Bioethics panel sets bar high for medical countermeasure studies in kids

first_imgMar 19, 2013 (CIDRAP News) – A presidential bioethics commission asked to study whether anthrax vaccine trials should be conducted in children before an event occurs released its assessment today, spelling out several steps that would need to be taken before research could proceed.The report from the Presidential Commission for the Study of Bioethical Issues also addresses the broader issue of the safety of other medical countermeasures (MCMs) in pediatric populations. It reviewed the issue after a 2012 request from Health and Human Services (HHS) Secretary Kathleen Sebelius.Her request grew out of a federal bioterrorism exercise in 2011 called Dark Zephyr. Based on a large-scale release of anthrax spores in a large city such as San Francisco, it estimated that nearly a quarter of the 8 million casualties would be children but determined that widespread vaccination with anthrax vaccine adsorbed (AVA) would play a key role in protecting people against the long-term threat from Bacillus anthracis spores, which cause anthrax.The exercise, however, highlighted that there was no information on the vaccine’s safety in children.In April 2011 Assistant Secretary for Preparedness and Response (ASPR) Nicole Lurie, MD, MPH, asked the National Biodefense Science Board (NBSB), a group that advises the federal government on biodefense countermeasure issues, to study the issue. In October of that year the NBSB approved a recommendation from its working group that the HHS develop a plan to study in advance of an attack the use of anthrax vaccine in children, contingent on a bioethics review.Amy Gutmann, PhD, chair of the president’s bioethics commission, said during a media telebriefing yesterday that the review posed difficult questions about balancing the need to protect children in an emergency setting with minimizing the risk to children when researching the safety and efficacy of AVA and other countermeasures.”The safety of our children is paramount, and we have to get this precisely right,” she said.In its report the group made six recommendations detailing conditions that would need to be met before pre-event studies of anthrax vaccine and other MCMs could be conducted, Gutmann said.The overarching principle is that children don’t benefit directly from participating in the study in advance of an attack, so risk must be kept small—such as limiting the risk to those routinely faced in daily life or at a medical visit, she said. In contrast, post-event studies would benefit participants and provide an opportunity to learn about the condition in a real attack setting.Pre-event trials shouldn’t go forward without more modeling studies, animal studies, and testing in the youngest adults, the report said. The commission recommended an age de-escalation approach that would use data from an older age-group to guide the design of the next research study and risk assessment for the next youngest group.She said that it’s possible to move forward with some studies, such as one that would explore AVA in young adults, such as military recruits, who have already had the vaccine.Gutmann, in a New England Journal of Medicine (NEJM) commentary today on the report, wrote that additional data from adult studies are needed, such as dose-sparing strategies, before pediatric testing can ethically be considered.When a pre-event medical countermeasure trial would pose more than a minimal risk, it must go though a “national-level review” of experts. Gutmann said examples of minor risks would include, for example, a skin biopsy or a chest x-ray.Christine Grady, RN, PhD, a commission member, told reporters that the panel would be convened by the HHS and would likely include experts in pediatrics and pediatrics research, as well as members of the general public.For the post-event scenario, the commission strongly recommended that federal officials proceed with designing research protocols for untested or minimally tested MCMs that would be triggered by an attack or emergency.The group also recommended that a plan be put in place to compensate victims from any harm that would come from the studies.Biosecurity expert Michael Osterholm, PhD, MPH, said the question of whether to proceed with pre-event testing is a difficult one, with no perfect answer.In the event of an attack and vaccines and antibiotics are deployed across a range of age-groups, he said the public might ask why medical authorities didn’t have more information on countermeasure use in children. And if there’s not an attack and the vaccine causes harm during studies, officials will face similarly tough questions.Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, publisher of CIDRAP News, said that what makes kids different is they can’t give informed consent and that AVA—unlike other vaccines that are studied for known threats—have no immediate benefit.One middle ground that most experts agree on is the need for protocols for research studies that would kick in as soon as an attack occurs and the countermeasures are deployed, Osterholm said.The HHS’s ASPR office said in an e-mail to CIDRAP News yesterday that the safety and security of the nations’ children is a top priority. “We thank the Presidential Commission for the Study of Bioethical Issues for their thoughtful recommendations. We look forward to fully reviewing the report.”See also:Mar 19 Presidential bioethics commission press releaseMar 19 Presidential bioethics commission reportMar 19 NEJM commentaryOct 28, 2011, CIDRAP News story “NBSB urges pre-attack studies of anthrax vaccine in kids”last_img read more

