A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
October 11, 2012
Instructions for Clinical Teams Regarding Diagnostic Testing and Specimen Submission to CDC – Outbreak Associated With Injection of Potentially Contaminated Steroid Products
The pathogens involved in this cluster of infections are still under investigation. At present, there is culture and/or histopathologic evidence of fungal infection in at least 9 patients; isolates have included Aspergillus spp. and Exserohilum spp. Because the ranges of pathogens associated with this outbreak may not have been fully determined, it is important to perform a thorough diagnostic work-up in exposed patient with signs and symptoms of CNS and/or parameningeal infections or septic arthritis. The following algorithm has been developed to help guide clinicians in their diagnostic work-up. These instructions are meant to supplement routine laboratory and microbiologic test deemed necessary by the clinical team and should not replace existing diagnostic protocol.
Meningitis Outbreak Sparks Call for FDA Action
U.S. Sen. Richard Blumenthal is calling for stronger government oversight of so-called "compounding pharmacies" amid a meningitis outbreak in several states that has killed several people. The Connecticut Democrat said that he will be writing to U.S. Food and Drug Administration Commissioner Margaret Hamburg to ask for stricter scrutiny of such pharmacies. He said the facilities appear to operate in a "regulatory black hole" and are only marginally overseen by the FDA.
Federal officials have linked the outbreak to a steroid for back pain produced by the New England Compounding Center in Framingham, Mass. More than 60 people in nine states have contracted fungal meningitis.
GOP Lawmakers Urge Halt on Meaningful-Use Payments
HHS should suspend incentive payments to providers in the electronic health-records program and delay penalties to those that do not integrate health IT until the federal department can define clear, interoperable standards, House Republican leaders suggested in a letter to HHS Secretary Kathleen Sebelius.
ONC chief Dr. Farzad Mostashari, speaking to a conference of chief medical information officers in Chicago, when asked during a question-and-answer session about the letter, said that his office was initially created by executive order of Republican President George W. Bush and has ever since “enjoyed bipartisan support.” But “a few weeks before an election is still the silly season,” Mostashari said. “That's what they call it in Washington.”
FDA Cracks Down on Websites Selling Bad Drugs
The U.S. Food and Drug Administration said it has cracked down on thousands of online pharmacies for selling potentially unsafe, unapproved or fake medicines, including the erectile dysfunction drug Viagra and antiviral Tamiflu.
The FDA, working with international regulatory and law enforcement agencies from about 100 countries, said that it took action against more than 4,100 Internet pharmacies, bringing civil and criminal charges, removing offending websites and seizing drugs worldwide.
High Court to Determine States’ Take of Medical Liability Awards
The U.S Supreme Court in its current term will weigh how much state Medicaid programs are entitled to recoup from beneficiaries who win medical liability awards. Justices have agreed to hear oral arguments in Delia v. E.M.A. The case, officially accepted Sept. 25 by the high court, centers on whether a North Carolina law that requires such plaintiffs to return to the state up to a third of any tort payments they receive is overly broad. The ruling will impact how state Medicaid programs are allowed to designate what is fair reimbursement from patients who have received subsidized care for their injuries.
The [Supreme Court] will hopefully solve this conflict among the states and provide some kind of uniformity on how Medicaid is supposed to be reimbursed.”
A new bill strongly supported within the diagnostics industry could put pressure on the Centers for Medicare & Medicaid Services to alter its procedures for setting reimbursement rates for molecular diagnostics.
HR 6446, introduced last week by Representative Peter Roskam (R-IL), would require the Secretary of the Department of Health and Human Services to establish payment rates for new diagnostics under CMS's gap filling process by considering how the test impacts patient care, the technology underlying the test, utilization data, lab charges, private insurance rates, and recommendations from a new advisory panel.
AHRQ Wants to Develop Rating System for EHR's Patient Education Components
The Agency for Healthcare Research and Quality (AHRQ) wants to develop a health information rating system for measuring the success of electronic health systems (EHRs) in patient education. AHRQ is asking the Office of Management and Budget to approve a request for research and planning for a rating system, AHRQ announced in the Federal Register.
