Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
September 18, 2014
- Obama Presses Leaders to Speed Ebola Response
- Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States
- Stakeholders Weigh-in on LDT Guidance
- Medical Labs Make Test Results Easier for Patients to Understand
- Doctors Order Unnecessary Tests Without Even Realizing it
- Cervical Cancer Screening Tests Continue to Evolve
- Next-Generation Sequencing Pinpoints Multiple Mutations
- New Gene Variants for Prostate Cancer Identified
- Blood Group 'Link to Memory Loss'
- CDC Report Finds High Sodium Consumption Among U.S. Kids
- WHO to Start New Global Health Initiative for Needle Safety
- ONC Rule Aims to Offer More Flexibility on EHR Certification
- Advancing Health IT With Congressional Asks
View Previous Issues - Healthcare News Archive
Leading News
Obama Presses Leaders to Speed Ebola Response
President Obama on Tuesday challenged world powers to accelerate the global response to the Ebola outbreak that is ravaging West Africa, warning that unless health care workers, medical equipment and treatment centers were swiftly deployed, the disease could take hundreds of thousands of lives. “This epidemic is going to get worse before it gets better,” Mr. Obama said here at the Centers for Disease Control and Prevention, where he met with doctors who had just returned from West Africa. The world, he said, “has the responsibility to act, to step up and to do more. The United States intends to do more.” Even as the president announced a major American deployment to Liberia and Senegal of medicine, equipment and 3,000 military personnel, global health officials said that time was running out and that they had weeks, not months, to act. They said that although the American contribution was on a scale large enough to make a difference, a coordinated assault in Africa from other Western powers was essential to bringing the virus under control.
President Obama on Tuesday challenged world powers to accelerate the global response to the Ebola outbreak that is ravaging West Africa, warning that unless health care workers, medical equipment and treatment centers were swiftly deployed, the disease could take hundreds of thousands of lives. “This epidemic is going to get worse before it gets better,” Mr. Obama said here at the Centers for Disease Control and Prevention, where he met with doctors who had just returned from West Africa. The world, he said, “has the responsibility to act, to step up and to do more. The United States intends to do more.” Even as the president announced a major American deployment to Liberia and Senegal of medicine, equipment and 3,000 military personnel, global health officials said that time was running out and that they had weeks, not months, to act. They said that although the American contribution was on a scale large enough to make a difference, a coordinated assault in Africa from other Western powers was essential to bringing the virus under control.
Source: http://www.nytimes.com/
Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States
Who this is for: Laboratorians and other healthcare personnel handling specimens for Ebola testing
What: CDC provides updated guidance for collecting specimens correctly, transporting and testing specimens from persons under investigation for Ebola virus disease.
How to use: This guidance should be used to explain exactly the biosafety requirements for how to collect and perform routine testing of specimens to staff working in laboratory and healthcare settings.
Key Points
Who this is for: Laboratorians and other healthcare personnel handling specimens for Ebola testing
What: CDC provides updated guidance for collecting specimens correctly, transporting and testing specimens from persons under investigation for Ebola virus disease.
How to use: This guidance should be used to explain exactly the biosafety requirements for how to collect and perform routine testing of specimens to staff working in laboratory and healthcare settings.
Key Points
- U.S. clinical laboratories can safely handle specimens from these potential Ebola patients by taking all required precautions and practices in the laboratory, specifically designed for pathogens spread in the blood.
- Risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible person to determine the potential for sprays, splashes, or aerosol generated during laboratory procedures.
- Any person collecting specimens from a patient with suspected Ebola virus disease should wear gloves, water-resistant gowns, full face shield or goggles, and masks to cover all of nose and mouth.
- Anyone collecting specimens from a patient should follow the procedures below for transporting them through the healthcare facility, clean-up of spills, storing, packaging and shipping to CDC for testing.
Source: http://www.cdc.gov/
Stakeholders Weigh-in on LDT Guidance
Representatives from lab and diagnostic groups gathered on Capitol Hill Sept. 9 to weigh in on Food and Drug Administration (FDA) plans to regulate lab-developed tests. While an FDA official defended the agency's decision to issue guidance instead of a formal rule, stakeholders testified why they thought the guidance was a bad -- or good -- approach. Alan Mertz, president of the American Clinical Laboratory Association, testified that his group fundamentally disagrees with the FDA guidance. He said that ACLA doesn't believe the FDA holds the statutory authority to regulate LDTs and wants tests developed by labs to be approved by the CMS. Meanwhile, Andrew Fish, executive director of AdvaMedDx, a trade association representing manufacturers of medical diagnostic tests, told the subcommittee that his group supports the FDA's efforts to regulate LDTs.
Representatives from lab and diagnostic groups gathered on Capitol Hill Sept. 9 to weigh in on Food and Drug Administration (FDA) plans to regulate lab-developed tests. While an FDA official defended the agency's decision to issue guidance instead of a formal rule, stakeholders testified why they thought the guidance was a bad -- or good -- approach. Alan Mertz, president of the American Clinical Laboratory Association, testified that his group fundamentally disagrees with the FDA guidance. He said that ACLA doesn't believe the FDA holds the statutory authority to regulate LDTs and wants tests developed by labs to be approved by the CMS. Meanwhile, Andrew Fish, executive director of AdvaMedDx, a trade association representing manufacturers of medical diagnostic tests, told the subcommittee that his group supports the FDA's efforts to regulate LDTs.
Source: http://g2intelligence.com/
Aid Worker Recovering From Ebola
Dr. Rick Sacra, an American aid worker stricken with Ebola in Liberia, is making a remarkable recovery, his wife and doctors said. One reason could be transfusions of blood plasma he received from Dr. Kent Brantly, a fellow missionary who recovered from the disease. Dr. Sacra received two infusions of plasma from Dr. Brantly last weekend, according to Dr. Phil Smith, the medical director of the special biocontainment unit at the Nebraska Medical Center in Omaha, where Dr. Sacra is being treated. It is thought that Dr. Brantly, who was infected in Liberia and recovered at Emory University Hospital in Atlanta, has antibodies in his blood that would be effective against the virus and would help Dr. Sacra. “We are hoping it jump-started his immunity,” Dr. Smith said during a news conference at the medical center. The World Health Organization is hoping to deploy the approach, using convalescent serum, in the Ebola outbreak in West Africa. However, it is not clear how well this approach works in general, nor how much the transfusions helped Dr. Sacra. He has also been receiving an experimental drug and supportive care to maintain his fluids and mineral balances.
