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Test for Respiratory Viruses Cleared by FDA

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The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.

The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.

"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health.

"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient’s test specimen."

Other viruses identified by the xTAG Respiratory Viral Panel:

  • influenza B – one of three types of human influenza, less severe than influenza A
  • respiratory syncytial virus subtype A and B – both are leading causes of infant pneumonia and bronchiolitis (an infection of the airways leading to the lungs) and often contribute to the development of long-term pulmonary disease
  • parainfluenza 1, 2 and 3 – all are leading factors in the croup and the common cold
  • rhinovirus – the most common viral infective agent in humans and a cause of the common cold
  • adenovirus – a cause of respiratory tract infections often similar to strep throat or tonsilitis

While the test is faster than conventional tests, it is specific to the dozen viruses listed and should be used with other diagnostics such as patient data, bacterial or viral cultures and X-rays. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

The xTAG Respiratory Viral Panel is manufactured by Toronto-based Luminex Molecular Diagnostics.

Source: FDA, January 3, 2008

Increased Risk for Heart Disease in Women May Be Linked to Calcium in Coronary Arteries

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Some 5% of women rated as low-risk for heart disease show indications of advanced coronary artery calcium, and may be at risk for cardiovascular problems, according to a report in Archives of Internal Medicine.

The standard method for assessing a person’s risk of developing coronary heart disease in the next 10 years is the Framingham risk score, which measures age, cholesterol and blood pressure levels, smoking habits and diabetes. Americans are considered low-risk if their risk is estimated at less than 10% in 10 years, and high risk if the risk is 20% or more in 10 years.

Approximately 95% of American women aged less than 70 are considered low-risk. “Nevertheless”, write the authors, “most women will ultimately die of heart disease, suggesting that the Framingham risk score alone does not adequately identify women in ways that would be useful for targeted preventive interventions”.

Susna G. Lakoski, M.D., M.S., of the Wake Forest School of Medicine, Winston-Salem, N.C., and colleagues measured 3,601 women aged 45 to 84, in 2000. Computed tomographic (CT) chest scans determined scores for coronary artery calcium. High scores pointed to considerable amounts of calcium deposits. Participants were interviewed by telephone every 9 to 12 months about any subsequent cardiovascular diagnoses and hospital admissions.

2,684 (90%) of women were assessed as low-risk by the Framingham score. 32% had detectable calcium in their coronary arteries, while during an average of 3.75 years, 24 of the low-risk women had heart attacks or heart pain, and 34% had a cardiovascular disease event such as heart attacks, stroke or death.

“Compared with women with no detectable coronary artery calcium, low-risk women with a coronary artery calcium score greater than zero were at increased risk for coronary heart disease and cardiovascular disease events,” the authors write. In addition, almost 5 percent of the low-risk women had advanced coronary artery calcium, defined as a score of 300 or greater. These women had a 6.7 percent risk of a heart event and 8.6 percent risk of a cardiovascular event over the 3.75-year follow-up.

The authors believe that these data provide new information on cardiovascular disease risk and the evaluation and treatment of it in middle-aged and older women. They also maintain that women with coronary artery calcium are at potentially higher risk that A Framingham risk score would suggest. Further studies with longer follow-up periods will be required to determine whether women should be screened for coronary artery calcium, or treated more aggressively for heart disease risk factors.

Source: Arch Intern Med. 2007;167(22):2399-2401

Physical Health After Age 49 Correlated to Stroke Risk

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People after the age of 40 who can climb stairs, kneel, bend and lift may lower their risk of stroke by 50%.

Between 1993 and 1997 researchers checked a sample of 13,615 men and women in the UK aged between 40 and 79. Participants had not had a stroke, heart attack or cancer. They reported on their physical ability 18 months later, itemizing their ability to climb stairs, carry groceries, kneel, bend and lift. The number of strokes suffered by the group through 2005 was also noted.

Participants who scored in the top 25% on the physical function test had a 50% lower rate of stroke than participants with the lowest scores. For every 10-point increase, the mens’ risk of stroke was reduced by 19% and the women by 29%.

“People who reported better physical health had significantly lower risk of stroke”, said study author Phyo Kyaw Myint, MRCP, of the University of Cambridge. “This is independent of the known risk factors for stroke in the general population”. Myint said that people with poor physical health could represent a high risk for stroke, while pointing to other health issues such as chronic inflammation, leading to vascular disease. Increased physical activity, and eating more fruit and vegetables might also help reduce risk of stroke, he said.