“Over the past several years, low health literacy has been identified as an important health care quality issue,” AHRQ wrote, citing one 2003 study estimating that only 12 percent of U.S. adults are proficient in health literacy and another study linking that lack of proficiency with as much as $73 billion in unnecessary healthcare spending every year. EHRs can connect “patients to helpful resources on treatment and self-management,” AHRQ wrote. “EHRs can also facilitate clinicians' use of patient health education materials in the clinical encounter.”
AHIMA Calls for Improved HI Governance to Unify Standards for EHR Use
The American Health Information Management Association (AHIMA) is calling for improved and unified health information governance to standardize electronic health record (EHR) use to ensure the technology fulfills its promise of guiding better, more efficient patient care.
AHIMA is ready to work with healthcare industry providers, health plans, quality organizations and vendors as well as the Department of Health and Human Services (HHS) to establish standards so healthcare providers have clear principles to guide their patient documentation.
AHIMA will analyze the latest feedback from its members as well as the findings from the AHIMA summit and expects to provide additional recommendations in early 2013.
HHS Plan Requires Employees to Outfit Personal Devices to Agency Standards
Health and Human Services Department employees who wish to work with personal smartphones and tablets should pay upfront for the configurations and services necessary to securely access agency information, according to a strategy from HHS’ Chief Technology Officers Council posted online.
Employees also should have to secure express approval from division technology chiefs before using personal devices for work, according to the HHS Mobile Technology Strategy [PDF 239.68KB]. Those divisions should be responsible for providing software that connects personal mobile devices with agency networks, the strategy said.
Source: Source: http://www.nextgov.com
Screening Guidelines for Cervical Cancer
Approximately 4,000 women in the United States die every year of cervical cancer. Fifty percent of women with cervical cancer have never been screened, and another 10% were not screened within the previous 5 years. Papanicolaou (Pap) testing has markedly reduced mortality from cervical cancer, helping lower it from first to 14th on the list of causes of cancer deaths in women.
New guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology address age-appropriate screening strategies, use of cytology and high-risk human papillomavirus (HPV) testing, follow-up, age to cease screening, and the approach to the HPV-vaccinated patient.
Strides in Medicine, and Their Price
Medicine has advanced more in the last century than in all of previous history, and technology’s fingerprints can be found on most of the gains — from new ways to teach medical students to care of patients in hospitals with the most sophisticated equipment to everyday practice in offices. Technology has even helped eradicate a disease, smallpox.
Laboratory and clinical techniques have allowed doctors to operate on the brain and heart, once considered taboo areas, and to perform other surgery through keyhole-size incisions, often with lasers.
But there can be too much of a good thing. Doctors may order a test because it is available or out of habit. Doctors were long taught to examine patients and then to order tests based on the various ailments they suspected a patient might have. Now, many doctors order CT X-ray scans and other costly tests before they even meet a patient. But the practice can be wasteful, subjects patients to unnecessary radiation and often creates a need for additional tests when an incidental finding is made simply to chase down a possible finding of unlikely significance
How to Raise a Laboratorian
Glen McDaniel met Jason at a local volunteer event. While we waited for the official set-up we exchanged pleasantries. At 19 years old, Jason is in his second year of college studying pre-pharmacy. When I suggested that pharmacy is a growing field with expanding scope of practice and great growth opportunity, Jason said almost dejectedly, "That's what everyone says." When he thought about pharmacy he felt no passion. He knew he wanted to "discover evidence" and so briefly considered becoming a forensic scientist or "a researcher of some sort", but he knew he also wanted to have his findings used in a more immediate way to make a difference right away.
I told him about medical laboratory science and his eyes lit up. "I thought lab technicians were trained on the job to help doctors, and not very well paid. You mean I can get a college degree, test human specimens and have the results used to make diagnosis?" Over the next couple of weeks we talked by phone several times and this young man has decided on his own to change his major to medical laboratory science. "This is something I could be passionate about and really get into," he said. "I even like that name; I could tell everyone I am a medical scientist!"
High school students uncover genes tied to prostate cancer.
