viernes, 24 de octubre de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


October 23, 2014

  • Institute of Medicine Plans Ebola Research Workshop
  • Tuning Light to Kill Deep Cancer Tumors
  • Versatile Antibiotic Found With Self-Immunity Gene on Plasmid in Staph Strain
  • CMS Issues Preliminary Lab Fee Schedule Determinations for Genomic Testing CPT Codes
  • CMS Issues Preliminary Medicare Coverage Determination for GenomeDx's Prostate Cancer MDx
  • Defining Critical Value Lists and Limits: How can Labs Balance Efficiency and Patient Safety?
  • Personalized Ovarian Cancer Vaccines Set for Human Trials
  • New Front in War on Alzheimer’s, Other Protein-folding Diseases
  • HHS Awards Contract for Ebola Vaccine Shown to be 100 Percent Effective in Animal Tests
  • Staph aureus Scheme Cuts Surgical Infection
  • Healthcare Workers in the Firing Line of Ebola Crisis
  • Presenteeism Among Healthcare Workers: A Negative Effect on Patient Safety
  • CHIME Aligns With HL7 to Advance Interoperability
  • Despite Challenges, Panels See Progress on Healthcare Interoperability
  • 6 Interoperability Suggestions for ONC


View Previous Issues - Healthcare News Archive


Leading News

Institute of Medicine Plans Ebola Research Workshop
The Institute of Medicine said it will hold a one-day workshop Nov. 3 to examine the areas of biomedical and public health research that should be conducted to best prepare the United States to safeguard the public as a result of the emergence of Ebola.
IOM said the workshop, requested by the Department of Health and Human Services, will provide a venue for real-time discussions about immediate science needs that will inform HHS, public health officials, providers and the general public with the most up-to-date information about virus transmission, mitigation of health risks and appropriate measures to prevent the spread of the disease.

Tuning Light to Kill Deep Cancer Tumors
An international group of scientists led by Gang Han, PhD, has combined a new type of nanoparticle with an FDA-approved photodynamic therapy to effectively kill deep-set cancer cells in vivo with minimal damage to surrounding tissue and fewer side effects than chemotherapy. This promising new treatment strategy could expand the current use of photodynamic therapies to access deep-set cancer tumors. “We are very excited at the potential for clinical practice using our enhanced red-emission nanoparticles combined with FDA-approved photodynamic drug therapy to kill malignant cells in deeper tumors,” said Dr. Han, lead author of the study and assistant professor of biochemistry & molecular pharmacology. “We have been able to do this with biocompatible low-power, deep-tissue-penetrating 980-nm near-infrared light.”
In research published online by the journal ACS Nano of the American Chemical Society, Han and colleagues describe a novel strategy that makes use of a new class of upconverting nanoparticles (UCNPs), a billionth of a meter in size, which can act as a kind of relay station. These UCNPs are administered along with the photodynamic drug and convert deep penetrating near-infrared light into the visible red light that is needed in photodynamic therapies to activate the cancer-killing drug.

Versatile Antibiotic Found With Self-Immunity Gene on Plasmid in Staph Strain
A robust, broad spectrum antibiotic and a gene that confers immunity to that antibiotic are both found in the bacterium Staphylococcus epidermidis Strain 115. The antibiotic, a member of the thiopeptide family of antibiotics, is not in widespread use, partly due to its complex structure, but the investigators, from Brigham Young University, Provo, Utah, now report that the mechanism of synthesis is surprisingly simple. "We hope to come up with innovative processes for large-scale production and derivitization so that new, and possibly more potent versions of the antibiotic can become available, says co-corresponding author Joel S. Griffitts. The research is published ahead of print in Journal of Bacteriology.
Source: Web Site Icon


