A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 12, 2015
- Community Health Status Indicators Website Launch
- HHS OKs Emergency Use of Unapproved Enterovirus D68 Tests
- Be Wary of Websites Selling Genetic Cancer Tests: Study
- Releasing Test Results Directly to Patients: A Multisite Survey of Physician Perspectives
- Researchers Develop First Validated Method of Detecting Drugs of Abuse in Exhaled Breath
- New Clinical Laboratory Test Exposes Cancer Cells with Ultra Violet Light: Improves Accuracy of Current Cancer Assays, Say Researchers
- Is Most of Our DNA Garbage?
- Scientists Identify People Most Likely to Benefit from Statins
- New Type of Biomarker Shows Promise in Improving Prostate Cancer Care
- Hormone-disrupting Chemicals ‘Cost Billions’
- More than Half of Middle-aged Adults 'at Lifetime Risk of Chronic Kidney Disease'
- Drug-resistant TB May Be Treatable with New Small Molecule Drug
- New NQF Committee Will Develop Framework to Assess, Advance HIT-related Patient Safety
- Some Smartphone Apps Have to Be Cleared by the FDA
- Simple EHR Changes Can Significantly Impact Lab Utilization
View Previous Issues - Healthcare News Archive
Community Health Status Indicators Website Launch
CDC released the updated Community Health Status Indicators (CHSI) online tool that produces public health profiles for all 3,143 counties in the United States. Each profile includes key indicators of health outcomes, which describes the population health status of a county and factors that have the potential to influence health outcomes, such as health care access and quality, health behaviors, social factors, and the physical environment. The re-designed online application includes updated peer county groups, health status indicators, a summary comparison page, and U.S. Census tract data and indicators for sub-populations (age groups, sex, and race/ethnicity) to identify potential health disparities. In this new version of CHSI, all indicators are benchmarked against those of peer counties, the median of all U.S. counties, and Healthy People 2020 targets. Organizations conducting community health assessments can use CHSI data to:
- Assess community health status and identify disparities;
- Promote a shared understanding of the wide range of factors that can influence health; and
- Mobilize multi-sector partnerships to work together to improve population health
HHS OKs Emergency Use of Unapproved Enterovirus D68 Tests
The Department of Health and Human Services (HHS) has paved the way for potentially more rapid testing of enterovirus D68 (EV-D68), an organism responsible for an outbreak of respiratory illness in 2014 that sickened more than 1000 Americans and killed more than a dozen, primarily children. The authorization gives the US Food and Drug Administration the ability to quickly review and approve new diagnostics aimed at detecting EV-D68. These types of orders are often used to respond to perceived national security threats from bioterrorism, for instance, or in cases where military personnel might be exposed to agents or organisms in battle. They are also used when there is the possibility of a public health emergency for Americans in the US or abroad — as was the case with such an order that expedited testing of vaccines and therapies for the Ebola virus. EV-D68 was first discovered in 1962, and a mix of enteroviruses circulates every year, with infection most likely in the summer and fall, according to the Centers for Disease Control and Prevention (CDC).
Be Wary of Websites Selling Genetic Cancer Tests: Study
Websites that offer personalized genetic cancer tests tend to overstate their supposed benefits and downplay their limitations, a new study says. And many sites offer tests that have not been proven to be useful in guiding cancer treatment, according to the Dana-Farber Cancer Institute team that analyzed 55 such websites. "We wanted to see if consumers are getting a balanced picture of benefits and limitations of these services," said study first author Dr. Stacy Gray in an institute news release. She is a medical oncologist and investigator at the Dana-Farber Center for Outcomes and Policy Research in Boston. "We found a lot of variation. Some of the information is good, but all of it needs to be looked at critically by consumers and health care providers," she said. In general, "the benefits of these personalized cancer products are reported much more frequently than are the limitations," Gray said. The researchers also found that 88 percent of the websites offered one or more "nonstandard" tests that lacked evidence of having value in routine cancer care. The study was published March 5 in the Journal of the National Cancer Institute.
Hospitals Don't Have to Tell You about Deadly Superbug Risks
If a hospital learns that hackers breached your medical records, federal law requires that it inform you. If the same hospital learns you may have been exposed to a deadly pathogen, it usually doesn’t have to say a thing. That's because hospitals don’t have a legal obligation to tell patients about the presence of pathogens—even antibiotic-resistant bacteria. These so-called superbugs are increasingly common, and are so deadly that Tom Frieden, head of the Centers for Disease Control (CDC), has described them as “nightmare bacteria." Recent outbreaks, linked to contaminated endoscopes at UCLA and other hospitals, are bringing this policy gap to the fore.
