A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 06, 2014
- Sen. Barbara Boxer Asks CDC to Investigate Cause of Polio-like Disease in Some California Children
- CDRH Identifies Strategic Priorities for 2014—Laboratory Developed Tests Were Not on the List.
- Quality Control Option Changing for Clinical Laboratories
- Myth or Truth - Are Non-gyn Labs Really Regulated?
- NIH Adds Substantial Set of Genetic, Health Information to Online Database
- Children With Rare Diseases to Benefit From New Genetic Tests
- Home Test Boosts Colon Cancer Screening
- Cheap Urine Test for Cancer Steps Closer
- Supercomputer Analyzes 240 Full Genomes in Two Days
- Google Glass App Turns Anyone into Rapid Diagnostic Test Expert
- MIT-Harvard Team Develops Immunoassay Version of Synthetic Biomarker Diagnostic Technology
- Common Strep Bacteria May Be Morphing Into 'Superbug'
- Rare Mutation Kills off Gene Responsible for Diabetes
- A Powerful New Way to Edit DNA
- Child Health Problems 'Linked to Father's Age'
- The Breast Cancer Racial Gap
- Take Blood Pressure in Both Arms
- Feds Promise to Publish FDASIA Report on HIT Regulation in March
View Previous Issues - Healthcare News Archive
Sen. Barbara Boxer is asking the Centers for Disease Control and Prevention to initiate a formal investigation into what has caused polio-like paralysis in about 20 children in California over the past 18 months. Boxer says in a letter sent to CDC Director Thomas Frieden that "we need answers." In particular, Boxer wants the agency to look into whether a virus is the culprit or if environmental factors are involved. She also wants to know if the agency has any way of knowing if there are other unusual reports of paralysis nationally.
Senators Question Military Health Program’s New Lab-fee Policy
A bipartisan group of senators has raised concerns about a change to the Defense Department’s health-care reimbursement policies that will force troops and their families to pay the full cost of certain tests done outside military clinics. The lawmakers, led by Sens. Richard Burr (R-N.C.) and Kay Hagan (D-N.C.), asked Defense Secretary Chuck Hagel in a letter on to answer questions about how the Pentagon justified the change and communicated it to beneficiaries, as well as what the appeals process would look like for whose lab work is not covered.
The Food and Drug Administration Center for Devices and Radiological Health issued its priorities for 2014—laboratory developed tests were not on the list. The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued its 2014 priorities. This year, the agency plans to focus its attention on three main areas: streamlining the clinical trials process; reforming the premarket and post-market data collection process; and improving its customer service. For more details, please visit the FDA website.
Individualized Quality Control Plan Replacing Equivalent Quality Control
The Centers for Medicare & Medicaid Services (CMS) introduced a new voluntary quality control option for clinical laboratories on January 1, 2014. The Individualized Quality Control Plan (IQCP) will replace existing Equivalent Quality Control (EQC) procedures after an education-and-transition period ending January 1, 2016. Under the IQCP, which applies to all specialties and subspecialties except pathology, organizations that meet manufacturers’ recommendations for quality control do not have to fully meet Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulatory requirements. Because EQC will no longer be an acceptable option for CLIA ’88 quality control compliance in two years, organizations must decide whether they will follow the CLIA regulatory requirements as written or implement the IQCP by January 1, 2016.
There seems to be a misconception that if a lab is only processing and signing out non-gynecological (NG) samples, then they don't have nearly the regulatory load as labs that process Pap (gynecological) specimens. While it's true that some of the CLIA regulations apply only to Pap labs, many of the regulations apply to NG as well as Pap labs. In a lab that processes NG samples, there has to be a process to prevent cross-contamination between other NG samples. Cytotechnologists should be well trained in the practice of workload documentation and workload regulations. Those same regulations apply to pathologists that are doing primary screening, even if they are only screening NG cases.