Source: http://www.nytimes.com/Dr. Rick Sacra, an American aid worker stricken with Ebola in Liberia, is making a remarkable recovery, his wife and doctors said. One reason could be transfusions of blood plasma he received from Dr. Kent Brantly, a fellow missionary who recovered from the disease. Dr. Sacra received two infusions of plasma from Dr. Brantly last weekend, according to Dr. Phil Smith, the medical director of the special biocontainment unit at the Nebraska Medical Center in Omaha, where Dr. Sacra is being treated. It is thought that Dr. Brantly, who was infected in Liberia and recovered at Emory University Hospital in Atlanta, has antibodies in his blood that would be effective against the virus and would help Dr. Sacra. “We are hoping it jump-started his immunity,” Dr. Smith said during a news conference at the medical center. The World Health Organization is hoping to deploy the approach, using convalescent serum, in the Ebola outbreak in West Africa. However, it is not clear how well this approach works in general, nor how much the transfusions helped Dr. Sacra. He has also been receiving an experimental drug and supportive care to maintain his fluids and mineral balances.
Laboratory Testing / Diagnostics
Medical Labs Make Test Results Easier for Patients to Understand
As more patients gain direct access to lab reports and test results, health care providers are offering new tools to help them navigate the maze of numbers and use the data to better manage their own care. Individual patients now can see their results on a wide variety of medical tests including complete blood counts, urinalysis and allergy tests, under a federal rule that went into effect in April and pre-empted a number of state laws prohibiting disclosure to individuals. The results must be available on request within 30 days, no physician's authorization required. Laboratories have until Oct. 6 to comply. The 30-day window provides doctors with time to review sensitive or complicated lab findings and meet with the patient in person to discuss them. For routine tests, though, more labs and hospitals are sending results directly to the patient, in some cases on the same day that the doctor receives them.
As more patients gain direct access to lab reports and test results, health care providers are offering new tools to help them navigate the maze of numbers and use the data to better manage their own care. Individual patients now can see their results on a wide variety of medical tests including complete blood counts, urinalysis and allergy tests, under a federal rule that went into effect in April and pre-empted a number of state laws prohibiting disclosure to individuals. The results must be available on request within 30 days, no physician's authorization required. Laboratories have until Oct. 6 to comply. The 30-day window provides doctors with time to review sensitive or complicated lab findings and meet with the patient in person to discuss them. For routine tests, though, more labs and hospitals are sending results directly to the patient, in some cases on the same day that the doctor receives them.
Source: http://online.wsj.com/
Doctors Order Unnecessary Tests Without Even Realizing it
Physicians order unnecessary tests and procedures to inoculate themselves from legal liability more than they realize, according to a new survey of physicians at several hospitals in one Massachusetts health system. Nearly a third of the orders that the surveyed physicians placed were defensive on some level. The researchers argue that clear communication about evidence-based guidelines and tort reform that would protect clinicians when they follow those guidelines would help reduce providers' fear and improve patient care. Fear of frivolous lawsuits may be so pervasive that it has changed what is considered an acceptable diagnostic approach, said Dr. Michael Rothberg, vice chair for research in the Medicine Institute of the Cleveland Clinic and lead author of a summary of the findings published inJAMA Internal Medicine.
Physicians order unnecessary tests and procedures to inoculate themselves from legal liability more than they realize, according to a new survey of physicians at several hospitals in one Massachusetts health system. Nearly a third of the orders that the surveyed physicians placed were defensive on some level. The researchers argue that clear communication about evidence-based guidelines and tort reform that would protect clinicians when they follow those guidelines would help reduce providers' fear and improve patient care. Fear of frivolous lawsuits may be so pervasive that it has changed what is considered an acceptable diagnostic approach, said Dr. Michael Rothberg, vice chair for research in the Medicine Institute of the Cleveland Clinic and lead author of a summary of the findings published inJAMA Internal Medicine.
Source: http://www.modernhealthcare.com/
More Media Reports of Health Insurers’ Reluctance to Reimburse for Genetic Tests, Thus Angering Many Patients and Causing Medical Laboratories to Go Unpaid
Concerned about the increased cost of genetic tests, health insurers are becoming reluctant to pay for many types of molecular diagnostics and gene tests. When refusing to pay for these tests, however, they face a buzz saw of angry patients—many of whom see a genetic test as their last resort for a diagnosis and selection of a therapy that might just work for them. Reuters recently reported that health insurance companies are reluctant to pay providers for genetic-sequencing tests until more research becomes available.
Concerned about the increased cost of genetic tests, health insurers are becoming reluctant to pay for many types of molecular diagnostics and gene tests. When refusing to pay for these tests, however, they face a buzz saw of angry patients—many of whom see a genetic test as their last resort for a diagnosis and selection of a therapy that might just work for them. Reuters recently reported that health insurance companies are reluctant to pay providers for genetic-sequencing tests until more research becomes available.
Source: http://www.darkdaily.com/
Cervical Cancer Screening Tests Continue to Evolve
Between 1955 and 1992, it is estimated that the rate of cervical cancer mortality decreased by about 70%, due largely to the widespread adoption of the Pap smear as part of the annual Ob/Gyn or well-woman visit. The first big change to the well-woman visit came several years ago when the United States Preventive Services Task Force and the American Cancer Society recommended against routine yearly Pap smear testing and first included HPV testing as part of cervical cancer screening. The new guidelines recommended Pap testing every 3 years for women aged 21 to 65 years. With the health care community only just adjusting to these updated screening recommendations, even more changes may be around the corner. In April, the FDA expanded the label for one of the HPV tests available on the market, the cobas HPV Test (Roche), approving it as a stand-alone test for primary screening of cervical cancer. Reaction to the FDA approval and the idea of using HPV testing alone to screen for cervical cancer has been mixed, and whether or not professionals will begin to use the HPV test for first-line screening is unknown. The Society for Gynecologic Oncologists and the American Society for Colposcopy and Cervical Pathology have announced plans to release interim guidelines on cervical cancer screening that will discuss use of the HPV test as a first-line screening method. In addition, the American Cancer Society is reviewing its guidelines and considering this new information.
