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October Issue 2015
Inside This Issue
BREAST CANCER AWARENESS: KNOW YOUR RISK AT EVERY AGE By: Dr. Adriana M. Higgins, Susan G. Komen® Houston Executive Director
Memorial Herman Helping to Stomp Out Smoking. See pg. 8
INDEX Legal Health..................pg.3 Mental Health...............pg.4 Healthy Heart................pg.5 Oncology Research......pg.6 Nutrition Corner...........pg.14
Studies Show Exercise is Safe, Improves Quality of Life for Pulmonary Hypertension Patients See pg. 12
October is Breast Cancer Awareness Month, and with the annual Susan G. Komen® Houston Race for the Cure® wrapping up the month on October 31, Komen Houston is encouraging Houstonians to support breast cancer education, garner information about screening and treatment options and continue to generate awareness efforts in the fight to end breast cancer. Education is a large part of Komen Houston’s mission. Houstonians should be aware of the two most common risk factors for breast cancer: being a female and simply getting older. Although some women stop getting routine mammograms after age 70 due to declining health, it is still an important screening to have on an annual basis, especially if the patient is in relatively good health and could potentially benefit from treatment in the event cancer is identified. A risk factor is anything that impacts your chance of developing a disease such as cancer. Some of these factors, like family history, background or age, cannot be changed, and others are linked to our environments
and habits and can be altered or changed over time. One way to better understand your is risk is to talk with family members about their health history and discuss your personal risk with your doctor. It is also important to know your normal, get screened and make healthy lifestyle choices.
these services at a lower cost. In 2014, Komen Houston’s fundraisers and community partner events raised $2,000,000 million for research, education, screening, and treatment. One of Komen Houston’s funded partners, the American Cancer Society, offers a transportation program, which helps patients find reliable transportation to and from treatment appointments. Oftentimes, radiation treatments may require daily trips for 6-to-8 weeks, and patients who no longer drive depend on a reliable form of transportation. With more than 80 percent of all breast cancers occurring in women over 50, and more than 40 percent being detected in women 65 and older, this transportation option is an extremely valuable service.
There are several factors which have been linked to a higher risk of breast cancer, including habits we can control ourselves, such as alcohol intake, significant weight gain and lack of exercise. Other risk factors include an inherited mutation in the BRCA1 or BRCA2 breast cancer genes, high breast density, hyperplasia, Ashkenazi Jewish heritage, use of birth control pills or menopausal hormone therapy, and not breastfeeding or waiting until later in life to have children. While At any age, a breast cancer these factors may increase your risk of diagnosis is incredibly scary and breast cancer, the exact causes of breast intimidating, and Komen Houston cancer are unknown. works with local organizations to help Komen Houston’s grants help patients cope and understand their to fund breast cancer screenings treatment process. From funding and treatments for at-risk and under support groups, such as those provided insured women and men all over by Reconstruction of a Survivor, to the Greater Houston area. Komen end-of-life care and counseling through Houston awards funds to more than Houston Hospice, Komen Houston’s 20 local organizations (called funded grants ensure patients receive support partners), which allow them to provide see Breast Cancer page 23
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Legal Health
THE FUTURE OF RESEARCH USING ELECTRONIC MEDICAL RECORDS DATA and extent to which this valuable resource will be used in the future.