What started as a high school science fair project has developed into groundbreaking preliminary research that could change the way prostate cancer is diagnosed and treated, improving the quality of life for thousands of men who face unnecessary treatment and severe side effects. The study, which appeared in the American Journal of Clinical Pathology, was authored by 18-year-old Ali Tradonsky and her friend Tammy Rubin.
The two teens worked with Tradonsky's mother, Dr. Sharon Mair, a pathologist and member of the American Society for Clinical Pathology, to identify four genes tied to prostate cancer prognosis. Tradonsky and Rubin began the study in 2009 with the goal of determining molecular cytogenetic markers that could help differentiate aggressive cases of prostate cancer from indolent cases
Prostate Cancer 'Barcode' Tests
A blood test that reads genetic results like a barcode can pick out the most aggressive prostate cancers, say experts. The test, which looks at the signature pattern of genes switched on and off in blood cells triggered by the tumour, can sort the "tigers" from the "pussycats".
London's Institute of Cancer Research trialled the test in 94 patients. The findings are published in the Lancet Oncology medical journal.
Newborn Genetic Test Catches Rare Diseases Earlier
A new technology can diagnose rare genetic disorders in critically ill newborns within a few days, rather than the weeks that are needed with current methods, researchers say. The technology involves sequencing the infant's genome, and then using new software to hone in on the genes most likely to be disease culprits. In a new study, researchers identified the genetic cause of a newborn's illness in three out of four babies tested. The whole process takes about 50 hours, they said.
Diagnosing genetic diseases
To begin a diagnosis with the new technology, the researchers take a drop of the baby's blood so that his or her genome can be sequenced. Next, a physician enters the patient's symptoms into a software program. The program scans the newborn's genome looking for genes that are likely to cause such symptoms.
The program identifies only diseases that are caused by a single genetic mutation. The researchers tested their program on 500 cases of children who had already been diagnosed, and found it was more than 99 percent accurate in finding the correct gene mutation that was causing the patient's symptoms. The researchers also tested the technology on four NICU babies who had not yet been diagnosed with a condition. In one case, the researchers quickly identified a gene that causes epilepsy.
A gene test that can identify people at risk for mouth cancer has been developed by British researchers. The test detects precancerous cells in patients with benign-looking mouth lesions and could lead to earlier treatment for at-risk patients and improve their chances of survival, according to the team at Queen Mary, University of London.
They used the quantitative Malignancy Index Diagnostic System test -- which measures the level of 16 genes -- on more than 350 head and neck tissue specimens from nearly 300 patients and found that it had a cancer detection rate between 91 percent and 94 percent.
The study was published Oct. 4 in the International Journal of Cancer.
A Simple Blood Test Could Be Used To Detect Breast Cancer
University of Leicester and Imperial College London in study to determine whether DNA in blood could show early signs of cancer A SIMPLE blood test could one day be a more accurate way to test for the early signs of breast cancer than using mammograms to spot a lump say researchers, as Breast Cancer Awareness Month gets underway. They also hope the blood test could improve treatment by detecting whether breast cancer patients are likely to relapse and what drugs their particular type of tumour will respond to.
This pioneering new clinical study – funded by Cancer Research UK in collaboration with the University of Leicester and Imperial College London – is about to start in the UK's largest breast screening clinic at Charing Cross Hospital, London. Researchers will take blood samples from women attending the breast screening clinic and compare the DNA in the blood of women who are diagnosed with breast cancer with those that do not have cancer to see what DNA markers are consistent.
Dr Jacqui Shaw, principal investigator from the University of Leicester, said: "This exciting research means we could one day have a blood test that detects the very early signs of cancer meaning women could have an annual blood test rather than breast screening. This would remove any worry and anxiety for women who are called for further investigations after a mammogram only to find they don't have cancer.
Blood Test Developed That Accurately Detects Early Stages of Lung, Breast Cancer in Humans
Researchers at Kansas State University have developed a simple blood test that can accurately detect the beginning stages of cancer. In less than an hour, the test can detect breast cancer and non-small cell lung cancer -- the most common type of lung cancer -- before symptoms like coughing and weight loss start. The researchers anticipate testing for the early stages of pancreatic cancer shortly. The test was developed by Stefan Bossmann, professor of chemistry, and Deryl Troyer, professor of anatomy and physiology.
