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FDA taking on unapproved ear infection meds and Senate bill gives states say ... - NOLA.com |
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Senate takes up bill giving states more say on school testing
After a one-week recess, the House and Senate return to Washington on Tuesday.
The Senate is taking up a replacement bill for the No Child Left Behind accountability law enacted during the George W. Bush administration.
The Every Child Achieves Actof 2015 would allow states to develop their own accountability systems, allowing them to decide how to use federally mandated testing for accountability.
Supporters said it will give states a freer hand to replace the Common Core accountability standards, which many conservatives, including Gov. Bobby Jindal, now oppose.
The bill continues the federally required two tests in reading and math per children in grades three through eight, and one exam in high school, as well as three science tests in grades 3-12.
FDA plans action against unapproved meds for ear infections
The Food and Drug Administrationannounced it intends to begin an enforcement action against companies that manufacture and/or distribute unapproved prescription ear drop medicine to relieve p0ain, infection and inflammation.
The agency says that the unapproved drugs are frequently prescribed for young children suffering from ear infections and that their use puts patients at risk because their safety and effectiveness haven't been determined.
"Taking enforcement actions against these unapproved products will protect patients from unnecessary risks," said Cynthia Schnedar, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products."
Another case when disaster preparedness is critical
Here's a study that residents in hurricane-prone Louisiana might want to ponder.
The U.S. Department of Health and Human Servicessaid it just completed a study that showed people with end-stage renal disease (ESRD) who receive dialysis in advance of natural disasters, such as hurricanes, are significantly less likely to need an emergency department or hospitalization visit in the week following the disaster and less likely to die within 30 days of the disaster.
According to HHS, the study showed that receiving early dialysis was associated with 20 percent lower odds of having an emergency department visit or 21 percent lower odds of a hospitalization after the storm, and 28 percent lower odds of death 30 days after the storm.
"Every disaster holds the potential to impact health and often disproportionately affect people who are medically vulnerable, including people who require dialysis," said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response, and one of the report's authors. "This study provides the first evidence that receiving early dialysis in advance of potential disasters helps protect health and saves lives for dialysis patients and suggests that early dialysis should become a standard practice and protective measure."
Ex-im bank posts closing notice it hopes will be temporary
On July 1, the Export Import Bank posted this notice on its website: "Due to a lapse in EXIM Bank's authority, as of July 1, 2015, the bank is unable to process applications or engage in new business or other prohibited activities."
That's because Congress hasn't acted to extend the authorization for the bank before its current mandate expired at midnight on June 30. The Senate voted before the July 4th recess 65-31 on a procedural vote to advance the export-import bank, which supporters of the bank saw as an encouraging sign. Sens. David Vitter, R-La., and Bill Cassidy, R-La., R-Baton Rouge, both voted no, saying they need to see significant reforms before they'll vote to continue the bank.
Speaker John Boehner, R-Ohio, said he'd allow the House to consider the bank's future if the Senate eventually votes to reauthorize the Export-Import Bank, but under a process that would allow amendments to put restrictions on the bank's operations.The bill faces significant opposition, including from top GOP House Leaders, Kevin McCarthy, R-Calif., and Steve Scalise, R-Jefferson.
Supporters of the bank said it plays a major role in helping businesses export U.S. products abroad by providing direct loans, loan guarantees and insurance. Opponents said the bank's record doesn't inspire confidence.
"The Ex-Im Bank may help a few American businesses, but only at the expense of hurting others," said Rep. John Fleming, R-Minden. "In actuality, the bank only serves less than 1 percent of small businesses. More than 60 percent of the bank's finances go to 10 large corporations — companies that do not need taxpayer help."
Rep. Garret Graves, R-Baton Rouge, said he'd like to see reforms in bank operations, but sees it playing an important role for Louisiana businesses.
"Louisiana is the top export state (per capita) in the nation," Graves said. "We have five of the country's top fifteen ports and hundreds of thousands of folks in Louisiana rely upon the employment opportunities associated with international trade. We strongly support free trade and believe that, if given a level playing field, Louisiana's small businesses and large industries can compete on a global scale."
