A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
June 13, 2013
- CDC Releases New H7N9 Testing Recommendations
- Triple Threat: Middle East Respiratory Virus And 2 Bird Flus
- Lab Group Submits Citizen Petition Against FDA Regulation of Lab Developed Tests
- The ‘70% Claim’: What is the Evidence Base?
- Trends in Laboratory Test Volumes for Medicare Part B Reimbursements, 2000–2010
- MDx Best Practices
- Rapid Malaria Test Uses the Power of Magnets
- Tiny Patients, Major Goals
- Promising New Cancer Drugs Empower the Body’s Own Defense System
- 15% Of Reusable Endoscopes Contaminated With Harmful Bacteria
- Research Forgotten by Budget Cuts
- Cleveland Clinic Opens EMR to Patients
View Previous Issues - Healthcare News Archive
CDC Harnesses Technology to Protect People and Save Lives
For more than 50 years, CDC's National Health and Nutrition Examination Survey (NHANES) has gathered gold-standard information about the health and nutritional status of Americans. NHANES data have been used by researchers to reveal and study key health issues ranging from arsenic levels in food to insights into our nation's obesity epidemic, and have provided businesses with crucial information about U.S. health trends that would be difficult to gather independently. NHANES data also help inform numerous policies, including driving a critically important decision that eliminated lead from gasoline.
And today CDC continues to work with cutting-edge technology to address public health challenges. For instance CDC is collaborating with the Georgia Institute of Technology (Georgia Tech), Oakridge National Laboratory and the NVIDIA Center of Excellence to leverage supercomputers and 3D printing to speed the discovery processes related to preventing 20 million hepatitis E infections each year. Thanks to the Keeneland supercomputer, researchers are accelerating numerical modeling 300 times faster than before, which will ultimately help prevent the spread and impact of hepatitis E and similar viruses.
As another example, CDC's BioMosaic tool, a collaboration with HealthMap and BioDiaspora, maps population migration and health data. That's important because exposures to infectious diseases differ around the world, and every year close to 500,000 immigrants come to the United States. Once fully implemented, BioMosaic will help health workers better understand the health needs of foreign-born populations in the United States and assist with public health planning in times of crisis.
CDC's Urgent Need for Expanded Capacity
While CDC has many success stories related to harnessing technology for data analytics, there is an urgent need for CDC to continue to grow its capacity for advanced science and technology. As the nation's health security agency, we rely on CDC to solve dangerous mysteries about what's making people sick. Five microbes (and counting) are nearly resistant to all available drug treatments. A deadly new coronavirus that emerged in the Middle East last year continues to sicken and kill people, even as CDC, the World Health Organization (WHO) and others are investigating the virus and how it spreads. In these times of shrinking federal budgets we can't afford to give the advantage to life-threatening diseases.
Germs will continue to evolve. Technology has to advance to keep pace.
CDC Releases New H7N9 Testing Recommendations
Only patients who meet specific exposure criteria and have respiratory illness severe enough to require hospitalization should be tested for H7N9 influenza, according to a June 7 Health Update from the Centers for Disease Control and Prevention (CDC).
The update also directs practitioners to report only confirmed and probable cases of human infection with H7N9 to the CDC.
Previous recommendations on April 5 directed testing of all patients with relevant exposure and influenza-like illness, regardless of illness severity. The changes in testing recommendations are the result of the current epidemiology of H7N9, which has shown that most infections have caused severe illness, and only rarely mild illness. The World Health Organization has released similar recommendations.
2013 Coronavirus Emergency Use Authorization (Potential Emergency)
On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the Middle East respiratory syndrome coronavirus (MERS-CoV).
On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors. This device will be distributed by CDC to qualified laboratories.
Triple Threat: Middle East Respiratory Virus and 2 Bird Flus
The World Health Organization is warning health care workers everywhere to suspect a disease called Middle Eastern Respiratory Syndrome, or MERS, whenever they see a case of unexplained pneumonia. This warning comes at the end of a six-day WHO investigation in Saudi Arabia, where 40 of the 55 cases of the respiratory disease have occurred. Sixty percent of those people with known infections died.
