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NEW EVIDENCE SHOWS AFFORDABLE CARE ACT IS WORKING IN TEXAS
Report shows state’s uninsured rate drops by nearly one-third and is lowest since 1999 By David Ruth
MD Anderson applauds FDA regulatory to all Tabacco products See pg. 9
INDEX Healthy Heart................pg.3 Legal Health..................pg.4 Oncology Research......pg.6 Age Well Live Well........pg.12
Largest-ever U.S. autism research study underway See pg. 14
The percentage of Texans without health insurance has dropped by 30 percent since the Affordable Care Act (ACA) went into effect, cutting the state’s uninsured rate below 1999 levels. That’s one of the conclusions of a new report released today by Rice University’s Baker Institute for Public Policy and the Episcopal Health Foundation (EHF). The report found the uninsured rate among Texas adults dropped from 26 percent in September 2013 to 18 percent in March 2016. Researchers also discovered a steady decline in the uninsured rate for every age, ethnic and income-level group across the state. their percentage of uninsured. The group’s uninsured rate plummeted “These latest numbers confirm from 21 percent to 10 percent since the continuing downward trend in the ACA went into effect -- a drop of the number of uninsured Texans that more than 51 percent. began as the ACA was implemented,” “For the older group, the ACA said Elena Marks, EHF’s president and CEO and a nonresident health policy made health insurance much more fellow at the Baker Institute. “For affordable, because the law limits more than a decade prior to the ACA, insurers from charging older adults no the uninsured rate remained above more than triple the cost for the same 20 percent and was rising. It’s now health insurance plans as younger clear that it’s moving in the opposite adults,” said Vivian Ho, the chair in direction, and the ACA deserves the health economics at the Baker Institute credit.” and director of the institute’s Center The report found that Texans for Health and Biosciences, a professor between the ages of 50 and 64 of economics at Rice and a professor experienced the largest decrease in of medicine at Baylor College of Medicine. “However, limiting premium variation by age made Marketplace policies less attractive to younger adults, which is why their uninsured rate fell less.”
“Texans with low to moderate incomes were able to use federal subsidies to help pay for health insurance premiums for ACA Marketplace plans,” Ho said. “Those subsidies made coverage affordable for many who could not have purchased plans without that help.” In fact, Ho and Marks note that the U.S. Department of Health and Human Services reports that 84 percent of the 1.3 million Texans now enrolled in ACA Marketplace health insurance plans received subsidies to help pay for premiums.
Researchers said that while it’s evident the ACA has helped drop the uninsured rate in Texas, it’s also clear that a significant number of Texans with the lowest incomes remain uninsured. The report found that 46 percent of Texans earning less Researchers also found the than $16,000 a year don’t have health percentage of uninsured Texans who insurance. earned annual incomes between “The ACA as implemented in $16,000 and $47,000 dropped by Texas offers little hope for Texans more than 42 percent. The group’s with the lowest incomes,” Marks uninsured rate declined from 23 said. “They make too much to qualify see Affordable Care Act page 17 percent in 2013 to 13 percent in 2016.
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Healthy Heart
Atrial Fibrillation: Learn How To Manage Your Heart And Get It Back In Rhythm By Apiyo Obala Director of Communications American Heart Association
I’m glad we found it early.” What happens during AFib?
Normally, your heart contracts and relaxes to a regular beat. In atrial fibrillation, the upper chambers of the heart (the atria) beat irregularly (quiver) instead of beating effectively to move If you or someone close to you has blood into the ventricles. About 15–20 recently been diagnosed with Atrial percent of people who have strokes Fibrillation (AFib), you probably have have this heart arrhythmia. a lot of questions or concerns. You “Anything that allows blood might also be feeling so overwhelmed to slow down or pool increases the by the diagnosis that you aren’t sure risk of clotting, and so increases the what kinds of questions to ask. You’ve risk of stroke,” says Dr. Steve Roach, taken the first step toward learning Professor of Neurology and Director of more, and we’re here to help. the Comprehensive Epilepsy Program Taking a proactive approach to at Wake Forest University Medical learn more about AFib is the next School.