Laboratory Testing / Diagnostics

CMS Issues Preliminary Lab Fee Schedule Determinations for Genomic Testing CPT Codes
The Centers for Medicare & Medicaid Services has released its preliminary clinical laboratory fee schedule (CLFS) determinations Adobe PDF fileExternal Web Site Icon in which the agency said that new current procedural terminology (CPT) codes describing advanced genomic sequencing procedures will be priced through the gapfill process. In March, the American Medical Association announced that it had accepted new CPT codes for advanced genomic tests, which simultaneously analyze multiple disease-linked markers and use next-generation sequencing technologies. The types of tests addressed by these codes include whole-genome and -exome sequencing-based cancer panels. Industry players had suggested some of the codes be priced through gapfill and some through crosswalking. However, CMS has now determined that these CPT codes (81410 through 81471) will all be priced using the gapfill process next year.
Under gapfill, Medicare contractors are slated to set preliminary prices for the new genomic CPT codes in the first quarter of 2015, at which point the public will get a chance to provide input. Based on the final prices published by Medicare, CMS will set 2016 test prices. 

CMS Issues Preliminary Medicare Coverage Determination for GenomeDx's Prostate Cancer MDx
The Centers for Medicare and Medicaid Services on Thursday published a draft local coverage determination (LCD) for GenomeDx's Decipher genomic test for men who have undergone a radical prostatectomy. The determination relates to Medicare coverage for the test. 
The Decipher test is for use by men who have had a radical prostatectomy and are considered to be at high risk for the return of their cancer. Such patients include men who have specific risk factors for the recurrence of prostate cancer, including positive surgical margins, stage T3 disease, or rising prostate-specific antigen levels after initial PSA nadir when PSA is undetectable, GenomeDx said. The 22-biomarker assay uses oligonucleotide microarray technology to interrogate 1.4 million RNAs from formalin-fixed, paraffin-embedded tissue blocks of radical prostatectomy specimen, according to the CMS draft proposal. 

Defining Critical Value Lists and Limits: How can Labs Balance Efficiency and Patient Safety? 
In this interview, Christine Schmotzer, MD, discusses how to design a critical value list and steps that labs can take to balance efficiency with patient safety. Schmotzer is the medical director of clinical chemistry at University Hospitals Case Medical Center and an assistant professor of pathology at Case Western Reserve University School of Medicine in Cleveland, Ohio. Despite the importance of critical values in patient care and the emphasis on effective communication of these results in the past decade, there is no widely accepted guideline for defining which analytes should be on a critical value list and how the ­cutoffs should be assigned. Developing a critical value list remains at the discretion of each institution. In practice, a common group of tests—including glucose, potassium, hemoglobin, hematocrit, and platelets—appear on the critical value list of nearly every institution. The specific values for these commonly covered analytes, as well as other analytes that should be included beyond the common ones, vary considerably between institutions. 
The art of critical value policy and procedure is to call all life-threatening results while not inundating clinicians with information they already know and slowing lab flow with unnecessary calls. As with any process geared toward improving patient safety, communication is critical. The more interaction and discussion a laboratory has with its clinicians on establishing a critical value list and clinically-appropriate reporting processes, the greater the impact on overall patient safety. 
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Getting the Job Done
This issue of Critical Values features the delivery of laboratory medicine services under conditions of extreme isolation or stress—including at Concordia Station in Antarctica, and aboard the International Space Station. In the case of Antarctica, a core of medical laboratory services is available to researchers stationed there, including fairly complex technologies required to support ongoing research—a testament to the commitment of laboratory professionals and pathologists to get the job done even in the face of substantial adversity.
Fortunately, there seems to be a new wave of recognition of this remarkable transformation. Those who may have overlooked laboratory medicine are now rediscovering its wonder in the form of genomics, proteomics, and computational medicine4—areas currently undergoing the transition to automation that began decades ago for a generation of testing now considered routine. The modernization that took place in the second half of the last century is reborn in a new generation of analytical diagnostics.