Meanwhile, recent reports in the journal Cell present evidence that two other worrisome viruses — H5N1 and H7N9 flu — may be on the verge of becoming more contagious in humans. Recent samples of these bird flu viruses are only one or two genetic mutations away from developing the ability to latch onto receptors lining the respiratory tracts of humans, biologists at the Massachusetts Institute of Technology say. "Some of them are one amino acid away from achieving the necessary strength or affinity to latch onto human receptors," Ram Sasisekharan of MIT tells Shots. "That's a key step."
Lab Group Submits Citizen Petition Against FDA Regulation of Lab Developed Tests
In its Citizen Petition, dated June 4, ACLA maintains that LDTs are not medical devices and as such do not fall under the agency's oversight as laid out under the Federal Food, Drug, and Cosmetic Act. ACLA has asked the agency to respond to its petition by confirming that LDTs are not devices as defined by the law. In short, according to ACLA, the FDCA defines devices as articles, such as an instrument, machine, or in vitro reagent that is used to diagnose disease.
The petition comes a few days after FDA Commissioner Margaret Hamburg spoke at the American Society of Clinical Oncology's annual meeting about the agency's intent to regulate LDTs, reviving a contentious issue over which the FDA has repeatedly clashed with the laboratory industry in recent years. Hamburg said at ASCO that the FDA is in the process of developing a risk-based regulatory framework for LDTs. "The agency is working to make sure that the accuracy and clinical validity of high-risk tests are established before they come to the market," she said.
In contrast to ACLA's position, many drug and device manufactures that support FDA regulation of LDTs believe that CLIA doesn't have sufficient measures in place to ensure the clinical validity of tests, and they have pushed for all diagnostics to be overseen under one regulatory pathway. Genentech submitted a Citizen Petition in 2008, saying as much.
In its petition, ACLA also highlighted the ability of labs under CLIA to quickly make available critical tests of public health importance before the FDA can approve such tests.
Medicare, the U.S. health program for the elderly and disabled, spends $900 million more a year than it should for medical lab services and should seek authority from lawmakers to cut its bills, auditors said. Medicare spent about $8.2 billion on lab services in 2010, more than any other insurer in the nation, while paying from 18 percent to 30 percent more for 20 of the highest-volume and most expensive tests, according to the Health and Human Services Department’s inspector general. The Centers for Medicare & Medicaid Services, which runs the $574 billion health program, said the agency is exploring whether it can revise payments to labs, according to a report issued by Daniel Levinson, the HHS inspector general. “The lab test payment rate structure is outdated and should be changed,” Levinson said in his report.
Quest Diagnostics Inc. (DGX) and Laboratory Corporation of America Holdings, the two largest lab services companies in the U.S., each receive at least 15 percent of their annual revenue from Medicare, according to data compiled by Bloomberg.
California Patient Gets Outrageous Clinical Pathology Laboratory Test Bill from Napa Hospital, Almost 10 Times Higher Than Similar Testing from Quest Diagnostics
Here’s how a community hospital that charges inpatient prices for clinical laboratory testing to a walk-up customer find itself at the center of a media news storm. In California, a newspaper trumpeted the story of an unhappy consumer stuck with a $4,316.55 bill for a panel of medical lab tests that a national lab would have performed for just $464, about 90% cheaper! Price transparency is a major trend in healthcare and consumers are catching on quickly. This raises the stakes for any hospital, medical laboratory, and anatomic pathology group that is slow to respond to the growing number of consumers who now price-shop whenever they need clinical laboratory tests. A hospital spokesperson explained the problem to the newspaper, saying that comparing Quest Diagnostics to a hospital laboratory is not like comparing “apples to apples.” Karen Anderson, QVMC’s Director of Patient Access and Patient Financial Services also sent Meinhardt a letter, the newspaper reported. The letter said, “Queen of the Valley Medical Center strives to provide the best quality care and remain competitive with other hospital facilities,” Anderson wrote. “In doing so, we need to meet our costs, which are greater than Quest, an independent laboratory.”
Research Forgotten by Budget Cuts
Because the cuts only affect the margins of a wide array of defense and domestic discretionary programs, there mostly hasn’t been an immediate pinch; the public backlash has been minimal. But the long-term consequences, in more than a few cases, are ominous.