If a clot breaks off, enters the step. Becoming an informed advocate bloodstream and lodges in an artery for yourself or a loved one is the best leading to the brain, a stroke results.“ approach for managing AFib. This clot risk is why patients with this What is Afib? condition are put on blood thinners. Atrial fibrillation (also called AFib) People with atrial fibrillation have an is a quivering or irregular heartbeat increased stroke risk of about five (arrhythmia) that can lead to blood percent per year.” It's the most common "serious" heart rhythm abnormality in people over the age of 65 years. Even though untreated atrial fibrillation doubles the risk of heart-related deaths and causes Here’s how patients have described a 4–5-fold increased risk for stroke, many patients are unaware that AF is their experience: a serious condition. “My heart flip-flops, skips beats, What are the consequences of and feels like it’s banging against my atrial fibrillation (AFib)? chest wall, especially if I’m carrying Although atrial fibrillation can stuff up my stairs or bending down.” feel weird and frightening, an “attack I was nauseated, light-headed, and of AFib” usually doesn’t have harmful weak. I had a really fast heartbeat and consequences by itself. The real danger felt like I was gasping for air.” is the increased risk for stroke. Even “I had no symptoms at all. I when symptoms are not noticeable, see Healthy Heart page 17 discovered my AF at a regular check-up. clots, stroke, heart failure and other heart-related complications. Some people refer to AFib as a quivering heart. An estimated 2.7 million Americans are living with AFib.
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Legal Health
the efficacy of Antineoplaston therapy. The clinical trial was being performed WILL SAD FACTS MAKE BAD LAW? pursuant to an Investigation New Drug Application (“IND”) that was By Daniel G. Gottlieb, Fachon was pursing an engineering in effect, pursuant to 21 CFR 312.40, J.D. degree at Northeastern University at the time Mr. Fachon was enrolled. Epstein Becker & Green, in Boston. While his fellow college Mr. Fachon enrolled in the study on P.C. students were trying to figure out March 13, 2016, becoming the first where to go for spring break, Mr. and only subject enrolled. On or Fachon was trying to figure out what to about the same day Mr. Fachon began do next in light of his grave prognosis. receiving the investigational drugs, Despite popular opinion, lawyers and judges are human and sometimes the facts of a case make it near impossible for judges to play the role of the modest umpire calling balls and strikes as described by Chief Justice Roberts in his confirmation hearing. Sometimes, bad facts make bad law because the plaintiff is so sympathetic that the just ruling may not be the “right” one. Fachon v. U.S. Food and Drug Administration et al., appears to be the epitome of this. Earlier this year, a 20-year old man, Eugene Neil Fachon, was diagnosed with Diffuse Intrinsic Pontine Glioma (“DIPG”) a form of brain cancer for which there is no cure. His doctors told him he had only three months to live. At the time of his diagnosis, Mr.
the investigational drugs, despite the clinical hold, Mr. Fachon filed suit seeking a preliminary injunction, a permanent injunction and temporary restraining order prohibiting FDA from enforcing its clinical hold and requiring FDA to allow him to continue receiving the investigational drugs. Mr. Fachon argued that FDA violated his due process rights under the 5th and 14th Amendments because FDA failed to notify Mr. Fachon of its intent to impose a clinical hold and grant Mr. Fachon an opportunity to be heard. On May 17th, Judge John J. McConnell, granted Mr. Fachon the temporary restraining order he requested.
In granting the temporary restraining order, Judge McConnell concluded that once Mr. Fachon started participating in the clinical trial, he had a protectable interest in continuing his participation that entitled him to due process. The key aspects of due Instead of undergoing the standard April 21, 2016, FDA placed a clinical process are notice and an opportunity treatment, radiation, which may have hold on the clinical trial and ordered to be heard. Thus, Judge McConnell had the potential to extend his life the study site to stop administering the concluded that before FDA could take for up to three additional months, investigational drugs to Mr. Fachon. away Mr. Fachon’s right to continue he decided to participate in a clinical receiving the investigational drugs, After being unable to convince trial that was intended to investigate FDA may have been required to FDA to allow him to continue receiving see Legal Health page 17
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June 2016
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Oncology Research
A new hope for patients suffering from bladder cancer By: Jorge Augusto Borin Scutti, PhD Houston Medical Times
There is new hope for patients with bladder cancer! The U.S. Food and Drug Administration (FDA) approved on May 18th the first product in its class (PD-1/PD-L1) called Tecentriq (Atezolizumab) to treat the most common type of bladder cancer - locally advanced or metastatic urothelial carcinoma, previously know as transitional cell carcinoma, a cancer that start growing in the urothelial cells that line inside of the bladder. This strategy reflects the advancements made in immunotherapy field in order to produce a sustained and effective
June 2016
anti tumor immune response. This particular type of cancer is the most common cancer involving the urinary system and the ninth most common malignancy worldwide. Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, only behind breast cancer (female), lung and bronchus cancer, prostate cancer and colon and rectum cancer. Unfortunately, this cancer has not received the same attention within the cancer community as other common cancers. In order to understand, according to National Cancer Institute – Surveillance, Epidemiology and End Results Program are expected in 2016, 76,960 new cases and 16.390 deaths – this means that bladder cancer represents 4.6% of all new cancer cases in the United States. Some risk factors
include: Cigarette smoke, occupational carcinogen exposure, HPV infections, having a family history of bladder cancer, drinking water with high levels of arsenic, having certain changes in the genes that are linked to bladder cancer and using urinary catheters for a long time. While bladder cancer is reflected a chronic condition, improvements in scientific research are getting innovative and enthusing treatments to people who have newly diagnosed, relapsed or refractory disease. More and more people are reaching lengthy remissions and are surviving for many years. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96% of people will live five or more years when diagnosed with the earliest stage of the disease, compared to 39% when diagnosed in advanced stages (stage III-IV) of the disease. Men are about three to four times more likely to get bladder cancer during their
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lifetime than women. Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1. This ligand are expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7-1 receptors. PD-1 is expressed on activated T cells and prevents, for example, T cells from attacking tumors. Furthermore, PD-1 is active at the point of dendritic cell activation of T cells in lymph nodes and at the site of T cell attack in the microenvironment of the tumor. Blocking PD-L1, Atezolizumab may see Oncology Research page 18
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Four Reasons the Patient Experience Makes a Difference for Pediatric Providers
By Donna Houlne and Jennifer Machado North Highland
care business model is out as there is a rise of consumerism in health care. Patients have new demands and expectations regarding their experience and how they receive care. These two expectations, along with outcomes, challenges the old model. Patients are viewed as “customers” and their customer experience, or CX, reigns supreme. Retailers have led CX for years, while health care providers continue to play catch-up. While health care providers may never match a buyer and seller like Amazon.com does, the experience is a key part of the process.
