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October Issue 2014
Inside This Issue
RAISING BREAST CANCER AWARENESS OUTSIDE OF OCTOBER By Adriana M. Higgins, Executive Director Susan G. Komen Houston”
Cost of Affordable Care Act Insurance in Texas See pg. 10
INDEX Legal Health..................pg.3 Mental Health...............pg.5 Healthy Heart................pg.7 The Framework..............pg.9 Age Well Live Well........pg.12
Eating to Boost Energy See pg. 18
As the flood of pink may tell you, October is Breast Cancer Awareness Month. Susan G. Komen® Houston is a local organization that is passionate about making a difference in breast cancer awareness, education, screening, treatment and research. As the nonprofit behind Houston’s largest annual footrace, raised through donations, Race for the Race for the Cure, our influence goes far Cure and other events throughout the beyond pink ribbons and an annual 5K. year, we were able to make grants to 23 local organizations in 2014, totaling At Susan G. Komen Houston, we $1.9 million, for lifesaving breast health love pink. We love what the color has services. come to symbolize, and enjoy seeing As the most common cancer among it pop up all over the city, but we also women, outside of skin cancers, breast want to inform Houstonians about what it is we do at Komen Houston, and how cancer accounts for almost 29% of we are impacting the community and newly diagnosed cancers in women in driving awareness beyond the Race for the United States, and it is estimated that there will be 232,670 new cases the Cure. of invasive breast cancer diagnosed in Every year, Komen Houston strives women this year, and approximately to fulfill our mission of educating women 2,360 new cases in men. These numbers about the importance of breast cancer highlight the importance of screening screening, to raising funds to help these and prevention, and Komen Houston men and women receive the vital breast is dedicated to seeing these numbers cancer services they need to prevent, decline, and ultimately, disappear. treat and cope with the disease, and to So where does the funding go, encouraging Houstonians to raise money exactly? 75% of the funds raised for an important cause. With the funds through Komen Houston efforts stay right here in Houston, funding grants to organizations in the seven-country area, consisting of Montgomery, Liberty, Harris, Chambers, Fort Bend, Brazoria and Galveston counties. The remaining 25% goes directly to research efforts on a national level. With such a renowned medical center in the heart of the city, Houston often sees 100% of the funding return to the city. With the grants given in the Houston area, our organization was
able to offer 3,781 clinical breast exams, provide 3,156 people with treatment assistance and perform 4,995 screening mammograms last year. In addition, 557 individuals received transportation to their treatment or appointments and 92,290 people were educated about breast cancer and the importance of getting screened. Finally, with similar funding in 2013, 61 people were enrolled in clinical trials and 68,664 patients were guided through their breast health services and hospital system with the help of patient navigators through Komen-funded programs. There are so many services that are vital to detecting and treating breast cancer. Susan G. Komen® Houston helps women and men all over Houston and the surrounding areas, regardless of background, afford these services by funding local organizations that can then provide them at a low cost to these at risk patients. While the fundraising season is highlighted by the annual Race for the Cure, breast cancer does not know a season, and is not unique to October. In order to bring an end to breast cancer and reduce the prevalence of and deaths due to the disease, it is important for us to continue its fundraising and awareness efforts throughout the year, see Breast Cancer Awareness page 20
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SAVE THE DATE
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Legal Health
Coming soon to a laboratory near you? FDA’s Proposed Framework for Laboratory Developed Tests By James A. Boiani JD, ESTEIN BECKER GREEN
and patients. However, these tests are self-validated by laboratories and subject to much less-extensive oversight by the Center for Medicare and Medicaid Services (“CMS”). For nearly 40 years, FDA has chosen not to regulate. However, on July 31st FDA signaled this may change soon due to Agency concerns about the lack of FDA oversight, and the negative impact the dual system of regulation has on development of IVDs.
On July 31, 2014, the U.S. Food and Drug Administration ("FDA”) announced plans to regulate laboratory developed tests (“LDTs”). LDTs are an integral part of healthcare today, serving as diagnostic tools for many serious diseases and genetic conditions, II. FDA’s Proposed Framework so it’s incumbent on everyone who is for LDT Regulation a physician, laboratorian, diagnostics FDA would require many LDTs to developer, or future patient (which is all of us) to understand the proposed plan come into compliance with FDA IVD requirements on a risk-based schedule. so we can consider its impact. The framework would be phased in over I. The Current State of nine years from date final FDA guidance Lab Diagnostic Regulation is published (there is no timeline for Currently, diagnostic tests used by finalization, but a year-plus would not
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clinical laboratories in the United States be unexpected, given that FDA will be are developed and introduced into the soliciting and considering comments clinical environment in one of two ways: from stakeholders). Subject to exceptions (discussed below) and assuming there 1. The IVD Path. In vitro were no changes from the proposal, diagnostics (“IVDs”) are tests after its finalization – that are intended to aid in ∙ Within six months, laboratories diagnosing disease. These tests must tell FDA what LDTs they are designed, manufactured, and perform, and begin reporting sold to clinical laboratories by serious injuries and certain FDA-regulated manufacturers malfunctions associated with that are subject to extensive LDTs. FDA requirements covering FDA review and marketing ∙ Within one year, a laboratory approval/clearance of IVDs, must submit an application for manufacturing, postmarket authorization to market high safety reporting, and product risk LDTs, including any LDT promotion. that is intended to substitute for an FDA-cleared/approved 2. The LDT Path. LDTs are tests companion diagnostic (tests designed and manufactured by a that guide the use of specific single laboratory for in-house use. therapeutics), FDA-classified An LDT provides diagnostic test results relied upon by physicians
Clinical translation is the ability to guide health-changing research discovery from the laboratory to its use in medical practice. The degree program, a collaboration between the University of St. Thomas and Houston Methodist Research Institute, teaches students to apply business principles to make this process more efficient and less expensive.