Protection without a Vaccine
Last month, a team of scientists announced what could prove to be an enormous step forward in the fight against H.I.V. Scientists at Scripps Research Institute said they had developed an artificial antibody that, once in the blood, grabbed hold of the virus and inactivated it. The molecule can eliminate H.I.V. from infected monkeys and protect them from future infections. But this treatment is not a vaccine, not in any ordinary sense. By delivering synthetic genes into the muscles of the monkeys, the scientists are essentially re-engineering the animals to resist disease. Researchers are testing this novel approach not just against H.I.V., but also Ebola, malaria, influenza and hepatitis. “The sky’s the limit,” said Michael Farzan, an immunologist at Scripps and lead author of the new study.
Releasing Test Results Directly to Patients: A Multisite Survey of Physician Perspectives
“We conducted a cross-sectional survey at five clinical sites in the US and Australia. The US-based study was conducted via web-based survey of primary care physicians and specialists between July and October 2012. An identical paper-based survey was self-administered between June and September 2012 with specialists in Australia.
- Physicians we surveyed generally favor direct notification of normal results.
- Physicians have substantial concerns about direct notification of abnormal results.
- Findings suggest direct notification should be accompanied by strategies to help patients interpret results.
- Health care institutions will need to develop proactive strategies to facilitate and evaluate this process.
In conclusion, despite meaningful use initiatives to facilitate patient access to medical information on the horizon, we found that physicians have substantial concerns about direct notification of test results. Most concerns are about abnormal test results and more specifically about sensitive tests although physicians are generally in favor of direct notification of normal test results to patients.”
Researchers Develop First Validated Method of Detecting Drugs of Abuse in Exhaled Breath
Drug testing is most commonly performed using urine samples. A group of researchers from the Department of Laboratory Medicine at the Karolinska Institute in Sweden have worked on developing a more donor-friendly alternative to urine testing for drugs by focusing on exhaled breath. The procedure involves a simple method of sample collection and preparation, which is followed by a highly sensitive analytical technique known as LC-MS (Liquid chromatography-mass spectrometry). The drug groups which are identifiable following the technique include amphetamines, methamphetamines, cannabis, cocaine, and heroin. "The underlying mechanism in exhaled breath drug testing is believed to be the formation of aerosol particles from the airway lining fluid by the breathing process. These aerosol particles may become contaminated with drugs present in the body, which enables drugs to be highlighted. A simple collection device is currently available which selectively collects the micrometer aerosol particles on a filter and enables further laboratory investigation of possible drug content," explains Beck.
New Clinical Laboratory Test Exposes Cancer Cells with Ultra Violet Light: Improves Accuracy of Current Cancer Assays, Say Researchers
In England, a university team has developed a new technology for detecting circulating cancer cells in blood. Their method uses ultraviolet light and the results are so promising that efforts are now underway to develop this method into a clinical laboratory test. That is why pathologists and medical laboratory professionals may soon have a new tool in their arsenal: one that significantly aids physicians and medical laboratories in the diagnosis of cancer. The LGS test’s potential is that it could be a “universal” blood test for diagnosing cancer that will greatly enhance current cancer diagnostic tests, a university news release stated.
New Peanut Allergy Test Goes Beyond Scratching the Surface
Current peanut allergy tests are not very reliable when it comes to diagnosing the severity of an individual’s allergic reaction, which can range from hives to life-threatening anaphylactic shock. With an estimated three million people in the United States allergic to peanuts and tree nuts, having a more precise and reliable allergy test could prevent hospitalizations and allow for better monitoring of individuals suffering from peanut allergies.
Three chemists at the University of Connecticut (UConn) are developing a more advanced peanut allergy test that, based on initial results, is many times more sensitive than current procedures. The new test is capable of determining the potential intensity of a patient’s allergic reaction through just a few drops of blood. Although the initial results are promising, the time frame for any clinical use of the test is still years away. “Eventually, we’d like to use maybe five different peptides and carbohydrate samples to see how these IgEs bind to them,” says Rusling. “That way, we could determine a clear fingerprint of a patient’s susceptibility to a specific allergen.” There has been some debate over the role carbohydrates play in allergies. Because the UConn test has the capacity to test both protein peptides and carbohydrate residues, the researchers hope it can be used to learn more about how specific protein and carbohydrate epitopes bind to antibodies to gain a better understanding of how allergies are induced.