Physical Activity Plus A Mediterranean Diet Can Lower Death Rate Over 5 Years

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Eating a Mediterranean diet and following nationally recommended physical activity are associated with a reduced risk of death over 5 years, according to two reports in Archives of Internal Medicine . Data provided by the National Institutes of Health-AARP Diet and Health Study was used in both studies, when 566,407 AARP members aged 50 to 71 returned questionnaires between 1995 and 1996.

A nine-point scale to measure conformity with the Mediterranean diet was used by Panagiota N. Mitrou, Ph.D and colleagues in 380,296 of the participants (214,284 men and 166,012 women) with no history of chronic disease. The diet included vegetables, legumes, fruits, nuts, whole grains, fish, ratio of monounsaturated fats, alcohol and meat. In the 5 years following, 12,105 sample members died, with 5,985 dying of cancer and 3,451 dying of cardiovascular disease. People with higher Mediterranean diet scores were less likely to die of any cause, or of cancer or heart disease.

The second study, supervised by Michael F. Leitzmann, M.D. Dr.P.H., of the National Cancer Institute, analyzed data provided by two questionnaires on physical activity from 252,925 participants (142,828 men and 110,097 women). 7,900 people died. The people who performed physical activity at least 30 minutes most days of the week (the amount of physical activity recommended in national guidelines) were 27% less likely to die. Those who performed vigorous physical activity recommended under the same guidelines (at least 20 minutes three times weekly) were 32% less likely to die. Lesser amounts of physical activity were associated with a 19% reduced risk of death.

Source: Arch Intern Med. 2007;167(22):2461-2468 and 2453-2460.

Elevated Blood Pressure May Result in Mild Cognitive Impairment

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A report in the December, 2007 issue of Archives of Neurology claims that high blood pressure can increase the risk of mild cognitive impairment, affecting the ability to thinking and learning.

About 9.9 of every 1000 elderly people who do not have dementia develop mild cognitive impairment early, and of these, 10%-12% develop Alzheimer’s disease. compared with 1%-2% of the general population. Dr. Christiane Reitz, M.D., Ph.D., and colleagues at the Columbia University Medical Center, New York, monitored 918 Medicare patients with an average age of 76.3 years, starting in 1992 through 1994. None had any mild cognitive impairment. Participants were then checked every 18 months, for an average of 4.7 years. People with mild cognitive impairment registered low cognitive scores and a defective memory, but were not diagnosed with dementia.

334 people developed mild cognitive impairment during the follow-up phase— including 160 cases of amnestic mild cognitive impairment, and 174 cases of non-amnestic mild cognitive impairment. High Blood pressure was connected with an increased risk of all types of mild cognitive impairment that was mostly associated with an increased risk of non-amnestic mild cognitive impairment. Hypertension was not associated with amnestic mild cognitive impairment, or a change in memory and language

"The mechanisms by which blood pressure affects the risk of cognitive impairment or dementia remain unclear," the authors write. "Hypertension may cause cognitive impairment through cerebrovascular disease. Hypertension is a risk factor for subcortical white matter lesions found commonly in Alzheimer’s disease. Hypertension may also contribute to a blood-brain barrier dysfunction, which has been suggested to be involved in the cause of Alzheimer’s disease. Other possible explanations for the association are shared risk factors," including the formation of cell-damaging compounds known as free radicals.

The authors believe that their findings support the hypothesis that hypertension increases the risk of incident mild cognitive impairment, especially non-amnestic mild cognitive impairment They conclude that preventing and treating hypertension may be important in lowering the risk of cognitive impairment.

Source: American Medical Association (AMA)

What You Don’t Want for Christmas: Weight Gain and Back Pain

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In a recent survey conducted by SpineUniverse, 69%
of people estimated that they typically gain up to 8 pounds during the
holiday season. Another 9% put their weight gain at over 8 pounds.

 Those extra pounds from sugar cookies and big family dinners don’t come
off easily, either: it takes 60% of the people surveyed up to 10 months
to lose their holiday weight. 11% said that they never lose the weight.
A study published in the New England Journal of Medicine agrees: most
people can’t shake their holiday weight until the next fall–just in
time for the Halloween candy.