Expansion, growth, and new construction. Amid a challenging economic environment, impacted by record low oil prices, these three words are constantly seen in Houston media headlines. But it’s not related to energy industry. The words summarize the charged-up health care ecosystem Houston is known for its innovative in Houston, Texas. A recent health care hub, especially in the area report released by Transwestern, a of pediatrics with industry leading Houston-based commercial real estate providers such as MD Anderson
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agency, revealed that roughly $5 billion is spent across the city on health care and life sciences related construction. This capital spend is spread out across a diverse group of market players, including hospitals (e.g. Memorial Hermann, Houston Methodist, Baylor St. Luke’s, Texas Children’s, MD Anderson, Ben Taub, Houston VA, and others), medical office buildings (mainly Memorial Hermann and Kelsey Seybold), and the life science sector. Regional experts forecast the construction pipeline will remain busy for the time being, to meet the diverse health care needs of the fastest growing city in the country. With all of this industry growth, Houston consumers have a myriad of options for where to receive their care and the care for their loved ones. Health care plans and providers seek advanced strategies to enhance the patient experience and improve outcomes. There is an imperative to bridge the gap between customer experience and workforce engagement and enablement. The traditional health
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Children’s Cancer Center and Texas Children’s Hospital. The role of CX in pediatrics grows increasingly important as nine thousand infants are born each day to millennial parents in the U.S. millennial moms and dads approach their children’s health care much differently than Generation X and Baby Boomers. This generation grew up with access to technology, instant information and sources at every turn. At the convenience of the mobile phone, millennials can review a physician before they make their care decision. They also share their experiences, good and bad, with their entire social communities. Moms turn to their “mommy groups” via Facebook to ask questions about their child’s conditions or symptoms before even consulting a physician. According to a survey by Nuance Communication, Inc., 60 percent of millennials share their health care experience with friends – not their doctors or health care facility – when they are unsatisfied. Based on these facts, pediatric care see Patience Experience page 18
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MD Anderson applauds extension of FDA regulatory authority to all tobacco products The University of Texas MD Anderson Cancer Center fully supports new rules issued by the Food and Drug Administration (FDA) today to extend federal regulatory authority to all tobacco products, including electronic cigarettes, cigars, hookah and other previously unregulated tobacco products. Ronald A. DePinho, M.D. “As an institution of healing and science, we applaud any and all instances where sound data informs public policy,” says Ronald A. DePinho, M.D., president of MD Anderson. “Including e-cigarettes within the FDA’s regulatory authority will provide a much-needed scientific evaluation of their safety and help limit youth exposure to these products that may lead to lifelong dependency.”
and Population Sciences. “This new rule represents a major step forward in advancing the health of all Americans through more effective tobacco control.” Ernest Hawk, M.D. Advocates of these new and emerging products often suggest they may be useful for smokers attempting to quit. MD Anderson is supportive of smokers using current evidence-based cessation methods. However, according to the CDC, there is not sufficient evidence to support that e-cigarettes are safe and effective cessation tools for smokers.
MD Anderson is concerned by the
The new regulatory authority allows the FDA to limit youth exposure to these products by prohibiting sales to minors, both in person and online, requiring age verification by photo ID, and not allowing
dramatic increase in the use of alternative tobacco products by adolescents. Data published last year by the Centers for Disease Control and Prevention (CDC) indicate that use of e-cigarettes among middle and high school students tripled between 2013 and 2014. Emerging data suggest youth initiation of e-cigarettes may serve as a gateway to tobacco products.
the distribution of free samples. Further, the ruling will require manufacturers, importers and/or retailers to register and report ingredient listings to the FDA, require premarket review of new tobacco products and place appropriate health warnings on packaging and advertisements.