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see Legal Health page 20
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Space: The final frontier … open to the public
UTMB research shows average people healthy enough for commercial space travel Historically, spaceflight has been reserved for the very healthy. Astronauts are selected for their ability to meet the highest physical and psychological standards to prepare them for any unknown challenges. However, with the advent of commercial spaceflight, average people can now fly for enjoyment. The aerospace medicine community has had very little information about what medical conditions or diseases should be considered particularly risky in the spaceflight environment, as most medical conditions have never been studied for risk in space — until now.
surgeries or disorders — would be able to tolerate the stresses of commercial spaceflight. Overall, they found that nearly everyone with well-controlled medical conditions who participated in this project tolerated simulated flight without problems. The study can be found in the journal Aviation, Space and Environmental Medicine.
“Physiological stresses of flight include increased acceleration forces, or ‘G-forces,’ during launch and re-entry, as well as the microgravity period,” said lead author Dr. Rebecca Blue. “Our goal was to see how average people with The aerospace medicine group at the common medical problems, who aren’t University of Texas Medical Branch at necessarily as fit as a career astronaut, Galveston recently studied how average would be able to tolerate these stresses of people with common medical problems an anticipated commercial spaceflight.” — high blood pressure, heart disease, Some medical conditions are of diabetes, lung diseases like asthma or particular interest within the commercial emphysema and back and neck injuries, spaceflight industry, either because of
the high rate of occurrence or because of the potential to cause sudden, serious medical events. The researchers studied how people with these common conditions performed when put through centrifuge simulations of spaceflight launch and re-entry.
expected in a commercial spaceflight profile are tolerable, but can be uncomfortable, for healthy individuals. The researchers wanted to see if they were equally tolerable for individuals with complex medical histories or whether there were certain conditions that would make it more difficult for The centrifuge allows researchers to them to handle the flight. mimic the acceleration of a rocket launch “This study further supports the or of a spacecraft re-entering through belief that, despite significant chronic the atmosphere. Astronauts regularly use centrifuges to train for their own medical conditions, the dream of spaceflights. The acceleration forces spaceflight is one that most people can achieve,” said Blue.
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Mental Health
No One Is Safe FromThe Prescription Drug Abuse Epidemic By Jason Powers MD, MAPP Chief Medical Officer Right Step & Spirit Lodge
Overdose deaths from prescription drugs are rising in this country, and none of us are immune: prescription drug abuse and overdose deaths are increasing across all sex, race, age, geographic location, and socioeconomic markers. While abusable drugs across the board are to blame, painkillers and sedatives account for nearly half of prescription drug overdose deaths. But overdose deaths are not the only reason why the Center for Disease Control (CDC) claims that we’re in the midst of an epidemic. Emergency department visits from prescription drug abuse climb higher year after year; admissions to rehabilitation facilities for prescription drug abuse increased over 700% between 1998 and 2010; and driving under the influence and motor fatalities are up, as
are thefts and robberies of pharmacies. It's clear that we are in an epidemic far worse than that of crack in the 1980’s. After marijuana, prescription drugs are abused more than any other drugs. These and other statistics are staggering. Approximately 30% of Americans who try an illegal drug for the first time do so with prescription drugs. According to the U.S. Department of Health and Human Services, over six million Americans admit to abusing prescription drugs. What’s even more frightening is this: girls between the ages of 12 and 17 who try a drug for the first time are more likely to use a prescription drug than either alcohol or marijuana. Addiction only afflicts a minority of the one in five Americans who will misuse a prescription drug at least once in their lifetime. Yet those of us who are predisposed to addiction are generally never prepared for how insidious prescription drug abuse can develop. From patients in physical and emotional pain to the health care providers who care for them, none of us are immune. Prescription drugs can be prescribed
for innocuous and even laudable reasons, further abuse. but among the vulnerable, these drugs work like all other drugs of abuse. While Prescription drug abuse is more the euphoric effects are greater, so too prevalent today because more people are are the devastating consequences. being exposed to them than ever before. According to the CDC, prescription Drug abuse begins for many drug overdoses continue to increase reasons, including seeking the rush of an year after year. More Americans died of incredibly intoxicating experience, but it drug overdoses in 2010 than from motor continues for different reasons altogether. vehicle accidents. In fact, the majority of Despite its initial lure, addiction is not a drug overdose deaths in 2010 involved pleasure disease—it's a painful-beyond- prescription medications—more than words runaway existence that most those caused by heroin and cocaine people cannot imagine. Like pouring combined. gas on a fire, persistent drug abuse in genetically predisposed individuals leads Since 2010, efforts to stem the rise in to greater brain dysregulation that, in turn, leads to a self-sustaining cycle of see Mental Health page 21
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Research May Lead to Reliable Alternative to Open-heart Surgery
UH Mathematician Suncica Canic Recognized as SIAM Fellow at Recent Ceremony
When you need it.
By Lisa Merkl University of Houston
University of Houston (UH) professor Suncica “Sunny” Canic is a mathematician, not a medical doctor, but her research could save the lives of heart patients. Working with collaborators from Houston Methodist Hospital on a minimally invasive experimental procedure for heart valve replacement, Canic’s work could lead to optimal design Professor Suncica “Sunny” Canic of an alternative to open-heart surgery for called the pulsatile flow loop, at the Methodist DeBakey Heart and Vascular treating failing heart valves. Center,” Canic said. “By combining 3-D “It almost sounds like science fiction,” human organ printing and computational Canic said. “Our project combines the simulations of anatomic and physiologic most recent breakthroughs in technology, conditions associated with TVR at this such as 3-D human organ printing, patient-specific level, the experimental and materials science, mathematics, scientific computational methods we’re developing computations and cardiovascular provide new information on the optimal design for this procedure.” sciences.”
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Specifically, together with Dr. Stephen Little, a cardiologist at Methodist, Canic is leading an interdisciplinary team to improve the treatment of dysfunctional heart valves. With the number of patients requiring valve replacement on the rise, Canic and her colleagues are working to design new strategies in a minimally invasive procedure called Transcatheter Valve Replacement (TVR). Their approach would minimize post-procedural complications and provide a safe alternative to open-heart surgery.
