House committee grills FDA over fungal meningitis outbreak

first_img In written testimony that she submitted along with her appearance before the committee, Lovelace urged members to put aside their partisan differences to pass laws to prevent another similar outbreak from contaminated compounding pharmacy drugs. “Don’t just investigate. Instead, legislate and regulate,” she wrote. “If you will do that, perhaps my family can take some solace in the fact that Eddie Lovelace’s public service continues even after his death.” Members of the House Energy and Commerce Committee also heard poignant comments from Joyce Lovelace, the wife of one of the first patients who died in the outbreak and whose death helped alert health officials to problems with methylprednisolone acetate injections from New England Compounding Center (NECC). So far 461 infections and 32 deaths from 19 states have been linked to the tainted steroids, which were used to treat back pain and joint problems, according to an update today from the Centers for Disease Control and Prevention (CDC). The total is 23 cases more than the last update on Nov 9. No new deaths were reported. The committee heard from and questioned two regulators, Margaret Hamburg, MD, commissioner of the US Food and Drug Administration (FDA), and Lauren Smith, MD, MPH, interim commissioner with the Massachusetts Department of Public Health. Hamburg is also scheduled to testify at tomorrow’s Senate hearing. See also: Eddie’s first symptom was hand numbness after the second injection, which progressed to headaches and neuromotor problems, she recalled. “It was a nightmare to see someone perfectly healthy go quickly downhill.” House Energy and Commerce hearing information As doctors at Vanderbilt University pieced together what caused Lovelace’s death, his wife said she first heard about a possible link to contaminated steroids through media reports, followed by calls from the clinic that administered the injections. Smith told legislators that she was brought in by Massachusetts officials 3 weeks ago to lead the department through its investigation of and response to how its pharmacy boards handled problems at NECC over the past several years. She said the board’s failure to take action contributed to the outbreak and that some staff who were involved in the decisions have been removed from their jobs. “We acknowledge the lapses,” she said. One subject that members of both parties agreed on was the value of small traditional compounders and that stricter oversight measures should avoid hurting their operations. Henry Waxman, D-Calif., pushed his colleagues to pass legislation to give the FDA more oversight of compounding pharmacies before the end of the year. “If there’s an ambiguity, it’s our job to clear it up,” he said. Waxman also accused some Republican legislators of picking on Hamburg, because she is a member of President Obama’s administration. Senate HELP Committee hearing information On Nov 6 the committee subpoenaed Barry Cadden, NECC’s president and co-owner, to testify at the hearing. He took the stand flanked by his attorneys but refused to answer questions, citing his Fifth Amendment right to not testify. The chair of the Oversight and Investigations Subcommittee, Cliff Stearns, R-Fla., excused Cadden after he repeated the same response to several of the committee members.center_img Nov 14 CDC fungal meningitis outbreak update Michael Burgess, MD, R-Tex., was among several on the committee who pushed Hamburg and the FDA to share more background e-mails and documents regarding events over the past year that touched on the agency’s oversight of compounding pharmacies and earlier problems over the years with NECC. Nov 14, 2012 (CIDRAP News) – The first congressional hearing today on the fungal meningitis outbreak linked to tainted steroids was marked by tough questions for regulators, political wrangling, and an appearance by the owner of the compounding pharmacy that produced the drugs, but he declined to testify. Hamburg said the FDA needs a tiered regulatory approach that holds nontraditional compounders that make high-risk products to the same standards as drug manufacturers, while allowing small, traditional pharmacies that make less-risky products to continue operating under a less restrictive framework. Legislators said the documents are crucial for getting a clear picture of the oversight problems. “If we’re going to craft legislation, how are we going to avoid making the same mistakes again?” he asked. The fungal meningitis outbreak has spotlighted past problems at NECC and similar pharmacies and has drawn attention to a host of regulatory gaps affecting large compounding pharmacies that have evolved to resemble drug manufacturers. The Senate Health, Education, Labor, and Pension (HELP) Committee will hold a hearing on similar issues tomorrow. Hamburg described a complex regulatory landscape that applies to large compounding pharmacies. She said federal laws exempt them from the same rules that cover drug manufacturers, and court decisions have muddled the authorities that the FDA does have over the pharmacies, leaving much of the regulatory work to states and opening up loopholes for an industry that has evolved from the image of the corner drugstore customizing ointments and treatments for individual patients. Edward Markey, D-Mass., whose office on Oct 29 issued a report detailing safety problems with products from compounding pharmacies over the past 10 years, said, “In that atmosphere of ambiguity, we have a mess on our hands.” NECC, based in Framingham, is in Markey’s House district. Some of the committee members complimented Smith for her comments taking responsibility, and charged Hamburg and the FDA with ducking the blame for the oversight lapses. Stearns said, “You’re practicing plausible deniability.” Several of the committee members, however, pressed Hamburg for answers on why the FDA didn’t do more to investigate and shut down NECC when problems surfaced about a decade ago. Members of both parties had tough questions for Hamburg, and some of the Republican members charged that the FDA already has the regulatory authority to oversee companies like NECC and questioned whether new laws were needed. Eddie Lovelace, a circuit court judge from Albany, Ky., died of a stroke on Sep 17 at age 78 after receiving three epidural injections—the last one on Aug 31— for back pain related to a March car accident. His wife told the committee that her husband walked 3 miles every morning and hoped to serve as a judge for 2 more years, then practice law alongside his granddaughter.last_img read more