Between 1955 and 1992, it is estimated that the rate of cervical cancer mortality decreased by about 70%, due largely to the widespread adoption of the Pap smear as part of the annual Ob/Gyn or well-woman visit. The first big change to the well-woman visit came several years ago when the United States Preventive Services Task Force and the American Cancer Society recommended against routine yearly Pap smear testing and first included HPV testing as part of cervical cancer screening. The new guidelines recommended Pap testing every 3 years for women aged 21 to 65 years. With the health care community only just adjusting to these updated screening recommendations, even more changes may be around the corner. In April, the FDA expanded the label for one of the HPV tests available on the market, the cobas HPV Test (Roche), approving it as a stand-alone test for primary screening of cervical cancer. Reaction to the FDA approval and the idea of using HPV testing alone to screen for cervical cancer has been mixed, and whether or not professionals will begin to use the HPV test for first-line screening is unknown. The Society for Gynecologic Oncologists and the American Society for Colposcopy and Cervical Pathology have announced plans to release interim guidelines on cervical cancer screening that will discuss use of the HPV test as a first-line screening method. In addition, the American Cancer Society is reviewing its guidelines and considering this new information.
Source: http://www.obgyn.net/
A Blood Test Could be Developed for Depression
A blood test could be used to diagnose depression, scientists have said, after finding chemicals in the blood in people with the condition. Currently depression is only diagnosed through consultations with doctors based on mood and screening tests using questionnaires. Finding a biological sign of depression also shows that the condition is a disease and not simply 'being sad all the time'. In a small complex study a team from Northwestern University in Chicago screened the blood of teenagers to look for chemicals that were present in those with early onset major depression and were not present in those who were healthy. The tests were based on animal studies and found 26 markers in the blood linked with stress and genetic features involved in brain damage.
A blood test could be used to diagnose depression, scientists have said, after finding chemicals in the blood in people with the condition. Currently depression is only diagnosed through consultations with doctors based on mood and screening tests using questionnaires. Finding a biological sign of depression also shows that the condition is a disease and not simply 'being sad all the time'. In a small complex study a team from Northwestern University in Chicago screened the blood of teenagers to look for chemicals that were present in those with early onset major depression and were not present in those who were healthy. The tests were based on animal studies and found 26 markers in the blood linked with stress and genetic features involved in brain damage.
Source: http://www.telegraph.co.uk/
Rosetta Genomics Launches Patient Registry Study to Track Utility of Cancer Origin Test
The company set up the registry in an effort to track the treatment decisions physicians make for their cancer patients based on the test results, as well as the therapeutic strategy they decide upon, the duration of patients' responses, survival, and other clinically relevant data. The registry is hoping to track this information for 400 patients diagnosed with cancer of unknown or uncertain primary or metastatic disease of unknown origin. The microRNA-based Cancer Origin Test can identify the origin of a primary and metastatic tumor.
The company set up the registry in an effort to track the treatment decisions physicians make for their cancer patients based on the test results, as well as the therapeutic strategy they decide upon, the duration of patients' responses, survival, and other clinically relevant data. The registry is hoping to track this information for 400 patients diagnosed with cancer of unknown or uncertain primary or metastatic disease of unknown origin. The microRNA-based Cancer Origin Test can identify the origin of a primary and metastatic tumor.
Source: http://www.genomeweb.com/
Astute Medical Receives FDA Clearance for NephroCheck Test, Begins Prepping US Launch
Astute Medical said that it has received US Food and Drug Administration 510(k) clearance for its NephroCheck Test System, a protein biomarker-based test for assessing risk of acute kidney injury [AKI]. The San Diego-based company said that it plans to launch US sales of the test in coming weeks through its strategic partner Ortho Clinical Diagnostics, the exclusive sales agent for NephroCheck. The test measures the presence of two proteins – insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) – in urine, allowing clinicians to assess in about 20 minutes the risk of a patient developing AKI in the next 12 hours. According to Paul McPherson, the company's chief scientific officer, the test is able to identify patients who go on to develop AKI with an accuracy of around 90 percent.
Astute Medical said that it has received US Food and Drug Administration 510(k) clearance for its NephroCheck Test System, a protein biomarker-based test for assessing risk of acute kidney injury [AKI]. The San Diego-based company said that it plans to launch US sales of the test in coming weeks through its strategic partner Ortho Clinical Diagnostics, the exclusive sales agent for NephroCheck. The test measures the presence of two proteins – insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) – in urine, allowing clinicians to assess in about 20 minutes the risk of a patient developing AKI in the next 12 hours. According to Paul McPherson, the company's chief scientific officer, the test is able to identify patients who go on to develop AKI with an accuracy of around 90 percent.
Source: http://www.genomeweb.com/
Pathologists Should Review Gastric Bypass Specimens
Most patients undergoing gastric bypass have unexpected findings in their surgical gastric sleeve specimens that necessitate treatment, report researchers who found clinically significant histologic findings, including chronic gastritis, gastrointestinal stromal tumor, and adenocarcinoma. "These surgeries are considered pretty routine," lead investigator Rachel Gordezky, MD, from the University of Illinois at Chicago, told Medscape Medical News, "but even in these routine cases, we found pathologies that required treatment," she said. "What first spurred the project is when we found gastrointestinal stromal tumor. We wondered how many times this has happened."
Source: http://www.medscape.com/Most patients undergoing gastric bypass have unexpected findings in their surgical gastric sleeve specimens that necessitate treatment, report researchers who found clinically significant histologic findings, including chronic gastritis, gastrointestinal stromal tumor, and adenocarcinoma. "These surgeries are considered pretty routine," lead investigator Rachel Gordezky, MD, from the University of Illinois at Chicago, told Medscape Medical News, "but even in these routine cases, we found pathologies that required treatment," she said. "What first spurred the project is when we found gastrointestinal stromal tumor. We wondered how many times this has happened."