By Amy Dow, J.D. and Mark Armstrong, J.D. Epstein, Becker & Green
One thing’s certain – the vast and growing supply of data contained in electronic medical records systems will play a significant role in improving the speed and efficiency of research into new treatments in the years to come. The challenge will be striking an appropriate balance between the unquestionable promise of this data to enable research – research that will enhance available treatments and save lives – with the rights of individual patients in the privacy of their health information. Attempts to strike that balance are at the heart of current legislative, regulatory and policy initiatives that will shape the manner
Included in the 21st Century Cures legislation that recently passed the U.S. House of Representatives are changes to the Health Insurance Portability and Accountability Act (“HIPAA”) intended to expand access to patient health records for research purposes. Specifically, subject to certain requirements, the changes permit use and disclosure of protected health information (“PHI”) by covered entities for research purposes and remove the prohibition on remote access by a researcher to PHI. More recently, a Notice of Proposed Rule Making (“NPRM”), published September 8, 2015, proposes to revise the Common Rule, the Federal regulation governing most Federally-funded research and other research conducted at many institutions that receive Federal research funding. The proposed revisions to
the Common Rule are intended to strike a balance between the need to protect subject autonomy and improve the public trust in research while facilitating valuable research activities by clarifying regulations, increasing efficiency of the review process and ensuring the burdens on research are commensurate with the level of human subject protections necessary for a particular research activity. Among the proposed revisions is the elimination of the need for IRB review of certain studies involving the collection of
identifiable private information. This includes: studies involving collection of information through educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording), as well as studies involving only the secondary analysis of identifiable private information originally collected for non-research purposes when the proposed privacy safeguards are met and prior notice is given. The newly proposed rules see Legal Health page 23
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Mental Health
Alcoholism: A step toward a treatment By Christina Sumners Texas A & M Health Science Center
A study, published in the Journal of Neuroscienceby researchers at the Texas A&M Health Science Center College of Medicine, finds that alcohol consumption alters the structure and function of neurons in the dorsomedial striatum, a part of the brain known to be important in goal-driven behaviors. The findings could be an important step toward creation of a drug to combat alcoholism. “Alcoholism is a very common disease,” said Jun Wang, M.D., Ph.D., the lead author on the paper and an assistant professor in the Department of Neuroscience and Experimental Therapeutics at the Texas A&M College of Medicine, “but the mechanism is not understood very well.” Now, Wang and his team have helped come a little closer to that understanding. Using an animal model, the researchers determined that alcohol actually changes the physical
structure of medium spiny neurons, the main type of cell in the striatum. These neurons can be thought of like a tree, with many branches, and many small protrusions, or spines, coming off of them. They each have one of two types of dopamine receptors, D1 or D2, and so can be thought of as either D1 or D2 neurons. D1 neurons are informally called part of a “go” pathway in the brain, while D2 neurons are in the “no-go” pathway. In other words, when D2 neurons are activated, they discourage action — telling you to wait, “You’ll have a craving.” That is to say, to stop, to do nothing. when neurons with D1 receptors are Although it is well known that the neurotransmitter dopamine is activated, they compel you to perform involved in addiction, this study goes an action — reaching for another further, showing that the dopamine bottle of tequila, in this case. This then D1 receptor also plays an important creates a cycle, where drinking causes role in addiction. The team found that easier activation, and activation causes periodic consumption of large amounts more drinking. of alcohol acts on D1 neurons, making These changes in activation of them much more excitable, which D1 neurons might be related to the means that they activate with less physical changes happening at the stimulation. sub-cellular level in brains that have “If these neurons are excited, you been exposed to alcohol. They have will want to drink alcohol,” Wang said. longer branching and more of the
mature, mushroom-shaped spines — the type that stores long-term memories — than their abstaining counterparts. Conversely, the placebo group, the ones not exposed to alcohol, tended to have more of the immature versions of the mushroom-shaped spines in D1 neurons of their brains. The total number of spines didn’t change in the two groups, but the ratio between mature and immature was dramatically different between the alcohol group and the placebo group. This has
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Healthy Heart
Walk, Don’t Run, Your Way Towards A Healthy Heart By: American Heart Association
of the shoe. Avoid cotton socks since they retain moisture and can promote OK, so you’re not much into blisters. running? Or maybe you’ve had an Here are some tips to get you injury and can’t run. Then just walk started: — every step you take is part of your ∙ Begin with short distances. journey to good heart health. Walking Start with a stroll that feels is low-risk and easy to start. It can help comfortable (perhaps 5-10 keep you stay fit and reduce your risk minutes) and gradually increase of serious diseases, like heart disease, your time or distance each week stroke, diabetes and more. by 10-20 percent by adding a The American Heart Association few minutes or blocks. If it’s recommends that adults get 150 easier on your joints and your minutes or more of moderate-intensity schedule to take a couple of 10physical activity or 75 minutes of to 20-minute walks instead of vigorous activity each week. Even short one long walk, do it! 10 minute activity sessions can be added up over the week to reach this goal! If you would benefit from lowering your blood pressure or cholesterol, aim
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for 40 minute sessions of moderate to vigorous activity 3 to 4 times a week. You could do this by walking 2 miles briskly (about 4 miles/hr). If that’s too fast, choose a more comfortable pace. A regular walking program can also: ∙
Improve your cholesterol profile
∙
Lower blood pressure
∙
Increase your energy and stamina
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your arms naturally. Avoid carrying hand weights since they put extra stress on your elbows and shoulders. Don’t overstride. Select a comfortable, natural step length. If you want to move faster, pull your back leg through more quickly.
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Breathe deeply. If you can’t talk or catch your breath while walking, slow down. At first, forget about walking speed. Just get out there and walk!