There is no better case study than Alzheimer’s disease. With the enforced cuts at the National Institutes of Health, research to find a cure or better treatment is slowing. Alzheimer’s, the most common form of dementia, is the sixth leading cause of death in the United States. Five million Americans are afflicted by the disease. It costs about $200 billion a year, creating severe strain for public health care and many families. Then there is the emotional toll: The Alzheimer’s Association estimates that caregivers had an extra $9 billion of health care costs last year.
The latest annual report on health statistics from the Centers for Disease Control and Prevention underscores the point. There is a lot of progress, in large part because of earlier N.I.H. efforts: The number of deaths from strokes and heart disease is down more than 30 percent over the past decade, and cancer deaths have declined almost 15 percent. The reverse has occurred with Alzheimer’s. Over a decade, deaths have risen sharply, up 38 percent for men and 41 percent for women. It is expected to get worse. The Alzheimer’s Association says that under current trends the cost will exceed $1 trillion annually by 2050. That would either bankrupt Medicare and Medicaid, the insurance programs for the elderly and the poor, or force tax increases.
Fact Sheet: Impact of Sequestration on the National Institutes of Health
The estimated numbers: (FY 2013 figures compared to FY 2012)
While much of these decreases are due to sequester, NIH funding is always a dynamic situation with multiple drivers:
- Approximately 700 fewer competitive research project grants issued
- Approximately 750 fewer new patients admitted to the NIH Clinical Center
- No increase in stipends for National Research Service Award recipients in FY2013
Delay in medical progress:
- Medical breakthroughs do not happen overnight. In almost all instances, breakthrough discoveries result from years of incremental research to understand how disease starts and progresses. Even after the cause and potential drug target of a disease is discovered, it takes on average 13 years and $1 billion to develop a treatment for that target.
Risk to scientific workforce:
- NIH drives job creation and economic growth. NIH research funding directly supports hundreds of thousands of American jobs and serves as a foundation for the medical innovation sector. For every six applications submitted to the NIH, only one will be funded. Sequestration is reducing the overall funding available for grants.
The ‘70% Claim’: What is the Evidence Base?
The earliest published reference to the claim, and the one most frequently cited, is from 1996, by Forsman at the MayoClinic in the USA. The author states: ‘We know that, although the laboratory represents a small percentage of medical center costs, it leverages 60–70% of all critical decisions, e.g. admission, discharge and therapy’. The evidence for this is not provided in the paper. It seems likely that the data on which the 70% claim is based represent unpublished studies and anecdotal observations, and cannot be objectively verified at this stage. The assertion in its original form (laboratory medicine data influencing 70% of critical [major] decisions) sounds plausible, but the evidence underpinning it is not available.
The value of laboratory medicine in patient care is unquestioned. A detailed study by the Lewin Group for the Centers for Disease Control and Prevention in the USA concluded ‘Laboratory medicine is an essential element of the health care system. It is integral to many clinical decisions, providing physicians, nurses, and other health care providers with often pivotal information for the prevention, diagnosis, treatment and management of disease’. However, demonstration of this value requires more sophisticated measurement than the high-level ‘blanket’ claims discussed here. Until a better evidence base is available, use of the various ‘70% claims’ should be resisted in favour of more specific and evidence-based indices of added value. (Hallworth MJ. The '70% claim': what is the evidence-base? Ann Clin Biochem 2011;48:487–8)
More than 70 medical, research and advocacy organizations active in 41 countries and including the National Institutes of Health announced that they had agreed to create an organized way to share genetic and clinical information. Their aim is to put the vast and growing trove of data on genetic variations and health into databases — with the consent of the study subjects — that would be open to researchers and doctors all over the world, not just to those who created them.
Millions more people are expected to get their genes decoded in coming years, and the fear is that this avalanche of genetic and clinical data about people and how they respond to treatments will be hopelessly fragmented and impede the advance of medical science. This ambitious effort hopes to standardize the data and make them widely available. “We are strong supporters of this global alliance,” said Dr. Francis Collins, director of the National Institutes of Health. “There is lots of momentum now, and we really do want to move quickly.”
Trends in Laboratory Test Volumes for Medicare Part B Reimbursements, 2000–2010
Although reimbursement volumes increased for most of the selected tests, other tests exhibited statistically significant downward trends in annual reimbursement volumes. The observed changes in reimbursement volumes may be explained by disease prevalence and severity, patterns of drug use, clinical or laboratory practices, and testing recommendations and guidelines, among others.
