A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
June 27, 2013
View Previous Issues - Healthcare News Archive
U.S. Unveils Health Care Web Site and Call Center
The Obama administration announced new steps to expand coverage under the federal health care law, less than a week after the Government Accountability Office, a nonpartisan investigative arm of Congress, found that the federal government and many states were “behind schedule” in setting up marketplaces where Americans are supposed to be able to buy insurance.
The steps — establishing a Web site and a telephone call center to provide information to consumers — are in preparation for what the government anticipates will be a flood of people buying health insurance starting Oct. 1. Kathleen Sebelius, the secretary of health and human services, said the call center would be in operation 24 hours a day. The phone number is 800-318-2596. The Web site, www.healthcare.gov, provides information promoting the 2010 health care law and describing new insurance options. The Web site and call center currently have only general information about coverage.
Bill Aims to Create Office of Wireless Health at FDA
Rep. Mike Honda (D-Calif.) reintroduced a bill that aims to boost investment and development in the mobile health market and establish an office within the Food and Drug Administration that is dedicated to wireless health. Honda, who represents Silicon Valley, had initially introduced the Healthcare Innovation and Marketplace Technologies Act in December. Along with the creation of the FDA's Office of Wireless Health, the legislation will develop programs that provide support mobile app developers, as well as offer grants that “encourage risk-taking” and low-interest small business loans to developers. It will also provide grants that can be used to aid employee training.
High Court Defines When Physicians Can Unite Against Insurers
Justices on June 10 ruled unanimously that doctors' payment disputes with insurers can be arbitrated as a group for cases in which contracts are silent on the issue of class arbitration. The decision enables New Jersey pediatrician John I. Sutter, MD, to continue fighting his payment battle against Oxford Health Plans as part of a class of about 20,000 other physicians in the insurer's network. The ruling highlights that class arbitration is the most ideal and cost-effective dispute resolution for all parties involved, said Melinda Martinson, general counsel for the Medical Society of New Jersey. The society, along with the Litigation Center of the American Medical Association and the State Medical Societies, issued a friend-of-the-court brief to the high court in support of Dr. Sutter. Class arbitration results in fewer transactional costs for insurers and physicians and more uniformity for like claims, Martinson said.
Patient Access Rule Expected Late Summer
A final rule allowing patients to have direct access to their laboratory test results is expected to be released by late summer, according to Judy Yost, director of the Division of Laboratory Services at the Centers for Medicare and Medicaid Services (CMS). The rule currently is being reviewed by the secretary of Health and Human Services and will then go to the Office of Management and Budget (OMB) for final review before publication.
Doctor-specific Medicare Claims Data Could Be Released
Proponents of releasing the data say it could help identify patterns of waste and fraud and help patients and insurance companies find doctors who deliver the most efficient and highest quality care. But medical groups have successfully fought to keep the payment information secret, saying it would violate physicians' privacy rights to disclose their Medicare claims data.
The AMA declined multiple requests for an interview, while the Florida Medical Association said it remains concerned that the data would be misused by the public. The two organizations were co-plaintiffs in lawsuit more than three decades ago that resulted in a permanent injunction preventing the release of physician-specific Medicare data. That all changed May 31, when a U.S. District Court judge in Jacksonville, Fla. dissolved the 1979 prohibition (PDF 200.77KB ).
The National Heart, Lung and Blood Institute (NHLBI) is getting out of the guideline-writing business -- raising concern about two much-anticipated sets of recommendations. The NHLBI will continue to conduct systematic evidentiary reviews, but will leave it to partner organizations "on the front line of clinical practice" to develop the guidelines, said NHLBI director Gary H. Gibbons, MD, during a press briefing. The announcement prompted questions about the long-awaited revised guidelines on hypertension (JNC 8) and cholesterol (ATP 4), both of which were expected to be published this year. Asked if those two sets of guidelines will be available this year, Gibbons said he is confident they will, a notion seconded by Michael Lauer, MD, director of the NHLBI's Division of Cardiovascular Sciences, during the press briefing. The evidentiary reviews for JNC 8 and ATP 4 are nearly finished, Gibbons said. Upon completion, they will be handed over to partner organizations for the development of guidelines. "The only difference is that the guidelines will not be part of a stand-alone NHLBI document," Gibbons said.
