Risky Behavior in Adolescents May Signal Mature Brain

A new study using brain imaging to study teen behavior indicates that adolescents who engage in dangerous activities have frontal white matter tracts that are more adult in form than their more conservative peers.

The brain goes through a course of maturation during adolescence and does not reach its adult form until the mid-twenties. A long-standing theory of adolescent behavior has assumed that this delayed brain maturation is the cause of impulsive and dangerous decisions in adolescence. The new study, using a new form of brain imaging, calls into question this theory.

In order to better understand the relationship between high risk-taking and the brain’s development, Emory University and Emory School of Medicine neuroscientists used a form of magnetic resonance imaging (MRI) called diffusion tensor imaging (DTI) to measure structural changes in white matter in the brain. The study’s findings are published in the Aug. 26, 2009 PLoS ONE.

“In the past, studies have focused on the pattern of gray matter density from childhood to early adulthood, says Gregory Berns, MD, PhD, principal investigator and professor of Psychiatry and Neuroeconomics at Emory University and director of the Center for Neuropolicy. “With new technology, we were able to develop the first study looking at how development of white matter relates to activities in the real world.”

Gray matter is the part of the brain made up of neurons, while white matter connects neurons to each other. As the brain matures, white matter becomes denser and more organized. Gray matter and white matter follow different trajectories. Both are important for understanding brain function.

The study enrolled 91adolescents ages 12 through 18 over a three-year period. Levels of engagement in dangerous behaviors were measured by a survey that included questions about the teens’ thrill seeking behaviors, reckless behaviors, rebellious behaviors and antisocial behaviors. DTI was used to measure corresponding structural changes in white matter.

“We were surprised to discover that risk-taking was associated with more highly-developed white matter – a more mature brain,” says Berns. “We were also surprised to learn that except for slightly higher scores in risk-taking, there was no significant difference in the maturity of the white matter between males and females.”

Berns suggests that doing adult-like activities requires sophisticated skills.

“Society is a lot different now than it was 100 years ago when teens were expected to go to work and raise a family,” says Berns. “Now, adolescents aren’t expected to act like adults until they are in their twenties, when they have finished their education and found a career.

“You could make the case that in this country, biological capacity shows up long before the wisdom that comes with time is fully developed,” notes Berns.

Berns says more studies need to be done to determine if early brain development predisposes someone to engage in risky behaviors, or if the risky behavior drives the maturation of the brain.

The CDC reports that, 27,000 people between the ages of 10 and 24 die from bad decisions in the United States per year. Additionally, it has been shown that the period of mid-adolescence (ages 15 through 19) is the time when teens are more likely to begin high-risk behaviors such as drinking, abusing drugs or driving recklessly.

Other researchers who contributed to this study include, Sara Moore, BS, Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine and C. Monica Capra, PhD, the Department of Economics and the Center for Neuropolicy, Emory University.

This study was funded by grants from the National Institute on Drug Abuse.

“Adolescent Engagement in Dangerous Behaviors Is Associated with Increased White Matter Maturing of Frontal Cortex”, PLoS ONE, 8/26/09, 10.1371
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Emory Eye Center Doctor Provides Retina Expertise at Emory Clark-Holder Clinic

Emory Eye Center physician Jiong Yan, MD, assistant professor of ophthalmology at Emory School of Medicine and retina specialist within Emory Eye Center, now sees patients at Emory Clark-Holder Clinic in LaGrange, Ga., in addition to her roles at Emory Eye Center and the Veterans Administration Medical Center. Yan will see patients in LaGrange every other Thursday of the month.

Yan’s expertise will enable the residents of Troup County to have access to an Emory Eye Center ophthalmologist who can provide the highest level of care for retinal disorders. Emory Eye Center is a top-ranked academic eye institution with a three-fold mission of quality patient care, innovative research, and ongoing education, training future ophthalmologists from around the world.

Yan’s interests include diabetic retinopathy, macular disease, retinal detachment and age-related macular degeneration. Additionally, she directs the inherited retinal disease unit at Emory Eye Center. In her position at Emory, she has been involved in eight clinical trials, serving as either principal investigator or co-investigator. She has published nearly 20 papers.

“We are pleased to be able to serve patients in the LaGrange community,” says Yan. “Our retina patients must often have a family member drive them to their clinic appointment. The Emory Clark-Holder Clinic location will help those in the immediate area have closer access to advanced ophthalmic care. Because many our of retina patients need treatments every two months, a more convenient clinic will allow them to make their appointments with more ease. We are excited to work with these patients and provide the care they need, near their homes.”

Timothy W. Olsen, director of the Emory Eye Center, says “Emory Eye Center is excited to have an opportunity to work with our neighbors to bring subspecialty care to West Georgia. I’m certain that the talent and compassion of Dr. Yan will benefit her patients as well as the community. We look forward to our ongoing collaborations at Emory Clark-Holder Clinic.”

Anna Kao, MD, an ophthalmologist serving at Emory Clark-Holder says, “Ophthalmology has been a long-standing tradition with Clark-Holder Clinic. It is very exciting to see the expansion of our service with Dr. Yan’s experience. With the advancement of new technology and medicine, we are able to make a significant difference in saving sight for retinal disorders such as age-related macular degeneration. Dr. Yan’s presence in LaGrange will allow our local and surrounding residents to be part of modern medical advances.”