Tests with the greatest decrease in reimbursement volumes were electrolytes, digoxin, carbamazepine, phenytoin, and lithium, with volume ratios ranging from 0.27 to 0.64 (P < .001). Tests with the greatest increase in reimbursement volumes were meprobamate, opiates, methadone, phencyclidine, amphetamines, cocaine, and vitamin D, with volume ratios ranging from 83 to 1510 (P < .001).
MDx Best Practices
A webcast discussing best practices clinical laboratories should use when performing molecular diagnostics testing
Bin Chen, PhD, FACMG, a member of the Division of Laboratory Science and Standards in the Office of Surveillance, Epidemiology, and Laboratory Services for the Centers for Disease Control and Prevention, discusses best practices in molecular diagnostics today and essential best practices clinical laboratories should use when performing molecular diagnostics testing.
- Molecular Genetic Testing
- Best Practices Guidelines for Clinical Laboratories
- Personnel Competency
Rapid Malaria Test Uses the Power of Magnets
A student-professor team at Case Western Reserve University has invented a hand-held malaria detector that works on an unusual principle: Malaria parasites are stuffed with iron, so their innards can be magnetized. The team, which has incorporated itself as the Disease Diagnostic Group, is seeking investors to pay for field tests to prove that its device works as well on the African front lines as it does in a Cleveland lab. Its pitch is that its battery-powered box, which costs $250 to make, can undercut the price of current chemical-based rapid test kits by at least 50 cents per test and pay for itself quickly. The company claims its test is far more accurate than the kits at detecting low-level infections.
Immunological Tests Superior in Colon Cancer Screening
"For the first time we have shown by direct comparison that the diagnostic performance of immunological stool tests is significantly higher than that of the enzymatic test at the same rate of positive results," says Hermann Brenner. In a number of European countries that offer cancer screening programs, immunological tests have already become the standard. Besides higher sensitivity, they offer further practical advantages: They can be more easily automated, and participants do not have to avoid certain types of food prior to the test.
Hermann Brenner and his coworker Sha Tao have directly compared the two methods in a large-scale study for the first time. 2,235 participants who underwent colon cancer screening colonoscopies between 2005 and 2009 provided stool samples immediately prior to the examination. These were tested for occult blood using both methods. Subsequently, the DKFZ researchers analyzed the test results by comparing them with the results from colonoscopies.
A more accurate test for Down's syndrome which can also be given earlier in pregnancy than current checks has been developed, say experts. A study of 1,000 pregnancies found the test of foetal DNA in maternal blood can show a baby is "almost certainly" affected or unaffected by Down's. The King's College London team behind it said it could help women decide if they needed further, invasive tests.
The Down's Syndrome Association said the new test was not "imminent".
Prof Kypros Nicolaides, who is leading the research and also developed the nuchal fold test, says the foetal DNA (cfDNA) test is much more definitive. The test shows there is either more than a 99% chance, or less than one in 10,000 that their baby has Down's syndrome. The research showing it is more sensitive, and less likely to offer a false-positive result, is published in Ultrasound in Obstetrics and Gynaecology. Prof Nicolaides said: “This test is nearly diagnostic. It tells you almost certainly your baby has Down's or almost certainly it does not.”
Faster Disease Diagnosis With New Single Virus Detection Techniques
Two independent teams have developed new optics-based methods for determining the exact viral load of a sample by counting individual virus particles. These new methods are faster and cheaper than standard tests and they offer the potential to conduct the measurements in a medical office or hospital instead of a laboratory. While Ozcan's group visually counts individual viruses, Schmidt's counts them by detecting their nucleic acids - the genetic makeup of the viruses. Unlike direct visualization techniques, Schmidt's chip-based method requires that the targeted virus particles be labeled. The labeling technique would allow clinicians to target specific viruses while ignoring unlabeled background material. This makes the process potentially useful in situations where clinicians already know what they are looking for - often the case for viral load tests.
