News Article | May 10, 2017
America, you have a new commissioner at the Food and Drug Administration. Dr. Scott Gottlieb, a 44-year-old physician, was confirmed by the Senate this week in a 57-42 vote. Many Democrats expressed concern about Gottlieb’s financial ties to the pharmaceutical industry. Sen. Lamar Alexander (R-Tenn.), who chaired the panel that forwarded the nomination to the Senate floor, countered that Gottlieb’s extensive experience in the drug industry would be an asset in his regulatory role. Here are four things you’ll want to know about Gottlieb. In his Senate confirmation hearings in early April, Gottlieb told senators that the epidemic of opiate drug abuse in the United States "is a public health emergency on the order of Ebola and Zika." On average, 91 Americans die each day of an opioid overdose. But the FDA’s power to reduce opioid drug use is limited. The agency’s past decisions have clearly contributed to overdose deaths. The FDA does not regulate physicians’ prescribing of drugs — an important contributor to Americans’ widespread opioid drug use (and subsequent addiction). All it can do is enforce legal limits on the marketing of drugs once they’ve been approved — strictures that drug manufacturers, in their bid to build their markets, routinely flout. The FDA also reviews new pain medications and new formulations of opioid-based drugs for the U.S. market. In considering whether to approve them, the agency walks a fine line between keeping pain medication available to those who need it and not creating new addicts. Some of the abuse-resistant formulations of opioid pain relievers approved for the market in recent years have driven many addicts to cheaper, more readily available street drugs such as heroin. In his April confirmation hearings, Gottlieb sought to defuse concerns that speeding up the drug approval process would allow less-safe medications to come to market. He called it a “false dichotomy that it all boils down to a choice between speed and safety.” He repeatedly called the FDA’s review process “the gold standard.” And he stopped short of endorsing proposals that had been floated by other candidates for the job, including plans to approve drugs after they had been tested for safety but before their effectiveness had been established. But he also said the FDA should “lean forward” to modernize and speed the approvals process. Gottlieb has long been a fan of what are known in the clinical-trial business as “adaptive trials.” Such human experiments, which are already in limited use, depart from what many scientists define as the “gold standard” in that their design, their study populations, and even their objectives can be altered along the way in response to early results. A drug company running a clinical trial might be allowed to increase or decrease the number of subjects assigned to different “arms” of a trial, or change who gets assigned to those arms, or how those assignments are made. The idea is that researchers could shift a clinical trial’s focus in response to early signs of a drug’s strength in, for instance, treating one population (people with very early Alzheimer’s disease, for instance) over another (say, those whose dementia has already progressed). Rather than conducting a lengthy and expensive series of separate trials to discover which patients might benefit most from a drug, a single adaptive trial could come to the same conclusion after only one study that was allowed to “flex” along the way. Gottlieb has been critical of President Trump’s key proposal to drive down the cost of prescription drugs: allowing their importation from countries that impose price controls. In a March 2016 article in Forbes, Gottlieb wrote that while Trump’s plan is “perhaps good politics,” it will “offer consumers little relief.” Drug manufacturers would be unlikely to cooperate because increasing their output of production lines abroad would undermine their own interests. And it’s just as unlikely that other countries would stand for having their medications “skimmed off, only to create local shortages of important medicines,” he wrote. In its central mission of evaluating the safety and effectiveness of drugs and granting companies the right to market them in the United States, the FDA is not permitted to take price into consideration. But the FDA’s power over the approval of generic drugs is a key lever for bringing down the cost of drugs, and Gottlieb has said he wants to see improvements there. The company that makes a drug has exclusive rights to the U.S. market for three to seven years after it is granted FDA approval. But once that protection ends, any drug company can seek FDA approval to market a generic version by proving it can manufacture the active drug ingredient and package it for human use safely and reliably. The result: competition that typically drives drug prices down steeply. So driving down the cost of many prescription drugs will require the FDA’s Office of Generic Drugs to be staffed adequately to speed approval of drug applications. That’s a tall order against the backdrop of the Trump administration’s proposed budget cuts to the Department of Health and Human Services, the FDA’s parent agency. Also, many drugs — including a broad new category of drugs known as “biologics” — are less simple to copy. The FDA’s