National Institutes of Health Launches Online Dietary Supplement Label Database
Ever wonder what’s in that vitamin you just popped in your mouth? This week, the U.S. National Institutes of Health (NIH) launched the Dietary Supplement Label Database, which lists ingredients for over 17,000 vitamins, minerals, herbs, and other dietary supplements. The free-to-use database is targeted toward both consumers and professionals. Consumers can access the database to find out exactly what is in their dietary supplements and use the NIH’s My Dietary Supplements online app for smartphones to track the supplements they use.
Clinical Laboratories Face Deadline to Comply With New Standard for Bar Code Labels on Specimens
Clinical laboratories have about nine months to comply with a new standard for bar code labels. The deadline for compliance to AUTO12-A, Specimen Labels: Content and Location, Fonts, and Label Orientation, is April 29, 2014. While compliance next year will not affect a lab’s accreditation, in the coming years accrediting bodies, such as The Joint Commission and the College of American Pathologists are expected to require medical laboratories to comply with this bar code label standard.
Clinical Laboratory Professionals Developed Bar Code Label Standard
AUTO12-A, the standard for bar code specimen labels, was developed by advisors from the clinical laboratory industry and is published by the Clinical and Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania. Labs that have already complied with this standard report that compliance has significantly improved specimen tracking. They also report reduced identification errors and increased productivity, according to Charles D. Hawker, Ph.D., MBA, FACB, the Scientific Director, Automation and Special Projects, for ARUP Laboratories in Salt Lake City, Utah.
Leveraging PEPFAR Investments in Laboratories Strengthen Health Systems and Save Lives
Strong laboratories and well-trained laboratory specialists are critical to well-functioning health systems, enabling clinicians and health workers to diagnose and treat a range of diseases and conditions. In the global response to HIV, reliable, accurate and efficient laboratories and skilled laboratory professionals are central to reaching people living with HIV as early as possible in their disease progression. Over the past nine years, PEPFAR has invested approximately $3 billion to create and strengthen lab networks, lab commodities, and the lab workforce, particularly in southern Africa. For example, PEPFAR has:
- As of 2012, assisted 21 partner countries (20 of these in Africa) in their development of National Strategic Laboratory Plans.
- Trained nearly 1,000 laboratory staff on specialized techniques at the PEPFAR-established African Center for Integrated Laboratory Training in Johannesburg
- Built, renovated or supported existing labs, and strengthened specimen referral networks.
- Worked with partner governments to create a laboratory platform in Africa, which the Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) has leveraged to help detect and respond to 900 global outbreaks since 2006, including Ebola and Marburg Hemorrhagic Fever in Uganda in 2012.
- Expanded the use of Dried Blood Spot (DBS) PCR testing for early infant diagnosis from three to 150 labs in 40 countries.
- Improved the quality control and quality assurance of HIV rapid testing through implementation of proficiency testing and standardized logbooks.
- Developed and implemented the use of a cost-effective HIV drug resistance test,
- Provided training on HIV and TB diagnosis and patient management in 43 PEPFAR partner countries.
How Labs Are Taming Test Utilization
Whatever the cause, health systems across the country are increasingly moving beyond education and retrospective review to more specific, targeted, prospective controls on test utilization. One of the most dramatic factors driving the trend is the number of new proprietary and genetic tests with four-figure prices. The $60 to $70 billion cost of clinical and anatomic pathology laboratory tests—which makes up four percent of the total U.S. health care tab—is on pace to double in three or four years. And ballooning molecular and genetic testing outlays are a major reason. “When a test costs $200, it’s a different scenario than when a test costs $5, 000,” says Curtis A. Hanson, MD, professor of laboratory medicine and pathology at Mayo Clinic, Rochester, Minn.
Based on research at his institution, Seattle Children’s Hospital, Michael Astion, MD, PhD, says utilization is a central problem in laboratory medicine. “In practice, you come to realize that the biggest errors in laboratory medicine that harm patients are doctors ordering the wrong tests, doctors misinterpreting laboratory results, and doctors failing to retrieve lab tests they’ve ordered,” says Dr. Astion, division chief of laboratory medicine at Seattle Children’s and professor of laboratory medicine at the University of Washington.