This regulation does not distinguish between pathologists and cytotechnologists. While the adequacy criteria of Pap samples has been clearly defined, we don't have universal criteria for NG specimens. Therefore, the lab must determine what renders an NG case unsatisfactory. Some labs or pathology groups process samples in one facility and ship them to another for final sign-out. Evaluations of any cytology samples, including NG cases, must occur in a lab certified to conduct cytology.
Researchers will now have access to genetic data linked to medical information on a diverse group of more than 78,000 people, enabling investigations into many diseases and conditions. The data, from one of the nation's largest and most diverse genomics projects -- Genetic Epidemiology Research on Aging (GERA) -- have just been made available to qualified researchers through the database of Genotypes and Phenotypes (dbGaP), an online genetics database of the National Institutes of Health. "Data from this immense and ethnically diverse population will be a tremendous resource for science," said NIH Director Francis S. Collins, M.D., Ph.D. "It offers the opportunity to identify potential genetic risks and influences on a broad range of health conditions, particularly those related to aging."
Patterns of Cancer Screening in Primary Care From 2005 to 2010
Guidelines for cancer screening in the primary care setting vary, especially with regard to breast, skin, and prostate examinations. Recommendations for cervical screening are less controversial, although they are constantly evolving. Several organizations, including the American Cancer Society (ACS), the US Preventive Services Task Force (USPSTF), and major organizations within each field, offer recommendations guiding clinical care. The opinions of each professional society’s recommendations often differ with regard to age of initiation and discontinuation of screening, frequency of screening, and screening tool. The conclusion is that current cancer screening practices in primary care vary significantly. Cancer screening may not follow evidence-based practices and may not be targeting patients considered most at risk. Racial and socioeconomic disparities are present in cancer screening in primary care.
UCD researchers at Our Lady’s Children’s Hospital Crumlin and the Children’s University Hospital, Temple Street, have developed new genetic tests that will speed up diagnosis of rare diseases in children and help avoid the need for invasive procedures. The tests which will be available at the National Centre for Medical Genetics were launched on European Rare Disease Day. The diagnostic tools include molecular genetics tests for: Anophthalmia (absence of one or both eyes, occurs in around 1 in 100,000 births), and its sister conditions Microphthalmia (small eye) and Coloboma (malformed eye); a DNA repair disorder which results in debilitating endocrine and haematological illness; and Infantile Liver Failure Syndrome.
Test Is Improved Predictor of Fetal Disorders
A test that analyzes fetal DNA found in a pregnant woman’s blood proved much more accurate in screening for Down syndrome and another chromosomal disorder than the now-standard blood test, a new study has found. The promising results may change how prenatal screening for genetic diseases is done, though the test is costly and generally not yet covered by insurance for women at low risk. The study, published in The New England Journal of Medicine, found that the fetal DNA test was 10 times better in predicting cases of Down syndrome than the standard blood test and ultrasound screening, and five times better in predicting the other disorder, Trisomy 18. It also greatly reduced the number of false-positive results.
Everybody's supposed to get screened for colon cancer starting at age 50, but many of us haven't gotten around to it. That's especially true in the Latino community, where about half of people are up to date on screening, compared to 66 percent of non-Latino whites. The numbers get even worse for people who don't have health insurance, with just 37 percent getting screened. So, researchers decided to see if something as simple as mailing free home colon-cancer test kits to patients of clinics that serve low-income residents in Portland, Ore., would help get more people screened for colon cancer. Short story, it did. A bit more than one-third of the 213 people who got the kits in the mail used them and mailed them back. Of the 81 patients who were tested, seven had a positive test result, indicating traces of blood in the stool. Those patients were referred for colonoscopies, and all but one patient went in for the procedure. About half of the participants were Hispanic, and most had household incomes below the federal poverty line.