Nanotechnology Device Aims to Prevent Malaria Deaths Through Rapid Diagnosis
A pioneering mobile device using cutting-edge nanotechnology to rapidly detect malaria infection and drug resistance could revolutionize how the disease is diagnosed and treated.
The device - the size and shape of a mobile phone - will use a range of latest proven nanotechnologies to rapidly analyse the parasite DNA from a blood sample. It will then provide a malaria diagnosis and comprehensive screening for drug susceptibility in less than 20 minutes, while the patient waits. With immediately available information about the species of parasite and its potential for drug resistance, a course of treatment personally tailored to counter resistance can be given.
Manipulating and Measuring Magnetic Particles without Contact, Potentially Enabling Multiple Medical Tests on a Tiny Device
If you throw a ball underwater, you'll find that the smaller it is, the faster it moves: A larger cross-section greatly increases the water's resistance. Now, a team of MIT researchers has figured out a way to use this basic principle, on a microscopic scale, to carry out biomedical tests that could eventually lead to fast, compact and versatile medical-testing devices. The results, based on work by graduate student Elizabeth Rapoport and assistant professor Geoffrey Beach, of MIT's Department of Materials Science and Engineering (DMSE), are described in a paper published in the journal Lab on a Chip.
This new technique, for the first time, allows these beads - each about one micrometer, or millionth of a meter, in diameter - to be used for precise measurements of tiny quantities of materials. This could, for example, lead to tests for disease agents that would need just a tiny droplet of blood and could deliver results instantly, instead of requiring laboratory analysis.
Rapid Diagnostic Tests Inspired by Nature
By mimicking nature's own sensing mechanisms, bioengineers at UC Santa Barbara and University of Rome Tor Vergata have designed inexpensive medical diagnostic tests that take only a few minutes to perform. Their findings may aid efforts to build point-of-care devices for quick medical diagnosis of sexually transmitted diseases (STDs), allergies, autoimmune diseases, and a number of other diseases. The new technology could dramatically impact world health, according to the research team.
The rapid and easy-to-use diagnostic test consists of a nanometer-scale DNA "switch" that can quickly detect antibodies specific to a wide range of diseases. The research is described in an article published this month in the Journal of the American Chemical Society.
Clinical Study Highlights Detection of Fetal Trisomy 13 With the Harmony™ Prenatal Test - Majority of Cases Detected
A new study published in the journal Ultrasound in Obstetrics and Gynecology, is the largest study to date of non-invasive prenatal testing (NIPT) for detecting fetal trisomy 13 (T13) and provides further evidence of the Harmony Prenatal Test's utility for detection of genetic conditions. T13 causes Patau syndrome and affects approximately one in 16,000 newborns. T13 is also associated with a high rate of spontaneous miscarriage
The test analyzes cell-free DNA circulating in maternal blood, which allows a high level of accuracy for detecting fetal trisomies. The test involves a single standard blood draw performed as early as 10 weeks' gestation.
Alternative Biomarkers Found for Head and Neck Cancers
Human papillomavirus is a cause of some head and neck cancers, including oropharyngeal cancer, and patients with this viral-associated disease tend to have a better clinical outcome.
Human papillomavirus (HPV) DNA positivity alone, particularly when assessed using polymerase chain reaction (PCR) methods, is a poor biomarker for HPV-driven head and neck cancers, and alternative potential markers are needed.
Scientists at the German Cancer Research Center (Heidelberg, Germany) analyzed 199 oropharyngeal squamous cell carcinoma specimens for HPV DNA, viral load, ribonucleic acid (RNA) expression patterns seen in cervical carcinomas and the HPV-targeted tumor suppressor protein p16. Their results indicate that the cervical cancer RNA expression pattern and viral load were associated with the lowest risk for death from oropharyngeal cancer. In contrast, a weaker association was found for samples that were HPV DNA-positive or that expressed the protein p16, which is associated with tumor suppression.
Are You Likely to Respond to Exercise?
Research has confirmed that people’s physiological responses to exercise vary wildly. Now a new genetic test promises to tell you whether you are likely to benefit aerobically from exercise. The science behind the test is promising, but is this information any of us really needs to know?