Hepatitis C Test for Baby Boomers Urged by Health Panel
An influential health advisory group has reversed itself and concluded that all baby boomers should be tested for hepatitis C, meaning that under the new health law many insurance plans will have to provide screening without charge to patients. The group, the United States Preventive Services Task Force, announced its change of heart, saying there was likely to be some benefit from such screening. An estimated 15,000 Americans a year die from the consequences of hepatitis C infection, which can cause liver scarring, liver failure and liver cancer, although such effects typically do not show up for decades, if at all.
The task force had said in a preliminary decision in November that screening all baby boomers would probably offer only a small benefit. That finding put it at odds with the Centers for Disease Control and Prevention, which had said a few months earlier that all people born between 1945 and 1965 should be offered a one-time test to see if they are infected with the hepatitis C virus. But the task force said on Monday that after reviewing some new studies and the public comments that it had received on its preliminary decision, it decided to recommend screening of baby boomers, saying there was a “moderate certainty” it would have a “moderate net benefit.”
Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium Tuberculosis Complex in Respiratory Specimens
The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Better Testing Catches Early HIV Infection
New approaches to HIV testing can detect acute infections that would have gone undetected with older methods, according to a CDC report. A 4th-generation immunoassay, coupled with an HIV-1/HIV-2 antibody differentiation test, picked up acute infections where traditional methods did not, according to two studies reported by CDC in the June 20 issue of Morbidity and Mortality Weekly Report. The acute phase of infection -- which plays a "disproportionate" role in transmission -- is the period between the appearance of HIV RNA in plasma and the detection of HIV antibodies, the agency noted.
Baylor Blood Test Detects Colon Cancer Before it Develops
A new blood test created at Baylor Research Institute detects colon cancer before it develops and could significantly reduce the need for colonoscopies, the study's lead author told me in an interview. The highly sensitive test detects cancer-related microRNA in blood of patients even before the development of colorectal cancer, said Ajay Goel, director of Epigenetics and Cancer Prevention at Baylor Research Institute. The development of this biomarker is promising because late detection of colorectal cancer results in higher mortality rates, Goel said. ”This test could be transformative in how we screen patients for colorectal cancer," Goel said.
New Technology Allows Fast, Reliable Pathogen Identification
Researchers from the University of Toronto have created an electronic chip with record-breaking speed that can analyze samples for panels of infectious bacteria. The new technology can report the identity of the pathogen in a matter of minutes, and looks for many different bacteria and drug resistance markers in parallel, allowing rapid and specific identification of infectious agents. The advance was reported this month in the journal Nature Communications. "The solution-based circuit chip rapidly and identifies and determines the antibiotic resistance of multiple pathogens - this represents a significant advance in biomolecular sensing," said Paul S. Weiss, Kavli Chair in NanoSystems Science and Director of the California NanoSystems Institute at UCLA.
Scientists at New Jersey Institute of Technology have developed new devices with which they’re looking for electrical signatures of healthy and sick cells. The tiny devices are made using complementary metal oxide semiconductor (CMOS) technology with carbon nanotubes deposited on top. They’re spaced only 6 μm, smaller than most cells, allowing voltage readings to be taken at a very high resolution. Nanotubes were found to be crucial to successfully detect the presence of cells. The devices are also able to distinguish between cells with different characteristics.
Quidel Says FDA Approves Streptococcus A Test
Quidel Corp. said that the Food and Drug Administration cleared a test that is designed to diagnose infections caused by Streptococcus A bacteria. Quidel said the bacteria are the most common cause of bacterial throat infections and can cause rheumatic fever and other illnesses. The Streptococcus test will run on the company's Sofia testing system, which is designed to return a result within five minutes. A Sofia test for influenza A and B was cleared in April 2012.
HCV Genotype Test Kit OK'd
The first standardized test kit for hepatitis C virus (HCV) genotyping has won FDA approval, the agency said. Abbott Molecular's RealTime HCV Genotype II test identifies the specific viral genotype -- classified as 1, 1a, 1b, 2, 3, 4, or 5 -- present in clinical samples. This information is vital for treatment planning, as available treatments for HCV infection vary in effectiveness according to genotype. The FDA emphasized that Abbott's test is not approved for diagnosing infection or for screening for the virus's presence in blood, blood products, or donor tissue.