On behalf of the Orthopedic Care Center
To warm up, walk at an easy tempo for the first several minutes. Then All you need to get started are gradually adopt a more purposeful comfortable clothes and supportive pace. A good way to add variety is to shoes. Layer loose clothing, keeping incorporate some brisk intervals. For in mind that brisk exercise elevates the example, walk one block fast, two blocks body’s temperature. Shoes designed for slow and repeat several times. Gradually walking or running are best. Make sure add more fast intervals with shorter you have a little wiggle room between recovery periods. Concentrate on see Healthy Heart page 24 your longest toe (1/2") and the end ∙
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Oncology Research
How do Clinical Trials work to cancer patients? By: Jorge Augusto Borin Scutti, PhD Houston Medical Times
Typically cancer researchers discover new targets and drugs through new insights that allow them to understand how cancer cells works. After they are able to design new strategies to stop or reverse the effects of cancer cells using several technologies such molecular biology, biochemistry, cell biology, immunology and pathology. At this point in the process thousands of compounds may be potential candidates for development. Before testing a drug in people researchers should find out whether it has the potential to cause toxicity. To solve this problem there are two types of preclinical studies: in vitro and in vivo experiments. Commonly pre clinical studies are not broad but they provide detailed information on dosing range and toxicity levels. Once researchers identify a potential drug
they drives some experiments to collect information on absorption, distribution, metabolization and excretion, best dosage, mechanism of action, the best way to delivery, side effects, interaction with other drugs and it is effectiveness as compared with similar drugs. After these preclinical research answers basic questions the next steps are verified on human body. Clinical research refers to studies or trials that are done in people. Clinical trials are key to developing new strategies to find and diagnose cancer, to prevent, manage symptoms and to treat cancer. There are designed to evaluate outcomes of human subjects under research and experimental conditions. The aims of these studies define whether a medical strategy or treatment is safe for application or consumption by humans. The effect of clinical trial not only enhances to the individual patient by improving a broader selection of powerful therapies as well as to society as a whole by enhancing the value of health care. It is not truth that clinical trials are only designed for people who have advanced cancer that
is not responding to treatment. According to U.S National Institute of Health there are some common reasons for conducting clinical studies: Evaluating one or more interventions (for example, drugs, medical devices, approaches to surgery or radiation therapy) for treating a disease, syndrome, or condition, finding ways to prevent the initial development or recurrence of a disease or condition. These can include medicines, vaccines, or lifestyle changes, among other approaches, evaluating one or more interventions aimed at identifying or diagnosing a particular
disease or condition, examining methods for identifying a condition or the risk factors for that condition, exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness. Drug developers or sponsors must submit as Investigational New Drug (IND) application to FDA before beginning clinical research. To start, every clinical trial should be led by a principal investigator who is often a medical doctor, research team, human volunteers (participants) and a plan see Oncology Research page 26
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Memorial Hermann Helping to Stomp Out Smoking During Houston Smoking Cessation Awareness Week By Kathryn Jungman Memorial Herman
campuses are also smoke-free. Outpatient tobacco cessation programs At Memorial Hermann, advancing are offered through the oncology and health in the communities we serve, cardiopulmonary departments at several also means leading by example. Memorial Hermann campuses as well That’s why Memorial Hermann is as the Memorial Hermann Medication participating this week in the Houston Therapy and Wellness Clinics. Smoking Cessation Awareness Week These programs, which are open campaign. to the general public and Memorial The city-wide initiative, which Hermann patients and employees, offer concluded on September 25, united resources to help people quit smoking the city of Houston, non-profit and cigarettes as well as using other tobacco for profit corporations, community products. The programs are located at agencies and other health systems in a Memorial Hermann-Texas Medical collective voice to raise awareness about Center, Memorial Hermann Southeast, smoking cessation resources available TIRR Memorial Hermann, Memorial
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in the Houston region, including those at Memorial Hermann. The idea is to empower and motivate Houstonians to quit smoking. “As the largest city in Texas with the largest medical center in the world, we have a responsibility to set an example not only in our state, but throughout the United States and beyond when it comes to raising awareness about the health risks associated with tobacco use,” said Dan Wolterman, president and CEO, Memorial Hermann. “We’re known for our amazing art and culture, international cuisine and Texas flair, but what if we could be known for being the city that puts an end to smoking? Together we believe it is achievable.” In the interest of leading by example, Memorial Hermann implemented a non-tobacco use policy several years ago for the purpose of advancing the health of its employees and patients. All Memorial Hermann October 2015
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Hermann Memorial City Medical Center and Memorial Hermann Northeast. Among the treatment services offered through the programs are: ∙
One-hour classes, once a week for one month
∙