The new test, which is being sold by a British company called XRGenomics, is available to anyone through the company’s Web site and involves rubbing inside your cheek with a supplied swab and returning the tissue sample to the company. Results are then available within a few weeks. It is based on a body of research led by James Timmons, a professor of systems biology at Loughborough University in England, and colleagues at the Pennington Biomedical Research Center in Louisiana and other institutions.
That original research, published in a landmark 2010 study, looked into the genetics of why some people respond to endurance exercise so robustly, while others do not. Some lucky men and women take up jogging, for example, and quickly become much more aerobically fit. Others complete the same program and develop little if any additional endurance, as measured by increases in their VO12 max, or their body’s ability to consume and distribute oxygen to laboring muscles.
FDA Clears Focus Diagnostics' Flu Test on 3M Integrated Cycler
The US Food and Drug Administration has given 510(k) clearance to Focus Diagnostics' Simplexa Flu A/B & RSV Direct test, Focus and 3M announced. The test, which aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus, was developed by Focus, a Quest Diagnostics business, which makes the Simplexa brand of molecular test kits, and runs on the 3M Integrated Cycler. The firms also launched the test in the US. The test, developed through, a collaboration by the two firms forged in 2009, received CE marking in 2011.The test, they said, is the first moderate-complexity molecular test from Focus' Simplexa product line
The Biomedical Advanced Research and Development Authority, within the US Department of Health and Human Services, awarded a $5.9 million contract for the development of the test.
Alere Inc said it reached an agreement with U.S. health regulators on product specifications related to the manufacture of its diagnostic test for critical disease. In March, the U.S. Food and Drug Administration began an inspection of the company's San Diego facility questioning the labeling and quality control of its Triage products.
While the agreement with the FDA will lead to lower manufacturing yields of the Triage products, the company will raise production to 3.3 million tests per month to meet demand, Alere said in a regulatory filing. "This represents closure on long process on discussions with the FDA and makes for a much clearer path for Triage business going forward," Wedbush Securities analyst Zarak Khurshid said.
Court Rules in Favor of Hologic's Gen-Probe in Patent Infringement Suit With BD
Hologic said that it has received a favorable ruling in the patent infringement lawsuit filed by subsidiary Gen-Probe against Becton Dickinson. In a decision handed down by the US District Court for the Southern District of California, Gen-Probe was granted summary judgment motions of direct infringement. Specifically, the court ruled that BD's ProbeTec Qx CT/GC assays for chlamydia and gonorrhea on the BD Viper system with XTR technology and its GBS assays on the BD Max system infringe three of Gen-Probe's patents covering automated nucleic acid testing. Hologic said that the court also granted summary judgment that BD's specimen collection products, used in conjunction with its ProbeTec Qx CT/GC assays, infringe another Gen-Probe patent covering penetrable caps.
A jury trial on remaining issues is scheduled to begin on Dec. 4.
Mitomics Inks Sales and Marketing Deal With LabCorp
Mitomics announced a deal with Laboratory Corporation of America to offer Mitomics' molecular prostate cancer test. Under the terms of the deal, urologists will be able to order Mitomics' Prostate Core Mitomic Test through Dianon Systems, LabCorp's specialized laboratory subsidiary focused on anatomic pathology. The mitochondrial DNA-based test uses previously obtained prostate biopsy tissue to determine the presence of malignant cells "via a cancerization field effect" by detecting molecular changes in tissue that appears normal.
Acquiring Pathology Laboratory Billing Expertise, McKesson Buys MED3000, Parent of PSAPath
Positioning itself to serve accountable care organizations, McKesson agrees to buy a company specializing in medical billing and physician practice management McKesson Corporation announced an agreement to acquire MED3000 of Pittsburgh, Pennsylvania. One aspect of this transaction will be of particular interest to anatomic pathologists and pathology practice administrators. When it closes the sale, McKesson’s ownership of MED3000 will increase its overall national market share of pathology billing and collection contracts.
Two Surveys Raise Questions about Willingness of Consumers to Pay Pathology Laboratories for Expensive Genetic Cancer Tests
This finding is reinforced by the fact that high-deductible health plans are now the second most popular plan option offered by the nation’s employers
Getting paid for expensive genetic cancer tests is likely to be tougher for clinical laboratories when the patient is covered by a high-deductible health plan. There are two trends that are contributing to this situation, each highlighted by recently-published studies.