Canic’s research group at UH includes Hugh Roy and Lillie Cranz Cullen Professor of Mathematics Roland Glowinski, assistant professor Annalisa Quaini and several post-doctoral associates and graduate and undergraduate students. Her team is considered a leader in developing mathematical and computational techniques analyzing the interaction between fluids and structures, such as blood and cardiovascular tissue. The methodology they are developing is based on new computational approaches for providing stable, computationally An emerging treatment for patients efficient algorithms for valve motion, with failing valves, TVR entails coupled with a novel approach to implanting a prosthetic valve through endovascular stent modeling. the skin, using catheterization to forgo more invasive surgery. Going through Recognized as one of the leading the groin area, a catheter containing experts in the world in the area of a replacement valve is guided to the mathematical modeling and scientific location of the failing valve. Canic says computing related to cardiovascular the stent holding this bioartificial valve science, Canic recently was honored is made of a shape memory alloy that at the 2014 Society of Industry and assumes a predefined shape optimized Applied Mathematics (SIAM) Annual for TVR procedures once it reaches the Meeting held in July. Canic, a Cullen patient’s body temperature of 98.6 degrees Distinguished Professor in the Fahrenheit. When the catheter reaches Department of Mathematics, was named the location of the failing valve, the stent to the 2014 SIAM Class of Fellows for expands and anchors the bioartificial her outstanding contributions to the valve in place. development of mathematical theory “Our computational results are being validated using functional, 3-D, patient-specific models in Dr. Little’s lab. We are then testing them with virtual TVR procedures performed in an apparatus,
October 2014
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and applications to the life sciences. Her interdisciplinary approach to studying TVR promises to provide a major breakthrough in the treatment and imaging of heart valve repair.
Houston Medical Times
Page 7
Healthy Heart Why Do You Walk?
By Shelly Millwee Director of Communications American Heart Association
While it’s free to register at www. houstonheartwalk.org, please consider donating or raising funds as you walk. The Houston Heart & Stroke Walk fundraising goal is $3.3 million!
The Walk isn’t just a one-day event. It’s also a great way to jump-start a lifetime of physical activity that can make you feel Walking is one of the best ways to better while avoiding deadly diseases. stay healthy, but did you know you can also save lives simply by walking? The Heart & Stroke Walk is part The American Heart Association’s of the American Heart Association’s My Houston Heart & Stroke Walk is set for Heart. My Life.™ healthy living initiative Nov. 8 at NRG Park. More than 35,000 that strives to help families, communities people are expected for this fun day of and corporations live healthier. We focus physical fitness for the whole family, and so much on walking because it’s one of money raised from the event goes toward the easiest and cheapest things you can research, education and various programs do for your heart. to fight heart disease and stroke. Of course, we know starting – and The American Heart Association maintaining – a fitness regimen can
needs you to join us because heart be difficult. Fortunately, we also have disease is a leading cause of death for solutions to those nagging “limitations” all Americans, and stroke ranks fourth. to healthy activity. That’s the big picture, but why should “My schedule is too hectic. I don’t you walk? have time.” You can walk to serve as a great You have lots of opportunities to example for your family. Walk because fit walking into your schedule, even if your nephew was born with a congenital heart defect, yet because of scientific you don’t have time to go to a gym. If research he can play baseball at age you drive to work, park at the farthest eight. Walk because your dad had a heart point of the parking lot and walk the transplant and walked you down the aisle difference. If you take the bus, get off on your wedding day. Walk in memory two stops earlier. Take a 10-minute walk during your lunch break, another during of a loved one. Walk for yourself. your coffee break and fit in another 10 The Heart & Stroke Walk is a 5K minutes after dinner. Walk in place while non-competitive walk, but it’s also a watching TV. Being active helps burn celebration. You can help raise awareness, more calories, which helps you manage generate lifesaving funds for research, your weight and other cardiovascular celebrate survivors, improve the health risk factors. of our families and honor those who “I can’t stay motivated.” have lost their battle to heart disease and stroke. A Walking Club can be a built-in The walk starts at 8:30 a.m. There support system to help you stick to a fitness will be heart-healthy giveaways, tasty routine. American Heart Association treats and heart-pumping family activities.
see Healthy Heart page 22 medicaltimesnews.com
October 2014
Page 8
Houston Medical Times
Texas Heart® Institute Begins Study to Help Identify Patients at Increased Risk for Heart Attacks Texas Heart® Institute (THI) at CHI St. Luke’s Health–Baylor St. Luke’s Medical Center announced today that it is enrolling participants in the Lipid-Rich Plaque (LRP) Study - a large-scale, multi-center, international study aimed at linking the presence of LRP, a type of fatty coronary artery plaque, to the occurrence of a heart attack or other cardiac event. LRP is associated with most heart attacks and will be identified in study participants using an intravascular imaging technology known as the TVC Imaging System™. THI is one of 100 international sites participating in this major research initiative, and is the first site in Houston to begin enrollment, as 176 of the study’s 9,000 participants
have already been enrolled. LRP and other coronary artery plaque is caused by the build-up of cholesterol and other materials inside the walls of the coronary arteries. Over time, the accumulation of plaque can gradually reduce blood supply to the heart, leading to chest pain during exertion. In addition, the plaque may also rupture, which can lead to a blood clot that could cause a heart attack, stroke or sudden death. Intravascular imaging using combined near-infrared spectroscopy (NIRS) and enhanced intravascular ultrasound (IVUS) is currently used at THI and Baylor St. Luke’s Medical Center to assess the structure and composition of plaque within the heart’s blood vessels. The information obtained is used to guide
interventional treatment for better adverse cardiac event. The study will procedural outcomes. initially focus on validating the ability The LRP Study, which launched of NIRS-IVUS intravascular imaging to in June 2014, will use NIRS-IVUS predict coronary events, including heart TVC Imaging to identify patients with attacks. If and when that goal is achieved, LRP, and monitor these patients for the study will transition to a blinded, two years for the incidence of a major randomized study of TVC-guided preventative treatment.