One-on-one counseling appointments for patients (who prefer that to group/class settings)
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Lung Cancer Screening program to provide an avenue for patients to receive help quitting, regardless if they are eligible for Lung Cancer Screening or not
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Educational information about online counseling, phone counseling, and apps that can help patients quit
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Information about prescription medications as well as see Stomp Out Smoking page 26
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Study finds exergaming improves physical and mental fitness in children with autism spectrum disorders
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A study conducted by The University of Texas Medical Branch at Galveston says games used for exercising can improve physical and mental fitness in children with autism spectrum disorders. The study, written by UTMB’s Claudia Hilton, associate professor, Tim Reistetter, associate professor and Diane Collins, assistant professor, all from the UTMB occupational therapy and rehabilitation sciences departments, concludes that findings suggest the use of exergaming, more specifically the Makoto arena, has the potential to serve as a valuable addition to therapies for children with autism spectrum disorders who have motor and executive function impairments. Executive function is the higher level of intelligence that helps us to
and to examine the changes that are occurring in the brain.” Children with ASD often experience executive function and motor impairments. They also experience lower rates of physical activity than children without ASD. As they get older, their physical activity declines and they deal with obesity problems more than other children. Comparing out of school activity participation, physical activity showed the greatest differences between ASD and control children, with the ASD children less active. As a way to combat a lack of physical activity, researchers investigated the use of the Makoto arena, a triangular shaped arena with pillars at each point, each with lights and sounds at various levels of the
plan and organize. It is used to redirect higher thinking when changing plans and suppressing inappropriate behaviors. It is important for being able to live independently as adults. Through the use of the exergame called the Makoto arena, researchers showed improvement in response speed, executive function and motor skills among children with ASD. The research was conducted with 17 subjects with an autism diagnosis over 30 sessions for over 1,800 total attempts to hit the targets. The International Journal for Sports and Exercise Medicine recently published the findings. “We think that the exertion of participating in this type of game helps to improve the neural connections in the brains of these children,” Claudia Hilton said. “This is a small pilot study, but we hope to obtain grant funding to confirm these findings in a larger group of children with autism
pillars. Those playing the game must hit the correct spots as they light up on different pillars. The study used 17 school-aged children and adolescents with ASD in two-minute sessions in the Makoto arena. The speed of the game increased when the participants reached 95 percent accuracy. Subjects competed in the Makoto arena an average six sessions per week. The study saw significant improvements across several physical and mental areas, including response speed. All areas of executive function improved, especially working memory. Motor ability also improved, especially in the areas of strength and agility. “It is difficult to get children with autism to participate in physically exerting activities,” Hilton said. “So finding an activity like the Makoto arena that they will actually do over an extended period like this is very exciting.”
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Studies show exercise is safe, improves quality of life for pulmonary hypertension patients, UT Southwestern cardiologists say
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The new findings do not mean those with pulmonary hypertension should jump on a bike, start jogging, or launch into some other exercise regimen without first consulting their physician, said Dr. Berry. Most of the studies the team examined had supervised exercise training and involved lower levels of Pulmonary hypertension is a type exercise intensity than traditionally of high blood pressure that affects the lungs and heart, making it hard prescribed for heart failure patients. “It is important for patients with to breathe, or making one weary or dizzy. The prevalence of pulmonary pulmonary hypertension to consult hypertension is estimated to be 10 to15 their doctor before starting any exercise Exercise training for patients with pulmonary hypertension was shown to be safe and to improve quality of life, according to an analysis by UT Southwestern Medical Center cardiologists of studies involving more than 400 participants.
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cases per million with a mortality rate of 15 percent annually. Left untreated, it can lead to heart failure. Left untreated, it can lead to heart failure. Researchers found that exercise training can reduce pressure in the arteries and increase exercise tolerance, all without compromising safety.
regimen, particularly for pulmonary hypertension patients,” said Dr. Ambarish Pandey, a cardiology fellow at UT Southwestern Medical Center and first author on the paper.
“Clinicians have traditionally been skeptical about prescribing exercise for patients with chronic pulmonary hypertension due to concerns that training might put further strain on the heart,” said senior author Dr. Jarett Berry, Associate Professor of Internal Medicine and Clinical Sciences, and Dedman Family Scholar in Clinical Care at UT Southwestern. “Our analysis found those concerns may be misplaced. More importantly, exercise had a positive effect on several measures of heart function as well as overall
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The meta-analysis appears in Circulation: Heart Failure.