“With great progress made in decreasing tobacco use rates in our country, the last thing we need is a new generation of non-smokers to develop nicotine dependencies that may lead to conventional tobacco use,” says Ernest Hawk, M.D., division head and vice president, Cancer Prevention
“The extension of these regulations will ensure these products are subjected to the same close scrutiny as conventional tobacco products,” says DePinho. “We see this is a great step forward in protecting our country’s public health, particularly that of our young people.”
NOW LEASING PHASE II
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ALS Advocacy Conference Gives Hope and a Voice for People with ALS
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Meg. They have four children between 10 and 18. In 2012, they adopted the three youngest – all siblings.
Juan Reyes is a man with ALS. He was diagnosed in October 2015, but in hindsight, he started showing symptoms in late 2013. What began as slight weakness in his left hand grip and thumb has progressed to severe weakness in all extremities and includes difficulty walking and loss of balance. He now uses a motorized wheelchair to get around, and many facets of his life have changed because of ALS. The big question he asks himself is, of course, “Why me?” and
“This disease threatens my time with them. Meg and I have put so much time and effort into creating our family, and I always cherish the time I have left with them,” Reyes said. “I regret that I won’t be able to teach our three youngest children the skills I bestowed on our oldest. Knowing that our children will lose me as part of their stability and safety net crushes me. I wanted to be here to help raise them and to show them that there is a better life than what they came from.”
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Juan Reyes and his wife Meg attended the ALS Association Advocacy Conference in Washington.
ALS has stolen much of Reyes’ “manhood.” Simple things like Unfortunately we don’t know, turning a screwdriver or opening a and probably won’t know anytime water bottle are no longer possible. soon. However, Reyes discovered that Eating is exhausting for him. military personnel are twice as likely to “Imagine putting elastic bands get it. He served in the Air Force as a with 20-pound weights around your medic for 21 years in various locations: Africa, Greece, UK, Germany, and wrists and having to lift them just to Saudi Arabia, and he loved every eat,” Reyes said. minute of my career. After a five-year Personal hygiene such as brushing stint as a defense contractor, Reyes his hair and teeth, putting on socks, transitioned to the nonprofit arena as buttoning his clothes, going to the the Executive Director for San Antonio restroom are already difficult, and they Area Command of the Salvation Army, aren’t even at the most trying time. from which he permanently retired in As a veteran, Reyes is able to March this year. access resources through the Veteran’s ALS has limited Reyes’ ability to Administration. The resources help drive, type, speak, stand, and walk. improve Reyes’ quality of life. He intended to continue working as “It breaks Meg’s and my heart to long as possible, but after learning know there are countless people with that he would have to wait five months ALS who can’t receive these benefits for social security benefits, he decided because they’re not veterans,” Reyes he didn’t want to strain his body, said. “We cannot fathom how they especially when he was already limited cope with having to fight for these in his remaining time. benefits or pass before any form of Twenty seven years ago, Reyes compensation is finalized.” married his high school sweetheart, see ALS page 19 “How did I get it?”
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Age Well Live Well
Help for Aging Adults, Kids with Disabilities is Just a Phone Call Away By Jeff Carmack, Managing Editor, Texas Department of Aging and Disability
community-based services to allow them to remain in their homes as long as possible.” Green said getting help from an ADRC is simple. “A caller will speak with a case manager who will do his or her best to identify the presenting issue and any other underlying issues,” she said. “The case manager will gather that information so he or she can identify at least a few resources to meet those immediate needs.
If you’re looking for help for an aged parent or a child with a disability, the task can be overwhelming. There are so many agencies and programs, and the services they offer can be confusing. Making heads or tails out Green said another great thing of all of them can be daunting. about ADRCs is that they serve Wouldn’t it great if you could everyone. “We don’t have any age pick up the phone, make one phone requirement or income restrictions or call, and get all the information you diagnosis, so it’s really a great source needed at once? for objective information for people of In Texas, you can do just that. By all ages with all kinds of disabilities.”
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calling your local aging and disability Many who seek help from resource center, you will be connected ADRCs are older, so ADRCs have with a trained case manager who can a special expertise in Medicaid will listen to your needs and send you programs and waivers, Green said.
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The 22 ADRCs in Texas are funded by the Texas Department of Aging and Disability Services (DADS). In January 2015, DADS launched a toll-free number (1-855-937-2372) to make getting services even easier. In the month following the launch of the number, ADRCs fielded more than 1,000 calls. Since that time, they have averaged more than 3,200 calls a month.