Research and Development
Next-Generation Sequencing Pinpoints Multiple Mutations
A typical cytology specimen contains sufficient DNA for next-generation sequencing, report researchers who suggest the tiny tissue samples should be routinely tested. Cytology specimens, such as fine-needle aspiration (FNA) samples, commonly used for diagnosing primary and metastatic cancers, are typically tested for 1 biomarker at a time, lead investigator Christopher Hartley, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, explained to Medscape Medical News. Unfortunately, cytology samples tend to contain small amounts of tissue and DNA and are inadequate for sequential testing. Next-generation sequencing allows for simultaneous analysis of multiple genes and is a much better use of limited tissue, he noted. "Next-generation sequencing is really the only solution to having all of these different mutations that you are looking for with targeted therapies," Dr. Hartley said. His poster was among the top 5 junior member abstract winners at the College of American Pathologists (CAP) 2014 meeting.
A typical cytology specimen contains sufficient DNA for next-generation sequencing, report researchers who suggest the tiny tissue samples should be routinely tested. Cytology specimens, such as fine-needle aspiration (FNA) samples, commonly used for diagnosing primary and metastatic cancers, are typically tested for 1 biomarker at a time, lead investigator Christopher Hartley, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, explained to Medscape Medical News. Unfortunately, cytology samples tend to contain small amounts of tissue and DNA and are inadequate for sequential testing. Next-generation sequencing allows for simultaneous analysis of multiple genes and is a much better use of limited tissue, he noted. "Next-generation sequencing is really the only solution to having all of these different mutations that you are looking for with targeted therapies," Dr. Hartley said. His poster was among the top 5 junior member abstract winners at the College of American Pathologists (CAP) 2014 meeting.
Source: http://www.medscape.com/
New Gene Variants for Prostate Cancer Identified
An international team of scientists has identified 23 new genetic variants linked to a greater risk for prostate cancer. Although more research is needed, the researchers said their findings, which bring the total number of common gene variants associated with prostate cancer to 100, could help doctors diagnose the disease earlier and could lead to the development of new treatments. "Our study tells us more about the effect of the genetic hand that men are dealt on their risk of prostate cancer. We know that there are a few major genes that are rare and significantly affect prostate cancer risk, but what we are now learning is that there are many other common genetic variants that individually have only a small effect on risk, but collectively can be very important," Ros Eeles, a professor of oncogenetics at The Institute of Cancer Research in London, explained in an institute news release.
An international team of scientists has identified 23 new genetic variants linked to a greater risk for prostate cancer. Although more research is needed, the researchers said their findings, which bring the total number of common gene variants associated with prostate cancer to 100, could help doctors diagnose the disease earlier and could lead to the development of new treatments. "Our study tells us more about the effect of the genetic hand that men are dealt on their risk of prostate cancer. We know that there are a few major genes that are rare and significantly affect prostate cancer risk, but what we are now learning is that there are many other common genetic variants that individually have only a small effect on risk, but collectively can be very important," Ros Eeles, a professor of oncogenetics at The Institute of Cancer Research in London, explained in an institute news release.
Source: http://consumer.healthday.com/
Blood Group 'Link to Memory Loss'
There may be a link between a rare blood type and memory loss in later life, American research suggests. People with AB blood, found in 4% of the population, appear more likely to develop thinking and memory problems than those with other blood groups. The study, published in Neurology, builds on previous research showing blood type may influence heart risk. A US team led by Dr Mary Cushman, of the University of Vermont College of Medicine, Burlington, analysed data from about 30,000 US citizens aged 45 and above. People with AB blood type made up 6% of the group who developed cognitive impairment, which is higher than the 4% found in the general population.
There may be a link between a rare blood type and memory loss in later life, American research suggests. People with AB blood, found in 4% of the population, appear more likely to develop thinking and memory problems than those with other blood groups. The study, published in Neurology, builds on previous research showing blood type may influence heart risk. A US team led by Dr Mary Cushman, of the University of Vermont College of Medicine, Burlington, analysed data from about 30,000 US citizens aged 45 and above. People with AB blood type made up 6% of the group who developed cognitive impairment, which is higher than the 4% found in the general population.
Source: http://www.bbc.com/
Blood for Transfusion Stiffens With Time
Using advanced optical techniques, the researchers measured the stiffness of the membrane surrounding red blood cells over time. They found that, even though the cells retain their shape and hemoglobin content, the membranes get stiffer, which steadily decreases the cells' functionality. Led by electrical and computer engineering professor Gabriel Popescu, the team published its results in the journal Scientific Reports. "Our results show some surprising facts: Even though the blood looks good on the surface, its functionality is degrading steadily with time," said Popescu, who is also part of the Beckman Institute for Advanced Science and Technology.
Using advanced optical techniques, the researchers measured the stiffness of the membrane surrounding red blood cells over time. They found that, even though the cells retain their shape and hemoglobin content, the membranes get stiffer, which steadily decreases the cells' functionality. Led by electrical and computer engineering professor Gabriel Popescu, the team published its results in the journal Scientific Reports. "Our results show some surprising facts: Even though the blood looks good on the surface, its functionality is degrading steadily with time," said Popescu, who is also part of the Beckman Institute for Advanced Science and Technology.
Source: http://www.medicalnewstoday.com/
Scientists Develop Method to Prevent Blood Clots in Lab-grown Kidneys
Researchers have made a potential breakthrough in kidney regeneration, finding a successful method to prevent severe blood clots commonly seen after transplantation of the lab-grown organs. Scientists at Wake Forest Baptist Medical Center worked with human-sized pig kidneys to develop a method to keep blood vessels in lab-grown kidneys open, allowing blood to flow through them. "Until now, lab-built kidneys have been rodent-sized and have functioned for only one or two hours after transplantation because blood clots developed," senior study author Dr. Anthony Atala, director and professor at the Wake Forest Institute for Regenerative Medicine, said in a press release. "In our proof-of-concept study, the vessels in a human-sized pig kidney remained open during a four-hour testing period. We are now conducting a longer-term study to determine how long flow can be maintained."