The Risks and Benefits of Home Use Tests 
Several trends are driving home use testing, including an aging population and wider adoption of care models utilizing patient-­centered medical homes. Safety is as imperative in home health settings as in professional healthcare settings. An important point is that not all home testing requires a doctor's order. Home tests potentially risk bypassing physician care, inappropriate testing, self-diagnosis, self-treatment­, testing isolated from clinical context, and misinterpreted results. At the same time, many studies demonstrate that patients can do quite well. The Food and Drug Administration (FDA) approves home use tests based on evidence that participants can properly use the test kits, generate accurate results, and correctly interpret the results. 
In addition to the evidence supporting the clinical utility of home use testing for certain conditions, there can be financial benefits for patients. For individuals without insurance, or those with high-deductible insurance, home tests are more affordable, even with an out-of-pocket expense. Home monitoring will supplant some conventional intermittent laboratory testing practices in the near future. Automated implant technologies allow for continuous monitoring at home with remote result review. For example, vendors are racing to develop and launch real-time glucose monitoring technology. 
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Research and Development

Personalized Ovarian Cancer Vaccines Set for Human Trials
It may not be too long before there is a personalized vaccine to treat patients with ovarian cancer, according to a new study. Researchers from the University of Connecticut say the vaccine stems from a new technique that identifies protein mutations in cancer cells, and the method is already set to enter human trials. The research team, including co-principal investigator Dr. Pramod Srivastava of the Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut (UConn), publish their findings in the Journal of Experimental Medicine
The team notes that this process has been conducted in previous studies, but researchers have only looked at the strength of the immune system in binding to epitopes of cancer cells. This only works in developing vaccines against viruses. To create a vaccine against cancers, the team adopted a novel technique; they assessed the differences between the mice's cancer cell epitopes and the epitopes of their healthy cells. If these vaccines prove to be safe and effective, the researchers say they will move on to a phase 2 clinical trial to investigate whether they prolong the lives of patients with ovarian cancer. 

New Front in War on Alzheimer’s, Other Protein-folding Diseases
A surprise discovery that overturns decades of thinking about how the body fixes proteins that come unraveled greatly expands opportunities for therapies to prevent diseases such as Alzheimer’s and Parkinson’s, which have been linked to the accumulation of improperly folded proteins in the brain. “This finding provides a whole other outlook on protein-folding diseases; a new way to go after them,” said Andrew Dillin, the Thomas and Stacey Siebel Distinguished Chair of Stem Cell Research in the Department of Molecular and Cell Biology and Howard Hughes Medical Institute investigator at the University of California, Berkeley. Dillin, UC Berkeley postdoctoral fellows Nathan A. Baird and Peter M. Douglas and their colleagues at the University of Michigan, The Scripps Research Institute and Genentech Inc., will publish their results in the Oct. 17 issue of the journal Science.

HHS Awards Contract for Ebola Vaccine Shown to be 100 Percent Effective in Animal Tests 
The Department of Health and Human Services awarded Tuesday an $8.2 million contract to Baltimore-based Profectus BioSciences Inc. for research and development of an Ebola vaccine proven 100 percent effective in animal tests, according to the company. The Defense Department’s Joint Project Manager Medical Countermeasure Systems located at Ft. Detrick, Maryland, is working with Australia and Canada on development of the Profectus vaccine to defend against bio-weapon attacks and to help public health agencies in all three countries combat Ebola, the unit’s commander, Col. Russell Coleman said in a Sept. 24 presentation Adobe PDF fileExternal Web Site Icon.
In a paper Adobe PDF fileExternal Web Site Icon presented to an international vaccine conference in 2012, Profectus said its vaccine provided 100 percent protection for monkeys and guinea pigs in tests with the Zaire variant of Ebola. The company saidExternal Web Site Icon its research has been backed by grants from the National Institute of Allergy and Infectious Diseases.

HHS Advances Development of Third Ebola Vaccine
Under a one-year contract with Profectus BioSciences Inc., headquartered in Baltimore, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide approximately $5.8 million in funding, in addition to subject matter expertise and technical assistance, to further develop an experimental Ebola vaccine. The company will manufacture vaccine for use in animal safety studies and future clinical trials and conduct animal studies to test safety. Clinical trials are under way with other experimental vaccines. NIAID currently is supporting Phase 1 clinical trials that examine an investigational Ebola vaccine developed by GlaxoSmithKline and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp. Phase 2 clinical efficacy trials for these vaccine candidates are expected in 2015.