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Air Products receives ‘Excellent Service Award’

first_imgSubscribe Get instant access to must-read content today!To access hundreds of features, subscribe today! At a time when the world is forced to go digital more than ever before just to stay connected, discover the in-depth content our subscribers receive every month by subscribing to gasworld.Don’t just stay connected, stay at the forefront – join gasworld and become a subscriber to access all of our must-read content online from just $270.last_img

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Italy: Sound Oil Discovers Gas at Nervesa Well

first_imgSound Oil confirmed a gas discovery following the recent Nervesa appraisal drilling.The Company confirms that mud log gas shows were recorded while drilling across multiple sandstone intervals in the target reservoir zone within the Miocene San Dona Formation. The Company has now completed logging operations and confirmed the identification of 476 metres (true vertical depth) of gross pay and 239 metres (true vertical depth) of gross reservoir with 46 metres (true vertical depth) of net gas pay in 13 separate zones.Planning for completion operations has now commenced with a view to providing the necessary well test data for certification by the Italian Ministry of Economic Development.A further announcement confirming the estimated quantity of commercial gas and expected cash flows will follow once the Company has fully reviewed the well test results and revised the subsurface model for the field. Following completion of testing, it is the Company’s intention to apply for a Production Concession – with a view to achieving first gas sales in 2015.James Parsons, Sound Oil’s Chief Executive Officer, commented: “In October 2012 we set a strategy of significant growth through the drilling of four material wells in Italy within twenty-four months. Nervesa is the first of those drills and has confirmed a gas discovery. Whilst a comprehensive technical review is now required to confirm the size of the discovery, it appears sufficiently large to deliver important cash flows and provide funding alternatives for the 2014 drill programme.“With this well the Company has also demonstrated to investors, the Italian authorities and the important local Italian communities that it can secure permits in Italy and successfully execute complex drill programmes safely.“At Nervesa we will now focus on the completion and testing of this well, the design and approval of a second well addressing the structure and the securing of the production concession.“Beyond Nervesa we are now able to execute our well prepared second phase of the plan which includes further preparing the Company for success at Laura (30 Bscf, Euro 66 million NPV) and Badile (175 Bscf, Euro 302 million NPV), introducing institutional investors to the register and growth through acquisition.”[mappress]LNG World News Staff, July 17, 2013; Image: Sound Oillast_img read more

