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January 31, 2008, 8:38 PM CT

FDA about updating requirements for drug approval

FDA about updating requirements for drug approval
Researchers and the Food and Drug Administration (FDA) are discussing how new technologies in ophthalmology, which make it possible to collect better data about experimental therapys, might affect FDA clinical trials requirements.

Scientists from the National Institutes of Healths National Eye Institute (NEI) and major US universities and research centers met in a roundtable discussion with FDA representatives before an audience of their peers on November 28-29, 2006 in Washington DC.

The discussion among the 30 participants focused on endpoints and clinical trial strategies for evaluating new therapys for age-related macular degeneration (AMD), diabetic retinopathy and other severe retinal disorders.

The exchange is the subject of Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium, an article in the February 2008 issue of ARVOs peer-evaluated journal, Investigative Ophthalmology and Visual Science (http://www.iovs.org/cgi/content/full/49/2/479). The authors are Karl G. Csaky of Duke University Medical Center, Elaine A. Richman of Richman Associates and Frederick L. Ferris III, of NEI.

The FDA currently recommends that clinical study sponsors compare changes in visual function (measured on a visual acuity chart of letters and numbers) as a primary endpoint in assessing the effect of a new compound for treating a disorder of the eye.........

Posted by: Janet      Read more         Source


January 30, 2008, 9:14 PM CT

Blue-eyed humans have a single, common ancestor

Blue-eyed humans have a single, common ancestor
New research shows that people with blue eyes have a single, common ancestor. A team at the University of Copenhagen have tracked down a genetic mutation which took place 6-10,000 years ago and is the cause of the eye colour of all blue-eyed humans alive on the planet today.

What is the genetic mutation.

"Originally, we all had brown eyes", said Professor Eiberg from the Department of Cellular and Molecular Medicine. "But a genetic mutation affecting the OCA2 gene in our chromosomes resulted in the creation of a "switch", which literally "turned off" the ability to produce brown eyes". The OCA2 gene codes for the so-called P protein, which is involved in the production of melanin, the pigment that gives colour to our hair, eyes and skin. The "switch", which is located in the gene adjacent to OCA2 does not, however, turn off the gene entirely, but rather limits its action to reducing the production of melanin in the iris - effectively "diluting" brown eyes to blue. The switch's effect on OCA2 is very specific therefore. If the OCA2 gene had been completely destroyed or turned off, human beings would be without melanin in their hair, eyes or skin colour - a condition known as albinism.

Limited genetic variation.

Variation in the colour of the eyes from brown to green can all be explained by the amount of melanin in the iris, but blue-eyed individuals only have a small degree of variation in the amount of melanin in their eyes. "From this we can conclude that all blue-eyed individuals are associated with the same ancestor," says Professor Eiberg. "They have all inherited the same switch at exactly the same spot in their DNA." Brown-eyed individuals, by contrast, have considerable individual variation in the area of their DNA that controls melanin production.........

Posted by: Janet      Read more         Source


January 29, 2008, 9:22 PM CT

Creative and noncreative problem solvers

Creative and noncreative problem solvers
Why do some people solve problems more creatively than others? Are people who think creatively somehow different from those who tend to think in a more methodical fashion? .

These questions are part of a long-standing debate, with some scientists arguing that what we call creative thought and noncreative thought are not basically different. If this is the case, then people who are thought of as creative do not really think in a fundamentally different way from those who are thought of as noncreative. On the other side of this debate, some scientists have argued that creative thought is fundamentally different from other forms of thought. If this is true, then those who tend to think creatively really are somehow different.

A new study led by John Kounios, professor of psychology at Drexel University and Mark Jung-Beeman of Northwestern University addresses these questions by comparing the brain activity of creative and noncreative problem solvers. The study reported in the journal Neuropsychologia, reveals a distinct pattern of brain activity, even at rest, in people who tend to solve problems with a sudden creative insight -- an Aha! Moment in comparison to people who tend to solve problems more methodically.

At the beginning of the study, participants relaxed quietly for seven minutes while their electroencephalograms (EEGs) were recorded to show their brain activity. The participants were not given any task to perform and told they could think about whatever they wanted. Later, they were asked to solve a series of anagrams scrambled letters that can be rearranged to form words [MPXAELE = EXAMPLE]. These can be solved by deliberately and methodically trying out different letter combinations, or they can be solved with a sudden insight or Aha! in which the solution pops into awareness. After each successful solution, participants indicated in which way the solution had come to them.........

Posted by: Janet      Read more         Source


January 28, 2008, 10:57 PM CT

Number of Russian women smokers has doubled

Number of Russian women smokers has doubled
In 1992, seven per cent of women smoked, in comparison to almost 15 per cent by 2003. In the same period, the number of men who smoke has risen from 57 per cent to 63 per cent.