A Mix of Water, DNA, and Gold Particles Could Lead to Faster Detection of Infectious Diseases
A "cocktail" of a drop of blood, a dribble of water, and a dose of DNA powder with gold particles may lead to quicker diagnosis and treatment of many infectious diseases in the near future. The new cocktail mix has been developed by researchers from University of Toronto's Institute of Biomaterials and Biomedical Engineering (IBBME) and its details have been published in the journal Angewandte Chemie . It consists of the same technology that is used in over-the-counter pregnancy tests and could be used to detect diseases from HPV and HIV to malaria. Now, scientists can pinpoint the exact disease they are looking for by linking gold particles with DNA strands - when a sample that has the disease gene is present, it clumps the gold particles - making the sample blue.
FDA Clears Meridian Bioscience M. Pneumonia MDx
Meridian Bioscience announced the US Food and Drug Administration cleared its molecular diagnostic test for Mycoplasma pneumonia. The test is the fourth cleared by FDA to run on the Cincinnati-based company's illumigene platform and follows FDA clearance of Meridian's C. difficile assay, Group B Streptococcus assay, and Group A Streptococcus assay. The M. pneumonia test amplifies specific DNA to detect the bacterium, providing a "definitive result" and ensuring patients receive appropriate treatment in a timely manner, Meridian said.
GE Healthcare Introduces a New Tumor Typing Platform
GE Healthcare has introduced MultiOmyx, a new platform for diagnostics in cancer biology. The system can analyze tumor samples on single cell level by studying the expression of more than 175 different proteins and disease markers per cell. Multiple stains can be added to a tumor slice and tumor antibodies directed to proteins of interest can be measured and quantified by fluorescence. Because multiple stains and markers can be measured in a single test, you don’t have to worry about the amount of provided sample tissue. Clarient Diagnostic Services, Inc, a laboratory of GE Healthcare, is planning diagnostic tests for Hodgkin’s lymphoma on the new platform by July 2013. Every cell gets addressed on a digital map creating a graphic representation of protein expression in the tumor tissue. The data can be matched and compared with known protein expression profiles in other tumors to provide information on tumor characteristics and prognosis.
Circulating tumor cells (CTCs) are very specific biomarkers found in blood that signal the existence of cancer in the body. Capturing and identifying these cells offers the possibility of early screening for a variety of cancers and the initiation of treatment before the disease spreads beyond control. Because CTCs are extremely rare, there’s been a lot of research work done around the world to create methods to efficiently capture these cells. Clearbridge BioMedics, a firm based in Singapore, has released a new device for detecting CTCs that does not require the use of antibodies or any other labeling methods to filter out the target cells.
Rosetta Inks Agreement With Three Rivers to Offer Access to Cancer Test
Rosetta Genomics said that it has signed a credentialing agreement with Three Rivers Provider Network, which will offer the firm's Cancer Origin Test to members of the preferred provider organization. The Rosetta Cancer Origin Test is a microRNA-based molecular diagnostic that is used to identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary.
FDA OK's Georgia Companies' Medical Devices
The U.S. Food and Drug Administration has approved a new batch of medical devices developed by Atlanta companies and organizations. The FDA said it approved the devices in May. Companies submit the devices to the FDA before they begin sales to demonstrate that they are at least as safe and effective as equivalent, legally marketed devices.
15% of Reusable Endoscopes Contaminated With Harmful Bacteria
Unacceptable levels of "bio dirt" were identified in three out of 20 scopes used to examine GI tracts and colons across five different hospitals in the U.S, according to a new study conducted in the U.S. Bioburden (bio dirt) is bacteria that live on the surface that haven't been sterilized.
Researchers presented the findings at the 40th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC). An analysis conducted by the 3M Infection Prevention Division included a total of 275 flexible duodenoscopes, gastroscopes, and colonoscopes. The investigators found that 30 percent, 24 percent, and 3 percent of the scopes (respectively) failed to pass the cleanliness rating.
AHRQ Revises Consumer Safety Reporting System, Seeks Comment
The Agency for Healthcare Research and Quality seeks public comment on a revised plan to build a prototype consumer reporting system for patient safety events. AHRQ proposed the project in September 2012, explaining that it hoped to reduce the number of adverse medical events that go unreported by enabling patients or families to report them. In a published notice requesting comments, the agency explained data collection processes that would support the reporting system, including development of Web and telephone methods of consumer reporting, and a follow-up survey of providers.
Federal health officials are calling for a new framework in quality measurement, as the U.S. healthcare system prepares for what is hoped to be a new era of accountability.