Doni Green, director of aging at the North Central Texas Council of Government’s ADRC, said, “ADRCs “Your ADRC really is a one-stop help people of all ages or their shop where people can get quick and caregivers, as well as those who just easy access to programs and chart out want to plan in advance, to identify their futures,” Green said.
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Largest-ever U.S. autism research study underway Baylor College of Medicine and Texas Children’s Hospital are part of an online autism research initiative, one of the largest studies on autism to be undertaken in the United States. The Simons Foundation Powering Autism Research for Knowledge, or SPARK, study will collect information and DNA for genetic analysis from 50,0000 individuals with autism and their families to advance the understanding of the causes of this condition and to promote the discovery of treatment and support.
genetic component. Already, about 50 genes have been identified that are believed to play a role in autism, and scientists estimate that an additional 300 or more are involved. By studying these genes, associated biological mechanisms and how genetics interact with environmental factors, researchers can better understand the condition’s causes and link them to the spectrum of symptoms, skills and challenges of The Baylor/Texas Children’s those affected. site is one of 21 research sites across SPARK aims to speed up the country that is collaborating in autism research by inviting this effort. Dr. Robin Goin-Kochel, assistant professor of pediatrics in participation from the large, diverse the section of psychology at Baylor autism community, with the goal
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and associate director for research at the Autism Center at Texas Children’s, will lead the study locally. Nearly 700 individuals with autism and their family members will be recruited annually over the next three years to participate in the effort at Baylor/Texas Children’s. “The SPARK study will empower researchers to make new discoveries that may ultimately lead to the development of new supports and treatments to improve the lives of people with autism,” said Goin-Kochel. “It is one of the most insightful research endeavors to date on this disease.” Autism is known to have a strong June 2016
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of including individuals with a professional diagnosis of autism of both sexes and all ages, backgrounds, races, geographic locations and socioeconomic situations. The initiative will catalyze research by creating large-scale access to study participants whose DNA may be selectively analyzed for a specific scientific question of interest. SPARK also will elicit feedback from individuals and parents of children with autism to develop a robust research agenda that is meaningful for them.
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Growing old gracefully and healthfully
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Many of the negative stereotypes of life as an older person are not inevitable, expert says
COME SEE FOR YOURSELF.
When you think about where and how you will grow old, what comes to mind? A dependent existence in a nursing home, with a variety of disabilities and a deteriorating mind?
active, but Ory doesn’t see any one type as being better than any other. “If you enjoy doing the crossword or playing brain games, that’s great,” she said. “But anything that challenges you That might have been the popular will work well and may actually help view of old age in the past, but it’s regain cognitive functions.” And although walking and less so as the public recognizes that cognitive and physical decline isn’t an gardening are the usual go-to exercise options for this age group, any inevitable part of aging. activity is good, especially if it can “It’s important to combat be combined with social interaction. stereotypes of old age and show people Being engaged with other people and that they still have something important with the community is an important to contribute both to their peers and to part of healthy aging. younger generations,” said Marcia G.
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Of course, eating well is also essential. It can be difficult to maintain a balanced diet with plenty of fruits and vegetables, but it’s vital for maintaining health at any age. Location
The built environment around you affects lifestyle choices. “When There are three determinants stores and amenities are closer, people of healthy aging, Ory said. Who are more likely to walk,” Ory said. you are (your genetics), what you do Therefore, much of her work has (your lifestyle) and where you live lately focused on community factors (your location, especially the type of like sidewalks, bike paths and distance community you live in). Although to the nearest store that sells healthy there’s nothing anyone can do about and affordable food. Many older adults the genetic hand they were dealt, don’t want to leave the homes they love, and instead choose to “age in place,” lifestyle and location are mutable. but it has become increasingly clear “There is no magic key, no one that transportation affects aging and way to promote healthy aging,” Ory many of our sprawling cities were not said. “But it’s important to have a full designed with aging drivers in mind. menu of programs and to tailor your Ory and other public health interventions to what people want.” researchers are working with those Lifestyle across the university who specialize Most people know that it is in everything from architecture and see Growing Old page 19 important to keep both mind and body
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Houston Medical Times
Page 17
Affordable Care Act Continued from page 1
for traditional Medicaid and not the ‘coverage gap,’ and unless Texas group, they will remained uninsured.” of color in working families and was recently estimated by the Kaiser enough to get a subsidy to help pay expands Medicaid or comes up with According to the report, the Family Foundation to include 766,000 for their premium. They’re stuck in another system of coverage for this “coverage gap” affects mostly people Texans.
Healthy Heart
Continued from page 3 AFib can increase a person’s risks for stroke and related heart problems.