cautious approach to approving generic versions of many of these drugs — widely used to treat cancers and autoimmune diseases — threatens to create “monopolies in perpetuity,” Gottlieb has said. If prescription drug prices are to drop, he said, the rules for approving those complex generic drugs need to be rewritten. Gottlieb is a cancer survivor, having been successfully treated for Hodgkin’s lymphoma. That experience prompted Gottlieb to become a cancer policy advisor for the National Coalition for Cancer Survivorship. The coalition, in turn, strongly endorsed his nomination to head the FDA. In a statement issued when Trump nominated him in mid-March, the coalition said that Gottlieb “understands the human toll cancer takes on individuals and families, during both treatment and long-term survivorship. He is open to a wide range of perspectives, including those of the patients whose lives depend on a strong FDA.” Gottlieb is a physician. He trained at Mount Sinai School of Medicine in New York and completed his residency in internal medicine at Mount Sinai Hospital. But his interest in the business and economics of medicine has been a more salient and recurring theme in his career than direct patient care. After graduating from Wesleyan University in Connecticut, Gottlieb worked as a healthcare analyst at the investment bank Alex. Brown & Sons in Baltimore, and then went to medical school. Between 2003 and 2007, Gottlieb served the Bush administration in a wide range of positions at the FDA and in the Centers for Medicare and Medicaid Services. Among his titles: deputy FDA commissioner for medical and scientific affairs. At the FDA, he helped develop standards for drug cocktails to be used for HIV treatment. He also helped draft strategic plans for U.S. biodefense countermeasures as a member of the White House Biodefense Interagency Working Group. Since 2007, he has been a venture partner at New Enterprise Associates, focusing on healthcare and medical devices investments, and a resident fellow at the American Enterprise Institute, a conservative think tank. He’s also been a clinical assistant professor at New York University School of Medicine and practiced medicine as an attending physician at Stamford Hospital in Connecticut. He has said he'd divest himself of medical company stocks and recuse himself for a year from decisions involving nearly two dozen companies, including Tolero Pharmaceuticals, Daiichi Sankyo Inc. and GlaxoSmithKline. Speed up drug approvals at FDA? It's already faster than Europe's drug agency Dying patients want easier access to experimental drugs. Here's why experts say that's bad medicine The odds of a drug having a significant safety issue after winning FDA approval are nearly 1 in 3, study finds
Krinsley J.S.,Stamford Hospital
Hospital practice (1995) | Year: 2012
Intensive monitoring of blood glucose levels and treatment of hyperglycemia in critically ill patients has become a standard of care over the past decade. Although diabetes is associated with a large burden of illness in outpatients, the "diabetes paradox" suggests that in patients admitted to intensive care units, the presence of diabetes as a comorbidity is not independently associated with increased risk of mortality. This review article 1) describes prospective trial and observational cohort literature addressing this issue, 2) addresses the potential mechanisms underlying the diabetes paradox, and 3) discusses implications for patient care and future research.
Bhalani V.V.,Stamford Hospital
Connecticut medicine | Year: 2012
Splenosis is the autotransplantation of splenic tissue to abnormal sites, either the abdomen or thorax, following traumatic injury of the spleen. For splenic tissue to reach the thorax, there must be concomitant diaphragmatic injury. Thoracic splenosis is usually discovered incidentally on routine thoracic imaging as single or multiple, indeterminate pleural-based masses limited to the left hemithorax. Traditionally, diagnosis required invasive procedures and/or surgery to acquire tissue samples in order to rule out other causes of lung masses, ie, cancer. We report a case in which nuclear imaging was used to make the diagnosis of thoracic splenosis, thus preventing the need for invasive procedures and avoiding unnecessary patient apprehension.
Krinsley J.S.,Stamford Hospital
Hospital practice (1995) | Year: 2011
Intensive monitoring of blood glucose concentrations in critically ill patients has become a standard of care in intensive care units over the past 10 years, following the publication of a single-center randomized trial targeting euglycemia in postoperative patients. This article summarizes the literature describing the relationship between hyperglycemia and mortality in the critically ill, the main findings of the major interventional trials of intensive insulin therapy, the association between hypoglycemia and increased glycemic variability with adverse outcomes, and the impact of a preexisting diagnosis of diabetes. A framework for understanding dysglycemia in the critically ill, an approach that recognizes disturbances in the "3 domains" of glycemic control--hyperglycemia, hypoglycemia, and increased glycemic variability--is presented. Finally, practical considerations relating to the implementation of glycemic management protocols are discussed.