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Zacks: NxStage Medical Receives Consensus Recommendation of Buy from ... - Dakota Financial News |
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 Shares of NxStage Medical (NASDAQ:NXTM) have earned an average broker rating score of 2.00 (Buy) from the six brokers that cover the stock, Zacks Investment Research reports. One research analyst has rated the stock with a strong sell recommendation, one has given a hold recommendation and four have given a strong buy recommendation to the company.
Brokers have set a 1-year consensus price target of $21.00 for the company and are expecting that the company will post ($0.10) EPS for the current quarter, according to Zacks. Zacks has also assigned NxStage Medical an industry rank of 152 out of 265 based on the ratings given to related companies.
Shares of NxStage Medical (NASDAQ:NXTM) opened at 14.25 on Wednesday. NxStage Medical has a 52 week low of $11.50 and a 52 week high of $19.63. The stock has a 50-day moving average of $15.74 and a 200-day moving average of $17.31. The company’s market cap is $901.14 million.
NxStage Medical (NASDAQ:NXTM) last issued its quarterly earnings data on Wednesday, May 6th. The medical device company reported ($0.09) earnings per share for the quarter, beating the analysts’ consensus estimate of ($0.11) by $0.02. The company had revenue of $79.50 million for the quarter, compared to the consensus estimate of $77.92 million. During the same quarter last year, the company posted ($0.09) earnings per share. NxStage Medical’s revenue was up 10.1% compared to the same quarter last year. On average, analysts predict that NxStage Medical will post $-0.36 earnings per share for the current fiscal year.
Separately, analysts at Zacks reiterated a “hold” rating on shares of NxStage Medical in a research note on Thursday, June 4th.
In other NxStage Medical news, President Joseph E. Turk, Jr. sold 2,000 shares of the stock in a transaction dated Tuesday, June 23rd. The shares were sold at an average price of $15.36, for a total transaction of $30,720.00. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which can be accessed through this link. Also, CEO Jeffrey H. Burbank sold 20,000 shares of NxStage Medical stock in a transaction that occurred on Thursday, June 18th. The stock was sold at an average price of $15.56, for a total transaction of $311,200.00. The disclosure for this sale can be found here.
NxStage Medical, Inc. (NASDAQ:NXTM)is a medical device company that develops, manufactures and markets products for the treatment of kidney failure, fluid overload and related blood treatments and procedures. The Company’s primary product is the NxStage System One (System One). It also sells needles and blood tubing sets primarily to dialysis clinics for the treatment of end-stage renal disease (ESRD). The Company operates in two segments: System One and In-Center. It distributes its products in three markets: home, critical care and in-center. In the System One segment it sells and rents the System One, PureFlow SL equipment and disposable products in the home and critical care markets. In the In-Center segment, it sells of blood tubing sets and needles for hemodialysis at dialysis centers and needles for apheresis. The Company’s products include the NxStage System One, Streamline Blood Tubing Sets and AV Fistula and Apheresis Needles.
To get a free copy of the research report on NxStage Medical (NXTM), click here. For more information about research offerings from Zacks Investment Research, visit Zacks.com
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Outcomes following 'mini' percutaneous nephrolithotomy for renal calculi in ... - UroToday |
INTRODUCTION: This retrospective review was undertaken to identify the postoperative outcomes of children undergoing 'mini' percutaneous nephrolithotomy (MPCNL) at a single institution.
OBJECTIVE: Outcomes measured included: percentage of stone clearance, postoperative analgesia requirements, the need for intraoperative or postoperative blood transfusion, length of stay and morbidity.
STUDY DESIGN: A total of 46 patients were reviewed over a two-and-a-half-year period; the mean age was 7.3 years (range: 1-16 years). The MPCNL was performed with a radiological-guided peripheral puncture, followed by dilatation of the nephrostomy tract to a maximum Amplatz sheath size of 16-French; an 11-French nephroscope was used. Stone disintegration was achieved either with pneumatic or laser lithotripsy.
RESULTS: Complete stone clearance was achieved in 35/46 children (76%). The remaining 11 children had a stone clearance rate of over 80%. No patients required intraoperative/postoperative blood transfusion. A total of 39% of patients were managed on simple/non-opiate based analgesia, with 54% requiring opioid analgesia postoperatively for less than 24 h. There were no procedure-related complications and no mortalities. The mean length of stay was 2.24 days.