“Meaningful quality measures increasingly need to transition from setting-specific, narrow snapshots, such as use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for patients with congestive heart failure, to assessments that are broad based, meaningful, and patient centered in the continuum of time in which care is delivered,” wrote CMS Chief Medical Officer Patrick Conway, MD, National Health IT Coordinator, Farzad Mostashari, MD, and AHRQ Director Carolyn Clancy, MD, in the Journal of the American Medical Association. The goal, they wrote, should be to “identify important measures” and “discontinue using those of little value.” For instance, in safety, they suggest that rather than just measuring central line infections, future measurements might report all patient harm, whatever the cause.
The Role of the Physician in Laboratory Medicine
Advances in medical laboratory technology have driven major changes in the practice of laboratory medicine over the past two decades by the development of automated, cross-disciplinary single platform analysers. This has led to the blurring of boundaries between traditional disciplines and the emergence of core automated or blood science laboratories. Over the past few decades advances in medical laboratory technology have significantly influenced and directed changing roles for physicians in many laboratory disciplines with the possible exception of histopathology.
Collaboration to Accelerate Genetics-based Clinical Research
Empire Genomics, Life Technologies Corporation and UB will embark on a new partnership to develop world-class, gene-sequencing facilities for genetics-based clinical research on the Buffalo Niagara Medical Campus. The advanced sequencing technology available from Life Technologies, combined with the expertise of UB researchers and the Empire Genomics team, will help clinical researchers develop new diagnostic tests.
Tiny Patients, Major Goals
The mouse hospital at Beth Israel Deaconess and a few similar ones elsewhere are at the forefront of a new approach to studying human cancers. The mice are given genes that make them develop tumors in the same organs as humans, which means the researchers need scanners to watch the tumors’ growth inside the animals’ bodies. So the mouse hospitals have tiny ultrasound machines, CT and PET scanners, and magnetic resonance imaging machines with little stretchers to slide the mice into the machines. They also have mouse pharmacies to formulate medicines in mouse-size doses and mouse clinical laboratories specially designed to do analyses on minute drops of mouse blood and vanishingly small quantities of mouse urine. That lets them follow cancers’ growth and responses to treatments.
What’s more, with genetic advances in studies of human tumors, the researchers do not have to implant human cancer cells in all their complexity into mice to study the cancers; instead, they can give the mice just a few mutated genes that seem to drive a tumor. They genetically alter the mice before they are born and then, with scanners, watch what happens as a cancer develops in the expected organ — the prostate, in this case. Then they can try out drugs designed to attack those gene mutations and the cancers they cause. The result, so far, has been astonishing.
Promising New Cancer Drugs Empower the Body’s Own Defense System
The early success of a new class of cancer drugs, revealed in test results released over the last several days, has raised hope among the world’s top cancer specialists that they may be on the verge of an important milestone in the fight against the disease. The drugs, still generally in early testing, work in an entirely new way, by unleashing the immune system to attack cancer cells much as it attacks bacteria. That could be an alternative to often-debilitating chemotherapy. The new drugs work by disabling a brake on the immune system called the programmed death 1 receptor, or PD-1.
Harnessing the immune system is appealing for several reasons. It might be applicable to many different types of cancer. It might produce longer lasting remissions than can be achieved by chemotherapy or the newer targeted drugs. And it seems somehow more natural and holistic.
“It seems the right thing to do to stimulate our body’s defense rather than take some kind of poison,” said Therese Bocklage, a cancer patient and pathologist from Albuquerque.
A bioengineered blood vessel implant in his arm has potentially given a 62-year-old Virginia man a new lease on life, after years of dialysis for end-stage kidney failure. "This is a pioneering event in medicine," said Dr. Jeffrey H. Lawson, the Duke University School of Medicine vascular surgeon who helped develop the groundbreaking technology and carried out the surgery, in a news release. "It's exciting to see something you've worked on for so long become a reality." The bioengineered blood vessel graft took place on June 5, a two-hour surgery that marked the beginning of the first American clinical trial to test the safety of lab-grown vein implants.