∙∙ Weakness
If you think you may have atrial fibrillation, here are your most important steps:
∙∙ Fatigue when exercising
1. Know the symptoms The most common symptom: a quivering or fluttering heartbeat. AFib is the most common type of irregular heartbeat. The abnormal firing of electrical impulses causes the atria (the top chambers in the heart) to quiver (or fibrillate).
rate (called rate control)
∙∙ Faintness or confusion ∙∙ Sweating ∙∙ *Chest pain or pressure *Chest pain or pressure is a medical emergency. You may be having a heart attack. Call 9-1-1 immediately. 2. Get the right treatment
∙∙ Preventing blood clots (called prevention of thromboembolism such as stroke) ∙∙ Managing risk factors for stroke ∙∙ Preventing additional heart rhythm problems
alcohol and caffeine ∙∙ Don’t smoke ∙∙ Control cholesterol ∙∙ Maintain a healthy weight All of these goals aide in the prevention of (reducing the risk for) heart disease, and will help keep your circulatory system in the best condition. If you or someone you love has atrial fibrillation, learn more about what AFib is, why treatment can save lives, and what you can do to reach your goals, lower your risks and live a healthy life. The American Heart Association is here to help you. Join our online community at myafibexperience.org and learn more about how to manage atrial fibrillation.
∙∙ Preventing heart failure The treatment goals of AFib start 3. Reduce risks for stroke and with a proper diagnosis through an heart failure in-depth examination from a physician. To reduce your risk for the onset Additional common symptoms of The exam usually includes questions of AFib, maintaining a heart-healthy atrial fibrillation. Sometimes people about your history and often an EKG or ECG. Some patients may need a lifestyle is always your best option. If with AFib have no symptoms and you have been diagnosed with AFib, thorough electrophysiology study. their condition is only detectable upon take medications if they are prescribed Although no one is able to physical examination. Still, others for you, and get proper treatment and My AFib Experience™ is an may experience one or more of the absolutely guarantee that a stroke or a management of your condition so you innovative and unique online clot can be preventable, there are ways following symptoms: can reduce the risk of AFib’s harmful community that can help people to reduce risks for developing these ∙∙ General fatigue consequences. Here’s how: understand the condition, learn problems. ∙∙ Rapid and irregular heartbeat how to better manage it and connect ∙∙ Get regular physical activity After a patient is diagnosed with ∙∙ Fluttering or “thumping” in AFib, the ideal goals may include: ∙∙ Eat a heart-healthy diet, low in with others who also experience it. the chest saturated fats, trans fats, and A collaboration of the American ∙∙ Restoring the heart to a Heart Association/American Stroke cholesterol ∙∙ Dizziness normal rhythm (called rhythm Association and StopAfib.org, with ∙ ∙ Manage high blood pressure control) support from Janssen Pharmaceuticals, ∙∙ Shortness of breath and ∙∙ Avoid excessive amounts of Inc. ∙∙ Reducing an overly high heart anxiety
Legal Health
Continued from page 4 notify Mr. Fachon and provide him should have) granted the temporary an opportunity to convince FDA restraining order without reaching the conclusion on the merits of the otherwise. However, other than concluding case and without concluding that Mr. that this right arose once Mr. Fachon Fachon was entitled to due process. started receiving the study drug, Judge McConnell did not provide much of explanation about this right, including the source of this right or the scope of the right. I am not saying that Judge McConnell was wrong in granting the temporary restraining order, to the contrary. I agree that the balance of the equities favored granting the temporary restraining order, but Judge McConnell could have (and I think
Because Judge McConnell chose to recognize this right, this case has the potential to significantly impact how clinical trials are conducted. To the extent participants in clinical trials are entitled to due process, some questions will need to be answered, including: • Would subjects who benefit from the investigational product during the study be entitled to continue receiving the investigational product until it is approved by FDA? This
is not an unusual concept as other rights. countries grant subjects this right • Before FDA places a clinical already. hold on a study that includes a • With respect to clinical trials requirement that enrolled subjects stop conducted at public institutions, how receiving the study drugs, will FDA be does this impact an investigator’s required to notify all study subjects ability to remove a subject from a study and provide them an opportunity to without the subject’s consent? Pursuant be heard before the clinical hold goes to 21 CFR 50.25(b)(2), an informed into effect? consent is required to describe the “[a] In addition to having the potential nticipated circumstances under which to impact clinical trials, this case may the subject's participation may be impact the implementation of state terminated by the investigator without “right to try” legislation, like H.B. 21. regard to the subject's consent.” The requirement for due process arises However, an informed consent cannot when a government actor attempts to include any language through which a limit a private individual’s rights in a subject waives any of his or her legal see Legal Health page 18
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June 2016
Page 18
Houston Medical Times
Legal Health
HOUSTON
Continued from page 17 protectable interest. Therefore, if a pharmaceutical company decides not to provide someone an experimental drug under a state “right to try” law, the patient likely could not rely on the Fachon decision to compel the company to do so. However, this case could potentially impact FDA’s ability
to compel a pharmaceutical company to stop providing an experimental drug under a state right to try law. For example, it is unclear whether a patient would have a protectable interest in continuing to receive the experimental drug under state law, if the drug was provided in violation of federal law.