DISCUSSION: The management of urolithiasis can be challenging in children. The use of percutaneous nephrolithotomy, is becoming increasingly popular in the treatment of paediatric urolithiasis. The stone clearance rate in children undergoing standard PCNL, has been reported to be 50-98% in the literature [1,2,3,4]. Samad et al. [2] in 2006, reported their experience in 188 consecutive PCNLs, using a 17Fr or 26Fr nephroscope. Their largest sub group included children aged >5-16 yrs. Within this group, 57% were treated with a 17Fr nephroscope and 43% with the 26Fr nephroscope, achieving stone clearance of only 47% with PCNL monotherapy. In this group the transfusion rate was 3% [2]. Badawy et al., reported their experience of 60 children in 1999, using a 26 or 28Fr Amplatz sheath. They reported an 83.3% stone clearance with single session PCNL, with only one procedure being abandoned due to intraoperative bleeding requiring blood transfusion [3]. In 2007, Bilen et al. reported their experience and compared the use of 26Fr, 20Fr and 14Fr (mini) PCNL. Stone size, previous surgery and the mean haemoglobin drop postoperatively did not change between the groups, however the blood transfusion rate was higher in the 26Fr and 20Fr Amplatz sheath groups. The stone clearance was highest in the 'mini PCNL' group at 90%, compared to 69.5% in the 26Fr and 80% in the 20Fr group [4]. MPCNL has become increasingly popular over recent years, with stone clearance reported as 80-85% [5-7] following a single session of MPCNL as monotherapy. In 2012, Yan et al. reported 85.2% stone clearance with mini PCNL monotherapy (tract size 14-16Fr), with no children requiring blood transfusion [6]. Zeng et al. reported their experience of 331 renal units in children, with stone clearance rates reaching 80.4% and a blood transfusion rate of 3.1% [8]. In our centre, we do not perform postoperative haemoglobin levels as a matter of routine and any investigations are performed on an intention to treat principle. Bilen et al. reported no blood transfusions being required in their cohort of patients undergoing MPCNL [4] and this is supported by Yan et al. [6].
CONCLUSION: Mini PCNL is an effective and safe procedure for the treatment of paediatric renal stones. In the present series, all children achieved greater than 80% stone clearance, none received a blood transfusion (intra/postoperatively) and there were no mortalities. Postoperative pain was managed with simple analgesia in 39%; however, the majority required opiate analgesia for less than 24 hours.
Written by:
Brodie KE, Lane VA, Lee TW, Roberts JP, Raghavan A, Hughes D, Godbole PP. Are you the author?
Department of Paediatric Urology, Sheffield Children's Hospital, Western Bank, Sheffield, S10 2TH, UK; Sheffield University Medical School, The University of Sheffield, Western Bank, Sheffield, S10 2TN, UK; Department of Paediatric Radiology, Sheffield Children's Hospital, Western Bank, Sheffield, S10 2TH, UK. This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.; This email address is being protected from spambots. You need JavaScript enabled to view it.
Reference: J Pediatr Urol. 2015 Jun;11(3):120.e1-5.
doi: 10.1016/j.jpurol.2014.09.008
PMID: 26048706
UroToday.com Endourology Section
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Cryoablation for small renal masses: Selection criteria, complications, and ... - UroToday |
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CONTEXT: Cryoablation (CA) is a minimally invasive modality with low complication rates, but its use in urology is relatively recent.
OBJECTIVE: To summarize available evidence for CA for small renal masses (SRMs) and to assess the selection criteria, complications, and functional and oncologic results based on the latest CA literature.
EVIDENCE ACQUISITION: A systematic literature search of the Medline, Embase, and Scopus databases was performed in August 2014 using Medical Subject Headings and free-text protocol. The following search terms were included: kidney cryosurgery, renal cryosurgery, kidney cryoablation, renal cryoablation, kidney cryotherapy, and renal cryotherapy.