 So year after year, people add on weight during the holidays, and in
the long-term, that holiday weight gain can add up–to back pain. Dr.
Steven Richeimer, a member of the SpineUniverse Editorial Board and
Chief of Pain Medicine at the University of Southern California, Keck
School of Medicine, explains, "If you’re overweight, your spine may be
overworked as it tries to carry that extra weight. This can produce
injury and back pain."

He continues, "When you’re overweight, you’re more likely to injure
your back, and it is more difficult to recover–the result can be
chronic back pain. Additionally, being overweight can exacerbate or
even lead to symptoms of degenerative disc disease, compression
fracture, osteoporosis, osteoarthritis, spinal stenosis, and
spondylolisthesis."

Thinking about back pain isn’t exactly full of holiday cheer. But
suffering excruciating back pain is even less cheerful. For some simple
steps to follow this holiday season to prevent the typical holiday
weight gain, visit Spine Universe.

Vaccination Controversy Spills Over to Video Sharing Site YouTube

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There is a growing debate over the necessity of the number of vaccines administered today. The controversy often surrounds a number of issues, such as pharmaceutical company lobbying to require administration of vaccinations that critics say have not undergone adequate testing.

For example, many states have pending bills that would require young girls to be vaccinated against HPV with Merck’s Gardasil. Currently only Virginia has passed a bill, as controversy has stalled bills in other states. The Virginia bill requires girls entering the sixth grade to be vaccinated, though it allows parents to opt their daughters out.

In February, 2007, Merck & Co. discontinued its lobbying of state
legislatures in an attempt to make it mandatory for girls to be inoculated with
Gardasil.

Others argue that over-vaccination will have long term detrimental effects on human immune systems. In the Journal Immunology Today researchers wrote:

Modern vaccinations, fear of germs and obsession with hygiene are depriving the immune system of the information input upon which it is dependent. This fails to maintain the correct cytokine balance and fine-tune T-cell regulation, and may lead to increased incidences of allergies and autoimmune diseases. If humans continue to deprive their immune systems of the input to which evolution has adapted it, it may be necessary to devise ways of replacing it artificially.

In a study published today in the Journal of the American Medical Association, University of Toronto researchers have uncovered widespread misinformation in related videos on YouTube.

The researchers, Dr. Kumanan Wilson and Dr. Jennifer Keelan, analyzed 153 videos about vaccination and immunization on YouTube, a popular online video-sharing site. Researchers found that more than half of the videos portrayed childhood, HPV, flu and other vaccinations negatively or ambiguously.

Of those videos, researchers report that about 45 per cent contained messages that contradict the 2006 Canadian Immunization Guide, which provides national guidelines for immunization practices. The Canadian recommendations are similar to guidelines from the American Centers for Disease Control and Prevention.

"YouTube is increasingly a resource people consult for health information, including vaccination," says first author Keelan, an assistant professor in U of T’s Department of Public Health Sciences. "Our study shows that a significant amount of immunization content on YouTube contradicts the best scientific evidence at large. From a public health perspective, this is very concerning."

The research team also found that videos skeptical of vaccinations—many of them highly provocative and powerful—received more views and better ratings by YouTube users than those videos that portray immunizations in a positive light.

"Health care professionals need to be aware that individuals critical of immunization are using YouTube to communicate their viewpoints and that patients may be obtaining information from these videos," says Wilson, senior author and an associate professor with U of T’s Department of Medicine. "YouTube users also need to be aware of this, so they can filter information from the site accordingly."

"The findings also indicate that public health officials should consider how to effectively communicate their viewpoints through Internet video portals," Wilson says.


Sources:

  • Journal of the American Medical Association, December 5, 2007
  • Universtiy of Toronto
  • Immunol Today, 1998 Mar;19(3):113-6.

Insufficient Sleep Could Lead to Overweight Kids

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Research findings from the University of Michigan C.S. Mott Children’s Hospital indicate that kids who don’t get enough sleep may be at increased risk of being overweight.

A study researching the connection between length of sleep and weigh for third and sixth grade children showed that kids who got less than 9 hours sleep per day were at greater risk of being overweight—regardless of their gender, race, socioeconomic status, or home environment quality.

The study showed that sixth graders short on sleep were more likely to be overweight. Third graders who got fewer hours of sleep—regardless of their BMI—were more likely to become overweight in sixth grade. The findings of this study appear in the November issue of the journal Pediatrics.