New Technique Helps Diagnose Consciousness in Locked-in Patients
People locked into a vegetative state due to disease or injuries are a major mystery for medical science. Some may be fully unconscious, while others remain aware of what’s going on around them but can’t speak or move to show it. Now scientists at Cambridge have reported in journal PLOS Computational Biology on a new technique that can help identify locked-in people that can still hear and retain their consciousness. Previously we’ve seen researchers use fMRI to recognize someone imagining playing tennisExternal Web Site Icon by detecting activity in the part of the brain responsible for controlling physical motion. The new research takes advantage of high-density EEG coupled with mathematical techniques from graph theory. They mapped out networks of activity within the brain and compared those with healthy individuals. Interestingly, those patients that were able to pass the imaginary tennis test also had networks that look similar to those produced by healthy brains.

Biocept, Rosetta Genomics Partner to Explore microRNA Analysis in CTCs for Cancer Diagnostics
Biocept and Rosetta Genomics said this week that they will pair Biocept's circulating tumor cell isolation technology with Rosetta's microRNA analysis platforms to investigate the possibility of developing blood-based cancer diagnostics and therapeutic response assays. For Rosetta, the partnership could provide it with additional new product opportunities as it seeks to diversify its current portfolio, which comprises microRNA-based cancer diagnostics that use tissue samples, President and CEO Ken Berlin told PCR Insider. 
Meantime, for Biocept, partnering with Rosetta gives it a foothold in the area of microRNA analysis, which fits into the company's strategy of applying its technologies to cellular and cell-free cancer biomarker detection, Biocept CEO Michael Nall told PCR Insider.
Source: Web Site Icon


Public Health and Patient Safety

Staph aureus Scheme Cuts Surgical Infection
Practices to eliminate Staphylococcus aureus are associated with significantly lower rates of surgical-site infection, according to a new study. The approach consists of screening the nostrils of patients for S aureus, decolonizing with mupirocin and chlorhexidine baths when necessary, and administering perioperative prophylactic vancomycin and cefazolin to patients with methicillin-resistant S aureus(MRSA). "We feel that if people actually did implement this bundle, it could substantially reduce patient morbidity and the cost of care," said Loreen Herwaldt, MD, from the University of Iowa Health Care in Iowa City. "Furthermore, it is very important to note that we really saw the effect only with the full bundle."
“Patients were followed for 90 days after surgery to monitor for surgical-site infection. Patients were screened for MRSA and methicillin-sensitive S aureus (MSSA) in the month before surgery, and were treated accordingly. If the screens were positive for any S aureus, patients were asked to apply intranasal mupirocin and to bathe with chlorhexidine for 5 days before surgery. We feel that if people actually did implement this bundle, it could substantially reduce patient morbidity and the cost of care.” 

Healthcare Workers in the Firing Line of Ebola Crisis
It is estimated that more than 425 HCPs [Health Care Professionals] have been infected, and 235 have died. According to estimates from the World Health Organization (WHO), the fatality rate is 57% among HCPs, whereas it is 47% in the general population. "Healthcare workers are Ebola's collateral damage," Håkon Bolkan, head of CapaCare, a nonprofit organization established in 2011 to train community health officers in Sierra Leone to perform life-saving surgeries, is quoted as saying in an article publishedExternal Web Site Icon in Science Daily. The discrepancy in fatality rates "is a natural occurrence, because healthcare workers are the ones who are dealing with patients infected with Ebola," WHO spokesperson Daniel Epstein is quoted as saying in response. However, that fatalistic notion is only part of the story. A number of factors have contributed to the high case and fatality rates among HCPs. For example, viral loads of the Zaire virus, which is responsible for the current outbreak, are higher than those seen in strains in previous epidemics.
"That means is that there's more virus in the blood, there's more virus in saliva, there's more virus in urine, there's more virus in any vomit or diarrhea," Jeremy Farrar, MD, director of the Wellcome Trust in the United Kingdom, told BBC Newsnight. "When you have more virus in those bodily fluids, it may be easier to transmit. The way it's transmitted has not changed.... But it may become more infectious if you have contact with those bodily fluids."