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Nutrition Corner
CLINICAL TRANSLATION MANAGEMENT
Probiotics
By E. Denise Hernandez, MS, RD, LD Houston Medical Times
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WHAT ARE THEY? Probiotics are living organisms that reside within our bodies, particularly within our intestines where they help digest food, destroy disease-causing bacteria, as well as produce vitamins such as vitamin K. Probiotics are considered bacteria, or microorganisms. Even though most of us are obsessed with antibacterial soaps, microorganisms outnumber human cells by 10 to 1. Let’s discuss
∙
Inflammation
The immune system, which is your body’s protective mechanism, keeps harmful bacteria, viruses, and chemicals at bay. One of the key and largest players in your body’s immune system is your gut. It is constantly exposed to toxins and foreign antigens from food and microbes. There are more than 400 species of healthy bacteria in your gut, also referred to as gut flora, and if you were to count them you would find more than 100 trillion bacteria. These healthy bacteria help maintain health by resisting bad bacteria and harmful substances. They help during digestion and nutrient absorption, making it so
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that you get the most out of the healthy foods you are eating. The latest research HOW THEY MAY HELP – is looking into how probiotics aid in Researchers are investigating probiotics alleviating the effects of inflammation beneficial role in preventing or in the body. alleviating the effects of the following PROBIOTICS IN YOUR DIET – conditions: You can get more probiotics in your diet ∙ Digestive disorders such as by including fermented dairy products diarrhea caused by infections, such as yogurt, kefir products, and antibiotic-associated diarrhea, aged cheese. These foods contain live irritable bowel syndrome, and cultures of lactobacilli or bifidobacteria. Look for specific symbols that specify inflammatory bowel disease ∙ Allergic disorders such as that the product you are purchasing has live active cultures if you don’t read that eczema and allergic rhinitis in the ingredient statement (see below). ∙ Liver disease Non-dairy sources of probiotics include ∙ Colic in infants kimchi, sauerkraut, miso, tempeh and ∙ Colds and flu – immune health soy beverages. why probiotics are necessary for healthy living.
October 2015
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You asked: Should I go gluten free? By Madison Matous Texas A & M Health Science Center
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Gluten-free brownies. Gluten-free pizza. Gluten-free beer. Gluten-free is all the rage in the world of fad diets, with celebrities praising its health benefits and grocery stores devoting whole aisles to products without gluten. It’s no surprise then that, according to a 2014 consumer report, 63 percent of Americans thought following a gluten-free diet would improve their physical or mental health. But is a gluten-free diet all it’s hacked up to be? Gluten, a protein found in the grains wheat, rye and barley, is what makes bread spongy and pizza dough stretchy. While gluten-free eating is the latest diet trend, its origin comes from a medically legitimate place. For the one percent of Americans, or one in 100, suffering from celiac disease, gluten-free is the only option.
Science Center Coastal Bend Health Education Center. “They contain folic acid and iron, along with many other minerals and vitamins. These whole grain foods also provide dietary fiber that can have a positive impact on lowering cholesterol levels.” According to Perkins, gluten-free products often contain additional fat, sugar and salt to compensate for the flavor and texture they lack from flour, leading to additional calories. They also tend to be more expensive. For those not fighting gluten sensitivity, avoiding gluten is not technically a health necessity, but it could lead to eating healthier overall. “Those who have benefited from a gluten-free diet may not be benefiting from the lack of gluten in their diet, but from an increased awareness of what they are eating,” Perkins said. Being gluten-free forces you to pay
A genetic autoimmune disorder, celiac disease is triggered by the ingestion of gluten, in which the body mistakenly reacts to gluten as if it were poison. The protein sparks an abnormal inflammatory response that damages the small intestine and impairs the body’s ability to absorb nutrients. “People with celiac disease have to cut gluten completely out of their diet because even 10 to 50 milligrams can cause damage,” said Vicky Keys, M.S.N., clinical assistant professor at the Texas A&M College of Nursing. To put that into perspective, a single slice of bread contains 1,600 milligrams of gluten. While those suffering from celiac disease must remove gluten from their diet entirely, it doesn’t necessarily mean a gluten-free diet is right for everyone, as foods containing this protein are packed with important nutritional benefits. “Foods that contain gluten are an important part of a healthy and balanced diet,” said Claudia Perkins, registered dietician at the Texas A&M Health
closer attention to nutrition labels, as many foods and products that you would not expect to contain the protein actually do. (Salad dressing is a good example.) Gluten-free diets also reduce calorie intake due to a decrease in the consumption of breads and pasta, along with processed foods and treats like cookies. Cutting out these processed foods and focusing on eating more fruits, vegetables and meats are more likely the reason people see results from going gluten-free. So, should you go gluten-free? If you have celiac disease or a gluten sensitivity, the answer is easy: Yes. For the other 90-plus percent of the population, gluten-free doesn’t necessarily equal healthy. “Before jumping on the gluten-free bandwagon consider first trying portion control, reducing intake of processed foods and increasing fruit and vegetable intake for a healthier diet,” Perkins said. “The key to healthy living is not a trendy diet, but eating healthier in general.”