One trend is the rapid growth of consumer-driven health plans (CDHPs). The second trend is growing evidence that patients, if they need to pay much money out of pocket, will decline to undergo genetic testing that is suggested by their physicians.
In a bioengineering laboratory at Stanford University, Christopher Contag, a microbiologist, is designing new approaches to “virtual” pathology. He has created a variety of instruments that can travel the esophagus, stomach and intestine, allowing pathologists to probe for cancers by peering in three dimensions below the surface of the skin.
Frustrated by the time between when a tissue sample is taken and when a pathology laboratory can examine it, Dr. Contag, who oversees a molecular imaging laboratory at Stanford, is experimenting with a variety of next-generation endoscopes. The new devices not only portray the surface of the skin, but also use a variety of optical and acoustical techniques to virtually “punch holes” in hundreds
Researchers Wring Hands as U.S. Clamps Down on Death Record Access
A shift last year by the Social Security Administration to limit access to its death records amid concerns about identity theft is beginning to hamper a range of research, including federal assessments of hospital safety and efforts by the financial industry to spot consumer fraud.
The Social Security Death Master File is an index of 90 million deaths that have been reported to the agency over 75 years by survivors, hospitals, funeral homes and state offices. The listings include names, Social Security numbers and dates of death.
The agency did not make the information public until 1980, after a legal ruling required that the data be disclosed. The list is updated weekly, and although it is neither comprehensive nor 100 percent accurate, it is considered the most current record of deaths nationwide, making it a rich trove for researchers.
A death index kept by the federal Centers for Disease Control and Prevention that, while more complete, is typically 14 months to 18 months out of date. In response to pressure from panicked medical researchers, the C.D.C. hopes to start updating its death index more quickly, but it will not be able to reduce the cost, said Charles J. Rothwell, the director of vital statistics. Federal agencies with a stake in medical research have been lobbying Social Security officials to consider a compromise.
In Congress, concerns about identity theft — some driven by tax fraud cases involving deceased children — have prompted proposals to restrict access even further.
Fresh Blood Cells No Better for Preemies
Outcomes in premature infants did not improve with use of fresh red blood cells (RBCs) compared with standard blood-banking practices, a randomized trial showed.
About 53% of infants had at least one of the adverse outcomes included in the composite, regardless of whether they received fresh or standard RBCs. Use of fresh RBCs also did not afford protection against nosocomial infection among premature newborns.
"Among critically ill premature infants, fresh RBC transfusions compared with standard RBC transfusion practice did not decrease or increase rates of complications or death in our composite measure," Dean A. Fergusson, PhD, of the Ottawa Hospital Research Institute in Ontario, and co-authors wrote in an article published online in JAMA.
Mouse Stem Cells Used to Produce Eggs, Japanese Scientists Say
Reaching a long-sought milestone, Japanese researchers have demonstrated in mice that eggs and sperm can be grown from stem cells and combined to produce healthy offspring, pointing to new treatments for infertility.
If the achievement can be repeated in humans — and experts said they are optimistic that such efforts will ultimately succeed — the technique could make it easier for women in their 30s or 40s to become mothers. It could also help men and women whose reproductive organs have been damaged by cancer treatments or other causes.
About one in 10 American women of childbearing age have trouble becoming or staying pregnant, and more than one-third of infertile couples must contend with a medical problem related to the prospective father, according to the national Centers for Disease Control and Prevention in Atlanta. Using current technology, only about one-third of attempts at assisted reproduction result in live births, CDC data show. Scientists, doctors and patients would like to boost that percentage.
Viruses Could Sanitize Water Plants and Fight Deadly Superbugs
Scientists who have developed a way of using viruses to kill colonies of the common disease-causing bacteria Pseudomonas aeruginosa, say it could be adapted to sanitize water treatment plants and help fight deadly antibiotic-resistant bacteria or so-called "superbugs". In a paper published recently in the journal Biotechnology and Bioengineering, Zhiqiang Hu, associate professor in the department of civil and environmental engineering at the University of Missouri, and Yanyan Zhang, a recent graduate of the department, describe how they used a group of viruses known as bacteriophages to tackle the challenge of destroying bacterial biofilms.