Researchers have made a potential breakthrough in kidney regeneration, finding a successful method to prevent severe blood clots commonly seen after transplantation of the lab-grown organs. Scientists at Wake Forest Baptist Medical Center worked with human-sized pig kidneys to develop a method to keep blood vessels in lab-grown kidneys open, allowing blood to flow through them. "Until now, lab-built kidneys have been rodent-sized and have functioned for only one or two hours after transplantation because blood clots developed," senior study author Dr. Anthony Atala, director and professor at the Wake Forest Institute for Regenerative Medicine, said in a press release. "In our proof-of-concept study, the vessels in a human-sized pig kidney remained open during a four-hour testing period. We are now conducting a longer-term study to determine how long flow can be maintained."
Source: http://www.foxnews.com/
Activated Gene Slows the Aging Process
Scientists at UCLA say they have identified a gene that can slow the aging process throughout the entire body when activated remotely in key organ systems. Working with fruit flies, the researchers activated the AMPK gene that is a key energy sensor in cells. It gets activated when cellular energy levels are low. Increasing the amount of AMPK in fruit flies' intestines increased their lifespans by about 30% (to roughly eight weeks from the typical six) and the flies stayed healthier longer as well. The study (“AMPK Modulates Tissue and Organismal Aging in a Non-Cell-Autonomous Manner”), published in Cell Reports, could have important implications for delaying aging and disease in humans, said David Walker, Ph.D., an associate professor of integrative biology and physiology at UCLA and senior author of the research.
Scientists at UCLA say they have identified a gene that can slow the aging process throughout the entire body when activated remotely in key organ systems. Working with fruit flies, the researchers activated the AMPK gene that is a key energy sensor in cells. It gets activated when cellular energy levels are low. Increasing the amount of AMPK in fruit flies' intestines increased their lifespans by about 30% (to roughly eight weeks from the typical six) and the flies stayed healthier longer as well. The study (“AMPK Modulates Tissue and Organismal Aging in a Non-Cell-Autonomous Manner”), published in Cell Reports, could have important implications for delaying aging and disease in humans, said David Walker, Ph.D., an associate professor of integrative biology and physiology at UCLA and senior author of the research.
Source: http://www.genengnews.com/
Novel Drugs Target Tough-to-treat Bacteria
Researchers described early progress in the development of new agents that target difficult-to-treat Gram-negative resistant bacteria, including one drug already in early human testing that uses a "Trojan Horse" concept. In preclinical testing in a mouse model, the parenteral siderophore cephalosporin named S-649266 showed in vitro and in vivo effectiveness in killing multidrug-resistant Pseudomonas and Acinetobacter species, and carbapenem-resistant Enterobacteriaceae in rodent models of thigh and lung infections, reported Yoshinori Yamano, PhD, vice president of medical research laboratories at Shionogi and Co., based in Osaka, Japan.
Researchers described early progress in the development of new agents that target difficult-to-treat Gram-negative resistant bacteria, including one drug already in early human testing that uses a "Trojan Horse" concept. In preclinical testing in a mouse model, the parenteral siderophore cephalosporin named S-649266 showed in vitro and in vivo effectiveness in killing multidrug-resistant Pseudomonas and Acinetobacter species, and carbapenem-resistant Enterobacteriaceae in rodent models of thigh and lung infections, reported Yoshinori Yamano, PhD, vice president of medical research laboratories at Shionogi and Co., based in Osaka, Japan.
Source: http://www.medpagetoday.com/
Scientists Unlock a Key to Cell Stress
A team of researchers has uncovered a key way that cells respond to stress. As they explain it, cells produce more than 25,000 different proteins with specific 3-D shapes, but when stressed, they can make mistakes and produce misshapen proteins that are unfolded or misfolded. Duke University researchers found, however, that cells are able to recognize this build-up of misshapen proteins and respond by temporarily slowing down production or shutting it off entirely.
A team of researchers has uncovered a key way that cells respond to stress. As they explain it, cells produce more than 25,000 different proteins with specific 3-D shapes, but when stressed, they can make mistakes and produce misshapen proteins that are unfolded or misfolded. Duke University researchers found, however, that cells are able to recognize this build-up of misshapen proteins and respond by temporarily slowing down production or shutting it off entirely.
Source: http://consumer.healthday.com/
Researchers Create World’s Largest DNA Origami
Researchers from North Carolina State University, Duke University and the University of Copenhagen have created the world’s largest DNA origami, which are nanoscale constructions with applications ranging from biomedical research to nanoelectronics. “These origami can be customized for use in everything from studying cell behavior to creating templates for the nanofabrication of electronic components,” says Dr. Thom LaBean, an associate professor of materials science and engineering at NC State and senior author of a paper describing the work.
Researchers from North Carolina State University, Duke University and the University of Copenhagen have created the world’s largest DNA origami, which are nanoscale constructions with applications ranging from biomedical research to nanoelectronics. “These origami can be customized for use in everything from studying cell behavior to creating templates for the nanofabrication of electronic components,” says Dr. Thom LaBean, an associate professor of materials science and engineering at NC State and senior author of a paper describing the work.
Source: http://news.ncsu.edu/
Schizophrenia is Eight Different Diseases, Not One
New research shows that schizophrenia is not a single disease, but a group of eight distinct disorders, each caused by changes in clusters of genes that lead to different sets of symptoms. The finding sets the stage for scientists to develop better ways to diagnose and treat schizophrenia, a mental illness that can be devastating when not adequately managed, says C. Robert Cloninger, co-author of the study published Monday in the American Journal of Psychiatry.
New research shows that schizophrenia is not a single disease, but a group of eight distinct disorders, each caused by changes in clusters of genes that lead to different sets of symptoms. The finding sets the stage for scientists to develop better ways to diagnose and treat schizophrenia, a mental illness that can be devastating when not adequately managed, says C. Robert Cloninger, co-author of the study published Monday in the American Journal of Psychiatry.