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Brain scientist Horner joins Houston Methodist Neurological Institute The Houston Methodist Neurological Institute's new Center for Neuroregenerative Medicine scientific director is Philip Horner, Ph.D., an expert on the use of stem cells to replace damaged brain and spinal cord tissue. "Phil brings incredible experience in adult central nervous system regeneration, stem cells and gene therapy," said Dr. Gavin Britz, chair of the Department of Neurosurgery. "His knowledge and investigations in cell repair and regenerative medicine will be a boon for our patients, and also extend the reach of neurosurgery science at Houston Methodist."
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Texas Children’s Health Plan helps members prepare for cold and flu season
Educational program and free Cold and Flu Survival Kit help reduce member visits By Jenn Jacome Texas Children’s Hospital
Last year during cold and flu season, Texas Children’s Health Plan developed a program to educate members, families and providers about proper treatment and prevention for the common cold, flu and upper respiratory infections (URIs). Members received a short educational session in English or Spanish, along with a “Cold and Flu Survival Kit.” As a result, the Health Plan saw a decline in the rate at which members sought care over an eight-month period from 3.5 visits per month prior to receiving the kit, to 2.95 visits per month after.
potentially preventable visits. For the Children’s Health Insurance Program (CHIP), URIs account for 19 percent of them. The goal of this program was to reduce the number of these preventable visits by educating families about colds, the flu and URIs and products that can be used safely at home.
Colds are caused by viruses; therefore antibiotics are not effective at helping children feel better quicker. While not a cure, the Cold and Flu Survival Kit contains items that can make it easier for families to help ease their children’s symptoms until the body naturally rids itself of the illness. The kit also includes educational pieces on how to use the items, know the difference between For the Medicaid State of Texas the cold and flu and correct dosage Access Reform (STAR) program, amounts for children. Items in the URIs account for 25 percent of kit include:
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Thermometer to track a child’s temperature
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Breast Cancer
Continued from page 1 throughout their care.
$150, so anything you can do to help us reach our goal of funding 25,000 mammograms will be key to reducing the number of breast cancer cases and deaths due to the disease. One appointment can save a life.
This year, Komen Houston aims to fund 25,000 mammograms in celebration of our 25th year serving Houston. We challenge each Houstonian to help us in this mission by raising or donating $1,500, or For more information and funding ten mammograms, by the end of the fundraising season on November resources, visit www.komen-houston. 30. The cost of one mammogram is org.
When you need it.
Legal Health
Continued from page 3 offer three avenues to meeting the data security and privacy protection requirements, all three of which are posited to be at least as protective as those typically employed by researchers whose studies are subject to IRB review, namely. ∙
The investigator is required by law to comply with, or voluntarily complies with, the privacy and security standards imposed by HIPAA and its implementing regulations;
∙
The activity is conducted by federal departments and agencies, and the activity is or will be maintained on information technology that is subject to and in compliance with the privacy provisions of the E-Government Act of 2002, or
∙
The investigator complies with the privacy safeguards promulgated by the Secretary of HHS (which standards will be designed so that they could be readily implemented by an individual investigator, and would involve minimal cost and effort to implement.)
In addition to other changes, the NPRM, when implemented, will require consent for research involving the secondary use of biospecimens. To reduce the associated burdens on researchers, the proposed rule would require the development by the Secretary of HHS of a broad template consent document that would be used to obtain a broad consent for future, unidentified research uses of the biospecimens. It is anticipated that in most instances, a second consent would not be required for
individual research projects in which the biospecimen is used. The NPRM proposes three additional elements of consent that are relevant to seeking an individual’s broad consent to the storage, maintenance, and secondary research use of biospecimens or identifiable private information. The three additional elements of consent include: (1) requiring that prospective subjects be informed that their biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit, (2) requiring prospective subjects be informed of whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions, and (3) providing subjects or their legally authorized representatives with an option to consent, or refuse to consent, to investigators re-contacting the subject to seek additional information or biospecimens or to discuss participation in another research study.