Presenteeism Among Healthcare Workers: A Negative Effect on Patient Safety 
Presenteeism received its name to contrast it with absenteeism, which refers to problems caused by not coming to work. The literature on presenteeism is dwarfed by the literature on absenteeism. In addition, discussions on loss of worker productivity dominate presenteeism literature, rather than the equally important effect of presenteeism on patient safety. The facts about presenteeism for healthcare workers are troubling. Healthcare workers, including physicians and nurses, are more likely to come to work sick than other workers. 
The solutions for reducing presenteeism are poorly studied but there is a reasonable consensus around some pragmatic measures. These include unrestricted paid sick leave of at least 3 days, meaning no need for certification from a medical doctor. Other worthwhile interventions include screening employees during infectious diseases outbreaks and enforcing back-to-work criteria, such as specifying the number of symptom-free days before resuming work. 
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Penn Medicine's 'Sepsis Sniffer' Generates Faster Sepsis Care and Suggests Reduced Mortality
An automated early warning and response system for sepsis developed by Penn Medicine experts has resulted in a marked increase in sepsis identification and care and transfer to the ICU, and an indication of fewer deaths due to sepsis. A study assessing the tool is published online in the Journal of Hospital Medicine. The Penn prediction tool, dubbed the "sepsis sniffer," uses laboratory and vital-sign data (such as body temperature, heart rate, and blood pressure) in the electronic health record of hospital inpatients to identify those at risk for sepsis. When certain data thresholds are detected, the system automatically sends an electronic communication to physicians, nurses, and other members of a rapid-response team, who quickly perform a bedside evaluation and take action to stabilize or transfer the patient to the intensive care unit if warranted.

Ebola may be Quietly Immunizing Many
A Canadian researcher is one of four scientists raising the issue that Ebola may be silently immunizing large numbers of people, who never fall ill or infect others yet become protected from future infection. Their letter was published in the medical journal The Lancet. If true, this finding could have significant ramifications for both projections of how widespread the disease will be, and strategies policy makers and health workers should use to contain the disease, say the authors. They call on public health authorities to determine how commonplace it is for people to be infected by Ebola without ever developing symptoms or spreading the disease and whether these individuals are then protected from future infection. The letter notes that researchers have found evidence of asymptomatic Ebola infection in the aftermath of earlier Ebola outbreaks, but it is yet unknown whether such infection provides immunity.
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Health IT

CHIME Aligns With HL7 to Advance Interoperability
The College of Healthcare Information Management Executives [CHIME], which represents more than 1,400 CIOs, and Health Level Seven International [HL7] are working together to promote a standardized approach for exchanging healthcare information and to highlight the importance of developing and adopting standards to achieve interoperability.
Key highlights of the HL7 28th Annual Plenary meeting included:
  • The potential benefits of a learning health system must be achieved for the industry to make important gains in effective treatment.
  • Standards initiatives, particularly HL7's Fast Healthcare Interoperability Resources, or FHIR, have the potential to address many of the concerns brought out in reports by JASON and other groups that have voiced concerns over interoperability.
  • Because the technology now is in widespread use to improve the health of patients, optimizing information exchange becomes an ethical issue; achieving interoperability is more than just the exchange of data as it directly impacts patients’ lives.