Parry M.F.,Columbia University |
Parry M.F.,Stamford Hospital |
Grant B.,Stamford Hospital |
Sestovic M.,Stamford Hospital
American Journal of Infection Control | Year: 2013
Background: Despite using sterile technique for catheter insertion, closed drainage systems, and structured daily care plans, catheter-associated urinary tract infections (CAUTIs) regularly occur in acute care hospitals. We believe that meaningful reduction in CAUTI rates can only be achieved by reducing urinary catheter use. Methods: We used an interventional study of a hospital-wide, multidisciplinary program to reduce urinary catheter use and CAUTIs on all patient care units in a 300-bed, community teaching hospital in Connecticut. Our primary focus was the implementation of a nurse-directed urinary catheter removal protocol. This protocol was linked to the physician's catheter insertion order. Three additional elements included physician documentation of catheter insertion criteria, a device-specific charting module added to physician electronic progress notes, and biweekly unit-specific feedback on catheter use rates and CAUTI rates in a multidisciplinary forum. Results: We achieved a 50% hospital-wide reduction in catheter use and a 70% reduction in CAUTIs over a 36-month period, although there was wide variation from unit to unit in catheter reduction efforts, ranging from 4% (maternity) to 74% (telemetry). Conclusion: Urinary catheter use, and ultimately CAUTI rates, can be effectively reduced by the diligent application of relatively few evidence-based interventions. Aggressive implementation of the nurse-directed catheter removal protocol was associated with lower catheter use rates and reduced infection rates. © 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc.
Krinsley J.S.,Stamford Hospital
Hospital practice (1995) | Year: 2014
The monitoring of blood glucose and treatment of hyperglycemia has been a standard of care in intensive care units since the publication of a single-center randomized controlled trial (RCT) of intensive insulin therapy in 2001 that demonstrated marked improvements in mortality. Professional societies created guidelines based on the results of this investigation, and revised them based on the results of a very small group of RCTs that followed. This commentary reviews the weight of evidence provided by the RCTs in comparison to the large body of evidence from observational studies regarding glycemic control of the critically ill, and suggests that the totality of evidence should be considered in the formulation of clinical practice paradigms.
Krinsley J.,Stamford Hospital |
Preiser J.-C.,Erasme University Hospital
Critical Care | Year: 2010
The major interventional trials of intensive insulin therapy in critically ill patients have reached divergent results. The present viewpoint article explores some of the potential reasons, including differences in monitoring technology and protocol design and performance, the occurrence of severe hypoglycemia and changes in the standard of care since publication of the landmark single-center trial. Recently published data detailing the deleterious effect of hypoglycemia are discussed, as is the emerging body of literature describing the important impact of glycemic variability on the risk of mortality in heterogeneous populations of acutely ill and severely ill patients. These new findings have important implications for the design of future interventional trials of intensive insulin therapy in the intensive care unit setting. © 2010 BioMed Central Ltd.
News Article | February 22, 2017
STAMFORD, Conn., Feb. 22, 2017 /PRNewswire/ -- The Competency & Credentialing Institute (CCI) announced Stamford Hospital of Stamford, CT as the 2017 TrueNorth Award winner. Competency & Credentialing Institute (CCI) is a leader in credentialing, nursing competency assessment and...
News Article | December 8, 2016
ALBANY, N.Y.--(BUSINESS WIRE)--In response to the critical need for better healthcare environments for children, EYP Inc., national leader in sustainability and comprehensive high-performance design, announced its intent to acquire Atlanta-based Stanley Beaman & Sears, an award-winning architecture and interior design firm and pioneer in the design of children’s hospitals. This union brings an additional specialization to EYP’s healthcare practice and specifically addresses the global need for high-quality, innovative pediatric care facilities. Both parties have signed a letter of intent with anticipation of closing by Dec. 31, 2016. Stanley Beaman & Sears was the first to integrate technology for education and entertainment into children’s hospitals to enhance young patients’ journey to health and wellness. Sharing EYP’s commitment to expertise driven design, Stanley Beaman & Sears has worked on pediatric care facilities for renowned clients, including St. Jude Children’s Research Hospital, Nemours Children’s Hospital, Children’s Healthcare of Atlanta, University of Chicago Comer Children’s Hospital, Children’s Hospital of New Orleans, and University of Virginia Medical Center, among others. Additionally, the pediatric firm is involved with a range of philanthropic work in support of child health in Africa. The addition of Stanley Beaman & Sears continues to grow EYP’s international healthcare presence. In 2014, EYP acquired WHR Architects to lead its healthcare practice, which is consistently ranked No.1 in healthcare renovation by Health Facilities Management Magazine. The group has seen continuous success and recognition for their deep expertise in evidence-based design, patient-centered care and behavioral healthcare in both new and renovation projects, such as Stamford Hospital, Jersey Shore University Medical Center, Fulton State Psychiatric Hospital, and Denmark’s Bispebjerg Somatic Hospital. As the premier pediatric design firm practice in the U.S., Stanley Beaman & Sears complements the expertise of the group and expands EYP’s team of experts in healthcare design, client-focused care and biomedical research. The combined resources of WHR Architects