Yan attended medical school at Louisiana State University (1998). She completed an internship at UMDNJ-Robert Wood Johnson Hospital in New Brunswick, N.J. (1999). She finished a residency in ophthalmology at Emory University (2002), a vitreo-retina fellowship at the Jules Stein Eye Institute, University of California (2004), and an honorary fellowship in retinal dystrophy and degeneration at Moorfields Hospital, London. She joined Emory Eye Center in fall 2004. Yan also serves as chief of the Retina Service in the department of ophthalmology at the Veterans Administration Medical Center, Atlanta.

Yan is board-certified in ophthalmology and is a fellow with the American Board of Ophthalmology. Memberships include the American Academy of Ophthalmology, the Association for Research in Vision and Ophthalmology, the American Society of Cataract and Refractive Surgery, and the Georgia Society of Ophthalmology.

Background
Emory Eye Center has a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 35 ophthalmologists, eight optometrists, ten basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Emory University School of medicine’s Department of Ophthalmology. Ophthalmology research is supported by current NIH funding - $20 million through 2010. The Department remains in the top rankings (#9 – 2009) by U.S. News & World Report for the 13 years the magazine has held a ranking for Ophthalmology. It also ranks in the Top Ten in all four categories surveyed by Ophthalmology Times annual report. http://eyecenter.emory.edu

Established in 1936, Clark-Holder Clinic is the largest multi-specialty group practice in West Georgia employing more than 30 doctors and other healthcare providers with a staff of 170. Key facilities are located in LaGrange, West Point and Newnan. Clark-Holder Clinic has provided medical services to the citizens of west Georgia and east Alabama for nearly 70 years. The partnership with Emory Healthcare physicians in January 2008 provided access to the highest level of care for the residents of Troup County and the surrounding areas.
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FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state "do not use" in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist.

Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children.

FDA has held two public meetings to hear from stakeholders and consumers on the issue, most recently, a public hearing that focused on labeling of these products on Oct. 2, 2008. In January of this year, FDA issued a nationwide Public Health Advisory recommending that these products not be used in children under the age of two because of the risk of serious and potentially life-threatening side effects.

Another part of the agency's work includes outreach to other public health agencies, consumer and patient groups companies that manufacture these products, and CHPA.

FDA will continue to work with the Centers for Disease Control and Prevention to monitor the ongoing use of these products and to develop educational materials for parents and consumers. The Agency will also continue to reach out to the scientific community to obtain more up-to-date information and scientific data about the effects of these products in children so that it can take the appropriate regulatory steps moving forward.

All these areas are vital to support the development and review of data regarding the safe and effective use of these products.

FDA is proceeding with its rulemaking process to update the existing OTC monograph for cough and cold products for children, and will consider input from the recent hearing of Oct. 2. The rulemaking process affords additional opportunity for the submission of data and public comment.

Until all these issues are resolved, FDA continues to recommend to parents and caregivers the following:

• Do not give children medications labeled only for adults.
• Talk to your healthcare professional if you have any questions about using cough or cold medicines in children.
• Choose OTC cough and cold medicines with child-resistant safety caps, when available. After each use, make sure to close the cap tightly and store the medicines out of the sight and reach of children.
• Check the "active ingredients" section of the DRUG FACTS label of the medicines that you choose. This will help you understand what symptoms the "active ingredients" in the medicine are intended to treat. Cough and cold medicines often have more than one active ingredient (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
• Be very careful if you are giving more than one medicine to a child. If you are giving more than one medicine to a child make sure that they do not have the same type of "active ingredients." If you use two medicines that have the same or similar active ingredients, a child could get too much of an ingredient and that may hurt your child. For example, do not give a child more than one medicine that has a decongestant.
• Carefully follow the directions for how to use the medicine in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. If you have a question about how to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of these products can lead to serious and potentially life threatening side effects such as rapid heartbeat, drowsiness, suppression of the respiratory system, seizures and other adverse events.
• Only use measuring devices that come with the medicine or those specially made for measuring drugs. Do not use common household spoons to measure medicines for children because household spoons come in different sizes and are not meant for measuring medicines.
• Understand that using OTC cough and cold medicines does not cure the cold or cough. These medicines only treat your child’s symptom(s) such as runny nose, congestion, fever and aches and do not shorten the length of time your child is sick.

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FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

The FDA's paper, "An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in the FDA's spontaneous adverse event reporting system," documents that during the course of long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. From this data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis (ALS) in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," said Dr. Avigan.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, Chief of the Division of Epidemiology, Stanford University School of Medicine, and colleagues at the Division of Research, Kaiser Permanente. Results from this study should be available within 6-9 months. FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

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Children Still Taking Dangerous OTC Medicine, Study Finds

HHH Note: We thought you'd be interested in reading this article. It appears as if some parents haven't gotten the word--- yet.

By Mark Huffman
ConsumerAffairs.com

Despite Food and Drug Administration concerns about the safety and efficacy of over-the-counter cold medicine for very young children, a new study shows it is still in widespread use.......

Read the story.