The scientists behind the study, reported in the journal Tobacco Control, blame the privatisation of the previously state owned tobacco industry and the behaviour of the transnational tobacco companies (TTCs) for what they describe as a "very worrying increase".

Between 1992 and 2000, TTCs such as Philip Morris, British American Tobacco and Japan Tobacco International invested approximately US$1.7 billion to gain a 60 per cent share of the privatised Russian tobacco market.

Tobacco advertising had simply not existed in the Soviet era. Yet as soon as the TTCs were there, it was rampant, say researchers. By the mid 1990s it was estimated that half of all billboards in Moscow and three quarters of plastic bags in Russia carried tobacco advertising.

"There can be no doubt that the marketing tactics of Philip Morris, British American Tobacco and the like directly underpin this massive increase in smoking that spells disaster for health in Russia," said Dr Anna Gilmore from the School for Health at the University of Bath, who carried out the study with academics from the London School of Hygiene & Tropical Medicine and University College London, and has been researching tobacco control in the region for over seven years.........

Posted by: Janet      Read more         Source


January 28, 2008, 10:51 PM CT

Over-the-counter eardrops may cause hearing loss

Over-the-counter eardrops may cause hearing loss
A new study, led by scientists at The Montreal Childrens Hospital (MCH) of the MUHC, has revealed that certain over-the-counter earwax softeners can cause severe inflammation and damage to the eardrum and inner ear. The results of the study, recently published in The Laryngoscope, suggest that use of these medications should be discouraged.

Patients often complain that wax is blocking their ears and is causing discomfort and sometimes deafness, says Dr. Sam Daniel principal investigator of the study and director of McGill Auditory Sciences Laboratory at The Childrens. Over-the-counter earwax softeners are used to breakup and disperse this excess wax. However, the effects of these medications on the cells of the ear had not been thoroughly analyzed.

Because some of these products are readily available to the public without a consultation with or prescription from a physician, it is important to make sure they are safe to use. Our study shows that in a well-established animal model, one such product, Cerumenex, is in fact, toxic to the cells of the ear, says Dr. Daniel.

Dr. Daniel and his team studied the impact of Cerumenex on hearing. In addition, overall toxicity in the outer ear and changes in the nerve cells of the inner ear were analyzed.

Harmful effects to a number of of the cells were observed after only one dose, says Dr. Melvin Schloss co-author and MCH Director of Otolaryngology. We observed reduced hearing, severe inflammation, and lesions to the nerve cells.........

Posted by: Sue      Read more         Source


January 28, 2008, 10:20 PM CT

Diuretics Excel in Drug Comparison Trial

Diuretics Excel in Drug Comparison Trial
UT-Houston's Barry Davis, M.D., Ph.D., Sara Pressel,
M.S., and Charles Baimbridge.
Diuretics were linked to reduced heart disease in a drug comparison trial involving 23,077 people with both hypertension and the metabolic syndrome, a cluster of risk factors for heart disease, report scientists from The University of Texas School of Public Health and Case Western Reserve University in the Jan. 28 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals. The cardiac benefits connected with diuretics were especially pronounced in blacks, who have a high occurence rate of hypertension or hypertension.

"In hypertensive patients with metabolic syndrome, initial therapy for high blood pressure should include a diuretic," said senior author Barry Davis, M.D., Ph.D., professor of biostatistics and the director of the Coordinating Center for Clinical Trials at the UT School of Public Health. "Diuretics are preferred over other major classes of blood pressure medications to prevent one or more forms of cardiovascular disease."

Hypertension is one of the risk factors included in the metabolic syndrome along with diabetes or pre-diabetes, excessive belly fat, high triglyceride levels, or low levels of high-density lipoprotein ("good" cholesterol). It is estimated that about 40 percent of adults age 60 years or older can be classified as having the metabolic syndrome.........

Posted by: Daniel      Read more         Source


January 28, 2008, 5:17 AM CT

Cutting caffeine may help control diabetes

Cutting caffeine may help control diabetes
Daily consumption of caffeine in coffee, tea or soft drinks increases blood sugar levels for people with type 2 diabetes and may undermine efforts to control their disease, say researchers at Duke University Medical Center.

Scientists used new technology that measured participants glucose (sugar) levels on a constant basis throughout the day. Dr. James Lane, a psychology expert at Duke and the lead author of the study, says it represents the first time scientists have been able to track the impact of caffeine consumption as patients go about their normal, everyday lives.

The findings, appearing in the recent issue of Diabetes Care, add more weight to a growing body of research suggesting that eliminating caffeine from the diet might be a good way to manage blood sugar levels.

Lane studied 10 patients with established type 2 diabetes and who drank at least two cups of coffee every day and who were trying to manage their disease through diet, exercise and oral medications, but no extra insulin. Each had a tiny glucose monitor embedded under their abdominal skin that continuously monitored their glucose levels over a 72-hour period.