Ethigen Launches Next Generation (NGS) BRCA Testing With Expanded Hereditary Cancer Panel
Ethigen announced the US launch of their expanded BRCA1 and BRCA2 testing service, providing next-generation sequencing (NGS) and rearrangement analysis of both genes. Analysis is available individually, or as part of an expanded hereditary cancer panel, including full coverage of up to seventeen additional genes with known links to cancer risk: MLH1, MSH2, MSH6, APC, MUTYH (MYH), PTEN, TP53, CDK4, STK11, SMAD4, BMPR1A, CDH1, MET, FH, FLCN, PDGFRA, and KIT.
Beckman Coulter Gets FDA Clearance of New Access AccuTnI+3 Troponin I Assay
Beckman Coulter, Inc., a subsidiary of Danaher Corp said the U.S. Food and Drug Administration, has granted clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. In October 2010, the FDA issued guidance to all manufacturers of troponin assays in an effort to modernize the performance evaluation and regulatory review of these critical tests. In accordance with the FDA's new requirements, Beckman Coulter conducted a large multicenter prospective clinical trial that enrolled over 1,900 subjects.
Diagnostic information services provider Quest Diagnostics announced that it had completed the acquisition of the clinical outreach services of Dignity Health, a California-based hospital. Terms of the acquisition were not disclosed, but Quest said it would perform the testing for the non-hospital labs at its clinical laboratories in California and Nevada. Dignity's hospital-based labs were not included in the transaction. So far this year, Quest has made three lab business acquisitions including Diginity's, having previously acquired the toxicology and clinical laboratory business of Humana subsidiary Concentra, and the clinical and anatomic-pathology outreach laboratory businesses of UMass Memorial Medical Center.
New $75M Washington University Lab to House Genomics Center, Genetics Department
The Washington University School of Medicine plans to break ground this summer on a new 138,000 square-foot building to house genomics, genetics, and regenerative biology labs, as well as labs for its Departments of Medicine and Developmental Biology. The six-story, $75 million building will be home to the Center for Genome Sciences and Systems Biology, and will consolidate most of the department of genetics faculty in one location.
Medtronic Insulin Pump Passes a Key Test; a Step Toward an 'Artificial Pancreas' for Diabetics
Doctors are reporting a major step toward an "artificial pancreas," a device that would constantly monitor blood sugar in people with diabetes and automatically supply insulin as needed.
A key component of such a system — an insulin pump programmed to shut down if blood-sugar dips too low while people are sleeping — worked as intended in a three-month study of 247 patients. This "smart pump," made by Minneapolis-based Medtronic Inc., is already sold in Europe, and the U.S. Food and Drug Administration is reviewing it now. Whether it also can be programmed to mimic a real pancreas and constantly adjust insulin based on continuous readings from a blood-sugar monitor requires more testing, but doctors say the new study suggests that's a realistic goal.
Research Could Lead to New Ways to Combat Chlamydia
A protein secreted by the chlamydia bug has a very unusual structure, according to scientists in the School of Medicine at The University of Texas Health Science Center San Antonio. The discovery of the protein's shape could lead to novel strategies for diagnosing and treating chlamydia, a sexually transmitted disease that infects an estimated 2.8 million people in the U.S. each year. The protein, Pgp3, is secreted by Chlamydia trachomatis, the bacterium that causes chlamydia. Pgp3's shape is very distinguishable - sort of like an Eiffel Tower of proteins. "From a structural standpoint, the protein is very odd indeed," said X-ray crystallographer P. John Hart, Ph.D.
Silver, the Secret Ingredient for Fighting Bacterial Infections
Traditionally, silver has been used in the medical field and clinics. Researchers have been aware that silver can be used to treat bacterial infections but did not know how. In a new study, researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University revisited the use of silver in combatting bacteria that have grown resistant to the current antibiotic treatments today. The researchers used a silver compound and were able to boost antibiotics strength in killing off bacteria.
