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Debate Over Psychiatry Bible DSM-5 Grows Days Before Release

May 16, 2013 By MedNews Leave a Comment

With the release of the fifth edition of the so-called psychiatrist’s bible — the “Diagnostic and Statistical Manual of Mental Disorders (DSM),” days away, the controversy surrounding the new publication is heating up.

The National Institute of Mental Health (NIMH) and the American Psychiatric Association (APA), which publishes the DSM, issued a clarifying statement Tuesday saying that they were working together to ensure that people with mental disorders would have better diagnostic resources available to them. However, while they emphasized that the new version, dubbed the “DSM-5,” will have the most up-to-date information for clinical diagnoses of mental disorders, the NIMH did not waver from its initial ruling that it would no longer use diagnoses listed in the DSM for its’ funded studies.
NIMH director Thomas Insel wrote in a statement earlier in May that the NIMH felt the proposed definitions for psychiatric disorders were too broad and ignore smaller disorders that were lumped in with a larger diagnosis.

Read more: CBS News

Filed Under: Mental Health Tagged With: American Psychiatric Association (APA), DSM-5, Psychiatry

Xofigo for Advanced Prostate Cancer Approved by FDA

May 15, 2013 By MedNews Leave a Comment

Xofigo approved three months ahead of schedule under priority review program

The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. [Read more…]

Filed Under: Uncategorized Tagged With: Astellas Pharma, Bayer Pharmaceuticals, Medivation, prostate cancer, radium Ra 223 dichloride, Richard Pazdur, Xofigo, Xtandi

FDA Approves Simponi to Treat Ulcerative Colitis

May 15, 2013 By MedNews Leave a Comment

The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy. [Read more…]

Filed Under: FDA News & Alerts Tagged With: Andrew E. Mulberg, colitis, fda, golimumab, Janssen Biotech, Simponi

Flu in Pregnancy May Increase Child’s Bi-Polar Risk 4x

May 14, 2013 By MedNews Leave a Comment

Pregnant mothers’ exposure to the flu was associated with a nearly fourfold increased risk that their child would develop bipolar disorder in adulthood, in a study funded by the National Institutes of Health. The findings add to mounting evidence of possible shared underlying causes and illness processes with schizophrenia, which some studies have also linked to prenatal exposure to influenza.

“Prospective mothers should take common sense preventive measures, such as getting flu shots prior to and in the early stages of pregnancy and avoiding contact with people who are symptomatic,” said Alan Brown, M.D., M.P.H, of Columbia University and New York State Psychiatric Institute, a grantee of the NIH’s National Institute of Mental Health (NIMH). “In spite of public health recommendations, only a relatively small fraction of such women get immunized. The weight of evidence now suggests that benefits of the vaccine likely outweigh any possible risk to the mother or newborn.” [Read more…]

Filed Under: Mental Health Tagged With: Alan Brown, Bi-Polar, flu, JAMA, NIH, pregnancy

Men’s Brains Respond Differently to Hungry Infant’s Crying

May 7, 2013 By MedNews Leave a Comment

Researchers have uncovered firm evidence for what many mothers have long suspected: women’s brains appear to be hard-wired to respond to the cries of a hungry infant.

Researchers asked men and women to let their minds wander, then played a recording of white noise interspersed with the sounds of an infant crying. Brain scans showed that, in the women, patterns of brain activity abruptly switched to an attentive mode when they heard the infant cries, whereas the men’s brains remained in the resting state.

“Previous studies have shown that, on an emotional level, men and women respond differently to the sound of an infant crying,” said study co-author Marc H. Bornstein, Ph.D., head of the Child and Family Research Section of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the institute that conducted the study. “Our findings indicate that men and women show marked differences in terms of attention as well.”

The earlier studies showed that women are more likely than men to feel sympathy when they hear an infant cry, and are more likely to want to care for the infant.

Dr. Bornstein collaborated with Nicola De Pisapia, Ph.D., Paola Rigo, Simona DeFalco, Ph.D., and Paola Venuti, Ph.D., all of the Observation, Diagnosis and Education Lab at the University of Trento, Italy, and Gianluca Esposito, Ph.D., of RIKEN Brain Science Institute, Japan.

Their findings appear in NeuroReport.

Dr. Bornstein says this research not only helps understand the specific wiring of the brain, but helps understand how the brain has developed. (MP3 – 00:01:12, 1,140 KB)

Transcript – Dr. Bornstein says this research not only helps understand the specific wiring of the brain, but helps understand how the brain has developed.

Previous studies have shown differences in patterns of brain activity between when an individual’s attention is focused and when the mind wanders. The pattern of unfocused activity is referred to as default mode, Dr. Bornstein explained. When individuals focus on something in particular, their brains disengage from the default mode and activate other brain networks.