HIV Shell Structure Cracked With Help of Supercomputer
A new study featured on the cover of Nature describes how researchers in the US have for the first time cracked the chemical structure of the capsid or protein shell of the human immunodeficiency virus (HIV). The breakthrough, which likely opens the way to powerful new drugs against the virus that causes AIDS, was made possible with the help of a new "petascale" supercomputer. As senior author of this new Nature study, Peijun Zhang, an associate professor of structural biology at the University of Pittsburgh School of Medicine, says in a statement: "The capsid is critically important for HIV replication, so knowing its structure in detail could lead us to new drugs that can treat or prevent the infection."
Ticks That Spread Red-Meat Allergy
If Lyme disease isn't reason enough to avoid ticks, here's another: the inability to enjoy a burger.
Odd as it seems, researchers say that bites from the voracious lone star tick are making some people allergic to red meat—even if they've never had a problem eating it before. The allergic reactions range from vomiting and abdominal cramps to hives to anaphylaxis, which can lead to breathing difficulties and sometimes even death. Unlike most food allergies, the symptoms typically set in three to six hours after an affected person eats beef, pork or lamb—often in the middle of the night. The bite that seems to precipitate it may occur weeks or months before, often making it difficult for people to make the link.
Anti-smoking Medication Shows Promise for Treating Alcohol Dependence
A smoking-cessation medication may be a viable option for the treatment of alcohol dependence, according to a study by scientists at the National Institutes of Health. The study found that varenicline (marketed under the name Chantix), approved in 2006 to help people stop smoking, significantly reduced alcohol consumption and craving among people who are alcohol-dependent. The findings were published online in the Journal of Addiction Medicine.
More Breast-Feeding Could Lower Breast Cancer Rates by Thousands
Breast-feeding isn't only good for the developing infant: It helps mom out too. A study published in Obstetrics & Gynecology on June 5 revealed that if people stuck with the recommended length of breast-feeding their newborn for at least one year, there would be 5,000 fewer cases of breast cancer, 54,000 fewer cases of hypertension and almost 14,000 less heart attacks in women each year. The researchers say low breast-feeding rates are “resulting in.” billions of dollars in health care costs each year.
The American Academy of Pediatrics recommends that babies are breast-fed exclusively for the first six months of life, and then have breast-milk supplementally given to them until they at least a year. Breast-feeding can continue as long as the mother, baby and physician feel it is appropriate. Solid food should only be introduced starting at six months of age, but the Centers for Disease Control and Prevention recently discovered that 40 percent of parents are giving their children solid food by the time they reach 4 months. The World Health Organization recommends even longer breast-feeding, with complementary foods [until] a child is 2-years-old and beyond.
Vitamin D Tests and Deficiency: New Patient Resource for GPs
Vitamin D testing is one of several medical tests appraised in the program that focuses on preventive health in 40 - 49 year olds. It encourages GPs to prioritise evidence-based risk assessments and tests, and avoid inappropriate testing that may cause more harm than good.
NPS MedicineWise clinical adviser Dr Andrew Boyden says that the vitamin D test is one for which there is a lack of evidence of benefit in people without risk factors for, or symptoms of vitamin D deficiency. "The new NPS MedicineWise patient information leaflet helps GPs talk to their patients about sensible sun exposure, diet and supplements, and is a useful tool to assist conversations." The vitamin D information leaflet includes answers to common patient questions .It also includes space for patients to record details about their blood test results and whether a supplement is recommended.
Cleveland Clinic Opens EMR to Patients
A half million Cleveland Clinic patients gained access to more of their healthcare information and by the end of the year – they will see all that is in their electronic medical record, including physician notes, via MyChart, the secure online portal. As Cleveland Clinic officials see it, it’s the right thing to do because it will give patients a more complete picture of their health and empower them to make better, smarter and more economical decisions about their care. Today patients can view their after-visit summary, medications list, allergies, immunization records, preventative care details, laboratory results, and radiology reports. If they want to see the rest of their medical records, they must contact the hospital to get hard copies of the EMR. The new transparent MyChart EMR will give patients access to pathology records, X-ray reports, physician notes, and the list of their current health issues, which physicians use to briefly describe a patient’s health status, recent concerns, and known diagnoses. Patients will be able to view online nearly everything their doctor sees in their EMR, except for behavioral health information, which is prohibited from release by state law. “Patients continue to ask for more, and we feel that they need to have more information in their hands to be more engaged in their care, said Kari Posk, MD, medical director for MyChart.”