Laboratory Launches More Accurate Carrier Screening Test for Spinal Muscular Atrophy
The Icahn School of Medicine at Mount Sinai announced the launch of a more accurate carrier screening test for spinal muscular atrophy (SMA), one of the most common and severe autosomal recessive disorders. This new test will help prospective parents more effectively identify whether they carry the mutation that will affect their offspring. The test screens for genetic variation discovered by Mount Sinai researchers, which has been demonstrated to identify silent carriers of SMA in certain populations with higher accuracy.
Gene Test Developed to Accurately Classify Brain Tumors
Scientists at The Wistar Institute have developed a mathematical method for classifying forms of glioblastoma, an aggressive and deadly type of brain cancer, through variations in the way these tumor cells "read" genes. Their system was capable of predicting the subclasses of glioblastoma tumors with 92 percent accuracy. With further testing, this system could enable physicians to accurately predict which forms of therapy would benefit their patients the most. Their research was performed in collaboration with Donald M. O'Rourke, M.D., a neurosurgeon at the University of Pennsylvania Brain Tumor Center, who provided the glioblastoma samples necessary to validate the Wistar computer model. Their findings were published online in the journal Nucleic Acids Research.
Non-infectious illnesses like cancer and cardiovascular diseases are rising globally, but they are hard to diagnose because of lack of biomarkers, and in countries with poor infrastructure, expensive diagnosis using mammograms and colonoscopy is not available to many. Now, a team has developed a test that uses injected nanoparticles that find diseased tissue and produce a biomarker in urine that can be detected within minutes using paper strips rather like a home pregnancy test. The researchers, from the Massachusetts Institute of Technology (MIT), Cambridge, report in the Proceedings of the National Academy of Sciences, PNAS, how they tested the new method in mice, using a single injection and a paper-strip urine analysis, to successfully detect diseases as diverse as solid cancer and blood clots.
IgE Falls Short As Marker for At-Home Allergen
Markers of allergic sensitization weren't great indicators of current exposure to the allergen, a national observational study of allergen-specific immunoglobulin E (IgE) showed. The level of IgE as a marker for sensitization generally didn't correlate strongly with levels of that allergen directly measured in the home, Herman Mitchell, PhD, of the contract research organization Rho in Chapel Hill, N.C., and colleagues found in preliminary analysis of 2005-2006 National Health and Nutrition Examination Survey (NHANES) data.
A scientific team at the University of Chicago reports that genome analysis can be radically accelerated by relying on supercomputers such as the one they used. This computer, known as Beagle and based at Argonne National Laboratory, is able to analyze 240 full genomes in about two days, according to the researchers. “The supercomputer can process many genomes simultaneously rather than one at a time,” said first author Megan Puckelwartz, a graduate student in McNally's laboratory. “It converts whole-genome sequencing, which has primarily been used as a research tool, into something that is immediately valuable for patient care.”
A study just published in ACS Nano discusses the development of a Google Glass app that lets a clinician simply look at the lines on a test strip and receive back the correct interpretation within seconds. The app is voice controlled and provides both yes/no, as well as quantitative results depending on the test. The strips are marked with individual QR codes to identify which test is being performed and the app is supported by a server that actually analyzes the images and sends results back to Google Glass.
A team led by researchers at the Massachusetts Institute of Technology and Harvard Medical School have developed a synthetic biomarker assay that they say could improve early detection and monitoring of a variety of diseases. In particular, the approach, which uses immunoassays run on inexpensive paper test strips as its read-out, could prove valuable in point-of-care and resource-constrained settings, Andrew Warren, an MIT researcher and one of the developers of the method, told ProteoMonitor. Detailed in a paper published in Proceedings of the National Academy of Sciences, the method uses ligand-encoded reporters linked to nanoparticles by synthetic peptide substrates. Upon injection into a patient, these conjugates are targeted via the nanoparticles to the site of interest, where native proteases linked to the disease process under investigation cleave the peptide substrate, freeing the reporter molecules.