Despite Challenges, Panels See Progress on Healthcare Interoperability
There is interoperability in American healthcare, more than is generally thought, a federal health IT official and multiple advisers noted during a rare joint meeting Wednesday of the two main federally chartered health information technology advisory panels. The Health Information Technology Policy and Standards committees focused on national interoperability planning with the goal of releasing a first, final version of a 10-year national interoperability plan by spring. Physicians are lagging hospitals, somewhat, however, she said. In 2013, only about one-third of physicians could exchange different types of patient data such as lab results (36%), medication lists (34%) and problem lists (33%). Interoperability, or the lack thereof, has been the focus of growing criticismExternal Web Site Icon of federal efforts to promote the use of electronic health-record systems to improve quality and reduce the cost of care. 

6 Interoperability Suggestions for ONC
The highly anticipated final recommendations from the JASON task force arrived on Wednesday afternoon [Oct 14]. Here are the half-dozen recommendations the JASON task force made to ONC...:
  1. Focus on interoperability. ONC and CMS should re-align the meaningful use program to shift focus to expanding interoperability, and initiating adoption of Public APIs.
  2. Establish an industry-based ecosystem. A Coordinated Architecture based on market-based arrangements should be defined to create an ecosystem to support API-based interoperability.
  3. Set up Data Sharing Networks. The architecture should be based on a Coordinated Architecture that loosely couples market-based Data Sharing Networks.
  4. Enable the Public API as basic conduit of interoperability. The Public API should allow data- and document-level access to clinical and financial systems according to contemporary Internet principles
  5. Create Priority API Services. Core Data Services and Profiles should define the minimal data and document types supported by Public APIs
  6. Institute the government as market motivator. ONC should assertively monitor the progress of exchange and implement non-regulatory steps to catalyze the adoption of Public APIs.  

Study: EHRs Decrease Patient Safety Events
Advanced use of EHRs was associated with a steep decline in patient safety events, according to a new study presented at the Workshop on Health IT and EconomicsExternal Web Site Icon. In the study, researchers gathered data from a group of Pennsylvania hospitals between 2005 and 2012 in addition to patient safety data from the Pennsylvania Patient Safety Authority. Results showed advanced use of EHRs led to a 27 percent overall decline in patient safety events in both hospitals and physician practices. 

What Ebola Tells Us About Health IT Outbreak Needs
The Ebola cases in the United States, despite their limited numbers, have generated considerable discussion and anxiety. The discussion has included health IT because of the initial assertion that the Dallas hospital's electronic health record led to the first US Ebola case being sent home. That claim was subsequently refuted, but it initiated conversation about whether the EHR was really to blame and, eventually, how EHRs might lean forward and help in such circumstances. Unfortunately, either way, the focus on EHRs in these Ebola discussions does not recognize more prominent outbreak health IT needs nor the ways we have yet to meet most of these needs with incentives and infrastructure.
An EHR did not cause the initial Ebola illnesses in the US, but health IT is also not yet aligned to substantially help with outbreaks either. In-line with their usual progression, here are some outbreak needs that are shared in part by the Ebola, Anthrax, SARS, Monkey pox and other emergency events and some conclusions about their health IT support:
  1. “Index” case detection: Decision support for “index case” detection is still experimental, hard to implement in EHRs, and should not distract from the established and substantive health IT needs of outbreak management.
  2. “Screening” and Subsequent Case Detection: By all means implement “wide-net” provision of guidance and methods of follow-up, but don’t overemphasize the automation of whether a patient is a suspect case or not – first do no harm. Recognize the limits of the role EHRs play here and focus more on critical non-EHR health IT.
  3. Case Reporting: Case reporting from EHRs to public health should be a top priority for Meaningful Use. Funds should also be provided to public health to support their side of this data exchange.
  4. Case management: Certification of public health systems to ensure interoperability is needed. Just as in e-prescribing, when the non-EHR system involves more than just data analysis, there is a critical need to have a reliable, active and well-tested connection to it.
  5. Contact tracing: Measure and track the functionality of public health systems as well as EHRs. Implement training and routine use of appropriate systems before emergency events and ensure that personnel are certified in their use.
  6. Countermeasure Administration: Interoperable countermeasure administration systems should be supported, certified, tested, and available to support several different levels of available vaccines, drugs and other countermeasures.
  7. Research: Interoperable EHRs and other systems need to share data appropriately with research-related systems to best learn from emergency events and plan future responses.
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4 Pieces of NIH's Big Data Puzzle
The National Institutes of Health (NIH) plans to develop four initiatives to better analyze and leverage the explosion of information available from complex biomedical data sets, known as Big Data. The four components of the BD2K [Big Data to KnowledgeExternal Web Site Icon] awards are:
  1. Centers of Excellence for Big Data Computing: These 11 centers will focus on specific research questions....
  2. BD2K-LINCS Perturbation Data Coordination and Integration Center: This center will act as a data coordination clearinghouse....
  3. BD2K Data Discovery Index Coordination Consortium (DDICC): This program will create a consortium to begin a community-based development of a biomedical data discovery index....
  4. Training and Workforce Development: This program will offer awards to support the education and training of current and future generations of researchers....
The NIH’s effort is being developed in the context of a number of related projects elsewhere in the world, including those under development in the United Kingdom and Australia, and by the European Union.