45 Technicians Honored At ASE Annual Meeting

first_imgFront row (L to R): Sean Newman, Jason Trimble, Joe Calaway, Jaime Pimenta, John Johnson, Tony Harrison, Larry Ellet, Bryan Mitchell, David Winger, Ryan Coberly, Rob Daigle2nd Row (L to R): Bob Olson, David Stapinski, Steve LaRose, Gary Sharits, Patrick Dennis, Scott Lawson, Derek Sorenson, Shawn Lemons, Rob Crawford, Matt Morrison, Anthony Long, Craig Head3rd Row (L to R): Andy Perazzo, Eric Taffs, Woody Robison, Rob Duchmann, Josh Kemmerer, Marlo Miranda, John Long, Bill Engler4th Row (L to R): Joe Domer, Craig Bekkala, Dennis Gillispie, TSgt Nicholas “Sev” Sevaaetasi, Tom Costantino, Eldon Owens, Gary Wilson, Terry UeckertTop Row (L to R): Aaron Kaurala, Patrick Doyle, Geoffrey “Norm” Gwisdala, Koda Colbert, Greg Shimanek, Dan RowlandForty-five automotive professionals were recognized on Nov. 16, at the Fall Board of Governors meeting of the National Institute for Automotive Service Excellence (ASE) held at the Embassy Suites in Concord, North Carolina.AdvertisementClick Here to Read MoreAdvertisementThe annual awards banquet spotlights top scorers on the ASE certification tests. Thirty-four different companies from both the OEM and aftermarket segments sponsored the individual technician recognition awards in the Auto, Truck, Collision and Parts categories, along with awards for automotive instructors. In addition to looking for top scores on ASE tests, award sponsors examine on-the-job excellence, community service and other factors when selecting honorees.“ASE has recognized the best of the best in our industry for more than 40 years, and this year we honored 45 outstanding individuals from all across the nation,” said Tim Zilke, ASE president and CEO. “We couldn’t do this without the support of our many award sponsors, whose ranks include some of the best-known names in the industry. Their commitment to excellence is reflected in the talented individuals receiving these awards each year. The enthusiasm and professionalism displayed by all of our award winners is a testament to the high-quality individuals wearing the ASE Blue Seal and we are proud to have them as part of the ASE family.”last_img read more

What do five housebuilder trading updates tell us?

first_imgTo continue enjoying Building.co.uk, sign up for free guest accessExisting subscriber? LOGIN Get your free guest access  SIGN UP TODAY Subscribe now for unlimited access Stay at the forefront of thought leadership with news and analysis from award-winning journalists. Enjoy company features, CEO interviews, architectural reviews, technical project know-how and the latest innovations.Limited access to building.co.ukBreaking industry news as it happensBreaking, daily and weekly e-newsletters Subscribe to Building today and you will benefit from:Unlimited access to all stories including expert analysis and comment from industry leadersOur league tables, cost models and economics dataOur online archive of over 10,000 articlesBuilding magazine digital editionsBuilding magazine print editionsPrinted/digital supplementsSubscribe now for unlimited access.View our subscription options and join our communitylast_img read more

ALE and Megatranz in 8,000 tonne load-out

first_imgThe module is for the Mexilhão field in the Santos Basin in Brazil. The field lies off the coast of Sao Paulo, approximately 160 km offshore and in water depths of between 320 m and 550 m. The total cost of the development has been put at around USD 1.9 billion.For the load-out, ALE used four x 850 tonne capacity strand hydraulic pulling units. The load out average speed was 11 metres per hour. The barge used for the load-out was the S-600 owned by Saipem.last_img

Uni-top adds European coverage

first_imgUni-top will operate three flights per week. The Chinese airline expects European manufacturers of automotive parts, particularly from Germany and the UK, to utilise the route in order to ship components to China.This is the latest European cargo route opened by the Chinese airline, after the introduction of a service from Luxembourg to Wuhan in January. The opening of these two air cargo routes will help Europe and China to share the benefits of the Belt and Road Initiative (BRI), adds Uni-top.At present, Uni-top Airlines owns 11 wide-body freighters, including three B747-200Fs, one B747-400F, and seven A300-600Fs.www.uw-air.comlast_img