A new stent graft made from a 3-D image of the patient’s anatomy is an option for people suffering from an abdominal aortic aneurysm sensation in the abdomen. The pain A new minimally-invasive surgery may last for hours or days. involving a stent graft made from a 3-D image of the patient’s anatomy In about 10 percent of these patients, eliminates the need for open surgery for surgery is complicated because the some patients suffering from abdominal position of the defect in the aorta is aortic aneurysms. extremely close to the arteries that go An abdominal aortic aneurysm is into the kidneys. an enlarged area in the lower part of The new Zenith Fenestrated AAA the aorta. Since the aorta is the main Endovascular Graft by Cook® Medical supplier of blood to the rest of the body, a ruptured abdominal aortic aneurysm is custom-made based on the patient’s can be fatal. Symptoms might include spinal CT scan. From the scan, the belly pain or discomfort, pain in the surgeon measures the position of the chest, lower back, or flank (over the vessels and where they feeding into the kidneys) possibly spreading to the kidneys, liver and intestines. Once the groin, buttocks, or legs and a pulsating location is determined, the company
makes the graft with few holes or flow to these vital organs.” “fenestrations” on the stent graft that Bechara says most patients go home are designed to ensure blood flow from a few days after the procedure with the aorta to the kidneys and the other minimal pain or discomfort. Results organs. have shown less blood loss, a shorter “In the past, we would have to open ICU stay, and a quicker return to a the belly and sometimes the chest to do normal diet and regular activities than this operation because it’s very complex,” patients who undergo an open procedure said Carlos Bechara, M.D., a vascular to fix this problem. surgeon with the Houston Methodist “In the past, patients with abdominal DeBakey Heart & Vascular Center. “For aneurysms so close to the renal arteries this surgery we go through the groin had very limited surgical options,” with no incisions and place the stent to Bechara said. “This new device gives cover the aneurysm and then bridge the us a new avenue to help these patients holes with stents to treat the aneurysm get back on their feet again.” and at the same time preserve blood
MD Anderson Lobby Home to Colorful Paper Dragon Crafted by 1500 Patients, Families, Staff The giant paper dragon, known as Okoa, makes its debut in the lobby of the Main Building at The University of Texas MD Anderson Cancer Center in honor of Childhood Cancer Awareness Month.
and created at a temporary art studio hosted by the Arts in Medicine Program at MD Anderson Children’s Cancer Hospital. The dragon even has a “gold” tooth, as designed by a young patient.
Okoa is a Swahili word that means “rescue, save, redeem or deliver,” and it Crafted by more than 1,300 MD was selected as the dragon’s name by Anderson pediatric and adult patients the many who helped create it. and their families over the last five Children’s Cancer Hospital. This is the hospital. months, the dragon is eight feet tall, Launched in 2010, the Arts seven feet wide and more than 21 feet in Medicine Program has focused first project to bring together patients, See video for more information: long. The vibrant paper scales, coffee on large-scale, long-term creative families and staff from the entire https://www.youtube.com/watch?. filter flowers and water color paintings collaborations with patients and families that make up the water were all colored undergoing treatment at MD Anderson’s October 2014
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The Framework
Texas A&M dedicates national pandemic influenza vaccine manufacturing facility, on track for 2016 start-up phase Texas Governor Rick Perry, Texas A&M University System Chancellor John Sharp, Texas A&M Health Science Center CEO Brett Giroir, M.D., and officials from the U.S. Department of Health and Human Services (HHS), State of Texas and biopharmaceutical company GSK today dedicated a national pandemic influenza vaccine manufacturing facility in
to be complete by early 2017. When fully functional, the facility is expected to have the capacity to produce the bulk antigen needed for up to 50 million adjuvanted pandemic influenza vaccine doses within four months of a declared influenza pandemic and availability of acceptable virus seeds. “This facility represents a huge step
Texas A&M’s national Pandemic Influenza Vaccine Facility in Bryan-College Station, Texas, expected to be fully complete by early 2017, is designed to supply bulk antigen to meet the U.S. Government requirements for 50 million doses of pandemic influenza vaccine within four months of receipt of a pandemic strain.
Bryan, Texas, which when complete will serve as an anchor for the Texas A&M Biocorridor – a rapidly evolving hub of economic development and scientific
forward for the State of Texas, and an important milestone in the United States’ battle against both contagious diseases and the specter of international bioterrorism,”
Representatives from Texas A&M, the State of Texas, GSK and the U.S. Department of Health and Human Services sign a beam from the Texas A&M Pandemic Influenza Vaccine Facility currently under construction.
discovery that is swiftly positioning Texas as the third coast in biotechnology. Construction of the 100,000-square-foot facility is on track for completion by the end of 2015, to be followed by start-up and validation phases that are expected
Gov. Perry said. “Our state has long been home to innovative minds willing to attempt giant leaps to great achievement, and this will serve as another instance where Texans are willing to lead the way see The Framework page 22 medicaltimesnews.com
October 2014
Houston Medical Times
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October 2014
second year of the Marketplace, penalties rise if you don’t buy health insurance. For someone making $35,000, the new penalty would be $700. We’ll be “More than 1.5 million people in interested to see whether more in the Texas who make between $16,000 and target population purchase plans when $46,000 a year remain uninsured,” said those penalties rise.” Elena Marks, CEO of the Episcopal The report is the eighth in a series Health Foundation and a nonresident fellow in health policy at the Baker on the implementation of the ACA in Institute. “People living on incomes of Texas co-authored by Marks and Ho. $35,000 a year may still find it difficult to The Health Reform Monitoring set aside $150 a month to pay for health Survey (HRMS)-Texas report is based insurance, particularly if they rarely seek on a national project that provides health care. And that’s for the lowest-cost timely information on implementation plan.” issues under the ACA and changes in health insurance coverage and related The more money individuals make, health outcomes. The Episcopal Health the more they pay for Marketplace Foundation and Baker Institute are insurance plans, as intended by the partnering to fund and report on key ACA. For example, a person in Houston factors about Texans obtained from making $17,000 a year paid $50 a month an expanded representative sample of for a “Silver” plan. A Houstonian who Texas residents. Today's report contains earns $23,000 paid $114 a month for the responses from 1,595 Texans in same plan and a person making $35,000 September 2013 and 1,538 in March 2014.