and Stanley Beaman & Sears now places EYP among the largest healthcare design practices in the country. Stanley Beaman & Sears also brings added expertise in experiential graphic design and interior design to EYP, complementing EYP’s offerings for the government, higher education, healthcare, science & technology and corporate industries. Stanley Beaman & Sears has provided these areas of expertise for such clients as Georgia Institute of Technology, University of Virginia, Children’s Healthcare of Atlanta, Children’s Hospital of Philadelphia, the Georgia Museum of Art and the new Mercedes Benz Stadium in Atlanta. “We design for clients who recognize that the fulfillment of their mission is directly linked to the performance of their facilities. For over 40 years, we have helped those clients—institutions of higher education, federal agencies, corporations and healthcare providers—advance their vision and goals by providing environments that are informed by deep, relevant knowledge,” said Tom Birdsey, AIA, President and CEO of EYP. “EYP and Stanley Beaman & Sears are united by passion and purpose, fueled by innovation, and focused on furthering our clients’ missions. Together with Stanley Beaman & Sears, we will continue to advance new methods of delivery that respond to the ever-changing needs of pediatric facilities nationwide. Expertise-driven design is our mission—it’s how we help our clients realize their vision.” “It’s hard to imagine a better fit for our culture than EYP,” said Kimberly Stanley, AIA, principal of Stanley Beaman & Sears, “and the benefits to our clients are outstanding. Both firms see design as a collaborative journey of discovery with our clients. We’re excited about having in-house engineers and energy specialists on our project teams as well as being able to offer EYP clients new expertise and services.” ABOUT STANLEY BEAMAN & SEARS: Stanley Beaman & Sears, based in Atlanta, Georgia, is an award-winning architecture, interiors and graphic design firm with a focus on healthcare, higher education and the arts. The firm has designed projects for notable universities and academic medical centers nationwide, and is a national leader in the design of healthcare facilities for children. For more information about Stanley Beaman & Sears Architects, visit www.stanleybeamansears.com. ABOUT EYP: EYP is a renowned global provider of high-performance building design, research, and consulting services for higher education, government, healthcare, and corporate clients. EYP is the only firm to have twice been ranked #1 for Energy & Sustainability by Architect Magazine. More than 650 professionals in architecture, engineering, energy, and interior design collaborate across 16 offices in the U.S. and Europe to deliver expertise-driven design. For more information, visit www.eypae.com.
News Article | February 22, 2017
The Competency & Credentialing Institute (CCI) announced Stamford Hospital of Stamford, CT as the 2017 TrueNorth Award winner. Competency & Credentialing Institute (CCI) is a leader in credentialing, nursing competency assessment and education for the perioperative nursing community. Its ultimate goal is to improve quality patient care in the surgical setting. The award recognizes facilities whose “true north” guides their operating room nursing staff to be lifelong learners, models of competent practice, and advocates for excellence in patient safety. Stamford Hospital was selected as the winner after being carefully considered along many other competitive facilities. The hospital supports operating room nurses through the entire process of becoming Certified Perioperative Nurses (CNOR-certified). This includes having a CNOR Coach available to all staff, free on-site CNOR prep courses conducted annually, a lending library, and programs that offer free contact hours that may be used towards recertification. Cheryl Petrarca, Clinical Operations Director Perioperative Services, Tully Center expressed the honor that the group effort achieved by exclaiming “perhaps my greatest professional achievement had been obtaining my MSN, until this past week when my organization was the recipient of the 2017 True North Award; truly an honor!” Craig Andrews, Director of Public Relations, Stamford Health expressed appreciation for the honor when she stated “Thank you so much for the honor – I know the periop[operative] team is over the moon receiving this recognition (as they should!)” “Stamford Hospital truly sets the standard for support of nursing certification. It is both a pleasure and an honor to see this facility bring to life the best practices we have seen to support the professional development of perioperative nurses,” said Dr. Jim Stobinski, acting chief executive officer of CCI. “The enthusiasm and dedication of the entire staff to include the most senior nursing leadership is very inspiring.” CCI developed the TrueNorth Award program primarily based on the organization’s firm beliefs in the role specialty nursing certification plays in quality patient care. Registered nurses are required to validate their specialized knowledge through the rigorous CNOR certification exam process. Certification in many ways acts as a compass directing a nurse's clinical practice towards industry accepted standards. It is this empowerment that CCI seeks to foster in certified nurses. Not only is there a link between CNOR certification and improved outcomes in surgical patients, certified nurses are also more confident in their skills. Previous winners include Doernbecher Children's Hospital in Portland, OR, St. Clare Hospital in Lakewood, WA, and Memorial Hermann The Woodlands Hospital, The Woodlands, TX. Established in 1978, the Competency and Credentialing Institute provides the CNOR® and CSSM® credentials to more than 37,000 registered nurses. As the only certification body for perioperative nurses, CCI is one of the largest specialty nursing credentialing organizations. The mission of CCI is to lead competency credentialing that promotes safe, quality patient care and lifelong learning.