.S. EPA as a SmartWay Partner in January 2006. It achieved this distinction by using the highest possible percentage of SmartWay member carriers for the transport of STERIS materials and by instituting fuel-saving strategies for transport vehicles. SmartWay was introduced by the EPA and a select group of 15 shipping and business leaders in 2004 as an innovative, market-based partnership to reduce fuel use, greenhouse gas emissions, and air pollutants from the freight sector. Today, more than 600 businesses and organizations have joined the Partnership, including companies of all sizes, from Fortune 500 companies to family-owned businesses, each working to improve their environmental performance. Together, these companies, including STERIS, are conserving more than 600 million gallons of diesel fuel per year, saving the trucking industry nearly $2 billion in annual fuel costs, and eliminating nearly 7 million metric tons of carbon dioxide emissions. By 2012, the EPA estimates that its SmartWay program will achieve annual savings of 3.3 to 6.6 billion gallons of diesel fuel, eliminating 33-66 million metric tons of carbon dioxide emissions and almost 200,000 tons of nitrogen oxide emissions. The companies receiving 2007 U.S. EPA SmartWay Environmental Excellence Awards by partner category are: IBM Corporation; Johnson & Johnson Sales & Logistics Company, LLC; JCPenney; Kimberly-Clark Corporation; Lowe's Companies Inc.; Michelin North America, Inc.; Office Depot; Sharp Electronics Corporation; and STERIS Corporation. For more information about SmartWay visit: http://www.epa.gov/smartway/index.htm Healthcare Supply Chain Standards Coalition endorses standards for organizational and product identifiers In a major step aimed at making healthcare more affordable while strengthening patient safety and outcomes, the Healthcare Supply Chain Standards Coalition (Standards Coalition) is calling for industry-wide adoption of organizational and product identifiers from GS1, an international organization dedicated to designing and implementing supply chain standards. Specifically, the Standards Coalition, a collaborative of 28 organizations representing the entire healthcare supply chain, is endorsing GS1.s Global Location Number (GLN) for organizational identification and its Global Trade Identification Number (GTIN) for product identification. “We have the opportunity, and truly, the obligation, as an industry, to transform how we do business,” said Joseph Dudas, Standards Coalition co-chairman and Mayo Clinic’s director of accounting and supply chain informatics. “With universal standards, every supply chain participant will be able to identify every organization and every product the same way. This is a monumental step forward from our current state, where trading partners record organizational and product information differently and often manually, leading to tremendous inefficiency, waste, and inaccuracy, as well as countless opportunities for error.” To reach its endorsements, the Standards Coalition spent the past year scoping the business problems, collecting industry input about identifiers, and evaluating standards options. As part of this effort, it conducted a survey that found 69 percent of 129 respondents were considering adopting an organizational identifier. Almost two-thirds said they were considering adopting GS1’s GLN. “After much work and consideration by the Standards Coalition subcommittees, we concluded that GS1’s standards offered the best solutions for the industry,” said Stephen D. Christian, Standards Coalition co-chairman. “GS1 offered a viable global approach, which is essential today, and healthcare organizations in other countries have already begun using its GLN and GTIN standards. GS1 has a successful track record that dates back to the universal product code (UPC) that was adopted by the retail and grocery industries over 30 years ago. We are working with GS1 standards to bring that measure of success to healthcare and streamline transactions and information across the entire supply chain.” To aggressively move the industry toward adoption, the Standards Coalition is actively working with GS1 to enhance its standards to meet healthcare’s needs. The Standards Coalition is also recommending GS1.s Global Data Synchronization Network (GDSN) serve as the healthcare industry’s system for registering, validating, disseminating, and synchronizing product identification information. Additionally, the Standards Coalition plans to shortly introduce implementation roadmaps for supply chain participants, including providers, manufacturers, distributors, and group purchasing organizations. In addition, the Standards Coalition has launched a website, www.hscsc.org, for healthcare organizations to learn more about the standards and other industry and government initiatives related to standards adoption and implementation. Members of the Standard’s Coalition Oversight Committee are: Abbott, American Hospital Association, Amerinet, Ascension Health, Association for Healthcare Resource & Materials Management (AHRMM), BD, Cardinal Health, Coalition for Healthcare eStandards (CHeS), Consorta Catholic Resource Partners, U.S. Department of Defense, U.S. Food and Drug Administration (FDA), Geisinger Health System Foundation, GHX, HCA, Inland Northwest Health Services, Intermountain Healthcare, Johnson & Johnson Med. Devices & Diagnostics, Lawson, Mayo Clinic, McKesson Corporation, MedAssets, Mercy Health Systems ROI, Owens & Minor, Novation, Premier Inc., Sentara Healthcare, Strategic Marketplace Initiative (SMI) and University Hospitals. More info: www.gs1.com. 6 Sigma decreases mortality in hospitalized patients; Performance improvement initiative decreases hospital stay and costs Although Six Sigma practices are widely used in the manufacturing industry, the performance improvement system also may provide significant benefits for hospitals, medical professionals, and patients. A new study presented at CHEST 2007, the 73rd annual international scientific assembly of the American College of Chest Physicians (ACCP), shows that Six Sigma performance improvement practices may help hospitals decrease in-patient mortality, length of hospital stay, and healthcare costs, and also improve compliance with Joint Commission (JCAHO) Core Measures as they relate to community-acquired pneumonia (CAP). “Although national guidelines for CAP care existed, they were not being followed consistently throughout our organization and percentages of patients with core measures met were lower than best practice hospitals,” said study author Karen Gamerdinger, RN, MSN, Mercy Medical Center, Des Moines, IA. “By implementing Six Sigma practices, we showed that a quality improvement project can lead to benefits, not only to the patients in decreased mortality, but also to physicians and nurses by making it easier for them to provide the best, evidence-based, guideline-directed care possible, and to the hospital itself with decreased lengths of stay and decreased costs.” Six Sigma is used the same way in healthcare as it is in technology and auto industries: to eliminate non value-added steps in processes and reduce defects and variation resulting in more efficient processes. “The focus is still on identifying defects and improving processes to reduce variation, whether that is improving how a patient navigates through the healthcare system or whether it is looking at how parts are assembled in an automobile factory,” said Gamerdinger. “This leads to improved quality care and cost-savings in healthcare organizations.” In a retrospective study, Gamerdinger and colleagues from Mercy Medical Center evaluated the outcomes of a Six Sigma performance improvement project focused on compliance with JCAHO CAP Core Measures to ensure that each measure of care was met. Utilizing Six Sigma methodology, researchers identified critical processes and key stakeholders in patient care and utilized specific tools for process flow, cause/effect matrices, and outcomes analysis. The hospital also dedicated several full-time positions to the new methodology and trained more than 100 individuals in the Six Sigma program. When deviations from the Six Sigma protocol occurred, timely feedback was provided to care providers. After program implementation, researchers collected and analyzed data related to core measures, length of stay, and mortality in 1,550 patients with CAP admitted to the hospital during the study period. Results indicated that compliance scores for each JCAHO Core Measure improved from 70% to over 90%. CAP order usage improved from 40 %to 73%, yielding an 82.5% increase. Mean length of stay was reduced from 5.9 days to 5.1 days, a 13.56% reduction, which was associated with over $300,000 in cost savings. By the end of the study period, in-hospital mortality rates also decreased from 6.7% to 3.5%, a 47.8% reduction. Although researchers specifically measured outcomes related to CAP, the hospital has applied Six Sigma to other in-patient populations, including patients with cardiac conditions, and to system-wide issues, such as delays in medical imaging, home medical equipment projects, and reducing patient registration times for in-patients. Large avian flu outbreaks more likely to involve duck meat industry, experts find Scientists at the University of Liverpool have found that 73% of avian flu outbreaks in the UK would not spread beyond the initial infected farm, but larger outbreaks are more likely to involve the duck meat industry. A team from the University’s Faculty of Veterinary Science and Department of Mathematical Sciences were approached by the Department of Environment, Food and Rural Affairs (DEFRA) to produce an avian flu model based on unique levels of detail including contact points between farms. The studies team believes that duck meat is more likely to cause large outbreaks of avian flu because ducks often do not show signs of the disease and as such delays diagnosis and control of the infection. Scientists used a computer model to simulate millions of outbreaks of avian flu, so that even rare outbreak scenarios could be observed in order to further understanding of how the disease might spread across the UK. Dr. Rob Christley from the University’s Faculty of Veterinary Science, explains: “Our model is unique in the level of detail regarding contact points between farms. We modelled four contact routes: local transmission, where infection is spread in the area due to wind and wild animals; transmission via delivery of feed where lorries may pick up the virus at one farm and carry it to another; transmission via slaughterhouse lorries and transmission via company workers, where personnel from a company may carry the virus to other farms within the same company as they go about their daily work. The model also provides analysis of government policy, such as the implementation of control zones. This strategy aims to limit the movement of birds as well as trace potential contacts where transmission of the disease is more likely. The team found that this strategy was beneficial in reducing the chance of very large outbreaks to almost zero.