Other News

Immune Therapy Induces Remission for Many With a Tough-to-treat Blood Cancer
An experimental immune-system therapy can often lead to complete remission in leukemia patients who have run out of other options, a new study confirms. Researchers found that 27 of 30 children and adults with advanced Acute Lymphoblastic Leukemia (ALL) went into full remission after receiving genetically tweaked versions of their own immune system cells. "Ninety percent of patients who had no options left went into complete remission. That's amazing," said senior researcher Dr. Stephan Grupp, of Children's Hospital of Philadelphia and the University of Pennsylvania. However, seven patients who went into remission did eventually suffer a relapse, according to the study. The findings, published Oct. 16 in the New England Journal of Medicine, confirm what smaller studies have suggested: The therapy offers hope to people with ALL that has repeatedly eluded standard treatments.
In July, the U.S. Food and Drug Administration granted the cell therapy a "breakthrough therapy" designation for advanced ALL – which could speed the treatment through the standard regulatory review process, according to the researchers.

Aethlon Hemopurifier Now Filtering Blood of Ebola Patient 
Now we learn that the Hemopurifier is being used to filter the blood of a Ugandan doctor in Germany who contracted Ebola while on a WHO mission in Sierra Leone. The device can be used with standard dialysis and continuous renal replacement therapy (CRRT) machines and doesn’t require any special hardware upgrades.
There is no word yet on how the patient is responding to this treatment, but the company claims that the Hemopurifier should help the patient by controlling the spread and replication of the viral load while also removing glycoproteins that are released that overwhelm the immune system. The doctors at the Frankfurt University Hospital promise to release news about the patient as soon as they have more concrete information on his status. In vitro validation studies that demonstrated the ability of the Hemopurifier to capture Zaire and other strains of Ebola virus were conducted by researchers at the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and the United States Centers for Disease Control and Prevention (CDC).

Another Look at Vitamin D: AHRQ Review Finds Limited Evidence for Benefits of Supplementation Beyond Bone Health
Vitamin D and calcium benefit the bones, but they may not be beneficial for other health outcomes, finds a new review by the Agency for Healthcare Research and Quality (AHRQ). The report, “Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update), Adobe PDF fileExternal Web Site Icon” says there is “inconsistent evidence regarding the effect of vitamin D alone or in combination with calcium on most health outcomes,” including heart disease, pregnancy, immune function, falls, and fractures, as well as breast, colon, and prostate cancers, and all-cause mortality. The authors examined 154 primary articles and two systematic reviews. They found that the findings were “inconsistent across studies for bone health; breast, colorectal, and prostate cancer; cardiovascular disease and mortality; immune function; and pregnancy-related outcomes.”