UW Researchers Develop Oral Swab for TB Testing
Researchers at the University of Washington in Seattle have developed a new approach that may help diagnose tuberculosis using oral swabs. The oral swab approach — which was inspired by veterinary medicine — allows clinicians to obtain a sputum sample from a patient and detect the disease much more easily than other approaches.
Specially Trained Pooch Sniffs-out Thyroid Cancer
Could a trained "sniffer dog" someday replace costly, invasive techniques used to spot thyroid cancer? That's the promise of an early report on one such canine, a German shepherd mix named Frankie. A team at the University of Arkansas in Little Rock said that Frankie can accurately sniff out cases of thyroid cancer when presented with patients' urine samples. If this early work pans out, "scent-trained canines could be used by physicians to detect the presence of thyroid cancer at an early stage and to avoid surgery when unwarranted," study senior author Dr. Donald Bodenner said in an Endocrine Society news release. The findings were scheduled for presentation at the society's annual meeting in San Diego.
Potential Biomarker Identified for Neonatal Sepsis in Preterm Infants
Leena Mithal, MD, pediatric infectious diseases fellow at Ann and Robert H. Lurie Children’s Hospital of Chicago, discusses new research which found that acute phase reactants in cord blood of premature infants could be used in detection and risk stratification for early onset sepsis. “[C-reactive protein], haptoglobin, serum amyloid A, Serum amyloid P and ferritin were severely elevated in the group with confirmed early onset sepsis, but were significantly different in patients with presumed early onset sepsis, late onset sepsis and controls,” Mithal told Infectious Diseases in Children. “Perhaps, these five biomarkers in umbilical cord blood can be used for risk stratification and improved diagnostics for neonatal early onset sepsis.”
Prenatal Blood Tests Detect Cancer Signal in Some Women
A new genetic test that sequences the blood of pregnant women for signs of diseases such as Down Syndrome in their fetuses are turning up unexpected results: a diagnosis of cancer in the mother. In as many as 40 cases, women who took Sequenom Inc's MaterniT21 test, which scans their genetic code and that of their fetus, had abnormal changes that could signify cancer. In at least 26 of these women, that test turned out to be accurate.
Is Most of Our DNA Garbage?
T. Ryan Gregory’s lab at the University of Guelph in Ontario is a sort of genomic menagerie, stocked with creatures, living and dead, waiting to have their DNA laid bare. The human genome contains around 20,000 genes, that is, the stretches of DNA that encode proteins. But these genes account for only about 1.2 percent of the total genome. The other 98.8 percent is known as noncoding DNA. Gregory believes that while some noncoding DNA is essential, most probably does nothing for us at all, and until recently, most biologists agreed with him. Surveying the genome with the best tools at their disposal, they believed that only a small portion of noncoding DNA showed any evidence of having any function. But in the past few years, the tide has shifted within the field. Recent studies have revealed a wealth of new pieces of noncoding DNA that do seem to be as important to our survival as our more familiar genes. Many of them may encode molecules that help guide our development from a fertilized egg to a healthy adult, for example. If these pieces of noncoding DNA become damaged, we may suffer devastating consequences like brain damage or cancer, depending on what pieces are affected. Large-scale surveys of the genome have led a number of researchers to expect that the human genome will turn out to be even more full of activity than previously thought. In January, Francis Collins, the director of the National Institutes of Health, made a comment that revealed just how far the consensus has moved. At a health care conference in San Francisco, an audience member asked him about junk DNA. “We don’t use that term anymore,” Collins replied.
Scientists Identify People Most Likely to Benefit from Statins
The American Heart Association’s 2013 recommendation for expanded statin use has raised eyebrows over whether the medications are now prescribed too much. But researchers at Washington University have found that analyzing genetics may help doctors determine who is most likely to benefit from the cholesterol-lowering therapy. For their study, published in The Lancet, scientists used statistical methods to examine heart attack risk among a total of 49,000 people enrolled in five studies. Researchers adjusted for traditional heart disease factors like age, sex, cholesterol levels, smoking history and diabetes diagnosis to designate the group of individuals deemed at a high risk for having a heart attack based solely on their genetics. According to a news release, the high-risk group had a 70 percent greater chance of having a heart attack compared to those at the lowest genetic risk. And statins— which help improve cholesterol and thus lower the likelihood of having a heart attack— helped reduce that risk by 48 percent among the high genetic-risk group, compared to a 29 percent reduced risk among the intermediate group and a 13 percent reduced risk among the low genetic-risk group.