‘MoKaKi’ project breaks ground in Mombasa

first_imgKENYA: A ceremony led by President Uhuru Kenyatta in Mombasa on November 28 marked the start of construction of the first phase of the planned 2 937 km standard gauge cross-border corridor linking the Kenyan port city with Kampala in Uganda and the Rwandan capital Kigali.The initial phase of the railway would provide a new route between Mombasa and Nairobi, supplementing the metre-gauge Kenya-Uganda Railway operated by Rift Valley Railways. With an estimated total cost of US$13·5bn, the so-called ‘MoKaKi’ project is being managed by Kenya Railways Corp, while China is providing financial support. Kenyatta was joined at the groundbreaking ceremony by Liu Qitao, Chairman of China Communications Construction Co. KRC is working on plans for the second phase from Nairobi to the Ugandan border at Malaba, while studies for the 250 km from Malaba to Kampala are also underway. The third phase covers 345 route-km from Kampala to Kasese and 200 km from there to the Rwandan border at Mirama Hills via Bihanga, leaving the Rwandan government responsible for the final section into Kigali. The three governments are considering the scope for a northern branch diverging at Eldoret to serve South Sudan. The line is being designed for passenger trains to run at 120 km/h and freight trains at 80 km/h, with a maximum axleload of 25 tonnes. ‘The project will define my legacy and it is my personal desire that the implementation is done to the highest standard’, Kenyatta said. ‘Kenya will fully meet its obligations towards the project.’last_img read more

Kirkcudbright Galleries Light At Night

first_imgImage Credit Alex Hussein AddThis Sharing ButtonsShare to FacebookFacebookFacebookShare to TwitterTwitterTwitterShare to LinkedInLinkedInLinkedInIn partnership with Kirkcudbright Festival of Light and Museums Galleries Scotland, Kirkcudbright Galleries are holding two events to kickstart the fantastic Festival weekend. The evening workshop offers members of the public, from all ages, a chance to create their own lantern illuminations which will be incorporated into the festival weekend.  The late-night gallery opening on the 10th October will provide visitors with a chance to visit all exhibitions at night, before going out and exploring the lights around the town.‘A Town of Light’ Miniature House Lantern Making Workshops at Kirkcudbright Galleries on Wednesday 9th October:Come along to Kirkcudbright Galleries on the evening of Wednesday the 9th October and learn how to create your own beautiful miniature house shaped lanterns! Inspired by the unique buildings in Kirkcudbright. Location: Mezzanine Level of GalleryCost of the workshop: Free!**However, places are limited to 20 people for each session. You can reserve a spot on these workshops through clicking the ‘RSVP’ button on our website: www.kirkcudbrightgalleries.org.ukThe workshops are divided into time slots, participants only need to attend one slot to make a lantern. The workshops are 1 hour 15 minutes in length each, and the first session is from 5pm-6:15pm, with the second session starting at 6:30pm-7:45pm. The House Lantern workshop is led by Festival of Light organiser Pauline Saul. ** Please note the sessions may over-run by 15 minutes on each end. The rest of the building will be closed during this evening.**Please note: The Lanterns made during these workshops will be houses for a special display in the Soaperie Gardens. Participants are welcome to collect their houses and take them home at the end of The Festival of Light Event. Due to house structures being more complex, the workshop is suited to teenagers and adults. However, families and younger children are welcome to join if a responsible adult is present!On the next evening, the second event Kirkcudbright Galleries is hosting in partnership with the Festival is: Kirkcudbright Festival of Light Launch Evening at The Galleries on Thursday 10th October from 7pm – 9pm.Come along for our late-night Gallery opening before going out to enjoy the delights of Kirkcudbright and our illuminated artists’ town. See our exhibitions in a new light and explore our magical building at night! Welcoming introduction to the Illuminaire at 7:15pm, light refreshments and live music, all galleries open for viewing. The launch evening is a free event and is open to all members of the public.** Please note, there is an admission fee for adults if you wish to visit the Gerald Scarfe: Stage and Screen Exhibition in Gallery 2. Admission (one ticket gives admission to the Gerald Scarfe Exhibition for a total of three visits including initial visit.) £5.00 for adults. Free admission for 18+U, Art Fund Members, Friends of Kirkcudbright Galleries.Hashtag: #KBTFestivalofLight‘A Town of Light’ House lantern workshop and The Festival of Light Launch Evening at Kirkcudbright Galleries have both been made possible through the supported funding from Museums Galleries Scotland.last_img read more