For about 15 minutes, participants listened to white noise interspersed with short periods of silence and with the sounds of a hungry infant crying. The patterns of their brain activity were recorded by a technique known as functional magnetic resonance imaging.

The researchers analyzed brain images from 18 adults, parents and nonparents. The researchers found that when participants listened to the typical infant cries, the brain activity of men and women differed. When hearing a hungry infant cry, women’s brains were more likely to disengage from the default mode, indicating that they focused their attention on the crying. In contrast, the men’s brains tended to remain in default mode during the infant crying sounds. The brain patterns did not vary between parents and nonparents.

Infants cry because they are distressed, hungry, or in need of physical closeness. To determine if adults respond differently to different types of cries, the researchers also played the cries of infants who were later diagnosed with autism. An earlier study of Dr. Bornstein and the same Italian group found that the cries of infants who develop ASD tend to be higher pitched than those of other infants and that the pauses between cries are shorter. In this other study, both men and women tended to interrupt their mind wandering when they heard these cries.

“Adults have many-layered responses to the things infants do,” said Dr. Bornstein. “Determining whether these responses differ between men and women, by age, and by parental status, helps us understand instincts for caring for the very young.”

In an earlier study, Dr. Bornstein and his colleagues found that patterns of brain activity in men and women also changed when they viewed an image of an infant face and that the patterns were indicative of a predisposition to relate to and care for the infant.

Such studies documenting the brain activity patterns of adults represent first stages of research in neuroscience understanding how adults relate to and care for infants, Dr. Bornstein explained. It is possible that not all adults exhibit the brain patterns seen in these studies.

Source: National Institutes of Health (NIH)

Filed Under: Pediatrics & Parenting Tagged With: Infants, Marc H. Bornstein, NICHD, NIH, parenting, pediatrics

Online Sign Up and Nationwide Testing Program Launched for Type 1 Diabetes Network

May 6, 2013 By MedNews Leave a Comment

Type 1 Diabetes NetworkPeople with a family history of type 1 diabetes can now conveniently participate in free screening to help find ways to delay or prevent the disease, even if they live far from a study site. This alternative to site-based initial screening comes as modern technology enables more secure online registration for medical research.

After volunteers consent online to participate in Type 1 Diabetes TrialNet — a study aimed at discovering ways to delay or prevent type 1 diabetes – they receive a screening kit in the mail, as shown, and will be directed to a local lab for a blood test at no cost to the volunteer. Courtesy of University of South Florida. [Read more…]

Filed Under: Diabetes Tagged With: Diabetes, Ellen Leschek, Griffin P. Rodgers, NIH, TrialNet, Type 1 Diabetes TrialNet

New Tool to Help Prevent Intentional Food Contamination

April 25, 2013 By MedNews Leave a Comment

The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.

The FDA does not require food facilities to implement food defense plans, but many facilities have voluntarily put such plans into place to safeguard their products. [Read more…]

Filed Under: FDA News & Alerts Tagged With: fda, food contamination

Mind Can Manipulate Digital Images, Research Shows

March 2, 2013 By MedNews Leave a Comment

A man is shown thinking about pictures of Michael Jackson and Marilyn Monroe in a conceptual rendering of the experiments in the study.

You don’t need a touchpad to manipulate complex visual images on a computer screen. Research shows that it can be done using only the mind.

A recent study, published in Nature found that when research subjects had their brains connected to a computer displaying two merged images, they could force the computer to display one of the images and discard the other. The signals transmitted from each subject’s brain to the computer were derived from just a handful of brain cells. [Read more…]

Filed Under: Featured Articles, Neurology Tagged With: brain, neurology, neurosurgery, NIH

Feed a Fever, Starve a Cold: Truth or Myth?

February 3, 2013 By MedNews 2 Comments

We’ve all heard it before: “Bundle up or you’ll catch cold.” “Don’t kiss me, I have a cold.” Or “Feed a fever, starve a cold.” While many old adages have truth to them, not all are entirely accurate. Read about some of the common myths and misconceptions about the common cold.
[Read more…]

Filed Under: Featured Articles

Juvisync Approved for Combined Treatment of Diabetes and High Cholesterol

October 7, 2011 By MedNews Leave a Comment

First combination drug to treat type 2 diabetes and high cholesterol in one tablet.

The U.S. Food and Drug Administration (FDA) today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

Source: FDA

Filed Under: Cholesterol, Diabetes Tagged With: (DPP-4, Diabetes, dipeptidyl peptidase 4, High Cholesterol, HMG-CoA reductase inhibitor, Juvisync, Mary H. Parks, MSD International GmbH Clonmel, simvastatin, sitagliptin, statin

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