Quest Diagnostics Expands Hereditary Cancer Screening Offering With Lynch Syndrome Blood and Biopsy Testing for Colorectal Cancer
Quest Diagnostics announced new pathology and blood test offerings to help identify and assess an individual's risk of Lynch syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC), an inherited genetic disorder that significantly increases the risk of colorectal and other cancers. The Lynch syndrome blood-test offering includes a comprehensive blood test panel that evaluates the genes MLH1, MSH2 (and EPCAM terminal deletions), MSH6 and PMS2 for inherited mutations that are responsible for the majority of Lynch syndrome cases. For individuals whose family history or tumor tissue results indicate targeting one or more of these genes, gene-specific tests are available. The offering also includes a menu of validated biopsy-tumor screening options for patients with a diagnosis of colorectal, endometrial or other Lynch-associated cancers.
C-Reactive Protein May Be Associated With PTSD Risk.
High levels of C-reactive protein (CRP), an inflammation marker, were seen in soldiers who later developed post-traumatic stress disorder, researchers said. Among U.S. Marines and Navy personnel who consented to participate in a prospective study, each 10-fold increment in CRP levels at pre-deployment baseline was associated with a 51% increased likelihood of showing at least one PTSD symptom after deployment to Iraq or Afghanistan (odds ratio 1.51, 95% CI 1.15-1.97, P=0.003), reported Dewleen Baker, MD, of the VA Healthcare System in San Diego, and colleagues. Writing online in JAMA Psychiatry, the researchers proposed that inflammation may predispose people to develop PTSD.
Elevated Homocysteine not Gender-specific in Schizophrenia
Japanese researchers have demonstrated that both men and women with schizophrenia have significantly higher plasma homocysteine levels than healthy controls. The findings arise from a series of analyses investigating the effects of gender and methylenetetrahydrofolate reductase (MTHFR) C677T genotype on blood homocysteine levels in Japanese patients with schizophrenia.
'Epidemic of Diagnosis' Associated With Thyroid Cancer
According to a new study published in JAMA Otolaryngology-Head & Neck Surgery, increased incidence of thyroid cancer may not be because of an increase in the disease, but an increase in diagnosis. Several types of cancer can affect the thyroid - a gland in the neck that produces hormones. Factors that make people more at risk of getting thyroid cancer include:
- Being between the ages of 25 and 65
- Being female
- Being Asian
- Having a history of thyroid disease in the family
- Having previously had radiation treatments to the head or neck.
To diagnose thyroid cancer, doctors use a combination of physical exam, blood tests, imaging tests and a biopsy. Since 1975, the incidence of thyroid cancer has nearly tripled, from 4.9 to 14.3 in every 100,000 people.
Risks Increase for Drug Testing Labs
A recent urine drug testing laboratory settlement may be indicative of more to come as evidenced by a comment in a Feb. 20 Health and Human Services (HHS) Office of the Inspector General (OIG) announcement indicating that the matter was begun as a result of OIG auditor’s data mining techniques. The unique aspect of this case is that the alleged improper billing was discovered through the use of a combination of data mining and audits. Drug testing labs and their compliance officers should take note.
Doctors report on antibiotic resistance in two unrelated cases
Doctors warn that a garden-variety type of bacteria, which is normally present in the human intestinal tract, may be morphing into a tough-to-treat superbug. A new report from physicians in New York, New Mexico and the U.S. Centers for Disease Control and Prevention describes the cases of two patients with group B streptococcus infections that turned out to be resistant to vancomycin, often considered an antibiotic of last resort. In the past, group B strep infections were relatively easy to subdue because the bacteria were vulnerable to penicillin and other common antibiotics.
A new study based on genetic testing of 150,000 people has found a rare mutation that protects even fat people from getting Type 2 diabetes. The effect is so pronounced — the mutation reduces risk by two-thirds — that it provides a promising new target for developing a drug to mimic the mutation’s effect. The mutation destroys a gene used by pancreas cells where insulin is made. Those with the mutation seem to make slightly more insulin and have slightly lower blood glucose levels for their entire lives. The study, published in Nature Genetics, involved a mutation so rare that finding it was only recently possible, with vast data from large numbers of people, researchers said.
