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The Healthy Debate About Mental Health

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dsm-5May 2013 may be remembered as a watershed (or maybe a Waterloo) in the history of psychiatry. Two major events have set the stage for a fundamental debate about how we should think about the nature of mental illness.

The American Psychiatric Association (APA) is about to publish the fifth edition of its diagnostic system of classification: DSM-5. And, three weeks before the publication, Thomas Insel, director of the National Institute of Mental Health (NIMH), announced that his agency will be moving away from funding studies based on the DSM categories. [Read more…]

Debate Over Psychiatry Bible DSM-5 Grows Days Before Release

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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

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

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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…]

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

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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)

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

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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…]

Mind Can Manipulate Digital Images, Research Shows

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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…]

Juvisync Approved for Combined Treatment of Diabetes and High Cholesterol

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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

FDA Awards Grants to Encourage Pediatrics Medical Device Development

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The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.

A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The recipients and grant amounts include:

• James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 million a year for two years.
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 a year for two years.
• Barbara Boyan, Ph.D. and the Atlanta Pediatric Consortium, $900,000 a year for two years.

“Congress provides FDA with this funding so that we can help connect innovators and their ideas to experienced professionals who can assist them through development,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Product Development. “Development of medical devices for children lags up to a decade behind similar devices used in adults.”

Children differ in terms of size, growth, and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the Office of Orphan Products Development, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.

Legislation passed by Congress in 2007 established funding for grants to nonprofit groups to help stimulate projects to promote the development and availability of pediatric medical devices. These grants are meant to encourage the development of multiple pediatric device projects. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide information clearinghouses to promote multiple projects.

This is the second round of this type of biennial grants to be awarded. Those receiving these grants will:

  • encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers
  • mentor and manage pediatric device projects through their development, including prototype design and marketing
  • connect innovators and physicians to existing federal and non-federal resources
  • assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.

As part of the legislation, each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.

Past grant awardees have assisted in the development of devices to treat scoliosis, pediatric valvular heart disease, and projectile vomiting in newborns, among other diseases.

 

Source: FDA

Rotavirus Vaccine Leads to Lower Doctor Visits and Health Care Costs

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Vaccinating infants against rotavirus has resulted in dramatic decreases in health care use and treatment costs for diarrhea–related illness in U.S. infants and young children, according to a new study by the Centers for Disease Control and Prevention. The study is published in the current issue of the New England Journal of Medicine.

“This is good news for parents and our health system overall,” said Dr. Umesh Parashar, medical epidemiologist and team leader for the Viral Gastroenteritis Team in CDC′s Division of Viral Diseases. “Rotavirus vaccine is one of the most effective ways to prevent severe diarrhea–related illness in young children and keep them healthy.”

Rotavirus is a major cause of severe diarrhea in infants and young children in the United States. Before vaccines were introduced in 2006, rotavirus was responsible for about 400,000 visits to doctor′s offices, 200,000 emergency room visits, 55,000 to 70,000 hospitalizations, and 20 to 60 deaths each year in children under 5 years old.

RotaTeq and Rotarix, the two U.S. licensed rotavirus vaccines, were 85 to 98 percent effective at preventing severe rotavirus disease in clinical trials in middle and high income countries, including the United States.

This new study used data from a large U.S. insurance database for 2001 to 2009 to assess rotavirus vaccine coverage and its impact on health care use and treatment costs for diarrhea–related illness in children under 5 years old. The study examined direct benefits to vaccinated children and indirect protective benefits to unvaccinated children. National declines in health care use and treatment costs were estimated by applying the declines seen in this study to children under 5 years old in the U.S population.

By the end of 2008, 73 percent of children under 1 year of age, 64 percent of 1–year–olds, and 8 percent of 2– to–4–year–olds had received at least one dose of rotavirus vaccine. Rotavirus–related hospitalizations decreased substantially compared with pre–vaccine levels in children under 5 years old—75 percent decline for 2007–2008 and 60 percent decline for 2008–2009.

Vaccinated children had 44 to 58 percent fewer diarrhea–related hospitalizations and 37 to 48 percent fewer emergency room visits for diarrhea than unvaccinated children during the 2008 and 2009 rotavirus seasons (January to June). Even in unvaccinated children, there were substantial declines in health care use during the 2008 rotavirus season compared with pre–vaccine levels—showing indirect protective benefits.

The study estimated that about 65,000 hospitalizations of children under 5 years old from 2007 to 2009 were averted nationally with a health care cost savings of about $278 million.

“This study provides more evidence that vaccinating against rotavirus substantially reduces suffering and health care costs for this common childhood illness,” said Dr. Mark Pallansch, director of CDC′s Division of Viral Diseases. “As more children get vaccinated against rotavirus, we expect to see even greater reductions in disease among all age groups.”

Source: CDC

Flu Prevention for Children and Teens – Report

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Although children and teenagers rarely die from flu–related causes, many of the deaths could have been prevented if the children had been vaccinated against the flu, according to a report by the Centers for Disease Control and Prevention.

The study reports 115 influenza–associated deaths of people younger than 18, from September 2010 through August 2011 and highlights the importance of both annual vaccination and rapid antiviral treatment.

“It′s vital that children get vaccinated,” said Dr. Lyn Finelli, chief of the CDC′s Surveillance and Outbreak Response Team. “We know the flu vaccine isn′t 100 percent effective, especially not in children with high risk medical conditions. That′s why it′s essential that these two medical tools be fully utilized. Vaccinate first; then use influenza antiviral drugs as a second line of defense against the flu. Right now we aren′t fully using the medical tools at our disposal to prevent flu illnesses and deaths in children.”

The study in CDC′s Morbidity and Mortality Weekly Report provides details on the deaths. Since 2004, states have been required to report influenza-associated deaths in children and teenagers, giving the CDC a chance to look closely at factors that can increase risk.

Among the most notable findings was the infrequent use of the most important influenza prevention measure – vaccination. Despite a recommendation for vaccination of all children 6 months of age and older having been in place since 2008, only 23 percent of the 74 children older than six months with a known vaccination history had received their flu vaccine last season.

While many people believe that healthy children can withstand a bout of flu, this is not always the case. About half of the children who died last season were previously healthy and did not have a medical condition that would put them at risk for flu complications. However, the report underscores the fact that young age in itself is a risk factor. The report identified that 46 percent of the children who died were younger than 5 years and 29 percent were younger than 2 years.

The other half of the children who died did have a medical condition that predisposed them to being at greater risk of flu complications. Of 57 children with a medical condition, 54 percent had a neurological disorder, 30 percent had pulmonary disease, 25 percent had a chromosome or genetic disorder and 19 percent had congenital heart disease or other cardiac disease.

The report also identified issues with the use of antiviral drugs, which provide effective treatment for influenza. Of the 94 children who died in a hospital or emergency department, only 50 percent were prescribed antiviral drugs. Since the 2009 H1N1 pandemic especially, CDC has recommended immediate treatment with influenza antiviral medications in severely ill patients with suspected flu.

Another report in the Sept. 16 MMWR provides a summary of influenza activity from mid–May to the beginning of September. “If trends in that report continue,” Finelli says, “we should have a vaccine that will offer good protection against the viruses we expect will circulate this season.”

This season′s influenza vaccine protects against three influenza viruses, the 2009 influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. These are the same three flu virus strains that were circulating in 2010–2011 – just the eighth time since 1969 this phenomenon has occurred. Moreover, it is important to note that vaccine immunity wanes over time so CDC is recommending that everyone get vaccinated this season, even if they got vaccinated last season, in order to be optimally protected.

Source: CDC