A large review of studies concludes that taking iron supplements during pregnancy reduces the risk for maternal anemia and for having a baby with low birth weight. The analysis covered 92 studies involving almost two million subjects. Some of the studies tested iron alone and others iron in combination with folic acid, which is routinely used to reduce the risk for birth defects.
Over all, the researchers found a significant inverse relationship between the dose of iron and the risk for maternal anemia in the third trimester. For every increase of 10 milligrams of iron, up to 66 milligrams, there was a 12 percent decrease in the risk for anemia.
Iron Deficiency Linked to Psychiatric Disorders in Kids
Children and adolescents with iron deficiency anemia (IDA) are at increased risk for psychiatric disorders, including depressive disorder, bipolar disorder, anxiety disorder, and autism, new research shows. "When encountering those with IDA in clinical practice, prompt iron supplementation should be considered to prevent possible psychiatric sequelae, and vice versa, psychiatrists should check the iron level in those children and adolescents with psychiatric disorders," study author Ya-Mei Bai, MD, PhD, Department of Psychiatry, Taipei Veterans General Hospital and National Yang-Ming University, in Taiwan, told Medscape Medical News.
The study was published online June 4 in BMC Psychiatry.
FDA Ban on Gay Men as Blood Donors Opposed by American Medical Association
"The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science," AMA board member Dr. William Kobler said in a statement. "This new policy urges a federal policy change to ensure blood donation bans or deferrals are applied to donors according to their individual level of risk and are not based on sexual orientation alone." The AMA recommends that the FDA change its policy so that gay men are evaluated on an individual level rather than being lumped together in a high-risk category, in addition to crafting a policy that more accurately represents scientific research. Robert Valadez, policy analyst for the HIV/AIDS advocacy group Gay Men's Health Crisis, said the ban was outdated in light of medical advances that can detect HIV in donated blood in nearly all blood donations.
FDA Backs Off on Regulation of Fecal Transplants
The Food and Drug Administration says the agency will exercise enforcement discretion and no longer require doctors to get the agency's approval before using "fecal microbiota for transplantation." The procedure is being used to treat people suffering from infection with the bacterium Clostridium difficile, or C. diff. These infections cause inflammation of the colon and severe, sometimes life-threatening diarrhea. They can be extremely difficult to treat and are becoming more common. About 14,000 Americans die from C. diff every year, according to the federal Centers for Disease Control and Prevention.
FDA Approves Morning-After Pill for Over the Counter Sale
The Food and Drug Administration has approved Plan B One-Step, an emergency contraceptive, for over-the-counter sale without any age restrictions to comply with a court order by a federal judge in New York. The Obama administration had been fighting in court to preserve restricted access for younger teens, but recently dropped the case after legal setbacks. The FDA then told the court it would quickly approve an application for over-the-counter sale by Teva, the manufacturer of Plan B One-Step.
It’s called ibrutinib, and it’s a potential breakthrough in treating chronic lymphocytic leukemia (CLL) that could leave patients with fewer side effects than chemotherapy. In research published in the New England Journal of Medicine (NEJM), scientists report that the experimental drug, which differs from broadly acting chemotherapy agents by specifically targeting certain cancer-causing processes, significantly prolongs the life of patients. Ibrutinib is currently being tested on tumors that target the body’s immune system, such as CLL and mantle cell lymphoma (MCL).
3-D Map of Human Brain Gives Unprecedented Detail
Researchers in Germany and Canada have produced a new map of the human brain — not the sort that shows every brain cell and its every connection or the kind that shows broad patterns of activity in brain regions, but a work of classic anatomy, done with high technology that shows a three-dimensional reconstruction of a human brain in unprecedented detail. The new map, called BigBrain, is 50 times as detailed as previous efforts and will be available to researchers everywhere, said Katrin Amunts of the Institute of Neuroscience and Medicine in Jülich, Germany, the lead author of a report on the project in the current issue of Science.