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Another piece of the puzzle came in the form of Proposed Privacy and Trust Principles for the Precision Medicine Initiative released by the White House on July 8, 2015. The Precision Medicine Initiative, first introduced in President Obama’s State of the Union Address and supported by $215 million in funding to the National Institutes of Health, National Cancer Institute, Food and Drug Administration, and Office of the National Coordinator for Health Information Technology, aims to establish a voluntary national research cohort made up of at least one million individuals who agree to contribute data from a range of sources, which see Legal Health page 24
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Houston Medical Times
Legal Health
Continued from page 23 may include access to medical records, analysis of biospecimens, environmental and lifestyle data, patient-generated information, and personal device and sensor data. This data will be aggregated and made available to qualified researchers, including those from academic, non-profit and for-profit entities. The proposed privacy and trust principles provide broad guidance regarding the operation of the research cohort, including its “governance; transparency; reciprocity; respect for participant preferences; data sharing, access, and use; data quality and integrity; and security.” Established by an ‘interagency working group’ convened by the White House, the principles are intended to build privacy into the cohort and ensure confidentiality of patient health information. Certain of the proposed principles will impact the accessibility and utility of the data to interested researchers, including those in the pharmaceutical and medical device industries, and
the details of the further development and implementation of these broad principles will be of critical importance to those who hope to use the cohort data in their future research. For example, the requirement that all data users must publish or post their summary research findings publically as a condition for use of data within the cohort may present challenges for many users. The nature of the findings that would be subject to that public disclosure requirement, and precisely how and when those findings must be disclosed, will impact whether industry, in particular, will be willing and able to leverage this valuable resource while maintaining necessary protections for proprietary information. Additionally, as the data are intended for use not only for hypothesis-driven research, but for hypothesis-generating and feasibility assessments as well, the nature of the findings that must be disclosed will need to be carefully considered to avoid imposing an undue burden by requiring publication of data with limited scientific value, and to avoid the
records research would have a significant impact on reducing the cost and time required to conduct research using cohort data. The extent to which the implementation of the consent process includes emerging practices for obtaining informed consent through Similarly, the manner in which remote, electronic means will impact certain principles are operationalized the magnitude of this potential burden. Each of these legislative, regulatory will determine how burdensome the use of cohort data will become. and administrative proposals for Specifically, the proposed principles modifications to the requirements contemplate a multi-layer consent applicable to the use of patients’ health model for participants in the cohort. information for research purposes The working group determined that attempts to balance the interests of the duration and potential breadth of researchers and individuals in different the research activities contemplated ways. How, and to what extent, these would render a single contact consent initiatives will be harmonized remains at the time of participant enrollment to be seen; yet the confluence of these insufficient. Instead, an ongoing, three initiatives over a period of a few dynamic consent process has been months sends a positive signal to proposed. As those involved in researchers and patients alike that we research know, the development, are moving toward a future in which IRB review and approval, and we can more effectively utilize the administration of the informed bountiful sources of health information consent process is burdensome, and and increasingly powerful data analytics the ability to forgo this consent for to develop new treatments to improve certain types of non-interventional lives. potential disclosure of commercially sensitive information on the early research strategy or direction being contemplated by a researcher; this may limit the extent to which researchers are willing to utilize the data to its full potential.
Mental Health
Continued from page 4 “Even though they’re small, D1 “We’re now able to study the important implications for memory brain at the neuron-specific and even receptors are essential for alcohol and learning in drug addiction. consumption,” Wang said. “When you drink alcohol, spine-specific level,” Wang said. Furthermore, and perhaps most How do you determine which long-term memory is enhanced, in a excitingly, when those same animal way,” Wang said. “But this memory neuron, which type of neurons or process is not useful — in fact, it which group of neurons is responsible models were given a drug to at least partially block the D1 receptor, they underlies addiction since it affects the for a specific disease? That’s what the showed much-reduced desire to ‘go’ neurons.” Because there was no next part of the study tried to answer. drink alcohol. However, a drug that difference in the number of each type The alcohol-consuming animal inhibited the D2 dopamine receptors of spine in the D2 (no-go) neurons models with the increased mature had no effect. “If we suppress this of alcohol-consuming and control spines in D1 neurons also showed activity, we’re able to suppress alcohol models, the researchers realized there an increased preference to drink large consumption,” Wang said. “This is the was a specific relationship between D1 quantities of alcohol when given the major finding. Perhaps in the future, choice. researchers can use these findings to neurons and alcohol consumption.
develop a specific treatment targeting these neurons.” The study, which was co-authored with researchers from the University of California San Francisco, was supported by a grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA). “My ultimate goal is to understand how the addicted brain works,” Wang said, “and once we do, one day, we’ll be able to suppress the craving for another round of drinks and ultimately, stop the cycle of alcoholism.”