New Type of Biomarker Shows Promise in Improving Prostate Cancer Care
Many men experience prostate cancer as a curable disease. But in those who recur in the form of metastasis death is inevitable. Pinpointing patients at high risk of relapse is imperative to giving them early treatment options when it’s more likely to be effective. Dr. Andrew Hsieh has identified two biomarkers that may improve oncologists’ ability to predict which patients’ prostate cancer will recur after surgery, long before the development of visible cancer elsewhere in the body. “It’s not like a factory that does the same thing every time. There are levels of regulation,” and changes in how key proteins are produced, independent of alterations to the proteins’ genes or messenger RNA, have been shown to drive cancer. YB-1 and MTA1 are just two of potentially hundreds of such proteins, and would never have been discovered if Dr. Hsieh had not ventured beyond traditional DNA and RNA biomarker discovery techniques.
The findings not only have the potential to improve care for prostate cancer patients, but strengthen the hypothesis that the control of protein abundance produces a potentially rich source of biomarkers for many types of cancer.
Customized DNA Minicircles Compel Cancer Cells to Excrete Biomarker
Researchers at the Stanford University School of Medicine are using tiny rings of DNA to induce cancer to reveal itself. Normally, clinicians search for biomarkers in blood and urine that cancers naturally excrete. This requires a separate test for each cancer type. But in the current research, the investigators developed the DNA rings that work by tricking cancer cells, but not normal cells, to produce a biomarker that can be easily detected. The technique works with a variety of cancer types, activating a mechanism that produces secreted embryonic alkaline phosphatase (SEAP). This protein is normally produced by embryos, while it doesn’t exist in adults.
NIH Launches Big Data Portal for Alzheimer’s Research
The National Institutes of Health announced a big data portal to speed the development of predictive models and effective therapies for Alzheimer’s disease (AD). The new data sharing and analysis web portal is an initiative of the Accelerating Medicines Partnership (AMP) – a joint effort among NIH, 10 biopharmaceutical companies and several nonprofit organizations –to discover novel, clinically relevant treatments and to develop biomarkers to help validate existing therapies. Although the focus now is to gather the datasets and make them available in their native formats, Sage told GenomeWebit plans to go through the individual studies and standardize the datasets so that all the analysts can more readily use it. Data may be used by the research community immediately and is not under embargo of any kind, NIH said.
Hormone-disrupting Chemicals ‘Cost Billions’
Common chemicals that disrupt human hormones could be costing more than €150bn ($165.4bn; £108.5bn) a year in damage to human health in Europe, a series of studies claims. The data suggests the high economic impact of chemicals in pesticides, plastics and flame retardants. The team, led by New York University, said the estimates were conservative. However, experts cautioned the findings were "informed speculation" and called for more detailed research. The data was presented at the annual meeting of the Endocrinology Society.
More than Half of Middle-aged Adults 'at Lifetime Risk of Chronic Kidney Disease'
A new study published in the American Journal of Kidney Diseases finds that more than 50% of middle-aged adults in the US are at risk of developing chronic kidney disease at some point in their lifetime. According to the National Kidney Foundation (NKF), around 1 in 3 Americans are currently at risk of developing CKD at some point in their lives. However, the investigators of this latest study, including Dr. Thomas Hoerger, a health economist and senior fellow at RTI International - a nonprofit research organization based in the US - found the risk of CKD may be even higher for those currently aged 30 or older. Around 16.7% of adults aged 30 and older will have CKD by 2030. To reach their findings, Dr. Hoerger and colleagues developed a model that allowed them to estimate the current prevalence of CKD among three age groups: 30-49, 50-64 and 65 and older. In addition, the team used the model to estimate what the prevalence of CKD would be by the years 2020 and 2030. The results surprised the researchers.