Tea and Coffee Lower Blood Pressure in Large French Registry
A large French retrospective analysis provides good news for caffeine lovers: investigators showed that drinking tea or coffee was associated with a small but statistically significant reduction in systolic and diastolic blood pressure. In addition, drinking tea and coffee was also associated with a significant reduction in pulse pressure and heart rate, although the heart-rate reductions were greater with tea. Presenting the data on 176 437 subjects aged 16 to 95 years of age who had a checkup at their center between 2001 and 2011, Pannier explained that the analysis was simply based on a questionnaire asking participants how much coffee or tea they drank per day. Individuals were classified into three groups: those who drank no coffee/tea, those who drank one to four cups, and those who drank more than four cups.
Big Drop in HPV, Vaccine Gets Credit
The prevalence of human papillomavirus (HPV) infection in young women has declined by more than half since the introduction of the HPV vaccine, despite low vaccine uptake, according to a study by the CDC. Compared with the 4 years prior to the vaccine's introduction, infection with the HPV strains covered by the vaccine decreased by 56% in 14- to 19-year-old girls in the first 4 years after the vaccine became available. The decline in HPV infection rate occurred despite the fact that only a third of eligible patients received the vaccine. HPV prevalence in other age groups did not differ significantly between the two time periods, the CDC announced at a press briefing and reported simultaneously in the Journal of Infectious Disease.
CDC Immunization Experts OK Egg-Free Influenza Vaccine
Members of the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) have voted 13 to 0 in favor of recommending Flublok (Protein Sciences Corporation) to vaccinate people aged 18 through 49 years who have an egg allergy. Flublok, a trivalent influenza vaccine, was approved on January 16 by the US Food and Drug Administration (FDA) and will be available for the 2013 to 2014 influenza season. Unlike other approved influenza vaccines, Flublok does not use the influenza virus or chicken eggs in its manufacturing process. At this time, it is the only recombinant influenza vaccine approved for influenza. The panel of experts also voted to add Fluzone (Sanofi Pasteur) to its list of available vaccines. Fluzone was licensed by the FDA earlier in June, said Lisa Grohskopf, MD, MPH, from the CDC's Influenza Division. It has a needle that is 90% smaller than average influenza hypodermics.
Flu shots likely prevented 13 million illnesses and more than 110,000 hospitalizations in the United States between 2005 and 2011, according to a new study. The impact of flu vaccination was greatest during 2010-2011, when 5 million flu cases, 2.1 million medical visits and 40,400 hospitalizations were avoided, according to researchers from the U.S. Centers for Disease Control and Prevention. The findings, published June 19 in the journal PLoS One, are based on a calculation of the health-care burden of flu cases that would have occurred in the absence of vaccination. Factors such as illness and hospitalization rates during the flu season, vaccination coverage and vaccine effectiveness were considered in the calculation.
New Bird Flu Is Less Deadly Than Previously Thought, Study Finds
The H7N9 strain of bird flu that has killed 38 people in China since March is less deadly than had been supposed, according to the most detailed analysis of the outbreak so far. The risk of death for patients admitted to a hospital with H7N9 infection is about 36 percent, researchers at the Chinese Center for Disease Control and Prevention and the University of Hong Kong wrote in The Lancet medical journal today. While initial reports of severe illness among most patients suggested the virus may be highly lethal, as many as about 27,000 undetected mild cases may have occurred, lowering the risk, the study said.
Still, H7N9 is only about half as deadly as the H5N1 bird flu strain that has killed about 60 percent of the 630 people it’s infected since 2003, the researchers wrote. The new virus, which has subsided with the onset of warmer weather and the closure of live bird markets in China, may rebound this year if it follows a similar pattern to H5N1, they said in a separate study. “This potential lull should be an opportunity for discussion of preventive public health measures,” the authors wrote.
Deadly MERS Virus Spread in Saudi Arabian Hospitals, Report Says
A team of U.S. and Canadian scientists has teamed with Saudi health officials and others to report on how MERS spread through four hospitals in the eastern part of the country, infecting 23 patients and healthcare workers and killing 15. Writing in the New England Journal of Medicine, Johns Hopkins epidemiologist Dr. Trish Perl and colleagues from other institutions described the outbreak, which took place in April and May. Sifting painstakingly through medical records compiled by their Saudi hosts and other data, Perl and the team reconstructed how the virus spread from patient to patient, discovering that it passed from person to person in dialysis and intensive care units -- and also when patients were transferred between hospitals.