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of each resident, ensuring dignity, choice, and self-determination. Additionally, Texas law requires facilities to protect and promote residents’ rights. The federal government has found that nursing homes that don’t provide a Mary wanted nothing more than to be gone. She was too small and frail to daily minimum of 4.1 hours of nursing use a wheelchair, so the staff put her in time per resident may be putting their a recliner – basically a restraint - and left residents at risk. Yet, despite this direct her in the doorway of her room all day. link between staffing and quality of care, nursing homes are not required to maintain a minimum number of staff Vickie Davison, a volunteer long-term on duty. Even the best nurses and nurse care ombudsman, asked Mary what aides can’t deliver quality care if there would make her happy. aren’t enough of them. “She said, 'I want to be in a wheelchair like everyone else.' “4.1 – It Can Be Done” is the theme “I spoke with the nursing staff and of the Consumer Voice’s campaign for they found a smaller wheelchair that Residents’ Rights Month in October, would work for her. On my next visit, which aims to educate the public and I saw her being wheeled around with a policymakers about the need for stronger big smile on her face. This was the first state and federal nursing home staffing time I’d seen her out of her room and laws. And ombudsmen can be an integral part of making sure residents’ rights are the first time I’d seen her smile.” respected and protected. Davison tells this story to illustrate one of the paybacks of being a volunteer Volunteers Always Welcome ombudsman: “Helping to put smiles on the faces of people who never smile.” It As our population ages and people also helps illustrate how ombudsmen help protect the rights, both big and live longer, most of us will be faced either with placing a loved one in a nursing
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home or an assisted living facility, or using their services ourselves. Additionally, the huge number of aging baby boomers who need long-term care makes the need As part of The Texas Long-term will for advocates even more critical. Care Ombudsman Program, Davison and 700 volunteer ombudsmen advocate serve a central role in for quality of life and care for residents of care Ombudsmen delivery. After 30 hours of training, long-term care facilities -- nursing homes volunteers are assigned to a facility (or and assisted living facilities (ALFs). facilities) as close to their as Administered by the Department of possible. They are requested tohomes visit their Aging and Disability Services (DADS) assigned facility a few times a month and the program identifies, investigates and visit as many residents as time allows. resolves complaints made by or on behalf of residents. It also provides services to To view the “Residents Bill of protect safety, welfare and rights. Rights,” visit www.dads.state.tx.us/news_ More than 40 percent of Americans info/publications/brochures/DADS141_ For who reach the age of 65 will spend some ALResidents_Bill_of_Rights.pdf. more information on residents’ right, time in a nursing home during their visit the Consumer Voice site http:// remaining years. With an expected 70 theconsumervoice.org/betterstaffing . million baby boomers crossing that line For detailed information about resident in the next 25 years, how those residents rights, contact your local Ombudsman are treated will matter to them and their Program at 1-800-252-2412 or email families. the Texas Department of Aging and The rights and privileges granted Disability Services at mail@dads.state. by the Constitution and Texas law tx.us. This information also is available don’t change when someone goes into in Spanish and Braille. a long-term care facility. These rights are To find out more about becoming guaranteed by the federal 1987 Nursing Home Reform Law, which requires each a volunteer ombudsman, call nursing home to care for its residents in a 1-800-252-2412 or visit www.dads.state. manner that promotes the quality of life tx.us/news_info/ombudsman/how_it_ works.html. small, of residents of the state’s long-term facilities.
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Studies Show Stroke on Rise Among Younger Adults An article in the Washington Post recently concluded that strokes, long on the decline among the elderly, are rising among younger adults. Experts speculate the increase may be due to a rise in risk factors such as diabetes, obesity, high cholesterol, and high blood pressure in this population. The article cited several studies, including a 2010 study in the journal Stroke that found the stroke rate tripled in 35- to 54-year-old women between 1988 and 2004, and a 2011 Centers for Disease Control and Prevention report that showed hospitalizations for stroke increased by more than a third in 15- to 44-year-olds in the 14-year period that ended in 2008. “The good news is many contributing risk factors can be minimized with lifestyle changes, such as a healthy diet and exercise,” said Reza Sadeghi, M.D., M.Sc., a Mischer
minutes, and 795,000 people suffer a new or recurrent stroke each year. “While the whole situation was extremely scary, I consider myself very lucky. My husband took action immediately to get me to Memorial Hermann where I could get help,” said Lisinski. “Today, I am about 98 percent back to normal, but I am stubborn and still working on total recovery.” Because stroke injures the brain, you may not realize you are having a stroke. To a bystander, someone having a stroke may just look unaware or confused. Stroke victims have the best chance if someone around them recognizes the symptoms and gets help quickly. The symptoms of stroke are distinct because they happen fast: ∙
Sudden numbness or weakness of the face, arm, or leg (especially
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on one side of the body) Sudden confusion, trouble speaking, or understanding speech
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Sudden trouble seeing in one or both eyes
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Sudden trouble walking, dizziness, loss of balance or coordination
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Sudden severe headache with no known cause
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Neuroscience Associates neurologist and clinical neurophysiologist affiliated with Memorial Hermann Southwest Hospital, a member of the Memorial Hermann Rehabilitation Network. “However, it is important to see your doctor for regular check-ups and to understand your potential risk for stroke and heart disease.” At 53-years-old, Valentina Lisinski was busy with life; scuba diving and traveling. While on vacation in South America, she woke up in the middle of the night with numbness on her right side. She was dizzy and unable to speak. Her friend heard her fall and came to her aid. Because Lisinski was in a remote location, specialized medical treatment for stroke was not readily available. Her husband quickly flew her back to Houston where she was admitted to Memorial Hermann Southwest, designated as a Primary Stroke Center by the Joint Commission. There, Lisinski underwent four weeks of intense stroke rehabilitation; relearning all the basics - how to speak, walk, and eat. According to the American Heart Association/American Stroke Association, stroke is the leading cause of long-term disability and the fourth leading cause of death in the United States. On average, someone suffers a stroke every 40 seconds, someone dies of a stroke every four October 2014
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Memorial Hermann recommends F.A.S.T. as an acronym to remember the sudden signs of stroke: Face drooping, Arm weakness, Speech difficulty, Time to call 9-1-1. “Within a few minutes of having a stroke, brain cells begin to die and symptoms emerge. It is important for everyone to recognize the symptoms because prompt treatment is crucial to recovery,” said Ajay Bindal, M.D., a neurosurgeon affiliated with Memorial Hermann Southwest. “Much of stroke prevention is based on living a healthy lifestyle. This includes identifying and controlling blood pressure, not smoking, treating diabetes properly, and managing stress.”