EVIDENCE SYNTHESIS: Due to the relatively recent mainstream utilization of CA and lack of long-term efficacy data from large prospective or randomized studies, most of the data available on CA are limited to treatment of SRMs in patients who are often older or are poor surgical candidates. The rates of major complications across the CA literature remain relatively low. Studies assessing renal function after CA suggest a degree of functional decline following CA because proper application includes freezing of a tumor margin; however, often this is not clinically significant. Specific oncologic outcomes should be evaluated in patients with biopsy-proven renal cell carcinoma; when SRM series include benign or unbiopsied tumors, the results of these outcomes are skewed. Although earlier series were suggestive of a higher recurrence rate after CA, some studies have challenged this view reporting recurrence rates comparable with extirpative nephron-sparing surgery.
CONCLUSIONS: CA represents an alternative approach to treatment for patients diagnosed with renal neoplasm. There is no consensus within the literature on the best patient selection criteria. Due to higher rates of treatment failure, it is often not offered to patients with minimal comorbidities and good life expectancy. In terms of functional outcomes, CA signifies a modality with minimum impact on renal function; however, well-designed studies precisely assessing this factor are lacking. CA is a minimally invasive modality with suitably low rates of complications, particularly if delivered via the percutaneous route.
PATIENT SUMMARY: Cryoablation (CA) represents an alternative approach for treating renal neoplasm. Excellent functional outcomes and low rates of complications make CA an ideal minimally invasive modality. Patient selection criteria and oncologic outcomes require further study.
Written by:
Zargar H, Atwell TD, Cadeddu JA, de la Rosette JJ, Janetschek G, Kaouk JH, Matin SF, Polascik TJ, Zargar-Shoshtari K, Thompson RH. Are you the author?
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Radiology, Mayo Clinic, Rochester, MN, USA; Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX; Department of Urology, Academic Medical Center, Amsterdam, The Netherlands; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, MD Anderson Cancer Center, Houston, TX, USA; Division of Urologic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA; Moffitt Cancer Center, Tampa, FL, USA; Department of Urology, Mayo Clinic, Rochester, MN, USA. This email address is being protected from spambots. You need JavaScript enabled to view it.
Reference: Eur Urol. 2015 Mar 25. pii: S0302-2838(15)00246-8.
doi: 10.1016/j.eururo.2015.03.027
PMID: 25819723
UroToday.com Renal Cancer Section
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CMS releases ESRD PPS proposed rule - Lexology (registration) |
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On June 26, 2015, CMS released a Proposed Rule to increase payments by 0.3% for end-stage renal disease (ESRD) care providers in 2016 under the ESRD Prospective Payment System (PPS) for renal dialysis services. CMS estimates that the proposed rule will result in an increase of approximately $20 million in payments in 2016: a 0.5% increase for hospital-based ESRD facilities, and a 0.2% increase for freestanding facilities. Comments on the Proposed Rule are due by August 25, 2015.
The proposed rule also includes provisions for adding new injectable and intravenous products into the bundled payment under the ESRD PPS and increasing outlier payments for ESRD beneficiaries requiring higher resource utilization, as well as revisions to the Low Volume Payment Adjustment eligibility criteria (excluding facilities of common ownership located within 5 miles from one another), and the continuing delay of payment for inclusion of oral-only ESRD drugs until January 1, 2025.
- Additionally, the Proposed Rule addresses the ESRD Quality Incentive Program, proposing changes including, among others:
- A potential reduction of up to 2% from Medicare payments each year for facilities that fail to achieve a minimum score for performance on certain quality measures;
- A reinstatement of the qualifying patient attestations for the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems measure beginning in 2017;
- Additions to the quality measure sets for the payment years 2018 and 2019;
- Replacement of the four individual dialysis adequacy clinical measures with a single comprehensive clinical measure (the “Dialysis Adequacy clinical measure”);
- Adoption of two new reporting measures beginning in 2019—the Ultrafiltration Rate reporting measure and the Full-Season Influenza Vaccination reporting measure;
- Modification of the “small-facility adjuster” calculation; and
- Continuation of the current data validation pilot program.
The proposal is set for publication in the Federal Register on July 1, 2015, with comments due August 25. The CMS fact sheet regarding the Proposed Rule is available here.
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