Drug-resistant TB May Be Treatable with New Small Molecule Drug
In a new study, scientists report how a new small molecule drug appears able to kill drug-resistant tuberculosis without toxic side effects. Improper use of antibiotics has led to new strains of TB that are resistant to the two most powerful drugs used to treat it: isoniazid and rifampicin. Now, researchers at the University of Georgia (UGA) in Athens have developed a new small molecule drug that may serve as a treatment against multidrug-resistant TB that cannot be cured with conventional drugs. The team reports the findings in the journal Bioorganic and Medicinal Chemistry Letters. The team was also surprised - when carrying out early tests on the new compound - that it shows strong anti-HIV properties. This could open the door to dual-purpose therapies, where the drug tackles more than one disease at the same time.
Officials Urge Testing as Portland, Oregon Sees Rise in Syphilis Cases
A spike in syphilis cases in Portland in the past three years has prompted concerned public health officials to urge more sexually active adults to get tested regularly for the treatable bacterial infection. The Portland metro area has seen about 240 new cases of the disease on average each year since 2012, many times more than the 10 to 30 cases that were detected annually before that. Across the country, incidences of syphilis are on the rise. The Centers for Disease Control and Prevention said last year the number of infections in the United States climbed by more than 10 percent in 2013 to 17,535 cases, compared with the previous year.
Lives at Risk as Women Are Too Scared to Find Out if They Carry the 'Faulty' BRCA Cancer Gene Mutation
According to new research by leading research charity, Ovarian Cancer Action, a quarter of women say they would choose NOT to be tested for the BRCA gene mutation (which can lead to both breast and ovarian cancer) if one of their family members had been previously diagnosed with the disease. The research, which has been released for Ovarian Cancer Awareness month, shows that whilst a family history of breast and/or ovarian cancer may indicate that there is the presence of a BRCA1/2 mutation, which increases the risk of getting ovarian cancer from one in 54 to one in two, many women preferred not to know or would be too scared to have the test. Furthermore, almost one in 20 women would refuse to inform other family members if they (or another family member) carried the BRCA gene - believing it was not their place to tell someone or not wanting to frighten them. Knowledge about family history and someone's BRCA status is crucial in order for their families to be tested and, if necessary, opt for risk reducing surgery to prevent developing ovarian and breast cancer.
New NQF Committee Will Develop Framework to Assess, Advance HIT-related Patient Safety
The adoption of health information technology (HIT) is widely viewed as essential to the transformation of healthcare and presents many new opportunities to improve patient care and safety. But, HIT adoption also can create new hazards that lead to HIT-related safety events. An NQF Committee is assessing the current environment related to measurement of HIT-related safety issues and is developing a comprehensive framework to effectively mitigate risk and advance measurement to improve health IT-related patient safety. “Rigorous measurement is one of the first steps to improving health IT-related safety and is essential to the development of a coordinated national strategy to maximize health IT benefits,” said HIT Safety Committee co-chair Hardeep Singh, MD, MPH, of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas. “Our recommendations will help prioritize risk areas and build a strong scientific foundation to advance measurement and improvement of patient safety in this area.”
Some Smartphone Apps Have to Be Cleared by the FDA
So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA). Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD). The best way to figure out how to classify your device is to find a “predicate”: something similar that is already on the market. With a predicate, you can file a 510(k) application rather than submit to the onerous Premarket Approval process.
Simple EHR Changes Can Significantly Impact Lab Utilization
Tweaking the menu in an electronic health record can have a direct impact on ordering patterns for laboratory testing, according to a new case study published in BMC Medical Informatics and Decision Making. The researchers, from the University of Iowa Hospital Clinics and elsewhere, noted concerns with laboratory testing utilization, including overutilization, underutilization and incorrect test ordering. They studied the effects of changes to the EHRs and computerized physician order entry (CPOE) to lab testing and ordering in a 711-bed academic medical center over a five-year period. Following the installation of the EHR, the academic medical center put interventions in place over time to promote better, more cost-effective utilization of lab testing, such as limits on selectable frequency of ordering lab tests, posting of lab test charges in the CPOE order entry, restricting the sending out of tests and expanding the checking for duplicative tests.