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Broach Foundation commits $5 million to brain cancer research
Supports research to defeat glioblastoma, aggressive disease that took founder’s life The Broach Foundation for Brain Cancer Research has made a $5 million commitment to support glioblastoma multiforme research at The University of Texas MD Anderson Cancer Center. In recognition, the institution has named two patient pods at the Brain and Spine Center. The first one is named in memory of the late James Broach and the other is in honor of the foundation he and his wife, Jamie, established in 2011, months after he was diagnosed with the most aggressive form of brain cancer.
process of discovering new treatments and delivering them to the patient,” said Lang. “Thanks to the Broach Foundation’s generous support, we have promising clinical trials underway that mean hope for patients and their friends and loved ones coping with the effects of this deadly disease.” Fighting cancer with laughter
Laughter and a positive outlook have been powerful weapons for the Broach family in their fight against a disease that There’s no known cure for is in no way funny. The couple chose to glioblastoma, and the low survival rate fight cancer with a combination of hard hasn’t improved in years, due in part to work and humor. They planned a comedy inadequate funds for clinical research. theme for their first gala fundraiser in May In hopes of changing the statistics, the 2012 and called it Stand-Up for Brain
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Broach Foundation directed its inaugural grant in 2012 toward research led by James’s physician, Frederick Lang, M.D., professor and director of clinical research in Neurosurgery. Dr. Lang’s lab focuses on a viral smart bomb developed at MD Anderson by Juan Fueyo, M.D., professor in Neuro-Oncology - Research, called Delta-24-RGD, a type of cold virus that’s engineered to infect and kill tumor cells. Lang pioneered the use of mesenchymal stem cells to deliver this virus and other biological therapies to brain tumors. Though James died at age 38 in 2013, the foundation continues to raise funds to support Lang and other collaborators at MD Anderson. “Philanthropy drives innovative research, which in turn drives the whole
Cancer. Actor, comedian and former “Saturday Night Live” cast member Kevin Nealon entertained a sold-out crowd at the River Oaks Country Club. Comedian Dennis Miller headlined the sold-out May 2013 event, followed by fellow “Saturday Night Live” alum Dana Carvey last April. Through gala proceeds, the Broach Foundation has contributed $1.7 million toward its $5 million commitment. “We’re grateful to everyone who has contributed so generously to our foundation. The more we spread the news about the cutting-edge research taking place at MD Anderson and how brain cancer research continues to be underfunded, the more excited people become about wanting to join the cause,” said Jamie.
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HCA Gives $1 Million in Aid for Ebola Response to CDC Foundation HCA, which operates 164 hospitals and 114 surgery centers in 20 states and England, and the CDC Foundation today announced a $1 million cash donation by HCA to the CDC Foundation to help support international Ebola epidemic response efforts involving the U.S. Centers for Disease Control and Prevention (CDC) and their work with partners on the ground in West Africa. “The U.S. and other nations around the world are surging our response to combat the Ebola epidemic in West Africa in an effort to save thousands of lives from this terrible disease,” said CDC Director Tom Frieden, M.D., M.P.H. “It’s still possible to reverse this epidemic and this contribution from HCA, and hopefully others like it, will
response in early July, more than 700 CDC staff members have provided logistics, staffing, communication, analytics, management and other support functions. The CDC currently has more than 100 staff deployed in Guinea, Liberia, Nigeria and Sierra Leone. The CDC Foundation is working with donors like HCA to provide much-needed supplies and equipment for use on the ground in West Africa. These items include personal protective equipment, infection control tools, ready-to-eat meals, generators, vehicles and motorcycles, hiring of locally employed staff, exit screening tools and supplies at airports such as thermal scanners to detect fever. The Ebola epidemic in West Africa
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help scale and speed up our response.” HCA is one of the leading providers of healthcare services in the U.S. and has a long history of supporting relief efforts including those following the earthquake in Haiti, the Indonesian tsunami, Hurricane Katrina and Typhoon Haiyan in the Philippines. The $1 million cash donation by HCA was made to the CDC Foundation’s Global Disaster Response Fund.
is a humanitarian crisis. The number of individuals infected with the Ebola virus doubles approximately every three weeks with more than 5,800 cases, based on the latest estimates. Tragically, the number of deaths has increased from 1,500 to more than 2,800 in the same time period. These numbers are only expected to climb without immediate action.
“Without additional public health interventions made possible by donations like that from HCA, CDC estimated that the number of Ebola cases in Liberia and Sierra Leone could reach hundreds of thousands or even to over one million people,” said Charles Stokes, President and CEO of the CDC Foundation. “It’s critical that organizations support this vital effort to provide flexible funding that can be used to meet needs on the ground in West Africa. Together, we Since the CDC ramped up its Ebola can all make a difference.”
“Ebola continues to spread rapidly in West Africa, and CDC and others have made it clear that the window of opportunity to contain the virus is closing quickly,” said R. Milton Johnson, President and Chief Executive Officer of HCA. “The time to act is now, and we strongly encourage other companies, particularly those in the healthcare industry, to join us in this important effort to save lives.”
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Eating to Boost Energy By Tara Gidus, MS, RDN, LDN, CSSD
Let’s face it, we are in an energy crisis. We, as a society, are busy, overweight, stressed, out of shape and have poor eating habits — all contributing to low energy levels. One way to fix our energy deficit is how we eat. The right combinations of food can give you a much needed boost. Follow these strategies to maximize your energy. 1. Eat often. Eating every 3 to 4 hours can help to fuel a healthy metabolism, maintain muscle mass and prevent bet ween-meal hunger that leads to unwise snacking. If you’re currently only eating 1 to 2 meals a day, this will be an adjustment. As you’re learning how to eat more frequently throughout the
day, remind yourself that you will feel better and be more focused when you have fuel in your system on a regular basis.
portions are often too large. If your meal carries you 5 to 6 hours without hunger pangs, it’s likely that you’re eating too much. Eating light will also prevent you from getting too full and feeling sluggish.