Healthy Heart
Continued from page 5 increasing your speed while maintaining during bad weather. good posture. The end of your walk is an ideal Walking hills is a great way to tone time to stretch since your body is your legs. Using Nordic walking poles warmed up. Stretch your hamstrings and can help your burn more calories and calves as well as your chest, shoulders give you better posture and overall and back. Hold each stretch for 15 to muscle endurance. Treadmill walking, 30 seconds. while not as scenic, can be convenient October 2015
Track your progress. Although of a day. The best schedule is one that experts recommend walking at least 30 keeps you walking and keeps you fit! minutes a day, there are no hard and Remember, always be safe! fast rules. Walking 60 minutes/day and ∙∙ Avoid traffic accidents. brisk intervals will help you burn more Listening to lively music while calories. Fit walking into your schedule you walk is a great way to whenever you can. That may mean energize your workout. But if three 10-minute walks over the course
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Healthy Heart
HOUSTON
Continued from page 24 you wear headphones, keep the volume down and watch out for traffic that you may not hear. Wear light colors or reflective clothing and carry a flashlight or glow stick if you walk when visibility is low.
the area you’ll be walking and know the location of emergency telephones. Walk on well-traveled streets rather than taking shortcuts in less crowded areas such as alleys or parking lots. If you give the message that you are calm, self-assured and have a purposeful gait, you’ll lower your chances of becoming a victim.
∙∙ Walking on sidewalks is best, but if you have to walk on the street, stick to streets with lower speed limits. Faster streets are ∙∙ Two heads are better than one. riskier because motorists are Walking with a partner or in less likely to see pedestrians groups discourages crime and and cannot stop as quickly. may help alert you to dangers Accidents involving pedestrians such as speeding motorists or have an 85 percent chance of unleashed dogs. becoming fatal if the car is moving at 40 mph as compared If you experience foot, knee, hip to only 5 percent if the speed is or back pain when walking, STOP 20 mph. and check with your doctor to find ∙∙ Know your area. Pay attention out the cause. You may need special to what businesses are open in exercises or better shoes. If you have
osteoarthritis and experience increased joint pain lasting an hour or two after walking, consider an alternate activity like stationery cycling or water exercise. But don’t stop exercising! The Houston Heart and Stroke Walk is at NRG Park on Saturday, November 7. Designed to promote physical activity and heart-healthy living, the Heart and Stroke Walk is a fundraising event that is also a celebration of life. Each year, more than 1 million walkers participate in the nearly 325 Heart and Stroke Walks across the country. Grab your friends and family, start a team and join us for this year’s walk! Find out more at www. houstonheartwalk.org. The American Heart Association has great resources available online that can provide more information on health and wellness, risk factors of heart disease, stroke, and more at www.heart.org.
Oncology Research Continued from page 6
for the trial (protocol). This protocol contains information about the reason for doing the trial, who can join the trial (eligibility requirements), how many people are needed for the trial, what types of information will be collected and what medical tests will be done. Clinical trials used in drug development are sometimes described by phase and the FDA defines these phases. Each phase is designed to answer a several research question. There are 4 phases: According to FDA, Phase I: Purpose – Safety and dosage. Researchers test a
new drug or treatment in a small group of people (20 to 100 healthy volunteers or people with the disease/condition) and can takes several months; Phase II: Purpose – Efficacy and side effects. The drug or treatment is given to a large group of people (up to several hundred people with the disease/condition) and can takes several months to 2 years; Phase III – Efficacy and monitoring of adverse reactions. The drug or treatment is given to a large groups of people (300 to 3,000 volunteers who have disease or condition) to
confirm it is effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug treatment to be used safely and Phase IV: Purpose – Safety and efficacy. Studies are done after the drug or treatment has been marketed to collect information and side effects associated with long-term use (Several thousand volunteers who have the disease/condition). Find a clinical trial accessing www.cancer.gov.
Stomp Out Smoking Continued from page 8
over-the-counter products used to help quit ∙∙ Information about stress relief such as guided meditation to assist patients with anxieties due to quitting ∙∙ Psychosocial expertise Tobacco use takes a significant toll on Texas. It costs lives and it costs money. Roughly one in seven adults in the greater Houston area continues to smoke, according to a Texas Department of State Health Services survey. The Campaign for Tobacco-Free Kids, estimates that October 2015
tobacco cuts short the lives of nearly 30,000 Texans annually – or roughly three people per hour. In Texas, tobacco accounts for an estimated $17 billion annually in health care expenditures and lost productivity. It results in increased health insurance premiums, higher worker absenteeism and lower worker productivity. In addition, government expenditures related to tobacco cost taxpayers $756 per household. The U.S. Surgeon General has said, “Smoking cessation represents the single most important step that smokers can take to enhance the length
and quality of their lives.” So, during the campaign, Memorial Hermann will be doing its part to educate its employees, the general public and patients about the harms of tobacco use and exposure. For more information about this week’s campaign and smoking cessation resources in the Houston region go to http://gohealthyhouston. org/houstonbootssmoking/. For information about Memorial Hermann Medication Therapy and Wellness Clinics call 713-704-2626 or 713-242-3564.
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