New ONC Resource Supports Consolidated CDA Standards Implementation
Since the launch of the Stage 2 Certification program, ONC has been actively listening to the buzz among implementers as EHR vendors strive to update their systems to conform to the Consolidated Clinical Document Architecture (Consolidated CDA) standard in order to meet the transition of care objective. The ability of EHR systems to generate and use the Consolidated CDA standard is critical in supporting seamless electronic exchange of health information among various health care providers, helping to reduce medical errors and the overall costs of healthcare. The Standards and Interoperability Framework has provided a great platform for the standards community to come together and agree on standards before taking them to the HL7 Standards Organization for balloting. However, up to this point, there has been no centralized venue for implementers to participate directly in this activity.
Mandatory Flu Vaccination of Healthcare Personnel Does Not Lead to Worker Exodus
A four-year analysis finds 99 percent get vaccinated; very few employees choose to terminate.
Flu infections result in approximately 150,000 hospital admissions and 24,000 deaths annually. The Centers for Disease Control and Prevention (CDC) recommends that all healthcare personnel (HCP) receive the annual flu vaccine, yet the national average for HCP vaccination is only 64 percent. “`First, do no harm’ is our mandate as healthcare workers,” said Dr. Jorge Parada, MD, MPH, FACP, FIDSA, study author and professor of medicine at Loyola University Chicago Stritch School of Medicine. “We should do all we can to not pass along illness to our patients.” In 2009 Loyola chose to mandate flu vaccination as a condition of employment, and extended this mandate to students, volunteers, and contractors. To support and encourage compliance, the center’s communications department developed facility-wide reminder emails and created short videos, which were displayed on flat screens throughout the hospital. In the first year of the mandatory policy (2009-‘10 season), 99.2 percent of employees received the vaccine, 0.7 percent were exempted for religious/medical reasons, and 0.1 percent refused vaccination and chose to terminate employment. The results have been sustained: in 2012, 98.7 percent were vaccinated, 1.2 percent were exempted and 0.06 percent refused vaccination.
“'Big Business' Serious Challenge to Global Health Promotion Efforts": WHO Chief
World Health Organization (WHO) Director-General Margaret Chan has warned that efforts to promote good health are more vital than ever given that non-communicable diseases have overtaken infectious diseases as the leading cause of death, but they face daunting challenges, including from 'big business.'
"It is not just Big Tobacco anymore. Public health must also contend with Big Food, Big Soda, and Big Alcohol. All of these industries fear regulation, and protect themselves by using the same tactics," according to the WHO chief. She said these tactics include front groups, lobbies, promises of self-regulation, lawsuits, and industry-funded research that "confuses the evidence and keeps the public in doubt." They also include gifts, grants, and contributions to worthy causes that cast these industries as respectable corporate citizens in the eyes of politicians and the public, she added. They include arguments that place the responsibility for harm to health on individuals, and portray Government actions as interference in personal liberties and free choice.
Pathology lab Confirmed Legionnaires' Disease a Week Before Queensland Health was Notified
One of Australia's biggest medical laboratories has admitted it failed to notify health authorities when it diagnosed a patient with legionnaires' disease last week. A 46-year-old woman remains in a serious condition in intensive care and a man is dead after contracting the disease at Wesley Hospital in Brisbane. Sullivan Nicolaides Pathology as the laboratory failed to notify health authorities when it detected Legionella bacteria last week. It is mandatory to report legionnaires' disease to Queensland Health, and authorities are usually notified within 24 hours of a positive test result.
Nodding Syndrome: A Devastating Medical Mystery in Uganda
It starts with the nodding — otherwise normal children begin to nod their heads, pathologically. Then come the seizures. The children stop growing and stop talking. Ultimately, the disease wrecks the children, physically and mentally. The strange and deadly illness known as nodding syndrome affects only children, and only in a small pocket of East Africa. It has affected more than 3,000 children since the late 1990s, when it first appeared in what was then southern Sudan. And for more than three years, the cause of nodding syndrome has eluded epidemiologists around the globe.
Investigators at the Centers for Disease Control in Prevention in Atlanta have made the syndrome among their top priorities on the short list of new, unexplained outbreaks.
But as they, and others, continue to investigate the syndrome — figuring out its origin and how it spreads — much of the work trying to treat affected children has been left to Uganda.
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