2. Eat light. Eating just
3. Balance plate. A balanced
enough, but not too much, helps to curb cravings and reduces chances of overeating. Keep in mind
meal includes whole grains, lean protein, fiber-rich fruits and vegetables, fat-free or low-fat dairy and a small amount of healthy
fats. Balance out your plate with all the food groups for sustained energy. 4. Snacks are a bridge. Don’t skip this important eating event. Snacks should have protein and fiber-rich carbohydrates to provide lasting energy. Grab an apple and a handful of nuts, carrots and string cheese, or Greek yogurt and fresh berries. Keep in mind that snacks are not intended to fill you up, but to bridge you from one meal to the next. 5. Remove energy zappers. Skip the soda, sugary coffee and energy drinks. These foods may leave you buzzing for an hour, but will likely cause an energy crash. Quench your thirst with water, fat-free or low-fat milk, low-calorie flavored water or unsweetened tea. ©2014 Tiff’s Treats
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Breast Cancer Awareness Continued from page 1
hosting charity events and encouraging forever. donations. There are numerous ways to get involved with Komen Houston and This year, Komen Houston is support our efforts, not only through doing something unique, with the donating, but also through other outreach goal of raising more funds for those and awareness events. We are hosting an in need than ever. We are challenging inaugural golf tournament on November Houstonians to raise or donate $100 17 at Champions Golf Course, and we by the end of the fundraising season, are always out in the community through on December 1st. $100 can provide events with community our partners, crucial services to at-risk men and such as North Cypress Medical Center’s women who need them most. These Project Pink Luncheon on October 11, smaller donations can add up quickly, Define Body and Mind Studio Pink and truly make a difference in impacting Ride on October 11, Katy High School the incidences and prevalence of breast Color Guard Spin-a-thon on October 12 cancer in Houston and the surrounding and Houston Rocket’s Go Pink Night seven-county area. With $100, a Komen vs. San Antonio Spurs on October 24. Houston grantee can provide a range of Additional community partnerships services to uninsured or underinsured include Texas Security Shredding’s patients, from a preliminary doctor’s Shred for Komen Program, DMarcos visit to support groups after treatment. Pizzeria in Sugarland, Panera Bread’s Our #RaceTo100 campaign Pink Ribbon Bagel and First Community challenges Houstonians to help us make Credit Union’s Pink on Parade with all an even bigger impact, and we hope of their Greater Houston Area branches people will join us in fundraising and going pink! For more information on helping to bring an end to breast cancer how to contribute to and participate in the fight to end breast cancer forever, visit www.komen-houston.org.
Legal Health
Continued from page 3
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as “high risk” test (“Class III” 1970s) would remain exempt from tests), or certain tests for blood marketing authorization requirements and blood products. and (potentially) manufacturing quality requirements. FDA’s goal is to Within five years, FDA will balance the potential benefits of FDA develop risk categories for oversight (greater assurance of test LDTs that do not have IVD safety, effectiveness, and quality) with equivalents (which are many) the potential drawbacks (greater hurdles/ and require labs to seek market costs in innovation, and more limited authorizations & comply test access). with manufacturing quality III. Congressional Response requirements for the remaining high risk tests. On September 9, 2014, Congress had Within nine years, FDA will require market ing authorizations and impose other IVD requirements on moderate risk (“Class II”) LDTs.
Under the proposal, exceptions to FDA regulation would, however, remain. Most notably, tests for rare diseases (tests used on fewer than 4,000 patients/year), unmet medical needs (an FDA-authorized IVD does not exist), and “traditional” LDT tests (the kind of old-technology LDTs that would have existed in the October 2014
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a hearing on FDA’s proposed regulatory framework. There was a consensus amongst stakeholders and Congress that more LDT regulation would be beneficial. But how to regulate, and who should regulate (FDA or CMS), were debated. Also, some Congresspersons expressed concerns that FDA’s process for developing the policy (development of a “guidance document” as opposed to a regulation) meant it would not evaluate the economic impact of the policy on the multi-billion dollar laboratory industry see Legal Health page 21
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Legal Health
Continued from page 20 and the healthcare system. Specific concerns about important details were also raised. For example, how would FDA handle off-label promotion? FDA requires that test manufacturers only “promote” a test for its FDA-authorized use to physicians and patients. The line between “promotion” and pure scientific communication about off-label uses (which may be allowed) can be fuzzy, and given that laboratories routinely work directly with physicians and patients (unlike traditional manufacturers) there could
be significant complexities to navigate. IV. Preparing for Greater LDT Regulation One thing seems clear from the proposed framework and Congressional hearing: some change is coming to LDT regulation. It is important for everyone to stay apprised of developments, and take part in the policy development process by submitting comments to Congress and FDA so everyone’s ideas are heard.
Mental Health
Continued from page 5 abuse have made it more difficult to get prescription pain pills, but unforeseen collateral damage has followed. I join many of my colleagues across the nation in witnessing a shocking trend: as laws have been passed to decrease the flow of prescription painkillers onto our streets, more people (especially the young) have turned to heroin as a cheap and readily accessible source of opioids.