"Many children aren’t getting enough sleep, and that lack of sleep may not only be making them moody or preventing them from being alert and ready to learn at school, it may also be leading to a higher risk of being overweight," says study lead author Julie C. Lumeng, M.D., assistant research scientist at the U-M Center for Human Growth and Development. "This study suggests that an increased risk for overweight is yet another potential consequence of short sleep duration, providing an additional reason to ensure that children are receiving adequate sleep, primarily through enforcing an age-appropriate bed time."

Data from the National Institute of Child Health and Human Development Study of Early Child Care and Youth Development on reported sleep problems, sleep duration and BMI for 785 elementary school children, aged 9 to 12, was reviewed . 50% were male, 81% were white, 18% were overeight in the sixth grade. The overweight sixth grade lids slept fewer hours than those were not overweight, with boys in the majority of overweight sixth grade children.

"Even more important," Lumeng says, "is emerging research that shows a connection between sleep disruption and the hormones that regulate fat storage, appetite and glucose metabolism. Short sleep duration alters carbohydrate metabolism, and leads to impaired glucose tolerance, which can affect a person’s weight. Circadian rhythms, too, affect the body’s leptin, glucose and insulin levels."

So weight gain may not be a result of sleep’s effect on behavior, notes Dr. Lumeng, but rather sleep’s effect on hormone secretion in the body, specifically leptin and grehlin.

The National Sleep Foundation recommends these basic daily sleep requirements for children, adolescents, pre-teens and teens:

  • Preschoolers: 11-13 hours
  • Elementary school students: 10-12 hours
  • Pre-teens: 9 – 11 hours
  • Teens: 8 ½ – 9 hours

In addition to Lumeng, co-authors from the U-M Center for Human Growth and Development are Deepak Somashekar, B.S., and Niko Kaciroti, Ph.D.; Danielle Appugliese, MPH, with the Data Coordinating Center, Boston University; and Robert F. Corwyn, Ph.D., and Robert H. Bradley, Ph.D., with the Center for Applied Studies in Education, University of Arkansas.

The study was supported by the American Heart Association Fellow-to-Faculty Transition Award, and the American Heart Association Midwest Affiliate Grant-in-Aid.

Reference: Pediatrics, November 2007, Vol. 120, Issue 5.

Boxed Warning Additions to GlaxoSmithKline’s Anti-Diabetes Drug Avandia

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The U.S. Food and Drug Administration has announced that GalaxoSmithKline, the manufacturer of Avandia (rosiglitazone), has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks. Avandia is used to treat type 2 diabetes.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

According to the FDA, over the past year the agency has analyzed various sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

The FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, the agency has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning—FDA’s strongest form of warning—includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Source: FDA

Speedy Hospitalization After Heart Attack Onset Greatly Improves Care

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A Mayo Clinic Research study finds that getting a heart attack patient to hospital within one to two hours of heart attack onset can assure that chances of receiving proper treatment are 70 percent better than a patient who waits 11 to 12 hours. The results of the study were presented at the American Heart Association’s Scientific Sessions 2007, In Orlando, Florida.

"This research should emphasize to patients that getting help immediately, by calling 911, gives them the best chance of receiving treatments we know can help save their lives or lessen the damage to their hearts" says Henry Ting, M.D., lead Mayo Clinic cardiovascular researcher on the national study. "If patients wait at home for hors with symptoms and come in later, unfortunately they aren’t getting the proper treatment."

The most serious type of heart attack is known as a STEMI, for which the best treatment is reperfusion therapy. The study documents how long it took for 440,398 heart attack patients to arrive at the hospital after heart attack onset, and correlate arrival time with the rates of reperfusion therapy they received upon arriving at the hospital.

  • Of patients who arrived at the hospital within one to two hours of heart attack onset, 77% received reperfusion therapy
  • Of those patients arriving at the hospital within two to three hours of attack onset, 73% received reperfusion therapy
  • Of those patients who reached the hospital within 11 to 12 hours of attack onset, only 46% received reperfusion therapy

"Although current guidelines recommend that STEMI patients who reach the hospital within 12 hours after their symptoms started should receive reperfusion therapy, we found that this is not happening," Dr. Ting says. "These delays represent a novel and modifiable risk factor and warrant further investigation. These results show that gaps remain in quality of care in patients with STEMI — first, we need to encourage patients with potential heart attacks to come to the hospital as early as possible; second, hospitals need to implement systems that treat all eligible patients rapidly regardless of the delay in presentation."

Source: Mayo Clinic