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ULJANIK Delivers Hull Superstructure for Costa Diadema

first_imgULJANIK shipyard has recently delivered to Fincantieri’s shipyard Marghera, located close to Venice, a funnel and part of the superstructure for a cruiser, which will be named “Costa Diadema”.The drawing up of workshop documentation started in February of this year and the same was done with Uljanik’s Hull Construction in accordance with Fincantieri class. Uljanik shipyard has also made the steel part of the construction section, while all the works on the aluminium part and locksmith activities were executed by the workers of Proizvodnja Opreme from Vodnjan, Croatia. As reported, the funnel section will be mounted in one piece on the cruiser.“Costa Diadema” will be the biggest Italian cruiser of the company Costa Crociera, and the delivery of the vessel is expected in October 2014. The vessel is 290 meters long and it will be able to transport 3500 passengers accommodated on 17 decks.[mappress]Press Release, September 17, 2013last_img read more

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People’s prince

first_imgStay 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 To 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 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

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My working day: Rob Charlton, _space group

first_imgTo continue enjoying Building.co.uk, sign up for free guest accessExisting subscriber? LOGIN 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 Get your free guest access  SIGN UP TODAY Subscribe now for unlimited access 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

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Baltimore signs WWL deal

first_img“Our entire administration is committed to making Maryland more business friendly, and today we add WWL to our state’s growing list of business success stories,” said Maryland Governor, Larry Hogan. “This new contract, tying WWL’s success to that of the Port of Baltimore for the next three decades, will support nearly 1,000 jobs here in Maryland and is a ringing endorsement of the strength and importance of this partnership.” This deal replaces an existing 20-year deal between WWL and the port, which was due to expire in 2021.”Baltimore is WWL’s largest port of business in the Americas, and a gateway to key markets in the US and around the globe,” said Raymond Fitzgerald, president – Atlantic at WWL. “WWL-operated ships call at Baltimore nearly 150 times each year to accommodate the needs of our customers – some of the largest and top vehicle, heavy machinery and ro-ro shippers in the world.”www.2wglobal.compob.mpa.state.md.uslast_img read more

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Delays in Court of Protection ‘readily tolerated’ – Munby

first_imgThe president of the Family Division has bemoaned what he called ‘systemic failures’ in Court of Protection procedures causing cases to take years to reach full hearing.Sir James Munby said the wait for a hearing in MN (Adult) had been ‘depressingly long’ and he urged a tightening of procedures as has taken place in the family court.The present proceedings had started in August 2011 in relation to a local authority’s responsibility for a disabled young man. His parents argued that his mother should help in his care when she visited his residential placement, and that MN should be allowed to visit his parents’ home for care.It took until November 2013 for a hearing in the Court of Protection and until December 2014 for an appeal of that decision by the parents.Munby used the comparison with care proceedings in the family court to show the ‘striking contrast’ in how long cases take to resolve.The judge said new guidelines in the Family Procedure Rules 2010, involving robust judicial case management and zero tolerance of non-compliance with court orders, had ‘radically improved’ the problems of delay.‘In the family court there has been a cultural revolution, from which the Court of Protection needs to learn,’ said Munby.‘The truth is that this case, like too many other ‘heavy’ personal welfare cases in the Court of Protection, demonstrates systemic failures which have contributed to a culture in which unacceptable delay is far too readily tolerated.’Munby admitted to being ‘surprised’ that the bundle in this case came to more than 2,000 pages of evidence.‘That, I have to say, is an indictment of the culture which has been allowed to develop in the Court of Protection. It must stop.’Munby said the case also highlighted the need to identify and address jurisdictional issues and legal arguments well before a personal welfare case. In this case, despite these types of arguments ‘bubbling under the surface for some time’, the court heard the local authority’s stance on a jurisdictional issue was only clarified in an email sent by counsel the night before the hearing was due to start.Munby said a similar problem had been identified by Charles J in A Local Authority v PB and P in 2011, and noted it was ‘depressing’ to see how little of what the judge said then had ‘percolated through’ to those involved in the present case.last_img read more