this news appears promising. But as I pointed out in this Huffington Post blog (http://www.huffingtonpost.com/ jason-powers/stonerturneddoctor-seesd_b_5671819.html), marijuana is not benign. Decreases in overdose deaths are a good thing, but only time will tell if our net gain is positive or negative. Based on the alarming upward trends in prescription drug abuse, coupled with collateral damage that does not get enough media attention, we should be exploring more salubrious solutions. We have made progress in helping people with substance use disorders improve by:
For most people, avoiding the hell of withdrawal drive them to use heroin. It’s simply a decision based on utility. Their lives revolve around eluding opioid withdrawal symptoms, which are by far the most agonizing class of drugs from which to withdrawal. And heroin is by and large easier and cheaper to obtain. - Embracing prevention strategies None of our patients claim they wanted that increase the perception of harm this life. That is, no child aspires to which effectively decreases drug abuse become a heroin addict when they grow up, nor do most people decide to rob - Coordinating state drug pharmacists at gunpoint as recreation. monitoring programs that can both decrease diversion of prescription drugs Desperation can push good people as well as help to identify those who to do heinous things. This paradox is not need help exposed as a means to cast law-breakers - Training physicians and other as passive victims to environment or prescribers in effective comprehensive happenstance—I support consequences. behavioral modification and medication Instead, I’m simply trying to underscore applications the need for better prevention and treatment measures. As more of the Things are not bleak - we have reason middle and upper class youth get hooked to be optimistic. Progress thus far has on heroin, the more I see even staunch begun to provide the health care and law libertarians see the folly in punishing a enforcement sectors with broader, more disease instead of treating it. Treatment rapid access to information and given works. Period. them the tools to start identification, Perhaps the best example of education and prevention sooner. However, too many people still die unintended collateral damage can be found in marijuana legalization. each year from this preventable and Maybe you have read recent evidence treatable illness… and it doesn't look that in states where marijuana is like those numbers will slow down any legal, prescription opioid deaths have time soon. decreased? On the surface, of course, medicaltimesnews.com
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Houston Medical Times
Healthy Heart
HOUSTON
Continued from page 7 research shows that American adults are 76 percent more likely to take a walk if another person is counting on them. Going to www.MyWalkingClub. org is the perfect way to connect with others who share your goals, lifestyles, schedules and hobbies. Join an existing club, or start your own. It’s easy, free and it could be a big step toward improving your health. “I don’t know where to walk.” Available for iPhone and Android devices, the American Heart Association has developed real-time tools to help increase motivation. Users can search for walking paths using GPS technology, create walking paths, save favorite paths to use regularly, attach a photo to a path or share paths via social networks and email. You can find a Walking Path for practically anywhere you want to go! You can also keep track of your progress by logging walks into a tracking tool. “Not fast enough. Not far enough. Not for me.” A huge myth is that exercise is
stress useless unless it’s strenuous and leaves us exhausted. But one of the simplest ∙∙ Counters anxiety and depression types of physical activity — walking — is also one of the most beneficial. Just ∙∙ Helps you fall asleep faster and 30 minutes of brisk walking, at least sleep more soundly five days a week can lower your risks ∙∙ Reduces coronary heart disease for heart disease, stroke and diabetes. in women by 30-40 percent And research indicates that for each one hour of regular exercise you get, you'll We hope you join us for the Houston gain about two hours of additional life Heart & Stroke Walk to kick start a expectancy. lifetime of healthy activity, improve the Walking as little as 30 minutes a hearts of our community and celebrate the lives we impact daily. Tell us why you day: walk at www.facebook.com/ahahouston! ∙∙ Improves blood circulation Walkers can register at www. ∙∙ Keeps weight under control houstonhear t walk.org or call and helps in the battle to quit 713-610-5000. The success of the My smoking Heart. My Life. Houston Heart Walk is ∙∙ Improves blood cholesterol due in part to national and local sponsors. The Heart & Stroke Walk is sponsored levels nationally by SUBWAY® restaurants, ∙∙ Prevents and manages high and locally by Schlumberger. Heart & blood pressure Stroke Walk presenting sponsors are ∙∙ Prevents bone loss, boosts Memorial Hermann, Halliburton, FMC energy level and helps manage Technologies and Noble Energy. Visit www.houstonheartwalk.org for a full list of our sponsors.
The Framework The Pandemic Influenza Vaccine Facility and the adjacent Viral-based Vaccine Facility, which recently entered final design development, will form the cornerstone of the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM), one of three such national centers for innovation supported by the U.S. Department of Health and Human Services and the only one housed at an academic institution. “Texas A&M has a long and proud tradition of dedicated service to our nation,” Sharp said. “This facility, and the Texas A&M CIADM in which it is housed, builds upon that tradition and helps put Texas A&M at the forefront of translational research and development so that research discoveries will advance to the field faster to save lives.”
therapeutics, and the importance of reliable, U.S.-based vaccine development and manufacturing capabilities and expertise. After the President’s Council of Advisors on Science and Technology report on reengineering the influenza vaccine manufacturing enterprise and the U.S. Department of Health & Human Services’ medical countermeasures review, HHS’ Biomedical Advanced Research and Development Authority (BARDA) embarked on new approaches to bolster pandemic influenza preparedness and biodefense.
The Texas A&M Center for Innovation in Advanced Development and Manufacturing was founded on a $285 million public-private partnership between HHS, and collaborating academic, commercial, and State of Texas stakeholders. Key objectives include performing advanced research and development, ensuring domestic Disease outbreaks, such as the manufacturing capacity, enabling FDA H5N1 avian influenza, H1N1 influenza approval of products, and mentoring pandemic of 2009, and more recently the next generation of public health the Ebola outbreak in West Africa, professionals through education, training exposed the need for quick access to and outreach. “This center is important high-quality, life-saving vaccines and October 2014
Editor Sharon Pennington Director of Media Sales Richard W DeLaRosa Creative Director Lorenzo Morales Account Executives Christina Pastrana Jessica Frantz Distribution Director Angelo Rose Accounting Liz Thachar Office: 713-885-3808 Fax: 281-316-9403 For Advertising advertising@medicaltimesnews. com Editor editor@medicaltimesnews.com
Continued from page 9
to a safer and more prosperous future.”
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for our nation, but also evidences a new paradigm for how academic health science centers must transform health by forging novel partnerships with the federal government and leveraging the expertise of world-leading commercial partners, such as GSK” Giroir said. “Texas A&M Health Science Center will continue to pioneer new pathways forward – this is the only way that unmet medical needs, locally and globally, will be addressed, and access to quality care can be achieved for all.” With the Texas A&M CIADM’s advancement of the Pandemic Influenza Vaccine Facility and the Viral-based Vaccine Facility – along with the recent retrofit completion of the Texas A&M National Center for Therapeutics Manufacturing, which offers flexible and adaptable biopharmaceutical development and manufacturing capabilities – the center is on track to meet its mission of bolstering the nation’s preparedness and response to public health threats, whether in the form of a naturally occurring emerging infectious diseases or a biological terrorist attack.
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