Source: http://www.usatoday.com/
A New Way to Look at Diabetes and Heart Risk
People with diabetes who appear otherwise healthy may have a six-fold higher risk of developing heart failure regardless of their cholesterol levels, new Johns Hopkins Bloomberg School of Public Health research suggests. In nearly 50 percent of people with diabetes in their study, researchers employing an ultra-sensitive test were able to identify minute levels of a protein released into the blood when heart cells die. The finding suggests that people with diabetes may be suffering undetectable – but potentially dangerous – heart muscle damage possibly caused by their elevated blood sugar levels. Cardiovascular disease is the leading cause of death among those with diabetes, and much of that has been blamed on atherosclerosis, or hardening of the arteries. The new research, reported online last month in the journal Circulation, suggests that a large subsection of people with diabetes are at increased risk of heart failure and cardiac death unrelated to the common culprits of cholesterol and atherosclerosis.
Source: http://www.jhsph.edu/People with diabetes who appear otherwise healthy may have a six-fold higher risk of developing heart failure regardless of their cholesterol levels, new Johns Hopkins Bloomberg School of Public Health research suggests. In nearly 50 percent of people with diabetes in their study, researchers employing an ultra-sensitive test were able to identify minute levels of a protein released into the blood when heart cells die. The finding suggests that people with diabetes may be suffering undetectable – but potentially dangerous – heart muscle damage possibly caused by their elevated blood sugar levels. Cardiovascular disease is the leading cause of death among those with diabetes, and much of that has been blamed on atherosclerosis, or hardening of the arteries. The new research, reported online last month in the journal Circulation, suggests that a large subsection of people with diabetes are at increased risk of heart failure and cardiac death unrelated to the common culprits of cholesterol and atherosclerosis.
Public Health and Patient Safety
CDC Report Finds High Sodium Consumption Among U.S. Kids
More than 90 percent of U.S. children aged 6-18 years eat more sodium than recommended, putting them at risk for developing high blood pressure and heart disease later in life, according to a new CDCVital Signs report.
Key findings in the Vital Signs report include:
More than 90 percent of U.S. children aged 6-18 years eat more sodium than recommended, putting them at risk for developing high blood pressure and heart disease later in life, according to a new CDCVital Signs report.
Key findings in the Vital Signs report include:
- U.S. children aged 6 to 18 years eat an average of about 3,300 mg of sodium a day before salt is added at the table. The 2010 Dietary Guidelines for Americans recommend that children eat less than 2,300 mg per day total.
- Most sodium is already in food before it is purchased or ordered. Approximately 65 percent comes from store foods, 13 percent from fast food and pizza restaurant foods, and 9 percent from school cafeteria foods.
Source: http://www.foodsafetynews.com/
WHO to Start New Global Health Initiative for Needle Safety
At the TEDMED conference in Washington, DC, Dr. Marie-Paule Kieny, assistant director general of the World Health Organization (WHO), revealed that the organization will announce its third-ever global health initiative and policy in October. The initiative this time is around needle safety. The announcement came during a TEDMED presentation by British inventor Marc Koska, who spent his early 20s creating the K-1 syringe: the first syringe to automatically disable once it’s used, making it impossible to use again. A small ring inside of the barrel of the syringe allows the plunger to move in one direction and not the other, so after an injection, the plunger is locked in place and will break if forced. The hope is that the WHO mandate, which will encourage the use of non-reusable syringes, will become a worldwide health safety standard.
At the TEDMED conference in Washington, DC, Dr. Marie-Paule Kieny, assistant director general of the World Health Organization (WHO), revealed that the organization will announce its third-ever global health initiative and policy in October. The initiative this time is around needle safety. The announcement came during a TEDMED presentation by British inventor Marc Koska, who spent his early 20s creating the K-1 syringe: the first syringe to automatically disable once it’s used, making it impossible to use again. A small ring inside of the barrel of the syringe allows the plunger to move in one direction and not the other, so after an injection, the plunger is locked in place and will break if forced. The hope is that the WHO mandate, which will encourage the use of non-reusable syringes, will become a worldwide health safety standard.
Source: http://time.com/
A Scientist Launches Global Crusade Against Dengue Fever
Scientists hoping to eliminate dengue fever, a debilitating disease of the tropics that has made its way to parts of the U.S., are launching an extensive eradication experiment in different regions of the world. An Australian-led team of scientists is preparing to fight back by releasing an army of mosquitoes specially bred with a bacteria called Wolbachia that they believe can virtually eliminate dengue. Thousands of the lab-raised mosquitoes were recently released in the ancient Indonesian city of Yogyakarta. The scientists plan another large-scale release in the sprawling, crowded shantytowns of Brazil's Rio de Janeiro in late September. The idea is that the carrier mosquitoes, mainly Aedes aegypti, will breed with wild insects, which would then pass the bacteria to their offspring and render them immune to dengue. Over time, researchers hope the wild populations capable of transmitting the dengue virus will plummet.
Scientists hoping to eliminate dengue fever, a debilitating disease of the tropics that has made its way to parts of the U.S., are launching an extensive eradication experiment in different regions of the world. An Australian-led team of scientists is preparing to fight back by releasing an army of mosquitoes specially bred with a bacteria called Wolbachia that they believe can virtually eliminate dengue. Thousands of the lab-raised mosquitoes were recently released in the ancient Indonesian city of Yogyakarta. The scientists plan another large-scale release in the sprawling, crowded shantytowns of Brazil's Rio de Janeiro in late September. The idea is that the carrier mosquitoes, mainly Aedes aegypti, will breed with wild insects, which would then pass the bacteria to their offspring and render them immune to dengue. Over time, researchers hope the wild populations capable of transmitting the dengue virus will plummet.