Hu says in a press statement: "Our experiment was the first to use bacteriophages in conjunction with chlorine to destroy biofilms, which are layers of bacteria growing on a solid surface."
Scientists have discovered a system that drains waste products from the brain. The finding may reveal new ways to treat neurodegenerative disorders like Alzheimer’s disease. Our bodies remove dead blood cells and other waste through a network of vessels called the lymphatic system. The brain, however, has a different method of keeping clean. Cerebrospinal fluid cleanses brain tissue. But how the fluid moves through the brain and clears waste wasn't well understood. Until now, scientists could only study brain tissue in animals that were already dead.
Tomatoes for Stroke Prevention?
Lycopene, which is found in high concentrations in tomatoes and tomato-based products, may lower stroke risk in men, researchers found.
Compared with the men who had the lowest serum concentrations of the carotenoid, those with the highest concentrations had significantly lower risks of any stroke (HR 0.45, 95% CI 0.25 to 0.95) and ischemic stroke (HR 0.41, 95% CI 0.17 to 0.97), according to Jouni Karppi, PhD, of the University of Eastern Finland in Kuopio, and colleagues. The relationships remained significant after adjustment for age, examination year, body mass index, systolic blood pressure, smoking, serum LDL cholesterol, diabetes, and history of stroke, the researchers reported in the Oct. 9 issue of Neurology.
The reason carotenoids in general might be expected to have an effect on stroke risk is that "oxidative stress through formation of reactive oxygen species plays a vital role in mediation of neuronal damage during cerebral ischemia," and carotenoids are antioxidants, according to the researchers.
"One possible reason that lycopene might decrease the risk of stroke more than other antioxidants ... may be the consequence of antioxidant activity," they wrote. "Lycopene is a potent antioxidant and the most effective quencher of singlet oxygen, and it was reported to be more effective than beta-carotene in cell protection against hydrogen peroxide and nitrogen dioxide radicals." Lycopene also has other functions -- reducing inflammation, blocking cholesterol synthesis, boosting immune function, and inhibiting platelet aggregation and thrombosis.
Thousands Exposed to Tainted Steroid, C.D.C. Says
About 13,000 people may have been exposed to the tainted steroid that has been linked to a growing outbreak of fungal meningitis, a spokesman for the Centers for Disease Control and Prevention said on Monday. The outbreak has killed 8 people and sickened 97 others in 23 states. More cases are expected.
The figure, the first estimate of how many people were injected with any of the 17,676 doses shipped around the country, is based on reports from state health departments and clinics that used the drug, methylprednisolone acetate. It was injected near the spine to ease back and neck pain, a treatment that about five million people in the United States undergo every year.
CDC Targets Holdout Health Workers on Flu Shots
All health care workers should receive the influenza vaccine for the upcoming flu season, not just the roughly two-thirds of them that did so during the previous season, federal health officials recommended. Still, physicians, nurses and other health workers do better on flu vaccination rates than the entire U.S. public, nearly all of whom are urged to receive the shots but fewer than half of whom actually do.
The Centers for Disease Control and Prevention issued its general recommendation for most of the U.S. population to be vaccinated against the influenza virus during a Sept. 27 briefing sponsored by National Foundation for Infectious Diseases in Washington.
Will a “Silent Exodus” from Medicine Worsen Doctor Shortage?
Frustrated by mounting regulation, declining pay, loss of autonomy and uncertainty about the effect of health system reform, doctors are cutting back the number of hours they work and how many patients they see.
Between 2008 and 2012, the average number of hour’s physicians worked fell by 5.9%, from 57 hours a week to 53, and doctors saw 16.6% fewer patients, according to a survey of nearly 14,000 doctors released in September. If the trend continues through 2016, it would equate to the loss of 44,250 full-time physicians, said the report, conducted by the doctor-recruiting firm Merritt Hawkins & Associates for the Physicians Foundation.