In the late 1980s, scientists at Osaka University in Japan noticed unusual repeated DNA sequences next to a gene they were studying in a common bacterium. They mentioned them in the final paragraph of a paper: “The biological significance of these sequences is not known.” Now their significance is known, and it has set off a scientific frenzy. The sequences, it turns out, are part of a sophisticated immune system that bacteria use to fight viruses. And that system, whose very existence was unknown until about seven years ago, may provide scientists with unprecedented power to rewrite the code of life. In the past year or so, researchers have discovered that the bacterial system can be harnessed to make precise changes to the DNA of humans, as well as other animals and plants. This means a genome can be edited, much as a writer might change words or fix spelling errors. It allows “customizing the genome of any cell or any species at will,” said Charles Gersbach, an assistant professor of biomedical engineering at Duke University.
Shape Change Turns Stem Cells Into fat Cells, Scientists Find
Japanese scientists have found a method to turn stem cells into fat cells just by changing their shape, which could lead to new treatments for cancer and obesity. A key factor, the scientists said, was MKL1, a protein that serves as the “switch” for various genes in cells. The disassembled actin cytoskeleton became bound to MKL1, causing another protein to deform the linear actin cytoskeleton into a crescent shape. “If we become able to alter the shape of actin cytoskeleton in cancer cells and turn them into fat cells in the future, we may be able to cure cancer,” said Hideyuki Saya, a genetic control professor at Keio University who led the team. “Preventing the structure from developing into a crescent shape may block production of fat cells, leading to new methods of preventing obesity.” The findings were published Feb. 26 in the British scientific journal Nature Communications.
Watch How a Virus Particle Enters a Cell in 3D
Recently nature videography jumped up a notch with a new video from Princeton University showing a virus-like particle breaking into a cell. The project, led by postdoctoral researcher Kevin Welsher, aims to further the current understanding of biological interactions on the nanoscale. It also offers a glimpse into the life of a profoundly strange organism that, depending on the preferred definition, may not even be alive. The unprecedented footage, which was shot in 3D, shows a nanoparticle (the dot) approach a cell (the green blob) and attempt to penetrate into the nucleus (the red blob inside the green blob). “Following the motion of the particle allowed us to trace very fine structures with a precision of about 10 nanometers, which typically is only available with an electron microscope,” Welsher explained.
Mature, Functioning Liver Cells Made From Skin Cells
There have been several reports in recent years of scientists reprogramming skin cells so they transform into cells that are similar to cells from other organs, such as the heart, the pancreas and even brain cells. However, these have fallen short of producing mature, fully functioning versions of organ cells - essential if they are to be of any use in life-saving regenerative medicine. Now, a new study reported in Nature shows how it may be possible, with a new method, to transform skin cells into mature, fully functioning liver cells that are practically identical to native cells in liver tissue. Not only this, but the new cells also flourish on their own, even after being transplanted into the livers of animals with engineered liver failure.
Great Ormond Street Doctors Aim to Grow Ears From fat
Doctors at Great Ormond Street Hospital in London are aiming to reconstruct people's faces with stem cells taken from their fat. The team has grown cartilage in the laboratory and believe it could be used to rebuild ears and noses. They say the technique, published in the journal Nanomedicine, could revolutionise care. Experts said there was some way to go, but it had the potential to be "transformative".