Source: http://online.wsj.com/
How Well the Flu Vaccine Works Affected by Gut Microbes
Annual flu epidemics cause millions of cases of severe illness and up to half a million deaths every year around the world, despite widespread vaccination programs. A study published by Cell Press in Immunity reveals that gut microbes play an important role in stimulating protective immune responses to the seasonal flu vaccine in mice, suggesting that differences in the composition of gut microbes in different populations may impact vaccine immunity. The study paves the way for global public health strategies to improve the effectiveness of the flu vaccine. "Our findings raise the possibility that antibiotic treatment prior to or during vaccination may impact immunity," says senior study author Bali Pulendran of the Emory Vaccine Research Center. "Another potential implication of our study is that we may be able to manipulate gut microbes in order to improve immune responses to the vaccine."
Source: http://www.medicalnewstoday.com/Annual flu epidemics cause millions of cases of severe illness and up to half a million deaths every year around the world, despite widespread vaccination programs. A study published by Cell Press in Immunity reveals that gut microbes play an important role in stimulating protective immune responses to the seasonal flu vaccine in mice, suggesting that differences in the composition of gut microbes in different populations may impact vaccine immunity. The study paves the way for global public health strategies to improve the effectiveness of the flu vaccine. "Our findings raise the possibility that antibiotic treatment prior to or during vaccination may impact immunity," says senior study author Bali Pulendran of the Emory Vaccine Research Center. "Another potential implication of our study is that we may be able to manipulate gut microbes in order to improve immune responses to the vaccine."
Health IT
ONC Rule Aims to Offer More Flexibility on EHR Certification
In the final rule, ONC wrote that feedback on the proposed 2015 rule prompted the agency not to adopt the proposed 2015 voluntary criteria. Instead, the agency said it will incorporate "a small subset" of the proposed 2015 voluntary criteria as "optional 2014 Edition EHR certification criteria," also known as the "2014 Edition Release 2."
Specifically, the "2014 Edition Release 2" includes 10 optional criteria and two revised criteria, including:
In the final rule, ONC wrote that feedback on the proposed 2015 rule prompted the agency not to adopt the proposed 2015 voluntary criteria. Instead, the agency said it will incorporate "a small subset" of the proposed 2015 voluntary criteria as "optional 2014 Edition EHR certification criteria," also known as the "2014 Edition Release 2."
Specifically, the "2014 Edition Release 2" includes 10 optional criteria and two revised criteria, including:
- Changing the view/download/transmit criterion; and
- Splitting criterion for the computerized physician order entry into three separate certification criteria.
The final rule also makes administrative changes to ONC's meaningful use EHR certification program, including:
- Removing the "complete EHR" certification concept; and
- Updating the standard for certification bodies authorized by ONC.
Source: http://www.ihealthbeat.org/
Advancing Health IT With Congressional Asks
Each year, a work group of HIMSS volunteers develops the organization’s “Congressional Asks” – formal requests to Congress to accomplish specific goals to advance health IT. This year, HIMSS focused on three very different, yet essential, topics within health IT. Our top three 2014 recommendations for Congress – the Congressional Asks – follow.
Ask #1: Minimize Disruption in our Nation’s Health System Emanating from Federally Mandated Health IT Program Changes.
Ask #2: Fund the National Coordinator for Health IT to Achieve Interoperability, Improve Clinical Quality, and Ensure Patient Privacy and Safety.
Ask #3: Expand Telehealth Services to Improve Patient Access and Outcomes and Decrease Healthcare Costs.
Each year, a work group of HIMSS volunteers develops the organization’s “Congressional Asks” – formal requests to Congress to accomplish specific goals to advance health IT. This year, HIMSS focused on three very different, yet essential, topics within health IT. Our top three 2014 recommendations for Congress – the Congressional Asks – follow.
Ask #1: Minimize Disruption in our Nation’s Health System Emanating from Federally Mandated Health IT Program Changes.
Ask #2: Fund the National Coordinator for Health IT to Achieve Interoperability, Improve Clinical Quality, and Ensure Patient Privacy and Safety.
Ask #3: Expand Telehealth Services to Improve Patient Access and Outcomes and Decrease Healthcare Costs.
Source: http://blog.himss.org/
Apple's Wellness Platform Arrives
Now, 30 years later, we’re on the cusp of a different kind of revolution - the consumerization of healthcare middleware that gathers data about your body/activity from multiple sensors and consolidates it into a secure container on your personal smartphone. No cloud storage is used. In fact, Apple has specifically changed its policies so that health data is never replicated to iCloud. Data remains on your device under your control. Apple does not specifically provide a function to transmit data off the device. The intent of Healthkit is that it serves as middleware, consolidating data and providing a container to share data with other apps that you specifically trust.
Now, 30 years later, we’re on the cusp of a different kind of revolution - the consumerization of healthcare middleware that gathers data about your body/activity from multiple sensors and consolidates it into a secure container on your personal smartphone. No cloud storage is used. In fact, Apple has specifically changed its policies so that health data is never replicated to iCloud. Data remains on your device under your control. Apple does not specifically provide a function to transmit data off the device. The intent of Healthkit is that it serves as middleware, consolidating data and providing a container to share data with other apps that you specifically trust.
Source: http://www.govhealthit.com/
Toshiba, Johns Hopkins Launch Project to Harness Big Data's Power
Electronics Company Toshiba has collaborated with Baltimore-based Johns Hopkins University to establish the Toshiba Center for Big Data in Healthcare at the Science + Technology Park on the university's medical campus. The partnership between the two organizations seeks to blend Toshiba's image analysis and data mining expertise with Johns Hopkins' clinical research and big data analysis techniques to harness the potential of big data to develop new technologies to better monitor and drive individual, personalized care.
Source: http://www.beckershospitalreview.com/Electronics Company Toshiba has collaborated with Baltimore-based Johns Hopkins University to establish the Toshiba Center for Big Data in Healthcare at the Science + Technology Park on the university's medical campus. The partnership between the two organizations seeks to blend Toshiba's image analysis and data mining expertise with Johns Hopkins' clinical research and big data analysis techniques to harness the potential of big data to develop new technologies to better monitor and drive individual, personalized care.