Participants took capsules containing caffeine equal to about four cups of coffee on one day and then identical capsules that contained a placebo on another day. Everyone had the same nutrition drink for breakfast, but were free to eat whatever they liked for lunch and dinner.........

Posted by: JoAnn      Read more         Source


January 24, 2008, 10:55 PM CT

Marijuana withdrawal as bad as withdrawal from cigarettes

Marijuana withdrawal as bad as withdrawal from cigarettes
Research by a group of researchers studying the effects of heavy marijuana use suggests that withdrawal from the use of marijuana is similar to what is experienced by people when they quit smoking cigarettes. Abstinence from each of these drugs appears to cause several common symptoms, such as irritability, anger and trouble sleeping - based on self reporting in a recent study of 12 heavy users of both marijuana and cigarettes.

These results indicate that some marijuana users experience withdrawal effects when they try to quit, and that these effects should be considered by clinicians treating people with problems correlation to heavy marijuana use, says lead investigator in the study, Ryan Vandrey, Ph.D., of the Department of Psychiatry at the Johns Hopkins University School of Medicine.

Marijuana is the most widely used illicit drug in the United States. Admissions in substance abuse therapy facilities in which marijuana was the primary problem substance have more than doubled since the early part of 1990s and now rank similar to cocaine and heroin with respect to total number of yearly therapy episodes in the United States, says Vandrey.

He points out that a lack of data, until recently, has led to cannabis withdrawal symptoms not being characterized or included in medical reference literature such as the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, (DSM-IV) or the International Classification of Diseases, 10th edition (ICD-10).........

Posted by: JoAnn      Read more         Source


January 22, 2008, 11:10 PM CT

Daily exercise dramatically lowers men's death rates

Daily exercise dramatically lowers men's death rates
Increased exercise capacity reduces the risk of death in African-American and Caucasian men, scientists reported in Circulation: Journal of the American Heart Association.

The government-supported Veterans Affairs study included 15,660 participants and is the largest known to assess the link between fitness and mortality.

It is important to emphasize that it takes relatively moderate levels of physical activity like brisk walking to attain the associated health benefits. Certainly, one does not need to be a marathon runner. This is the message that we need to convey to the public, said Peter Kokkinos, Ph.D., lead author of the study and director of the Exercise Testing and Research Lab in the cardiology department at the Veterans Affairs Medical Center in Washington, D.C.

Professor Kokkinos and his colleagues investigated exercise capacity as an independent predictor of overall mortality for African-American men (6,749) and Caucasian men (8,911) and also examined whether racial differences in exercise capacity influence the risk of death. Veterans were tested by a standardized treadmill test to assess exercise capacity between May 1983 and December 2006 at Veterans Affairs medical centers in Washington, D.C., and Palo Alto, Calif. The men were encouraged to exercise until fatigued unless they developed symptoms or other indicators of ischemia. These individuals were then followed for an average of 7.5 years and death rates were recorded.........

Posted by: Daniel      Read more         Source


January 22, 2008, 11:08 PM CT

Questions About Diagnosis, Medical Treatment Of ADHD

Questions About Diagnosis, Medical Treatment Of ADHD
A new UCLA study shows that only about half of children diagnosed with attention-deficit hyperactivity disorder, or ADHD, exhibit the cognitive defects usually linked to the condition.

The study also observed that in populations where medicine is rarely prescribed to treat ADHD, the prevalence and symptoms of the disorder are roughly equivalent to populations in which medicine is widely used.

The results of the first large, longitudinal study of adolescents and ADHD, conducted among the population of northern Finland, appeared in several papers in a special section of the Journal of the American Academy of Child and Adolescent Psychiatry published in December and are currently online.

ADHD is a common, chronic behavioral disorder characterized by inattention, hyperactivity and impulsivity that is thought to affect some 5 to 10 percent of school-age children worldwide.

In adolescence, ADHD is generally linked to cognitive deficits, especially with working memory and inhibition, which have been associated with overall intelligence and academic achievement, as per UCLA psychiatry professor Susan Smalley, who headed the research. Interestingly, the study showed that these deficits are only present in about half of adolescents diagnosed with ADHD.........

Posted by: JoAnn      Read more         Source



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Did you know?
Adolescents who suffer physical injuries are vulnerable to emotional distress in the months following their hospitalization, yet almost 40 percent of hospitalized adolescents interviewed for a new study had no source for the follow-up medical care that could diagnose and treat symptoms of post-traumatic stress. These young trauma survivors are at risk for high levels of post-traumatic stress and depressive symptoms, as well as high levels of alcohol use, according to research by researchers at the Harborview Injury Prevention and Research Center.

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