Epigenetic Factor Revealed as Weak Link in Malaria Transmission
In hopes of fighting malaria by interfering with the life cycle of the malaria parasite, scientists have focused on a potential weak point—the part of the cycle in which the parasite, while in human blood, switches from asexual multiplication to sexual development, which involves the formation of gametocytes. The asexual-to-sexual switch, scientists realized, had to depend on molecular mechanisms involving DNA, whether the mechanisms were direct or indirect. That is, scientists were aware that there were variations in gametocyte production, but they were not certain whether these variations were due to mutations in DNA or something outside the genes that affected DNA transcription. Now, however, two teams of scientists have published independent studies indicating that there is indeed something outside the genes—a transcriptional regulator—that controls gametocyte production. Both teams found that the same regulatory protein acts as a genetic switch. The protein, called AP2-G, activates genes that commit the malaria parasite to sexual development. The teams published their results in separate papers, both of which appeared February 23 in Nature. Members of both teams expressed optimism that knowledge of the genetic switch could be exploited to prevent transmission of the parasite.
A wide range of disorders and problems in school-age children have been linked to delayed fatherhood in a major study involving millions of people. Increased rates of autism, attention deficit hyperactivity disorder (ADHD), bipolar disorder, schizophrenia, suicide attempts and substance abuse problems were all reported. The study, in JAMA Psychiatry, suggests mutated sperm were to blame. However, experts say the benefits older dads bring may outweigh any problems. The investigation by Indiana University, in the US, and Sweden's Karolinska Institute has been described as the largest and one of the best designed studies on the issue. The researchers looked at 2.6 million people and at the difference between siblings born to the same father as it accounts for differences in upbringing between families.
Comparing children of a 45-year-old dad to those of a 24-year-old father it indicated:
- autism was more than three times as likely
- a 13-fold increased risk of ADHD
- double the risk of a psychotic disorder
- 25 times more likely to have bipolar disorder
- 2.5 times more likely to have suicidal behaviour or problems with drugs
- lower scores at school
30,000-year-old Giant Virus 'Comes back to life'
An ancient virus has "come back to life" after lying dormant for at least 30,000 years, scientists say. It was found frozen in a deep layer of the Siberian permafrost, but after it thawed it became infectious once again. The French scientists say the contagion poses no danger to humans or animals, but other viruses could be unleashed as the ground becomes exposed. The study is published in the Proceedings of the National Academy of Sciences (PNAS). Professor Jean-Michel Claverie, from the National Centre of Scientific Research (CNRS) at the University of Aix-Marseille in France, said: "This is the first time we've seen a virus that's still infectious after this length of time."
South African Scientists Map HIV Antibodies in Vaccine Hunt
Scientists in South Africa have mapped the evolution of an antibody that kills different strains of the HIV virus, which might yield a vaccine for the incurable disease, the National Institute of Communicable Diseases said. The scientists have been studying one woman's response to HIV infection from stored samples of her blood and isolated the antibodies that she developed, said Lynn Morris, head of the virology unit at the NICD. The study, by a consortium of scientists from the NICD, local universities and the U.S. Vaccine Research Centre of the National Institute of Allergy and Infectious Diseases, was published in the journal Nature.
Promising Target for Dengue Virus Vaccine Discovered
Scientists at the University of North Carolina, Chapel Hill say they have found a new target for human antibodies that could hold the key to a vaccine for a globally widespread mosquito-borne disease. Using an experimental technique new to the dengue field, the labs of Ralph Baric, Ph.D., and Aravinda de Silva, Ph.D., showed that a molecular hinge where two regions of a protein connect is where natural human antibodies attach to dengue 3 to disable it. Their study (“Dengue virus envelope protein domain I/II hinge determines long-lived serotype-specific dengue immunity finding”), published in the Proceedings of the National Academy of Sciences, illustrates that after primary infection most human antibodies that neutralize the virus bind to the hinge region. It's the first study to demonstrate how these binding sites–composed of just 25 amino acids–can be genetically swapped out for amino acids from another dengue type without disrupting the integrity of the virus.
Can a Genetic Model Predict Next Year's Flu Strain?