Intolerance of Error, and Blame Culture, Drive Medical Excess, Say US Doctors
A zero tolerance for error and uncertainty drives the culture of overdiagnosis and overtreatment, say two senior US doctors in The BMJ. Professor Jerome Hoffman and Veterans Affairs/Robert Wood Johnson fellow Hemal Kanzaria from the University of California argue that efforts to reduce overdiagnosis and overtreatment "should focus on changing professional and public attitudes towards medical error and uncertainty."  Instead, they suggest that intolerance of both uncertainty and error - among physicians, in the larger medical culture, and in general Western culture - may be the most important reason that physicians engage in medical excess. "Both need to be confronted if we are to tackle the problem of "too much medicine," they say. 

Breakthroughs in Narcolepsy: A Postinfectious Autoimmune Syndrome? 
A major breakthrough in narcolepsy came from studies demonstrating that the syndrome most typically is associated with particular human leukocyte antigen (HLA) haplotypesExternal Web Site Icon in patients. Patients with these HLA haplotypes are susceptible to narcolepsy on a sporadic basis, suggesting that there may be an autoimmune basis for narcolepsy in many patients. The next significant breakthrough was the linkage of a distinct genetic form of narcolepsy identified in experimental animals with mutations in the orexin/hypocretin ligand receptor. This linkage suggested that there may be a defect in the orexin/hypocretin-controlled hypothalamic circuit regulating sleep and arousal. What is the inciting event that leads to the loss of these neurons in patients with narcolepsy? Recent studies have suggested that H1N1 influenza might be the trigger for some patients in whom narcolepsy develops. One indication of this was epidemiologic data showing that narcolepsy has a seasonal incidence and that there wereincreases in incidence after H1N1 outbreaks Adobe PDF fileExternal Web Site Icon. Interestingly, there also were outbreaks associated with H1N1 vaccination in Scandinavian countries . 

VGTI Florida Launches the Center for Diseases of Aging
The Vaccine & Gene Therapy Institute of Florida (VGTI Florida) has announced the launch of its Center for Diseases of Aging (“CDA”), a major initiative to accelerate the discovery and advancement of novel, best-in-class healthcare interventions for the prevention and treatment of diseases commonly associated with aging. The CDA’s research teams include prominent medical scientists from Sweden’s renowned Karolinska Institutet on programs targeting infectious disease, cancers, neurodegenerative conditions, cardiovascular disease, metabolic disorders and related projects designed to boost overall immunity and vitality in the aging and elderly. Karolinska Institutet is perhaps best known internationally for its Nobel Assembly annually awarding the Nobel Prize in Physiology or Medicine.
Some of the innovative discoveries to be initially advanced at the CDA will include: personalized cancer vaccines to prevent recurrence of breast and ovarian cancers; novel T-cell therapies targeting malignant melanoma and other solid tumors; regenerative approaches to restore heart muscle and tissue following cardiovascular events; and next-generation anti-viral vaccines to boost immunity in the aging, including the development of a universal flu vaccine capable of protecting against any strain of influenza.

FDA Clears Brain Health Assessment App
The US Food and Drug Administration (FDA) has cleared a computerized cognitive test battery known as DANA, its developer, AnthroTronix, announced today [Oct. 17]. DANA is a phone- or tablet-based app for the Android or iOS operating system and can be used as part of the overall clinical assessment of a patient suspected of having cognitive or psychological problems, the company reports. "DANA provides clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual's medical or psychological state," a company news release explains Adobe PDF fileExternal Web Site Icon.

Prime Minister Declares a 'National Emergency' as the Caribbean Nation Works to Combat the Mosquito-borne Virus
Jamaican prime minister Portia Simpson Miller announced that the island nation is in a 'national emergency' this week over the outbreak of Chikungunya. The mosquito-borne virus shares similar symptoms to Dengue, often leading to fever and joint pain that can last from days to years. Earlier this month the Jamaican government launched an Emergency Response Team to coordinate national actions to contain the Chikungunya virus and reduce the number of cases. The disease has spread throughout the region since surfacing in St. Martin in 2013, with almost 800,000 suspected cases in the Caribbean reported. The majority of these are in the Dominican Republic.
Source: Web Site Icon

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