Through what Perl called "the CSI part" of the research, they showed that the virus is able to pass from person to person to person. "This moves it to the next level," she said, in an interview. "We have ongoing propagation."
Rubella Epidemics in Japan and Poland
Japan and Poland are both experiencing epidemics of rubella, and the Centers for Disease Control and Prevention has issued travel warnings suggesting that women who are pregnant or might be consult their doctors before visiting either country. The disease, also known as German measles, usually causes only mild fever and rash in adults and children, but can be devastating to a fetus, causing stillbirth or a host of birth defects, including developmental disabilities, deafness, heart problems and cataracts.
Yaz, Yasmin BCPs Linked to 23 Deaths in Canada
Health Canada records indicate that at least 23 deaths and 600 adverse reactions have been reported among women taking the birth-control pills (BCPs) Yaz and Yasmin (Bayer) in that country. News of the reports was first reported by the Canadian Broadcasting Corporation (CBC) and has been widely picked up by Canadian media. The pills already carry a label warning that BCPs containing drospirenone--a synthetic progestin produced by Bayer--carry a risk of venous thromboembolism that is 1.5 to three times higher than seen with other birth-control pills. The FDA added a warning to drospirenone BCP labels in 2012.
Doctors Perform Thousands of Unnecessary Surgeries
Tens of thousands of times each year, patients are wheeled into the nation's operating rooms for surgery that isn't necessary, a USA TODAY review of government records and medical databases finds. Some, fall victim to predators who enrich themselves by bilking insurers for operations that are not medically justified. Even more turn to doctors who simply lack the competence or training to recognize when a surgical procedure can be avoided, either because the medical facts don't warrant it or because there are non-surgical treatments that would better serve the patient. The scope and toll of the problem are enormous, yet it remains largely hidden. Public attention has been limited to a few sensational cases, typically involving doctors who put cardiac stents in patients who didn't need them. In fact, unnecessary surgeries might account for 10% to 20% of all operations in some specialties, including a wide range of cardiac procedures — not only stents, but also angioplasty and pacemaker implants — as well as many spinal surgeries. Knee replacements, hysterectomies, and cesarean sections are among the other surgical procedures performed more often than needed, according to a review of in-depth studies and data generated by both government and academic sources.
Plan Aims to Lift Restrictions on Doctor-Patient Discussions
Two proposals up for debate before American Medical Association (AMA) delegates seek to remove barriers to doctor–patient conversations in the exam room.
One is a resolution proposed by the American College of Physicians Wisconsin Delegation asking the AMA to support an end to government interference in what doctors can discuss with patients. In Florida, for instance, the Firearm Owners' Privacy Act, enacted in 2011, forbids doctors from asking patients whether there's a gun in the house; the penalty for contravening the Act is a fine or loss of license. Other legislation in Pennsylvania bars doctors from discussing exposure to certain chemicals because of proprietary information. Physicians can access information about the chemicals used in fracking or the extraction of oil and natural gas, for example, but they can't discuss those chemicals with patients.
Another proposal to be presented at the AMA 2013 Annual Meeting addresses the potential for interruptions in face-to-face conversations with patients when a physician is entering information into a computer.
AMA House Votes Against Council, Calls Obesity a Disease
Obesity should be called a disease and not simply a condition, the American Medical Association's policy-making House of Delegates voted. The vote -- approved by roughly 60% of the AMA's full House -- goes against the recommendation of its Council on Science and Public Health, which issued a report earlier saying that calling obesity a disease would be problematic.
The resolution was backed by delegates from the American Academy of Pediatrics, the American Academy of Family Physicians, the American Association of Clinical Endocrinologists, and the American Society of Bariatric Physicians. "We felt it's time to take a stance and say we're going to identify this as a disease," AMA committee on public health member Douglas Martin, MD, told MedPage Today. "We think that's going to send a message not only to the public but to the physician community that we really need to make it a priority and put it in our cross hairs."
AMA Takes On ICD-10, Sugary Drinks, Guns
The American Medical Association's policymaking House of Delegates wrapped up its annual meeting with votes on a wide variety of subjects, from ICD-10 to sugar-sweetened drinks to gun control.