The seasonal flu has met its enemy, and it’s calculus. A theoretical physicist and computational biologist analyzed the genetic code of thousands of strains of Influenza A that occurred over a 44-year period to create a model that accurately predicts which strain will prevail in the pitched evolutionary battle between human antibodies and the rapidly mutating virus. Their method proved more accurate for selecting an appropriate vaccine than the current method used by public health officials, according to a report published online Wednesday in the journal Nature.
Blame Open Plan Offices for Making Cold and Flu Season Worse
The most popular office design in the United States is a large open plan office. People who have seen such offices half empty or full of sniffling people during the winter flu season won’t be surprised to hear they make people more likely to get sick. Compared to people in mostly or partially private spaces, people in open plan offices of all sizes report taking more sick leave, according to a recent study. Open plan offices were connected to increased instances of sick leave lasting seven days or less, what you’d expect from an employee who caught a bad cold or the flu as opposed to something more serious.
Stethoscopes Could Play a Part in Spreading Germs
New study shows that the amount of bacteria on a stethoscope can be higher than all parts of the doctor's hand except for the fingertips after examining a patient. Doctors' hands touch dozens of patients a day and medical standards require them to sanitize after they examine a patient, but what about their stethoscopes? With germs from many patients coming into contact with stethoscopes each day, a new study published in the Mayo Clinic Proceedings, suggests the stethoscope should be subject to the same sanitary procedures as doctors' hands.
Vinegar May Be Cheap, Safe Way to Kill TB Germ
A potent weapon against a dangerous class of bacteria may be as close as the kitchen cupboard, new research suggests. Scientists say common vinegar may be an inexpensive, non-toxic and effective way to kill increasingly drug-resistant mycobacteria -- including the germ that causes tuberculosis. Although researchers often use chlorine bleach to clean tuberculosis bacteria on surfaces, the study authors pointed out that bleach is also both toxic and corrosive. Meanwhile, other disinfectants may be too costly for tuberculosis labs in poor countries were the illness most often occurs. But the research team found that acetic acid, the active ingredient in vinegar, does the trick cheaply and effectively.
Hepatitis C Cases Fall 16% in U.S., CDC Survey Finds
The number of Americans with hepatitis C fell 16 percent to 2.7 million over almost a decade, a government survey found, just as new, more effective treatments for the chronic liver disease reach the market. The survey by the Centers for Disease Control and Prevention covers data gathered from 2003 to 2010. It updates information collected in 1999 to 2002 that counted 3.2 million people as being infected. Hepatitis C can be symptomless for years before it begins to scar the liver, leading to cancer, organ failure and, eventually, a transplant.
New CDC Data Shows 43 Percent Drop in Obesity Rates Among Children 2 to 5
New federal data published show a 43 percent drop in obesity rates among children ages 2 to 5 during the past decade, providing another encouraging sign in the fight against one of the country’s leading public health problems, officials said. The finding comes from a government study considered a gold standard to measure public-health trends. Researchers found that just over 8 percent of children 2 to 5 were obese in 2011-2012, down from nearly 14 percent in 2003-2004. Although the drop was significant, federal health officials noted that obesity rates for the broader population remain unchanged, and for women older than 60, obesity rates rose about 21 percent during that period.
A troubling racial divide in breast cancer mortality continues to widen in most major cities around the country, suggesting that advances in diagnosis and treatment continue to bypass African-American women, according to new research. An analysis of breast cancer mortality trends in 41 of the largest cities in the United States shows that the chance of surviving breast cancer correlates strongly with the color of a woman’s skin. Black women with breast cancer — whether they hail from Phoenix or Denver, Boston or Wichita, Kan. — are on average about 40 percent more likely to die of the disease than white women with breast cancer.
The researchers said the difference is explained by lower access to screening, lower-quality screening, less access to treatment and lower-quality treatment among black women. The research also dispels the notion that black women face a higher risk of breast cancer because of genetic differences. While they are at greater risk for some types of breast cancers, that doesn’t explain the widening mortality gap developing in a relatively short period of just two decades. “Mathematically, it can’t be anything genetic,” Dr. Whitman said. “How could genes change in 20 years?”