These are complicated issues that are best suited for legislative and regulatory solutions. Therefore, hopefully the parties and the judge can find an appropriate resolution to this case that allows Mr. Fachon to pursue this experimental treatment without opening up Pandora’s box.
Oncology Research the immune system, responsible for immunosurveillance now becomes weak, inactive and inefficient. Immunotherapy is one of the best therapies compared to traditional therapies that may cause potential toxicities such as chemotherapy and radiation. For several reasons the cancer patient’s immune system stops fighting and gives up the battle. So we have to reverse this situation. The potential use of immunotherapy is to restore the immune system of patients in attempt to stimulate it to
Editor Sharon Pennington Director of Media Sales Richard W DeLaRosa Creative Director Lorenzo Morales Sales & Events Nicole Ropp
Continued from page 6
enable the activation of T cells. Once PD-L1 binds to PD-1, an inhibitory signal is conducted into the T cell, which decreases cytokine production and suppresses T-cell proliferation and activation. Tumor cells use this immune checkpoint pathway as a strategy to evade detection and inhibit the immune response. Several studies have investigated the immune system of cancer patients, and them suffer from large immunosuppression mainly due to decrease lymphocyte proliferation and cytotoxic activity. This means that
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reject and destroy tumors. Cancer immunotherapy offers new weapons against cancer and it is particularly promising, because the immune system has a plenty of features that make immunotherapy different from any other approach to the treatment of cancer. In additional to Nivolumab and Pembrolizumab (both anti-PD-1) Atezolizumab (anti-PD-L1) can be an effective strategy to activate the immune system and start fighting bladder cancer.
Patient Experience
Writers Jorge Augusto Borin Scutti, PhD Denise Hernandez MS,RD,LD Accounting Liz Thachar Distribution Robert Cox Guillermo Mendez Office: 713-885-3808 Fax: 281-316-9403 For Advertising advertising@medicaltimesnews. com Editor editor@medicaltimesnews.com
Continued from page 8
patient experience (PX) must be approached differently than adult care services. Driving high-quality, value-rich PX demands an advanced and integrated understanding. There are four main differentiators between pediatric and adult medicine that if considered, can help pediatric health care providers position themselves for future successful PX with a growing patient population:
understood. Additionally, real-time, 24/7 information and access is expected in this digital age. Providers need established dynamic information channels capable of providing customized levels of information. 2) It’s not as simple as serving the needs of small adult bodies. Treatment plans for children need to be customized.
Determining the correct care for a child is not the same as how a provider approaches treating a small adult body. From prescribing The experience of the full caregiver treatments to thinking about patient network for pediatric patients matters. engagement, providers must customize It’s a network that extends beyond their approach based on their patient’s parents to include siblings, friends, sequential developmental stage. teachers, babysitters, grandparents, Parents and caregivers feel the coaches and neighbors. The bigger impact of these developmental the network, the more complicated and critical it is to streamline milestones, too. Thinking about communication and access to children in the following age-specific information. Pediatric health care cohorts can help providers adeptly organizations need to prioritize formulate the unique interaction communication to the different approach that will drive excellent PX. 3) Pediatric hospitals have a higher decision-makers in a child’s life by providing resources to caregivers case mix index and diverse patient that can be readily shared and easily population. 1) It takes village to raise a child - the entire caregiver network is your audience.
June 2016
Because pediatric hospitals have a larger catchment area, the factors necessitate robust population health management programming and partnerships with community organizations to ensure the best quality care, irrespective of geography. In addition, it is critical for pediatric providers to have an organization-wide understanding of cultural differences within their catchment area to ensure that patients and families receive culturally competent care. For example, for the Hispanic patient population, health care decisions are made as a family and institutional trust of the health care system is low. Pediatric hospitals should ensure they have bilingual staff, Spanish signage and materials and cultural competency to improve the overall experience for this population group. 4) Health care is both mental and physical. The health care experience is no longer exclusively centered on the clinical service rendered. Current thinking shifted the focus
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see Patient Experience page 19
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Houston Medical Times
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Patient Experience Continued from page 18
from “health care” to the broader concept of “wellness,” which extends beyond physical health to encompass emotional and financial health. Just last year, the American Academy of Pediatrics recommended in that kids and young adults ages 11 to 21 be screened annually for depression. The recommendation stems from an alarming statistic that in 2013, suicide was the leading cause of death after “unintentional injury” for those ages
15 to 34. Mental health as focus for are getting it right, but there is still and customer experience. adolescents and their overall health is much work to be done. The health care Jennifer Machado is a consultant a priority for providers. community has a unique opportunity at North Highland’s Houston Patient demographics and to lead the way in pediatrics and set the office and has a deep expertise in socio-economic factors drive different standard for PX care. pediatrics having formerly worked for PX strategies. There is not a one-sized Donna Houlne is a health care children’s hospitals. Her functional fits all approach. The pediatric health clinician with over 30 years’ experience care industry has unique challenges working with both payer and providers. areas of expertise include business to provide the best PX experience to As part of North Highland’s national analysis, process improvement, quality improve patient care and reduce health health care practice, Donna has a assurance, and organizational change care costs. Houston pediatric providers passion to improve clinical outcomes, management.