- A key concern for the House is the move to ICD-10. The AMA will continue its fight to bypass ICD-10 completely, and go directly to ICD-11.
- The AMA should work to remove sugar-sweetened beverages from the federal Supplemental Nutrition Assistance Program (SNAP), delegates voted.
- In another vote, the House of Delegates directed the AMA to lobby Congress to study gun-related deaths by funding and using state and national firearm injury databases, including the National Violent Data Reporting System.
Blue Cross Plan to Provide Telehealth
Blue Cross and Blue Shield of Louisiana this fall will offer members of a new health insurance plan the ability to consult their doctors via their iPads, iPhones, Android devices and webcam-equipped PCs. It’s the first time the state’s largest health insurer will offer a telehealth benefit. “This is a huge, I would say a landmark shift for us,” Chief Medical Officer Dr. David Carmouche said. Blue Cross is launching the service as part of its Quality Blue Primary Care plan, which pays physicians more for keeping patients healthy. The program emphasizes the management of chronic diseases, such as high blood pressure and diabetes. Blue Cross made the move for a couple of reasons. First, telehealth helps address concerns about access to care; and, second, online visits can help control costs in a number of ways, including improving the management of chronic diseases.
EHR Systems Pose Serious Concerns, Groups Say
Electronic health-record systems used in emergency departments are beset with poor data displays, loaded with so many alerts warning of potential patient-safety issues that they can lead to user alert fatigue, and may be generating incorrect physician orders, according to a report by two emergency physicians' study groups. Meanwhile, providers wanting to address these EHR issues are hampered by a lack of research and solid evidence of the extent of the problem with these systems, and by contract provisions with EHR vendors that stymie the free flow of information about system-linked safety concerns, the report authors say. Two study groups from the American College of Emergency Physicians have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care. ACEP workgroups on informatics and on quality improvement and patient safety published their findings in an article, “Quality and Safety Implications of Emergency Department Information Systems,” in the current issue of the Annals of Emergency Medicine.
The workgroups came up with seven recommendations:
- appointing an emergency department “clinician champion,”
- creating within healthcare delivery organizations an EDIS performance improvement group and an ongoing review process,
- paying timely attention to EDIS-related patient-safety issues raised by the review process,
- disseminating to the public lessons learned from performance improvement efforts,
- distributing vendors' product updates in a timely manner to all EDIS users and
- removing the “hold harmless” and “learned intermediary clauses” from vendor contracts.
Mostashari: No More ICD-10 Extensions
Farzad Mostashari, MD, the national coordinator for healthcare IT, asserted there would be no extension of the deadline for switching from the ICD-9 medical coding system to ICD-10. The deadline for conversion would remain Oct. 1, 2014, Mostashari said in a keynote delivered this morning at the HIMSS Media ICD-10 Forum in National Harbor, Md. “There are no plans for any more extensions,” he told attendees, repeating it twice, for emphasis.
Patients Lead the Way as Medicine Grapples With Apps
Health apps like MyFitnessPal are turning smartphones and tablets into exercise aids, blood pressure monitors and even devices that transmit an electrocardiogram. But the explosion of apps is way ahead of tests to determine which ones work. Doctors aren't sure which of the roughly 40,000 available apps do what they claim to do. The Food and Drug Administration divides health apps into two categories: those that help with healthful lifestyles and those that turn your phone into a medical device to, say, record blood pressure or an EKG, and then send those readings to a doctor. The FDA is working on regulations for the mobile medical apps that can turn a mobile platform into a medical device. It does not plan to regulate diet or exercise apps. A few private companies are stepping in to do that task.
Sociologists Believe Literacy, Not Income, Is Key to Improving Public Health in India
Pro-market policies for developing countries have long been based on the belief that increasing average income is key to improving public health and societal well-being. But new research on India published in the journal Social Science and Medicine shows that literacy - a non-income good - has a greater impact on public health in India. A poor district can nonetheless enjoy relatively good public health if it has a high literacy rate, say researchers. Literacy acts as a base, enabling populations to understand medicine labeling, access healthcare, and engage with public health programmes. Using data on income, education, and under-five and infant mortality, the researchers suggest that policymakers concerned with public health should focus on literacy levels rather than average income.
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