Making Health IT More 'Meaningful' in a Value-based Care Environment
Health information technology (IT) holds the potential to enable higher-quality, lower-cost health care and has been a major focus of federal health care policy. Formed by executive action in 2004, the Office of the National Coordinator for Health IT soon received Congressional support with the goal of achieving widespread use of health IT within a decade. As part of the 2009 American Recovery and Reinvestment Act, Congress enacted the Meaningful Use (MU) program to provide financial incentives to accelerate EHR uptake and other health IT tools, including more timely access for patients to their personal health information. To date, the MU program been successful in leading to substantial adoption of EHRs by health care providers across the United States, with approximately half of US providers now using an EHR that is MU certified. MU has also been credited as being largely responsible for the rapid adoption of e-prescribing and the increased use of health information exchanges. However, the promise of health IT has not yet been fulfilled. Despite progress on adoption, many providers do not believe that certified EHRs have significantly reduced their practice burden. Similarly, MU has been criticized by providers for its reliance on a general set of specific mandatory functions and workflows that define data collection and EHR capabilities in a way that may not be a good fit with their most pressing practice needs. Providers have also complained of excessive costs associated with clinical interoperability.
Docs Sound Warning about ICD-10 Dangers
In a letter this week to the Centers for Medicare & Medicaid Services, more than 100 medical societies aired "a number of concerns that do not appear to be addressed" as the ICD-10 deadline looms. Writing March 4 to CMS Acting Administrator Andrew Slavitt, the groups – including American Medical Association, the American Academy of Family Physicians and most state medical associations – made the case that "the transition to ICD-10 represents one of the largest technical, operational, and business implementations in the health care industry in the past several decades." As they gird for the "profound impact" the code set change will have on physicians, the medical groups pointed to several areas they find lacking less than seven months from the Oct. 1, 2015, transition deadline.
Apple Launches Medical Research App, Tools for Cyber Checks
Patients with asthma, Parkinson's, breast cancer and other conditions can use iPhones to take part in medical research studies using their devices, Apple announced. It's already been working with some big research institutions to design apps using ResearchKit, which lets patients use iPhones interactively to send researchers data about heart rate, coordination and symptoms. "ResearchKit is a framework that enables medical researchers to more easily design the apps they're going to use for clinical studies," said Dr. Stephen Friend, president and CEO of Sage Bionetworks, which is working with Apple to develop the apps. Apple will not see data that people are sending to their doctors, the company said, while also stressing the ease of use.
The Weird Benefit of Eating Salty Food
Too much salt can lead to heart disease, but there may be a healthy side to salt that hasn’t been appreciated — until now. If you’re an average American, chances are that you’re eating too much salt. But the latest research — which, the scientists stress, is still in its early stages — hints that there may be some benefits to salt that have gone unnoticed. Salt, it seems, may be an ancient way for the body to protect itself against bacteria. Reporting in the journal Cell Metabolism, Jonathan Jantsch, from the University of Regensburg in Germany, says that salt may be an effective way to ward off microbes. In a series of studies using both mice and human cells, he and his colleagues found that levels of sodium go up around an infection site, and that without salt, bacteria tend to flourish and grow better.
A Faster Way to Try Many Drugs on Many Cancers
This spring, a federally funded national program will start to screen tumors in thousands of patients to see which might be attacked by any of at least a dozen new drugs. Those whose tumors have mutations that can be attacked will be given the drugs. The studies of this new method, called basket studies because they lump together different kinds of cancer, are revolutionary, much smaller than the usual studies, and without control groups of patients who for comparison’s sake receive standard treatment. Researchers and drug companies asked the Food and Drug Administration for its opinion, realizing that if the F.D.A. did not accept the studies, no drugs would ever be approved on the basis of them. But the F.D.A. said it sanctioned them and could approve drugs with basket study data alone. Instead of insisting on traditional studies, said Dr. Richard Pazdur, who directs the F.D.A. office that approves new cancer drugs, the agency will look at the data and ask, “Is the American population going to be better off with this drug than without it?”
Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled ``Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.'' The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
This New Drug Turns ‘Bad’ White Fat into ‘Good’ Brown Fat
GC-1 could have the potential to treat obesity and metabolic disease Scientists claim they have found an experimental drug that turns “bad” white fat cells into “good” brown ones. Known as GC-1, the drug speeds up metabolism, or the burning off of fat cells, reports Science Daily. Researchers found it caused weight loss in fat mice. “GC-1 dramatically increases the metabolic rate, essentially converting white fat, which stores excess calories and is associated with obesity and metabolic disease, into a fat like calorie-burning brown fat,” said study author Kevin Phillips of the Houston Methodist Research Institute. Until recently, scientists thought only animals and human infants had these energy-burning “good” brown-fat cells.
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