Accountable care organizations (ACOs) that improved diabetes outcomes by as much as 10% achieved minimal or no cost savings, results of a published simulation showed. The simulation found that a 10% clinical improvement would create just 1.22% in savings for Parts A and B -- well below the level needed to trigger savings sharing, results published online in Health Affairs showed. That's bad news for those who were hoping to reap some revenue from ACOs.
Medicaid’s High Marks on Preventive Care Contrary to its Stingy Image
A new study indicates that most state Medicaid programs are doing an above-average job of covering needed preventive services for beneficiaries.
States generally aren’t required to cover preventive services for Medicaid adults at the same levels as they do for children. But in surveying 48 states (Hawaii, Wisconsin and the District of Columbia did not participate), the Kaiser Commission on Medicaid and the Uninsured found that most state Medicaid programs covered the bulk of 42 recommended services for nonelderly adults through fee for service, particularly for cancer and sexually transmitted infection screenings as well as pregnancy care.
Medicare Fraud Strike Force Charges 91 Individuals for Approximately, $430 Million in False Billing.
Medicare Fraud Strike Force operations in seven cities have led to charges against 91 individuals – including doctors, nurses and other licensed medical professionals – for their alleged participation in Medicare fraud schemes involving approximately $429.2 million in false billing, Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius announced.
Attorney General Holder and Secretary Sebelius were joined in the announcement of the nationwide takedown by Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division, FBI Associate Deputy Director Kevin Perkins, Inspector General Daniel R. Levinson of the HHS Office of Inspector General (HHS-OIG) and Dr. Peter Budetti, Deputy Administrator for Program Integrity of the Centers for Medicare and Medicaid Services (CMS).
BYOD Security Monitoring Is Not the Norm
More than 82 percent of federal computer security professionals have policies for safeguarding government data on employees’ personal smartphones -- but most have no idea whether those policies are being followed every day, according to new research.
The findings of the survey by cybersecurity compliance firm nCircle suggest that many agencies are embracing the concept of bring-your-own-device, or BYOD, for office work. Yet they are sacrificing data protection to make that happen. While government-owned electronics use “continuous monitoring” -- or near-real-time reporting of security status through sensors and other automated tools -- the technology to track personal devices doesn’t quite exist in the government yet, the study revealed.
Britain’s Gurdon, Japan’s Yamanaka Share Nobel Medicine Prize for Stem Cell Research
Two scientists from different generations won the Nobel Prize in medicine for the groundbreaking discovery that cells in the body can be reprogrammed into completely different kinds, work that reflects the mechanism behind cloning and offers an alternative to using embryonic stem cells.
The work of British researcher John Gurdon and Japanese scientist Shinya Yamanaka — who was born the year Gurdon made his discovery — holds hope for treating diseases like Parkinson’s and diabetes by growing customized tissue for transplant. And it has spurred a new generation of laboratory studies into other illnesses, including schizophrenia, which may lead to new treatments.
Basically, Gurdon, 79, and Yamanaka, 50, showed how to make the equivalent of embryonic stem cells without the ethical questions those very versatile cells pose, a promise scientists are now scrambling to fulfill. Once created, these “blank slate” cells can be nudged toward developing into other cell types. Skin cells can ultimately be transformed into brain cells, for example. Just recently scientists reported turning skin cells from mice into eggs that produced baby mice, a possible step toward new fertility treatments.
Medical device groups were quick to criticize aspects of the new regulatory guidelines, which still need to clear hurdles before final implementation, saying certain updates stall innovation rather than bolster safety.
European authorities have been assessing medtech review standards, which haven't changed much in 2 decades, since the European Commission in 2008 identified several vulnerabilities. Regulators came under intense pressure to revise security standards for medical devices after a wide-scale breast implant recall dramatically exposed weaknesses in the system.
Johns Hopkins to Help Establish Network of Clinics in India
Baltimore-based Johns Hopkins Medicine International has agreed to establish a network of outpatient primary-care clinics throughout India with India-based Bharat Family Clinic.
The partnership will allow faculty from Johns Hopkins to advise the privately owned Bahrat Family Clinic on developing clinical programs and to help with the facility design and operation of both primary and secondary clinics across the country. The first clinic is scheduled to open in November and the rest will follow over the next decade.
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