Roseau South MP speaks out after latest killing

first_imgMember of Parliament for the Roseau South constituency, Joshua Francis (file photo)Parliamentary Representative for the Roseau South Constituency Joshua Francis has spoken out what seems to be the latest trend on the island, gun violence.Curtson Charles, 25, of Silver Lake, was gunned down by masked men at about 7:30 p.m. Wednesday in his community. Francis who took to Facebook shortly after learning about the killing called it a senseless act. “If what I hear is true, allow me to take the opportunity to condemn such senseless killing. I have not gotten all the information, but nonetheless I have received adequate information which will suggest that another young man has lost his life as a result of a shooting, senseless in terms of what we know as opposed to what the deceased and the shooter would know.”He added that there seems to be a cloud of darkness hanging over the country even as the island is still recovering from hurricane Maria. “We cannot continue to be in a country where we hear of shootings, we experience natural disasters, our economy keep contracting, we stand for what is wrong and we take it for granted.”The time he said has come for some questions to be asked continuing, “For if we fail to do so, the next shooting may be our child, may be our neighbour, maybe our friend. We really need to take heed of ourselves in this country”. Francis therefore called on everyone to be a leader wherever they may be to bring change to Dominica. “The change must not only be political but that change must be echoed at our homes, in our communities, at our schools, in our churches and in our country by extension,” he explained, “We need to go back to the drawing board.” Sharing is caring! Share 326 Views   3 comments Sharecenter_img LocalNews Roseau South MP speaks out after latest killing by: Dominica Vibes News – August 30, 2018 Share Tweetlast_img read more

AceAxis Unveils Flexible Radio Platform for Network Simplification

first_imgAceAxis has introduced the Flexar platform for remote radio units (RRU), which offers an unprecedented level of modularity and flexibility for a variety of applications that include disaster recovery, hardened industrial radio networks, and ground-based and airborne transport, as well as small cells and macrocells.Flexar builds on the rich heritage of AceAxis in the design and delivery of high performance radios to the cellular market, with over 70,000 units deployed in the last five years. Configurable for any frequency band in the range 400 MHz to 6 GHz, and with either FDD or TDD duplex schemes, Flexar has the ability to incorporate LTE-A carrier aggregation of up to four component carriers (4CC) and up to 8 x 8 MIMO.Traditionally radios were designed to order, and used to follow a lengthy development process, as well as requiring specialist installation. AceAxis is committed to working towards open standards in the key areas of open interfaces, standard radio modules, test, and software, in order to reduce complexity and simplify radio, and launching Flexar is part of this strategy. By creating partnerships and challenging conventional design processes, as well as increasing volumes to lower costs, they believe that this will this help to open up the supply chain, enabling radios become a commodity item accessible to a wide range of customers.AceAxis is exhibiting at Mobile World Congress 2017, where it is also showing a live demonstration of its recently-announced PIM cancellation platform.last_img read more

Cut for a Cause

first_img Share RelatedSWEETEST OF SENTIMENTS: Wife’s Valentine’s Day gesture uniqueBy CRAIG ALANIZ Reporter/Photographer press@portisabelsouthpadre.com  Thursday was the annual celebration of love, and this Valentine’s Day was made special for a local business owner. Enrique Saldaña was surprised by his wife Thursday morning when he found his car covered with balloons and love notes written by his wife Janett. Saldaña…February 14, 2013In “News”Writer’s Block: Cleared Shelter, Full Heart, Can’t LoseBy DINA ARÉVALO Port Isabel-South Padre Press editor@portisabelsouthpadre.com Each day, when I get home from work, I walk up the path to my front door. I jiggle the key in the lock, push open the door and am greeted by a friendly face. Sitting a few paces from the reach of…August 17, 2018In “Editor’s Column”Purple Heart monument to be installed by Veterans DayBy MARTHA McCLAIN Special to the PRESS A Purple Heart Monument, commemorating Purple Heart recipients, will be installed in time for Veterans Day ceremonies at Laguna Vista’s Veterans Memorial Park. Amid discussion of the proposed addition to the park by Laguna Vista Town Council members Tuesday, Councilman Gary Meschi said that…August 12, 2016In “News” Want the whole story? Pick up a copy of the Port Isabel-South Padre Press, or subscribe to our E-Edition by clicking here.center_img Self-described biker donates hair after a decade of growthBy ESTEVAN MEDRANOPort Isabel-South Padre Presspress@portisabelsouthpadre.comGary Snyder has been growing his hair out for 10 years. Very early on in the process of doing so he thought about one day donating it to someone in need. That day came Tuesday afternoon at Kool Cuts in Port Isabel. Snyder’s wife accompanied himto witness the milestone event.“We wanted to donate the hair to a worthy cause,” said Snyder. “It was easy to grow the long hair because I’ve been a biker for years and it kind of fits in really good,” he said. “But I wanted to make sure it got to some agency that would use it for a good purpose… I think it’s a good thing and I think everyone who can spare the hair ought to contribute,” he added.The hair donation is a remarkable 32 inches in length. His wife, however, approved of his new clean-cut look.The hair has been sent to Pantene Beautiful Lengths, partnered with the American Cancer Society, to become a wig to help women fighting cancer.last_img read more