Other News
GHP Joins CDC-Led Team to Boost Laboratory Quality in Kazakhstan
The CLSI Global Health Partnerships (GHP) team has embarked on a new 16-month laboratory reform project in Kazakhstan overseen by the National Foundation for the Centers for Disease Control and Prevention Foundation (CDCF). The CDCF manages about 200 programs worldwide that involve a partnership of CDC experts, outside funding partners, and nonprofit organizations. CLSI is collaborating on the project with MRIGlobal of Kansas City, Missouri, USA; Booz Allen Hamilton, Mclean, Virginia, USA and a consultant from the University of Washington, Seattle, Washington. USA. Based in the CDC's Almaty office, the CDCF team will support Kazakhstan's drafting of a National Laboratory Strategic Plan, a path to accreditation for four laboratories with an infectious diseases focus and a national clinical reference laboratory, and the creation of a Regulatory Reform Proposal for both infectious and noninfectious diseases.
This project is designed to develop an overall strategic plan for clinical laboratories and to quickly move several selected laboratories toward accreditation. Kazakhstan will use the experience with the selected laboratories as the basis for creating a program for the remaining laboratories that moves them forward on the path to accreditation as well.
The CLSI Global Health Partnerships (GHP) team has embarked on a new 16-month laboratory reform project in Kazakhstan overseen by the National Foundation for the Centers for Disease Control and Prevention Foundation (CDCF). The CDCF manages about 200 programs worldwide that involve a partnership of CDC experts, outside funding partners, and nonprofit organizations. CLSI is collaborating on the project with MRIGlobal of Kansas City, Missouri, USA; Booz Allen Hamilton, Mclean, Virginia, USA and a consultant from the University of Washington, Seattle, Washington. USA. Based in the CDC's Almaty office, the CDCF team will support Kazakhstan's drafting of a National Laboratory Strategic Plan, a path to accreditation for four laboratories with an infectious diseases focus and a national clinical reference laboratory, and the creation of a Regulatory Reform Proposal for both infectious and noninfectious diseases.
This project is designed to develop an overall strategic plan for clinical laboratories and to quickly move several selected laboratories toward accreditation. Kazakhstan will use the experience with the selected laboratories as the basis for creating a program for the remaining laboratories that moves them forward on the path to accreditation as well.
Source: http://clsi.org/
CMS Delays Dialysis Center Five-star Rating System
The federal government will wait until January to roll out its five-star rating system meant to help consumers compare quality at dialysis centers across the country. Use of the system on the CMS' dialysis centers compare website had been scheduled for October, but was met with angst by dialysis providers who questioned the methodology and said the program was likely to be more confusing than helpful. In response, the federal agency announced that it has moved the date by about three months. The CMS began using the rating program on nursing homes in December 2008 and earlier this year applied a similar rubric to physician groups. In July, the agency announced plans to extend the program to dialysis facilities starting Oct. 9.
The federal government will wait until January to roll out its five-star rating system meant to help consumers compare quality at dialysis centers across the country. Use of the system on the CMS' dialysis centers compare website had been scheduled for October, but was met with angst by dialysis providers who questioned the methodology and said the program was likely to be more confusing than helpful. In response, the federal agency announced that it has moved the date by about three months. The CMS began using the rating program on nursing homes in December 2008 and earlier this year applied a similar rubric to physician groups. In July, the agency announced plans to extend the program to dialysis facilities starting Oct. 9.
Source: http://www.modernhealthcare.com/
Physician "Culture of Perfection" Keeps Medical Errors High
Reducing medical errors means rethinking a culture that encourages doctors to conceal them, argues a doctor at Bellevue Hospital Center at New York University, MedCityNews reports.
"We need to undo a toxic culture of perfection when it comes to medical error," Danielle Ofri, M.D., author of "What Doctors Feel—How Emotions Affect the Practice of Medicine," said at TEDMED 2014 in the District of Columbia, according to the article. Ofri admitted that she failed to report an error she made while training to be a physician. If the healthcare culture doesn't change, Ofri said, fear of repercussions for errors will continue to drive doctors to hide medical mistakes rather than report them. Hospital medical errors are now the United States' third-leading cause of death, costing as many as 400,000 lives a year, far higher than the numbers in the seminal 1999 report "To Err is Human,"
Reducing medical errors means rethinking a culture that encourages doctors to conceal them, argues a doctor at Bellevue Hospital Center at New York University, MedCityNews reports.
"We need to undo a toxic culture of perfection when it comes to medical error," Danielle Ofri, M.D., author of "What Doctors Feel—How Emotions Affect the Practice of Medicine," said at TEDMED 2014 in the District of Columbia, according to the article. Ofri admitted that she failed to report an error she made while training to be a physician. If the healthcare culture doesn't change, Ofri said, fear of repercussions for errors will continue to drive doctors to hide medical mistakes rather than report them. Hospital medical errors are now the United States' third-leading cause of death, costing as many as 400,000 lives a year, far higher than the numbers in the seminal 1999 report "To Err is Human,"
Source: http://www.fiercehealthcare.com/
Gates Foundation to Spend $50M on Ebola Response
The Bill & Melinda Gates Foundation announced that it will spend $50 million — on top of $10 million already committed — to support emergency response to the Ebola outbreak in West Africa, marking the group's largest donation to a humanitarian effort. The Seattle-based foundation said the money will go to the United Nations, the World Health Organization, the U.S. Centers for Disease Control and Prevention and international organizations involved in fighting transmission of the virus. The money will be used to purchase supplies and to develop vaccines, therapies and better diagnostic tools. The foundation wants to help stop the outbreak as well as accelerate development treatments and improve prevention.
Source: http://www.usatoday.com/The Bill & Melinda Gates Foundation announced that it will spend $50 million — on top of $10 million already committed — to support emergency response to the Ebola outbreak in West Africa, marking the group's largest donation to a humanitarian effort. The Seattle-based foundation said the money will go to the United Nations, the World Health Organization, the U.S. Centers for Disease Control and Prevention and international organizations involved in fighting transmission of the virus. The money will be used to purchase supplies and to develop vaccines, therapies and better diagnostic tools. The foundation wants to help stop the outbreak as well as accelerate development treatments and improve prevention.
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