ALS
Continued from page 10 At the early stages of diagnosis, our clinics, and to create a network of of the ALS Association, Reyes and his Reyes and his wife connected with the patients and families who understand wife decided to attend. local ALS Association of Texas. what they’re going through.” “On the trip, we met so many “From the onset of my diagnosis, Initially, Reyes and his wife inspiring people living with ALS, many the Texas Chapter has been a were hesitant about attending the of whom have exceeded the normal life godsend,” Reyes said. “They stepped National ALS Advocacy Conference expectancy. Talk about a blast of much in with guidance and resources, and in Washington, D.C., because they needed hope!” Reyes exclaimed. Meg and I quickly realized that we were so new to the ALS community Reyes and his wife were blown must get involved in supporting the and weren’t sure about what they could away by the number of attendees. ALS Association as it continues to offer through the trip. The conference “We discovered that we do have be underfunded compared to other is held every year in conjunction with a voice and that we need to use it conditions.” ALS Awareness Month. ALS Texas to encourage our elected officials to The ALS Association provides staff members, ALS patients, caregivers, support research, access to care, and local care to people needing help now, and supporters travel to Washington, disability resources, and, ultimately, to advocates on behalf of people with ALS D.C., to tell their stories to the people educate them about the far-reaching to ensure that public policy serves their who have the most capacity to improve impact of ALS on families and needs, and funds extensive research so their lives – their elected officials. caregivers,” Reyes said. that one day, no one will suffer from “ALS Advocacy Day is an Additionally, Reyes learned that ALS again. important day for elected officials to see many researchers and supporters “Our goal here at the ALS first-hand ALS and its effects on people make a difference every day. The Association is to alleviate as much of and families and for ALS advocates to Texas Chapter of the ALS Association the burden on patients and families as urge those officials to increase funding coached the conference attendees possible,” said Tanner Hockensmith, to research and to make sure patients and paired them with experienced Executive Director of the Texas have access to essential medical care volunteer advocates. Reflecting on the Chapter. “We provide local services to and services,” said Mark Murtagh, conference, Reyes and his wife agreed people with ALS and their families to Director of Community Affairs and that it was worth attending, and they help improve their quality of life, to give PR at the Texas Chapter. would recommend to others as not them top-notch, comprehensive care at
Advocacy but also as an opportunity to provide insight into life with ALS for members of Congress. “We know this disease has yet to show its true colors, but we are grateful that we have time to be a family,” Reyes said. “We have the time to make sure we cherish every day with ‘I LOVE YOUs,’ hugs (while we can), family dinners, and trips to make memories.” Reyes’ last words of advice were these: “ALS, just like any terminal condition, forces you to slow down. I know I can’t battle ALS – ultimately, it will win. However, I don’t have to bow down to it. Being a strong military family, we will adapt and enjoy every day to the fullest, of course, with a few naps thrown in there…”
To read more courageous stories of people living with ALS and to learn how the ALS Association of Texas serves people with ALS across the With the encouragement and help only an opportunity to learn about ALS state, visit alstexas.org.
Growing Old
Continued from page 16 urban planning to computer sciences and engineering to study the planned community at the site of the old Austin airport. The new Mueller development, which includes several housing options just for those 55 or older, will serve as a great test of how a mixed-use community can promote healthy aging. Interventions Researchers at the School of
Public Health are working to combat the negative side effects of aging that once were considered unescapable. “It used to be that people thought falls were inevitable as they aged,” Ory said. “Now we know that’s not true. There are ways to prevent falling and associated injuries.”
personal and social impacts can be minimized. Programs that help people manage their chronic conditions— especially those led by other seniors— can be very effective. The School of Public Health has evaluated a program called Texercise that helps older adults meet their exercise and nutrition goals, Although older adults may share and they found it to be very effective. “We’re constantly working to test some common health issues, the medicaltimesnews.com
evidence-based ways to help older adults achieve optimal physical, mental, and social well‐being and function,” Ory said. “The whole community is our learning living lab.” It’s especially heartening to acknowledge the contribution of seniors during Older Americans month in May.” June 2016
Houston Medical Times
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