It may be a good idea to get a blood pressure reading in both arms rather than just one. A difference in those readings, a new study suggests, is an independent risk factor for heart disease. The study, in the March issue of The American Journal of Medicine, found that a difference of 10 or more between the two readings increased the risk for a cardiac event by about 38 percent. The increase was independent of age, cholesterol, body mass index, hypertension and other known cardiovascular risk factors.
FDA Proposes Updates to Nutrition Facts Label on Food Packages
The U.S. Food and Drug Administration proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes. The proposed updates reflect new dietary recommendations, consensus reports, and national survey data, such as the 2010 Dietary Guidelines for Americans, nutrient intake recommendations from the Institute of Medicine, and intake data from the National Health and Nutrition Examination Survey (NHANES). The FDA also considered extensive input and comments from a wide range of stakeholders.
AMA Urges HHS to Reconsider New ICD-10 Codes
The American Medical Association (AMA) has written to Health and Human Services (HHS) Secretary Kathleen Sebelius urging her to ‘reconsider’ the Department’s decision to implement the ICD-10 codes. According to the medical society, the new coding system, which takes effect October 1st, would significantly increase the regulatory burden and costs to physicians’ without any corresponding improvement in patient care. A cost analysis of the impact on small physician practices indicates that the ICD-10 coding system will cost physicians $56,000 to $226,000 to implement. Senator Tom Coburn (R-OK), and a number of his colleagues, have introduced legislation, S.972, the Cutting Costly Codes Act of 2013, that would bar HHS from implementing the new ICD-10 codes. As of now, HHS is unlikely to further delay the ICD-10 state date.
HHS Clawed Back $4.2B From Healthcare Fraud
The Obama Administration recovered more than $4.2 billion in the 2012 fiscal year from entities and individuals that attempted to defraud the Medicare and Medicaid programs, the U.S. Department of Health & Human Services announced. "This was a record-breaking year for the Departments of Justice and Health and Human Services in our collaborative effort to crack down on healthcare fraud and protect valuable taxpayer dollars," Attorney General Eric Holder said in a statement.
Federal officials speaking at a panel discussion at HIMSS14 in Orlando, Fla., said they expect to publish a draft report on a risk-based regulatory framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication by the end of March. The report, mandated by the Food and Drug Administration Safety and Innovation Act of 2012, was supposed to be released last month. "We don't have a report out yet because we have had such a collaborative process," Daniel said. "I can vouch personally for the level of engagement and collaboration that we've all had in trying to think this through."
4 Things to Know About Health IT Security
As health records move from being paper-based to totally electronic, concerns around the security of patient information are growing in the health information technology (IT) world. In fact, security was one of the major topics at Healthcare Information and Management Systems Society (HIMSS) annual conference. A person's health information is worth 15 to 20 times more than financial information, said Robert Wah, MD, president-elect of the American Medical Association and chief medical officer for CSC, a health IT company in Falls Church, Va. A stolen credit card can be cancelled, but a medical record contains much more rich data and information about a person -- family history, financial information, of course, medical history.
Here are four things physicians should be aware of as the debate continues about the security of digital health information.
- The Opportunity for Theft Is Growing
- Your Employees Are Your Own Worst Enemy
- Violators Must 'Fess Up
- An Insurance ID Is a Valuable Thing
U.S. Device Makers Laud India's New Medtech Proposal
U.S. medical device makers lauded India’s healthcare officials for progress on a bill that would for the 1st time separate medical device regulation from pharmaceuticals. The bill was introduced last year and then referred to a standing committee. The committee’s recommendations were tabled in December and are now under review by India’s union health ministry, according to the Indo-Asian News Service.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
This symbol means you are leaving the CDC.gov Web site. For more information, please see CDC's Exit Notification and Disclaimer policy.