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WIN AT AINTREE TAKES TWYNOLM LASS ‘FIONA’ TO NATIONAL FINALS

first_imgAddThis Sharing ButtonsShare to FacebookFacebookFacebookShare to TwitterTwitterTwitterShare to LinkedInLinkedInLinkedIn Twynolm Lass ‘Fiona Stryjewski’ a Dressage rider, and her 7 year old Horse ‘Devon-B’ a Dutch warmblood who Fiona has owned since July 2014, Won the elementary restricted class at the Petplan Area festival at Aintree last weekend.Fiona who also does  dressage coaching with Stewartry pony club, works for ‘Robinsons Scotland Ltd’ in Lockerbie as General Manager told DGWGO Sports News “There were 38 competitors in the class who qualified to be in the area final. The class started at 7.30am and we were on at 8.15am. The class did not finish until 1pm. ”“The tension was unbearable as it was such a long wait – my mum and I were trying to kill the time and each time we went back to the scoreboard we were expecting our score to have been beaten!Fiona and Devon-B at Aintree at the weekendAt 1pm we knew that I had finished in the top 10 , so were required to take part in the prize giving, but with four scores still to go up, I had to go and get myself and Devon ready – still not knowing if we had earned a qualifying place (top four qualify for the National Petplan Championship to be held at Hartpury College in April 2016) When we returned for the prize giving the final scores were still not up. Finally at 1.35pm, waiting to go into the prize giving – my mum gave me the thumbs up – we had WON! – When I qualified and entered the competition the goal was to finish in the top 10 and if I was really lucky to finish in the top four – and secure my place in the final at Hartpury in April – and in doing so achieve one of my Dressage ambitions.”Fiona went on to say “The prize giving was amazing – leading off the lap of honour with the fabulous sash round our neck – with the top ten then getting a lap just myself and Devon in the arena – it was the best feeling and something I will never forget! I could not believe we had actually won the whole class. All three judges (sat at different part of the arena) had placed us first.”Fiona’s other achievements this year – competing in the Regional Finals in Yorkshire (at Novice Open level) in the summer and being selected as a member of the Scottish dressage team for the Senior Home international (also at Novice Open Level) held at Hartpury back in August. Though we were not in the placings at either the experience all helps to build the partnership between Devon and myself. (Note: elementary is the next level up from Novice)Fiona said “None of this would have been possible if it was not for my parents and my Uncle helping me to buy Devon (my first “proper” dressage horse) back in July 2014, without the training given by Jo Hamilton in Edinburgh and Clive Halsall in Preston (we had stopped in at Clive’s on route to Aintree for a pre-competition run through to tidy things up), without the experience and lessons other horses have given me over the last six “dressage years” and without the help and support from my friends. Hopefully this is only the start for Devon and myself….”“My mum had came with me to Aintree and my Dad had the equally important job of staying home and looking after my other horse and dog!”Fiona now goes on to compete in the National Championships held at Hartpury College in April 2016last_img read more

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The Tokyo Olympics Will Begin on July 23, 2021

first_imgMIAMI, Florida -The Tokyo Olympics, which were postponed due to the global coronavirus pandemic, will be held from July 23 to August 8 in 2021, the games’ organizing committee announced.The leaderships of the key parties came together via telephone conference on March 30 and agreed on the new schedule.The Paralympic Games, which was also postponed, will now be held from August 24 to September 5, 2021.In a statement, the Olympic committee said that the decision was taken based on three main considerations:1. To protect the health of the athletes and everyone involved, and to support the containment of the COVID-19 virus.2. To safeguard the interests of the athletes and of Olympic sport.3. The global international sports calendar.These new dates give the health authorities and all involved in the organisation of the Games the maximum time to deal with the constantly changing landscape and the disruption caused by the COVID-19 pandemic.The new dates are scheduled exactly one year after those originally planned for 2020 (Olympic Games: 24 July to 9 August 2020 and Paralympic Games: 25 August to 6 September 2020).Following today’s decision, the IOC President said: “ With this announcement, I am confident that, working together with the Tokyo 2020 Organising Committee, the Japanese Government and all our stakeholders, we can master this unprecedented challenge. Humankind currently finds itself in a dark tunnel. These Olympic Games Tokyo 2020 can be a light at the end of this tunnel.”It has previously been confirmed that all athletes already qualified and quota places already assigned for the Olympic Games Tokyo 2020 will remain unchanged.last_img read more

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